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HUMAN RESOURCES

FOR MEDICAL DEVICES


The role of biomedical
engineers
WHO Medical device technical series
WHO MEDICAL DEVICE TECHNICAL SERIES: TO ENSURE IMPROVED ACCESS, QUALITY AND USE OF MEDICAL DEVICES

Global atlas of
medical devices

DEVELOPMENT
OF MEDICAL HUMAN RESOURCES
FOR MEDICAL DEVICES
DEVICE POLICIES, The role of biomedical

STRATEGIES AND 2017 engineers


WHO Medical device technical series

ACTION PLANS

Research
WHO MEDICAL DEVICE TECHNICAL SERIES

and development

*in development
2011 2017
Medical device
innovation
WHO Medical device tecHnical series
Management
Research and development
Medical devices

Regulation
Regulation

Assessment

Global Model Regulatory


Framework for Medical
Devices including in vitro
diagnostic medical devices
WHO Medical device technical series

ISBN 978 92 4 150140 8


Department of Essential Health Technologies
World Health Organization
20 Avenue Appia
CH-1211 Geneva 27
Switzerland
Tel: +41 22 791 21 11
E-mail: medicaldevices@who.int
http://www.who.int/medical_devices/en/

2017

Medical devices Management Assessment


*in development

Medical device NEEDS ASSESSMENT HEALTH TECHNOLOGY


noMenclature PROCESS ASSESSMENT OF
WHO Medical device tecHnical series WHO MEDICAL DEVICE TECHNICAL SERIES
MEDICAL DEVICES
WHO MEDICAL DEVICE TECHNICAL SERIES

Interagency list of priority medical


2011 2011
devices for essential interventions WHO list of priority
for reproductive, maternal, medical devices for
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Prostate

WHO MEDICAL DEVICE TECHNICAL SERIES

2016 2017

2011 2011
*in development

INTRODUCTION TO MEDICAL EQUIPMENT COMPUTERIZED Safe uSe of Decommissioning


MEDICAL EQUIPMENT MAINTENANCE MAINTENANCE medical deviceS meDical Devices
WHO Medical device tecHnical series
INVENTORY PROGRAMME MANAGEMENT WHO Medical device tecHnical series
MANAGEMENT OVERVIEW SYSTEM
WHO MEDICAL DEVICE TECHNICAL SERIES WHO MEDICAL DEVICE TECHNICAL SERIES WHO MEDICAL DEVICE TECHNICAL SERIES

2011 2011 2011


HUMAN RESOURCES
FOR MEDICAL DEVICES
The role of biomedical
engineers
WHO Medical device technical series
Human resources for medical devices, the role of biomedical engineers
(WHO Medical device technical series)

ISBN 978-92-4-156547-9

© World Health Organization 2017

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Contents

Preface.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Medical device technical series – methodology. . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Definitions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

Acknowledgements. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

Acronyms and abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

Executive summary.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

Biomedical engineers as human resources for health. . . . . . . . . . . . . . . . . . . . . . 20


Responsibilities and roles. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Biomedical engineering. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Global Strategy on Human Resources for Health: Workforce 2030. . . . . . . . . . . 27

1 Global dimensions of biomedical engineering. . . . . . . . . . . . . . . . . . . . . . . . . 30


1.1 Biomedical engineers – global data. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
1.2 Women in biomedical engineering. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
1.3 Biomedical engineering in international organizations . . . . . . . . . . . . . . . 37
Conclusion. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

2 Education and training. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39


2.1 Defining training and education . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
2.2 Core curriculum and elective specialization. . . . . . . . . . . . . . . . . . . . . . . . 39
2.2.1 Core curriculum. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
2.2.2 Elective specialization. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
2.3 Universities – global data. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
2.4 Education and training by region . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
2.4.1 Africa . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
2.4.2 Asia-Pacific. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
2.4.3 Australia and New Zealand. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
2.4.4 Europe. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
2.4.5 Latin America . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
2.4.6 North America (USA and Canada only). . . . . . . . . . . . . . . . . . . . . . . 50
2.5 International accreditation agreements.. . . . . . . . . . . . . . . . . . . . . . . . . . . 51
Washington Accord, 1989. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
Bologna Declaration, 1999. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
2.6 List of educational institutions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52

3 Professional associations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
3.1 Purpose of professional associations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
3.2 Global biomedical engineering associations . . . . . . . . . . . . . . . . . . . . . . . 55
3.2.1 International Union for Physical and Engineering Sciences
in Medicine. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
3.2.2 International Federation for Medical and Biological Engineering. . . . . 56

WHO Medical device technical series 1


3.2.3 Institute of Electrical and Electronics Engineers - Engineering in
Medicine and Biology Society . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
3.3 Professional biomedical associations – global data. . . . . . . . . . . . . . . . . . 56
3.4 Phases of institutional development of a profession. . . . . . . . . . . . . . . . . 59
3.4.1 Institutional maturity of biomedical engineering . . . . . . . . . . . . . . . . 59

4 Certification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
4.1 Defining certification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
4.2 International certification of biomedical engineers . . . . . . . . . . . . . . . . . . 63
4.3 Certification by region . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
4.3.1 Certification in Africa . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
4.3.2 Certification in the Americas . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
4.3.3 Certification in Asia . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
4.3.4 Certification in Europe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68

5 Development of medical devices policy. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73


5.1 Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
5.2 International organizations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
5.2.1 United Nations Population Fund. . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
5.2.2 United Nations Office for Project Services. . . . . . . . . . . . . . . . . . . . . 74
5.2.3 United Nations Children’s Fund. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74
5.2.4 World Health Organization. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76
5.3 National organizations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
5.4 World Health Organization – medical devices. . . . . . . . . . . . . . . . . . . . . . 78
5.5 Conclusion. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78

6 Medical device research and innovation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80


6.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80
6.2 The field of medical device innovation. . . . . . . . . . . . . . . . . . . . . . . . . . . . 82
6.3 Innovation competencies. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82
6.4 Skills requirements. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83
6.5 Innovation and teams. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84
6.6 The innovation process and its increasing scope. . . . . . . . . . . . . . . . . . . 84
6.7 Medical device innovation for low-resource settings . . . . . . . . . . . . . . . . 85
6.8 Conclusion. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87

7 Role of biomedical engineers in the regulation of medical devices . . . . . . 89


7.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89
7.2 Need for biomedical engineers in regulatory affairs. . . . . . . . . . . . . . . . . 89
7.3 Medical devices regulation – scope and function in different countries.. 91
7.4 Professionals in the field of medical devices regulation. . . . . . . . . . . . . . 91
7.5 Biomedical engineers as regulatory specialists in industry.. . . . . . . . . . . 92
7.6 Professional functions fulfilled by biomedical engineers in the
regulatory domain. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93
7.6.1 New product planning.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93
7.6.2 Research and development. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93
7.6.3 Clinical research. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93
7.6.4 Quality management systems and manufacturing operations . . . . . 94
7.6.5 Marketing and sales. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94
7.6.6 Technical writing. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95
7.6.7 Health economics and health technology assessment. . . . . . . . . . . 95
7.6.8 Standards and standardization bodies. . . . . . . . . . . . . . . . . . . . . . . . 95

2 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers


7.7 Industry and government affairs. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95
7.8 Education and experience of industry regulatory affairs
professionals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95
7.9 Conclusion. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96

8 Role of biomedical engineers in the assessment of medical devices. . . . . 99


8.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99
8.1.1 From performance to use in health care . . . . . . . . . . . . . . . . . . . . . 101
8.2 Methods of health technology assessment. . . . . . . . . . . . . . . . . . . . . . . . 102
8.3 Different disciplines in health technology assessment. . . . . . . . . . . . . . 103
8.4 Core competencies required for health technology assessment. . . . . . 103
8.4.1 Interdisciplinary teams. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103
8.5 Survey of biomedical engineers involved in health technology
assessment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105
8.6 The developing role of biomedical engineers. . . . . . . . . . . . . . . . . . . . . . 107
8.7 Professional societies and international collaboration in health
technology assessment.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 108
8.7.1 Health Technology Assessment international. . . . . . . . . . . . . . . . . . 108
8.7.2 International Network of Agencies in HTA. . . . . . . . . . . . . . . . . . . . 109
8.7.3 EuroScan International Network. . . . . . . . . . . . . . . . . . . . . . . . . . . . 109
8.7.4 HTAsiaLink. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109
8.7.5 La Red de Evaluación de Tecnologías Sanitarias de las Américas . 110
8.7.6 European Network for HTA. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 110
8.7.7 Eastern Mediterranean Regional Network in HTA.. . . . . . . . . . . . . 110
8.7.8 Health Care Technology Assessment Division (IFMBE). . . . . . . . . . 110
8.8 Conclusion. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111

9 Role of biomedical engineers in the management of medical devices. . . 113


9.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113
9.2 Biomedical engineering activities through the life cycle of devices
and systems. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114
9.2.1 Health technology assessment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 116
9.2.2 Procurement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 116
9.2.3 Health risk management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 116
9.2.4 Health information technology. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 116
9.2.5 Health technology management. . . . . . . . . . . . . . . . . . . . . . . . . . . . 117
9.2.6 Education and user training. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 118
9.2.7 Ethics committee.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 118
9.3 Organizational models of biomedical engineering services . . . . . . . . . . 118
9.3.1 In-house personnel model. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 118
9.3.2 Mixed model. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119
9.3.3 Third-party multi-vendor service model. . . . . . . . . . . . . . . . . . . . . . 119
9.3.4 Biomedical engineering departmental structures within hospitals.. . 120
9.3.5 Key roles in a biomedical engineering department . . . . . . . . . . . . . 121
9.4 Biomedical engineering around the world. . . . . . . . . . . . . . . . . . . . . . . . 121
9.4.1 Global survey of biomedical engineering. . . . . . . . . . . . . . . . . . . . . . 123
9.5 Conclusion. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 125

10 Role of biomedical engineers in the evolution of health-care systems . . . . 127


10.1 Biomedical engineering for 21st-century health-care systems . . . . . . . 127
10.2 Revolutions impacting biomedical engineering. . . . . . . . . . . . . . . . . . . . 127

WHO Medical device technical series 3


10.3 Other contextual factors driving change in health-care systems. . . . . . 129
10.4 Biomedical engineers work in many sectors. . . . . . . . . . . . . . . . . . . . . . 129
10.4.1 Evolution in biomedical engineering career paths. . . . . . . . . . . . . . 131
10.5 Evolution of modern medical devices. . . . . . . . . . . . . . . . . . . . . . . . . . . . 131
10.5.1 Telehealth and telemedicine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 131
10.5.2 More sophisticated organizational and IT requirements. . . . . . . . . 132
10.6 Mission critical: Systems engineering and systems of systems
engineering . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 132
10.7 Elements of an ideal, integrated health and information technology
system. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133
10.8 Establishing a comprehensive biomedical engineering value
proposition. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 134
10.9 Build competencies in strategic, clinical and operational domains. . . . 136
10.10 Dimensions of career development in biomedical engineering. . . . . . . 138
10.10.1 A biomedical engineer’s career anchor considerations. . . . . . . . . 138
10.10.2 Biomedical engineering career stages. . . . . . . . . . . . . . . . . . . . . . 138
10.10.3 Key emerging biomedical engineering competency opportunities . 139
10.11 Training topics. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 140
10.12 Conclusion. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 141
10.13 Further reading. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 141

11 Conclusions and recommendations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 144


11.1 Future role of biomedical engineers in low- and middle-income
countries. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 145
11.2 Reclassification of biomedical engineers and technicians. . . . . . . . . . . 146
11.3 Final statement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 147

Annex 1 Biomedical engineers by country and relevant demographic


indicators. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 149

Annex 2 Educational institutions with biomedical engineering programmes.. . 154

Annex 3 National and international professional biomedical engineering


associations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 207

Annex 4 Survey respondents. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 212

Annex 5 Global Strategy on Human Resources for Health: Workforce 2030 –


summary.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 213

Annex 6 UN High-Level Commission on Health Employment and


Economic Growth. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 216

Annex 7 Current and proposed profiles for ILO for biomedical engineers and
biomedical engineering technicians. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 218

Annex 8 Declaration of interests. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 220

References.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 222

4 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers


Preface

Health technologies are essential for a fully functioning health system. Medical devices,
in particular, are crucial in the prevention, diagnosis, treatment and palliative care of
illness and disease, as well as patient rehabilitation. Recognizing this important role of
health technologies, the World Health Assembly adopted resolution WHA60.29 in May
2007. The resolution covers issues arising from the inappropriate deployment and use of
health technologies, and the need to establish priorities in the selection and management
of health technologies, specifically medical devices.

This publication has been produced in accordance with the request to the World Health
Organization (WHO) by Member States in the WHA60.29.(1) The resolution:

1. URGES Member States:


“(1) to collect, verify, update and exchange information on health technologies, in
particular medical devices, as an aid to their prioritization of needs and allocation of
resources;

(2) to formulate as appropriate national strategies and plans for the establishment
of systems for the assessment, planning, procurement and management of health
technologies, in particular medical devices, in collaboration with personnel involved in
health-technology assessment and biomedical engineering…”

2. REQUESTS the Director General:


“to work with interested Member States and WHO collaborating centres on the
development, in a transparent and evidence-based way, of guidelines and tools,
including norms, standards and a standardized glossary of definitions relating to health
technologies in particular medical devices”(2)

By adopting this resolution, delegations from Member States acknowledged the


importance of health technologies for achieving health-related development goals, urging
expansion of expertise in the field of health technologies, in particular medical devices,
and requesting that WHO take specific actions to support Member States.

One of WHO’s strategic objectives is to “ensure improved access, quality and use
of medical products and technologies.” To meet this objective, WHO and partners
have been working towards devising an agenda, an action plan, tools and guidelines
to increase access to good quality, appropriate medical devices. The Medical device
technical series developed by WHO already includes the following publications:
• Development of medical devices policies(3)
• Health technology assessment for medical devices(4)
• Health technology management
›› Needs assessment process of medical devices(5)
›› Procurement process, resource guide(6)
›› Medical devices donations, considerations for solicitation and provision(7)
›› Introduction to medical equipment inventory management(8)
›› Medical equipment maintenance overview(9)
›› Computerized maintenance management systems(10)

WHO Medical device technical series 5


• Priority medical devices
›› Interagency list of priority medical devices for essential interventions on
reproductive, maternal, new born and child health(11)
›› Protective equipment for Ebola(12)

And will include, in 2017, the following publications, which are under development:
• Human resources for medical devices (the present document)
• Model regulatory framework for medical devices
• Priority medical devices for cancer management

These documents are intended for use by policy-makers at ministries of health,


biomedical engineers, health managers, donors, nongovernmental organizations and
academic institutions involved in health technology at the district, national, regional and
global levels.

Medical device technical series – methodology

The first documents in the Medical device technical series were written by international
experts in their respective fields, and reviewed by members of the Technical Advisory
Group on Health Technology (TAGHT). The TAGHT was established in 2009 to provide
a forum for both experienced professionals and country representatives to develop
and implement the appropriate tools and documents to meet the objectives of the
Global Initiative on Health Technologies (GIHT). The group met on three occasions.
The first meeting was held in Geneva in April 2009 to prioritize which tools and topics
most required updating or developing. A second meeting was held in Rio de Janeiro in
November 2009 to share progress on the health technology management tools under
development since April 2009, to review the current challenges and strategies facing the
pilot countries, and to hold an interactive session for the group to present proposals for
new tools, based on information gathered from the earlier presentations and discussions.

The last meeting was held in Cairo in June 2010 to finalize the documents and to help
countries develop action plans for their implementation. In addition to these meetings,
experts and advisers have collaborated through an online community to provide
feedback on the development of the documents. The concepts addressed in the Medical
device technical series were discussed further during the First Global Forum on Medical
Devices in September 2010. Stakeholders from 106 countries made recommendations
on how to implement the information covered in this series of documents at the country
level.(13) These extensive discussions formed the background for the current book in
the series: Human resources for medical devices.

For the development of the current book the following activities took place:

1. Global BME surveys, the outcomes of which are highlighted in this book and results
presented in the WHO medical devices website and in the WHO Global Health
Observatory.(14)

In 2009, WHO launched “Biomedical engineering global resources,”(15) a WHO


programme to gather information on academic programmes, professional societies and
the status of BME worldwide.

6 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers


Figure 1 WHO Medical device technical series
WHO MEDICAL DEVICE TECHNICAL SERIES: TO ENSURE IMPROVED ACCESS, QUALITY AND USE OF MEDICAL DEVICES

Global atlas of
medical devices

DEVELOPMENT
OF MEDICAL HUMAN RESOURCES
FOR MEDICAL DEVICES
DEVICE POLICIES, The role of biomedical

STRATEGIES AND 2017 engineers


WHO Medical device technical series

ACTION PLANS

Research
WHO MEDICAL DEVICE TECHNICAL SERIES

and development

*in development
2011 2017
Medical device
innovation
WHO Medical device tecHnical series
Management
Research and development
Medical devices

Regulation
Regulation

Assessment

Global Model Regulatory


Framework for Medical
Devices including in vitro
diagnostic medical devices
WHO Medical device technical series

ISBN 978 92 4 150140 8


Department of Essential Health Technologies
World Health Organization
20 Avenue Appia
CH-1211 Geneva 27
Switzerland
Tel: +41 22 791 21 11
E-mail: medicaldevices@who.int
http://www.who.int/medical_devices/en/

2017

Medical devices Management Assessment


*in development

Medical device NEEDS ASSESSMENT HEALTH TECHNOLOGY


noMenclature PROCESS ASSESSMENT OF
WHO Medical device tecHnical series WHO MEDICAL DEVICE TECHNICAL SERIES
MEDICAL DEVICES
WHO MEDICAL DEVICE TECHNICAL SERIES

Interagency list of priority medical


2011 2011
devices for essential interventions WHO list of priority
for reproductive, maternal, medical devices for
newborn and child health cancer management
B
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PROCUREMENT
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MEDICAL DEVICE
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PROCESS DONATIONS:
Co
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RESOURCE GUIDE
Le u

CONSIDERATIONS FOR
kem
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WHO MEDICAL DEVICE TECHNICAL SERIES


SOLICITATION AND
ung

PROVISION
Prostate

WHO MEDICAL DEVICE TECHNICAL SERIES

2016 2017

2011 2011
*in development

INTRODUCTION TO MEDICAL EQUIPMENT COMPUTERIZED Safe uSe of Decommissioning


MEDICAL EQUIPMENT MAINTENANCE MAINTENANCE medical deviceS meDical Devices
WHO Medical device tecHnical series
INVENTORY PROGRAMME MANAGEMENT WHO Medical device tecHnical series
MANAGEMENT OVERVIEW SYSTEM
WHO MEDICAL DEVICE TECHNICAL SERIES WHO MEDICAL DEVICE TECHNICAL SERIES WHO MEDICAL DEVICE TECHNICAL SERIES

2011 2011 2011

WHO Medical device technical series 7


Since the programme began, WHO has collected and compiled data in five stages with
different institutions, colleagues and tools, all coordinated by Adriana Velazquez from
WHO. Table 1 outlines the details for each stage.

Table 1 WHO surveys on biomedical engineering availability

Year Lead Methodology Outcome


2009 S Calil (University of Campinas) Conducted active search for First global database of BME
universities and professional resources (http://who.ceb.
societies unicamp.br/)
2013 Survey developed by D Desai Developed survey with IT tool Updated global database of BME
(Boston University) with support that was sent to WHO BME resources (http://apps.who.int/
from J Barragan (WHO), S contacts medical_devices/edu/)
Mullally (WHO) and N Jimenez
(WHO)
2014 C Long (WHO) and R Magjarevic Developed survey with Information on biomedical
(IFMBE) LimeSurvey tool to collect the engineer density (http://
specific number of biomedical hqsudevlin.who.int:8086/data/
engineers per country and node.main.HRMDBIO?lang=en)
integrate it with information
from the IFMBE database of
national societies
2015 D Rodriguez (WHO), M Smith Developed survey with WHO Organization of data from 85
(WHO) and R Martinez (WHO) DataForm tool. Collected data countries
were integrated with data
from the 2009, 2013 and 2014
investigations
2016 D Rodriguez (WHO), C Soyars Compiled information from all Annex 1,2 and 3 of this
(WHO) and R Martinez (WHO) stages of data collection publication

To collect the information, an electronic survey was tailored for each of the four stages of
the project. Surveys were distributed through a network of over 3200 BME professionals
using the WHO medical devices Listserv tool.(16) Survey participants were encouraged
to resend the survey to other key informants with the intention of collecting a greater
amount of current global information.

The surveys were consistently structured into three sections: (1) country profile;
(2) educational institutions; and (3) professional societies. An additional section (4)
was added to the 2015 version targeting international organizations and including
questions regarding female presence within the profession. The survey was designed
so respondents only completed the section for which they held information, ensuring
that information was supplied by national health authorities or similar for section 1,
BME academics for section 2, professional societies secretariats for section 3 and
international organization focal points for section 4. For the data analysis, 140 fully
completed survey forms were retrieved from the data collection tool (WHO DataForm).
(17) Additional information was collected from IFMBE reports, other BME professional
organizations and web-based inquiries.

The collected data are available at the WHO medical devices site: http://www.who.int/
medical_devices/support/en/ and the density of biomedical engineers is available on
WHO Global Health Observatory (GHO) as a new indicator of global health: http://apps.

8 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers


who.int/gho/data/node.imr.HRH_40?lang=en and further information can be found at:
http://apps.who.int/gho/data/node.main.504?lang=en.

WHO intends to collect data annually and expects to retrieve data from unreported
countries, validate reported data, maintain accurate estimates and record global trends
in BME.

2. Professionals of different branches of biomedical engineering (BME) were invited


by WHO in 2013 to become chapter coordinators. The chapter coordinators
wrote sections and organized the input of 40 collaborators from around the world
who contributed their expertise on design, development, regulation, assessment,
management and safe use of medical devices.

3. The Second Global Forum on Medical Devices, held in November 2013, included
a session focused specifically on human resources for medical devices and the
required survey methodology addressing the role of the biomedical engineer.(18)
The forum had diverse country representation, with a total of 572 participants
representing 103 countries.

4. Formal discussions about the role of BME in Hangzhou, China, at a global BME
summit on 23 October 2015, following the First International Clinical Engineering
and Health Technology Management Congress, which was sponsored by the
Chinese Society of Biomedical Engineering. The congress was organized by a
leadership panel of 25 representatives of national and international organizations
related to BME. The group produced a document that lays out the scope of
professional activities of biomedical engineers and provides a rationale and evidence
for the recognition and proper classification of BME.(19)

5. Review of whole text by international experts on biomedical engineering.

Scope

WHO invited global collaboration of biomedical engineering professionals to support


the development of the present publication in order to describe the different roles of
biomedical engineers as specialized human resources on medical devices, in order to
support their classification in Member States as well as labour and other organizations.

It should be noted that there are many professionals who use medical devices, for
example radiographers, sonographers, laboratory technicians, surgeons, anaesthetists,
ophthalmologists, orthopaedists, neurologists, radiologists, radiotherapists, pathologists,
nurses, and almost all health-care workers. And, there are others who manage their
supply, such as procurement and logistics officers, others that evaluate them as health
economists, others that support the design and manufacture, including engineers,
industrial designers, chemists, physicists, etc.

This publication addresses only the role of the biomedical engineer in the development,
regulation, management, training and use of medical devices in general, and it should

WHO Medical device technical series 9


be noted that this happens with interdisciplinary collaboration according to rules and
regulations in every country.

Definitions

Recognizing that there are multiple interpretations for the terms listed below, they
are defined as follows for the purposes of this publication of the WHO Medical device
technical series.

“Biomedical engineering” includes equivalent or similar disciplines, whose names might


be different, such as medical engineering, electromedicine, bioengineering, medical
and biological engineering and clinical engineering.

Health technology: The application of organized knowledge and skills in the form of
devices, medicines, vaccines, procedures and systems developed to solve a health
problem and improve quality of life.(20) It is used interchangeably with health-care
technology.

Medical device: An article, instrument, apparatus or machine that is used in the


prevention, diagnosis or treatment of illness or disease, or for detecting, measuring,
restoring, correcting or modifying the structure or function of the body for some health
purpose. Typically, the purpose of a medical device is not achieved by pharmacological,
immunological or metabolic means.(21) This category includes medical equipment,
implantables, single use devices, in vitro diagnostics and some assistive technologies.

Medical equipment: Used for the specific purposes of diagnosis and treatment of
disease or rehabilitation following disease or injury; it can be used either alone or in
combination with any accessory, consumable or other medical equipment. Medical
equipment excludes implantable, disposable or single-use medical devices. Medical
equipment is a capital asset and usually requires professional installation, calibration,
maintenance, user training and decommissioning, which are activities usually managed
by clinical engineers.(22)

Health technology assessment (HTA): The term refers to the systematic evaluation of
properties, effects and/or impacts of health technology. It is a multidisciplinary process to
evaluate the social, economic, organizational and ethical issues of a health intervention
or health technology. The main purpose of conducting an assessment is to inform a
policy decision-making process.(23)

Biomedical engineering (BME): Medical and BME integrates physical, mathematical


and life sciences with engineering principles for the study of biology, medicine and
health systems and for the application of technology to improve health and quality of
life. It creates knowledge from molecular to organ systems levels, develops materials,
devices, systems, information approaches, technology management and methods for
assessment and evaluation of technology, for the prevention, diagnosis and treatment
of disease, for health-care delivery and for patient care and rehabilitation.(24)

10 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers


Among the sub-specialities of biomedical engineering, or engineering and technology
related professions, are the following:

Clinical engineer: In some countries, this defines the biomedical engineer that works in
clinical settings. The American College of Clinical Engineering defines a clinical engineer
as, “a professional who supports and advances patient care by applying engineering and
managerial skills to health care technology”.(25) The Association for the Advancement
of Medical Instrumentation describes a clinical engineer as, “a professional who brings
to health-care facilities a level of education, experience, and accomplishment which will
enable him to responsibly, effectively, and safely manage and interface with medical
devices, instruments, and systems and the user thereof during patient care…”.(26)

Biomedical engineering technician/technologist (BMET): Front-line practitioners


dedicated to the daily maintenance and repair of medical equipment in hospitals,
meeting a specified minimum level of expertise. BMETs who work exclusively on complex
laboratory and radiological equipment may become certified in their specialism, without
needing to meet the more general professional engineering requirements. The difference
between a technician and a technologist relates to the level and number of years of
training. Normally technicians train for two years, technologists for three years, but this
can differ per country.

Rehabilitation engineers: Those who design, develop and apply assistive devices and
technologies are those whose primary purpose is to maintain or improve an individual’s
functioning and independence to facilitate participation and to enhance overall well-
being.(27)

Biomechanical engineers: Biomechanical engineers apply engineering principles


to further the understanding of the structure of the human body, the skeleton and
surrounding muscles, the function and engineering properties of the organs of the body,
and use the knowledge gained to develop and apply technologies such as implantable
prostheses and artificial organs to aid in the treatment of the injured or diseased patient
to allow them to enjoy a better quality of life.

Bioinstrumentation engineers: Bioinstrumentation engineers specialize in the detection,


collection, processing and measurement of many physiological parameters of the
human body, from simpler parameters like e.g. temperature measurement and heart
rate measurement to the more complex such as quantification of cardiac output from
the heart, detection of the depth of anaesthesia in the unconscious patient and neural
activity within the brain and central nervous system. They have been responsible for
the development and introduction of modern imaging technologies such as ultrasound
and magnetic resonance imaging (MRI).

In order to raise awareness on the importance of biomedical engineers within health


systems worldwide, WHO is producing the present publication, in conjunction with a
global BME survey. WHO, along with international professional organizations, such as
IFMBE, is also advancing a proposal to update the ILO classification,(28) requesting a
specific classification for biomedical engineers as a distinct professional category.

WHO Medical device technical series 11


Acknowledgements

The publication Human resources for medical devices: The role of biomedical engineers
was developed under the coordination of Adriana Velazquez Berumen, WHO Senior Advisor
and Focal Point on Medical Devices, with the supervision of Gilles Forte and Suzanne Hill in
the WHO Essential Medicines and Health Products Department, and from James Campbell
and Giorgio Cometto, in the Health Workforce Department under the Health Systems and
Innovation Cluster of the World Health Organization.

Each chapter of the book was authored by an expert in the field, along with contributions
from collaborators from different regions of the world and diverse sectors of the BME field
during 2014 and 2015.

The BME 2015 survey was developed in January 2015 by Daniela Rodriguez-Rodriguez
and Megan Smith. The first results were presented in the World Congress on Biomedical
Engineering and Medical Physics in Toronto, June 2015, and are included in this publication.

The first draft of this book was edited in 2015, for discussion at the First International Clinical
Engineering and Health Technology Management Congress in China.(29)

The International Federation of Medical and Biological Engineering (IFMBE, an NGO


in official relations with WHO, chaired by James Goh, Singapore) generously supported
the development of this publication, including technical editing and graphic design, and
appointed Fred Hosea to support the compilation of the chapters, conducting teleconferences
with the authors and collaborators.

Data analytics and editorial reviews were done by Daniela Rodriguez-Rodriguez,


Ileana Freige and Ricardo Martinez. Final integration of edits was done by Anna Worm and
Adriana Velazquez.

WHO is grateful to the following chapter coordinators for their contributions of content,
editorial advice, and for managing the input from contributors from around the world; and
to the chapter contributors for their expert research and information submitted.

Biomedical engineers as human resources for health


Chapter coordinator: Adriana Velazquez
Chapter contributors: Michael Flood, Australia, Fred Hosea, Ecuador; Anna Worm, Benin.

1 Global dimensions of biomedical engineering


Chapter coordinator: Adriana Velazquez Berumen, WHO.
Chapter contributors: Michael Flood, Australia; Daniela Rodriguez-Rodriguez, Mexico;
Ratko Magjarevic, Croatia; Megan Smith, Canada.

2 Education and training


Chapter coordinator: Herbert F Voigt, United States of America.
Chapter contributors: Fred Hosea, Ecuador; Kenneth I Nkuma-Udah, Nigeria;
Nicolas Pallikarakis, Greece; Kang Ping Lin, China; Mario Secca, Mozambique;
Martha Zequera, Colombia.

12 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers


3 Professional associations
Chapter coordinator: Yadin David, United States of America.
Chapter contributors: Stefano Bergamasco, Italy; Joseph D Bronzino, United States
of America; Saide Calil, Brazil; Steve Campbell, United States of America; Tom Judd,
United States of America; Niranjan Khambete, India; Kenneth I Nkuma-Udah, Nigeria;
Paolo Lago, Italy; Consuelo Varela Corona, Cuba; Herb Voigt, United States of America;
Zheng Kun, China; Zhou Dan, China.

4 Certification
Chapter coordinator: Mario Medvedec, Croatia.
Chapter contributor: James O Wear, United States of America; Anthony Chan, Canada.

5 Development of medical devices policy


Chapter coordinator: Adriana Velazquez Berumen, WHO.

6 Medical device research and innovation


Chapter coordinator: Mladen Poluta, South Africa.
Chapter contributors: David Kelso, United States of America; Einstein Albert Kesi, India;
Victor Konde, South Africa; Paul LeBarre, Denmark; Amir Sabet Sarvestani, United
States of America.

7 Role of biomedical engineers in the regulation of medical devices


Chapter coordinator: Saleh Al Tayyar, Saudi Arabia.
Chapter contributor: Michael Gropp, United States of America. Josephina Hansen, WHO.

8 Role of biomedical engineers in the assessment of medical devices


Chapter coordinator: Reiner Banken, Canada.
Chapter contributors: Karin Diaconu, Bulgaria; Erin Holmes, United States of America;
Debjani Mueller, South Africa; Leandro Pecchia, Italy.

9 Role of biomedical engineers in the management of medical devices


Chapter coordinators: Corrado Gemma, Italy; Paolo Lago, Italy.
Chapter contributors: Firas Abu-Dalou, Jordan; Roberto Ayala, Mexico; Stefano
Bergamasco, Italy; Valerio Di Virgilio, Panama; Tom Judd, United States of America;
Niranjan Khambete, India; Sitwala Machobani, Zambia; Mario Medvedec, Croatia;
Shauna Mullally, Canada; Valentino Mvanga, United Republic of Tanzania; Ebrima
Nyassi, Gambia; Ledina Picari, Albania; Adriana Velazquez Berumen, WHO.

10 Role of biomedical engineers in the evolution of health-care systems


Chapter coordinator: Elliot Sloane, United States of America.
Chapter contributor: Fred Hosea, Ecuador.

WHO Medical device technical series 13


Acronyms and abbreviations

AAMI Association for the Advancement of Medical Instrumentation


ABEC African Biomedical Engineering Consortium
ABET Accreditation Board for Engineering and Technology
ACCE American College of Clinical Engineering
ACPSEM Australasian College of Physical Scientists and Engineers in Medicine
AEMB Alpha Eta Mu Beta
AFR African Region (WHO)
AFPTS Association Francophone des Professionnels des Technologies de Santé
AHF Asian Hospital Federation
AHT assistive health technology
AIIC Associazione italiana ingegneri clinici (Italy)
AIMBE American Institute for Medical and Biological Engineering
AMR Region of the Americas (WHO)
ANS affiliated national society
ANVISA Agência Nacional de Vigilância Sanitária (Brazil)
BME biomedical engineering
BMES Biomedical Engineering Society
BMET biomedical engineering technician
CAHTMA Commission for the Advancement in Healthcare Technology Management in Asia
CBET certified biomedical equipment technician
CCE certified clinical engineer
CE clinical engineer
CED Clinical Engineering Division (IFMBE)
CEO chief executive officer
CET certified electronics technician/certified engineering technologist
CFO chief financial officer
CIO chief information officer
CIS cardiology information system
CLES clinical laboratory equipment specialist
ComHEEG High-Level Commission on Health Employment and Economic Growth
CORAL Consejo Regional de Ingeniería Biomédica para América Latina
CPD continuing professional development
CQI continuous quality improvement
CRES certified radiological equipment specialist
CSE clinical systems engineer
CTO chief technology officer
DBE Directorate of Biomedical Engineering (Jordan)
EAMBES European Alliance for Medical and Biological Engineering and Science
ECA Economic Commission for Africa
ECG electrocardiogram
ECTS European Credit Transfer System
EESC European Economic and Social Committee
EHEA European Higher Education Area
HER Electronic health records
EMBS Engineering in Medicine and Biology Society
EMR Eastern Mediterranean Region (WHO)
ENA Eastern Neighbouring Area
ESEM European Society of Engineering and Medicine
EUnetHTA European Network for HTA
EUR European Region (WHO)
EWH Engineering World Health
FDA Food and Drug Administration (USA)
GHO Global Health Observatory (WHO)
GIHT Global Initiative on Health Technology
GHTF Global Health Task Force
GMP good manufacturing practice
HIC High income country
HIT health information technology

14 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers


HRM health risk management
HTA health technology assessment
HTAD Healthcare Technology Assessment Division (IFMBE)
HTAi Health Technology Assessment international
HTM Health Technology Management
HTCC Health Technology Certification Commission (ACCE)
HTTG Health Technology Task Group (IUPESM)
IAIE International Atomic Energy Agency
ICC Certification Commission for Clinical Engineering and Biomedical Technology
ICMCC International Council on Medical and Care Compunetics
ICSU International Council of Science
IEEE Institute of Electrical and Electronics Engineers
IFMBE International Federation for Medical and Biological Engineering
ILO International Labour Organization
IMDRF International Medical Device Regulators Forum
INAHTA International Network of Agencies for Health Technology Assessment
INCOSE International Council on Systems Engineering
IOMP International Organization for Medical Physicists
ISO International Standards Organization
IRB International Registration Board
ISCO International Standard Classification of Occupations
ITIL Information Technology Infrastructure Library
IUPESM International Union for Physical and Engineering Sciences in Medicine
LIC Low income country
LIS laboratory information system
LMIC low- and middle-income countries
MNCH maternal, newborn and child health
MRA mutual recognition agreement
MRI magnetic resonance imaging
NEA national examining authority
NGO nongovernmental organization
OEM original equipment manufacturer
PACS picture archiving and communication system
PAHO Pan American Health Organization
PET positron emission tomography
PPE personal protective equipment
PPM planned preventive maintenance
QA quality assurance
QMS quality management systems
R&D research and development
RAC Regulatory Affairs Certification
RAPS Regulatory Affairs Professionals Society
RCEC Registered Clinical Engineer Certification
RedETSA Red de Evaluación de Tecnologías Sanitarias de las Américas
RIS radiology information system
SDG Sustainable Development Goals
SEAR South-East Asia Region (WHO)
SoS systems of systems
SoSE systems of systems engineering
TAGHT Technical Advisory Group on Health Technology (WHO)
THET Tropical Health & Education Trust (UK)
TSBME Taiwan Society for Biomedical Engineering
UCT University of Cape Town
UHC universal health coverage
UNECA United Nations Economic Commission for Africa
UNFPA United Nations Population Fund
UNICEF United Nations Children’s Fund
UNOPS United Nations Office for Project Services
V&V verification and validation
WHO World Health Organization
WMDO World Medical Device Organization
WPR Western Pacific Region (WHO)

WHO Medical device technical series 15


JAM Jamaica
Country acronyms JOR Jordan
JPN Japan
AFG Afghanistan KEN Kenya
ALB Albania KGZ Kyrgyzstan
ARE United Arab Emirates KIR Kiribati
ARG Argentina KOR Republic of Korea
AUS Australia LAO Lao People's Democratic Republic
AUT Austria LBN Lebanon
BEL Belgium LBR Liberia
BEN Benin LKA Sri Lanka
BFA Burkina Faso LTU Lithuania
BGD Bangladesh LVA Latvia
BGR Bulgaria MDA Republic of Moldova
BHR Bahrain MEX Mexico
BIH Bosnia and Herzegovina MKD The former Yugoslav Republic of Macedonia
BLZ Belize MNE Montenegro
BOL Bolivia (Plurinational State of) MNG Mongolia
BRA Brazil MOZ Mozambique
BRB Barbados MYS Malaysia
BRU Brunei NAM Namibia
BTN Bhutan NGA Nigeria
CAN Canada NLD Netherlands
CHE Switzerland NOR Norway
CHL Chile NPL Nepal
CHN China NZL New Zealand
CIV Côte d'Ivoire PAK Pakistan
CMR Cameroon PAN Panama
COD Democratic Republic of the Congo PER Peru
COL Colombia PHL Philippines
CUB Cuba POL Poland
CYP Cyprus PRT Portugal
CZE Czech Republic PRY Paraguay
DEU Germany ROU Romania
DJI Djibouti RUS Russian Federation
DNK Denmark RWA Rwanda
DOM Dominican Republic SAU Saudi Arabia
DZA Algeria SDN Sudan
ECU Ecuador SEN Senegal
EGY Egypt SGP Singapore
ESP Spain SLE Sierra Leone
EST Estonia SLV El Salvador
ETH Ethiopia SRB Serbia
FIN Finland SUR Suriname
FRA France SVK Slovakia
FSM Micronesia (Federated States of) SVN Slovenia
GBR United Kingdom SWE Sweden
GEO Georgia SWZ Swaziland
GHA Ghana TCD Chad
GIN Guinea THA Thailand
GMB Gambia TLS Timor-Leste
GRC Greece TTO Trinidad and Tobago
GRD Grenada TUN Tunisia
GTM Guatemala TUR Turkey
GUY Guyana TZA United Republic of Tanzania
HND Honduras UGA Uganda
HRV Croatia UKR Ukraine
HTI Haiti URY Uruguay
HUN Hungary USA United States of America
IDN Indonesia VEN Venezuela (Bolivarian Republic of)
IND India VNM Viet Nam
IRL Ireland VUT Vanuatu
ISL Iceland YEM Yemen
ISR Israel ZAF South Africa
ITA Italy ZMB Zambia

16 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers


Executive summary

Continuous developments in science and technology are increasing the availability


of thousands of medical devices – all of which should be of good quality and used
appropriately to address global health challenges. It is recognized that medical devices
are becoming ever more indispensable in health-care provision and among the key
specialists responsible for their design, development, regulation, evaluation and training
in their use – are biomedical engineers.

In this book, part of the Medical device technical series, WHO presents the different
roles the biomedical engineer can have in the life cycle of a medical device, from
conception to use.

It is important to mention that for this publication, the concept “biomedical engineer”
includes medical engineers, clinical engineers and related fields as categorized in
different countries across the world and encompasses both university level training as
well as that of technicians.

Working together with other health-care workers, biomedical engineers are part of the
health workforce supporting the attainment of the Sustainable Development Goals,
especially universal health coverage.

This book has two parts. The first looks at the biomedical engineering profession
globally as part of the health workforce: global numbers and statistics, and professional
classification, general education and training, professional associations and the
certification process.

The second part addresses all the different roles that the biomedical engineer can have
in the life cycle of the technology, from research and development, and innovation,
mainly undertaken in academia; the regulation of devices entering the market; the
assessment or evaluation in selecting and prioritizing medical devices (usually at
national level); to the role they play in the management of devices from selection and
procurement, to safe use in health-care facilities.

Finally, the annexes present comprehensive information on academic programmes,


professional societies and relevant WHO and UN documents related to human resources
for health, as well as the reclassification proposal for ILO.

This publication can be used to encourage the availability, recognition and increased
participation of biomedical engineers as part of the health workforce, particularly
following the recent adoption of the recommendations of the UN High-Level Commission
on Health Employment and Economic Growth, the WHO Global Strategy on Human
Resources for Health, and the establishment of national health workforce accounts. The
document also supports the aim of reclassification of the role of the biomedical engineer
as a specific engineer that supports the development, access and use of medical
devices, within the national, regional and global occupation classification system.

WHO Medical device technical series 17


The biomedical engineer can play a crucial role in supporting the best and most
appropriate use of medical technologies to help in achieving universal health coverage
and the targets of the Sustainable Development Goals. Biomedical engineers can take
their share of responsibility and develop continuously better competencies to help
achieve these goals, so vital for those in most need in and with least resources.

18 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers


Credit: Clark Daniel, Medical Physics and Clinical Engineering, Nottingham University Hospitals NHS Trust, UK.
Biomedical engineers as human resources for
health
Biomedical engineering is one of the more recently recognized disciplines in the practice
of engineering. It is a field of practice which brings many, if not all of the classical fields
of engineering together to assist in developing a better understanding of the physiology
and structures of the human body, and to support the knowledge of clinical professionals
in prevention, diagnosis and treatment of disease and modifying or supplementing the
anatomy of the body with new devices and clinical services.

Biomedical engineering is considered as the profession responsible for innovation,


research and development, design, selection, management and safe use of all types
of medical devices, including single-use and reusable medical equipment, prosthetics,
implantable devices and bionics, among others.

A key objective of biomedical engineers is to have devices that are of good quality,
effective for the intended purpose, available, accessible and affordable. When these
objectives are met and devices are used safely, patients’ lives may be saved, quality of
life increased and there will be positive economic outcomes; the final goal is attainment
of better levels of care. The prerequisites for this to happen are health technology policies
in national health plans, available human and financial resources, and scientific and
technological advances that lead to usable knowledge and information. The interrelations
of these concepts are presented in Figure 2.

Figure 2 Medical devices process from policies to health outcomes

Input Process Device use Outcomes


Biomedical Health-care worker/
• Health technology policies engineering patient • Quality of life
• Human resources • Life saving
• Innovation • Quality
• Financial resources • Independence
• Research and • Safety and effectiveness
• Technology development development by industry • Economic development
industry • Affordability
and academia • Attainment of highest
• Knowledge and • Appropriateness level of health (WHO)
• Regulation by national
information authorities • Accessibility
• Assessment by national • Availability
or local committees • Acceptability
considering also equity,
ethics, feasibility
• Management by national
or local units: selection,
procurement, installation,
maintenance and safe use

20 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers


The practice of BME is not new. Indeed, the first known use of a functioning medical
prosthesis for a toe is traceable to the African continent; specifically, to Egypt. It could
be argued that Leonardo da Vinci (1442–1519) and many of the ancient philosophers
could be considered among the first biomedical engineers. Among his other interests, da
Vinci studied the anatomy of the human skeleton, the muscles and sinews of the body.

Figure 3 Da Vinci’s Vitruvian Man drawing (from around 1490) featured on a key reference book on medical
instrumentation

Responsibilities and roles

Biomedical engineering professionals are key players in developing and advancing the
usage of medical devices and clinical services. Depending on their training and sector
of employment, the responsibilities of biomedical engineering professionals can include
overseeing the research and development, design, safety and effectiveness of medical
devices/systems; selection and procurement, installation, integration with electronic
medical records systems, daily operations monitoring, managing maintenance and
repairs, training for safe use and upgrading of medical devices available to health-care
stakeholders. Biomedical engineering professionals are employed widely throughout
the health technology and health-care industries, in the research and development
(R&D) of new technologies, devices and treatment modalities, in delivery of health-care
in hospitals and other institutions, in academia, government institutions and in national
regulatory agencies.

WHO Medical device technical series 21


Research and development
When employed in research and development including both industry as academic
institutions, the role of the biomedical engineering professionals is typically one of
bringing together the specialist skills of the other engineering disciplines such as
mechanical, materials, signal processing and others, using their broad engineering
knowledge, coupled with their knowledge of medical practice, the human physiology
and body structures to ensure the end result of their collective work is a product that
is safe, effective and performs as intended for the benefit of the patient. As devices
become “smarter” through the inclusion of increasingly powerful hardware and software
capabilities, devices can take on increasingly comprehensive monitoring, alert and
control functions that define clinical best practices. This “smart device” revolution is
extending the domain of BME into wider and wider realms of creativity and professional
practice, extending health-care services far beyond the hospital.

Health-care providers
When biomedical engineering professionals are employed in health-care institutions,
their roles can include asset management, equipment selection, installation and
maintenance, planning of clinical areas for health-care delivery, support other health-
care professionals to define appropriate technologies for patient diagnostic, treatment
and rehabilitation as well as development of specialized instruments or devices for
research or treatment and customized, patient-specific devices.

Government
Many biomedical engineering professionals are also engaged by government such
as ministries of health, working on central or regional level health-care technology
management, or governmental organizations such as health technology assessment or
regulatory agencies, where their skills are applied to the evaluation for selection of public
procurement, reimbursement schemes or examination or testing of medical devices to
ensure those to be placed on the market are safe and in compliance with international
standards and regulatory requirements.

Industry
A part of the biomedical engineering professionals in industry work in R&D. Another
branch of activities is in sales and service, where biomedical engineering professionals
can play a role in assuring customers are supported in making choices and providing
after-sales service, like training, maintenance and repair.

22 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers


Figure 4. Roles of biomedical engineers

INNOVATIONS
• R&D
• Basic Sciences • Clinical trials
• Applied Sciences • Lobbying
• Standards • Manufacturing
• Legislation Biomaterials • Marketing, Sales
• Regulation Industry Clinical services • Third-party services
• Safety Prototyping
Devices
• Grants Startups
• Service programs Artificial organs
• Credentialling Patents R&D partnerships Support systems
• Accreditation
• Licensing Device design
• Safety-nets
Registration Academic education, • Tech assessment
• Public Health
R&D, Continuing Ed • Acquisition,
Licensing contracting
R&D Degrees
Certification Fellowships • Supply-chain mgt
Credentials • IT integration
Conferences
INSTITUTIONAL • Service strategy
FOUNDATIONS • Planning
Health-care • Project mgt
Government Biomedical and • Training
Providers
Clinical Systems • Tech management
Engineering • Risk management
• Quality and Safety

• Stewarship: Body of Knowledge OPERATIONS


• Stewarship: Body of Practice
Dynamic SYNTHESIS

Professional • Conferences • Leadership development • Educational standards, curricula


Societies • Training • Technical standards • Publications
• Credentialing criteria • Job families • Professional development

Source: Fred Hosea, 2016.

Biomedical engineering tasks and responsibilities defined


During the 2015 Global Clinical Engineering Summit (2015)(30) the following roles and
responsibilities were defined, as well as the subspecialisms of BME (shown in Table 1).

Applying knowledge of engineering and technology to health-care systems to optimize


and promote safer, higher quality, effective, affordable, accessible, appropriate, available,
and socially acceptable technology to populations served by:

1. Advancing health and wellness using technologies for prevention, diagnosis,


treatment, rehabilitation and palliative care across all levels of the health-care
delivery;

WHO Medical device technical series 23


2. Innovating, designing, developing, regulating, managing, assessing, installing, and
maintaining such technologies for their safe and cost effective use throughout their
life cycle;
3. Applying engineering principles and design concepts to medicine and biology for
the pursuit of new knowledge and understanding at all biological scales;

Table 1. Subspecialisms of BME

Research and development Rehabilitation Application and operation:


Biomechanics Artificial organs clinical engineering
Neural engineering Technology management
Biomaterials
Tissue engineering /regenerative Quality and regulatory
Bioinformatics
assurance
Systems biology Mechatronics
Education and training
Synthetic biology Assistive devices and software
Ethics committee, clinical trials
Bionics Prosthetics
Disaster preparedness
Biological engineering e-health (telemedicine,
Nanotechnology m-health)
Genomics Wearable sensors/products
Population health/data Health economics
analytics Health systems engineering
Epidemiology (computational) Health technology assessment/
Intellectual property/innovation evaluation
Theranostics Health informatics
Biosignals Service delivery management
Field service support
Security/privacy/cybersecurity
Forensic engineering/
investigation
Manufacturing QMS, GMP
Medical imaging
Project management
Robotics
Virtual environments
Risk management
EMI/EMC compliance
Technology Innovation
strategies
Population- and community-
based needs assessment
Engineering asset management
Environmental health
Systems science

24 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers


4. Designing devices, software, processes and techniques to be used in wellness and
health care, including consumables, artificial organs and prosthesis, diagnostic
and therapeutic instrumentation and related systems such as magnetic resonance
imaging, and devices for automating insulin injections or controlling body functions;
5. Designing, developing and managing technologies used to promote and support
life quality and longevity, including assistive technologies and technologies for
monitoring or rehabilitating activities of daily living; such as wheel chairs, prosthesis
leg, hearing aid and personal emergency response systems;
6. Designing, developing and managing technologies for focus areas such as
reproductive, maternal, neonatal, and child health;
7. Designing, developing and managing systems for optimal sustained health-care
operations in both resource-scarce and well resourced settings as well as during
challenging events such as disasters; and
8. Designing, developing and applying safety programme methodologies to mitigate
risks when dealing with medical devices and procedures throughout their life cycle.
Including biosafety and environmental health such as waste disposal and personal
radiation protection.

Health-care technologies include: health, wellness and rehabilitation products and


systems, artificial biological structures, organs, and prostheses, instrumentation,
software and multi-technology systems.

Biomedical engineering

Trained and qualified BME professionals are required within health-care systems
in order to design, evaluate, regulate, acquire, maintain, manage and train on safe
medical technologies. The BME profession, however, is often not included in the official
definitions of the health workforce or policy frameworks, and this absence significantly
impairs the advancement and sustainability of these health-care systems, even in
settings with available resources.

The International Labour Organization (ILO) manages the International Standard


Classification of Occupations (ISCO), which organizes the tasks and duties of jobs,
with the objective of having international reporting and statistical data of occupations
and serves to enhance national and regional classification of occupations. The current
system, ISCO-08, classifies BME professionals as a part of Unit Group 2149 “Engineering
Professionals not Elsewhere Classified.”(31) The classification of and statistics regarding
biomedical engineering professionals by the ILO are undergoing formal review as part
of the ILO’s 10-year cycle for classifying the world’s professions.

According to the current ISCO-08, from 2008, “biomedical engineering” professionals


are considered to be an integral part of the health workforce alongside those occupations
classified in Sub-major Group 22: Health Professionals. It is important to recognize that
although ISCO-08 has “noted” biomedical engineers as an integral part of the health
workforce, the profession has not yet been independently re-classified as a specialized

WHO Medical device technical series 25


type of engineering. Specialized classification has been requested in the past, but the
small number of countries with biomedical engineering professionals and the shortage
of professionals at that time made this impossible.

In the past, biomedical engineering professionals have worked “in the shadow” of more
recognized professions, such as doctors and nurses. This has been in part due to lack
of official research and dissemination of information about the presence and essential
value of biomedical engineering professionals worldwide. This gap in acknowledgement
and inclusion of BME within the health-care workforce, and the lack of current data
on the profession, both urgently need to be addressed, to ensure that the health-care
sector has the necessary mix of professionals to guide the dynamic changes in science,
technology and services in the 21st century.

In recent years, numbers have increased significantly, with documentation showing


biomedical engineering professionals in 126 out of 194 WHO Member States (64%),
and the scope and depth of BME expertise increasing with a growing presence of the
profession globally in health-care systems. In 2012, data from the United States Bureau
of Labor Statistics and other governmental agencies ranked BME as the second best
profession based on five criteria: physical demand, work environment, income, stress
and hiring prospects.(32)

Should ISCO re-classify biomedical engineering professionals along with other health-
care professions in 2018 or future years, more statistics and data will be available at the
country level, and formal recognition processes could be initiated by member countries
to recognize BME as a profession within their national or regional labour organizations
and ministries.

According to the International Federation of Medical and Biological Engineers (IFMBE)


— an NGO in official relations with WHO that represents professional and scientific
interests of 59 national member societies from around the world – BME is defined as
follows:

Medical and biological engineering integrates physical, mathematical and life


sciences with engineering principles for the study of biology, medicine and health
systems and for the application of technology to improving health and quality of
life. It creates knowledge from the molecular to organ systems levels, develops
materials, devices, systems, information approaches, technology management,
and methods for assessment and evaluation of technology, for the prevention,
diagnosis, and treatment of disease, for health care delivery and for patient care
and rehabilitation.(33)

In order to update these issues on the classification, statistics and recognition of


the BME profession, WHO began efforts to track the presence of BME professionals
and technicians worldwide. In 2009, WHO launched “Biomedical engineering global
resources,”(34) a WHO programme to gather information on academic programmes,
professional societies and the status of BME worldwide; the results of which are
presented in this publication.

26 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers


Global Strategy on Human Resources for Health: Workforce 2030

In May 2014, the Sixty-seventh World Health Assembly adopted resolution WHA67.24 on
Follow-up of the Recife Political Declaration on Human Resources for Health: renewed
commitments towards universal health coverage. In paragraph 4(2) of that resolution,
Member States requested the Director-General of WHO to develop and submit a new
global strategy for human resources for health (HRH) for consideration by the Sixty-
ninth World Health Assembly. A summary of the Global Strategy on Human Resources
for Health: Workforce 2030 can be found in Annex 5.(35)

The goal of the global strategy is: to improve health, social and economic development
outcomes by ensuring universal availability, accessibility, acceptability, coverage and
quality of the health workforce through adequate investments to strengthen health
systems, and the implementation of effective policies at national, a regional and global
levels.

The global strategy, includes all cadres involved in delivery of health services, as
described section 16 of the strategy:

16. "This is a cross-cutting agenda that represents the critical pathway to attain coverage
targets across all service delivery priorities. It affects not only the better known cadres of
midwives, nurses and physicians, but all health workers, from community to specialist
levels, including but not limited to: community-based and mid-level practitioners, dentists
and oral health professionals, hearing care and eye care workers, laboratory technicians,
biomedical engineers, pharmacists, physical therapists and chiropractors, public
health professionals and health managers, supply chain managers, and other allied
health professions and support workers. The Strategy recognizes that diversity in the
health workforce is an opportunity to be harnessed through strengthened collaborative
approaches to social accountability, inter-professional education and practice, and closer
integration of the health and social services workforces to improve long-term care for
ageing populations."

The global strategy requests the support of professional organizations to regulate the
workforce competency as described below:

36. "Professional councils to collaborate with governments to implement effective


regulations for improved workforce competency, quality and efficiency. Regulators
should assume the following key roles: keep a live register of the health workforce;
oversee accreditation of pre-service education programmes; implement mechanisms
to assure continuing competence, including accreditation of post-licensure education
providers; operate fair and transparent processes that support practitioner mobility and
simultaneously protect the public; and facilitate a range of conduct and competence
approaches that are proportionate to risk, and are efficient and effective to operate. (49)
Governments, professional councils and associations should work together to develop
appropriate task-sharing models and inter-professional collaboration, and ensure that
all cadres with a clinical role, beyond dentists, midwives, nurses, pharmacists and
physicians, also benefit in a systematic manner from accreditation and regulation
processes".

WHO Medical device technical series 27


The United Nations High-Level Commission on Health Employment and Economic
Growth was established in March 2016, to recommend the creation of 40 million
jobs in the health and social sector, particularly in low- and middle-income countries
(LMIC), for 2030. It made 10 recommendations to transform the health workforce for
the SDG era. These recommendations include job creation, gender and women’s rights,
education and training skills, health service delivery and organization, partnership and
collaboration, and data, information and accountability (further information can be
found in Annex 6). It is important to note the Commission already acknowledges the
role of technological advances related to medical devices in encouraging economic
development and supporting the health sector:

"The innovation and diversification pathway illustrates how some countries have invested
in their health sector specifically to promote economic growth. The health sector has
been driving technological innovations in many areas, including genetics, biochemistry,
engineering and information technology. Exports of pharmaceuticals, equipment and
medical services have also been an important driver of growth in many countries."
http://www.who.int/hrh/com-heeg/reports/en/

The commission’s recommendations are aligned with the SDGs. The specific target and
goals related to this publication on human resources for medical devices are:

SDG 3: Good health and well-being


Target 3.c: Substantially increase health financing and the recruitment, development,
training and retention of the health workforce in developing countries, especially in least
developed countries and small island developing States.

SDG 4: Quality education


Target 4.3: By 2030, ensure equal access for all women and men to affordable and
quality technical, vocation and tertiary education, including university.

Target 4.b: By 2020, substantially expand globally the number of scholarships available
to developing countries, in particular least developed countries, small island developing
States and African countries, for enrolment in higher education, including vocational
training and information and communications technology, technical, engineering and
scientific programmes, in developed countries.

28 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers


Credit: Adriana Velazquez; World Health Assembly, 2016.
PART I: THE INSTITUTIONAL FOUNDATIONS OF
BIOMEDICAL ENGINEERING

1 Global dimensions of biomedical


engineering

1.1 Biomedical engineers – baseline data that indicate the availability


global data of professional biomedical engineers by
country without specifying the distribution
This section presents a baseline by professional sector. Further studies
distribution of BME professionals globally, need to be conducted to retrieve this
based on data collected by government workforce information.
offices and ministries of health, the IFMBE
and other professional societies and Figure 1.1 illustrates the estimated
universities offering BME programmes. number of biomedical engineers per
The total number of biomedical engineers 10 000 population by country. As shown,
identified in 2015 was 117 935, distributed the lowest densities occur in low- and
in 129 countries. It is very important to lower middle-income countries, which
note that the 129 countries listed in this emphasizes the need for promotion of
present chapter, include many low- and educational programmes for biomedical
middle-income countries with a small but engineers in developing health systems.
emerging BME labour force due to only Additionally, the WHO African Region and
recent creation of in-country academic Eastern Mediterranean Region presented
programmes. This chapter presents the highest number of unreported

Figure 1.1 Density of biomedical engineers per 10 000 population globally (as at January 2016)

Source: Data was collected from three different sources: government offices and ministries of health (through surveys launched by WHO between 2010–2015); IFMBE; and
universities offering BME programmes.

30 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers


countries. Region-specific figures and These figures highlight the lack of BME
more detailed information by country are professionals especially in the African
described below. Region (AFR) and some countries of
the South-East Asia Region (SEAR).
The figures in the following section Compared with AFR and SEAR, the
describe the density of biomedical Region of the Americas (AMR) reported a
engineers per 10 000 population. higher density of biomedical engineers; for
Annex 1 includes a complete list instance, Mexico, Trinidad and Tobago, El
with all surveyed countries’ “absolute Salvador, Argentina, Chile, United States
numbers of biomedical engineers” and of America and Panama show a density
demographic indicators used to compute over 0.2 biomedical engineers per 10 000
the distribution shown in Figure 1.1. population or one per 50 000 people.
Tables 1.1–1.6 show the density of BME Nevertheless, distribution within AMR
professionals for each WHO Region. Zero varies greatly and some countries, such as
indicates that it was specifically reported Jamaica, Haiti, Honduras and Guatemala
that no biomedical engineer is available have a presence of BME professionals less
in the country. than 0.01 or one per million people.

Table 1.1 Biomedical engineering professionals per 10 000 population in the WHO African Region

BWA 0.23

GMB 0.09

ZAF 0.06

ZMB 0.03

CIV 0.02
NGA 0.02

SEN 0.02

ETH 0.02

BEN 0.01

UGA 0.01

TCD 0.01

CMR 0.01

SWZ <0.01

KEN <0.01

RWA <0.01

NAM <0.01

BFA <0.01
n=25
COD <0.01

SLE <0.01

GHA <0.01

TZA <0.01

DZA <0.01

MOZ 0.00

LBR 0.00

GIN 0.00

0.00 0.10 0.20 0.30 0.40 0.50


Source: Data was collected from three different sources: government offices and ministries of health (through surveys launched by WHO between 2010–2015); IFMBE; and
universities offering BME programmes.
WHO Medical device technical series 31
Table 1.2 Biomedical engineering professionals per 10 000 population in the WHO South-East Asia Region

IND 0.31

BTN 0.08

MDV 0.03

TLS 0.01

LKA 0.00
THA <0.01

NPL <0.01
n=10
BGD <0.01

MMR <0.01

IDN <0.01

0.00 0.10 0.20 0.30 0.40 0.50


Source: Data from surveys launched by WHO 2010–2015.

Table 1.3 Biomedical engineering professionals per 10 000 population in the WHO Region of the Americas

PAN 0.83

USA 0.49

CHL 0.36

ARG 0.35

SLV 0.31

TTO 0.29

MEX 0.24

CAN 0.18

PER 0.11

DOM 0.09

GRD 0.09

SUR 0.09

COL 0.06

PRY 0.05

CUB 0.05

BOL 0.04

BRB 0.04

URY 0.03

BLZ 0.03

VEN 0.02

BRA 0.02

ECU 0.02

GUY <0.01

JAM <0.01
n=27
HTI <0.01

HND <0.01

GTM <0.01

0.00 0.10 0.20 0.30 0.40 0.50 0.60 0.70 0.80 0.90 1.00
Source: Data from surveys launched by WHO 2010–2015.
32 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
Table 1.4 Biomedical engineering professionals per 10 000 population in the WHO Western Pacific Region

SGP 5.71

JPN 1.58

MYS 0.82

MNG 0.81

KIR 0.27

AUS 0.13
VNM 0.11
NZL 0.06

FSM 0.04

VUT 0.04

CHN 0.03
FJI 0.03
LAO 0.01 n=15
PHL <0.01
KOR <0.01

0.00 0.50 1.00 1.50 2.00 2.50


Source: Data from surveys launched by WHO 2010–2015.

Table 1.5 Biomedical engineering professionals per 10 000 population in the WHO Eastern Pacific Region

LBN 1.28

JOR 0.66
EGY 0.11

SAU 0.10

SDN 0.09

PAK 0.02

TUN 0.02
BHR 0.01

DJI 0.01

ARE <0.01
n=12
YEM <0.01

AFG <0.01

0.00 0.50 1.00 1.50 2.00 2.50


Note: Lebanon reported the highest density in the region, though information from 10 of the 22 countries in the region is missing.
Source: Data from surveys launched by WHO 2010–2015.

The European Region (EUR), Eastern reported the highest density (1.58). In
Mediterranean Region (EMR) and the European Region, Finland (2.73 or
Western Pacific Region (WPR) reported one per 3663 people) and Israel (2.48
the greatest density of BME professionals; or one per 4032 people) reported the
nonetheless all regions reported some highest densities. All three are classified
country densities below 0.01 (one per as high-income countries.
million people). Japan, in the WPR,

WHO Medical device technical series 33


Table 1.6 Biomedical engineering professionals per 10 000 population in the WHO European Region

FIN 2.73

ISR 2.48

LVA 1.78

ISL 1.70

AUT 0.94

SWE 0.87

LTU 0.87

BEL 0.87

SVN 0.84

DNK 0.79

IRL 0.70

ROU 0.64

GEO 0.63

HRV 0.47

EST 0.46

HUN 0.41

SRB 0.34

NLD 0.30

GRC 0.27

DEU 0.25

MNE 0.24

ITA 0.23

ESP 0.22

ALB 0.18

CHE 0.14

CYP 0.13

TUR 0.12

SVK 0.12

FRA 0.09

PRT 0.09
UKR 0.08

GBR 0.07

BGR 0.05

POL 0.04

MKD 0.02

BIH 0.01

KGZ <0.01 n=12


MDA <0.01

NOR <0.01
RUS <0.01

0.00 0.50 1.00 1.50 2.00 2.50

Note: Finland and Israel reported the highest densities in this region, with more than five BME professionals per 10 000 of the population.
Source: Data from surveys launched by WHO 2010–2015.

34 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers


Table 1.7 Reported density of hospitals with biomedical department/unit/service per 100 000 country
population by WHO region.

SWZ 0.80
TZA 0.54  African Region
ZAF 0.34  Region of the Americas
CIV 0.30  South-East Asia Region
BFA 0.18  European Region
ZMB 0.14  Eastern Mediterranean Region
 Western Pacific Region
BEN 0.10
KEN 0.09
NGA 0.09
ETH 0.09
SLE 0.39
RWA 0.03
COD 0.02
MOZ 0.00
BRA 1.25
PAN 0.74
TTO 0.80
SUR 0.54
MEX 0.16
URU 0.15
CHL 1.25
ARG 0.05
ECU 0.03
JOR 0.16
TUN 0.37
LBN 0.21
SDN 0.18
EGY 0.16
BEL 1.35
IRL 1.21
MKD 0.71
SWE 0.52
EST 0.47
SRB 0.32
ROU 0.30
ISR 0.09
UKR 0.01
MNE 0.00
CYP 0.00
BIH 0.00
BHU 0.40
IND 0.12
FSM 4.83
JPN 3.50
KIR 2.93
BRU 1.25
MYS 0.84
VUT 0.79
MNG 0.74
AUS 0.43
LAO 0.30
n=54
PHL 0.05
PAK 0.01
VNM 0.01

0.00 1.00 2.00 3.00 4.00 5.00 6.00


Source: Data were taken from responses to January 2015 Global Survey - Professional and Academic Profiles on Biomedical Engineers and Technicians launched by WHO.

WHO Medical device technical series 35


Table 1.8 Reported proportion of male and females (2015)

MYS 0.8
UKR 0.62
MKD 0.6
0.58  Female
SDN
 Male
ARG 0.52
SWE 0.5
CHL 0.5
BTN 0.5
BEL 0.48
MEX 0.46
JOR 0.45
EGY 0.45
BOL 0.45
VNM 0.4
ROU 0.4
BRA 0.4 n=55
MNG 0.39
PAK 0.3
KIR 0.3
ISR 0.3
BRU 0.267
URY 0.25
SRB 0.25
TTO 0.2
SUR 0.2
JPN 0.2
GRC 0.2
EST 0.2
HRV 0.2
PAN 0.18
TUN 0.15
KEN 0.15
IND 0.12
ZMB 0.1
MNE 0.1
LBN 0.1
ECU 0.1
CIV 0.1
BFA 0.1
AUS 0.1
CYP 0.07
ETH 0.06
BEN 0.06
SWZ 0.05
PHL 0.05
IRL 0.05
NGA 0.01
COD 0.01
BIH 0.01
VUT 0
TZA 0
SLE 0
RUS 0
FSM 0
LAO 0

0.00 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1
Source: January 2015 Global Survey - Professional and Academic Profiles on Biomedical Engineers and Technicians.

36 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers


Table 1.9 Reported numbers of biomedical engineers
Table 1.7 depicts the density of hospitals
at some international organizations (2015)
with a BME department/unit/service per
100 000 population. This indicator is
BME
calculated considering the data provided Organization staff
by some Member States that reported Doctors Without Borders 13
BME units in hospitals. It provides a first
Global Medical Equipment Repair Training 1
glance of the availability of biomedical
engineers in country health systems Medics Without Vacations 1
and shows disparity between Member MedShare International 3
States and regions. In order to increase United Nations Children's Fund 3
the relevance of this indicator, further United Nations Office for Project Services 1
information needs to be gathered and World Health Organization 4
validated by the pertinent in-country
health authorities.
engage biomedical engineering
professionals. However, according to
1.2 Women in biomedical the 2015 survey, their numbers are few.
engineering The reported numbers of biomedical
engineers are listed in Table 1.9. More are
The most recent stage of the survey needed to increase advocacy of emerging
compiled gender information by country. and existing medical technologies and
Table 1.8 shows the three times greater their role in achieving the missions of
proportion of male biomedical engineers these institutions.
(77%) compared with female (23%).
Nevertheless, five countries (Argentina,
Ukraine, Macedonia, Malaysia and Conclusion
Sudan) reported more women than men.
In contrast, countries like Lao People’s As of 2016, Biomedical engineering
Democratic Republic, Micronesia, professionals can be found in 129 of
Rwanda, Sierra Leone, United Republic 194 Member States of WHO. Many new
of Tanzania and Vanuatu reported no BME programmes are being initiated in
female biomedical engineers at all. different LMIC, therefore it is expected
that the number will increase. It is
important to note also that there is an
1.3 Biomedical engineering in increasing female population of BME and
international organizations that more are being hired in international
organizations. The following chapters
Many international organizations with an will present more information on the
agenda in public health, including WHO, academic programmes as well as the
Doctors Without Borders and the United national and international professional
Nations Children’s Fund (UNICEF), societies.

WHO Medical device technical series 37


Credit: Tropical Health & Education Trust (THET)/Anna Jennings; students at Northern Technical College, Zambia, learning the working principles of a resuscitaire.
2 Education and training

2.1 Defining training and and artificial organs to aid in the treatment
education of the injured or diseased patient to
allow them to enjoy a better quality of
In general, learning can be split into life. Biomechanical engineers have
education and training; education is been responsible for the development
about acquiring knowledge whereas of devices such as prosthetic implants
training is about acquiring skills. When to replace diseased or damaged
both forms of learning are related to skeletal joints such as hips, knees and
the biomedical profession and teaching shoulders. Their understanding of the
institutions, education relates to biomechanics and fluid dynamics of the
universities creating biomedical engineers central circulatory system has helped
and vocational training institutes creating the development of artificial heart valves
biomedical engineering technicians and and implantable stents used to improve
technologists. Training includes pre- blood flow in diseased blood vessels.
service training, meaning a training one Development of other, less complex,
finishes before joining the workforce, implants such as bone plates and
normally being full time and in-service screws also benefits from the skills and
training, which can be via short-term knowledge of the biomechanical engineer
courses or part-time training. Where in understanding the mechanical loading
vocational training institutes normally requirements imposed on bone structures
teach pre-service training, commercial to ensure these devices can safely replace
companies, professional associations or or supplement the bone.
other stakeholders can provide in-service
training. Engineering: Biomedical engineers
working in areas associated with
diagnosis and treatment of disease or
2.2 Core curriculum and elective injury, biological signal measurement
specialization and processing, diagnostic imaging and
ensuring a safe environment for patient
The biomedical profession includes many treatment, need exposure to knowledge
different professions, normally coming often associated with electronic
from a similar base (the core curriculum), engineering. As examples, biomedical
with different specializations (elective engineers working on bioinstrumentation
specializations). specialize in the detection, collection,
processing and measurement of many
2.2.1 Core curriculum physiological parameters of the human
Human anatomy and physiology: body, ranging from the simple, such
Biomechanical engineering professionals as temperature measurement, ECG
apply engineering principles to further detection and heart rate measurement, to
the understanding of the structure of the more complex, such as quantification
the human body, the skeleton and of cardiac output from the heart, detection
surrounding muscles and the functioning of the depth of anaesthesia in the
of the body’s organs. They use the unconscious patient and neural activity
knowledge gained to develop and apply within the brain and central nervous
devices such as implantable prostheses system. They have been responsible

WHO Medical device technical series 39


for the development and introduction of mechanically strong enough to withstand
modern imaging technologies such as the environment and stresses imposed
ultrasound and MRI for scanning the soft in the body and perform as intended
tissues of the body, digital X-ray imaging for its projected lifetime. Biomaterials
of the skeletal structure and organs of research and development by biomedical
the body, and tumour localization using engineers has led to the development of
PET scanning and other technologies. new alloys, ceramics, composites and
Biomedical engineers working in combination materials and polymers that
areas of tissue engineering, material have all found successful application in
biocompatibility, organ systems, fluid flow implantable devices.
and dynamics need knowledge common
to basic mechanical and chemical Clinical engineering: Clinical engineers
engineering. Thus, core subjects in use their specialized engineering
circuits, electronics, fluid mechanics, knowledge in implementing health-
solid mechanics, materials, systems, care technologies and strategies in
signals, instrumentation, programming hospitals and other health-care settings.
and controls are often part of the The selection, installation and ongoing
undergraduate BME curriculum. support of appropriate technologies and
associated equipment used by health-
2.2.2 Elective specialization care professionals are critical to the
Artificial organs and support systems: delivery of safe and effective health-care.
When developing artificial organs or
support systems such as haemodialysis Clinical engineers play a central role in
systems for removal of toxins from the defining technology needs and identifying
blood, wearable insulin pumps or an planning options for institutions;
artificial pancreas for the treatment of participating in assessment and
diabetes, the biomedical engineer needs acquisition of appropriate technologies;
to understand the chemistry of the blood supervising or undertaking installation of
and the biochemical and physiological equipment; managing and maintaining
operation of the kidneys that normally assets through their working life;
remove toxins from the blood, or the integrating devices with IT and business
normal role of the pancreas in producing systems and electronic medical records.
the hormones responsible for glycaemic Finally, they manage the removal, safe
control within the body. disposal and replacement of devices
or technology at the end of their useful
Biomaterials: In this field, biomedical life, or when superior technologies
engineers study and have technical become available and affordable. In
understanding of the physical and undertaking this role, which may involve
chemical properties of the tissues of managing thousands of individual items
the body, and use that knowledge to of equipment ranging from patient beds,
develop new and safe materials for use in infusion pumps, anaesthesia equipment,
implantable medical devices. The human patient monitoring systems through to
body has natural defence mechanisms large multi-modal imaging machines and
and tends to reject any introduced foreign their associated digital imaging processors
bodies, so developing new materials, with and storage systems, the clinical engineer
appropriate physical properties to allow for requires not only engineering expertise
long-term implantation without provoking but considerable financial, planning and
autoimmune rejection, is very challenging. management skills as well.
The material needs to be non-toxic, non-
carcinogenic, chemically inert, stable and

40 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers


Computational modelling: A major Neural engineering: Application of
contribution of the biomedical engineer engineering principles and techniques
is in the application of computational have greatly assisted the study of, and
modelling approaches to molecular, interaction with, the nervous system. Our
cellular and physiological systems. understanding of hearing, for example,
Complex computer models of the would be greatly hampered were it
cardiovascular system, for example, not for engineering approaches to the
have led to a better understanding of the study of the cochlear and the auditory
physiology of the heart and circulatory system. This includes using mathematical
system. Computer models of neurons models, computers in the generation
and neural networks provide deeper of acoustic signals and acquisition of
insight into the functioning of the nervous biological signals, and advanced data-
system. Models of protein structure processing techniques in preparing and
and the interactions of molecular and conducting experiments and analysing
genetic circuits are greatly enhancing our complex data. The same can be said for
knowledge of the relationships between a large number of sensory, motor and
structure and function. general nervous system investigations.
Cochlear and cochlear nucleus implants
Implants and prosthetics: Biomedical are successful examples of advanced
engineers involved in the development, engineering applied to deafness. Retinal
replacement and support of implantable implants are not far off and computer-
devices need skills ranging from brain interfaces are already making a
materials science, materials compatibility, tremendous impact, albeit for only few
mechanical and electronic engineering, people.
as well as a sound understanding of the
physiology and chemistry of the human Regulatory standards: In regulatory
body. or standards-setting organizations,
biomedical engineers play a role in
Materials chosen for the construction of bringing together the more traditional
implantable devices must be physically bodies of engineering knowledge to set
and chemically stable, compatible with appropriate safety and performance
long-term implantation in the body and standards and then assess medical
mechanically robust. An artificial hip, for devices against those standards prior to
example, must be capable of withstanding a regulator giving marketing approval. In
the rigours of continual movement and such work, the engineer needs further
widely varying loading with the weight of knowledge of the often complex legal
the body, for many years. and legislative structure in which those
standards and regulations are developed
Active implants, such as pacemakers and implemented.
and neural stimulators, require signal
detection, processing and stimulation Rehabilitation: Biomedical engineers work
capabilities supported by a power source closely with clinical personnel (including
capable of providing energy to the implant physical and occupational therapists) to
to allow many years of operation between help patients who have suffered injury
replacements. They also require non- or disease to achieve normality in their
contact communication technologies and life. They assist by developing diagnostic
software support to allow programming equipment to analyse a patient’s range of
and altering of operational parameters, movement or motion, and by designing
after implantation, to support the clinical and producing personalized solutions
needs of the patient. to assist the patient. Rehabilitation

WHO Medical device technical series 41


engineers work with a wide range of such as project management, process
patients and solutions can be as simple engineering, budgeting, procurement,
as engineering an externally worn knee contracting, IT integration, change
brace to assist and support a damaged management, supply-chain management,
skeletal joint, specifying a wheelchair performance monitoring and reporting,
design for a patient or as complex as staff supervision and training, service
designing a complex computer controlled management, vendor management,
artificial limb to replace a partial or disaster preparedness and response
complete amputation, or an exoskeleton and recall management. Depending on
that restores mobility to patients with organizational resources and maturity,
neurological or physical injuries. some of these different functions may
be assigned to a single person (e.g.
Process and systems engineering: maintenance of instrumentation),
In all of these fields of BME, a strong whereas in other situations, an individual
understanding of systems engineering is may have responsibility for a wide range
required to enable the engineer to apply functions over an extended geographical
their engineering knowledge and tools region.
of analysis, design and implementation
to problem solving within the complex
structure of the human body and the 2.3 Universities – global data
equally complex organizational and
institutional systems through which health In line with the objective of disseminating
care is provided. Solutions typically involve information about BME educational
integrating knowledge of the physiology of programmes, WHO included educational
the body with engineering knowledge in institutions in the Biomedical Engineering
the many disciplines which we consider to Surveys (2009/2016). Figure 2.1 shows
be “conventional” engineering, as well as the number of universities that completed
an extensive range of organizational skills the WHO survey.

Figure 2.1 Universities offering biomedical engineering degrees by country

Source: Data from surveys launched by WHO 2009–2015.

42 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers


2.4 Education and training by The ABEC in 2016 is composed of 16
region organizational members organising an
innovation summer school every two
There follows a summary of the current years:(39)
BME educational programmes on offer • Addis Ababa Institute of Technology
worldwide. (Ethiopia)
• Cairo University (Egypt)
2.4.1 Africa • Dar es Salaam Institute of Technology
(United Republic of Tanzania)
Biomedical engineering education • Jimma University (Ethiopia)
In Africa, the development of BME • Kenyatta University (Kenya)
education can be traced to the late • Kyambogo University (Uganda)
1960s. In 1969, the Medical Physics and • Makerere University (Uganda)
Bioengineering Department was formed • Malawi University of Science and
in the University of Cape Town (UCT), Technology (Malawi)
South Africa.(36) Four years later, UCT’s • Mbarara University of Science and
Biomedical Engineering Department Technology (Uganda)
was established as a separate entity • Muhimbili University of Health and
and postgraduate programmes in BME Allied Sciences (United Republic of
were introduced. In the early 1970s, the Tanzania)
College of Medicine, University of Lagos, • Technical University of Mombasa
Nigeria, established a BME department (Kenya)
to train low- and middle-level human • Uganda Industrial Research Institute
resources in BME. In 1976, the Systems (Uganda)
and Biomedical Engineering Department • University of Cape Town (South
was established in the Faculty of Africa)
Engineering, Cairo University, Egypt, and • University of Eldoret (Kenya)
produced its first graduate in 1980. In the • University of Ibadan (Nigeria)
late 1990s and early 2000s, there was a • University of Lagos (Nigeria).
plethora of African academic institutions
launching programmes in BME. A list of Biomedical engineering training
BME programmes in Africa can be found Most of the early developmental efforts
in Annex 2. in African BME have been in the area
of training, through short courses,
Participants at the “Innovators Summer continuing education, professional
School for 2012,” supported by the development or conferences. This is to
United Nations Economic Commission for be expected as this aspect of human
Africa (ECA), resolved to form an African resources development can be sponsored
Biomedical Engineering Consortium and provides channels for individuals
(ABEC).(37) The mission(38) of the ABEC making changes in their fields of interest.
states: (40,41,42,43)

“The African Biomedical Engineering Initial entrants into the BME profession
Consortium (ABEC) is a regional held degrees and/or certificates in
platform for promoting innovation traditional engineering areas such
and entrepreneurship in health-care as electrical, mechanical or chemical
infrastructure and technologies for engineering. These individuals needed to
improved health-care outcomes in acquire BME skills to be able to manage
Africa.” biomedical equipment. While “formal
education” emphasizes the development

WHO Medical device technical series 43


of knowledge, “training” emphasizes the a result, many teaching hospitals and
development of skills that can come ministries of health have recognized
in the form of continuing education, and created separate BME units or
continuing professional development or departments. Biomedical engineering
short courses.(44) practice in academia is also improving
in Africa. This is understandable given
Attempts at BME training in Africa started the increase in educational institutions
even earlier than BME education. Many offering BME programmes.
non-BME institutions have conducted
courses. Specifically, in South Africa, Pure BME research centres are rare in
even before the University of Cape Town Africa. Those that do exist are in the
commenced specific BME programmes, it educational institutions running BME
had, in conjunction with other institutions, programmes. A handful of ancillary
organized workshops and courses in research centres, such as those in cancer
BME in the 1960s. In Nigeria, in the research, biotechnology, pharmaceutics/
early 1970s, the Nigerian Association of vaccine, agriculture and medical areas,
Health Engineering, based in the BME are present. Nigeria, for instance, has
department of the College of Medicine, the Cancer Research Centre, National
University of Lagos, conducted a number Biotechnology Centre, National Vaccine
of seminars and conferences in BME. Centre, National Virology Institute and the
Their first conference was held in 1974. Nigerian Institute for Medical Research.
After South Africa and Nigeria, sub- Consequently, there are biomedical
Saharan Africa biomedical engineering engineers engaged in these research
training (BMET) started in the 1980s centres. The industry sector suffers most
at the Mombasa Polytechnic in Kenya from the paucity of professional practice of
(now Technical University of Mombasa) BME in Africa. There is some small-scale
and many sub-Saharan countries now biomedical equipment manufacturing
offer BMET training programmes. in Africa, mostly in the production of
These programmes lead to advanced biomedical accessories and disposables.
certificates, diplomas and advanced The African BME industry is based largely
diplomas, depending on the national on the distribution of finished products
educational systems. BMET courses and services.
normally include industrial or clinical
placements and sometimes internships Accreditation
to familiarize students/graduates with the Every African country has its own
reality of their profession. accreditation bodies and procedures,
however, in general, a national
Biomedical engineering practice accreditation board linked to the
Initiated through the establishment of a ministry of education accredits academic
handful of educational institutions and programmes where technical and
professional associations in the 1960s, vocational education and training (TVET)
African BME professional practice is normally accredit training programmes.
now expanding exponentially in the 21st
century. Most BME professionals work 2.4.2 Asia-Pacific
in hospitals, medical and health centres
or other clinical health-care settings. Biomedical engineering education
Among the five career areas of BME – Japan initiated BME education in the
clinical, industry, research/development, Asia-Pacific region by establishing the
academia and government – the clinical region’s first BME department in 1963.
setting holds the greatest prospect. As Subsequently, Taiwan, China (1972),

44 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers


China (1977), Republic of Korea care quality for patients. The special
(1979), Mongolia (1996), Malaysia role biomedical engineers play in the
(1997), Indonesia (2004), Hong Kong clinical care of patients has gradually
(SAR), China (2005) and Thailand developed as an important sub-area of
(2006) successively established BME BME expertise; since the 1990s known
departments (see Annex 2). These in hospitals in the Asia-Pacific region as
efforts have fostered the growth of BME “clinical engineering”.
professionals in the region and more
and more universities have established Currently, in the Asia-Pacific region,
departments and/or programmes ranging only hospitals in Japan and China
from undergraduate to doctoral studies. have permanent clinical engineering
departments. Other countries are working
The areas of expertise for BME education to achieve this goal, but they are stymied
in the Asia-Pacific region are classified by current policies and regulations for
as biomedical electronics, biomedical government health-care departments.
materials, biomechanics, biomedical This affects the role of clinical engineers
imaging and biomedical informatics. in hospitals, and, as a result, some
According to the latest survey in 2015, medical devices and instrumentation are
the majority of graduates have expertise maintained by nurses instead of clinical
in biomedical electronics, which is in engineers. In addition, when problems
contrast to biomedical informatics with, or malfunctions of, medical
(corresponding to the BME lecturers’ devices occur, the hospital will often
expertise). seek assistance from suppliers, because
there is lack of trained clinical engineers.
In 2015 Kang-Ping Lin conducted a This situation is common in hospitals in
BME education survey in nine Asia- the Asia-Pacific countries, with notable
Pacific countries.(45) Graduate schools exceptions in Japan and some areas of
were surveyed regarding student skills China.
training, course information and graduate
employment. Currently, over 300 Accreditation
universities have a BME department with Most BME departments in China are
more than 2600 professional lecturers. accredited via the Washington Accord
(see section 2.5). Although BME
Biomedical engineering practice education in Japan is the oldest in the
Regarding careers, over 50% of BME region, only some of its universities
graduates work in BME related fields. have been accredited according to
These employment opportunities range the Washington Accord. China was
widely as a result of BME being long preparing for accreditation in 2014.
established. Examples of positions Other Asia-Pacific countries have not yet
commonly available include: service or established the accreditation system of
sales engineers in global enterprises for the Washington Accord.
medical devices; engineers in R&D in
medical devices companies; educators; 2.4.3 Australia and New Zealand
and engineers in hospitals responsible Kirsner and McKenzie make a convincing
for equipment repair, maintenance, case that David Dewhurst is the father
procurement and administration. Such of BME in Australia.(46) There is little
wide ranging roles has a tremendous doubt that Australia has made significant
impact on the advancement of advances in the area of BME. The multi-
maintenance, R&D and medical devices channel cochlear implant is undoubtedly
producing and improving medical the most successful neural prosthetic

WHO Medical device technical series 45


developed to date. A recent review of new study programmes in the Eastern
the BME programmes in Australia, Neighbouring Area (ENA) countries, and
however, suggests that improvements in promote the reform of existing ones.
programme offerings could be made.(47)
Programme data for both Australia and BME education
New Zealand can be found in the Annex The survey of over 300 BME study
2 (WPR). programmes in Europe carried out within
the CRH-BME Tempus project to evaluate
2.4.4 Europe the present status and future needs in
BME education has shown that second
European Higher Education Area cycle (MSc level) programmes currently
harmonization dominate (30% BSc, 50% MSc, 20%
The creation of the European Higher PhD).(48) This is not surprising since
Education Area (EHEA) aims to lead the profile of a biomedical engineer is
to comparability of degrees, both that of an engineer cross-trained and
undergraduate and postgraduate (cycles), specialized in biomedical application
across Europe. A major tool applied areas. The most straightforward pathway
towards this goal is the establishment to such a profile is, therefore, to recruit
of the European Credit Transfer System students from the pool of graduates
(ECTS), which allows comparable of “classical” engineering disciplines
degrees to be mutually recognized, and (e.g. electrical, mechanical) or physical
facilitates an increased flow of students sciences (e.g. physics). Only first- and
and teaching staff between universities. second-cycle degrees (BSc and MSc),
However, the ECTS is still only partially as defined by the Bologna Declaration,
implemented. The BME field, belonging were considered here. The third-cycle
to the broader engineering subject area (PhD) programmes are of a much more
with traditionally five years of studies for specialized nature and differ significantly
graduation, has faced strong opposition among different European universities.
to reformation. Today, there are countries Therefore, studies leading to a doctoral
in the broader European area that have degree are not considered. Concerning
fully adopted the three plus two years’ the creation of the BME programmes,
scheme (first and second cycles), but only 15% were in existence 20 years ago,
others are still offering only one five-year and 67% have started since 2000. The
cycle for engineers leading directly to oldest programme has been running since
a second level degree. Harmonization, 1967, and new ones are continuously
therefore, remains a difficult task in such being planned and implemented. A list
a diverse environment. The Tempus IV of BME programmes in Europe can be
joint project “Curricula Reformation and found in Annex 2.
Harmonization in the Field of Biomedical
Engineering” (CRH-BME) had, as a main There are three distinct generic types of
objective, to propose an updated generic BME programmes in Europe:
curriculum. Our findings on European
BME study programmes is mainly based • Type 1: First-cycle BME programme
on the results and recommendations (BSc)
of this project. A new Tempus initiative • Type 2: Integrated first- and second-
has just been awarded funding from the cycle BME programme (MSc)
European Union – the BME-ENA project. • Type 3: Stand-alone second-cycle
This project will implement the previously BME programme (MSc).
harmonized standards in the creation of

46 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers


These programmes can be further which the application-oriented courses
distinguished into three sub-types can build. The programmes commence
according to entry requirements: with education in basic engineering and
physical sciences, and basic biological
• Entry from a first-cycle BME and biomedical sciences. The duration
programme and content of this aspect of programmes
• Entry from a first-cycle engineering depend on the prior knowledge and
(non-BME) or physical sciences experience of the students. Students
programme undertaking a first-cycle programme or
• Entry from a first-cycle medical or an integrated first- and second-cycle
biological programme. programme are expected to have very
limited knowledge in both basic areas
The majority of BSc programmes (63%) and the time (and ECTS) devoted to basic
run for six semesters. More than half material should be considerable.
of the MSc programmes take four
semesters, and one third of the MSc Students entering second-cycle
programmes are only two semesters long. programmes can be expected to have
Concerning doctoral programmes, more high-level knowledge acquired from
than two thirds take a minimum of six their first-cycle degree. The duration
semesters, while the remaining one third of the basic aspects of the programme
last from eight to ten semesters. Due to is correspondingly decreased and
the significant differences between the tailored to the nature of the student’s
existing study programmes in terms of total prior knowledge, e.g. whether it was
duration (in years) and the organization of an engineering or biomedical based
the studies (e.g. semesters or trimesters), degree. There is also recognition of the
from the harmonization point of view non-technical competencies and skills
the programmes are specified in terms needed to practise BME in an academic,
of ECTS credits representing student industrial or health-care context. Effective
workload. The minimum number of communication, both written and verbal,
ECTS is prescribed for each programme, is vital for effective team working – central
but the total number of credits of any to many BME activities. Additionally,
combination of first- and second-cycle management skills are essential to obtain
programmes is at least 300, as required the best results from such teamwork. All
according to the Bologna Declaration, students must be aware of the ethical
while type 3 programmes must deliver 90 context in carrying out and publicizing
ECTS as a minimum. research, as well as the specific ethical
constraints of working within the medical
Most BSc and MSc programmes in area. These non-technical aspects are
Europe incorporate education in basic either delivered as stand-alone courses, or
engineering and physical sciences are integrated within the other programme
(maths, physics, programming, electrical, topics. Students are also expected to
mechanical and/or chemical engineering) carry out research of significant depth
as well as basic biological and biomedical to demonstrate their expertise in the
sciences (e.g. cell biology, basic anatomy application of ideas and techniques.
and physiology). The duration and In general, the topics included in BME
content of the basic aspects reflect the education in Europe can be grouped into
requirements for prior knowledge and the following areas: basic engineering
experience of the students enrolled in and physical sciences, engineering
the programme. All study types include and physical sciences focused on
courses that provide the foundations on BME applications, basic biological and

WHO Medical device technical series 47


biomedical sciences, general introduction specialization of their staff, the level of
to BME and BME specialization, generic international collaboration or perceived
skills, ethics (general, medical, research), social, health-care or industrial needs.
management, visits to/from companies or The most common topics identified in the
lectures/seminars from staff of relevant above-mentioned survey include:
institutions and BME research project
for thesis. • Anatomy and physiology
• Artificial intelligence and neural
European core biomedical engineering subjects networks
The core subjects/topics identified as the • Bioethics, humanities
basic components of BME programmes • Biology and biochemistry
of any type are: • Biomedical electronics
›› Nanotechnology
• Biomaterials ›› Ultrasound
• Biomechanics • Bionics, biocybernetics and robotics
• Biomedical data and signal • Cell and tissue engineering
processing • Clinical engineering
• Biomedical instrumentation and • Control theory, modelling and
sensors simulation
• H e a l t h t e c h n o l o g y d e s i g n , • Diagnostic and therapeutic methods
assessment and management • Gene and molecular engineering
• Information and communication • Mathematics, statistics and data
technologies in medicine and health analysis
care • Patient safety, hospital environment
• Medical imaging and image • Physics (acoustics, electricity,
processing. mechanics, optics, etc.)
• Quality management, health-care
In this context the term subject/topic is assessment
generally meant to represent a category ›› H e a l t h - c a r e o r g a n i z a t i o n ,
broader than a single course. A particular management and legislation
core topic can be covered by more than ›› H e a l t h - c a r e t e c h n o l o g y
one course within a BME programme, assessment and quality of life
depending on specific needs. A first- or ›› Medical technology, marketing
second-cycle study programme should and economics
cover at least four of these core subject/ • Rehabilitation engineering
topics in depth in order to be considered • Research methodology
as a typical BME programme. • Telemedicine and virtual reality.

Electives The exact wording and depth of the


The purpose of BME elective topics is elective topics titles may differ from
to cover teaching content not identified programme to programme.
as part of core topics and thus allow for
the introduction of new and emerging Internship/cooperative (co-op) education
technologies and applications. Elective requirements
subjects represent approximately 30% Internship is also promoted and facilitated.
of the overall study programmes but Many universities have agreements with
with a lot of variation across Europe. The companies or service providers and
elective subjects offered depend on the students may spend between a month
specialization of the departments involved and one year in an internship. The
in the BME education, the expertise and recognition placed on this activity as

48 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers


part of the educational process however Bolivarian Republic of Venezuela, Brazil,
varies considerably among the different Colombia, Cuba, Peru and Uruguay.
institutions.
The number of BME and bioengineering
Study abroad undergraduate and graduate programmes
Student exchange and mobility is has increased from 50 to 60 since 2007.
very much promoted in Europe today. (49,50) The number of countries and
Approximately 90% of BME programmes universities that offer these programmes
apply the ECTS facilitating study abroad. are shown in Table 2.1 and a list of BME
More than two thirds of programmes programmes in Latin America can be
accept foreign students, and 70% found in Annex  2.
have bilateral agreements with other
universities. English is offered by the
majority of programmes as a teaching Table 2.1 Latin American countries offering BME and
bioengineering programmes
language, and often two teaching
languages are used.
2007 2015
Accreditation Latin American countries 23 23
The accreditation of BME programmes
Latin American countries with 9 12
in Europe today implies that institutions BME undergraduate education
should have a policy and associated Latin American universities 50 117
procedures for the assurance of the quality with BME and bioengineering
and standards of their programmes. They programmes
should also commit themselves explicitly
to the development of a culture that
recognizes the importance of quality, and The early stages of bioengineering
quality assurance, in their work. and BME education in Latin America
was mainly based on electronics and
2.4.5 Latin America bioinstrumentation, leaving aside
biomechanics and biomaterials.(29,48)
Biomedical engineering education Most of the universities prepared
According to Allende et al, BME “is a professionals dedicated to installation
multidisciplinary field that integrates and maintenance of medical devices.
various sciences, such as physics, In the last five years, however, this
chemistry, biology, mathematics, model has evolved with changes in
electronics and informatics, with the aim the main regional health needs and
at developing technology innovations the emerging technologies in the fields
in health-related areas, at improving of bioinformatics, neural engineering
prevention, diagnostic and pathologies telemedicine, therapeutic systems and
treatments and, thus, at improving the the new “internet of things” trend in
life quality of people.”(50) health care that allows patients to monitor
their own health data. Among the factors
Biomedical engineering in Latin America that influenced this change are the
has a nearly 40-year-old history. The first increasing rate of chronic conditions and
academic undergraduate programmes their risk factors that are now the major
in Latin America were established in causes of death, disability and illness in
Mexico and in Colombia in the 1970s the region. Based on these issues, BME
and in Argentina in 1985. Subsequently, programmes now include new areas of
graduate programmes were created in the interest to ensure new engineers have
sufficient skills to create new designs

WHO Medical device technical series 49


and develop and improve new medical • Bioinformatics and computational
solutions in order to increase the quality biology, systems biology, and
of life of the region’s population. modelling methodologies
• Bioinstrumentation, biosensors,
In addition, there is also a field focused on biomicro/nanotechnologies
clinical engineering which is important for • Biomaterials and biomechanics
engineers to acquire the tools to support • Biomathematics, modelling and
a hospital with optimal management of simulation
medical technology through technology • Clinic engineering and hospital safety
acquisition management and ensure • Design and equipment construction
ongoing safety.(51) • Electromedicine and
bioinstrumentation
According to Allende et al, “since the • Signal and image processing
early times of BME as an undergraduate • Telemedicine and telesurgery
academic programme, a hot debate has • Therapeutic systems, devices
arisen as to whether to train generalist and technologies, and clinical
engineers or specialist professionals – engineering.
specialization may prove necessary in
developed countries, where a biomedical Accreditation
engineer can work within a predetermined The government in each country has
family of medical devices. Nevertheless, an accreditation programme for their
by being specialized in some area of universities. To guarantee standards each
interest, the professional loses some global academic programme is evaluated by
knowledge in other important areas. In a group of experts nominated by the
particular, in Latin American countries, a government, every four or five years in
biomedical engineer must be proficient order to get their accreditation renewed.
enough to adapt themselves and solve very For international accreditation, ABET
different problems, in health centres as is the most implemented system,
well as in medical device companies. The which accredits “college and university
best conditions arise when an extensive programs in the disciplines of applied
education is given so that it covers a science, computing, engineering, and
wide range of knowledge with which the engineering technology at the associate,
engineer can effectively deal with whatever bachelor, and master degree levels, to
situations arise. This mainly occurs in ensure students, employers, and the
undergraduate programmes, where the society we serve can be confident that a
future engineer studies fundamental program meets the quality standards that
topics throughout five or six years of produce graduates prepared to enter a
education. "If they wish to go on, further global workforce.”
specialization is given along with graduate
studies, thus increasing their domain of 2.4.6 North America (USA and
competence."(51) Canada only)

In Latin America the same tendency Biomedical engineering education


is observed in the newly created BME The maturation of BME programmes in
programmes. In general, their curricula the United States of America is advancing
include the following fields: rapidly, producing practitioners who
work in academia, industry and in the
• Bioelectricity and biomagnetism health-care professions as academics,
• Bioinformatics and communication engineers, physicians and other
theory professionals devoted to knowledge

50 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers


creation, medical device design, and States.(56) The Biomedical Equipment
delivery of health care. Very few graduates Maintenance Technician Training
of undergraduate BME programmes work Program of the Defence Health Agency
in industry immediately after obtaining provides training for the military.(57)
their degrees unless they have had some
internship or co-op experience. Industry, Accreditation
for some time, has been insisting on an In the United States, accreditation of
MSc in BME as the entry-level degree, engineering programmes is done by the
unless the applicant has had a significant Accreditation Board for Engineering and
industrial internship or co-op experience. Technology (ABET). Today ABET is a not-
A few BME undergraduates, upon for-profit, nongovernmental accrediting
receiving their degree, work in hospitals agency for programmes in applied
or shared-service organizations, but they science, computing, engineering and
often lack experience in critical clinical engineering technology recognized as
environments to be effective immediately. an accreditor by the Council for Higher
They need additional training to become Education Accreditation. By receiving
effective. ABET accreditation, college and university
programmes are assured of meeting
There are 97 accredited bioengineering the quality standards of the relevant
or BME undergraduate programmes profession for which the programme
in the United States today,(52) but no prepares graduates. Programmes,
undergraduate programmes offering not institutions, are accredited and
clinical engineering degrees.(53) In fact, accreditation is voluntary. It provides
there are no MSc clinical engineering specialized accreditation for post-
degree programmes (although the secondary programmes within degree-
University of Connecticut offers an granting institutions already recognized
MSc in BME with a substantial clinical by national or regional institutional
engineering internship component). In accreditation agencies and national
Canada there are 36 universities offering education authorities worldwide. To
BME degrees,(54) but only two offering date, approximately 3600 programmes
MSc programmes in clinical engineering. across 700 colleges and universities
in 29 countries have received ABET
From 1999 to 2007, the Vanderbilt- accreditation. Each year around 85 000
N o r t h w e s t e r n - Te x a s - H a r v a r d - M I T students graduate from ABET-accredited
(VaNTH) Engineering Research Center in programmes, and millions of graduates
Bioengineering Educational Technologies have received degrees from ABET-
existed for the purpose of examining accredited programmes since 1932.(58)
BME programmes in the United States
of America in order to provide:
2.5 International accreditation
• A listing of recommended core agreements
content, as opposed to core courses,
for BME undergraduate programmes. In addition to accreditation organizations,
• Recommendations for creation of a number of important accords have been
curricula in terms of both content established.
and pedagogy.(55)
Washington Accord, 1989
Biomedical engineering training This multinational agreement set in
There are only eight accredited BME motion the progression toward the mutual
technology programmes in the United recognition of engineering accreditation.

WHO Medical device technical series 51


The major aim was to attain the substantial and doctoral. Through promoting this
equivalency of accredited engineering common higher educational dimension,
degrees among the respective signatory whereby the degree-granting systems of
countries. The accrediting bodies of the various countries become reasonably
eight countries (Australia, Canada, compatible, the Bologna Process aims at
Hong Kong (SAR) China, Ireland, New making it easier for students to work and
Zealand, South Africa, United Kingdom study abroad.(59)
and United States of America) were the
original signatories. Numerous additional 2.6 List of educational institutions
countries have subsequently been
accepted as signatories. 1050 educational institutions offering
BME degrees were identified through the
Bologna Declaration, 1999 surveys worldwide:
This European educational reform
declaration set forth the Bologna • 52 African Region
Process, a series of specific action items • 33 Eastern Mediterranean Region
for creating the EHEA. These measures • 253 European Region
concern degrees, credits, mobility, quality • 360 Region of the Americas
assurance and “the European dimension” • 119 South-East Asia Region
though well-defined masters and doctoral • 233 Western Pacific Region.
programmes. As an intergovernmental
initiative launched by 29 European A detailed list of all identified institutions
countries, it affirmed the establishment is attached as Annex 2.
of three degree levels: bachelors, masters

52 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers


Credit: THET/Anna Worm; first meeting of sub-Saharan professional BME associations, Johannesburg, October 2015.
3 Professional associations

3.1 Purpose of professional of patients’ conditions and caregivers


associations converge, are rapidly growing. This
dependence, along with the limited
Professional associations provide a availability of resources globally,
valuable service to the wider society by means that strategies and methods are
helping to formalize the evolution and increasingly important for professionalized
transmission of specialized knowledge management of technology throughout its
through research, training and certification life cycle. The use of organized scientific
of skills and recognition of excellence and technology knowledge, working in
which define a given area of professional multidisciplinary teams, and technical
practice. We live in a world that is management methodologies, are all
continuously evolving, and its dependence competencies that are now recognized
on technology for supporting quality of life as common and necessary elements of
has never been greater. The acceleration the profession, and the list of required
of scientific, technological, economic and capabilities continues to grow as health-
political pressures is forcing established care systems become more complex.
professions to become more dynamic and
adaptive, and is creating incentives for new Belonging to professional associations
professions to form in order to address can be beneficial, indeed essential,
new societal needs and opportunities. for individuals seeking to enter and to
practise in the field, as they strive to
For the purposes of this chapter, BME understand, adapt to and influence the
will be used in a generic sense to rapid changes in technology, regulatory
represent a diverse set of interrelated and accreditation rules, globalization of
professional bodies of knowledge and markets and rapidly growing dependence
practice that contribute to the broad of health-care systems on technology
spectrum of expertise required to design, for delivery of services. Professional
produce, install and manage health-care associations typically provide specialized
technologies that are safe, effective and information resources, legal advocacy,
affordable. These disciplines include professional development workshops,
clinical engineering, biomechanical mentoring and supportive career
engineering and biomechanics, nano- guidance as members proceed along
engineering, molecular engineering, their professional career paths. The
biomaterials, rehabilitation engineering professions of BME, clinical engineering,
and other related disciplines. rehabilitation engineering, engineering for
medicine and biology and related health
Health-related services depend technology management (HTM) and
significantly on technology to promote health technology assessment, among
healthy behaviour and to manage illness others, have been developing such
when it occurs, through detection, resources nationally and internationally
treatments, monitoring palliative care and for many years. Furnishing this range
rehabilitation. In particular, the demand of services is the main reason that the
for and deployment of technology at BME associations are growing rapidly –
the point-of-care, where management in number, membership and scope of

54 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers


services offered. These associations also • Consejo Regional de Ingeniería
represent their constituents to policy- Biomédica para América Latina
makers and other associations, as well (CORAL).
as to other co-workers who share in While all organizations share in the
the critical mission of managing global common pursuit of promoting BME,
health-care delivery systems. national associations are geared to serving
the needs of their local memberships.
The activities of the major international
3.2 Global biomedical professional organizations are described
engineering associations below.

Globalization of BME activities is 3.2.1 International Union for Physical


underscored by the fact that there and Engineering Sciences in Medicine
are several major professional BME The IUPESM is the international umbrella
associations currently operational organization for BME and medical
throughout the world. The various physics. An account of its development,
countries and continents to have aims and activities was recently
developed concerted “action” groups in presented by Nagel (2007).(60) It is a
BME are Europe, the Americas, Canada union of two international organizations –
and the Far East, including Japan and the International Federation for Medical
Australia. The WHO survey documented and Biological Engineering (IFMBE)
the following international professional founded in 1959, and the International
associations: Organization for Medical Physics (IOMP)
founded in 1963. Every three years,
• International Union for Physical and IUPESM co-hosts, with the IFMBE
Engineering Sciences in Medicine and IOMP, and two local associations
(IUPESM) (one BME and one medical physics)
• International Federation for Medical a World Congress on Medical Physics
and Biological Engineering (IFMBE) and Biomedical Engineering. Further
• Institute of Electrical and Electronics information can be found at: http://www.
Engineers - Engineering in Medicine iupesm.org/
and Biology Society (IEEE - EMBS)
• Commission for the Advancement in In 1999, IUPESM was acknowledged
Health-care Technology Management by the International Council of Science
in Asia (CAHTMA) (ICSU) as a scientific organization. Within
• European Alliance for Medical and the IUPESM, the Health Technology
Biological Engineering and Science Task Group (HTTG) has the mission
(EAMBES) to promote health and quality through
• European Society of Engineering and the advancement of application and
Medicine (ESEM) management of health technology.
• International Council on Medical and In pursuit of its mission, the HTTG
Care Compunetics (ICMCC) promotes international cooperation and
• Australasian College of Physical communication among those engaged
Scientists and Engineers in Medicine in health-care technology. Additional
(ACPSEM) information and educational material
• Association Francophone des can be found at: http://www.iupesm.org/
Professionnels des Technologies de health-technology-tas-group-httg/
Santé (AFPTS)

WHO Medical device technical series 55


3.2.2 International Federation for provide the forum for enhancing local
Medical and Biological Engineering activities supplemented by EMBS’s
Founded in 1959, the IFMBE is the special initiatives that provide faculty and
principal organization representing financial subsidies to such programmes
biomedical and biological engineers in through the society’s distinguished
over 50 nations. The IFMBE comprises lecturer programme and its regional
53 national medical and biological conference committee. The EMBS
engineering associations and six publishes three journals: Transactions
transnational associations. A history of the on Biomedical Engineering, Transactions
first 40 years of the IFMBE was published on Rehabilitation Engineering and
in 1997(61) and Launching the IFMBE Transactions on Information Technology
into the 21st century was published in Biomedicine and a bi-monthly
more recently.(62) The federation has magazine (IEEE Engineering in Medicine
two divisions: the Clinical Engineering and Biology Magazine). EMBS is a
Division (http://cedglobal.org/) and the transnational voting member society of
Health Technology Assessment Division the IFMBE. For further information see:
(http://2016.ifmbe.org/organisation- http://www.embs.org/
structure/divisions/htad/).

The IFMBE publishes a journal, Medical 3.3 Professional biomedical


& Biological Engineering & Computing associations – global data
(MBEC), which celebrated its 50th
anniversary in 2013. As of 2016, IFMBE In order to understand the status
has been an NGO in official relations with and profile of biomedical engineers
WHO for more than 10 years. Further globally, WHO integrated data from
information about the federation can be 2009 to 2016, which are presented in
found at: www.ifmbe.org Figure 3.1, documenting the existence
of international, national and regional
3.2.3 Institute of Electrical and associations, which are key for promoting
Electronics Engineers - Engineering collaboration between individuals,
in Medicine and Biology Society governing bodies and academic
The IEEE (www.ieee.org) is the largest institutions of biomedical engineering.
international professional organization in High numbers of active members
the world and accommodates 37 different within these associations encourages
associations under its umbrella structure. collaboration between sectors and
Of these 37, the EMBS represents the rapid development of curriculum. It is
foremost international organization important to note that this report does not
serving the needs of nearly 8000 BME in any way endorse the work performed
members around the world. The field by the professional associations listed,
of interest of EMBS is application of the but simply serves to compile information
concepts and methods of the physical on these groups and raise awareness of
and engineering sciences in biology and initiatives in the BME field.
medicine. Each year, the society sponsors
a major international conference while In total, 164 BME professional
co-sponsoring a number of theme- associations and associations were
oriented regional conferences throughout identified. The Region of the Americas
the world. A growing number of EMBS accounts for the greatest number,
chapters and student clubs globally though it is important to note that the

56 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers


United States of America accounts for Figure 3.2 illustrates the percentage of
more than half of this number, as it has countries with at least one biomedical
several subnational associations and engineering professional association.
associations. In contrast, most of the In total BME association presence was
other countries report only one national identified in 86 countries distributed
BME professional society or association. by region as follows; African Region
The complete list of all associations and (17 countries), Region of the Americas
federations can be found in Annex 3. (11 countries), South-East Asia Region
(4 countries), European Region
Figure 3.1 illustrates the total number (43 countries), Eastern Mediterranean
of identified biomedical engineering Region (6 countries) and Western Pacific
professional associations by region Region (7 countries).
including international associations not
specifically classified in any WHO region. Figure 3.3 depicts the percentage
In total, 160 biomedical engineering of countries with BME professional
professional associations were identified associations by income grouping. This
by compiling all sources of information, figure underlines disparities between
though only 25 completed the WHO high- and Low income countries. 44%
2015 survey. It is important to note that of countries with at least one identified
Andorra, Armenia, Azerbaijan, Belarus biomedical engineering association are
and the Russian Federation reported High income countries while only 12%
the presence of BME associations within of these countries are grouped as Low
the country though the name of such income. Low- and lower middle-income
associations was not stated and is missing countries together only account for 27%
in this report. In contrast, most of the other of the identified biomedical engineering
countries incorporate only one national professional associations. Nevertheless
BME professional association. Figure the data for 109 countries is still missing
3.1 also includes three international thus further efforts are needed in the
associations and organizations. future to fill this information gap.

Figure 3.1 Number of biomedical engineering professional associations at global, national and subnational
level stratified by WHO region

Biomedical engineering professional


associations

African Region of the South-East European Eastern Western


International
Region Americas Asia Region Region Mediterranean Pacific Region
Region
IUPESM
17 4
6
19 IFMBE

64 50
IEEE

WHO Medical device technical series 57


Figure 3.2 Countries with at least one BME professional association by WHO region

 AFR 8%
 AMR
 EMR 5%
17%
 EUR
 SEAR
 WPR

13%

50% 7%

Source: Data was reported in surveys launched by WHO from 2009–2015.

Figure 3.3 Countries with at least one BME professional society by income grouping

 Low income
 Lower middle income 12%
 Upper middle income
 High income

44% 15%

29%

Source: Data was reported in surveys launched by WHO from 2010–2015.

58 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers


3.4 Phases of institutional ideal of service to society. A code of
development of a profession ethics usually comes at the end of the
professionalization process. Efforts to
One can determine the stage and status adopt codes of ethics have been seen
of the professionalization of a social recently – the BMES in 2004,(64) and
institution by noting the accomplishment IFMBE in 2010.(65,66)
of six crucial events:(63)
As health services grow ever more
• First training school t e c h n o lo g y in t e n sive a n d t h e ir
• First university school dependence on that technology
• First local professional association increases, the professional characteristics
• First national professional association of those engineers who develop and
• First state licensing law manage this critical environment, and
• First formal code of ethics. the organizations that guide their career
development, promote a commitment to
The early appearances of training schools serve human needs ethically, honestly and
and university affiliation underscore competently in accordance with highest
the importance of the cultivation of a standards of professional conduct.
knowledge base. The strategic innovative There are so many challenges facing
role of the universities and early teachers young biomedical/clinical engineers –
lies in linking knowledge to practice whether in coping with work pressures,
and creating a rationale for exclusive budgetary constraints, value conflicts or
jurisdiction. Those practitioners pushing interpersonal communications – that it
for prescribed training then form a is essential to have a support system(67)
professional association. The association that collects and shares experiences in
defines the task of the profession: the form of a professional organization,
raising the quality of recruits, redefining where knowledge, commitment and
their function to permit the use of less professional responsibility to those served
technically skilled people to perform the are explicit pillars of practice.
more routine, less involved tasks and
managing internal and external conflicts. 3.4.1 Institutional maturity of
In the process, internal conflict may arise biomedical engineering
between those committed to established In BME, all six critical steps mentioned
procedures and newcomers committed above have been clearly taken. It has
to change and innovation. At this stage, demonstrated the sequence of maturing
some form of professional regulation, organizational capabilities required to
such as licensing or certification, surfaces qualify as a legitimate and credible
because of a belief that it will ensure profession by both historical and societal
that minimum standards are met for the standards. In April 2015, the European
profession, enhance its status and protect Economic and Social Committee (EESC)
the layperson in the process. drew up its own initiative on promoting
the European single market combining
The last area of professional development BME with the medical and care services
is the establishment of a formal code of industry. In this initiative, the EESC
ethics, which usually includes rules to recognizes the role of BME in society,
exclude unqualified and unscrupulous and recommends following the American
practitioners, reduce internal competition example and recognize the discipline as
and protect clients and emphasize the a stand-alone science.

WHO Medical device technical series 59


Credit: James Wear; Chinese clinical engineering certification exam.
4 Certification

4.1 Defining certification as committed to their profession, and


provide assessment and recognition
Professional certification is the process of their background, experience and
of issuing a certificate formally attesting legitimacy to meet predetermined and
that the knowledge, know-how, skills and standardized criteria.
competences acquired by professionals
have been assessed and validated by Certification: This is generally a third-party
a competent body against predefined attestation that specified requirements
standards. Appropriate career paths and related to persons, products, processes
opportunities, including professional or systems have been fulfilled. In order to
registration, certification or licensing, apply professional standards, increase the
should be available to all health level of practice and protect the public,
professionals for the benefit of public a professional organization may establish
health and patient safety. This chapter a certification. Professional certification
describes the introductory information, earned by an individual to perform a job or
history, current status and future task is often simply called “certification”.
prospects of professional certification, and In this context certification is the process
gives a number of examples of different of issuing a certificate – a statement or
national, transnational and global models. declaration such as a diploma, degree,
Biomedicine and health-care challenges title, clearance, etc. – formally attesting
in the 21st century demand regulation that knowledge, know-how, skills and
of all health professions worldwide, so competences acquired by an individual
certification of professionals in the field of have been assessed and validated by
BME is among the global priorities. a competent body against predefined
standards. Professional certification may
One of the professional approval further require certain work experience
processes used in BME is certification; in a related field before certification is
but this term is sometimes confused awarded, either for a lifetime or as a
with related terms like registration, time-limited recognition of an individual.
accreditation, credentialing and licensing. Certifications are usually earned from
To clarify the definitions, similarities and professional associations, but also from
differences between the terms within the universities and private certifiers for some
professional context is outlined below. specific certifications. Certifications are
Credentialing: An umbrella term used for very common in the health-care sector
different approval processes including and are often offered by particular
accreditation, certification, licensing and specialisms. An example of such a
registration. “Credential” is defined as an certification process is a physician who
attestation of qualification, competence receives certification by a professional
or authority of professionals issued to specialism board in the practice of, for
individuals by a third party with the instance, radiology. The most general
authority to do so. Obtained professional type of certification is profession-wide
credentials demonstrate proficiency in the and is intended to be portable to all
field of interest and identify individuals places a certified professional might

WHO Medical device technical series 61


work. Certification is a voluntary process requirements set for licensing. When
and it is based on the premise that applied to an organization, or part of
there is a right to work. However, it is an organization, such as a laboratory,
not a permission to work, but rather a certification usually implies that the
statement of completion or qualification, organization has additional services,
with the purpose to educate and inform. technology or capacity beyond those
Certification may be withdrawn at any found in similar organizations.
time by the issuing organization, but this
does not stop individuals from working. Licensing: This is generally a
Licensing and certification are similar in mandatory approval process by which
that they both require the achievement of a governmental authority grants time-
a certain professional level. limited permission (licence) to individuals
or organizations, after verifying that they
Accreditation: A third-party attestation met predetermined and standardized
related to a conformity assessment criteria, to perform an activity that
body conveying formal demonstration is otherwise forbidden, considered
of its competence to carry out specific hazardous or which requires a high
conformity assessment tasks. It is a level of expertise. Licensing presumes
formal process of quality assurance that engagement in the particular field
through which accredited status is is a privilege rather than a right, so the
granted, showing it has been approved given privilege may be withdrawn at
by the relevant legislative or professional any time by the issuing authority. The
authorities by having met predetermined purpose of licensing is to restrict entry
standards. Accreditation standards and strictly control a profession or activity
are usually regarded as optimal and by ensuring that the licensee has met
achievable, and are designed to eligibility requirements and passed some
encourage continuous improvement form of assessment, usually at the state
efforts within accredited organizations. level and required by law. The licence
Accreditation is often a voluntary may be renewed periodically through
process in which organizations choose payment of a fee or proof of continuing
to participate, rather than a process professional development, by inspection,
required by laws and regulations. It is etc. Licensing is common in medicine,
common in the health-care sector, and nursing, pharmacy, psychology, social
an accreditation decision about a specific work, engineering, etc., but hardly ever
health-care organization is usually made in BME. The main aim of licensing is to
following a periodic on-site evaluation protect public health and ensure patient
by a team of peer reviewers, typically safety. Professional associations are often
conducted every few years. Although the an important resource and support to
terms “accreditation” and “certification” those looking to obtain a special level of
are used interchangeably, accreditation certification or licence.
usually applies only to organizations, while
certification may apply to individuals, as Registration: This concerns insertion on an
well as to organizations. When applied official register organized by a regulatory
to individual practitioners, certification body, usually by recording or registering
usually implies that the individual has certificates. Registration implies standards
received additional education and for training, professional skills, behaviour,
training, and demonstrated competence health etc., which registrants must meet
in a specialist area beyond the minimum in order to become registered and must

62 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers


continue to meet in order to maintain their The International Registration Board
registration or licence. In most cases, the (IRB) is responsible for the registration of
terms “licensing” and “registration” are clinical engineers. The IRB consists of the
also used interchangeably.(68,69,70) chair of the national examining authority
(NEA) from each of the ANS party to
the agreement, plus representatives
4.2 International certification of of independent international bodies
biomedical engineers and others as appropriate. Each ANS
establishes the NEA in its country, and
There is considerable variety in the acts as a communication channel with the
ways that different nations manage IRB. Each NEA recommends individual
the certification of BME and related candidates to the IRB for registration.
disciplines, including clinical engineers, The CED establishes the constitution and
rehabilitation engineers and biomedical by-laws of the IRB to be approved by the
technicians. IFMBE Administrative Council. A non-
refundable fee for certification covers
The International Federation for Medical the cost of processing applications. Each
Electronics and Biological Engineering NEA publishes operational guidelines,
was founded in 1959 and eventually submits its constitution and by-laws to
shortened its name to the International be approved by the IRB, takes care of
Federation for Medical and Biological funding, participates in IRB’s activities
Engineering (IFMBE). Two special divisions through its chair, organizes collection and
are currently part of the organizational processing of applications, sets up and
structure: Clinical Engineering Division conducts examinations for candidates,
(CED), and Healthcare Technology and recommends actions to the IRB. The
Assessment Division (HTAD). Originally exact form of the examination process
established as a working group in 1979, (written, oral, view, etc.) is left to the
the CED attained official division status individual NEA, but has to satisfy the
in 1985. requirements of the IRB, i.e. has to be
meaningful so that successful candidates
In 1981, the Agreement on Mutual perform well within the specialism without
Recognition of Qualifications for Clinical preventing well qualified individuals from
Engineers was signed by 22 affiliated attaining certification.
national associations (ANS) of the IFMBE
(Austria, Australia, Belgium, Canada, In order to obtain international registration
Denmark, Finland, Federal Republic of as a clinical engineer, the agreement
Germany, France, German Democratic defined that a candidate must have
Republic, Hungary, Israel, Italy, Japan, successfully completed a basic education
Mexico, Netherlands, Norway, Spain, in engineering or applied sciences to BSc
South Africa, Sweden, United Kingdom, level and to have more than three years’
United States of America and Yugoslavia), relevant clinical engineering experience,
mutually agreeing to recognize any holder or, in addition to achieving a BSc, to
of IFMBE’s Certificate of Registration as have a MSc or PhD and/or training in
a Clinical Engineer, subject only to such BME and to have more than two years’
additional criteria as might be specified relevant clinical engineering experience.
by individual ANS. NEAs may, at their discretion, but with the
approval of the IRB, impose additional
Mechanisms of registration were requirements as dictated by local national
developed and elaborated as follows. practices. Two years’ relevant experience

WHO Medical device technical series 63


counts as one year of training, where requirements. They also include
experience is offered instead of training. medical equipment repair personnel.
In Zimbabwe the Health Profession Act
Formally, this agreement seems still to does not recognize biomedical equipment
be in place, but since registration and/ technicians and engineers under allied
or certification have never been made health professionals. However, there
mandatory by national legislation in most is a Chief Medical Engineer in the
of the countries, the agreement has been Ministry of Health. The technicians and
neglected and the project of international engineers are in the process of forming
registration and/or certification has a national association to advocate for
actually never been accomplished to a legal recognition within the act. Once
full extent using defined mechanisms, they are recognized, they will be able
as elaborated above. A possible initial to participate in the annual review of
attempt to resolve this appeared via the human capacity needs for the health-
first issue of an international directory of care sector. The Zimbabwean situation is
clinical engineers in 1994, containing a good example of the situation in most
names of more than 1200 individuals sub-Sahara African countries, although
from 62 countries, with the intention to at least 17 countries have a registered
improve recognition, communication association.
and networking within the global clinical
engineering community.(71) 4.3.2 Certification in the Americas

Though neither the law nor employers Canada


usually require certificates in clinical Certified biomedical engineering technologists
engineering, there is a significant interest and technicians
in and need for clinical engineering A group of biomedical engineering
certification, as shown by the latest global professionals started the discussion of
CED survey among clinical engineering certification in 1976 during a national
professionals and associations. conference which led to the creation of
Biomedicine and health-care challenges the Canadian Board of Examiners for
in the 21st century demand regulation Biomedical Engineering Technologists
of all health professions worldwide, thus and Technicians in 1981. The board was
an international umbrella programme initially affiliated with the AAMI sponsored
for certification in clinical engineering is International Certification Commission
among the priorities of the global clinical (ICC) until it was replaced by the AAMI
engineering community. Currently an Credential Institute (ACI) in 2016.
ongoing CED project on international
clinical engineering certification is Certified clinical engineers
expected to help in finally achieving this By 1980, it was recognized that engineers
goal. working in clinical engineering required
a distinct but unrecognized body
4.3 Certification by region of knowledge to perform their tasks
competently. Since there was no licensing
4.3.1 Certification in Africa process in place specifically for clinical
South Africa has a voluntary registration engineering, leaders in Canada decided
programme of clinical engineers, to establish a certification process that
clinical engineering technologists and would be administered by competent
clinical engineering technicians, which members of the profession. In order to
is based on experience and academic begin such an effort, discussions were

64 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers


held with colleagues in the United States knowledge of American codes, standards
of America who had undertaken a similar and regulations. Canadian candidates
approach under the leadership of AAMI. are examined through a slightly different
Canadians with established track records but parallel process to their American
working in the profession were certified counterparts.(72)
(on the grounds of experience), and
established the first Canadian Board It was agreed that Canadian applicants
of Examiners for Clinical Engineering would register and be administered by
Certification. They developed a written the secretariat to the American board,
and an oral exam. This process of to avoid setting up a parallel office in
certification continued for a number Canada. Sites are available in Canada
of years. However, the initial rush of to sit for the written exam, which is
applicants dwindled and it remained a made available in both countries on a
voluntary activity with limited visibility in single date and time each year, early in
the health-care community. November. All policies and procedures
are harmonized and the Canadian
Adding further credibility to the process, board assists the American board in the
the US Board of Examiners is accountable generation of new written and oral exam
to the Health Technology Certification questions. Members of the two boards
Commission (HTCC), which oversees the discuss their work on a regular basis, and
work of the board and ultimately decides the chairs of each sit on the HTCC. The
on recommendations from the board to harmonized process was established in
certify individuals. Discussions between 2010 and remains in place. There has
the Canadian and American boards been good communication between the
gained support and encouragement from two boards, and a generally high level of
American colleagues. Under the laws of support for the harmonized process.
the Canadian provinces and territories,
the use of the title “engineer” in a job United States of America
description requires that the incumbent Certified biomedical equipment technicians
be licensed as a professional engineer Certification in the United States of
in that jurisdiction. Canada has always America in the clinical engineering
taken the position that to be eligible to field began with biomedical equipment
seek certification in clinical engineering technicians. A taskforce was established
an applicant must first obtain a licence by the Association for the Advancement
as a professional engineer. Once a person of Medical Instrumentation (AAMI) to look
is licensed as a professional engineer at the BMET field and the maintenance
and is working in the field of clinical of medical equipment in hospitals. The
engineering, then they can apply to the taskforce decided that certification was
Canadian Board of Examiners for Clinical needed to allow BMETs to demonstrate
Engineering Certification. Another main that they had a minimum level of
issue of divergence of practice between expertise. A board of examiners was
clinical engineers in the two countries established by AAMI and the first exam
relates to the country specific codes, set in 1971. Individuals who passed the
regulations and standards, an important written exam became certified biomedical
but relatively small part of the written equipment technicians (CBETs).
exam. In discussion, it was agreed that
members of the Canadian board would Specialist exams were also developed by
review the American written exam, to AAMI for BMETs who work on laboratory
identify those questions requiring specific and radiological equipment. These

WHO Medical device technical series 65


BMETs do not have to take the general 4.3.3 Certification in Asia
exam since they only work on specialized
equipment, but they need certification to Commission for the Advancement of Health-
demonstrate a minimum level of expertise care Technology Management in Asia
in their specialism. Individuals who pass The Commission for the Advancement
these exams become certified radiological of Health-care Technology Management
equipment specialists (CRES) and clinical (CAHTMA) was initiated in 2005
laboratory equipment specialists (CLES). with the endorsement of the Asian
Hospital Federation (AHF), which is
Certified clinical engineers an international NGO, supported by
Individuals must meet the following members from 14 countries in the Asia-
qualifications to take the certified clinical Pacific region. CAHTMA is a member of
engineer (CCE) exam: three years of the IFMBE. It was established to provide
clinical engineering experience plus a a platform for health-care professionals
professional engineer licence or MSc in to discuss and exchange ideas on health-
engineering or a BSc in engineering plus care technologies and practices. Central
four years’ total engineering experience, to these objectives are the promotion
or BSc in engineering technology plus of best technology management
eight years’ total engineering experience. practices, the certification of clinical
engineering practitioners and health-care
The written and oral exams are developed professionals, and the dissemination of
by the board of examiners and are based appropriate management tools through
on the body of knowledge developed seminars and workshops.
by the American College of Clinical
Engineering (ACCE).(73) CAHTMA has certified a few clinical
practitioners. Technicians are certified
Brazil as a level one clinical practitioner with
In the 1990s, nine Brazilian clinical a written exam and experience which is
engineers were certified by the ICC and the similar to the ICC BMET. Engineers are
Brazilian Board of Examiners for Clinical certified as level two clinical practitioners
Engineering Certification was created. with a written exam and an oral exam and
However, a certification programme has experience which is similar to the HTCC
not yet been developed.(74) CCE. To encourage more engineers to
become certified, CAHTMA is going to
Mexico use the process of certifying individuals
In 1991, the first Mexican clinical based on credentials similar to the initial
engineer was certified by the ICC and programme in the United States of
in 1993 the CCE exam was given in America.
Mexico and three more Mexican clinical
engineers were certified. In 1994, CAHTMA is also the certifying faculty
the Mexican Board of Examiners was for BME technology programmes which
approved by the ICC which accepted are developing with the increased need
the affiliation of the Mexican Certification for technologists to maintain medical
Commission. The recently established equipment. In 2012, lecturers at one
Mexican College of Biomedical Engineers school were tested as assessors and
will certify biomedical engineers, BMETs certified by CATHMA with the Certification
and rehabilitation engineers. For further for Clinical Engineering Assessors.
information see: http://www.cib.org.mx/ Lecturers who completed five weeks
servicios.html.(75) of training and passed the exams were

66 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers


certified by CATHMA with the Certification China is establishing continuing
for Clinical Engineering Trainers.(76) education for both certifications to
maintain and improve the quality of
China the clinical engineers. The Medical
In 2005, international clinical engineer Engineering Division plans to recommend
certification was introduced in China. to the government to officially authorize
The Medical Engineering Division of the clinical engineer training and certification.
Chinese Medical Association hosted the (77) In Hong Kong (SAR), China, BMETs
first international clinical engineering take the ICC exam used in the United
certification training courses and States of America; no Hong Kong board
certification examination. The written of examiners has been appointed. For
exam is based on the ACCE body of CCE they use the American exam process
knowledge with some adjustment for under the HTCC.(78)
the practice of clinical engineering in
China. The written exam is in English The Taiwan Society for Biomedical
and is prepared by international senior Engineering (TSBME) performs
specialists. Individuals who pass this certification in clinical engineering
100-question multiple choice exam have in Taiwan, China. In 2000, TSBME
to then pass an oral exam in English to established the Certification Executive
become certified. The oral exam is given Committee for Clinical Engineering
by the international senior specialists. In certification. The first testing for
the seven training sessions since 2005, certification of clinical engineers and
760 clinical engineering personnel have technologists of medical equipment
attended. Some 252 individuals have was in 2007. The TSBME provides
passed the two exams and been certified certification for clinical engineers,
as international clinical engineers. The medical equipment technicians and
candidates for certification are mostly biomedical engineers. In 2010 they
senior clinical engineers with more than had certified 93 clinical engineers, 132
10 years’ experience. In 2012, the Medical medical equipment technicians and 224
Engineering Division of the Chinese biomedical engineers. Clinical engineers
Medical Association carried out Chinese and medical equipment technicians work
Registered Clinical Engineer Certification in hospitals and biomedical engineers
(RCEC) training and examination. The work in the medical device industry. This
candidates were junior engineers in large is the only certification that has a separate
hospitals or new graduates with majors certification programme for hospital and
in medical engineering. This exam is the industry engineers.(79)
basic admission exam to the occupational
qualification of clinical engineering. The Japan
RCEC exam consists of a theoretical exam In Japan the government certifies clinical
and practical test. There is a Chinese engineering technologists (CET), who
exam question bank from which the must graduate from a clinical engineering
theoretical questions are randomly training school which can be a university,
selected. Candidates then take a practical junior college or training school and pass
test including repair, measurement and a national exam to be certified. CETs
maintenance of medical devices. A are also called clinical engineers and
committee of Chinese clinical engineering are paramedics who specialize in the
experts evaluates the ability of the medical equipment essentials in medical
candidates and determines if they are care. About 35% work in haemodialysis
qualified to receive the Registered Clinical and about 20% in maintenance. Others
Engineer Certification. work in respiratory care, operating

WHO Medical device technical series 67


rooms, intensive care units, heart Czech Republic
related, hyperbaric and other areas. In Since 2004, the Act on Nonmedical
1987 the clinical engineering system Health Service Occupations and related
was established by the Clinical Engineers regulations has recognized health service
Act. This act created the CET as a professionals with technical competences
professional medical position responsible (biomedical technicians with a BSc in
for the operation and maintenance of life- biomedical technology and biomedical
support systems under the direction of engineers with a MSc in biomedical
doctors. This act established a national engineering) and health service specialists
qualification including a 180-question with specialized technical competences
exam in medicine, engineering and (clinical technicians with BSc in clinical
medical technology. In 2010 there were technology and clinical engineers with a
about 28 000 certified CETs and about MSc in clinical engineering), in addition
18 000 currently working in the field. The to similar legislation that had existed
certification of CETs is most equivalent to for decades for medical professionals.
the CBET in the ICC system in the United If workers with technical competences
States of America.(80,81) come into contact with patients or if
they can directly impact patient health
In addition to the CET certification by through their professional activities, they
the government, the Japan Society for are required to have the qualification
Medical and Biological Engineering has of either health service professional or
a BME certificate programme, which has health service specialist. There is an
two classes of certification for biomedical established system of both undergraduate
engineers. The first is for experienced and postgraduate, specialized and
clinical engineers and in 2008 the pass life-long education, accredited by
rate was 22.2% for 433 applicants. This ministries of education and health,
exam covers basic aspects of medical to gain qualifications and appropriate
engineering and medical device related certifications.
subjects. The second exam is for students
or recent graduates of clinical engineering The graduates of accredited study
and many take it as preparation for the programmes and fields get a certificate
national CET exam. In 2008 the pass of qualification to perform health service
rate for this exam was 29.3% for 1398 occupations. Graduates of other BSc
applicants.(82) or MSc study programmes in electrical
engineering can obtain a qualification
4.3.4 Certification in Europe for health service workers with technical
In the European Union BME is not a competence if they complete the
regulated profession; hence there is course in BME (MSc in engineering) or
no centralized, common certification biomedical technology (BSc) accredited
programme that establishes certification by the Ministry of Health. Graduates of
standards for all European Union other study programmes must complete
Member States. Further research will be specialized postgraduate courses
needed to develop a strategy for official in BME. The specialized technical
acknowledgement and certification for competences for clinical technicians
biomedical engineers in this region. and clinical engineers can be obtained
by completing specialized education
and training provided by institutions

68 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers


accredited by the Ministry of Health, engineers from academia, practitioners
and by passing an official examination from the public and private sector, and
in front of the board appointed by the representatives of publically and privately
Ministry of Health. Clinical engineering funded hospitals. The plan considered
as specialized education and training education, clinical engineering
for biomedical engineers, and clinical experience, ethics, professional standing
technology for biomedical technicians and continuing professional development
are types of education organized by the (CPD).
Institute for Postgraduate Education in
Health directly controlled by the Ministry The plan is based on achieving Engineers
of Health. Ireland’s professional titles (engineering
technician, associate engineer and
The Ministry of Health issues the official chartered engineer). Engineers Ireland
certificates for biomedical technicians/ has statutory responsibility for the title of
engineers and clinical technicians/ “chartered engineer” in Ireland. The three
engineers. Then they can apply for protected titles of Engineers Ireland require
registration in the Registry of Health the achievement of a specified academic
Care Professionals, which is a part of the standard, a specified minimum number
National Health Care Information System. of years of experience, an interview based
They receive a certificate that is valid for on a set of published competencies, and
six years and renewable thereafter under an engagement with a code of ethics.
defined criteria.(83) Engineers Ireland also has a well-developed
Germany plan to support “grandfathering” with a
Germany has developed a certified process which recognizes experience
clinical engineering programme, but it in lieu of academic qualifications by
does not require an exam. It is based on assessing candidates’ ability with respect
experience and academic background. to specific competencies. In addition,
They are also planning to develop a the plan includes an application form
certified BMET programme. In most where two recognized practitioners sign-
European countries, there are more off on the candidates’ experience in the
engineers than technicians and so the clinical engineering field. A voluntary
certification of the engineer is more CPD scheme was also developed. Since
important. clinical engineering is a small profession
in Ireland, statutory registration will not
Ireland be implemented for some years. It is
In 2003, in anticipation of forthcoming thought the Clinical Engineering Voluntary
legislation for Statutory Registration of Registration Board plan will meet the
Health and Social Care Professions, the short-term requirements for a registration
Biomedical Engineering Association of plan.(84)
Ireland and Biomedical Engineering
Division of Engineers Ireland established Italy
the Clinical Engineering Voluntary In Italy, a process of defining common
Registration Board and an associated rules for recognizing the activities of
clinical engineering registration scheme, biomedical and clinical engineers and for
as a voluntary professional registration the certification of the skills of engineers
plan. The Clinical Engineering Voluntary is currently in progress. The Territorial
Registration Board was composed of Associations of Professional Engineers

WHO Medical device technical series 69


have the right to set up voluntary theoretical parts of the state exam in front
certification of skills for their members. of the State Examination Commission.
Recent Italian laws have explicitly Professional competences gained
mentioned clinical engineers and clinical during postgraduate education, entitles
engineering services, making the need for successful individuals to work in clinical
a certification procedure more pressing. environments as a medical engineer.
The laws state that the Territorial Moreover, a participation of certified
Associations of Professional Engineers specialists in medical engineering in some
are responsible for defining a set of rules advanced medical procedures is also
for certification. The document, being required by law, as well as in the positions
drafted by local BME committees, will of national and regional consultants for
identify a metric of evaluation that is medical engineering issues.(86)
based on the verification of the contents
of the documents submitted for the Sweden
recognition of skills, on the interview with The Swedish Society for Medical
the candidate and on the evidence for Engineering and Physics started the
continuity of professional activity.(85) Certification of Clinical Engineers in 1994.
The certification is performed by an
Poland examination at two levels, corresponding
In 2002 the programme of specialization approximately to BSc and MSc degrees
in medical engineering for engineers as in engineering, respectively. The BSc
professionals in clinical environments was in engineering, as the lower level of
introduced by national legislation, under certification, was chosen because in 1989
the auspices of the Ministry of Health, the a Swedish law came into force, stating
Medical Centre of Postgraduate Education that a worker should preferably have at
and the national consultant in the field of least this level of education to work in
medical engineering, in a way similar to clinical engineering. At the time, there
education and training programmes for were many engineers working in clinical
medical professionals. The candidates engineering departments in hospitals who
for this specialization must have a MSc in did not possess a BSc but rather an older
BME, automatics and robotics, electronics degree from a polytechnic institute. These
and telecommunications, mechanical engineers were accepted for certification
engineering or computer science, and if their degree dated 1989 or earlier, but
at least three years’ work experience in they had to have at least six years’ instead
a clinical environment. The workload of of three years’ work experience.
this postgraduate medical engineering Applications for certification are sent to
specialization programme is 1700 hours the society twice a year, and are reviewed
over two to three years, with about and judged by a certification committee
half filled with lectures and laboratory with the mandate from the society’s
exercises, and the rest placement in board. The certification committee
hospitals and clinics with appropriate consists of a chair (preferably a lawyer
facilities, equipment and staff for such from a state health-care organization or
activity, and being accredited by the State a health-care provider), two university
Commission for Accreditation. professors in BME, and two experienced
certified clinical engineers.
At the end of the programme, in order
to obtain the title and the certification as The requirements, besides the
a specialist in medical engineering, the engineering degree and minimum
candidate has to pass the practical and three years’ hospital work experience

70 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers


as a clinical engineer supervised by an minimum of 30 ECTS points. Certification
experienced and preferably certified of specialists is also performed at both
clinical engineer, are university/institution/ BSc and MSc level in engineering. To
company courses in biomedical or clinical keep specialist certification, clinical
engineering, medicine or related fields engineers should continue with their
corresponding to at least 30 ECTS points professional development through
assigned and collected under defined ongoing training and education. Different
criteria. Since 1994, there have been a specialist programmes are currently under
total of 695 applications, 571 at BSc level development: medical imaging, dialysis,
and 124 at MSc. Some 391 have been intensive care, computers in health care,
certified (304 BSc and 87 MSc). responsibility and management, etc.(87)

A programme that certifies specialists United Kingdom


in clinical engineering was developed in The United Kingdom initially developed
2014. To become a certified specialist in a certification for clinical engineers in
clinical engineering, the engineer should the 1990s but this programme has been
have at least two years’ specialist training dropped due to lack of interest. Currently
supervised by an experienced and certified there is voluntary registration for clinical
specialist in clinical engineering. The scientists and clinical technologists,
specialist training programme consists of which includes professionals working
courses corresponding to CPD, which are in the field of clinical engineering and
classified by the certification committee. medical physics.
Specialist training years should equal a

WHO Medical device technical series 71


Credit: Adriana Velazquez; launch of the European Parliament interest group in biomedical engineering, May 2016.
PART II: THE PRACTICE OF BIOMEDICAL
ENGINEERING

5 Development of medical devices policy

5.1 Introduction for, the exploration of new medical


technologies and their role in achieving
Only in recent years have biomedical the aims of these global institutions.
engineers begun moving into senior
positions in governments, international The United Nations family includes
organizations, hospitals, academia and various global organizations, but the 2015
the medical devices industry. This chapter survey indicates only the United Nations
presents a profile of their activities, Population Fund (UNFPA), United Nations
within these different settings, at senior Office for Project Services (UNOPS),
management level and considers the UNICEF and WHO with staff with a BME
roles biomedical engineers can have profile. Key organizations such as the
in the planning and development of Word Bank, World Trade Organization and
health technology policies and in the World Intellectual Property Organization,
implementation of medical devices even though all deal with procurement,
policies at government and international trade or intellectual property and medical
organization level. technologies, do not have positions for
biomedical engineers. They do have
specialists in the area of health products,
5.2 International organizations mainly dedicated to medicines, but are
lacking the expertise of biomedical
A few international organizations and engineers or related fields, to target the
NGOs with an agenda in public health medical devices challenges.
engage biomedical engineers, including
United Nations agencies such as UNICEF An explanation of what biomedical
and WHO and Doctors Without Borders. engineers undertake in the different
organizations will be presented.
However, according to the January 2015
Global Survey - Professional and Academic 5.2.1 United Nations Population Fund
Profiles on Biomedical Engineers and In support of reproductive health and
Technicians, their numbers are still very maternal health programmes and
limited. Worldwide, Doctors Without services, UNFPA procures medical
Borders currently employs 12 biomedical devices and medical equipment in
engineers, UNICEF six and Medics the following categories: medical
Without Vacations (which contributes and surgical instruments, diagnostic,
to the sustainable improvement of care laboratory, medical electrical, anaesthetic,
in African hospitals) only one. Although sterilization, medical renewable supplies,
some biomedical engineers exist in this medical attire and medical utensils. A full
capacity, many more are needed for a list of commodities can be found at: https://
better understanding of, and advocacy www.unfpaprocurement.org/products

WHO Medical device technical series 73


In collaboration with partners, UNFPA In 2015, UNOPS was involved in
has developed interagency reproductive implementing 28 health projects in Latin
health kits for use in crisis situations. America and the Caribbean and created a
These kits have been designed to facilitate professional network on health, including
the provision of priority reproductive 20 biomedical engineers, specialists
health services to displaced populations and professionals related to medical
without medical facilities, or where technology. This network is present in
medical facilities are disrupted during 15 countries, promoting the sharing of
a crisis. They contain essential medical knowledge, skills and experiences, to
equipment and supplies and medicines support health projects, increasing the
to be used for a limited period of time and effectiveness and efficiency of all those
a specific number of people. In addition, specialized services provided by UNOPS,
UNFPA, following input from health- and optimizing the technical resources
care professionals and other experts, inside the organization.
has compiled a number of standardized
surgical sets for sexual and reproductive In the medical equipment field, UNOPS
health procedures. supports the equipment of existing or
new hospitals, like the Gonaïves Hospital
Because quality is crucial to UNFPA, in Haiti, the Dr Alejandro Davila Bolaños
efforts are made to ensure, in line with Hospital in Nicaragua and the 24 health
international standards and guidelines, facilities for the Social Security Institutes
that the medical devices provided to in Guatemala and Panama, which it is
relevant countries are safe and of good assisting in building.
quality. The quality assurance (QA)
process is conducted by the team in In 2014, UNOPS supported the Honduras
the QA Cluster in collaboration with Ministry of Health in the renegotiation
the technical division, with assistance of an existing contract to purchase
from external technical experts where and maintain medical equipment,
necessary. generating US$ 47 million in savings.
In 2014 and 2015, UNOPS supported
5.2.2 United Nations Office for the Social Security Institute of Panama
Project Services to build a national teleradiology network
This agency is an operational arm of connecting 38 health facilities throughout
the United Nations, supporting the the country: investment value US$ 89
successful implementation of its million, including equipment renewal
partners’ peacebuilding, humanitarian and radiology information system/picture
and development projects around the archiving and communication system
world. It provides project management, (RIS/PACS) implementation. Further
procurement and infrastructure services information can be found at: https://www.
to governments, donors and United unops.org/english/About/Pages/default.
Nations organizations. aspx

In Latin America and the Caribbean, 5.2.3 United Nations Children’s Fund
UNOPS manages health projects from The health technology area in UNICEF’s
the planning, design, construction and Supply Division in Copenhagen deals with
reconstruction of health facilities, to the procurement, supply chain of essential
procurement of medical equipment and products, including medical devices
medicines, including the analysis and and assistive devices for children in low-
reorganization of the supply chain at resource settings. Biomedical engineers
national or institutional levels. play an essential role within UNICEF,

74 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers


providing medical device expertise along In the Health Technology Centre more
the entire supply chain for essential broadly, three additional units oversee
medical supplies for health programmes the technical and commercial aspects
and emergency response. of procurement of injection devices, cold
chain equipment, rapid diagnostic tests
UNICEF works in over 190 countries and bed nets; several of the technical
globally to promote the rights of children staff in these units are also biomedical
and is a major source of health, nutrition, engineers by training.
education, water and sanitation and
child protection supplies in low-resource The Medical Devices Unit’s technical
settings. In 2014, for example, UNICEF team is also responsible for developing
procured US$ 3.3 billion worth of and managing medical kits for
supplies for development programmes emergency response and health system
and humanitarian emergencies, of which replenishment, often in coordination with
approximately US$ 140 million was WHO and other United Nations partner
medical devices and kits for maternal, agencies. In addition to medical and
newborn and child health (MNCH) clinical laboratory devices and medical
interventions. kits, UNICEF’s biomedical engineers are
product experts on in vitro diagnostics,
UNICEF has five health technology personal protective equipment (PPE)
managers currently working on medical used in health emergencies, such as
devices and medical kits. They include the Ebola response, as well as assistive
two biomedical engineers, two biomedical health technologies (AHTs) for children
scientists and one clinician. They work with disabilities, and training products for
in the technical team within the Medical health-care workers on essential MNCH
Devices Unit of the Health Technology interventions.
Centre, and are responsible for the
technical aspects of the selection and In addition to managing medical device
procurement of over 800 medical and procurement, the team advises on supply
clinical laboratory devices that form chain management and health technology
UNICEF’s standard product range, which management in-country, beginning with
can be seen at: https://supply.unicef.org/ needs assessments. They also work
unicef_b2c/app/displayApp/(layout=7.0- closely with WHO and other partners
12_1_66_67_115&carea=%24ROOT)/. to foster product innovation, produce
do?rf=y guidance for medical device selection
in low-resource settings and harmonize
The technical aspects of the work specifications for essential supplies for
include outlining the need for the MNCH. The biomedical engineers also
devices, developing specifications, conduct fit for purpose evaluations and
ensuring relevant QA standards are market research on essential, strategic
met and overseeing how the devices devices.
perform technically in the field. Within
the Medical Devices Unit, there is also Some examples of current projects the
a team of contracting colleagues, who team is managing include: strengthening
focus on all the commercial aspects MNCH services in the Democratic
of the procurement exercise and are Republic of the Congo through the supply
accountable for an understanding of of medical devices to equip 200 hospitals
the market for all of the devices in the and 1000 health centres nationwide;
portfolio. leading two projects to foster innovation
for child wheelchair solutions for use

WHO Medical device technical series 75


in emergencies and for improved acute development of medical devices policies,
respiratory infection diagnosis for children regulation, innovation, health technology
in their communities; and working with assessment and health technology
partners to evaluate new point of care HIV management of medical devices and a
diagnostics in seven African countries. diverse range of publications annually.
Their expertise is essential to ensuring Guidance on how to increase access
quality medical devices are available to safe, effective and affordable and
where they are most needed. appropriate medical technologies to meet
the global needs is the objective. Recent
5.2.4 World Health Organization publications include the 18-book Medical
The primary role of WHO is to direct device technical series, the annual
and coordinate international health Compendium of Innovative Technologies
within the United Nations system. The for Low Resource Settings and numerous
main areas of work, are: health systems, technical specifications. The team
promoting health through the life course, is currently developing the following
noncommunicable and communicable Essential Lists of Medical Devices: for
diseases, and preparedness, surveillance reproductive, maternal, newborn and
and response. child health; for all stages of cancer
care; and for ageing populations. Other
One of the six strategic objectives of WHO key areas in which the team is involved
is to increase access to health products, include, medical devices pricing and
which include medical and assistive feasibility tools for local production, PPE
devices, vaccines and medicines. and medical devices for emergencies or
However, the medical devices work for outbreak response and preparedness.
has historically received less resources
than medicines and vaccines. And so The team’s wide ranging involvement
in 2016, very few staff work in this area; and contribution demonstrate the
only .05% of the WHO staff have a BME need for ongoing interdepartmental
background, which include five staff in and interagency collaboration within
headquarters working on: prequalification international organizations – specifically
of in vitro diagnosis; in vitro diagnostic between researchers, policy-makers and
innovation; assistive technologies; and biomedical engineers. This is to ensure
a senior advisor on policies, selection, that advancements in the understanding
assessment and procurement of medical of diseases and treatments and WHO
devices. Outside headquarters, only one recommendations, are in synchrony with
biomedical engineer is engaged as a the availability of effective, reliable and
senior advisor on health technologies – affordable medical technologies, with
in the EMR region and two in country which to administer these solutions.
offices (Iraq and Brazil). Each year,
the Medical Devices Unit benefits from The Medical Devices Unit currently
around 10 interns from different countries has eight collaborating centres (in
or university programmes and volunteers Brazil, Canada, China, Colombia, India,
who work on a range of projects. Not all Mexico and United States, many of
the interns have a BME background; some which are led by biomedical engineers)
are medical doctors, health economists, and maintains official relations with 16
nurses, international relations, lawyers NGOs(88), specialized in different fields
and other engineers. related to medical devices, like pathology,
laboratory, radiology, BME, hospital
The team uses its technical knowledge engineering and medical devices trade
to provide resources to support the associations, among others. Ideally in the

76 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers


future, more BME experts will become • Management and participation in
staff in regional offices and country offices the process of the adverse event
to incentivize the work around medical reporting process.
devices at country level. • Preparation of the process of medical
device recalls or limitation in their
More information on publications and use when incidents related to safety
global collaboration can be found at: are encountered.
http://www.who.int/medical_devices/en/ • In the registration of the device for
market approval.

5.3 National organizations Refer also to Chapter 7.

Generally, every ministry of health has Health technology agency or reimbursement


an agency, unit or service dealing with commission or similar:
health technologies and medical devices
with different functions and objectives • To support the assessment of the
depending on the country and whether it medical devices, understand not just
is a low- or High income nation. the cost effectiveness but the relation
of the device within the package of
The specialized staff in these units interventions that will be supported
support the formulation, monitoring and by a benefits package in the health
evaluation of national health technologies system.
policies within the national health plan. • To define the “positive list” or “basic/
They may also liaise between the national priority medical devices authorized
regulatory authority section on medical for public procurement”.
devices, national reimbursement and • Establishing and updating a standard
procurement units and allocation of equipment list in line with the national
resources. They participate in working package of health-care interventions,
groups established by the health ministry in the framework of universal health
for sector strategies in cooperation with coverage (UHC).
other ministries for the issues related to
health, environment, economy or in case Refer also to Chapter 8.
of emergencies and disasters.
Health technology management national
There are key units in ministries of health unit or similar:
where a biomedical engineer can have a
substantive role: • Coordinating medical devices
maintenance and put in place
Regulatory agency: planned preventive maintenance
(PPM) standard procedures for
• It is proposed that the medical devices health technologies.
should be analysed by specialized • Management and participation in
human resources like biomedical the political documents preparation
engineers who can understand the (orders of the minister, policy
standards compliance, the parts documents, recommendations and
involved in the equipment or the use guidelines) regarding the selection,
the devices will have and the risk distribution, use, and maintenance
level and the importance of quality. of medical devices.

WHO Medical device technical series 77


• Preparation and/or approval health plan. As the WHO Medical device
of medical devices technical technical series demonstrates, it is very
specifications, aiming at the best important that health technology policies
procurement for resource allocations are aligned with the national health
or standardization of health policies and plans of the country. This
technologies used in public hospitals includes all aspects of research and
and increase in quality of care. development, selection, use of medical
• Promoting the use of appropriate devices according to country needs,
medical equipment accordingly to available infrastructure and specialized
interventions for the established human resources for health delivery.
levels of medical care, depending Working at higher levels requires not only
on the population needs. knowledge of BME core competencies but
additional skills in strategic management,
Refer also to Chapter 9. planning, monitoring and prioritization,
among others. WHO has requested
Participation in procurement procedures ministries of health in Member States to
when high and sophisticated technology nominate a focal point for medical devices
is being procured centrally (CTs, MRIs, retrieval and dissemination of technical
etc.) at the ministry of health. information. These designated individuals
liaise with the medical devices staff in
However, the majority of countries aim to WHO and are part of an information
establish medical devices management network to allow global communication to
policies and instruments, for a safe, enhance the best use of medical devices
appropriate and efficient use of technology globally according to country needs.(89)
in the national health system.

Traditionally a clinical engineer figure is 5.5 Conclusion


associated with hospital environments
and a biomedical engineer with research The challenges are enormous but the
and academia; but either profile, medical technologies require good
combined with extensive expertise and management at all levels – international,
technical knowledge in the field, would country and health facility – and thus
allow them to work at senior level in the biomedical engineer and related
health-care institutions, and at national professions should have the tools and
level, in particular, ministries of health or background to further develop this
in international organizations. important area of health-care services.

Successful biomedical engineers have


5.4 World Health Organization – become senior managers and leaders,
medical devices and it is important to promote their role
model in any institutions, countries and
It should be noted that development international organizations that manage,
of national health technology policies use or advise on health technologies,
requires full expertise in the field and especially medical devices to target
collaboration with colleagues in the priority health needs in Member States.
ministry of health developing the national

78 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers


Credit: Kelso lab setting, CIGHT @ NU; biomedical engineers demonstrate the simplicity and accuracy of a rapid test for
infant HIV developed at the Center for Innovation in Global Health Technologies (CIGHT) at Northwestern University, Chicago.
6 Medical device research and innovation

This chapter offers insights on how That medical devices (including in vitro
biomedical engineers can lead the diagnostics) play an important role in health
innovation process in the design of care at all levels of health system delivery,
medical devices to respond to health and in both well resourced and poorly
needs, paying particular attention to the resourced settings, is widely accepted. Yet
roles and responsibilities they may have there remain many challenges, globally in
in different sectors and resource settings. optimizing the technology mix to ensure
optimal efficiencies (both allocative and
technical). WHO has been instrumental
6.1 Introduction in helping address these challenges with,
inter alia, the publication of a series of
The world has changed greatly since the technical guides covering many aspects
1950s and the dawn of the electronic of the health technology/medical device
age when innovators such as Wilson life cycle (Medical device technical series).
Greatbach, an assistant professor of WHO has also played a leading role in
electrical engineering at the University of examining and supporting the role of
Buffalo in the United States of America, medical device innovation, with a particular
built the first cardiac pacemaker in his focus on developing countries.(90)
garage. The regulatory requirements
alone could render such a scenario It is worth noting at this point that
impossible today. And yet there are some there are different types of generic
similarities with those times 60 years ago. innovation, ranging from basic research
With software now also classified as a to incremental (by far the most common
medical device, why couldn’t a student at type of innovation in the context of medical
any university, say, develop a new mobile devices), breakthrough, disruptive and
phone or tablet app that would have the sustaining (see Table 6.1).
same impact in terms of health outcomes
that Greatbach’s invention has achieved The following disclaimer should be noted
globally? with regard to this chapter. There are
many texts dealing with medical device
Therein lies the excitement of medical innovation as well as with the various
device innovation, attracting some of the fields of BME research. This chapter
brightest talent on the one hand while therefore, aims to provide an overview
on the other maintaining a multi-billion of medical device innovation from
dollar global industry, and given the the perspective of applied biomedical
wide range of medical devices, from a engineering to underline the importance
syringe to a MRI scanner (there are some of the knowledge, skills and competencies
10 000 generic items in the medical of the thousands of individuals and
device universe) and changing disease teams that engage themselves in both
patterns globally, there remains a strong the art and the science of medical device
demand for investment in medical device innovation. Space constraints do not allow
innovation, with biomedical engineers in for in-depth examination of all the many
particular playing a central role. relevant issues.

80 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers


Table 6.1 Innovation matrix for biomedical devices

Single disease Multiple


Disease focus disease
Component of disease burden Mortality Morbidity Both
addressed
Targeted level of health-care Individual focus Community- Primary Secondary Tertiary Specialized Combination All
delivery (self-care) based
Preventive/ Screening Diagnose Treatment Palliation Rehabilitation Assistive Combination All
Phase of care promotive
Scope of market Country Region Global
Target patient group(s) Infants Children Women Mothers Disabled Men (adult) Adolescents Combination All
Basic (e.g. Medical Accessory to Medical device Medical device Medical Information Management/ Other
water) consumable existing medical (low complexity) (medium device (high system process
Type of health technology device complexity) complexity) intervention
Basic Product/Device Process Financial Other
technology/
cross cutting/
Type of innovation upstream
Incremental Sustaining Disruptive Breakthrough Game changer Adapted (tech
Level of innovation transfer)
Improved Improved Improved service Improved patient Improved health Combination
resource access/ delivery safety/quality of outcomes
Anticipated impact utilization coverage care
Level of development of targeted Low Medium High Combination
market(s)
Level of infrastructure needed None Low Medium High Combination
Specification Development Commercialization Manufacturing Marketing/ Adoption/ Utilization/ Discontinuation/
Product cycle distribution incorporation support disposal
Advisory Group on Innovative
Source: Adapted from the Report of the Meeting of the WHONeeds Research for Resource-Scarce
Technologiesand Settings, Singapore, 20–21
Cross-functional June 2009.
Legal/IP Regulatory Quality Clinical Manufacturing Financial (incl.
Innovation functional areas assessment Development management reimbursement)
Individuals Communities Health Health technology Health-care Government/ NGOs Private sector/ Medical insurance
professionals regulators/ providers policy-makers industry companies/health-
Stakeholders standards bodies care funders

WHO Medical device technical series


81
6.2 The field of medical device expressions of best-practice design are
innovation brought to fruition when the principles of
people-centred research and inclusive
Table 6.1 shows the multiple dimensions (universal) design are combined, coupled
and layers associated with medical device with collaboration between engineers,
innovation; it is worth noting that each clinicians and other members of the
cell in the matrix – assuming all others innovation teams.(92)
remain unchanged – could be associated
with any number of innovations and, by
extension, BME practitioners with very 6.3 Innovation competencies
different skills sets.
Some of the core competencies biomedical
There are many models to support engineers will need for innovation in high-
the medical device innovation process resource settings are illustrated in the
and, as mentioned earlier, it is not the “stage-gate process model” developed
intention here to dwell on these. The at Stanford University, as unpacked
United Kingdom’s Design Council in below ((Figure 6.1).(93) They include,
2005 defined a four-stage innovation among others: academic and corporate
process (Figure 6.1): discover, define, R&D, device prototyping, clinical trials,
develop, deliver.(91) Such (generic) manufacturing processes, regulatory

Figure 6.1 Biodesign model (innovation phases) (functional groups and activities)
Journal of Medical Devices

pathology area is also conducted, as well as an early-stage tech-


A review of the existing IP landscape within a specific market or
review, and competitive product assessment are often performed.
treat the condition. Next, a preliminary market analysis, financial

Fig. 9 Linear medical device development model


and initial reimbursement strategies assessed.
Potential regulatory paths and their associated risks are studied
technology concepts that have been identified in Phase 0 and I.
nology risk assessment. The IP review includes evaluation of the
JUNE 2009, Vol. 3 / 021004-7

Source: Pietzsch JB et al (2009). Stage-gate process for the development of medical devices. Journal of Medical Devices.

82 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers


requirements, intellectual property (b) decoupling these competencies from
law, cross-functional management, current products in order to create and
reimbursement policy, facility operations, exploit new opportunities.(95) Given that a
quality controls, clinical practices, product-centred perspective provides little
marketing and sales. The model insight or guidance about the process by
identifies five phases of development, which a firm’s strategy can contribute to
with four decision gates to evaluate its future success, the distinction between
whether to proceed with the innovation a firm’s products and the underlying
effort. The phases involve coordination of competencies used to create its products
multidisciplinary fact-finding, consultations has led to increased exploration of
and evidence-based reviews that assess how competencies are developed over
the readiness of the innovation to move to time. In environments characterized by
the next phase. rapid change, accelerating product life
cycles and technological discontinuities,
While such models increase the chances traditional product-centred strategies
of success, they are not of themselves provide little long-term strategic
determinants of success. The importance advantage.(96) These realities have led
of people with the requisite skills and to renewed efforts to understand how
teams with the right balance of skills firms can develop dynamic capabilities
are key. that enable them to adapt, integrate and
reconfigure their skills and competencies.
Cascaded down to individual level, it
6.4 Skills requirements becomes clear that biomedical engineers
working in such settings should remain
The previous section suggests that a wide tapped into such trends and adapt/adjust
range of skills are required as part of the their own competencies as needed.
medical device innovation process and
related activities. Even if we were to focus This applies also to the medical device
on the roles of biomedical engineers, sector, be it in developed or developing
skills requirements at a particular step country settings. In the case of the
in the innovation process for a specific former, the medical device industry has
technology would typically require the conducted situational analyses to help
collective and complementary skills of ensure that the capacity development
a number of individuals, each on their pipeline continues to provide the skills
own skills development trajectory(94) and in the mixes and numbers required. As
career path (the important role of teams an example, a 2007 Australian report(97)
is addressed in the next section). The identified skills shortages and skills gaps
skill sets would also differ depending on existing for product R&D engineers,
whether the biomedical engineers were business development and project
in an academic, health-care or industry management personnel, and regulatory
setting. Since academic and health-care affairs specialists, amongst others, with
settings are covered elsewhere in this the greatest needs concentrated at the
publication, the focus here will be on pre-manufacturing start-up level. An Irish
industry. report(98) highlighted the need – based
on evidence from study visits to America
Increasingly dynamic environments also – to increase entrepreneurial activity in
require industrial firms to focus on: (a) order to develop new businesses, whether
building market-driven, technological stand-alone businesses or within existing
and integration competencies, not a companies. The report also saw great
stream of product improvements; and potential for developing opportunities

WHO Medical device technical series 83


related to deepening technological body of clinical, engineering and
convergence in the area of medical business literature.
devices. This convergence will impact on • The clinician, who understands
skills requirements in a number of ways: it the complex issues associated with
will broaden the range of disciplines that introducing a new technology into
are core to the medical devices sector, clinical practice.
from mechanical engineering, BME,
materials engineering and medicine, In their view, “individual team members
to also include biological sciences, may be more than one of these
electronic engineering, pharmacology phenotypes, but all four need to be
and chemistry. Technologies that represented in the team for it to be highly
will emerge that are core to areas of functional”. The reviewers also highlight
convergence will have to be understood the importance of managing interpersonal
by significant numbers of people from dynamics and communication within a
different disciplines. multidisciplinary team, and the need to
learn to navigate potential conflict.

6.5 Innovation and teams The important roles of stakeholders


impacting on the medical device innovation
Health professionals (most often as and diffusion processes, including users,
users), health-care experts, patients patients (and their advocates), health
and their advocates seek technologies to economists, government officials, health-
meet health needs. Innovators – be they care managers, insurers and regulators
engineers, material scientists, systems must also be recognized.(101) These
specialists, biologists and others – seek increasingly contribute to identifying
beneficial use for their technologies. needs and demands for new technologies
The challenge lies in exploring potential as well as determining which of these
matches between these two camps. will be integrated into mainstream care,
In some cases, one person completely how they will be used, distributed, paid
bridges the two but more often the task, for, evaluated and monitored. As such,
nowadays, requires organized teams.(99) they are significant determinants of
successful innovation; and innovators
The importance of team composition is need to develop the skills to manage the
highlighted by the Stanford University many interaction/engagement interfaces.
Biodesign Program leadership in
their review of the first 12 years of the
programme.(100) While ranking dedicated 6.6 The innovation process and
mentorship as the most critical component its increasing scope
of the programme, they emphasize the
importance of having more than just a Although the stage-gate model, unpacked
mix of different engineering and medical in Figure 6.1 provides a detailed overview
backgrounds and suggest four main of the medical device innovation process,
profiles of “innovation personalities”: significant opportunities for innovation lie
both upstream and downstream of the
• The builder, well-versed in design process as indicated.
and prototyping.
• The organizer, with the skills to keep Upstream, forecasting the cost
the team on track. implications of a new technology early
• The researcher, who will extract in the innovation process (102) is being
maximum value from the existing increasingly accepted as a valuable

84 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers


contribution to ensuring affordable stakeholders are able to agree on more
implementation (often linked to appropriate business models, at least in
reimbursement) and therefore greater terms of incentives relating to supply and
likelihood of successful adoption and demand. Even so, distribution of these
utilization; this is closely linked to much-needed interventions is hampered
what is known as early stage health by weak health systems.
technology assessment. HTA, in its
own right, currently plays an important Much the same also applies to medical
role in decisions relating to adoption of devices, given that almost 80% of medical
health-care interventions and related devices in Low income countries (LICs) are
technologies and devices.(103) acquired by donation,(106) and given the
absence of technical support capability
Downstream opportunities include (adding in many low-resource settings, these
value through provision of product-related countries continue to rely on donations
services, i.e. viewing the product sale to replace devices and equipment that
as a way to open the door for provision cannot be maintained or repaired. Non-
of future services. In many industries governmental organizations such as
today, the sale of a product accounts for Engineering World Health (EWH) have
only a small portion of overall revenues. established a niche in filling the gap with
(104) The spectrum of downstream regard to technical support in some LICs,
opportunities includes embedded although needs continue to far outstrip
services and/or comprehensive services, the supply of adequate capability.
integrated solutions and distribution
control. Particularly in resource-scarce In addition to donations, medical devices
settings, where medical devices are often are also acquired through technology
donated, downstream innovations linked transfer: local production of devices
to user training, technical support and that resemble technology designed for
maintenance, calibration and testing, use in High income countries (HICs)
etc. present significant opportunities or the low-cost sale of older models
for innovation. In this context, medical of devices originally designed for use
devices should be seen as part of an in HICs.(107) However, use of medical
integrated technology package, rather devices in LICs that were originally
than as isolated products. designed for use in HICs is not entirely
successful; one study noted that 40%
of medical devices were dysfunctional
6.7 Medical device innovation in LICs versus less than 1% in HICs.
for low-resource settings (104,108) In LICs, constraints including
unreliable energy supply and water,
It is widely recognized that many diseases limited distribution and infrastructure,
affecting millions of poor people in low- inadequate or untrained workforces, lack
resource settings are not being addressed of spare parts, required consumables,
by the pharmaceutical industry since the and high costs affect the availability
demand for drugs that would address this and acceptability of many devices.(109)
component of the global diseases burden A more recent and emerging practice
is driven by the ability of consumers/ is for medical devices multinationals to
beneficiaries to pay.(105) In some establish a presence in selected LICs
instances, as has been the case with to design and manufacture devices
the waiving of patents for HIV-related that are appropriate for local needs and
drugs by select multinationals in order conditions, and therefore perform better
for these to be made available affordably, and are more sustainable than devices

WHO Medical device technical series 85


acquired through other means; General devices may benefit low-resource settings
Electric’s Healthymagination and related that have limited access to highly trained
activities in India is a case in point.(110) physicians, and high-resource settings by
Such initiatives will significantly promote informing the design and development
the development of BME capability that of easy to use medical devices that may
is best suited to respond to local needs be suitable for home-based health-care
through appropriate innovations. services, or for lower cost hospital services.

The limited availability of highly trained WHO has been instrumental in supporting
health providers presents another the innovation of medical devices for low-
extraordinary challenge in providing resource settings, particularly through
universal quality care. For instance, while initiatives such as its Compendium of
Africa bears more than 24% of the global innovative health technologies for low-
burden of disease, it only has access to resource settings: Assistive devices,
2% of the global supply of physicians;(111) eHealth solutions, medical devices
47% of the WHO Member States reported published in 2014. The objective of the
having less than one physician per 1000 compendium series is to provide a neutral
population.(112) The mismatch reported platform for technologies which are likely
between the number of commercially to be suitable for use in low-resource
available medical devices and the settings. It presents a snapshot of several
projected global burden of disease, as well health technologies which might have the
as the limited number of available devices potential to improve health outcomes and
designed for use in primary health-care the quality of life, or to offer a solution
facilities by lay health workers (30 out of to an unmet medical/health technology
358 medical devices) will challenge policy- need. It celebrates notable success stories
makers and the global health community while raising awareness of the pressing
to provide intellectual, financial and need for appropriate and affordable
regulatory support in order to develop the design solutions and to encourage more
necessary technology in a timely manner. innovative efforts in the field. This effort
(113) Although it is not possible to separate also aims to encourage greater interaction
the effects of medical devices from the among ministries of health, procurement
effects of social, political, economic and officers, donors, technology developers,
health-care measures on mortality in manufacturers, clinicians, academics
LICs,(106) availability and accessibility and the general public, to ensure greater
of medical devices are important and, investment in health technology and to
if part of a comprehensive solution, can move towards universal access to essential
positively impact global mortality and health technologies.
morbidity trends.
Resources such as the WHO compendium
This poses a design challenge on how to serve as effective stimulants of further
develop medical devices that are simple R&D and innovation of medical devices
enough to use that lay health providers for low-resource settings, as well as
can deliver or perform some of the more supporting the development of local and
common and urgent health services regional capabilities. The constraints
and tasks previously undertaken only typical of low-resource settings also
by highly trained health providers. This present opportunities for innovation
can have a tremendous implication for by encouraging the design of devices
both developing and developed countries. that are adaptable to the realities of
Such, presumably task shifting, medical health care in these settings, such as

86 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers


unreliable power supplies, the lack of enough – they need to be combined
user training and technical support and with innovations in processes and
low budgets to procure consumables/ health systems strengthening as well
disposable.(114) Innovators wishing to as matching interventions in other
be successful in bridging the significant sectors(119) to have the optimal effect.
resource gap between developed and (120) This is turn will require new sets of
developing nations need to immerse skills for biomedical engineers and their
themselves in resource-scarce settings peers and counterparts.
to fully understand the solutions they
need to deliver, and how.
6.8 Conclusion
The importance of human factors is
a determinant of “user-friendliness” This chapter has provided some snapshots
and therefore greater likelihood of of where we stand currently with regard
correct and safe operation of devices. to medical device innovation and some
While consideration of human factors pointers to what the future holds. As the
is important for devices intended for principles of lean design converge with,
any setting,(115,116) it is particularly on the one hand ageing societies in the
relevant to low-resource settings where developed north and younger emerging
users may have received less exposure societies in the developing south, and
to technologies generally and medical leap-frogging technologies such as the
devices specifically, and little or no smartphone on the other, it is expected
user support is available (this is very that ever greater proportions of health
common for equipment donations, with technology innovations that align with
medical devices and their accessories the imperatives of universal health
and consumables often sourced from access and coverage – underpinned
different manufacturers, making it by the complementary drivers of equity
practically impossible to standardize). and cost-effectiveness – will emerge
Increasing attention is also being focused with innovative BME practitioners
on the concept of jugaad innovation – playing important catalytic roles. How
cost-effective technologies developed for appropriate, the adage that “the best
low-resource settings – and emerging way to predict the future is to create
market needs being taken to developed it”. With needs (in both well-resourced
country settings and markets.(117,118) and low-resourced settings) as the driver,
biomedical engineers and their peers
Lastly, medical device innovations should as innovators – enabled and supported
be seen – through an integrating lens by the quadruple helix of government,
– as part of a broader set of health- private sector/industry, academia and
related technology innovations since the the NGO sector – the vision of better
needs of communities in low-resource health for all through, inter alia, improved
settings are multiple and multifaceted, access to medical devices at all phases
and similar approaches and tools can and levels of health-care delivery seems
be used to address them. Importantly, more achievable than ever before.
devices or technologies alone are not

WHO Medical device technical series 87


Credit: Adriana Velazquez; regulations of medical devices meeting in Saudi Arabia,
coordinated by Dr Adham Ismail, April 2016.
7 Role of biomedical engineers in the
regulation of medical devices

7.1 Introduction developing this chapter, shedding light on


the many issues related to medical device
There is growing demand for access to regulation, from both regulatory authority
affordable, appropriate, safe and high and industry perspectives. Among the
quality medical devices around the world. subjects addressed in this chapter are:
The constant integration of new medical
devices and treatments into coherent • Identifying the need to regulate
health-care programmes is requiring medical devices
more comprehensive professional skill • Examining interactions of medical
sets and organizational capabilities devices with information technology
and biomedical engineers are actively systems
involved in meeting these challenges on • I n v e s t i g a t i n g t h e r e s e a r c h ,
many fronts. development and management
aspects of medical devices
The medical devices industry is growing • Pre-market assessment and approval
rapidly as a tide of technological phase to post-market surveillance
innovations floods the world market. • Different registration standards for
Medical device technologies require medical devices
developers and regulators to have a strong • Role of biomedical engineers in
scientific background and knowledge to regulating medical devices
ensure that efficient verifications and • Skill sets of biomedical engineers
marketing approvals assure safety, quality, involved with regulating medical
effectiveness and performance of the devices
technologies according to the intended • Interactions of medical device
purpose of the device. Regulation must industry regulatory specialists with
occur in reasonable time to allow patients other professionals.
and health-care providers access to the
most advanced medical technology. In 2012, data from the United States
Bureau of Labor Statistics and other
In addition to ensuring safe performance governmental agencies ranked BME as
of medical equipment in the operational the second best profession based on
settings of health-care facilities, five criteria: physical demand, work
biomedical engineers may play a crucial environment, income, stress and hiring
role in the design and evaluation of prospects. This analysis indicates BME is
medical devices. In their regulatory a rewarding profession from both financial
roles, biomedical engineers evaluate and moral standpoints.
information technically and scientifically
for the purpose of obtaining marketing
authorization provided by the industry to 7.2 Need for biomedical
regulatory authorities. engineers in regulatory affairs

Three international experts in medical Worldwide shifts in the global burden of


device regulation, with extensive disease, ageing populations, increasing
experience in regulatory authorities, prosperity, spreading economic
industry and academia, participated in development and increasing access to

WHO Medical device technical series 89


information are driving global societal of medical devices. Such systems may
demand for access to medical device complement alternate systems, either
technology. Users (government agencies, voluntary or mandatory, required by
hospitals, doctors and nurses, insurers professionals or lay users for reporting
and patients) all demand technologies adverse events.
that are appropriate for their context
of use and are accessible, affordable The regulatory authority may have a
and available to intended users and system for registering active medical
stakeholders of health-care systems. device manufacturers, importers
Users also expect that medical devices, and distributors in their territory. The
including in vitro diagnostic medical authority may also require listing devices
devices, are reasonably safe when that are placed on the market within the
used as intended, perform as specified, authority’s jurisdiction. These systems
achieve their diagnostic or therapeutic facilitate authority surveillance of the
purposes, and are of appropriate quality. market, oversight of promotional activities,
Manufacturers are primarily responsible identification of adverse event trends,
for fulfilling users’ expectations, in and enforcement action as necessary.
addition to all parties in the supply chain Systems also serve as the basis for
from the purchaser to end user. Medical international cooperation and exchanging
personnel and users also share in those information on adverse events and post-
responsibilities.(121) marketing manufacturer field safety and
corrective actions.
In many, but not all, countries, laws
and regulations have been established In some countries, the regulatory process
to protect the public from unsafe and for medical devices is identical to, or
ineffective medical devices. One based upon, that for medicines. In other
or more regulatory authorities and/ countries, a separate process specific to
or conformity assessment bodies medical devices has been established.
typically ensure manufacturers fulfil Regulatory processes specific to medical
safety responsibilities and comply with devices more appropriately reflects the
regulatory controls throughout the fundamental differences in technologies,
product life cycle. Regulatory authorities modes of action in or on the human body,
and assessment bodies may also regulate product life cycles, and methods of use
device use, clinical investigations and between product sectors. A medical
promotional activities as well as conduct device regulatory system should also
post-marketing surveillance of user reflect the varying levels of risk associated
experience with medical devices. For with different product categories (e.g.
some or all devices, the regulatory tongue depressors or simple dressings
authority or assessment body may use compared with artificial heart valves),
controls including pre-market review of with corresponding regulatory controls
manufacturers’ evidence of device safety proportionate to relative risks.
and performance, evaluation and risk
assessments. Authorities may conduct In all countries, compliance with relevant
audits of manufacturers’ facilities and regulatory requirements is an essential
quality management systems pre- and part of a manufacturer’s civic duties,
post-marketing. In some countries, reputation and public trust. Such
manufacturers are required to inform the compliance is “the price of admission”
regulatory authority promptly of adverse that manufacturers pay to compete in the
events associated with post-market use marketplace.

90 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers


7.3 Medical devices regulation patients, health-care workers or the
– scope and function in community.
different countries

Medical device regulations define 7.4 Professionals in the field of


requirements in the design, development medical devices regulation
and manufacture to ensure that the public
receives safe, efficient and effective The work of medical device regulation
products. is dynamic and diverse, requiring
professionals from a variety of
There are different regulatory bodies backgrounds to interact with each
worldwide; however, the Global Health other as they deal with the various
Task Force (GHTF) strived towards technical, scientific and medical aspects
global uniformity in the industrialized of a device, from its development to
nations. GHTF was set up in 1992 by a commercialization, utilization, and
group of representatives from regulatory monitoring performance feedback during
authorities and industry in Australia, the operational phase. Thus a regulatory
Canada, Japan, the European Union and professional in industry may deal with
the United States of America, with the others from R&D, production, marketing
purpose of harmonizing medical device and sales.
regulation in order to standardize the
quality of medical devices worldwide and Medical device regulatory activities
to facilitate international trade. occur throughout the whole life cycle
of a medical device: from pre-market
In 2011, a voluntary group of medical to the post-market phases and even in
device regulators formed an International the market placement. The pre-market
Medical Device Regulators Forum phase starts with conception and
(IMDRF) based on the foundational design of the product and encompasses
work done by the GHTF, in order to manufacturing and packaging and
accelerate international harmonization labelling. The post-market phase deals
and convergence on regulations. with the actual use and disposal and
re-use of the product, while advertising
Medical device regulations do not exist and sale is the commercial phase of the
in all countries, especially those with product life cycle.
resource-poor settings. However, most
industrialized nations have medical device • Regulatory professionals are not only
directives. The European Union has in demand in the manufacturing
directives for approval of devices for the sector, in government agencies,
European market, and the United States clinics and hospitals, and
Food and Drug Administration (FDA) has consultancies but also in universities
separate and distinct requirements for and clinical research organizations.
the attributes of medical devices being So, what are the backgrounds of
introduced into its market.(122) professionals involved in this field?
They may have a background in
Regulations should specify that all R&D, life cycle management and
medical devices, whether imported or regulation of products and also in
locally produced, must meet international clinical professions.
norms and standards in order to bring • A biomedical engineer can take an
public health benefits without harming active part in the field of regulation,
from the pre-market phase until

WHO Medical device technical series 91


the product is on sale. With their a broad understanding of regulatory
background and special skills, system requirements and recognize how
biomedical engineers can play a requirements influence both product
crucial role in the medical device development strategies and the current
industry, which is increasingly and future business climate. Through
changing into a technology-driven their words and actions, board members
field, in activities including: and executive managers set a precedent
›› Acting as an advisor on legal and for compliance within the company.
scientific requirements
›› Actively participating in design and Background, training and expertise of
development government and industry regulatory
›› Participating in developing specialists for medicines differ
appropriate pre-clinical and (or should differ) from regulatory
clinical plans to evaluate safety specialist qualifications for medical
and effectiveness devices. Knowledge of engineering
›› Collecting, collating and evaluating (i.e. mechanical, electrical or software)
scientific data and materials science is essential,
›› Actively participating in preparation and direct experience using medical
of registration documents for devices in a hospital clinical laboratory
regulatory agencies or bodies or BME department will serve as valuable
›› Being involved in the negotiations background.
necessary to obtain and maintain
marketing authorization of the As medical device technology continues
product to advance, developers will focus more
›› Acting as technical advisor on “combination products” to address
›› Ensuring that proper reporting and unmet diagnostic and therapeutic needs.
input is given to the commercial Combination products contain elements
development of the product that, standing alone, would typically be
›› Being involved in the recall process regulated as medicines, medical devices
›› Supporting development of or biologics. By combining product
standards. elements, significant new regulatory
questions will arise, requiring cross-
sectoral and multidisciplinary expertise.
7.5 Biomedical engineers as
regulatory specialists in Within a medical device development
industry and/or manufacturing company, the
biomedical engineer who has regulatory
Medical device manufacturers’ specialization typically takes the lead in
compliance with all relevant laws and developing required submission plans
regulations begins with an in-depth for any relevant regulatory authorities
understanding of regulatory requirements and/or conformity assessment bodies.
at both the working and strategic levels. Submissions may support product pre-
For all but the most basic, low-risk marketing authorization applications
class of devices and basic regulatory (usually required for higher risk class
requirements, effective compliance will devices) or notifying changes to products
require manufacturers to follow adequate already authorized for marketing.
and dedicated specialized technical Regulatory professionals are generally
resources and be qualified through both responsible for drafting, compiling,
training and experience. Board members verifying and submitting applications
and senior level managers must have and handling all follow-up questions

92 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers


and requests from the authoritative
body. In some organizations, regulatory 7.6.2 Research and development
professionals are also responsible
for writing post-marketing reports of • What are the relevant international
adverse events or field safety corrective and national standards that may
actions, whereas in other organizations, apply?
quality assurance groups assume these • What detailed technical information
responsibilities. will be required, and at what
stages of the development process,
In fulfilling regulatory roles, the specialists for inclusion in a pre-marketing
will typically collaborate with colleagues conformity assessment dossier, if
in other functional areas of the company. required?
• What information should be
developed and retained in the
7.6 Professional functions product summary technical file (to
fulfilled by biomedical support a submission and/or be held
engineers in the regulatory for future product audits)?
domain • What elements of a device design
may require clarification of regulatory
There is an extensive range of issues requirements?
and questions that biomedical engineers • What are the requirements for
may be called upon to address in the interfaces between a product and
regulatory domain. other products with which it may
reasonably be foreseen to be
7.6.1 New product planning combined in a new “system”?
• Beyond the requirements of the
• What is the claimed intended use(s) medical device regulator, are there
for a new device? other regulatory regimes to be
• What regulatory requirements will considered, e.g. telecommunications
apply to proposed new products? or radio compatibility or environmental
• What evidence will be required to regulations?
demonstrate conformity to those • Are there regulatory requirements
requirements (e.g. will a de novo or standards for human factors
clinical investigation be required)? evaluation for safe use by the
• How long will it take to develop that intended user(s)?
evidence? • How will required labelling and
• Are similar products already in the instructions for use be incorporated
market and what was their regulatory in the product design?
pathway? • How will regulatory requirements for
• Does a proposed new product target risk management be incorporated
new intended uses or users? in the product development process
• Will regulatory determinations on new and timeline?
pathways or policies have to be made
by the authority? 7.6.3 Clinical research
• Does inclusion of a new technology
(or one not previously used in • What existing clinical evidence, e.g.
medical devices) raise important new from similar previous products and/
questions of regulatory requirements? or published literature, may be used
• How do those considerations affect to demonstrate clinical safety and
project costs, timelines, risks and performance?
returns on investment?

WHO Medical device technical series 93


• How relevant is it to a new product? • What is required to comply with
• Is new clinical evidence required? regulatory requirements for post-
• Will that evidence require a new marketing surveillance, complaint
clinical investigation? handling and adverse event or
• What are the appropriate clinical vigilance reporting?
investigation designs to generate
evidence required for regulatory 7.6.5 Marketing and sales
purposes? In what form?
• Will the statistical design of a study • For what intended use(s) does the
be sufficient for regulatory purposes? manufacturer wish to promote the
• D o e s t h e p r o p o s e d c l i n i c a l medical device?
investigation fulfil all relevant ethical • Are there any specific regulatory
requirements and standards? requirements or limitations on such
• Does the study design and claims?
implementation fulfil all relevant • What technical and clinical evidence
regulatory requirements, e.g. will be required to support such
for investigator qualifications, claimed intended uses?
recordkeeping and monitoring? • What intended uses are claimed by
similar devices?
7.6.4 Quality management systems • What has been the regulatory
and manufacturing operations pathway for competitive devices?
• Who are the intended users of the
• Are there any specific regulatory device?
requirements for design verification • What are the regulatory requirements
and validation, manufacturing, and international standards
acceptance or certification of a (including symbols) for labels,
product? labelling, and instructions for the
• Are there any relevant international device?
or national standards that apply • Are there regulatory requirements
to the operations? What QMS and for user testing and validation of
manufacturing information must be instructions for use?
prepared for the product summary • What languages are required in
technical file, for possible submission labelling?
and/or future auditing? • Is labelling in alternative media such
• What are the documentation and as via the internet or on CD-ROM
recordkeeping requirements? What permitted?
are the requirements for training and • When must proposed labelling be
certification of personnel? available for inclusion in a pre-
• How will regulatory requirements for marketing regulatory submission?
risk management be incorporated in • When does a change in labelling
the product manufacturing planning require notification of, and review by,
process? the regulatory authority?
• When does a change in specifications • What are the regulatory requirements
or manufacturing process require a for, and constraints upon, advertising
notification to the regulatory authority and promotional materials?
or conformity assessment body? • Does the regulator require specific
• What are the requirements, and how user training as a condition of
can the manufacturer be prepared, marketing the device?
for external audits of the QMS?

94 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers


7.6.6 Technical writing e.g. industry standards?
• What are the opportunities for the
• Does safe use of the device over its manufacturer’s technical experts
life cycle require detailed instructions to participate in the development
for use and/or technical service of standards? Can those experts
manuals? support government experts in
• Is it intended that the user or medical standardization work?
institution will maintain or calibrate
the device?
• What are the regulatory requirements 7.7 Industry and government
for such instruction materials? affairs

7.6.7 Health economics and health Regulatory requirements and practices


technology assessment are important factors in determining
A small but growing number of countries whether a country’s policy environment
face the hurdle of marketing authorization is conducive to investing in research
by regulatory authorities prior to bringing a and developing accessible, appropriate,
new medical device to market. Health-care affordable and available medical
systems may require evidence of clinical technologies. The regulatory affairs
utility, cost effectiveness of a device, professional may be called upon to advise
associated therapy or diagnostic tests as industry groups or company government
conditions of payment or reimbursement. affairs staff on how regulations may be
• How would the regulatory affairs improved. When regulatory authorities
professional work with health publish proposed regulations for public
economists and others to fulfil input, regulatory professionals may
those requirements, as well as to analyse proposals and submit comments,
assure consistency between clinical either directly or through industry groups.
evidence and claimed intended use
for regulatory purposes and HTA The complexity of these issues grows
purposes? with the nature of the device, its degree
of novelty, risk classification, diversity of
7.6.8 Standards and standardization product range, the number of countries/
bodies regions in which the manufacturer
In many jurisdictions, evidence of a plans to offer a medical device, and the
device’s or manufacturer’s conformity comprehensiveness and sophistication
with recognized international or national of national regulatory systems. The
standards is deemed to be evidence experience and training of, and resources
of compliance with relevant regulatory available to, the regulatory affairs
requirements. professional, must reflect the degree of
• What standards apply to a device? complexity. The role is not, and should
• H o w a r e i n t e r n a l p r o d u c t not be seen as, a purely administrative
specifications kept up-to-date as position.
those standards are revised?
• How should the manufacturer 7.8 Education and experience
demonstrate conformity with of industry regulatory affairs
standards requirements? professionals
• W h e r e r e l e v a n t r e c o g n i z e d
international or international standards The 2012 Scope of Practice and
do not exist, are there other standards Compensation Report for the Regulatory
acceptable for regulatory purposes, Profession by the Regulatory Affairs

WHO Medical device technical series 95


Professionals Society (RAPS) is based accrue eight years of “other”
on a survey of nearly 3000 regulatory professional experience prior to
affairs professionals in 58 countries. moving into a regulatory position.
(123) The report provides information on Immediately prior to transitioning
the most recent data from 22 years of to regulatory positions, 83% of
surveys examining the scope of work professionals worked in positions
and compensation of regulatory affairs closely aligned with research,
professionals from industry and regulatory product development, clinical
authorities, as well as consultancies, research, manufacturing or quality
academic institutions, basic and clinical of clinical care. Prior experience
research organizations, and care delivery would include biomedical engineers
settings. As such, the report may be the previously practising in health-care
most comprehensive and systematic and academic settings.
profile of the international regulatory
affairs profession. To help regulatory affairs professionals
attain and maintain requisite regulatory
Though not exclusive to medical devices, knowledge, some academic institutions
report findings indicated: offer courses in regulatory science.
Additionally, RAPS offers reference
• Approximately 65% of survey materials, training conferences and online
respondents work with medical remote learning programmes, many of
devices or in vitro diagnostic medical which specific to medical devices, to
devices. regulatory professionals. Some courses
• More than 98% hold a university may lead to certificates, including the
degree, and 70% have pursued Regulatory Affairs Certification (RAC)
postgraduate education; 20% (124) – a professional certification for
hold doctorates and 40% masters medical device regulation earned by
degrees. passing an examination administered by
• 90% hold university degrees in an accredited third-party testing provider.
the sciences, clinical disciplines The RAC requires re-certification every
and engineering and/or technical three years by acquiring credits from
sciences including chemistry and regulatory-oriented activities. Other
physics. 13% of professionals, and bodies, including the World Medical
20% of those with five or fewer years Device Organization (WMDO),(125) also
of regulatory experience, participated offer online learning tools focused on
in postgraduate certificate or graduate medical devices.
degree programmes in regulatory
affairs or regulatory science, in order
to transition into regulatory positions. 7.9 Conclusion
• O v e r a l l , 1 4 % o f r e g u l a t o r y
professionals also hold degrees in A biomedical engineer may perform
business, with 12% holding masters many different roles in the regulatory
in business administration. process, depending on what stage of a
• The vast majority of regulatory product’s journey to market and beyond
professionals (96%) did not begin is involved. The medical device industry is
their careers in a regulatory position. an evolving field demanding various types
Most regulators transitioned through of expertise from engineers, not only in
one or more areas of work before research, project management, analytics,
moving into regulatory positions. On interpretation and negotiation, but also
average, regulatory professionals skills in business and communication.

96 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers


Biomedical engineers, in addition to their and strategic thinking, and relationships
engineering education, need training in management by the regulatory affairs
management and regulation of medical professional are important in determining
devices. Furthermore, regulatory whether a “breakthrough” medical device
professionals have to deal with increasing technology is successfully brought from
globalization of health-care products, the the laboratory bench to the clinical
changing needs of the public and patients, bedside – and ultimately contributes to
differing marketing and post-marketing better health outcomes.
approval surveillance requirements of
different regions. They may coordinate Through country-specific policies and
scientific design with regulatory demands international collaboration, national
throughout the life cycle of the product, governments should develop a robust
to ensure that innovations deliver the regulatory capacity by educating and
maximum benefit to all stakeholders. retaining skilled professional work forces
in industry, academia and government.
Experienced biomedical engineers Increasing regulatory capacity ultimately
may find rewarding professions in the contributes to improving timely public
field of regulatory affairs. The quality of access to appropriate, affordable and
advice and work products, analytical available medical technologies.

WHO Medical device technical series 97


Credit: Jitendar Kumar; 6th HTA fellowship, School of Public Health,
Postgraduate Institute of Medical Education & Research, Punjab, India, January 2016.
8 Role of biomedical engineers in the
assessment of medical devices

8.1 Introduction • All Low income countries surveyed


and 85% of middle-income use HTA
Health technology assessment is for planning and budgeting.
used to inform policy- and decision- • Middle-income countries used HTA
making in health care, especially on to inform clinical practice guidelines
how best to allocate limited funds to and protocols (85%).
health interventions and technologies. • High income countries use HTA for
The assessment is conducted by determining service reimbursement
interdisciplinary groups using explicit or inclusion on a benefits package.
analytical frameworks, drawing on
clinical, epidemiological, health economic In the specific case of medical devices,
and other information and methodologies. HTA has emerged as an important tool
for supporting the core functions of
With WHO’s drive to achieve UHC as effective and sustainable health systems
outlined in Sustainable Development and defining prioritization, incorporation
Goal (SDG) 3, the need to choose and selection of medical devices. Health
and effectively manage technologies technology assessment of medical
to be adopted within countries’ health devices, part of the WHO’s Medical device
systems, particularly in a context of technical series, provides an overview
limited resources, is a critically important of HTA.(130) It presents how health
undertaking. Countries are called on to technology regulations, health technology
consider establishing national systems management and HTA are all important
of health intervention and technology in the medical devices life cycle; these
assessment and encourage the are interrelated and complementary, but
systematic and transparent utilization distinct functions. All these issues are
of independent health intervention and addressed in the present publication (see
technology review evidence. Developing chapters 7 and 9). All three (regulation,
and strengthening national capacity health technology assessment and
will have to build on established best management) are needed for better
practices, information exchange and health care and population health in a
collaborative approaches to make the country. Along with other professionals,
best use of limited resources and yield biomedical engineers have different
robust scientific assessments.(126) functions in these three areas as indicated
in Figure 8.2.(131)
The WHO 2015 Global Survey on
Health Technology Assessment by A s i n d i c a t e d i n Wo r l d H e a l t h
National Authorities,(127) conducted Assembly resolution WHA 60.29 on
as recommended by World Health health technologies the term “health
Assembly resolution WHA 67.23 on technologies” includes not only medical
health intervention and technology devices, but also pharmaceuticals,
assessment in support of universal health interventions and other forms of
coverage,(128) indicates (as shown in application of organized knowledge and
Figure 8.1): skills.(132) However, not all assessments
or evaluations of technologies should be

WHO Medical device technical series 99


Figure 8.1 Purpose of undertaking health technology assessment by region and country income(129)

 AFR  EUR
Certificate of need/carte sanitaire  AMR  SEAR
 EMR  WPR
100%

80%

60%
Reimbursement/package of benefits 40%
Clinical practice guidelines and
protocols
20%

Indicators of quality of care Planning and budgeting

Pricing of health products

Certificate of need/carte sanitaire  Low income


100%  Lower middle income
 Upper middle income
80%  High income
60%
Reimbursement/package of benefits 40% Clinical practice guidelines and
protocols
20%

Indicators of quality of care Planning and budgeting

Pricing of health products

Figure 8.2 Domains of health technology processes

Health technology
Health technology
Health technology management
assessment
regulation
Procurement
Clinical effectiveness
Safety Selection
Ethics
Performance Training
Social issues
Quality Use
Organizational

100 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
called HTA. HTA “refers specifically to or technical or economic dimensions are
the systematic evaluation of properties, not considered full HTA if they are not
effects, and/or impacts of health run systematically and in multidisciplinary
technology. It is a multidisciplinary perspective.(135)
process to evaluate the social, economic,
organizational and ethical issues of a Technical and economic evaluations
health intervention or health technology. are important primary studies and the
The main purpose of conducting an HTA knowledge synthesis that is key to full
assessment is to inform policy decision- HTA. Without such primary studies
making.”(133) by biomedical engineers, clinicians,
epidemiologists, economists, social
8.1.1 From performance to use in scientists, ethicists and other researchers
health care and evaluators, it is impossible to do
Figure 8.3 represents the stages and comprehensive HTA. Effective HTA
values of HTA and their relationship mobilizes the scientific knowledge
to regulatory processes.(134) There is of stakeholders, including clinicians,
a lack of emphasis on organizational administrators and patients to inform
impact, equity, ethical issues, feasibility decision-making processes.(136)
considerations and acceptability to
patients and health-care providers. The important contribution of biomedical
Value for money is similarly neglected engineers in HTA goes beyond producing
unless the device forms part of a vertical primary evidence to be included in HTA,
programme that needs to be assessed – especially regarding medical devices.
even then the individual device may not They have an essential part to play in the
always be considered; shared use devices comprehensive HTA process for medical
are rarely evaluated. devices as they have specific knowledge
and background to analyse and review
It is important to note that, partial technical characteristics, clinical use and
assessments focusing “only” on clinical

Figure 8.3 Stages and values of HTA and their relationship to regulatory process
Health technology assessment

Implementation
How should the technology be
implemented in this setting?
Appropriateness
Should the technology be
implemented in this setting?
Effectiveness

Can the technology work Efficacy


in this setting?
Regulation

Can the technology work?


Technical
performance

WHO Medical device technical series 101


Figure 8.4 Health technology assessment priorities
 Always almost always (80%-100%)
 Frequently (60%-79%)
 Sometimes (40%-59%)
 A few times (20%-39%)
 Never‚ almost never (0%-19%)
Safety

Acceptability to patients
80% Clinical
70%
effectiveness
60%
50%
40%
Acceptability to health 30% Economical considerations
care providers 20% (e.g. cost-effectiveness analysis)
10%

Feasibility considerations
(e.g. availability
of: budget‚ human Budget impact analysis
resources‚ infrastructure)

Ethical issues Organizational impact


Equity issues

quality and safety issues, pricing and of HTA reports. Nevertheless, HTAs
comparison with similar technologies. systematically examine various
The purpose of this chapter is to combinations of the following dimensions:
describe the current and potential role of the technical performance, safety, clinical
biomedical engineers in HTA in national efficacy and effectiveness, cost, cost-
agencies. It should be noted that HTA can effectiveness, organizational implications,
be developed at various levels: social consequences, and legal and
ethical implications of the application
• Global or national to enhance policy of a health technology. A HTA report is
decision-making. based on sound evidence and not only
• Meso- and micro-level, e.g. in contains investigations on all aspects that
hospital-based HTA which directly influence the technology but also those
support decision-making in hospitals, aspects that the technology influences.
where biomedical engineers The choice of the different dimensions
play a fundamental role in the for an assessment report depends on the
interdisciplinary analysis on medical specific context of the policy question –
devices to be used in the institution. one can concentrate on safety, clinical
efficacy and effectiveness and cost as in
Biomedical engineers typically work in the pre-marketing phase(137,138,139) or
hospitals but an increasing number is more on organizational issues as in the
moving into national policy positions hospital-based HTA.(140)
related to the HTA process.
A HTA report starts with the policy
question. A policy question is raised
8.2 Methods of health technology either by the decision-makers or by the
assessment institution itself. If the policy question
Worldwide there are various methods, is not properly defined, then the first
degrees of detail and scope of practice step is to formulate it. One framework

102 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
proposed by the European Collaboration medical devices.(145) Conversely, the
on HTA(141) contains the following increasing application of HTA to inform
steps: submission of an assessment decisions around medical devices and
request, followed by prioritization and the shift in health-care costs towards
commissioning, conducting the particular medical devices will require biomedical
assessment, and then dissemination. The engineers to play a greater role in HTA
assessment process itself comprises of than they have in the past.
defining the policy question, a preliminary
protocol, collection of background For example, a recent study on medical
information, definition of the research device prioritization in Gambia and
questions, data search pertaining to Romania revealed a lack of biomedical
the different dimensions, draft report engineers across both countries; where
which is reviewed externally and, finally, present biomedical engineers were not
publication. invited to take part in HTA or resource
allocation decisions, instead they were
An alternative programme of HTA(142) only consulted on maintenance and
may go through identification and servicing issues. Should biomedical
specification of assessment topics, engineers be consulted and empowered
evidence retrieval and collection to play a role in HTA, it is reasonable
of appropriate data, appraisal and to assume both settings would see
integration of evidence followed by report considerable improvements in medical
generation and dissemination. However, devices management and use.(146)
not all agencies or Institutions follow
all the steps or as a matter of fact in a
chronological order. 8.4 Core competencies required
for health technology
There are numerous materials on the assessment
methodology of conducting HTA, e.g.
the handbook on HTA published by the A pre-workshop on capacity building for
Danish Centre for Health Technology an efficient and effective HTA agency
Assessment, which gives a sound was conducted at the Health Technology
overview on the methodologies.(143) Assessment international conference in
Washington (DC), USA in June 2014. The
objective of this workshop was to provide
8.3 Different disciplines in health a preliminary exploratory discussion on
technology assessment the skills needed for HTA. The results
of the workshop showed certain skills
By definition, HTA is a multidisciplinary (both “hard” and “soft”) or competencies
field of policy analysis. The three most needed to practise or use HTA (see
common disciplines involved in HTA are Table 8.1).(147)
evidence-based medicine, economic
evaluation in health care, and population 8.4.1 Interdisciplinary teams
and public health ethics.(144) Currently, In 2008, a survey of international HTA
the discipline of BME is less represented organizations revealed that the majority
in HTA agencies, than in other areas like of the participating organizations had
R&D, regulation or health technology “clinical specialists” (71.1%) in their
management. One of the reasons could organizations followed by “economists”
be that national agencies do not have (68.4%) and “information specialists”
specific teams of procedures for HTA of (65.8%) (Table 8.2). In addition to the

WHO Medical device technical series 103


Table 8.1 Competencies needed to practise HTA

Skill sets Specific skills


“Hard” scientific skills Literature search Health-care policy
Critical appraisal of literature Statistics
Evidence-based medicine Ethics
Mathematical modelling (e.g. Markov Priority setting in HTA
models)
Health economics Formulating recommendations
Economic analysis CPGs evaluation AGREE instrument
Epidemiology Horizon scanning
Clinical effectiveness Multi-criteria decision analysis
“Soft” consensus- Team building Understanding culture, local context
building and
Working in (and communicating with) a Report writing – catering to different
communication skills
multidisciplinary team audiences
Coordinating and managing HTA project How to “read” a report
and project team including stakeholders
Way to communicate to patient and public Consensus-building skills
Communication between different
organizational structures that are
involved
Know-how to adapt reports to local
context

Table 8.2 Background of the professionals in HTA organizations(149)

Notes: *None: Number of HTA agencies with no specialist professional working in the organization; 1–5: number of HTA agencies with 1 to 5 specialist professionals; >5: number
of HTA agencies that had more than 5 specialist professionals.
** Number of respondents replying to each category.

104 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
other professionals listed in Table 8.2, analysis, priority setting, legal, social and
biomedical engineers were mentioned in ethical aspects.(151) The specific roles
an additional category of content specific of these professions vary across HTA
experts such as dentists, pharmacists, organizations, but they are all likely to be
physiotherapists, lawyers, chemists and involved in the collection and synthesis of
nutritionists.(148) clinical and/or economic data, which form
the basis for evidence-based decision-
The WHO 2015 Global Survey on Health making. HTA specialists should be able
Technology Assessment by National to perform literature searches, assessing
Authorities documented that legal, and avoiding the several types of bias (e.g.
4.4 Professionals involved
engineering and information professionals in HTA ing epidemiologists, biostatisticians, health economist
publication bias,
preparation and decision making and others) and language
experts in bias,
clinicalretrieval
sciences (medical
are involved in the assessment of medical bias,
doctors, nurses, pharmacists, and healththe
reporting bias), synthesizing professional
Respondents
devices, as reported
can be seen that the in preparation
Figure 8.5.of HTA re-evidence (may be
organizations) qualitative,
(Chart 4.4a). Thequantitative
involvement of different
ports and the decision-making process had high level
[meta-analysis]
professionals in HTA ordidformal
not varydecision-
markedly across tech-
of involvement from public health professionals (includ-
As shown in Figure 8.5,(150) the analysis) and publishing the results (both
nologies or interventions (Chart 4.4b).
number of engineers increased when paper and electronic versions).(152)
CHART 4.4: Number and proportion of professionals involved in (a) preparation of HTA reports
the objective of HTA was medical devices.
and (b) making decision
Individuals from these professions have 8.5 Survey of biomedical
knowledge
A and skills in the areas of engineers involved in health
Clinical interventions 120 118
clinical epidemiology, evidence-based technology15assessment
44 15

Medical devices 112 102 12 64 14


medicine, clinical trials, health services
research, meta-analysis, economic
Medicines 123 A survey was developed17 in 2013 by
133 11 40

(cost-effectiveness) analysis,
Population level health consensus
interventions 132 Holmes, 91 Banken 24 and
41 Muller,
28 to gather
conferences, technology
Service deliverymanagement,
models 94 information
78 for this
18 section
34 21and it showed
decision-making, Surgicalpolicy-making/
interventions 102 that 94the involvement 10 42 of12 biomedical
Vaccines 115 99 7 32 16
0 20 40 60 80 100
%
Public Clinical Bioethics and Legal, Engineering Consumer
health science sociology and information science needs
Figure 8.5 Professionals involved in assessment of medical devices

Clinical interventions 125 162 21 46 30

Medical devices 98 142 14 69 27


Medicines 125 196 16 35 39
Population level health interventions 144 135 33 31 43
Service delivery models 107 124 25 33 34

Surgical interventions 75 133 15 29 26

Vaccines 135 161 20 26 26


0 20 40 60 80 100

%
Public Clinical Bioethics and Legal, engineering and Consumer
health science sociology information science needs

Public health: Epidemiologists, Biostatisticians / Statistician, Economists/ health economists, Public Health professional
Clinical science: Medical doctor, Nurse, Pharmacist, Health professional organization
Bioethics and sociology: Sociologist, Ethicist
Legal, Engineering and information science: Biomedical and /or clinical engineer, Lawyer, Librarian/information specialist
Consumer needs: Civil society representative, Patients representative

19

WHO Medical device technical series 105


engineers in HTA varies internationally, Conversely, the situation is much more
though few HTA organizations report fragmented in Asia. For instance, a
having individuals with these credentials respondent from Singapore notes: “We
on their staff. In saying this, most HTA do not have any assessment processes
organizations noted that biomedical that require a biomedical engineer
engineers may have a growing role to specifically. Our staff who have biomedical
play in the future. Similarly, international engineering background function as HTA
HTA experts and policy-makers recognize researchers and would carry out the same
the vital role biomedical engineers play assessment processes as any other staff
in HTA and medical devices selection, performing that role.”
prioritization and management more
generally.(153) Likewise, in the Republic of Korea: “They
are involved with an overall process of
Biomedical engineers are not commonly HTA including synthesizing evidences
found in most HTA organizations, and [sic] through systematic reviews. We train
where they do work, they usually perform them exactly [the] same as other staffs
the same role as other members of an [sic], many with [a] clinical background.”
HTA team; their role is not specific to
their training as a biomedical engineer. The HTA division of IFMBE states that
However, a few exceptions exist in Europe. “the role of biomedical engineers is
For instance, in the United Kingdom, peculiar … as their activities go from
one of the 23 members of the National the medical devices research, design,
Institute for Health and Care Excellence development, utilization, management
Medical Technologies Advisory Committee and assessment.”(158) Further on, they
is a biomedical engineer while in Italy the mention that due to their background
national agency for public procurement in biomedical engineers “may play a very
health employs five biomedical engineers important role in early stage HTA.”(159)
and several hospital HTA units are
headed by biomedical engineers (e.g. In organizations where they are employed
Ospedales Pediatrico Bambino Gesù, or consulted specifically for their
Rome and Azienda Sanitaria Locale, biomedical expertise, it is customary
Benevento). In the HTA unit in CEDIT, for to provide advice around the technical
Paris public Hospitals, the unit comprises characteristics, usability and safety of
biomedical engineers, physicians and devices, particularly when the evidence
methodologists.(154) base traditionally used for HTA is limited.

HTA is a core topic in the majority of Some HTA agencies do not usually have
European BME courses. In 2010, it was job descriptions specific to biomedical
included among the core topics of BME. engineers – rather the same skills are
(155) required as for any other member of
the HTA team. However, one of the
In Latin America(156) there are more agencies stated that they specifically hire
biomedical engineers working in HTA biomedical engineers in their unit in order
agencies, as can be found in the National for them to contribute and share their
Center for Health Technology Excellence expertise “on the technical aspects of
in the Ministry of Health in Mexico medical devices and procedures”.
(CENETEC).(157)
The few agencies(160) that have job
descriptions specifically for biomedical
engineers, request a postgraduate

106 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
Figure 8.6 European patent applications

Evolution 2006–2015

Evolution 2006-2015 and Top 10 technical fields

Medical technology
11 124
Top 10 technical fields
Electrical machinery,
appartus, energy
10 944

Digital
communication
Pharmaceuticals
10 018
5 270

Engines,
pumps, turbines Computer
5 318 technology
9 869
Biotechnology
5 905
Transport
7 533
Organic
fine chemistry
Measurement
6 132
7 228

qualification in BME in addition to the directly informing decision-making


standard14 skills needed for HTA.
Innovation
at different levels in health systems.
• It is imperative that proper educational
8.6 The developing role of programmes be developed to prepare
biomedical engineers engineers for a broader role in health
care, and, more specifically, the
The findings from the 2013 survey are principles and concepts of HTA.
consistent with the conclusions drawn in
the 1990s by Menon:(161) As discussed above, the important
contribution of biomedical engineers in
• Their expertise should be part of HTA goes beyond producing primary
the interdisciplinary work of HTA evidence to be included in HTAs,

WHO Medical device technical series 107


especially regarding medical devices. on HTA;(168,169) in August 2016 the first
They have an essential part to play in IFMBE HTA Division content management
the HTA process especially considering system was published;(170) November
that the focus of health-care innovations 2016 the first IFMBE eLearning platform
is shifting from drugs towards medical was developed and since then, more than
devices. In fact, in the past 10 years, the 20 hours of training material on HTA have
number of medical technologies patented been uploaded.(171,172,173)
each year has doubled compared with
that for drugs and biotechnologies – in
2014, for example, medical technologies 8.7 Professional societies and
ranked first in intellectual property international collaboration in
applications in Europe. health technology assessment

This implies that over the next years, Is global collaboration in HTA necessary?
thousands of new medical devices will Global collaboration can facilitate the
be available for adoption, causing a exchange of know-how (between limited
significant shift in health-care costs from resource countries and developing
drugs to devices, and a growing request countries, between individuals,
for HTA studies focusing on devices. To agencies, and industry and policy-
cope with this huge change, the European makers), lessons learned and global/
legislation on medical devices is currently regional/national work. This section will
under revision and, according to first consider the different activities and goals
drafts, will require device assessment as of international organizations dealing
a prerequisite for market admission. This with HTA and also some of the regional
is a huge challenge for HTA as, different networks that have emerged in the
from drugs, there is a well-recognized Americas, Europe and Asia.(174)
lack of methods and tools to support HTA
for medical devices,(162) especially in Depending upon the background and
pre-market phases,(163,164) which many interest of the individuals – whether they
authors tend not to consider relevant for are users, producers and those interested
HTA field. in HTA – they could become members in
one or more of the organizations, societies
This shift will require a reinforcement of or networks mentioned below.
BME contribution in HTA studies, which
has already been recognized by the BME One of the strengths in using HTA
international community; though this as a tool in decision-making is that it
will take a few years to work through to involves a multidisciplinary team in which
national HTA entities. For the first time biomedical engineers have an important
HTA was introduced as a core topic for role to play to play.
biomedical engineers in 2009;(165) since
2012 all the IFMBE conferences(166) 8.7.1 Health Technology Assessment
have had sessions on HTA(167) and since international
2015 a whole dedicated track, which in H e a l t h Te c h n o l o g y A s s e s s m e n t
IFMBE conferences is a pool of invited international (HTAi) is an interdisciplinary
and proposed sessions chaired by one or global scientific and professional society
two experts and often resulting in special with a focus in HTA.(175) Its members
issues on relevant BME journals; and for come from academic institutions, health
the first time there was an invited keynote service producers, industry, business,
talk at the 2015 World Congress of BME government, patients and consumers

108 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
from all continents and it acts as a The INAHTA website plays an important
neutral forum for collaboration, sharing part in facilitating communication
of expertise and information. between the members and includes
information on HTA reports and ongoing
The objectives of the society are: activities. The Brief series of INAHTA
encourages member agencies to present
• To collaborate actively with WHO, their overviews on recently published
various networks and regionally reports, with some indication of impacts
based HTA societies to increase the on decisions made by governments at
application of HTA in health policy- regional, national or international level.
making Furthermore, the website encourages
• Support the HTAi policy forum by member agencies and/or individuals
fostering open debates on issues to take a consistent and transparent
involving HTA related to health policy approach to HTA.(176)
matters both in the public and private
sectors 8.7.3 EuroScan International Network
• Conduct annual international The International Information Network on
meetings, which serve as meeting New and Emerging Health Technologies
points for all stakeholders and (EuroScan International Network)
address the interests and needs of is a collaborative network of member
the members agencies for the exchange of information
• To develop its work with interest on emerging new drugs, devices,
subgroups and facilitate information procedures, programmes and settings in
exchange in specific focus areas health care.(177)
• To support the publication and
diffusion of the International Journal The members of the network strive to:
of Technology Assessment in Health
Care. • Establish a system of sharing skills
and experiences in early awareness
8.7.2 International Network of and alert activities.
Agencies in HTA • Develop applied methods for early
The International Network of Agencies in identification and assessment.
HTA (INAHTA), which was established in • E x c h a n g e a n d d i s s e m i n a t e
1993, has 57 member agencies from six information on new and emerging
continents. All members are non-profit technologies.
making organizations linked to regional
and national government, which produce 8.7.4 HTAsiaLink
HTA reports. The members meet face-to- HTAsiaLink was established in 2010.
face once a year in conjunction with the The aim of the network is to strengthen
HTAi conference. Additionally, INAHTA individual and institutional capacity in the
provides networking opportunities field of HTA and enhance the integration
throughout the year as a member of the of evidence into policy decisions. The
various community of practices. It serves network facilitates information exchange
as a platform to share information and (not only between members but also
provides opportunities for cooperation other networks and organizations),
internationally and regionally. It also joint research projects, annual regional
facilitates information exchange between conference and other activities.(178)
members through Listserv.

WHO Medical device technical series 109


8.7.5 La Red de Evaluación de within existing health systems. Both
Tecnologías Sanitarias de las meetings resulted in the introduction of
Américas a regional network that includes over 100
RedETSA was formally launched in 2011 experts as well as national and regional
and has currently members from 25 champions. The network has grown
institutions and 13 countries from the and now includes countries from WHO
region. Initially it was funded by PAHO SEAR and WPR as well. In order to seek
(Pan American Health Organization) the political and financial commitment
and ANVISA (Agência Nacional de needed to establish/strengthen national
Vigilância Sanitária), Brazil. The aim of HTA programmes, Member States were
the network is to promote and strengthen alerted to the importance of building
HTA as a tool to support decision-making their HTA technical capacities during the
through regional exchange relating to the regional committee meeting conducted in
introduction, dissemination and use of the Kuwait in October 2015. The presentation
technologies and by adopting common was well received and resulted in several
methodologies, and capacity building official requests from Member States
measures through cooperation.(179) such as Egypt, Iran (Islamic Republic
of), Oman, Qatar, Saudi Arabia, Sudan
8.7.6 European Network for HTA and Tunisia.
The European Network for HTA
(EUnetHTA) has evolved into an 8.7.8 Health Care Technology
international collaboration among Assessment Division (IFMBE)
HTA researchers and policy-makers in The IFMBE was established in 1959
European countries. It was established when a group of medical engineers,
in 2008 to create an effective and physicists and physicians met in Paris to
sustainable network and has developed create the international scientific society
and implemented practical tools, after of biomedical engineers. The IFMBE is a
careful piloting, to provide reliable, timely, United Nations recognized NGO holding
transparent and transferable information a seat in all the UN agencies (e.g. WHO)
to contribute to varied HTA research and is part of a global system working
in member states.(180) EUnetHTA to improve health worldwide. Being a
coordinates the efforts of 39 institutions federation of scientific societies, IFMBE
from 30 countries. is not open to individuals, but rather
national and regional societies. In 2016,
8.7.7 Eastern Mediterranean it represented 54 national societies, seven
Regional Network in HTA transnational associations (e.g. IEEE-
A regional network has been setup and EMBES), accounting for about 120 000
hosted by WHO EMR to provide a platform members from six continents. It has two
for members to pose queries, exchange divisions:
news and resources, and request advice.
The members come from 22 countries • Clinical Engineering Division (CED),
and comprise HTA advocates, champions mainly focused on the management
and international experts.(181) of health-care technology.
• Healthcare Technology Assessment
Key progress has been made in the area Division (HTAD), focused only on
of HTA in EMR through two intercountry HTA. The goal of HTAD is to promote
meetings aimed at technically supporting HTA within the biomedical and
the Member States in the development clinical engineering community.(182)
of their own national HTA programmes

110 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
The specific activities covered by HTAD 8.8 Conclusion
include:
In quite a few HTA agencies biomedical
• To increase the knowledge of HTA engineers are part of multidisciplinary
among biomedical engineers, teams. However, they are still not
supporting the introduction of HTA automatically involved when health
related content at BSc, MSc, PhD technologies, particularly for medical
and continuous education levels, and devices, are assessed. HTA of medical
developing learning resources. Here, devices seems to be the area in which
the division has produced more than the contribution of biomedical engineers
100 hours of eLearning content on to the HTA process will grow significantly,
basic concepts, methods, tools together with early stage HTA.
and case studies, which are freely
accessible to the IFMBE associates The Sustainable Development Goals
through their member societies’ published in 2015, include universal
websites. Moreover, a summer school health coverage, under Goal 3. This
on HTA, specifically conceived for implies that decisions on coverage
biomedical engineers and medical will have to be made on the selection,
physicists was launched in 2015 and prioritization, and reimbursement
will run every two years.(183) of medical technologies. Decisions
• Encouraging basic and applied are required to select priority clinical
research in HTA; an open access interventions for prevention, screening,
journal is being launched,(184) and diagnostic, treatment, rehabilitation
increasing space has been devoted and palliative care. When medical
to HTA in IFMBE conferences since technologies are being assessed it is
2012. important to consider the competencies
• Stimulating cooperation and of the biomedical engineer. Therefore,
promotion of worldwide collaboration HTA agencies should consider including
between different societies involved this profession in their multidisciplinary
in HTA. HTA teams developing assessments and
• To support guidelines and case providing information for better policy
studies of particular relevance (e.g. decision-making, especially involving
HTA of medical devices, guidelines medical technologies.
for multi-criteria decision analysis for
HTA of medical devices, early stage In settings with few resources in HTA,
HTA). where it may not be possible to hire
• Reinforcing the dialogue between biomedical engineers, strong links could
medical device researchers and be developed with BME departments
policy-makers, through HTA. HTAD in hospitals and universities, to share
coordinated the organization of the knowledge and resources. By improving
first European Parliament Interest the contribution of biomedical engineers
Group on BME, launched the 31 May to the HTA process, the necessary links
2016 at the European Parliament. This between innovation, regulation, HTA
group of six Members of the European and HTM of medical technologies will
Parliament from five countries, will be strengthened and the contribution of
meet twice a year, supporting action HTA to sustainable health systems will be
regarding HTA of medical devices enhanced.(186)
in European regulations (e.g. the
regulation on medical devices,
currently under revision).(185)

WHO Medical device technical series 111


Credit: James Goh; biomedical engineers in surgery room in China.
9 Role of biomedical engineers in the
management of medical devices

9.1 Introduction and promotes patient care by applying


engineering, economic, communication
The professional figure typically assigned and managerial skills to health
to manage medical devices in health- technologies. As clinical medicine has
care facilities is the biomedical engineer, become increasingly dependent on
although in some countries, they are more sophisticated technologies and the
called clinical engineers or medical complex equipment associated with it,
engineers. Clinical – or biomedical the biomedical engineer, as the name
engineers (as referred to here) – are implies, has become the bridge between
generally considered a specialization of modern medicine and equally modern
work in BME. Whereas in some countries engineering, supplemented with a
BME is practised primarily in academic combination of education in life sciences,
institutions, the research laboratory or human factors, systems analysis,
manufacturing, “clinical engineering” medical terminology, measurements,
is practised in hospitals and other communication systems and
environments where medical device instrumentation. Such cross-disciplinary
technologies are used.(187) However, knowledge and skill plays an increasingly
some countries have BME departments vital role in ensuring the safe and effective
in hospitals and health-care services, integration and interoperability of many
responsible for the management of all medical devices and innovations with
medical technology. There is no definitive existing IT systems, business systems
definition of a clinical engineer but over and organizational processes.
the years several societies have attempted
to provide an appropriate definition: Biomedical engineers take care of medical
devices throughout their life cycle within
• ACCE: A professional who supports health-care facilities, managing not only
and advances patient care by medical equipment, but also implantable
applying engineering and managerial medical devices, in order to safeguard
skills to health-care technology.(188) patients’ lives. Biomedical engineers may
also train clinicians, nurses and other
• AAMI: A professional who brings professionals operating in health-care
to health-care facilities a level facilities for the best and safe use of
of education, experience, and medical devices.
accomplishment which will enable
him to responsibly, effectively, and Biomedical engineers work in different
safely manage and interface with levels of health-care facilities. Biomedical
medical devices, instruments, and engineers should participate in the
systems and the user thereof during planning of areas or new units of hospitals
patient care.(189) as well as in the planning of health-care
facilities, to support the decision-making
However, today these definitions of medical technologies requirements
are obsolete and need redefining to depending on the clinical interventions
reflect the new role of the biomedical that would take place responding to the
engineer in health-care systems as a population needs.
health-care professional who supports

WHO Medical device technical series 113


Figure 9.1 A biomedical (or clinical) engineer’s interactions

While working in hospitals, where they decommissioning. The WHO health


directly interface with medical devices, technology life cycle (Figure 9.2)
clinical staff and operations personnel, describes all the phases of health
biomedical engineers may also work technology.
in higher levels of health care, such as
ministries of health and international Biomedical engineers not only manage
organizations. day-to-day operations to ensure that
the medical device infrastructure is
performing reliably, but they are also
9.2 Biomedical engineering responsible for understanding and
activities through the life managing the longer term issues of
cycle of devices and systems technology assessment, installation,
integration with IT systems, managing
A biomedical engineer at the hospital hazard alerts and recalls, upgrades
level is responsible for managing and developing transition strategies for
health technologies from assessment replacement technologies.
and introduction within the hospital to

114 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
Figure 9.2 Health-care technology life cycle

HEALTHCARE TECHNOLOGY LIFE CYCLE


Manufacture PROVISION
Marketing Testing
Transfer Development
Distribution Research
Assessment of needs

Technology assessment
Evaluation
De-commissioning
Planning
Maintenance
Procurement
Training
Installation
Operation
ACQUISITION Commissioning UTILISATION

Source: Medical device regulations: Global overview and guiding principles (http://www.who.int/medical_devices/publications/en/MD_Regulations.pdf).

Figure 9.3 Major life cycle functions for medical devices

Information about the


new health technology
(Innovation)

HTA

DEPARTMENT OF BLOOD SAFETY AND CLINICAL TECHNOLOGY


WORLD HEALTH ORGANIZATION
1211–GENEVA–27 Procurement
Information about the 92 4 154618 2
SWITZERLAND new health technology
(Increase)
Fax 41 22 791 4836
E-mail bct@who.int Acceptance Testing
www.who.int/bct
Information about the
new health technology
(Replacement)

HTM

Decommissioning

WHO Medical device technical series 115


9.2.1 Health technology assessment and to identify causes of errors (e.g.
Biomedical engineers are sometimes wrong maintenance, design deficiencies,
involved in HTA committees in order to human-machine interaction deficiencies,
evaluate efficacy, safety and effectiveness inappropriate use, etc.).(191)
of health technologies. The HTA process
focuses on different technology aspects 9.2.4 Health information technology
(such as clinical, technical, economic, Health information technology (HIT)
ethical and legal). Biomedical engineers involves the exchange of health
contribute to the process with their information in an electronic environment.
technical knowledge and capacity to Widespread use of HIT within health-care
interact with different fields professionals. facilities will improve the quality of health
Further details on HTA can be found in care, prevent medical errors, reduce
Chapter 8. health-care costs, increase administrative
efficiencies, decrease paperwork and
9.2.2 Procurement expand access to affordable health care.
Procurement is the process of obtaining It is imperative that the privacy and
planned requirements according to security of electronic health information
transparency and anti-corruption be ensured as this information is
rules. Biomedical engineers work maintained and transmitted electronically.
with procurement departments in the
acquisition of planned health technologies Biomedical engineers, as health
planned. According to Bailey’s “five technology experts, are involved in HIT
rights”,(190) to obtain the right product in diverse ways within hospitals. Their
or service, a generic description within a expertise concerns the knowledge of
clear specification is required. Biomedical certification procedures of software in
engineers are in charge of assessing medical devices, and standards, such as
the technical specifications of different IEC 80001-1, concerning best practice
manufacturers’ bids, and recommending for IT-networks incorporating medical
the best overall solution. devices. As with other health technologies,
staff training and comprehensive service
9.2.3 Health risk management agreements are essential for effective
Health risk management (HRM) is defined installation and use of software.
as the combination of strategic activities
used to prevent, or reduce to a minimum, In some hospital settings, biomedical
adverse events. Risks in health-care engineers may be involved in the
facilities are various: clinical, financial, management of the hospital information
strategic, legal, etc. Risk assessment system (HIS), which is a comprehensive,
requires the joint participation of different integrated information system used to
stakeholders within the organization. manage data flow in hospitals. As more
Biomedical engineers are an essential and more devices become networked,
component of multidisciplinary HRM dedicated expertise is needed to ensure
teams operating within health-care these devices are integrated into the IT
facilities, analysing accidents involving network infrastructure, which data models
medical devices which have caused – or are compatible, and that coordinated
contributed to produce – severe injuries change management is built into the
to patients or health workers. They are working relationships between the
often the only professionals available who biomedical and IT departments and staff.
possess a broad span of health technology
knowledge that allows them to analyse HIS is not the only information system
deeply the operation of medical devices within the hospital. Other systems

116 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
include cardiology information system day it arrives. The safety of the medical
(CIS), laboratory information system device must be guaranteed and verified in
(LIS), PACS and RIS. These systems are order to protect patients and health-care
totally independent even if they could workers. Generally, an acceptance form
interact and exchange information. More is filled out for this process (see sample
information can be found in Chapter 10. acceptance test log sheet for equipment).
(193) The acceptance test includes:
9.2.5 Health technology management
Traditionally, the core activities of a • Correspondence check of medical
biomedical engineer concern HTM, and device purchased with that delivered
include all management activities relating • Visual inspection
to medical devices within the hospital. • Functional check
In HTM activities a biomedical engineer • Electrical safety check
is often supported by a biomedical • Calibration and measurement (for
equipment technician who is in charge specific medical devices).
of detailed technical activities. The most
important tool for HTM is the medical Each acceptance test should be recorded
devices inventory, which provides a as “pass/fail” or not applicable (n/a). Once
technical assessment of the technology all the regulatory criteria for acceptance
on hand, giving details of the type and have been satisfied, the device can be
quantity of equipment, and the current labelled with an asset number, and then
operating status. Furthermore, when formally handed over to the user.(194)
linked to standard equipment lists and
an appropriate nomenclature, it provides Maintenance
the basis for effective asset management, These activities represent an essential
including facilitating scheduling and segment of HTM activities. There are two
tracking of preventive maintenance, types of maintenance activities: corrective
repairs, alerts and recalls.(192) and preventive. Corrective maintenance
involves activities aimed at fixing a
Key elements of the HTM life cycle are: medical device following a breakdown.
The biomedical engineer’s role is to
• Acceptance testing: The act of identify a breakdown and its causes
accepting a new medical device in and to manage all activities, technical,
a hospital, checking it is safe and organizational and logistic, which
functional. allow re-establishing medical device
• Maintenance: Keeping a medical functionality. Preventive maintenance or
device in safe and functional planned preventive maintenance (ppm)
condition by regular checks and is identified as the set of maintenance
repair as necessary. activities carried out at pre-set intervals
• Decommissioning: Permanent or according to predetermined criteria.
removal of a medical device from This kind of maintenance is necessary to
use in a hospital, for obsolescence reduce breakdown likelihood, to maintain
or other reasons. medical equipment functionality, and to
prevent possible damage for patients
Acceptance testing and health-care workers. The biomedical
This process checks that a medical engineer should plan a real maintenance
device meets safety standards, clinical policy, established and discussed within
requirements and the procurement the hospital, in order to ensure the
requirements of the hospital from the

WHO Medical device technical series 117


permanence of safety and efficacy, and effective and safe use of resources, and
the replacement of older equipment. the significance of new developments.

Decommissioning 9.2.7 Ethics committee


This process is the well considered, An ethics committee is a body consisting of
final phase of the health technology health-care professionals and nonmedical
life cycle. The aim of the process is members, whose responsibility is to
to guarantee the appropriateness of protect the rights, safety and well-being
the whole health technology asset, of human subjects involved in a clinical
and to permit permanence in activity trial. The committee also provides public
only for those health technologies that assurance of that protection, by, among
are safe, useful and economically other things, expressing an opinion on
sound, and accord with applicable the trial protocol, the suitability of the
standards. A biomedical engineer is investigators and the adequacy of facilities,
the health professional able to manage and on the methods and documents
the whole decommissioning process to be used to inform trial subjects and
appropriately, from the identification obtain their informed consent.(195) Ethics
of decommissioning processes to the committees’ competences concern, in
definition of appropriate criteria to assess addition to clinical trials on medicinal
if the identified health technologies may products for human use, issues on
be decommissioned. In this process, a medicines, medical devices, and on the
biomedical engineer may collaborate use of clinical and surgical procedures.
with other health professionals (doctors, Biomedical engineers' are essential
nurses, etc.) in order to understand all members of ethics committees, because
the factors involved. they are medical devices experts, and they
have the knowledge of the technological
9.2.6 Education and user training and organizational hospital context.
This activity is fundamental to a biomedical
engineer’s work. Indeed, education and
user training could reduce damage 9.3 Organizational models of
both for users and patients. Biomedical biomedical engineering
engineers' interdisciplinary knowledge services
allows them to organize lectures,
workshops and courses aimed at different In a health-care facility there is no single
health professionals. In these events they organizational model for BME services.
teach how to use medical devices, what The managers and others responsible for
the technology can offer the patient, the BME service can consider a variety of
but also the cost and organizational options and their ramifications – including
problems that need to be considered. cost considerations – in order to arrive at
In this way health professionals acquire the best decision for their environment.
awareness of the importance of the best (196,197) However, it is possible to identify
use of technology and which behaviours three basic models.
to avoid. Biomedical engineers can
also provide in-service training for BME 9.3.1 In-house personnel model
personnel, e.g. biomedical equipment In this model all biomedical equipment
technicians, regarding electrical safety maintenance activities (consultations,
and maintenance. Finally, they may give safety verifications, etc.) are executed
advice to consumer representative groups by in-house personnel located in the
on the availability of technology, the hospital, including the management of

118 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
Figure 9.4 In-house personnel model – main activities

 Maintenance  External contracts


activities

 External corrective
interventions

 Spare part

Figure 9.5 Mixed model

 Third-party
(ISO) service
 In-house personnel

 Manufacturer
(OEM) service

supplying spare parts and contracts with service organization (ISO) or a mix of
manufacturers.(10) the two.(11,198) The management of the
contracts with manufacturers and the
9.3.2 Mixed model provisioning of spare parts and other
In this model the hospital stipulates high-level activities are carried out by in-
contracts regarding servicing the house personnel.
maintenance of biomedical equipment.
BME department managers should decide 9.3.3 Third-party multi-vendor
if this service should be performed by the service model
original equipment manufacturer (OEM), In this model the hospital stipulates
by a third party such as an independent a contract to service the full-risk

WHO Medical device technical series 119


maintenance activity and for other BME health-care providers and from country
services with an ISO.(11) In this way to country. However, it is possible to
the health-care facility does not need to describe a generic BME department
be concerned with the management of – see Figure 9.6. Generally, it comes
biomedical (test) equipment and medical under the medical department director.
devices. This position is strong evidence that
biomedical engineers cover a key health-
9.3.4 Biomedical engineering care role within hospitals and health-care
departmental structures within facilities. Furthermore, BME departments
hospitals liaise with other departments, interacting
The BME department or service is an with all the different professionals within
internal structure within hospitals. It a health-care facility: physicians, nurses,
is specific for each health-care facility pharmacists, economists etc.
and can vary in its composition between

Figure 9.6 Typical BME department in a hospital

President/Director General

Medical or Administrative
Director

Biomedical
engineering
Pharmacy department head

Procurement office HTA Team

Medical
Departments Tech Specs Spare parts
Institutional
Procurement
Department
Surgical
Departments Research Lab CE Service Center

Inventory Installation

Acceptance Training

Calibration Maintenance

Warehouse

Source: Fred Hosea, 2016.

120 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
9.3.5 Key roles in a biomedical engineer will have a BSc in BME
engineering department and (depending on the position) four
These functions would differ depending to five years’ hospital experience
on the type of health facility, the in: conducting research; leading
organization, the needs and the resources procurement processes; organizing
available. and supervising service centre
activities; and supervising technicians,
• Biomedical engineering director/ students.
manager: The biomedical engineering
director acts as a manager and • Biomedical engineering technician:
technical director of the BME A biomedical equipment technician
department or service. Their typical is an engineering technician or
background will be a MSc in BME other technical equipment specialist
or equivalent programme and three “trained to maintain instruments
years’ minimum experience as a biomedical equipment used in
biomedical engineer. Furthermore, hospitals, laboratories and other
they must have some business clinical areas”.(199) They perform
knowledge and management skills troubleshooting, corrective and
that enable them to participate in preventive maintenance, electrical
budgeting, cost accounting and safety tests and calibration of a wide
personnel management.(1) variety of medical devices, medical
equipment and in vitro diagnostics
devices.
9.4 Biomedical
• Biomedical engineering
engineer/junior biomedical
around the
engineer: world a biomedical
Typically,

African Region: Gambia

Distribution of biomedical engineers: No data


BME societies: Early stage
Main BME activities: HTM (maintenance)

Gambia does not possess a programme for general training on medical devices maintenance that would
provide the fundamental qualifications to work safely as a biomedical technician in hospitals and other
health-care facilities. Generally, maintenance staff working on medical devices in all health-care facilities
only had prior professional training in electrical/electronic technologies. However, the Medical Research
Council Unit, in Gambia has, by contrast, a quite successful BME department. In 2015, the department
consisted of a biomedical engineer, one senior BMET, three BMETs, two assistant BMETs and two local
trade students. The department now supports almost 99% of biomedical technologies “in-house” and
performs regularly with measurable indicators.

WHO Medical device technical series 121


African Region: Zambia

Distribution of biomedical engineers: No data


BME societies: Early stage
Main BME activities: HTM (installation, maintenance, decommissioning)

The acceptance of BME in the health system is improving because the failure of a single item of equipment
has the potential to bring service delivery to a standstill and serious suffering to patients. The main
difficulties faced are the absence of strong financial support and a safety standards system within the
health-care system. There is a need for the government to introduce schools to train engineers in this
discipline and to develop specific policies to help improve the situation.

Eastern Mediterranean Region: Jordan

Distribution of biomedical engineers: Medium (90 for 30 ministry of health hospitals and 1200 health-care
medical centres)
BME societies: Absent
Main BME activities: HTM, procurement

Jordanian BME experience is the only one in the EMR. It belongs to the Directorate of Biomedical
Engineering (DBE), officially established in 2001 to be the technical arm for the Jordanian Ministry of
Health and to overcome all the challenges and difficulties related to medical equipment. Nowadays DBE
has become a unique establishment covering all issues and activities related to medical devices and
equipment life cycle, with fully automated, web-based, paperless software as an integrated comprehensive
solution. All HTM system components and procedures are automated, locally developing and implementing
a unique technical management software system, within DBE according to DBE needs.

The complete web-based system includes a powerful software package designed on an Oracle base and
implemented on a network covering different locations of the DBE. The core of the system is a fully paperless
computerized maintenance management system where all maintenance operations are performed fully
paperless, including spare orders management. The system also includes a powerful reporting module
capable of producing all types of standard and customized reports about all activities and information related
to any medical equipment such as inventory information, life cycle cost and including any other information
such as staff productivity, travel hours, performance, training etc. The main lesson learned was that every
country or health organization needs a HTM system developed to meet local requirements. Copying systems
from more developed countries may not necessarily work. This system presents a unique model in terms of
setup, cost and performance. It contributes to better quality patient care.

Region of the Americas: United States of America

Distribution of biomedical engineers: High


BME societies: ACCE, 50 state and regional societies
Main BME activities: HIT, HRM, HTM, procurement, ethics committee

The main challenge currently is to transform the health-care system into an interoperable health-care
system. Medical device interoperability refers to the ability of medical devices to exchange information
with each other and with patient data repositories such as electronic health records (EHRs). In the context
of device and EHR interoperability, it refers to information sharing from one device to another or between
devices and EHRs.

122 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
European Region: Croatia

Distribution of biomedical engineers: Medium (about 1 per million population)


BME societies: Croatian Medical and Biological Engineering Society (1984–2015) renamed Croatian
Biomedical Engineering and Medical Physics Society (2015 onwards)
Main BME activities: HIT (HIS – rarely, PACS, RIS, LIS – occasionally), HTM (acceptance testing –
occasionally, corrective maintenance – rarely, preventive maintenance – rarely, electrical safety test
– never, decommissioning – occasionally, user training – rarely), procurement (technical specifications –
occasionally, selection – rarely).

European Region: Italy

Distribution of biomedical engineers: High


BME societies: Associazione italiana ingegneri clinici – Italian Association Clinical Engineers (AIIC)
Main BME activities: HIT, HRM, HTM, ethics committee, procurement

In Italy there is great mobilization concerning biomedical engineer recognition as health-care


professionals. In 2014 the government approved the undertaking to accord biomedical engineers as
national health system health-care professionals. If biomedical engineers’ activities mainly concerned
medical equipment in the past, nowadays they extend to medical devices. For this reason, medical devices
will be the main topic of the 15th AIIC national congress.

South-East Asia Region: India

Distribution of biomedical engineers: Low (1500 estimated for 16 000 health-care facilities)
BME societies: Biomedical Engineering Society of India, Clinical Engineering Society of India has been in
existence for a couple of decades
Main BME activities: HTM (focusing on corrective maintenance), procurement

Leaders of health-care systems in India are well aware that use of modern medical technology is essential
for providing advanced diagnostic and therapeutic services to patients. In recent years, there has been
a great influx of modern, sophisticated and expensive equipment into all types of hospitals. However, an
understanding that well qualified, highly trained and certified biomedical engineers are equally essential
within the system for effectively and safely managing this advanced technology, has been lacking. This
has been one major factor for causing suboptimal development of the BME profession in India. Absence of
a formal state recognized nationwide programme for certification of biomedical engineers is another hurdle
in correctly projecting the importance of this profession to other health-care professionals and to the
society at large. Though recent efforts have managed to make some progress in attracting the attention of
health-care system leaders and policy-makers towards these lacunae, much more effort is needed to bring
about the required strengthening of the BME profession in India.

9.4.1 Global survey of biomedical country reporting BME professionals.


engineering However, it provides a tangible
The January 2015 Global Survey - comparison of the level of involvement of
Professional and Academic Profiles on biomedcal engineers in country health
Biomedical Engineers and Technicians, systems, and it shows the disparity not
conducted by WHO, investigated only between Member States, but also
the number of hospitals with BME between regions. Currently, no data have
departments/service worldwide. Table been provided for SEAR, where further
9.1 depicts the density of hospitals with a information is needd In order to increase
BME department per 100 000 population. the relevance of the indicator.
This indicator was not reported by every

WHO Medical device technical series 123


Table 9.1 Density of hospitals with BME service per 100 000 population by WHO region

124 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
9.5 Conclusion physicians and nurses. For this reason,
it is important that they become more
This chapter presents a general overview involved in health-care delivery systems,
of BME in hospitals. It could be useful for with countries recognizing the biomedical
those health-care facilities considering engineer as an essential professional for
introducing a BME service, as well as 21st-century health-care.
for those who wish to improve their
department. WHO encourages all biomedical engineers
to dedicate substantial time during their
Activities performed inside a BME service academic preparations in hospital settings
are diverse, but all are related to medical (via internships, fellowships, practicals) to
devices and health technologies. The understanding health technologies for the
most important is undoubtedly HTM, widest contexts and uses.
which is the core of BME. Nevertheless,
HTA, research, procurement, planning This recognition of biomedical engineers
of health facilities and other activities as essential health-care figures is very
are performed with the same aims of important for WHO, IFMBE and other
HTM: patient safety, proper use of health national BME associations globally.
technologies and cost minimization of Today, these organizations are making
health-care services. great efforts to increase the availability
of biomedical engineers worldwide in
It is important to underline that the figure order to support health service delivery.
of the biomedical engineer is the only one It is therefore important to advocate for
assigned to the management of medical the inclusion of the biomedical engineer
devices, encompassing both hardware (and clinical engineer) in the national and
and software functions. Biomedical regional classifications of occupations as
engineers could be considered as well as in the International Classification
health-care professionals in parallel with of Occupations published by ILO.(200)

WHO Medical device technical series 125


Credit: IFMBE; clinical engineering in hospital setting, Brazil.
10 Role of biomedical engineers in the
evolution of health-care systems

10.1 Biomedical engineering for levels. The specific professional


21st-century health-care competencies needed will depend on
systems each organization’s level of resources and
complexity, the kinds of services being
The world of medical devices is going offered, and the fiscal, organizational and
through economical, technological, and technical maturity of the organization. The
globalization revolutions simultaneously, biomedical engineer’s skill sets are in the
which are radically changing the health- process of being expanded, re-focused
care processes and relevant professional and refined to meet the organization’s
skills that biomedical engineers need to goals, in order to ensure that technologies
develop and manage medical devices, are appropriately designed, evaluated,
along multi-year and multi-decade chosen, installed, integrated with IT
product life cycles. This is particularly systems and efficiently maintained over
true for BME professionals working their life cycle to deliver the safest, most
in hospital systems who must ensure effective, affordable care.
that hundreds of medical device types
work harmoniously in the complex
ecosystems of IT, business systems and 10.2 Revolutions impacting
organizational processes. These changes biomedical engineering
are putting unprecedented technical,
financial, societal and political pressure Table 10.1 presents a partial snapshot
on all health-care systems, regardless of of the revolutions that are re-defining
size or wealth; but these changes also BME, requiring changes in organizational
create new opportunities for better, safer strategy for clinical services and expansion
and more universally accessible care, if of the training of biomedical engineers
the appropriate professional capabilities as caretakers of systemic intelligence
are established in hospitals, academia, and capabilities across multiple clinical
professional associations, government domains. As science and innovations
and industry. are advancing, biomedical engineers
will need to broaden their professional
BME professionals need new skills and horizons as well to incorporate changes
education so they can fill a larger and more constructively rather than reactively.
complex role as subject matter experts For example, the fields of molecular
and as advocates for systemic intelligence and nano-technological engineering are
across the various stakeholders in yielding new sensors and actuators that
complex health-care systems. Those allow tools that can operate at the atomic
new skills will allow them to shape how and molecular level. Other revolutionary
these new challenges and opportunities factors are:
are understood and managed at varied
local, regional, national and international

WHO Medical device technical series 127


Table 10.1 New developments and innovations impacting biomedical engineering

Devices are being made dramatically smaller, enabling portable monitoring and
Miniaturization
decentralized management of care.
Devices that used to require external power, controls and maintenance can be
Implantation
implanted for long periods of time, with mobile power sources and controls.
Multicore processors and increased memory capacity enable medical devices to
execute a much wider range of functions, including self-monitoring and reporting,
Smart device
remote management, process controls, embedded security and stand-alone
functions when disconnected from the network.
Devices can synthesize multiple functions previously requiring several devices,
Hybridization servers and databases, expanding to include monitoring, diagnostic and
treatment capabilities.
Devices can connect to other devices and wired/wireless networks, disseminating
Networking data to aggregators, monitoring stations, mobile devices, specialized servers,
EMRs and exercising new safety controls.
Devices now must produce data in formats that are compatible with national
Informatics standard
standards that cross organizational and sectoral boundaries.
Clinical process re- Devices will play an increasing role in controlling compliance with built-in safety
engineering “guardrails” and best clinical processes.
The granularity and scale of what constitutes a medical device is becoming
Molecular and nano- increasingly refined to molecular and nano-scale structures and processes,
technical engineering creating radically new levels of specificity for detection, diagnosis, monitoring and
treatment.
Models of care are expanding beyond the hospital to include retail sites, business
Virtualization of care
locations, other community-based locations such as gyms, shops, schools,
away from hospital
monitoring and advice centres, and to include new providers and services.
Point-of-care labs on a Micro-diagnostic technologies will enable rapid and decentralized laboratory
chip services, extending care into new locations and populations.
New materials will enable devices to be used in novel ways, swallowed as pills,
implanted as dissolvable devices, materials with bonding specificity that pairs
Materials science
with imaging and ultrasound technologies to target diagnosis and therapies more
precisely.
Multiple devices and information systems may need to interact with each other in
Interoperability order to monitor and adjust care in real-time. Timing synchronization, data models
and control language will require standardization.
Devices will play a stronger role in providing clinicians with decision support at
Clinical decision support the point of care and remotely. Device reliability will be crucial to reliable decision
support.
Telehealth and wellness New devices will come into use as consumers and providers move to adopt more
models of care preventive, mobile models of “care anywhere.”
New research methods New methods and disciplines will be needed to take advantage of cloud- and
based on new sources of crowd-sourced health data derived from multiple new sources and device types.
data
Biomedical and clinical engineers will need to take a more active role in shaping
Design and performance
the design of medical devices, and evaluating competing alternatives in terms of
analytic
the overall system life cycle of costs, benefits and operational requirements.
Increasingly, devices will be defined by changeable software capabilities that
will enable more rapid upgrading and evolution of medical devices, requiring
Software evolution
significant skills in configuration, change management and ongoing IT
partnerships.
New devices, analytics and procedures will enable health care to be delivered in
Personalized medicine
ways that are specific to individual genetic and personal circumstances.

128 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
Device performance and safety characteristics are becoming interdependent with
other devices and/or information systems. e.g. self-adjusting medication infusion
Interdependencies
may be controlled by one or more physiological monitoring systems and/or central
clinical decision support software.
Devices are expected to function without wires that limit deployment flexibility or
Wireless and mobility
that can themselves introduce hazards into the clinical environment.
Devices can be worn by the patient, which has some of the benefits of
Wearable technologies implantation but exposes the device to additional environmental risks and risks of
interruptions in wireless communication.
Smart, networked medical devices are now being hacked and attacked, creating
Cybersecurity
novel safety and performance threats which may be hidden from easy detection.
Heterogeneous Devices are being combined in novel ways that challenge traditional detection or
integration of multi- assignment of “fault”.
vendor, multi-modality
devices

10.3 Other contextual factors Taken together, these forces lay out
driving change in health-care a challenging landscape that both
systems experienced and novice biomedical
engineers need to consider, understand
In addition to the technological and and respond to with critical thinking,
clinical changes identified in Table 10.1, study, formal education, interdisciplinary
there are numerous socioeconomic discussions with health-care colleagues,
factors that both inspire and constrain life-long learning and a spirit of innovation
change, including: that attempts to envision more effective
health-care, not just in terms of devices,
• Supply-chain problems that obstruct but also in terms of processes, multiple
the economic and timely flow of parts interacting systems and systems-of-
and services needed to keep medical systems.
devices in proper running condition,
affordably.
• Aggressive plans for modernization 10.4 Biomedical engineers work
of obsolete national health-care in many sectors
infrastructures.
• Embedded traditions of business and Because of how critical medical devices
political corruption, institutional and are in all health-care programmes,
professional rigidity, and outmoded biomedical engineers have evolved
bureaucratic practices that impede diverse career paths to ensure that
adoption of more effective, affordable appropriate engineering and clinical
health-care practices. expertise is applied along the entire
• New ethical questions about eligibility strategic and operational life cycle of
for care, end-of-life care, and medical devices and the systems they
prioritization of care under conditions interact with.
of limited resources.
• Increasing numbers of well-educated These practitioners may have similar
health-care professionals are capable academic preparation, but eventually
and motivated to create 21st-century develop specialized skills as they move
health-care systems, but they often between sectors. These careers may
must work against historical, political evolve in different directions over time
and economic obstacles. depending on personal motives, abilities,
training, certification and organizational

WHO Medical device technical series 129


policies on human resources. This diversity innovation and management and
of professional practice is a manifestation operations. These domains present a
of the growing need for “horizontal wide range of career opportunities
intelligence” to cut across health-care for biomedical engineers, and also
sectors and create devices and clinical demonstrate where BME expertise is
capabilities that work harmoniously with needed in every institution and sector
IT and electronic medical record systems, that is involved in the science, technology,
business systems and the wider system policy, funding, design, testing, market
of standards, policy and accreditation. development, service strategy and
operational management of medical
All of these careers will likely be affected devices. This chapter provides some basic
by the rapid, sometimes disruptive, conceptual frameworks and guidance for
changes and transformations of biomedical engineers in many widely
the underlying health and wellness varied settings, including academic
sciences, engineering, technologies, and training centres, hospitals and
clinical practices, policies and business clinics, ministries of health, health-care
strategies. innovation centres and manufacturers.

There are three major domains and Being trained as a biomedical engineer
institutional complexes where BME can lead to employment in a wide range
expertise is needed to create and manage of sectors, with a variety of job titles
safe and effective medical devices and (Figure 10.1).
services – institutional foundations,

Figure 10.1 Diversity of job fields and titles


Professional job

Biomedical Biomedical Clinical engineer Clinical systems


family title

technician (BMET) engineer (BME) (CE) engineer (CSE)

May be employed as:


• Technician • Technician • Clinical engineer • Clinical engineer
• Supervisor • Supervisor • Project manager • Biomedical
• Project manager • Manager engineer
• Manager • Service/programme • Project manager
• Trainer, instructor, director • Manager
professor • Scientific • Systems engineer
• Account investigator • Service/Programme
Employment titles

representative • Inventor director


• Programme director • Account executive • Scientific
• Scientific • Trainer, instructor, investigator
investigator professor • Inventor
• Inventor • Consultant • Account executive
• Consultant • Policy-maker • Instructor,
• Executive, CEO, • Executive, CEO, professor
CTO, CIO, CFO CTO, CIO, CFO • Consultant
• Policy-maker
• Executive, CEO,
CTO, CIO, CFO

Source: Fred Hosea, 2016.

130 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
10.4.1 Evolution in biomedical being designed with software/firmware
engineering career paths features and control capabilities that
Traditional BME responsibilities typically are critical to their interactive role with
have included: informatics systems, electronic medical
records, clinical decision support systems,
• Evaluation of the existing device and both patients and caregivers.
infrastructure Stand-alone devices, single-purpose
• Identification and evaluation of devices, and/or hardware-defined
emerging technologies in terms of devices are quickly becoming obsolete
cost, effectiveness, efficiency, safety or marginalized to narrow roles. Most
and fit with clinical interventions devices use embedded microprocessors,
• Procurement and contracting of new data storage and communication chips
devices, support services, rentals that allow them to be networked to
and parts deliver sophisticated new functions. New
• Installation of new technologies safety and clinical features are emerging
• Planning of health facilities through local and distributed-intelligence
• Integration of medical technologies capabilities, remote software and data
with electronic medical records and access, configurability, and sharing and
other IT systems functional interoperability with other
• Training of health-care workers devices and systems. Today’s software-
• Ongoing maintenance and repairs based devices are configurable to provide
• Documentation required for hospital customized or optimized functions and
accreditation features throughout their life cycle. Such
• Analysis of failure trends and devices need to be understood both as
costs, in order to identify need for evolving, adaptive technologies and as
replacements components or subsystems within larger
• Management of hazard alerts and clinical systems of systems (SoS), not
recalls merely as static, fixed machines. This
• Forensic investigation of product- evolutionary SoS framework adds a
related failures, injuries and deaths significant, highly dynamic dimension
• Retirement or cascading re-use of to the BME career that calls for constant
ageing devices. learning, research, collaborative design
intelligence and troubleshooting, and
Many of these traditional responsibilities leadership skills for working in wider
will undergo significant transformation institutional contexts. This new expertise
and growth in coming years as a can help inform and guide the health-
consequence of the numerous changes care strategy of provider organizations,
in technology, government policy and regulators, insurers and manufacturers.
models of care.
10.5.1 Telehealth and telemedicine
Technological innovations in telehealth
10.5 Evolution of modern medical and telemedicine are expanding the
devices physical and social dimensions of health
care, and the range of services, beyond the
Modern medical devices are evolving to traditional hospital setting, with increasing
be smarter and more complex – more emphasis on prevention, wellness,
interconnected, integrated, interoperable real-time monitoring and use of social
and interdependent. They are increasingly media. This expanded scope involves

WHO Medical device technical series 131


wider groups of health “partnerships,” skills. They will also need appropriate
data strategies and service models that project management skills for the software
go far beyond the traditional roles and and system development life cycle
market mechanisms that have defined (SDLC), continuous quality management
health care for decades. Health coaches, capability, the ability to supervise
health advocates, advice nurses, gym technical staff with appropriate skills,
staff, social media, family members and and the ability to communicate effectively
support groups may all play a role in with clinical and technical experts from
the complex mix of voluntary, everyday related disciplines.
activities (diet, exercise, education,
support) and evidence-based clinical
care plans. These new dimensions 10.6 Mission critical: Systems
of care will require sophisticated engineering and systems of
advances in workflow design, clinical systems engineering
and ethnographic research, service
management, service strategies and Medical device functions are still
systems integration. These systems critical success factors in the detection,
challenges are a central component of the diagnosis and treatment of most medical
BME career. Biomedical engineers need conditions. However, as information and
to be prepared to lead, collaborate with communication technology becomes a
and support these innovative engineering ubiquitous and pervasive part of health
efforts. Designing, planning and managing care, the devices themselves are only
these clinical devices, processes and part of the overall system of care. At the
systems will require engineering skills same time, numerous technologies that
– and nimble organizations – that are support wellness, fitness and medical
dynamic beyond anything currently in care are reaching into the home and may
existence. Tomorrow’s devices will have be worn or carried by individuals during
to be more agile and responsive to real- everyday activities. Health, wellness
time – or near real-time – clinical and/ and medical care are therefore weaving
or environmental patient needs. To linked systems of medical devices and
avoid premature obsolescence, these information systems into a flexible and
devices must also be able to adapt over extensible fabric of health and wellness.
time to changes in clinical practice and Ensuring that health-care services
informatics requirements. This built-in perform continuously at the place and
“developmental headroom” in devices time of need will be more cost effective
will be essential to more efficient and than waiting for crises and hospitalization;
affordable adoption of clinical innovations. but understanding and managing multiple
distributed medical devices in such a
10.5.2 More sophisticated fabric represents a complex systems of
organizational and IT requirements systems engineering (SoSE) challenge
In addition to traditional operational skills that will require upgrading the traditional
required for managing deployments, model of health-care professions across
recalls, maintenance and repairs, BME the board. Understanding the complex
staff will need a dynamic range of new and extended nature of health-care
knowledge and organizational skills technology systems, and the interaction
related to computer architecture and and interdependence of innovative
performance, network technology, data systems of systems, will be essential to
modelling and database management, the effective practice of BME, whether
troubleshooting, telecommunications in urban centres, small towns or remote
and software programming/configuration rural clinics.

132 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
The International Council on Systems replacement parts, ergonomic design,
Engineering (INCOSE) provides supply-chain weaknesses, facility
networking and training resources to infrastructure needs, weaknesses in the
support formal education in the emerging managerial and leadership levels, end-
SoSE field. Because the language user training, vulnerabilities to variations
and focus of INCOSE’s community is in IT system performance, etc.
generalized for many different industrial
fields, the biomedical engineer will need Because of this wider, “end-to-end”
to adapt it to the health-care paradigm. systems perspective, biomedical
Given the enormous importance and cost engineers often understand the
of health-care systems, it may become a bigger picture better than many of the
societal imperative to develop health-care administrative, financial and IT specialists
systems engineering as a profession of who may be making important decisions
importance equivalent to that of engineers with incomplete understanding or
who design outer-space systems, large historical experience. Biomedical
metropolitan settlements, and national engineers may be better prepared to
security infrastructures. work in the planning and budgeting
discussions, to ensure that their systemic
Biomedical engineers could explore experience informs the decision-making
the V-model of system verification and process.
validation (V&V) that has been described
by INCOSE and others instructive for Working upward from the most basic
managing SoSE projects. Also, writings level of services (from family homes and
by Barry Boehm(201) on the “spiral schools to village outposts and clinics
model” of project management may to hospitals, regional systems, national
assist in mapping traditional “waterfall” systems and international systems),
and newer “agile” and “extreme” project health-care planners and biomedical
management methods into longer term, engineers can use tools such as WHO’s
multi-year projects such as hospital or OneHealth(202) software, “to link strategic
health system modernization. objectives and targets of disease control
and prevention programmes to the
required investments in health systems.
10.7 Elements of an ideal, The tool provides planners with a single
integrated health and framework for scenario analysis, costing,
information technology health impact analysis, budgeting and
system financing of strategies for all major
diseases and health system components.
Health-care systems of all kinds are It is thus primarily intended to inform
evolving through several stages of sector wide national strategic health plans
maturity to achieve higher levels of and policies”.
clinical quality and wider extension
of their services. Because biomedical Within this strategic framework,
engineers may work for years in hospitals representatives from the various
or regional service networks, they often jurisdictions can begin to coordinate
have extensive experience with the their plans and staffing models to provide
numerous performance issues affecting the desired capabilities. All medical
clinical services, not just related to devices must be understood in terms of
devices but to the wider “performance the medical services they support, and
ecosystem” of manufacturers, third party the contextual factors impacting those
service providers, physical materials and services. As medical devices evolve,

WHO Medical device technical series 133


so do those services. Each medical increasingly stringent requirements of
device may be surrounded by a complex clinical practice guidelines.
network of connective factors that must
be studied and closely managed –
e.g. organizational and infrastructural 10.8 Establishing a comprehensive
changes, logging accurate clinical biomedical engineering value
metrics for grants and research projects; proposition
secure data and network transactions;
supply-chain needs; pharmaceuticals; In order to ensure that the full range
training requirements; IT connectivity of professional responsibilities is clearly
requirements; changes in network assigned to biomedical engineers –
security and access precautions; surges encompassing all health and information
of displaced persons from epidemics, technologies – the field requires clear
climate change or political persecution and comprehensive written definitions
that require additional organizational that can be considered at the policy level
capabilities, clinical skills and security of ministries of health, regulatory bodies,
precautions; upgrades, recalls and professional associations, hospitals and
hazard alerts that must all work together health-care systems. These definitions
harmoniously to provide safe, effective allow development of statements of
and affordable health care. vision, mission and goals, and help argue
for appropriate institutional resources
While most other professionals in the needed to fulfil those duties.
health-care system are organized
around specialized “vertical” expertise, Three crucial dimensions of the BME
experienced biomedical engineers responsibilities in a hospital system are:
can often provide unique “horizontal”
perspectives on the complex end-to- • Enterprise strategy: Biomedical
end operational factors that are involved engineers can contribute to a cost-
in translating plans into successful focused strategy for the enterprise
clinical services over the lifetime of the by providing expert technical and
medical devices they are responsible for. business consultations to the
Biomedical engineers may participate organization’s standards bodies,
in, or manage, clinical technology to supply-chain and contracting
committees that bring together doctors, stakeholders, to national and
nurses, and financial stakeholders to international standards bodies,
evaluate and prioritize replacement regulatory agencies and professional
technologies. Biomedical engineers may associations, and by facilitating
participate in regular quality improvement expert design relationships with
meetings, to identify defects in device manufacturers.
performance or clinical processes, • Clinical strategy: Biomedical
and recommend new requirements engineers can manage innovation
for replacement technologies and and integration activities along the
related warranty terms and contract life cycle of all clinical technology
specifications. Biomedical engineers devices and systems in the health-
will increasingly devote time working care system, facilitating clinician-
with researchers and manufacturers to led research design, technology
improve medical device design and to re- assessment, integration and
engineer clinical processes and services deployment of emerging technologies,
related to new device capabilities and in support of rapidly evolving clinical
priorities and operational needs.

134 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
Figure 10.2 Clinical system life cycle

CLINICAL SYSTEMS STRATEGY / PLAN PROJECT MANAGEMENT / BUILD OPERATIONS / RUN

STRATEGIC TECHNOLOGY EQUIPMENT INSTALLATION TECHNICAL


PLANNING EVALUATION PLANNING SERVICES

1 7 13 18 24

Manage receipt,
Manage multi- Define integration Implement preventive
Conduct lifecycle staging, inspection, and remote support
equipment inventory disciplinary technology and interoperability testing, assembly
assessment teams requirements, and services and monitor
and cost analysis of new devices and systems performance
deployment plans systems

2 8 14 19 25

Produce five-year Support technology Manage equipment Perform systems


technology planning Define implementation and systems
standards setting, requirements, administration,
projections and templates for new installation, capacity management,
regional clinical timelines, facility implementation of
facilities and updates specifications and security functions
technology plan (CTP) interface.

3 9 15 20 26
Maintain asset and
Maintain utilization Coordinate data service management
and performance Upgrade and migration (when
Engage in design needed), testing, databases, accounts
partnerships with databases, for replacement planning payable, metrics,
capacity planning and toward national configuration, quality
industry and user acceptance safety, service level
management standards agreements and
testing compliance documents

4 10 21 27
Define clinical and PROCUREMENT Perform ongoing
technical requirements, Coordinate
Support multi-region infrastructure upgrades
repairs, corrective
plans and working process & functional and preventive
specifications, service and integration across
relationships divisions
maintenance on
level agreements schedule

5 11 16 22 28
Conduct state-of-art Schedule and
technology evaluations, Tag new system for
Maintain service area Submit and monitor asset management
implement upgrades,
representation on including evidence- purchase requests, application patches,
based and life cycle and develop system
assessment teams orders documentation
manage hazard alerts
cost analysis and equipment recalls

6 12 17 23 29

Maintain state-of-art Manage portfolio


Conduct compatibility Consult to national Perform electrical of vendor and
audits, interoperability team expertise and product council, safety and calibration/
working relations manufacturer support
and IT integration sourcing and tests and check agreements and
planning with industry standards teams equipment into service contracts

SAFETY, RISK, COMPLIANCE, GOVERNANCE, CAPITAL PLANNING, HOSPITAL STATEGY, UTILIZATION, CAPACITY,
METRICS, ANALYTICS
Source: Fred Hosea, 2016.

WHO Medical device technical series 135


• Operational excellence: Biomedical more comprehensive skill set beyond the
engineers can deliver or manage traditional ones.
timely, professional field services
around the clock, to satisfy legal, Strategic services: These are concerned
regulatory and compliance standards with issues three to five years in the
for accreditation readiness through future, including standards development,
rigorous maintenance, repair and regulatory policies, device design, R&D
quality assurance procedures. alliances, academic partnerships,
Biomedical engineers can ensure market development, professional
highly professionalized teamwork scopes of practice, professional training,
with enterprise partners in the credentialing and continuing education.
technical integration and project A long-term strategic overview is needed
management of emerging clinical in order to determine how best to divide
technology systems. up the new responsibilities between IT,
biomedical, clinical and other facility
The scope of professional capabilities staff. The strategic clinical services that
outlined in this value proposition is biomedical engineers provide could
ambitious but essential for hospital include the capacity to design and
systems which want to gain greater evaluate clinical research, design and
control over the growing “grey” areas evaluate new clinical practices, and
that are currently not part of anyone’s consult with clinicians and all system life
job description, but which can increase cycle stakeholders to develop coherent
medical risk, cost significant time and models of care. New operational skills
money and lead to inefficiency when they will be needed to troubleshoot complex
are not professionally understood and networked and virtualized environments
addressed. of care, to manage the constant updating
and upgrading of medical devices,
For one example of how a large, multi- and to provide ongoing feedback to
hospital system organizes clinical systems organizational planners regarding the
engineering functions for its 10 million performance of the existing device
members, see Figure 10.2. infrastructure.

Convergence: Devices and information


10.9 Build competencies in systems will continue to converge,
strategic, clinical and making separation of one from the
operational domains other harder and harder. Although skill
specialization may often be valued, cross-
At the hospital level, an effective training and collaborative team problem
clinical technology programme could solving may be equally important. New
be staffed to provide a dynamic range skills will be needed by these BME
of strategic, clinical and operational managers, because the stakeholders they
services. Historically, most hospital- work with span such a large number of
based biomedical engineers have been disciplines and professions. Their skills
originally assigned to operational duties of should be situationally and contextually
managing, planning, maintaining, training appropriate, flexible and adaptable for
on use of medical devices; but there communications between learning teams,
are significant new “grey” areas in the coaches, mentors leaders, partners, and
design and management of future health- providers.
care systems that are going to require a

136 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
IT systems alignment and integration: safety risks and challenges, clinical
Biomedical engineers, clinical engineers technology management staff will likely
and biomedical equipment technicians will need EMR/EHR support skills in order
need more than a casual understanding to perform point-to-point or device-to-
of core IT infrastructure components device or device-to-system safety and
and skills, including topics like performance validation and verification.
software, networks, databases, security
management, change management, The ITIL framework: The Information
user interface design and configuration, Technology Infrastructure Library (ITIL)
decision support systems and wireless provides an indispensable model for
communication systems. Many, perhaps aligning mission-critical services, business
most, devices will have one or more of processes, data models and activities
these IT components embedded, and the between IT and biomedical systems.
selection, safe deployment, and ongoing The criticality of aligning these dynamic
maintenance and repair will require service functions cannot be overstated,
competent IT troubleshooting with IT as IT and biomedical systems become
peers, and coordinated repair processes. more interoperable and interdependent.
Further, because most devices will likely Biomedical engineers are urged to
be interconnected with one or more receive formal training in the ITIL model
electronic medical record systems (EMR and participate in ongoing efforts to
or EHR) and since those systems may architect the organizational capabilities
themselves introduce significant patient needed to enable IT and biomedical

Figure 10.3 The ITIL service life cycle

Service Transition
ITIL® SERVICE LIFECYCLE • Transition Planning and
Support
• Change Management
• Service Asset and
Service Strategy Configuration Management
• Service Portfolio • Release and Deployment
Management Management
• Financial • Service Validation
Management Management
• Demand • Service Validation and


Management
ROI
Service Service Testing
• Evaluation
Design Transition • Knowledge Management

Service
Strategy

Service Design
• Service Catalogue
Management
• Service Level Service Operation
Management • Event Management
• Capacity Service • Incident Management
• Request Management

Management
Availability
Operation • Problem Management
• Access Management
Management Functions
• IT Service ⁻ Service Desk
Continuity Continual Service Improvements ⁻ Technical Management
• Information • Seven Step Improvement ⁻ Application
Security Management
Management ⁻ Operations
Management

WHO Medical device technical series 137


systems to interact and co-evolve in a anticipating the kinds of personal needs
rational, mutually supportive fashion. and motives that affect professional
The ITIL service life cycle identifies engagement and development. The
essential business processes that IT anchors Schein identified are:
and biomedical functions must align in
a constant and systematic fashion.(203) 1. Technical/functional competence
2. General managerial competence
3. Autonomy/independence
10.10 Dimensions of career 4. Security/stability
development in biomedical 5. Entrepreneurial creativity
engineering 6. Service/dedication to a cause
7. Pure challenge
One major difference between a job and 8. Lifestyle.
a professional career is the presence in
the profession of a sustained trajectory of Anchors 2 and 5 focus attention and skills
personal aspiration, commitment, learning on both leadership and management for
and fulfilment that will span decades of biomedical engineers. As Joel Nobel,
professional life. Careers in BME could founder of the Emergency Care Rescue
provide opportunities for continuing Institute (ECRI), often posited, there is a
growth, responsibility and creativity that difference between leading people and
give engineers a vital and authentic managing things. The leadership side of
investment in improving the well-being a biomedical engineer’s career includes
of their society, their organizations and intra- and inter-organizational skills,
of the patients they serve. Biomedical including coaching subordinates, trainees
engineering must be understood and and interns, and incorporating human
valued as an expansive career of life- and contextually oriented elements of
long learning, personal growth and listening, observing and constructive
creativity. This growth dimension must be dialogue that must be communicated
valued not only by biomedical engineers upwards to supervisors and senior
themselves, but also by employers and managers as well as laterally to peers. To
social institutions invested in health-care, be successful, these skills may need to
through the support of: span one or more enterprises, countries,
cultures or languages. Management skills
• Regular release time and financial that biomedical engineers may need to
support for continuing education develop include, but are not limited to:
• Attendance at conferences effective written and oral communication,
• Membership and activity in general and ICT technology project
professional associations management (including system and
• Allocation of a suitable portion of the software development) and business or
BME job description to participation government policy management.
in “horizontal”, cross-functional
committees, quality improvement 10.10.2 Biomedical engineering
projects and innovation initiatives. career stages
Individuals and organizations are urged
10.10.1 A biomedical engineer’s to envision career paths that anticipate
career anchor considerations personal and professional needs across
Edgar Schein identified eight generic the life span of a career, in order to
“career anchors” that affect personal provide sustained and evolving career
competence and fulfilment over time. paths that keep people involved and
(204) These frameworks can be useful in growing, in tempo with technological and

138 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
Figure 10.4 Internal and external career paths

clinical changes. Biomedical engineers not addressed, or paid for, in the daily job
will need to pursue activities outside of descriptions that govern formal work life.
their primary employing organization
to build knowledge, connections and In view of the increasing speed of change,
experience that will nurture their career complexity of devices and processes,
possibilities. These “external” professional and the interdependencies of systems,
development activities not only improve biomedical engineers will need to
career potential as an employee; they have very dynamic, life-long learning
also lay the foundation for meaningful approaches to their professional life, and
professional service after retirement. organizations are urged to provide routine
support for this learning process.
In addition to the “internal” career stages
typical of professional employment, 10.10.3 Key emerging biomedical
Figure 10.4 identifies other external engineering competency
disciplines, institutions and initiatives opportunities
where biomedical and clinical engineers The following trends are re-defining the
can become fruitfully involved. These realities that biomedical engineers will
“outside” activities can be indispensable need to understand, to provide new
not only for the aspiring professional value-added competencies:
personally, but for the wider society as
well, because they create considerable • Convergence of technologies: This
value-added in social capital – in will accelerate novel decision support
knowledge, creativity and alignment of tools (IBM’s emerging Watson
professional resources that are typically programme is an example) using

WHO Medical device technical series 139


many artificial intelligence methods. a “capability maturity model”
New skills will be needed for design, appropriate to its resources and
implementation, management, economic prospects.
disaster/business continuity planning
and support. Also, as mentioned
above, novel SoSE skills and tools 10.11 Training topics
will be essential.
• Human-computer interaction of all Depending on the economic
stakeholders: This will be a weak circumstances and existing infrastructure
point that must be considered and of the health-care system, other topics
incorporated in HR skill development. for professional development may be
e.g. interview and related written important to consider:
and oral communication skills may
become more crucial. Biomedical • Requirements engineering
engineers might lead or participate in • Epidemiology
process re-engineering, ethnographic • Clinical process modelling, process
studies, human factors analysis and re-engineering
user experience design. • Public health
• Risk and project management: This • Electronic medical record
will continue to require larger and • Personal health record
larger matrices of interdependencies. • Telehealth
Skills and tools for identifying, • Telemedicine
mapping and managing risk need to • Medical tourism
be developed. Planning and change • Clinical decision support
management will remain crucial, • Medical anthropology
but the complexity will increase. • Ethnography
As business and clinical processes • Clinical trials
become increasingly complex, there • Patient care services
will be increasing need for process • Continuity of care
automation software skills, where • Consumer health education
biomedical engineers might excel • Human factors analysis
because of their experiences with the • General systems theory
system life cycles of many devices, • Project management
with clinicians and with operations • Six Sigma and lean manufacturing
stakeholders. • Innovation methodology (e.g. IDEO)
• D i v e r s e e c o n o m i c s e t t i n g s : • IT life cycle management models
The biomedical engineer’s skill (e.g. comprehensive delivery
requirements will vary significantly process)
between high-, medium- and low- • Root-cause analysis
resource settings and countries. • Wireless spectrum management
Clinical strategy and resource • Use-case development
planning could be staged so that • Developing technical requirements
each stage lays a coherent foundation and specifications
for each subsequent stage, with • Testing and certification
a minimum of obsolescence and • Translational research methodology
disruption, unless the disruption • Process modelling, mapping and
is well understood and carefully automation
planned. Each jurisdiction needs to • IPv6
conduct a formal self-assessment • Rapid prototyping methodology
and plot its plans on the basis of • Scenario methodology

140 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
• Legal and regulatory definitions are created to support its evolution in
of medical devices and medical coming years.
information systems
• Hospital accreditation procedures.
10.13 Further reading

10.12 Conclusion Articles


Taktak A, Ganney P, Long D, White P
Biomedical engineering is growing into (eds) (2013). Clinical engineering: A
dramatically new areas of professional handbook for clinical and biomedical
knowledge and responsibility, which engineers. Oxford: Academic Press.
will need to be cultivated and organized
through ongoing efforts outside the Wang B (2012). Medical equipment
primary employment location of maintenance: Management and oversight
the engineer. Individual hospitals (synthesis lectures on biomedical
or departments are unlikely to have engineering. Williston (VT): Morgan and
sufficient staffing levels, budgets or Claypool.
infrastructures to understand or manage
these emerging complexities; so it will Zenios S, Makower J, Yock P (eds) (2010).
be necessary to address these needs Biodesign: The process of innovating
through a variety of inter-organizational medical technologies. Cambridge, UK:
efforts involving professional associations, Cambridge University Press.
provider consortia, academic liaisons,
innovation centres and partnerships, Books
national research programmes funded by AAMI, ACCE, ECRI (2013). Healthcare
government agencies or philanthropies, technology in a wireless world. AAMI.
and industry consortia. Organizations Available at: http://www.connectblue.
employing biomedical engineers must com/fileadmin/Connectblue/Web2006/
understand and support the value of Documents/In_the_news/2012_Wireless_
such “outside” activities through release Workshop_publication.pdf
time, conference expenses and outside
committee work. ACCE (2017). 2017 Candidate handbook
for certification in clinical engineering by
Because biomedical engineers may the Healthcare Technology Certification
possess substantive historical knowledge Commission. Available at: http://accenet.
that spans multiple device types, org/CECertification/Documents/CCE_
departments, hospital stakeholder groups Handbook.pdf
and manufacturers, they are often the
best prepared people to provide the Baine C (2007). Is there a biomedical
“horizontal intelligence” that will be engineer inside you? A student’s guide
increasingly needed to ensure that the to exploring careers in biomedical
various “vertical” professions of the engineering and biomedical engineering
health-care system actually cohere technology. Bonamy Publishing.
and deliver the best care for the lowest
cost. Hospitals, payers, government and Dyro J (2004). Clinical engineering
professional sectors must understand the handbook. Burlington (MA): Elsevier.
critical value-added of 21st-century BME,
to ensure that appropriate resources, job Enderle J, Bronzino J (2012). Introduction
families and organizational frameworks to biomedical engineering. Cambridge
(MA): Academic Press, Elsevier.

WHO Medical device technical series 141


David Y, von Maltzahn WW (2003). Clinical CED Global: www.CEDGlobal.org
engineering (Principles and applications in
engineering). Boca Raton(FL): CRC Press. IHE Patient Care Device Domain,
including the multi-vendor, multi-modality
National Academy of Engineering IHE Rosetta Terminology Mapping System
and the Institute of Medicine (2005). Project: https://www.ihe.net/Patient_
Building a better delivery system: A new Care_Devices/
engineering/health care partnership.
Washington (DC): National Academies International Council on Systems
Press. Available at: http://www.nap.edu/ Engineering (INCOSE): http://www.
catalog/11378/building-a-better-delivery- incose.org/
system-a-new-engineeringhealth-care-
partnership. World Health Organization (Medical
devices): http://www.who.int/medical_
National Research Council (2007). devices/en/
Human-system integration in the system
development process: A new look. World Health Organization (Biomedical
National Academies Press. Washington engineering global resources): http://
(DC): National Academies Press. Available www.who.int/medical_devices/support/
at: http://www.nap.edu/catalog/11893/ en/
human-system-integration-in-the-system-
development-process-a-new World Health Organization (Publications
and other resources): http://www.who.int/
Saltzman WM (2015). Biomedical medical_devices/links/en/
engineering: Bridging medicine and
technology. Cambridge, UK: Cambridge
University Press.

Websites
ANSI Health Information Technology
Standards Panel Useful Clinical
Engineering standards in c lu d e :
Interoperability Standard (IS-77): Remote
Patient Monitoring and the Technical
Note (TN-905): General Medical Device
Interoperability: http://www.HITSP.org

142 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
Credit: Adriana Velazquez; policy-makers at the Ethiopian Ministry of Health, November 2016.
11 Conclusions and recommendations

The Sustainable Development Goals, sourced pandemic tracking, big data,


approved in September 2015, include telemedicine, robotics, 3D printing of
Goal 3 “Ensure healthy lives and promote prosthetics and organ tissue to nano- and
well-being for all at all ages”, which molecular engineering, miniaturization
specifically lists the need for universal of lab analytics, disaster management,
health coverage. In order to support the microbiomes and epigenetics. These
achievement of this goal, it is required innovations put considerable change
that biomedical engineers play a role pressures on all health-care systems,
in health-care systems and therefore organizationally and personally – from
consider in their academic programmes national to local levels – requiring increased
and professional development: both attention to the design, regulation and
innovations in science and technology, assessment of medical devices, and to
and global health priorities and economic the multiple interdependencies that will
challenges, while aiming to increase exist between medical devices, clinical
access to medical devices that are of good and IT processes, business systems,
quality and that can be safe, affordable, accreditation standards, staffing models,
acceptable, appropriate and available to scopes of professional practice, and
the final users. expanding service models oriented
toward wellness promotion.
At the same time that new technologies
are extending diagnostic and therapeutic The purpose of the BME profession is to
capabilities down to nano-and molecular understand, manage and improve the
scales, health-care services in many life cycle of operational complexities of
countries are expanding dramatically medical devices, systems and services in
outward, beyond the traditional hospital- a disciplined and skilled manner, building
centric model into outpatient specialized on core competencies that are augmented
clinics, homes and emergency settings, over time with specialized training and
and wearable personal sensors, as well as project work with diverse stakeholders
via mobile phones, tablets, mobile clinics, spanning the health-care sectors.
teleconsultations and portable diagnostic Biomedical engineers increasingly work
devices for remote and low-resource across the entire spectrum of employment
regions. This veritable flood of innovations sectors to improve the design of medical
poses significant, often destabilizing, devices, verify their quality and safety
challenges for health-care systems through regulatory processes, define
worldwide, because public expectations in which clinical interventions they are
escalate easily and most hospitals and useful, improve standards and policies,
health authorities are not well equipped to bring practical clinical experience into
track, evaluate and incorporate changes BME projects in academic and R&D
of such magnitude, complexity, cost and settings, and provide ongoing expertise in
functional interdependency. the integration of health-care innovations
in hospitals, clinics and decentralized
The current innovation revolutions range services worldwide.
across areas as diverse as biomimetic
engineering, electronic medical Through evidence-based understanding
records, telehealth technologies, crowd- of the “system life cycle” of medical

144 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
technology innovations, biomedical manage the transition into 21st-century
engineers can help integrate the vertical care. The relentless flood of scientific
intelligences of the various sectors in an and technological innovation is radically
integrated, holistic manner according redefining the nature of health care in
to population needs. As is shown in virtually every dimension, from nano-
the present publication, the role of engineered theranostics at the molecular
biomedical engineers spans national level to telehealth and telemedicine
policy, regulation, technical standards, at the national and global level. The
professional education, academic challenge of achieving universal health
and industry R&D, device and service coverage implies having appropriate
design, prototyping, clinical research health technologies, in particular, medical
and trials, technology assessment, devices, to support health interventions
contracting, supply chain and service from prevention to early diagnostics,
strategy, deployment, integration with screening when possible, effective
IT and business systems, operational treatment, and palliative care. There
monitoring, process re-engineering, are many challenges in this respect: the
device maintenance and repairs, hazard availability of the technology (medical
alerts and recalls, inventory analysis and devices), the availability and training of
replacement planning. This “life cycle” health-care workers and the affordability
intelligence is an essential professional of interventions. Most health-care systems
resource for any 21st-century health-care are not adequately staffed to comprehend
innovator, manufacturer, planner, care or manage these forces of change. Most
provider or relevant government agency; systems are structured around vertically
and should, therefore, be considered as expert professions (doctors, nurses,
such along with other members of the administrators) and annual plans, and
health workforce. most lack the expertise that biomedical
engineers can provide, to understand
and manage the complex life cycles of
11.1 Future role of biomedical medical devices and processes.
engineers in low- and
middle-income countries Low- and middle-income countries,
especially, face a double challenge of
In order to support the Sustainable selectively “catching up” with developed
Development Goals and the universal countries (in terms of infrastructure and
health coverage included in Goal 3 human resources), at the same time
(Health), it is necessary that medical that developed countries themselves
devices are safe, of good quality and are re-defining their models of care,
accessible to health-care providers. beyond hospital-centric “ill care” to
The biomedical engineer can play an include wellness promotion, remote
important role in this, especially in LMICs, monitoring and decentralized, point-
as described in this publication. of-care technologies that enable “care
anywhere”. Biomedical engineers can
Beyond the ongoing health-care play vital roles in all sectors of this
burdens of population growth, political transformation, as guarantors that new
and economic instability, disease medical devices and related processes
management, disasters, millions of are intelligently designed and managed
refugees, accidents, terror attacks from the outset with careful understanding
and routine medical services, our of all performance requirements at each
world’s health-care systems are facing stage of the life cycle of medical services.
enormous organizational challenges to This expertise will be of critical value in

WHO Medical device technical series 145


low-resource settings, where there is no delivery systems include the biomedical
room for waste or inefficiency. engineer in the selection, and best use
of medical devices globally, according to
As the Ebola crisis demonstrated, specific settings and depending on local
multidisciplinary team expertise and needs.
collaboration are keys to success; yet
most professional training ignores these The activities developed by these
“horizontal” dimensions of competency specialized human resources for health
and success. The effective health are related to medical devices and medical
workforce of the 21st century will consist technology, from development to use, in
of more than individual physicians, all contexts. Although the ILO counts
nurses and administrators. Medical them as part of the health workforce
devices play a growing role in creating this category of engineers do not have a
new clinical services that are dramatically classification of their own, which makes
more effective, timely and less costly. it difficult to track the statistical trends
In academia, government and industry, and pinpoint their availability in Member
we find teams of biomedical engineers States. Therefore, it is proposed that a
and design innovators who integrate specific classification is made in the ISCO
knowledge of standards, science, for biomedical engineers, considering
technology, regulations and clinical their importance in providing support for
strategy to create new clinical tools that medical technologies to support universal
save lives and money. In hospitals, we health coverage to reach the Sustainable
find biomedical engineers who ensure Development Goals.
the proper acquisition, installation and
operation of devices and systems. With There is an immediate priority to
the increasing role of technology in health upgrade the professional standing of
care, professional comprehension and biomedical engineers worldwide. The
design expertise for the entire span of classification as a distinct professional
the technology life cycle – across systems group within engineering professionals,
and sectors – will be critical to ensuring will help validate the essential role that
the best outcomes clinically, economically biomedical engineers should play in
and operationally. health-care systems, and support the
various institutional initiatives (policy,
Based on the these needs, there training, certification, staffing, budgets,
should be a higher investment in the operational infrastructure, etc.) that will
education of biomedical engineers and be needed to establish and maintain high
technicians, to respond to demand, and global standards for health-care services.
create funded positions in the health-care
sector, particularly in LMICs, following Considering all the information presented
the mandates of the Global Strategy on in this publication, a proposal to change
Human Resources for Health and the to the profile of the biomedical engineer
UN ComHEEG. and technician has been developed,
from that currently outlined in the ISCO,
dating from 2008. This proposal, for
11.2 Reclassification of consideration by national, regional and
biomedical engineers and global organizations, to facilitate a specific
technicians classification of biomedical engineers
and technicians, can be found in Annex
The continuous advances in science and 7.(205)
technology for health, require that health

146 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
11.3 Final statement sector in more than 100 countries. These
numbers express only a head count and
Recalling the WHO resolutions on some data on certification, accreditation of
medical devices, the SDGs, the WHO programmes and roles in the health-care
Global Strategy on Human Resources sector. A priority for the near future is that
for Health, and ComHEEG, this book on data should be compiled and classified
human resources for medical devices to include biomedical engineers within
raises awareness of the role of biomedical National Health Workforce Accounts, so
engineers in health sector provision to as to be able to adequately monitor their
ensure appropriate medical technologies workforce situation to achieve universal
are used depending on local settings and health coverage, define gaps and suggest
needs to comply with universal health ways to address them locally.
coverage.
This publication demonstrates the
The book Human resources for medical availability and the different areas of
devices, the role of biomedical engineers is work of biomedical engineers. However,
part of the WHO Medical device technical specifically in LMICs, it will be important
series and it comprehensively presents to increase: academic programmes,
the different roles biomedical engineers demand within the health-care sector,
perform in the development, innovation, availability, and funded positions in
regulation, assessment, supply and use health-care services, at national level
of medical devices in the health-care for policy-making and at local level
sector. The biomedical engineer needs (particularly in secondary and tertiary
to interact with many other professionals level hospitals) and ensure cadres are
in engineering, economic, political and developed locally to meet local needs,
clinical spheres. Most users of medical in line with the WHO Global Strategy on
technologies are health-care workers with Human Resources for Health.
medical and clinical background.
This book is a contribution to the evolution
It is important to note that the studies, of the profession itself, and serves as a call
surveys and review of published material to institutional leaders to look to BME to
clearly show there are biomedical expand the professional capabilities that
engineers and biomedical technicians health-care systems worldwide need as
in more than 100 Member States of they grapple with the often overwhelming
WHO, including LMICs, across the six complexities and questions that no one
WHO regions. The data presented in this seems adequately prepared to answer.
publication were compiled from 2009 Biomedical engineering is and most
to 2015, and demonstrate the growing certainly will be part of the solution to
initiatives in education at professional and providing better health care to those in
technical level and theincreasing uptake need in order to achieve the Sustainable
of biomedical engineers in the health-care Development Goals.

WHO Medical device technical series 147


Credit: Shauna Mullally; University Teaching Hospital, Zambia
Annex 1 Biomedical engineers by country
and relevant demographic indicators

Number of
Reported biomedical
number of engineers per
Population Income biomedical 10 000
Country Code (2015) grouping engineers (2015)
African Region
Algeria DZA 39 666 519 Upper middle- 1 0.000252102
income
Benin BEN 10 879 829 Low income 16 0.014706113
Botswana BWA 2 262 485 Upper middle- 52 0.229835778
income
Burkina Faso BFA 18 105 570 Low income 7 0.003866214
Cameroon CMR 23 344 179 Lower middle- 19 0.008139074
income
Chad TCD 14 037 472 Low income 12 0.008548548
Côte d'Ivoire CIV 22 701 556 Lower middle- 50 0.022024922
income
Democratic COD 7 726 6814 Low income 20 0.002588433
Republic of the
Congo
Ethiopia ETH 99 390 750 Low income 150 0.015091948
Gambia GMB 1 990 924 Low income 17 0.085387488
Ghana GHA 27 409 893 Lower middle- 4 0.001459327
income
Guinea GIN 12 608 590 Low income 0 0
Kenya KEN 46 050 302 Lower middle 20 0.004343077
income
Liberia LBR 4 503 438 Low income 0 0
Mozambique MOZ 27 977 863 Low income 0 0
Namibia NAM 2 458 830 Upper middle- 1 0.004066975
income
Nigeria NGA 182 201 962 Lower middle- 280 0.015367562
income
Rwanda RWA 11 609 666 Low income 5 0.004306756
Senegal SEN 15 129 273 Lower middle- 23 0.015202317
income
Sierra Leone SLE 6 453 184 Low income 1 0.001549623
South Africa ZAF 54 490 406 Upper middle- 300 0.055055563
income
Swaziland SWZ 1 286 970 Lower middle- 1 0.007770189
income
Uganda UGA 39 032 383 Low income 49 0.012553679
United Republic TZA 53 470 420 Low income 4 0.000748077
of Tanzania
Zambia ZMB 16 211 767 Lower middle- 46 0.028374452
income

WHO Medical device technical series 149


Number of
Reported biomedical
number of engineers per
Population Income biomedical 10 000
Country Code (2015) grouping engineers (2015)
Americas Region
Argentina ARG 43 416 755 Upper middle- 1500 0.34548874
income
Barbados BRB 284 215 High income 1 0.035184631
Belize BLZ 359 287 Upper middle- 1 0.027832902
income
Bolivia BOL 10 724 705 Lower middle- 45 0.041959196
(Plurinational income
State of)
Brazil BRA 207 847 528 Upper middle- 250 0.012028048
income
Canada CAN 35 939 927 High income 642 0.178631415
Chile CHL 17 948 141 High income 650 0.362154498
Colombia COL 48 228 704 Upper middle- 300 0.06220362
income
Cuba CUB 11 389 562 Upper middle- 59 0.051801816
income
Dominican DOM 10 528 391 Upper middle- 100 0.094981275
Republic income
Ecuador ECU 16 144 363 Upper middle- 30 0.018582337
income
El Salvador SLV 6 126 583 Lower middle- 190 0.31012393
income
Grenada GRD 106 825 Upper middle- 1 0.093611046
income
Guatemala GTM 16 342 897 Lower middle- 1 0.000611887
income
Guyana GUY 767 085 Lower middle- 1 0.013036365
income
Haiti HTI 10 711 067 Low income 2 0.001867228
Honduras HND 8 075 060 Lower middle- 1 0.001238381
income
Jamaica JAM 2 793 335 Upper middle- 1 0.00357995
income
Mexico MEX 127 017 224 Upper middle- 3000 0.23618844
income
Panama PAN 3 929 141 Upper middle- 325 0.827152805
income
Paraguay PRY 6 639 123 Lower middle- 35 0.052717806
income
Peru PER 31 376 670 Upper middle- 360 0.114734929
income
Suriname SUR 542 975 Upper middle- 5 0.092085271
income
Trinidad and TTO 1 360 088 High income 40 0.294098617
Tobago

150 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
Number of
Reported biomedical
number of engineers per
Population Income biomedical 10 000
Country Code (2015) grouping engineers (2015)
United States of USA 321 773 631 High income 15700 0.487920653
America
Uruguay URY 3 431 555 High income 10 0.029141308
Venezuela VEN 31 108 083 Upper middle- 60 0.019287592
(Bolivarian income
Republic of)
Eastern Mediterranean Region
Afghanistan AFG 32 526 562 Low income 1 0.000307441
Bahrain BHR 1 377 237 High income 2 0.014521829
Djibouti DJI 887 861 Lower middle- 1 0.011263024
income
Egypt EGY 91 508 084 Lower middle- 1000 0.109279963
income
Jordan JOR 7 594 547 Upper middle- 500 0.658367115
income
Lebanon LBN 5 850 743 Upper middle- 750 1.281888471
income
Pakistan PAK 188 924 874 Lower middle- 360 0.019055193
income
Saudi Arabia SAU 31 540 372 High income 300 0.095116189
Sudan SDN 40 234 882 Lower middle- 365 0.090717303
income
Tunisia TUN 11 253 554 Upper middle- 20 0.017772163
income
United Arab ARE 9 156 963 High income 3 0.003276195
Emirates
Yemen YEM 26 832 215 Lower middle- 1 0.000372686
income
European Region
Albania ALB 2 896 679 Upper middle- 53 0.182968151
income
Austria AUT 8 544 586 High income 800 0.936265373
Belgium BEL 11 299 192 High income 980 0.867318654
Bosnia and BIH 3 810 416 Upper middle- 5 0.013121927
Herzegovina income
Bulgaria BGR 7 149 787 Upper middle- 35 0.048952507
income
Croatia HRV 4 240 317 High income 200 0.47166285
Cyprus CYP 1 165 300 High income 15 0.128722217
Denmark DNK 5 669 081 High income 450 0.79377945
Estonia EST 1 312 558 High income 60 0.457122657
Finland FIN 5 503 457 High income 1500 2.725559589
France FRA 64 395 345 High income 600 0.093174437

WHO Medical device technical series 151


Number of
Reported biomedical
number of engineers per
Population Income biomedical 10 000
Country Code (2015) grouping engineers (2015)
Georgia GEO 3 999 812 Lower middle- 250 0.625029376
income
Germany DEU 80 688 545 High income 2050 0.254063325
Greece GRC 10 954 617 High income 300 0.273857133
Hungary HUN 9 855 023 Upper middle- 400 0.40588439
income
Iceland ISL 329 425 High income 56 1.699931699
Ireland IRL 4 688 465 High income 330 0.7038551
Israel ISR 8 064 036 High income 2000 2.480147658
Italy ITA 59 797 685 High income 1366 0.228436937
Kyrgyzstan KGZ 5 939 962 Lower middle- 3 0.005050537
income
Latvia LVA 1 970 503 High income 350 1.77619623
Lithuania LTU 28 78 405 High income 250 0.868536568
Montenegro MNE 625 781 Upper middle- 15 0.23970047
income
Netherlands NLD 16 924 929 High income 500 0.295422214
Norway NOR 5 210 967 High income 1 0.00191903
Poland POL 38 611 794 High income 163 0.042215081
Portugal PRT 10 349 803 High income 94 0.090822985
Republic of MDA 4 068 897 Lower middle- 1 0.002457669
Moldova income
Romania ROU 19 511 324 Upper middle- 1250 0.640653602
income
Russian RUS 143 456 918 High income 2 0.000139415
Federation
Serbia SRB 8 850 975 Upper middle- 300 0.338945709
income
Slovakia SVK 5 426 258 High income 63 0.116102109
Slovenia SVN 2 067 526 High income 174 0.841585547
Spain ESP 46 121 699 High income 1000 0.216817685
Sweden SWE 9 779 426 High income 850 0.869171667
Switzerland CHE 8 298 663 High income 120 0.144601606
The former MKD 2 078 453 Upper middle- 5 0.024056353
Yugoslav income
Republic of
Macedonia
Turkey TUR 78 665 830 Upper middle- 960 0.122035196
income
Ukraine UKR 44 823 765 Lower middle- 350 0.078083579
income
United Kingdom GBR 64 715 810 High income 469 0.072470699

152 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
Number of
Reported biomedical
number of engineers per
Population Income biomedical 10 000
Country Code (2015) grouping engineers (2015)
South East Asia Region
Bangladesh BGD 160 995 642 Low income 2 0.000124227
Bhutan BTN 774 830 Lower middle- 6 0.077436341
income
India IND 1 311 050 527 Lower middle- 40000 0.305098844
income
Indonesia IDN 257 563 815 Lower middle- 1 3.88253E-05
income
Maldives MDV 363 657 Upper middle- 1 0.027498439
income
Myanmar MMR 53 897 154 Low income 1 0.000185539
Nepal NPL 28 513 700 Low income 1 0.000350709
Sri Lanka LKA 20 715 010 Lower middle- 3 0.001448225
income
Thailand THA 67 959 359 Upper middle- 5 0.000735734
income
Timor-Leste TLS 1 184 765 Lower middle- 1 0.008440492
income
Western Pacific Region
Japan JPN 126 573 481 High income 20001 1.580188823
Malaysia MYS 30 331 007 Upper middle- 2500 0.824239037
income
Mongolia MNG 2 959 134 Lower middle- 240 0.811048097
income
Kiribati KIR 112 423 Lower middle- 3 0.26684931
income
Australia AUS 23 968 973 High income 320 0.133505929
Viet Nam VNM 93 447 601 Lower middle- 1000 0.107011843
income
New Zealand NZL 4 528 526 High income 26 0.057413825
Micronesia FSM 526 344 Lower middle- 2 0.037997963
(Federated income
States of)
Vanuatu VUT 264 652 Lower middle- 1 0.037785469
income
China CHN 1 376 048 943 Upper middle- 4497 0.032680524
income
Fiji FJI 892 145 Upper middle- 1 0.01120894
income
Lao People's LAO 6 802 023 Lower middle- 7 0.010291056
Democratic income
Republic
Philippines PHL 100 699 395 Lower middle- 50 0.004965273
income
Republic of KOR 50 293 439 High income 5 0.000994165
Korea
Singapore SGP 5 603 740 High income 320 0.57104

WHO Medical device technical series 153


Annex 2 Educational institutions with biomedical
engineering programmes

Income Educational Level


Country group institution City Programme BSc MSc PhD Other

African Region
Algeria Upper middle University of Tlemcen Tlemcen
Benin Low Ecole Polytechnique Cotonou Département X
Abomey Calavi part de Maintenance
of Université Abomey Biomédicale et
Calavi Hospitalière
Burkina Faso Low Ecole Superieur des Ouagadougou Génie Biomédical X
Techniques Avancees
Burkina
Faso Low Institut Superieur de Ouaga-dougou Génie Biomédical X
Technologies IST
Cameroon Lower middle Lycée Technique de
Garoua
Cameroon Lower middle Universite de Yaoundé Biomedical X
Yaoundé Equipment
Maintenance
Cameroon Lower middle Université des Bangangte Ingénierie X
Montagnes Biomédicale
Cameroon Lower middle Université des Bangangte Génie Biomédical X
Montagnes
Cameroon Lower middle Université des Bangangté Ingénierie X X
Montagnes Filère Biomédicale
Instrumentation
et Maintenance
Biomédicale
Democratic Low Institut Supérieur Kinshasa Maintenance de
Republic of des Techniques Matériel Médical
Congo Appliquées
Ethiopia Low Addis Abba Addis Ababa Biomedical X X
University Engineering
Ethiopia Low Comcbocha College Comc-bocha BMT X
Ethiopia Low Debere Markos Debre Markos BMT X
College
Ethiopia Low Jimma Institue of Jimma Biomedical X
Technology and Engineering
Engineering
Ethiopia Low Tegbare-ID College BMT X
Ghana Lower middle All Nations University Koforidua Biomedical X
Engineering
Ghana Lower middle Kwame Nkrumah Kumasi
University of Science
and Technology,
Ghana Lower middle University of Ghana Accra Biomedical X
Engineering

154 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
Income Educational Level
Country group institution City Programme BSc MSc PhD Other
Ghana Lower middle Valley View Adentan Bio-Medical X
University Equipment
Technology
Kenya Lower middle Kenya Medical Nyeri Medical X
Training College Engineering
Kenya Lower middle Kenya Medical Eldoret, Medical X
Training College Loitokitok, Engineering
(KMTC) Nairobi
Kenya Lower middle Technical University Mombasa Medical X
Mombasa (fomerly Engineering
Mombasa Services
Polytechnic)
Madagascar Low Institut Superieur de Antananarivo Génie Biomédical X X
Technologies (IST)
Malawi Low Malawi University Blantyre BME X
of Science and
Technology
Malawi Low The Malawi Blantyre BME X
Polytechnic
Mozambique Low Centro Regional de Maputo Health X
Desenvolvimento Maintenance
Sanitário (CRDS) Technology
Namibia Low Polytechnic of Windhoek
Namibia
Nigeria Lower middle Ahmadu Bellon Zaria Biomedical X
University Teaching Engineering
Hospital Technologist
(BMET)
Nigeria Lower middle Bells University of Ota Biomedical X
Technology Engineering
Nigeria Lower middle Federal University of Akure Biomedical X
Technology, Akura Engineering
Nigeria Lower middle Federal University of Owerri Biomedical X
Technology, Owerri Engineering
Nigeria Lower middle School of BME, Zaria BMET X
Ahmadu Bellon
University Teaching
Hospital
Nigeria Lower middle School of BME, Biomedical X
University of Benin Engineering
Teaching Hospital Technology
Nigeria Lower middle School of BME, BME X
University of
Maiduguri Teaching
Hospital
Nigeria Lower middle University of Benin Benin City Biomedical X
Teaching Hospital Engineering
Technology
Nigeria Lower middle University of Ilorin Ilorin Biomedical X
Engineering
Nigeria Lower middle University of Lagos Lagos Biomedical X
Engineering

WHO Medical device technical series 155


Income Educational Level
Country group institution City Programme BSc MSc PhD Other
Nigeria Lower middle University of Maiduguri Biomedical X
Maiduguri Teaching Engineering
Hospital
Nigeria Lower middle University of Port Port Harcourt Biomedical X
Harcourt Engineering
Rwanda Low IPRC Kigali Biomedical X
Equipment
Technology (BMET)
Senegal Lower middle Centre National Diourbel Hospital X
de Formation Maintenance
de Techniciens
en Maintenance
Hospitalière
(CNFTMH)
South Africa Upper middle Tshwane University Pretoria Clinical X X X
of Technology Engineering
South Africa Upper middle University de Stellenbosch Biomedical X X
Stellanbosch Engineering
South Africa Upper middle University of Cape Cape Town Biomedical X X
Town Engineering
South Africa Upper middle University of Johannesburg Biomedical X
Witwatersrand Engineering
Uganda Low Ernest Cook Kampala
Ultrasound Research
and Education
Institute
Uganda Low Kyambogo University Kampala Biomedical X
Engineering
Uganda Low Makere University Kampala Biomedical X
Engineering
United Low Arusha technical Arusha X
Republic of College
Tanzania
United Low Dar es Salaam Dar es Salaam X
Republic of Institute of
Tanzania Technology
Zambia Lower middle Northern Technical Ndola Biomedical X
College Engineering
Technologist
(BMET)

Eastern Mediterranean Region


Afghanistan Low American University Kabul
of Afghanistan
Bahrain High Kingdom University Manama
Bahrain High University of Bahrain Manama
Egypt Lower middle Ain Shams University Cairo
Egypt Lower middle University of Madison
Wisconsin System
Iran (Islamic Upper middle Amirkabir University Tehran Biomedical Faculty X X X
Republic of) (Tehran Polytechnic)

156 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
Income Educational Level
Country group institution City Programme BSc MSc PhD Other
Iran (Islamic Upper middle Iran University Tehran Biomechanics X X X
Republic of) of Science and
Technology
Bioelectrics
Iran (Islamic Upper middle Isfahan University of Isfahan
Republic of) Technology
Iran (Islamic Upper middle K.N. Toosi University Tehran Bioelectrics X
Republic of) of Technology
Iran (Islamic Upper middle Shahid Beheshti Tehran Bioelectrics X
Republic of) University
Iran (Islamic Upper middle Sharif University Tehran Bioelectrics X X
Republic of)
Iran (Islamic Upper middle Tabriz Modares Tehran Bioelectrics X X
Republic of) University
Biomaterials
Iran (Islamic Upper middle University of Isfahan Tehran Biomechanics X X
Republic of) Biomaterials
Iran (Islamic Upper middle University of Tehran Tehran Biomechanics
Republic of) Bioelectrics
Jordan Upper middle Al-Ahliyya Amman Amman X
University
Biomaterials
Jordan Upper middle German Jordan Amman
University
Jordan Upper middle Hashemite University Zarqa
Jordan Upper middle Institute of Amman
Biomedical
Technology/Royal
Medical Services
Jordan Upper middle Jordan University Irbid
of Science and
Technology
Jordan Upper middle Yarmouk University Irbid
Lebanon Upper middle American University Beirut
of Beirut
Oman High College of Muscat
Engineering at
Sultan Qaboos
University (SQU)
Pakistan Lower middle Aga Khan University Karachi
Hospital, Nairobi
Pakistan Lower middle Hamdard University Karachi
Pakistan Lower middle Mehran University Jamshoro
Pakistan Lower middle NED University of Karachi
Engineering and
Technology
Pakistan Lower middle Sir Syed University Karachi
of Engineering and
Technology

WHO Medical device technical series 157


Income Educational Level
Country group institution City Programme BSc MSc PhD Other
Saudi Arabia High King Faisal Ashaa
University, College of
Engineering Nasha
United Arab High Ajman University Ajman
Emirates of Science and
Technology
United Arab High American University Sharjah
Emirates of Sharjah
United Arab High Higher Colleges of Abu Dhabi
Emirates Technology
United Arab High Khalifa University Sharjah
Emirates
Yemen Lower middle Lebanese Yemen
International
University

European Region
Armenia Lower middle State Engineering Biomedical X X
University of Armenia Engineering
Armenia Lower middle UNESCO Chair in Biomedical X X
Life Sciences - Life Engineering
Science International
Postgraduate
Educational Center
Austria High Fachhochschule Vienna Biomedical X X
Technikum Wien Engineering
Austria High Fachhochschule Vienna Healthcare and X
Technikum Wien Rehabilitation
Technology
Austria High Medical University of Vienna
Vienna
Austria High Technische Graz Biomedical X X
Universität Graz Engineering
Austria High Technische Graz Electrical and X
Universität Graz Biomedical
Engineering
Austria High Technische Graz Molecular X
Universität Graz Bioengineering
Austria High UMIT Österreich
Austria High Upper Austria Linz Medical X X
University of Applied Engineering
Sciences
Azerbaijan Upper middle Khazar University Biomedicine X X
Belarus Upper middle Belarussian National Biotechnical and X X
Technical University medical apparatus
and systems
Belarus Upper middle Belarussian National Instruments and X
Technical University articles for medical
purposes

158 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
Income Educational Level
Country group institution City Programme BSc MSc PhD Other
Belarus Upper middle Belarussian State Medical Electronics X X X
University of
Informatics and
Radioelectronics
Belgium High IBiTECH Universiteit Gent
Gent
Belgium High Katholieke Diepenbeek
Hogeschool
Limburg - Radiation
Protection
Belgium High Katholieke Heverlee Biomedical X
Universiteit Leuven and Clinical
Engineering/
Biomedical
Technology
Belgium High Université Louvain Biomedical X X
Catholique de Engineering
Louvain
Belgium High Vrije Universiteit Brussels Biomedical X
Brussel and Ghent Engineering
University
Belgium High Université Libre de Brussels Civil Biomedical X X
Bruxelles Engineering
Bulgaria Upper middle Technical University Plovdiv Electronics X
of Sofia - Branch
Plovdiv
Bulgaria Upper middle Technical University Medical Electronics X X
of Varna
Croatia High University of Zagreb Zagreb Medical X
Construction
Design
Croatia High University of Applied Biomedical X
Sciences Varaždin Electronics
Czech High Brno University of Brno Biomedical X
Republic Technology Technology and
Bioinformatics
Czech High Brno University of Brno Biomedical and X
Republic Technology Environmental
Engineering
Czech High Czech Technical Prague Biomedical and X X X
Republic University Clinical Technology
Czech High Czech Technical Prague Radiological X X X
Republic University Technology
Czech High Czech Technical Prague Devices and X
Republic University Methods in
Biomedicine/
Biomedical and
Rehabilitation
Engineering
Czech High Czech Technical Prague Artificial X
Republic University Intelligence and
Biocybernetics/
Biomechanics

WHO Medical device technical series 159


Income Educational Level
Country group institution City Programme BSc MSc PhD Other
Czech High Technical University Biomedical X
Republic Ostrava Technology
Denmark High Aalborg University Biomedical Science X
and Engineering
Denmark High Aalborg University Biomedical X
Engineering and
Informatics
Denmark High Technical University Medicine and X X
of Denmark Technology
Denmark High Aarhus University Biomedical X
Engineering/
Cardiovascular
Technology
Estonia High Tallinn Technical Tallinn Biomedical X X
University Engineering and
Medical Physics
Estonia High University of Tartu Medical Technology X
Estonia High University of Tartu Medical Physics X
and Biomedical
Engineering
Finland High Helsinki University Espoo Biomedical X
of Technology (Aalto Engineering as a
University) Major in Technical
Physics and
Mathematics
Finland High University of Oulu Oulu Medical X X X
Technology/
Biophysics in the
technology of
medicine
Finland High University of Turku Biomedical X
Engineering as a
Minor for Electrical
and Information
Technology
Finland High Tampere University Biomedical X X
of Technology Engineering
Finland High University of Kuopio Medical Physics X
and Engineering
France High L’Université de Besançon
Franche-Comté
France High Université Claude Lyon
Bernard Lyon 1
France High Université de la Marseille Bioinstrumentation/ X
Méditerranée Biomedical
Engineering
France High Université de Compiègne
Technologie de
Compiègne
France High ESEO Group Biomedical X
Technology

160 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
Income Educational Level
Country group institution City Programme BSc MSc PhD Other
France High Ecole Centrale Paris Engineering of X
Medical Research
Biotechnological
Data
France High Groupe des Ecoles Biomedical X
des Mines, Graduate engineering
School of Nancy/
Saint-Etienne
France High University Joseph Health and Medical X
Fourier, Grenoble and Engineering
Grenoble Institute of
Technology
Germany High Aachen University of Jülich Biomedical X X
Applied Sciences Engineering
Germany High Anhalt University of Köthen Biomedical X X
Applied Sciences Engineering
Germany High Ansbach University Ansbach Biomedical X
of Applied Sciences Engineering
Germany High Bautzen University Bautzen Medical
of Cooperative Engineering
Education
Germany High Chemnitz University Chemnitz Medical X X
of Technology Engineering
Germany High Dresden University of Dresden
Technology
Germany High Hamburg University Hamburg Biomedical X X
of Applied Sciences Engineering
Germany High Hamm-Lippstadt Hamm Biomedical X X
University of Applied Engineering
Sciences
Germany High Heidelberg University Heidelberg Biomedical X
Engineering
Germany High Hochschule Furtwangen Biomedical X
Furtwangen Engineering
University
Germany High Hochschule Furtwangen Medical X
Furtwangen Engineering
University
Germany High Ilmenau University of Ilmenau Biomedical X X
Technology Engineering
Germany High Jade University of Wilhelmshaven Biomedical X
Applied Sciences Engineering
Germany High Koblenz University of Remagen Medical X
Applied Sciences Engineering
Germany High Landshut University Landshut Biomedical X
of Applied Sciences Engineering
Germany High Leibniz University of Hannover Biomedical X
Hanover Engineering
Germany High Mannheim University Mannheim Biomedical X
of Applied Sciences Engineering

WHO Medical device technical series 161


Income Educational Level
Country group institution City Programme BSc MSc PhD Other
Germany High Münster University Steinfurt Biomedical X
of Applied Sciences Engineering
Germany High Otto-von-Guericke Magdeburg Medical X
University Engineering
Magdeburg
Germany High Otto-von-Guericke Magdeburg Medical Systems X
University Engineering
Magdeburg
Germany High Pforzheim University Pforzheim Medical X
of Applied Sciences Engineering
Germany High Ruhr-University Bochum
Bochum
Germany High RWTH Aachen Aachen Biomedical X
University Engineering
Germany High Saarland University Saarbrücken Biomedical X X
of Applied Sciences Engineering
Germany High South Westphalia Hagen, Medical X
University of Applied Lüdenscheid Engineering
Sciences
Germany High Technical University Hamburg Medical X
of Hamburg Engineering
Germany High Technical University Darmstadt
of Darmstadt
Germany High Technical University Berlin Biomedical X
of Berlin Engineering
Germany High Technical University Garching Medical Technology X
of München and Engineering
Germany High Technische Nürnberg Electronical X
Hochschule Medical
Nürnberg/Nuremberg Engineering
Tech
Germany High Trier University of Trier Medical X
Applied Sciences Engineering
Germany High Ulm University of Ulm Medical X X
Applied Sciences Engineering
Germany High University of Bremerhaven Medical X
Applied Sciences Engineering
Bremerhaven
Germany High University of Applied Amberg- Medical X X
Sciences Amberg- Weiden Engineering
Weiden
Germany High University of Applied Jena Medical X X
Sciences Jena Engineering
Germany High University of Applied Lübeck Biomedical X
Sciences Lübeck Engineering
Germany High University of Applied Lübeck Biomedical X
Sciences Lübeck & Engineering
University of Lübeck
Germany High University of Giessen Biomedical X X
Applied Sciences Engineering
Mittelhessen

162 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
Income Educational Level
Country group institution City Programme BSc MSc PhD Other
Germany High University of Applied Offenburg Medical X X
Sciences Offenburg Engineering
Germany High University of Applied Stralsund Medizinisches X
Sciences Stralsund Informations
management/
eHealth
Germany High University of Applied Stralsund Medizintechnische X
Sciences Stralsund Systeme
Germany High University of Applied Schweinfurt
Sciences Würzburg-
Schweinfurt
Germany High University of Duisburg, Medical X X
Duisburg-Essen Essen Engineering
Germany High University of Erlangen Medical X X
Erlangen-Nuremberg Engineering
Germany High University of Lübeck Lübeck Medical X X
Engineering
Science
Germany High University of Rostock Rostock Biomedical X X
Engineering
Germany High University of Stuttgart Medical X X X
Stuttgart Engineering
Germany High University of Tübingen Biomedical X X
Tübingen Technologies
Germany High West Saxon Zwickau
University of Applied
Sciences of Zwickau
Germany High Westphalian Gelsenkirchen Mikrotechnology X
University of Applied and Medical
Sciences Engineering
Greece High National Technical Athens
University of Athens
Greece High University of Patras Patras Biomedical X X
Engineering
Greece High Aristotle University of Thessaloniki Medical Informatics X X
Thessaloniki
Hungary Upper middle Budapest University Budapest Biomedical X
of Technology and Engineering
Economics
Iceland High Reykjavik University Biomedical X
Engineering
Ireland High Dublin Institute of Dublin Signal Processing X
Technology Engineering with
Biomedical and
Advanced Image
Processing
Ireland High Trinity College Dublin Bioengineering/ X
Clinical
Engineering
Ireland High University of Biomedical X
Limerick Engineering

WHO Medical device technical series 163


Income Educational Level
Country group institution City Programme BSc MSc PhD Other
Israel High Ben-Gurion Beer Sheva Biomedical X X X
University Engineering
Israel High Jerusalem College of Jerusalem
Technology
Israel High Hebrew University Biomedical X
Engineering
Israel High Tel-Aviv Academic Tel Aviv Biomedical X X X
College of Engineering
Engineering
Israel High Israel institute Biomedical X X X
of Technology Engineering
(Technion)
Italy High Università degli Bologna Biomedical X
Studi di Bologna Engineering
Italy High Università degli Bologna Post-MSc (II lev) X
Studi di Bologna Master Course
in Clinical
Engineering
Italy High Università degli Cesena Biomedical X X
Studi di Bologna Engineering
Italy High Università Ancona Biomedical X
Politecnica delle Engineering
Marche
Italy High Università degli Cagliari Biomedical X
Studi di Cagliari Engineering
Italy High Università degli Catanzaro Biomedical and IT X
Studi "Magna Engineering
Graecia" di
Catanzaro
Italy High Università degli Firenze Biomedical X
Studi di Firenze Engineering
Italy High Università degli Firenze Post-Bachelor X
Studi di Firenze (I lev) Master
Course in Clinical
Engineering
Italy High Università degli Firenze Post-Bachelor (II X
Studi di Firenze lev) Master Course
in Healthcare
Engineering and
HTA
Italy High Università degli Genova Biomedical X X
Studi di Genova Engineering
Italy High Università degli Genova Bioengineering X
Studi di Genova
Italy High Politecnico di Milano Milano Biomedical X X
Engineering
Italy High Politecnico di Milano Milano Bioengineering X
Italy High Università degli Napoli Biomedical X X
Studi di Napoli Engineering
"Federico II"

164 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
Income Educational Level
Country group institution City Programme BSc MSc PhD Other
Italy High Università degli Napoli Biomedical and ICT X
Studi di Napoli Engineering
"Parthenope"
Italy High Università degli Padova Biomedical X X
Studi di Padova Engineering
Italy High Università di Pisa Pisa Biomedical X X
Engineering
Italy High Università di Pisa Pisa Automation, X
Robotics and
Bioengineering
Italy High Politecnico di Torino Torino Biomedical X X X
Engineering
Italy High Università degli Roma Clinical X
Studi di Roma "La Engineering
Sapienza"
Italy High Università degli Roma Biomedical X
Studi di Roma "La Engineering
Sapienza"
Italy High Università degli Roma Automation and X
Studi di Roma "La Bioengineering
Sapienza"
Italy High Università degli Roma Medical X
Studi di Roma "Tor Engineering
Vergata"
Italy High Università degli Roma Electronic/ X X
Studi “Roma Tre” Biomedical
Engineering
Italy High Università “Campus Roma Biomedical X
Bio-Medico” Engineering
Italy High Università degli Pavia Bioengineering X X
Studi di Pavia
Italy High Università degli Pavia Bioengineering and X
Studi di Pavia Bioinformatics
Italy High Università degli Trieste Clinical X
Studi di Trieste Engineering
Italy High Università degli Trieste Information X
Studi di Trieste Engineering
Italy High Università degli Trento Tissue-materials X
Studi di Trento Interactions
Italy High Università degli Trieste Post-Bachelor X
Studi di Trieste (I lev) Master
Course in Clinical
Engineering
Italy High Università degli Trieste Post-MSc (II lev) X
Studi di Trieste Master Course
in Clinical
Engineering
Italy High Università degli Pavia Post-MSc (II lev) X
Studi di Pavia Master Course
in Clinical
Engineering

WHO Medical device technical series 165


Income Educational Level
Country group institution City Programme BSc MSc PhD Other
Latvia High Biomedical
Engineering and
Nanotechnologies
Institute
Latvia High Riga Technical Riga Biomedical X X X
University Engineering and
Medical Physics
Latvia High Riga Technical Riga Biomaterials and X
University Biomechanics
Latvia High University of Latvia Biomedical Optics X
Lithuania High Vilnius Gediminas
Technical University
Lithuania High Kaunas University of Biomedical X
Technology Engineering
Malta High University of Malta Biomedical X
Engineering
Moldova Lower middle Technical University Biomedical X X
of Moldova Systems
Engineering
Netherlands High Delft University of Delft Biomedical X X
Technology Engineering
Netherlands High Technical University Eindhoven Biomedical X X X
Eindhoven Engineering
Netherlands High Technical University Enschede Biomedical X
Twente Engineering
Netherlands High University of Groningen Biomedical X
Groningen Engineering
Norway High Stavanger Stavanger
Universitetssjukehus
Norway High Norwegian University Trondheim Medical Technology X
of Science and
Technology
Poland High AGH-University Krakow Biomedical X X X
of Science and Engineering
Technology
Poland High Politechnika Gdańska Gdansk
Portugal High Universidade Rio de Mouro
Católica Portuguesa
Portugal High Universidade de Lisboa Bioengineering X
Lisboa
Portugal High Universidade de Lisboa Biological and X
Lisboa Medical Imaging
Portugal High Universidade de Biomedical X X
Coimbra Engineering
Romania Upper middle “Gr.T.Popa” Lasi
University of
Medicine and
Pharmacy

166 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
Income Educational Level
Country group institution City Programme BSc MSc PhD Other
Romania Upper middle University Bucharest Bioinformatics/ X
“Politehnica” of Medical
Bucharest and Clinical
Engineering/
Biomaterials
Russian High Kursk State Kursk
Federation Technical University
Russian High Ryazan State Ryazan
Federation Radio Engineering
University
Russian High Tomsk Polytechnic Tomsk Biomedical X
Federation University Engineering
Russian High Nizhny Novgorod Nizhny Biomedical X
Federation State Technical Novgorod Engineering
University
Russian High Vladimir State Bio-Technical X
Federation University and Medical
Apparatuses
and Systems/
Engineering in
Medical-Biological
Practice
Serbia Upper middle University of Novi Novi Sad
Sad
Serbia Upper middle University of Belgrade Biomedical X
Belgrade Engineering and
Technologies
Slovakia High The Technical Kosice Prosthetics and X
University of Košice Orthotics
Slovakia High The Technical Kosice Bionics and X
University of Košice Biomechanics
Slovakia High University of Zilina Biomedical X X
Engineering
Slovakia High Slovak University Bratislava Radioelectronics, X
of Technology in specialization
Bratislava Biomedical
Technology
Slovenia High University of Maribor Biomedical X
Technology
Spain High Universidad de Pamplona Biomedical X X
Navarra Engineering
Spain High Universidad de Valencia Biomedical X X
Valencia/Universidad Engineering
Politécnica de
Valencia
Spain High Universidad Madrid Bioengineering and X X
Politecnica de Telemedicine
Madrid, E.T.S.I. de
Telecomunicacion

WHO Medical device technical series 167


Income Educational Level
Country group institution City Programme BSc MSc PhD Other
Spain High Universitat Barcelona Biomedical X X
de Barcelona/ Engineering
Universitat
Politècnica de
Catalunya
Spain High Universidad de Zaragoza Biomedical X X
Zaragoza Engineering
Sweden High Chalmers University Goteborg Biomedical X
of Technology Engineering
Sweden High Linköping University Linköping Biomedical X
Engineering
Sweden High Luleå University of Luleå Biomedical
Technology Engineering and
Physics
Sweden High Royal Institute of Stockholm Medical X
Technology (KTH) Engineering
Sweden High Umeå University Umeå Radiation Physics X
and Biomedical
Engineering
Sweden High University of Borås Borås Electrical/ X
Biomedical
Engineering
Switzerland High Bern University of Bern Biomedical X X
Applied Sciences Engineering
Switzerland High Interstaatliche Buchs
Fachhochschule für
Technik Buchs
Switzerland High Swiss Federal Zurich Biomedical X
Institute of Engineering
Technology
Turkey Upper middle Afyon Kocatepe
University
Turkey Upper middle Akdeniz University
Turkey Upper middle Ankara University
Turkey Upper middle Bahçeşehir
University
Turkey Upper middle Başkent University Ankara Biomedical X
Engineering
Turkey Upper middle Biruni University
Turkey Upper middle Boğaziçi University Biomedical X X
Engineering
Turkey Upper middle Bülent Ecevit
University
Turkey Upper middle Çukurova University
Turkey Upper middle Düzce University
Turkey Upper middle Erciyes University
Turkey Upper middle Fatih Sultan Mehmet
Vakif University
Turkey Upper middle Fatih University Genetics and X X
Bioengineering

168 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
Income Educational Level
Country group institution City Programme BSc MSc PhD Other
Turkey Upper middle Gediz University
Turkey Upper middle Işik University
Turkey Upper middle İstanbul Arel
University
Turkey Upper middle İstanbul Medeniyet
University
Turkey Upper middle İstanbul Medipol
University
Turkey Upper middle İstanbul Technical
University
Turkey Upper middle İstanbul University
Turkey Upper middle İzmir Katip Çelebi Biotechnology, X
University Bioengineering
Turkey Upper middle Karabük University
Turkey Upper middle Kocaeli University
Turkey Upper middle Middle East Bioelectric X
Technical University Engineering/
Biomaterials/
Biomechanics/
Biomolecular
Engineering
Turkey Upper middle Namik Kemal
University
Turkey Upper middle Near East University
Turkey Upper middle Pamukkale
University
Turkey Upper middle Sabanci University Istanbul Biological Sciences X X X
and Bioengineering
Turkey Upper middle Süleyman Demirel
University
Turkey Upper middle Tobb University
of Economics and
Technology
Turkey Upper middle Yeditepe University Biomedical X
Engineering
Turkey Upper middle Yeditepe University Genetics and X
Bioengineering
Turkey Upper middle Yeni Yüzyil University
Ukraine Lower middle Kharkov National Kharkov Biomedical X
University of Radio engineering
and Electronics
Ukraine Lower middle Kharkov National Kharkov Biotechnical and X
University of Radio Medical Apparatus
and Electronics and Systems/
Biomedical
Electronics
Ukraine Lower middle National Technical Kiev Medical Equipment X
University of Ukraine and Systems

WHO Medical device technical series 169


Income Educational Level
Country group institution City Programme BSc MSc PhD Other
Ukraine Lower middle The International Biotechnical and X X
Solomon University Medical Devices
and Systems
Ukraine Lower middle Sumy State Sumy Oblast
University
United High Cardiff University Cardiff Clinical X
Kingdom Engineering
United High Durham University Durham
Kingdom
United High Imperial College London Biomedical X
Kingdom London Engineering
United High Keele University Biomedical X
Kingdom Engineering/
Cell and Tissue
engineering
United High King's College London Medical X X
Kingdom London Engineering and
Physics
United High Queen Mary, London Biomedical X
Kingdom University of London Engineering
United High Queen Mary, London Biomedical X
Kingdom University of London Materials Science
United High University College London Biomaterials and X
Kingdom Tissue Engineering/
Engineering in
Medicine
United High University College London Biomedical X
Kingdom Engineering
United High University of Aberdeen Biomedical X
Kingdom Aberdeen Engineering
United High University of Biomaterials X
Kingdom Birmingham
United High University of Biomedical and X
Kingdom Birmingham Microengineering
United High The University of Bradford Medical X
Kingdom Bradford Engineering
United High The University of Bradford Clinical Technology X
Kingdom Bradford
United High The University of Medical Physics X
Kingdom Edinburgh and Medical
Engineering
United High The University of Medicine and X
Kingdom Manchester Engineering/Tissue
Engineering
United High University of Oxford Oxford Biomedical X
Kingdom Engineering

170 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
Income Educational Level
Country group institution City Programme BSc MSc PhD Other
United High University of Glasgow Biomedical X
Kingdom Strathclyde Engineering/
Medical Technology
United High University of Surrey Surrey Biomedical X
Kingdom Engineering
Region of the Americas
Argentina Upper middle Instituto Tecnológico Buenos Aires Bioengineering X
de Buenos Aires
Argentina Upper middle Universidad de Buenos Aires Biotechnology X
Buenos Aires
Argentina Upper middle Universidad de Buenos Aires Bioengineering X
Maimonides and Biomedical
Engineering
Argentina Upper middle Universidad de Mendoza Bioengineering X
Mendoza and Biomedical
Engineering
Argentina Upper middle Universidad del Mar Mar del Plata
del Plata
Argentina Upper middle Universidad Favaloro Buenos Aires Biomedical X
Engineering
Argentina Upper middle Universidad Nacional Buenos Aires Bioengineering X
Arturo Jauretche
Argentina Upper middle Universidad Nacional Córdoba Biomedical X
de Córdoba Engineering
Argentina Upper middle Universidad Nacional Entre Ríos Bioengineering X X
de Entre Ríos and Biomedical
Engineering
Argentina Upper middle Universidad Nacional San Juan Bioengineering X
de San Juan
Argentina Upper middle Universidad Nacional San Miguel de Bioengineering X
de Tucumán Tucumán and Biomedical
Engineering
Argentina Upper middle Universidad Nacional San Luis Bioengineering X
de Villa Mercedes
Argentina Upper middle Universidad Mar del Plata
Tecnológica Nacional
Bahamas High The College of the Nassau
Bahamas
Barbados High University of the Cave Hill
West Indies
Belize Upper middle Universidad de
Concepción
Belize Upper middle University of Belize Belmopan
Bolivia Lower middle Universidad Católica Biomedical X
(Plurinational Boliviana San Pablo Engineering
State of)
Bolivia Lower middle Universidad del Valle Biomedical X
(Plurinational Engineering
State of)

WHO Medical device technical series 171


Income Educational Level
Country group institution City Programme BSc MSc PhD Other
Bolivia Lower middle Universidad Católica La Paz
(Plurinational Boliviana “San
State of) Pablo”
Bolivia Lower middle Universidad Privada Cochabamba
(Plurinational del Valle
State of)
Brazil Upper middle Centro de
Engenharia
Biomédica
Brazil Upper middle Escola de Porto Alegre
Engenharia da
Universidade Federal
do Rio Grande do Sul
Brazil Upper middle Federal University of São José dos Biosystems X
São João Del-Rei Campos Engineering
Brazil Upper middle Instituto de
Engenharia
de Sistemas e
Tecnologia de
Informação
Brazil Upper middle Pontifícia São Paulo
Universidade
Católica de Chile
Brazil Upper middle Pontifícia Curitiba
Universidade
Católica do Paraná
Brazil Upper middle Pontifícia Porto Alegre
Universidade
Católica do Rio
Grande do Sul
Brazil Upper middle Universidad de Porto Alegre
Valparaiso
Brazil Upper middle Universidade Pelotas Biotechnology X
Católica de Pelotas
Brazil Upper middle Universidade de Mogi das Biotechnology X X
Mogi das Cruzes Cruzes
Brazil Upper middle Universidade de São São Paulo Bioengineering X X
Paulo
Brazil Upper middle Universidade do Vale São José dos
do Paraíba Campos
Brazil Upper middle Universidade Estácio Rio de Janeiro
de Sá
Brazil Upper middle Universidade Federal São Paulo Biotechnology X
da Paraíba
Brazil Upper middle Universidade Federal Itajubá Bioprocesses X
de Itajubá Engineering
Brazil Upper middle Universidade Federal São Paulo Biomedical X
de Pernambuco Engineering
Brazil Upper middle Universidade Federal Santa Catarina
de Santa Catarina

172 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
Income Educational Level
Country group institution City Programme BSc MSc PhD Other
Brazil Upper middle Universidade Federal São Paulo
de São Paulo
Brazil Upper middle Universidade Federal São Paulo Biomedical X X
de Uberlândia Engineering
Brazil Upper middle Universidade Federal Rio de Janeiro Bioprocesses X X X
do Rio de Janeiro Engineering
Brazil Upper middle Universidade Guarapuava Biotechnology X
Tecnológica Federal Engineering
do Paraná
Canada High British Columbia Vancouver Biomedical X
Institute of Engineering
Technology
Canada High Carleton University Ottawa Biomedical, Elec, X X X X
Mech. Engineering
and MEng Clinical
Engineering
Canada High College of The North Station Seal Electronics X
Atlantic Cove Engineering
Technology
(Biomedical)
Canada High Concordia University Montreal
Canada High Dalhousie University Halifax Biomedical X X
Engineering
Canada High Durham College Oshawa Biomedical X
Engineering
Technology
Canada High École Polytechnique Montreal Biomedical X
Montréal Technology
- Electronic
Instrumentation
Canada High McGill University Montreal Biological and X X
Biomedical
Engineering
Canada High McMaster University Hamilton Biomedical X X X
Engineering
Canada High Memorial University St. Johns Biomedical X X X
of Newfoundland Engineering
Program
Canada High Northern Alberta Edmonton Biomedical X
Institute of Engineering
Technology Technology
Canada High Queen's University Kingston Biomedical X X
Engineering
Canada High Ryerson University Toronto Biomedical X X X
Engineering
Canada High Simon Fraser Burnaby Biomedical X X X
University Engineering
Canada High St. Clair College Biomedical X
Engineering
Technology

WHO Medical device technical series 173


Income Educational Level
Country group institution City Programme BSc MSc PhD Other
Canada High Université de Moncton
Moncton
Canada High Université de Montreal
Montréal
Canada High Université de Quebec
Sherbrooke
Canada High Université du Québec Trois Rivieres
À Trois-Rivières
Canada High Université Laval Laval
Canada High University of Alberta Edmonton Biomedical X X X
Engineering
Canada High University of British Vancouver Biomedical X X
Columbia Engineering
Canada High University of Calgary Calgary Biomedical X X X
Engineering
Canada High University of Guelph Guelph
Canada High University of Winnipeg Biomedical X X
Manitoba Engineering
Canada High University of New Fredericton Biomedical X
Brunswick Engineering
Program
Canada High University of Ottawa Ottawa Biomed Mech Eng, X X X X
Biomedical Eng,
MEng Clinical Eng.
Canada High University of Prince Charlotte town
Edward Island
Canada High University of Regina Biomedical X X
Saskatchewan Engineering
Canada High University of Toronto Toronto Biomedical X X X
Engineering
and Clinical
Engineering
Canada High University of Victoria Victoria Biomedical X
Engineering
Canada High University of Waterloo Biomedical X
Waterloo Engineering
Canada High University of Western London
Ontario
Canada High University of Windsor Windsor
Chile High Universidad de Concepcíon Civil Biomedical X
Concepción Engineering
Chile High Universidad de Viña del Mar Civil Biomedical X X
Valparaíso Engineering
Colombia Upper middle Escuela Colombiana Biomedical X
de Ingeniería Engineering
Julio Garavito /
Universidad del
Rosario

174 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
Income Educational Level
Country group institution City Programme BSc MSc PhD Other
Colombia Upper middle Escuela de Medellín Biomedical X
Ingeniería de Engineering
Antioquia
Colombia Upper middle Instituto Tecnológico Medellín
Metropolitano
Colombia Upper middle Pontificia Bogotá Bioengineering X
Universidad
Javeriana
Colombia Upper middle Universidad Antonio Bogotá Biomedical X
Nariño Engineering
Colombia Upper middle Universidad Manizales Biomedical X
Autónoma de Engineering
Manizales
Colombia Upper middle Universidad
Autónoma del Caribe
Cebi
Colombia Upper middle Universidad Cali Biomedical X
Autónoma Occidente Engineering
de Cali
Colombia Upper middle Universidad CES Medellín
(convenio)
Colombia Upper middle Universidad de Bioengineering X
Antioquia
Colombia Upper middle Universidad de la Bogotá Bioscience X
Sabana Doctorate
Colombia Upper middle Universidad de los Biomedical X X
Andes Engineering
Colombia Upper middle Universidad Manuela Bogotá Biomedical X
Beltrán Engineering
Colombia Upper middle Universidad Medellín
Pontificia
Bolivariana
Colombia Upper middle Universidad Cali Bioengineering X
Santiago de Cali
Cuba Upper middle Instituto Superior Havana Biomedical X X X
Politécnico José Engineering
Antonio Echeverría
Cuba Upper middle Universidad “Martha Las Villas Signal processing X X
Abreu” and Systems
Cuba Upper middle Universidad de Santiago de Biomedical X X X
Oriente Cuba Engineering
Dominica Upper middle Dominica State
College, Escuela de
Salud Pública
Dominican Upper middle Universidad Santo Domingo
Republic Autónoma de Santo
Domingo
Ecuador Upper middle Universidad Central
del Ecuador
El Salvador Lower middle Don Bosco University San Salvador Biomedical X
Engineering

WHO Medical device technical series 175


Income Educational Level
Country group institution City Programme BSc MSc PhD Other
El Salvador Lower middle Universidad El Salvador
Cristiana
Latinoamericana
Grenada Upper middle St. George’s St. George
University
Guatemala Lower middle Universidad de San Guatemala
Carlos de Guatemala
Guyana Lower middle University of Guyana Greater
Georgetown
Haiti Low Université Quisqueya Port-au-Prince
Honduras Lower middle UNITEC Academic Tegucigalpa
Head of
Electromechanical
Engineering
Honduras Lower middle Universidad Nacional Tegucigalpa
Autónoma de
Honduras
Jamaica Upper middle University of the Jamaica
West Indies
Mexico Upper middle Centro de Mexico City Master of Science X X
Investigación y de in Bioelectronics
Estudios Avanzados
Mexico Upper middle Instituto Politécnico Mexico City Biomedical X
Nacional Engineering
Mexico Upper middle Instituto Tecnológico Hermosillo Biomedical X
de Hermosillo Engineering
Mexico Upper middle Instituto Tecnológico Mérida Biomedical X
de Mérida Engineering
Mexico Upper middle Instituto Tecnológico Tijuana Biomedical X
de Tijuana Engineering
Mexico Upper middle Instituto Tecnológico Monterrey Biomedical X X
y de Estudios Engineering/
Superiores de Biotechnology
Monterrey
Mexico Upper middle Tecnológico de Aguas Biomedical X
Monterrey Campus calientes Engineering
Aguascalientes
Mexico Upper middle Tecnológico de Chihuahua Biotechnology X
Monterrey Campus
Chihuahua
Mexico Upper middle Tecnológico de Mexico City Biomedical X
Monterrey Campus Engineering
Ciudad de México
Mexico Upper middle Tecnológico de Guadalajara Biomedical X
Monterrey Campus Engineering
Guadalajara
Mexico Upper middle Universidad Anáhuac Mexico City Biomedical X
Campus Norte Engineering
Mexico Upper middle Universidad Chihuahua Biomedical X
Autónoma Engineering
Chihuahua

176 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
Income Educational Level
Country group institution City Programme BSc MSc PhD Other
Mexico Upper middle Universidad Aguas Biomedical X
Autónoma de calientes Engineering
Aguascalientes
Mexico Upper middle Universidad Tijuana Bioengineering X
Autónoma de Baja
California
Mexico Upper middle Universidad Mexico City Biomedical X X X
Autónoma Engineering
Metropolitana
Mexico Upper middle Universidad Querétaro Biomedical X
Autónoma de Engineering
Querétaro
Mexico Upper middle Universidad Querétaro Biosystems X
Autónoma de Engineering
Querétaro
Mexico Upper middle Universidad San Luis Potosí Biomedical X
Autónoma de San Engineering
Luis Potosí
Mexico Upper middle Universidad de Celaya Biomedical X
Celaya Engineering
Mexico Upper middle Universidad de Guadalajara Biomedical X
Guadalajara Engineering
Mexico Upper middle Universidad de León Biomedical X
Guanajuato Engineering
Mexico Upper middle Universidad de la Mexico City Biomedical X
Salle Engineering
Mexico Upper middle Universidad de las Puebla Biomedical X
Américas Engineering
Mexico Upper middle Universidad de Monterrey Biomedical X
Monterrey Engineering
Mexico Upper middle Universidad Mexico City Biomedical X
Iberoamericana Engineering
Mexico Upper middle Universidad Nacional Mexico City Biomedical X
Autónoma de México Systems
Engineering
Mexico Upper middle Universidad Guanajuato Biomedical X
Politécnica Engineering
Bicentenario
Mexico Upper middle Universidad Chiapas Biomedical X
Politécnica de Engineering
Chiapas
Mexico Upper middle Universidad Pachuca Biomedical X
Politécnica de Engineering
Pachuca
Mexico Upper middle Universidad Sinaloa Biomedical X
Politécnica de Engineering
Sinaloa
Panama Upper middle Universidad Especial Panamá City Biomedical X
de las Américas Engineering with
specialization in
Electromedicine

WHO Medical device technical series 177


Income Educational Level
Country group institution City Programme BSc MSc PhD Other
Panama Upper middle Universidad Latina Panamá City Biomedical X
de Panamá Engineering
Paraguay Lower middle Universidad Nacional
de Asunción
Peru Upper middle Peruvian Engineering Lima
College
Peru Upper middle Pontificia Lima Biomedical X
Universidad Catolica Engineering
del Peru
Peru Upper middle Universidad Nacional Lima
de Ingenieria
Peru Upper middle Universidad Nacional Lima
Mayor de San Marcos
Peru Upper middle Universidad Lima Biomedical X
Tecnólogica del Peru Engineering
Trinidad and High University of Trinidad Biomedical X
Tobago and Tobago Engineering
United States High Albany Technical Albany, New
of America College York
United States High Arizona State Tempe, Arizona Biomedical X X X
of America University Engineering
United States High Binghamton Binghamton, Bioengineering X X X
of America University, State New York
University of New
York
United States High Boston University Boston, Biomedical X X X
of America Massachusetts Engineering
United States High Brown University Providence, Biomedical X X X
of America Rhode Island Engineering
United States High Bucknell University Lewisburg Biomedical X
of America Pennsylvania Engineering
United States High California Institute Pasadena, Bioengineering X X
of America of Technology California
United States High California San Luis Biomedical X X
of America Polytechnic State Obispo, Engineering
University, San Luis California
Obispo
United States High Carnegie Mellon Pittsburgh, Biomedical X X X
of America University Pennsylvania Engineering
United States High Case Western Cleveland, Biomedical X X X
of America Reserve University Ohio Engineering
United States High Catholic University of Washington Biomedical X X X
of America America (DC) Engineering
United States High Cedar Crest College Allentown,
of America Pennsylvania
United States High Cincinnati State Cincinnati, Biomedical X
of America Technical and Ohio Equipment and
Community College Information
Systems Technology
(BMET)

178 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
Income Educational Level
Country group institution City Programme BSc MSc PhD Other
United States High City College of New New York, New Biomedical X X X
of America York York Engineering
United States High City University of New York, New Biomedical X X X
of America New York York Engineering
United States High Clemson University Clemson, Bioengineering X X X
of America South Carolina
United States High Colorado State Fort Collins, Bioengineering X X
of America University Colorado
United States High Colorado State Fort Collins, Biomedical X
of America University Colorado Engineering
United States High Colorado State Pueblo, Biomedical X
of America University Colorado Engineering/
Chemical and
Biological
Engineering
United States High Colorado State Pueblo Bioengineering X X
of America University
United States High Columbia University New York, New Biomedical X X X
of America York Engineering
United States High Cornell University New York, New Biomedical X X
of America York Engineering
United States High Cornell University New York, New Biological X X X
of America York Engineering
United States High Cuyahoga Cleveland, Electrical/ X
of America Community College Ohio Electronic
Engineering
Technology-Bio-
Medical (BMET)
United States High Devry Institute of Rego Park, New
of America Technology and York
Keller Graduate
School of
Management, New
York
United States High Devry University, Phoenix, Biomedical X
of America Arizona Arizona Engineering
Technology
United States High Devry University, Pomona, Biomedical X
of America California California Engineering
Technology
United States High Devry University, Colorado
of America Colorado Springs,
Colorado
United States High Devry University, Hollywood, Biomedical X
of America Florida Florida Engineering
Technology
United States High Devry University, Decatur, Biomedical X
of America Georgia Georgia Engineering
Technology
United States High Devry University, Downers Grove, Biomedical X
of America Illinois Illinois Engineering
Technology

WHO Medical device technical series 179


Income Educational Level
Country group institution City Programme BSc MSc PhD Other
United States High Devry University, Kansas City,
of America Missouri Missouri
United States High Devry University, North Biomedical X
of America New Jersey Brunswick Engineering
Township, New Technology
Jersey
United States High Devry University, Columbus, Biomedical X
of America Ohio Ohio Engineering
Technology
United States High Devry University, Fort Biomedical X
of America Pennsylvania Washington, Engineering
Pennsylvania Technology
United States High Devry University, Austin, Irving Biomedical X
of America Texas and Mesquite, Engineering
Texas Technology
United States High Devry University, Federal Way
of America Washington
United States High Drexel University Philadelphia, Biomedical X X X
of America Pennsylvania Engineering
United States High Duke University Durham, North Biomedical X X X
of America Carolina Engineering
United States High East Tennessee Johnson City, Biomedical X
of America State University Tennessee Engineering
Technology
United States High Florida Agricultural Tallahassee, Biological and X
of America and Mechanical Florida Agricultural
University Systems
Engineering
United States High Florida Gulf Coast Fort Myers, Bioengineering X
of America University Florida
United States High Florida State Tallahassee, Biomedical X X X
of America University Florida Engineering
United States High Florida International Miami, Florida Biomedical X X X
of America University Engineering
United States High Fox Valley Technical Appleton,
of America College Wisconsin
United States High Gannon University Erie, Biomedical X
of America Pennsylvania Engineering
United States High George Mason Fairfax, Bioengineering X X X
of America University Virginia
United States High Georgia Institute of Atlanta, Biomedical X X X
of America Technology/Emory Georgia Engineering;
University Bioengineering
United States High Harvard University Cambridge, Biomedical X X X
of America Massachusetts Engineering
United States High Hi-Tech School of Miami, Florida
of America Miami
United States High Howard Community Columbia,
of America College Maryland
United States High Illinois Institute of Chicago, Biological X
of America Technology Illinois Engineering

180 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
Income Educational Level
Country group institution City Programme BSc MSc PhD Other
United States High Illinois Institute of Chicago, Biomedical X X X
of America Technology Illinois Engineering
United States High Indiana Institute of Fort Wayne, Biomedical X
of America Technology Indiana Engineering
United States High Indiana University Bloomington, Biomedical X X X
of America Indiana Engineering
United States High Indiana University Indianapolis, Biomedical X X X
of America - Purdue University Indiana Engineering
Indianapolis
United States High Indiana University Indianapolis, Biomedical X
of America - Purdue University Indiana Engineering
Indianapolis Technology
United States High Iowa State University Ames, Iowa Biological Systems X X X X
of America Engineering
United States High Johns Hopkins Baltimore, Biomedical X X X
of America University Maryland Engineering
United States High Johns Hopkins Baltimore, Bioengineering X
of America University Maryland Innovation and
Design
United States High Johnson College Scranton,
of America Pennsylvania
United States High Kansas State Manhattan, Biological Systems X X X
of America University Kansas Engineering
United States High Lawrence Southfield, Biomedical X
of America Technological Michigan Engineering
University
United States High Lehigh University Bethlehem, Bioengineering X X X
of America Pennsylvania
United States High Louisiana Tech Ruston, Biomedical X X X
of America University Louisiana Engineering
United States High Louisiana State Ruston, Biological X X X
of America University and A&M Louisiana Engineering
College
United States High Manhattan College New York, New
of America York
United States High Marquette University Milwaukee, Bioengineering X X X
of America Wisconsin
United States High Massachusetts Cambridge, Biological X X X
of America Institute of Massachusetts Engineering
Technology
United States High Massachusetts Cambridge, Biomedical X
of America Institute of Massachusetts Engineering
Technology
United States High Mayo Graduate Rochester,
of America School Minnesota
United States High Mercer University Atlanta, Biomedical X X
of America Georgia Engineering
United States High Miami University Oxford, Ohio Bioengineering X
of America

WHO Medical device technical series 181


Income Educational Level
Country group institution City Programme BSc MSc PhD Other
United States High Michigan State East Lansing, Biomedical X X X
of America University Michigan Engineering
United States High Michigan Houghton, Biomedical X X X
of America Technological Michigan Engineering
University
United States High Milwaukee School of Milwaukee, Bioengineering X
of America Engineering Wisconsin
United States High Mississippi State Starkville, Biological X X X
of America University Mississippi Engineering
United States High Mississippi State Starkville, Biomedical X X
of America University Mississippi Engineering
United States High New Jersey Institute Newark, New Biomedical X X X
of America of Technology Jersey Engineering
United States High New York University New York, New Biomedical X X
of America Polytechnic School of York Engineering
Engineering
United States High Normandale Bloomington,
of America Community College Minnesota
United States High North Carolina Greensboro, Bioengineering X X X
of America Agricultural and North Carolina
Technical State
University
United States High North Carolina Greensboro, Biological X X
of America Agricultural and North Carolina Engineering
Technical State
University
United States High North Carolina Raleigh/ Biological X X X
of America State University at Chapel Hill, Engineering
Raleigh/University North Carolina
of North Carolina,
Chapel Hill
United States High North Carolina Raleigh/ Biological X X X
of America State University at Chapel Hill, Engineering
Raleigh/University North Carolina
of North Carolina,
Chapel Hill
United States High North Dakota State Fargo, North Agricultural X X X
of America University Dakota and Biosystems
Engineering
United States High North Seattle Seattle,
of America Community College Washington
United States High Northwestern Evanston, Biomedical X X X
of America University Illinois Engineering
United States High Ohio State University Columbus, Biomedical X X X
of America Ohio Engineering
United States High Oklahoma State Stillwater, Biomedical X
of America University Oklahoma Engineering
United States High Oral Roberts Tulsa,
of America University Oklahoma
United States High Oregon State Corvallis, Bioengineering X
of America University Oregon

182 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
Income Educational Level
Country group institution City Programme BSc MSc PhD Other
United States High Pennsylvania State University Bioengineering X X
of America University Park,
Pennsylvania
United States High Pennsylvania State University Biomedical X
of America University Park, Engineering
Pennsylvania
United States High Pennsylvania State University Biological X X X
of America University Park, Engineering
Pennsylvania
United States High Pennsylvania State New Biomedical X
of America University Kensington, Engineering
Pennsylvania Technology (BET)
United States High Portland Community Portland,
of America College Oregon
United States High Purdue University Lafayette, Biomedical X X X
of America Indiana Engineering;
Biological
Engineering
United States High Rensselaer Troy, New York Biomedical X X X
of America Polytechnic Institute Engineering;
Chemical and
Biological
Engineering
United States High Rice University Houston, Texas Bioengineering X X X
of America
United States High Rose-Hulman Terre Haute, Biomedical X X X
of America Institute of Indiana Engineering
Technology
United States High Rutgers University - New Biomedical X X X
of America Cook College Brunswick, Engineering
New Jersey
United States High Saint Augustine Raleigh, North
of America College Carolina
United States High Saint Louis St. Louis, Biomedical X
of America Community College- Missouri Engineering
Florissant Valley Technology
United States High Saint Louis St. Louis, Biomedical X X X
of America University Missouri Engineering
United States High Snead State Boaz, Alabama
of America Community College
United States High Southwest Georgia Thomasville,
of America Technical College Georgia
United States High Stanford University Stanford, Bioengineering X X X
of America California
United States High Stevens Institute of Hoboken, New Biomedical X X X
of America Technology Jersey Engineering
United States High Stony Brook Stony Brook, Biomedical X X X
of America University New York Engineering
United States High Syracuse University Syracuse, New Bioengineering X X X
of America York

WHO Medical device technical series 183


Income Educational Level
Country group institution City Programme BSc MSc PhD Other
United States High State Technical Linn, Missouri Electronics X
of America College of Missouri Engineering
Technology -
Biomedical
Engineering
Technology Option
United States High Temple University Philadelphia, Bioengineering X X X
of America Pennsylvania
United States High Texas A & M College Biological and X X X
of America University Station, Texas Agricultural
Engineering
United States High Texas A & M College Biomedical X X X
of America University Station, Texas Engineering
United States High Texas State Technical Harlingen, Biomedical X
of America College-Harlingen Texas Equipment
Technology
United States High The College of New Trenton, New Biomedical X
of America Jersey Jersey Engineering
United States High The George Washington Biomedical X X X
of America Washington (DC) Engineering
University
United States High Trinity College Hartford, Engineering with X
of America Connecticut a concentration
in Biomedical
Engineering
United States High Trinity University San Antonio,
of America Texas
United States High Tufts University Medford, Biomedical X X X
of America Massachusetts Engineering
United States High Tufts University Medford, Bioengineering X X
of America Massachusetts
United States High Tufts University Medford, Chemical and X X
of America Massachusetts Biological
Engineering
United States High Tulane University New Orleans, Biomedical X X X
of America Louisiana Engineering
United States High Union College Schenectady, Bioengineering X X X
of America New York
United States High University at Buffalo, Buffalo, New Biomedical X X X
of America State University of York Engineering
New York
United States High University at Buffalo, Buffalo, New Chemical and
of America State University of York Biological
New York Engineering
United States High University of Akron Akron, Ohio Biomedical X X X
of America Engineering
United States High University of Birmingham, Biomedical X X X
of America Alabama at Alabama Engineering
Birmingham

184 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
Income Educational Level
Country group institution City Programme BSc MSc PhD Other
United States High University of Arizona Tucson, Arizona Biosystems X X X
of America Engineering;
Biomedical
Engineering
United States High University of Fayetteville, Biological and X X X
of America Arkansas Arkansas Biomedical
Engineering
United States High University of Berkeley, Bioengineering; X X X
of America California - Berkeley California Translational
Medicine
United States High University of Davis, Biomedical X X X
of America California - Davis California Engineering;
Biological Systems
Engineering
United States High University of Irvine, Biomedical X X X
of America California - Irvine California Engineering
United States High University of Los Angeles, Bioengineering X X X
of America California - Los California
Angeles
United States High University of Riverside, Bioengineering X X X
of America California - Riverside California
United States High University of La Jolla, Bioengineering X X X
of America California - San California
Diego
United States High University of La Jolla, Biotechnology; X
of America California - San California Bioinformatics;
Diego BioSystems
United States High University of Central Orlando, Bioengineering X
of America Florida Florida (minor)
United States High University of Central Edmond, Biomedical X
of America Oklahoma Oklahoma Engineering
United States High University of Cincinnati, Biomedical X X X
of America Cincinnati Ohio Engineering
United States High University of Boulder, Chemical and X X
of America Colorado Colorado Biological
Engineering
United States High University of Hartford, Biomedical X
of America Connecticut Connecticut Engineering
(Clinical
Engineering)
United States High University of Storrs, Biomedical X X X
of America Connecticut Connecticut Engineering
United States High University of Newark, Biomedical X X X
of America Delaware Delaware Engineering
United States High University of Florida Gainesville Agricultural X X X
of America Florida and Biological
Engineering
United States High University of Florida Gainesville Biomedical X X X
of America Florida Engineering
United States High University of Georgia Athens, Biological X X X
of America Georgia Engineering

WHO Medical device technical series 185


Income Educational Level
Country group institution City Programme BSc MSc PhD Other
United States High University of Hartford West Hartford, Biomedical X X X
of America Connecticut Engineering
United States High University of Hawaii Honolulu, Biological X X
of America at Manoa Hawaii Engineering
United States High University of Hawaii Honolulu, Molecular X X
of America at Manoa Hawaii Biosciences and
Bioengineering
United States High University of Houston Houston, Texas Biomedical X X X
of America Engineering
United States High University of Idaho Moscow, Idaho Biological X X X X
of America Engineering
United States High University of Illinois Chicago, Bioengineering X X X
of America at Chicago Illinois
United States High University of Urbana Illinois Agricultural X X X
of America Illinois at Urbana- and Biological
Champaign Engineering
United States High University of Champaign, Bioengineering X X X
of America Illinois at Urbana- Illinois
Champaign
United States High University of Iowa Iowa City, Iowa Biomedical X X X
of America Engineering
United States High University of Kansas Lawrence, Bioengineering X X
of America Kansas
United States High University of Louisville, Bioengineering X X
of America Louisville Kentucky
United States High University of Maine Orono, Maine Biological X
of America Graduate School of Engineering
Biomedical Sciences
(GSBS)
United States High University of Maine Orono, Maine Bioengineering X
of America
United States High University of College Park, Bioengineering X X X X
of America Maryland Maryland
United States High University of Memphis, Biomedical X X X
of America Memphis Tennessee Engineering
United States High University of Miami Coral Gables, Biomedical X X X
of America Florida Engineering
United States High University of Ann Arbor, Biomedical X X X
of America Michigan Michigan engineering
United States High University of Minneapolis, Biomedical X X X
of America Minnesota Minnesota Engineering
United States High University of Minneapolis, Bioproducts X X X
of America Minnesota Minnesota and Biosystems
Engineering
United States High University of Columbia, Biological X X X
of America Missouri - Columbia Missouri Engineering
United States High University of Lincoln, Biological Systems X
of America Nebraska at Lincoln Nebraska Engineering

186 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
Income Educational Level
Country group institution City Programme BSc MSc PhD Other
United States High University of North Chapel Hill, Biomedical and X X X
of America Carolina at Chapel North Carolina Health Sciences
Hill Engineering;
United States High University of Norman, Biomedical X X X
of America Oklahoma Oklahoma Engineering
United States High University of the Stockton, Bioengineering X
of America Pacific California
United States High University of Philadelphia, Bioengineering X X X
of America Pennsylvania Pennsylvania
United States High University of Pittsburgh, Bioengineering X X X
of America Pittsburgh Pennsylvania
United States High University of Rhode Kingston, Biomedical X
of America Island Rhode Island Engineering
United States High University of Rochester, New Biomedical X X X
of America Rochester York Engineering
United States High University of South Columbia, Biomedical X X X
of America Carolina South Carolina Engineering
United States High University of South Tampa, Florida Biomedical X X X
of America Florida Engineering
United States High University of Los Angeles, Biomedical X X X
of America Southern California California Engineering
United States High University of Los Angeles, Neuroengineering; X
of America Southern California California Medical Imaging;
Medical device
Engineering
United States High University of Knoxville, Biomedical X X X
of America Tennessee Tennessee Engineering
United States High University of Texas at Arlington,Texas Biomedical X X X
of America Arlington Engineering
United States High University of Texas at Austin, Texas Biomedical X X X
of America Austin Engineering
United States High University of Texas at El Paso, Texas Biomedical X X X
of America El Paso Engineering
United States High University of Texas at San Antonio, Biomedical X X X
of America San Antonio Texas Engineering
United States High University of Toledo Toledo, Ohio Bioengineering X X
of America
United States High University of Toledo Toledo, Ohio Biomedical X
of America Engineering
United States High University of Utah Salt Lake City, Biomedical X X X
of America Utah Engineering
United States High University of Virginia Charlottesville, Biomedical X X X
of America Virginia Engineering
United States High University of Seattle, Bioengineering X X X
of America Washington Washington
United States High University of Madison, Bioengineering; X
of America Wisconsin Wisconsin Biological Systems
Engineering
United States High University of Laramie,
of America Wyoming Wyoming

WHO Medical device technical series 187


Income Educational Level
Country group institution City Programme BSc MSc PhD Other
United States High Utah State University Logan, Utah Biological X X X
of America Engineering
United States High Vanderbilt University Nashville, Biomedical X X X
of America Tennessee Engineering
United States High Vermont Technical Randolph
of America College Center,
Vermont
United States High Virginia Richmond, Biomedical X X X
of America Commonwealth Virginia Engineering
University
United States High Virginia Polytechnic Blacksburg, Biological Systems X
of America Institute and State Virginia Engineering/
University with Wake Biomedical
Forest University Engineering
United States High Walla Walla College College Place, Bioengineering X
of America Washington
United States High Washington State Pullman, Bioengineering X
of America University Washington
United States High Washington State Pullman, Biological Systems X X
of America University Washington Engineering
United States High Washington St. Louis, Biomedical X X X
of America University in St. Missouri Engineering
Louis
United States High Wayne State Detroit, Biomedical X X X
of America University Michigan Engineering
United States High Western New Springfield, Biomedical X X X
of America England University Massachusetts Engineering
United States High Wichita State Wichita, Biomedical X
of America University Kansas Engineering
United States High Worcester Worcester, Biomedical X X X
of America Polytechnic Institute Massachusetts Engineering
United States High Wright State Dayton, Ohio Biomedical X X
of America University Engineering
United States High Wright State Dayton, Ohio Medical and X
of America University Biological Systems
United States High Yale University New Haven, Biomedical X X X
of America Connecticut Engineering
Uruguay High Universidad de la Montevideo Biological X
República Oriental Engineering
del Uruguay
Venezuela Upper middle Universidad de los Mérida Biomedical X
(Bolivarian Andes Engineering
Republic of)
Venezuela Upper middle Universidad Táchira Biomedical X
(Bolivarian Experimental Engineering
Republic of) Francisco de
Miranda
Venezuela Upper middle Universidad Simón Caracas Biomedical X
(Bolivarian Bolivar Engineering
Republic of)

188 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
Income Educational Level
Country group institution City Programme BSc MSc PhD Other

South-East Asia Region


Bangladesh Low Bangladesh Dhaka
University of
Engineering and
Technology
Bangladesh Low University of Dhaka Dhaka
Bhutan Lower middle Royal Technical
Institute
Democratic Low Pyongyang University Pyongyang
People’s of Science and
Republic of Technology
Korea
India Lower middle Aarupadai Veedu
Institute of
Technology
India Lower middle ACS College of Bangalore
Engineering
India Lower middle Adesh Institute of
Engineering and
Technology
India Lower middle Adhiyamaan College
of Engineering
India Lower middle All India Institute of New Delhi
Medical Sciences
India Lower middle Alpha Institute of
Engineering and
Technology
India Lower middle Anna University Chennai
India Lower middle Avinashilingam
Deemed University
for Women
India Lower middle Avinashilingam Coimbatore
Institute for Home
Science and Higher
Education for Women
India Lower middle Banaras Hindu Varanasi
University Institute
of Technology
India Lower middle Bapuji Institute of
Engineering and
Technology
India Lower middle Bhagwant Institute
of Technology for
Women
India Lower middle Bharath Institute
of Science and
Technology
India Lower middle Bharati Vidyapeeths
College of
Engineering

WHO Medical device technical series 189


Income Educational Level
Country group institution City Programme BSc MSc PhD Other
India Lower middle Bharat-Ratna Indira
Gandhi College of
Engineering
India Lower middle BMS College of
Engineering
India Lower middle C.R. State College of
Engineering, Murthal
India Lower middle C.U. Shah College
of Engineering and
Technology
India Lower middle College of
Engineering
India Lower middle College of Bhubeneswar
Engineering and
Technology
India Lower middle Dayanand
Sagar College of
Engineering
India Lower middle Deenbandhu Chhotu Murthal
Ram University
of Science and
Technology Murthal
India Lower middle Dhanlakshmi
Srinivasan
Engineering College
Perambalur
India Lower middle Dr Ambedkar
Institute of
Technology
India Lower middle Dr B.R. Ambedkar New Delhi
Center for
Biomedical Research
India Lower middle Dr Bhausaheb
Nandurkar College of
Engineering
India Lower middle Dronacharya College
of Engineering
India Lower middle Dwarkadas J. Mumbai
Sanghvi College of
Engineering
India Lower middle Eastern Academy
of Science and
Technology
India Lower middle Gayatri Vidya
Parishad College
of Engineering for
Women
India Lower middle Godavari Institute
of Engineering and
Technology

190 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
Income Educational Level
Country group institution City Programme BSc MSc PhD Other
India Lower middle Gokaraju Rangaraju Telengana
Institute of
Engineering and
Technology
India Lower middle Government Gandhinagar
Engineering College,
Gandhinagar
India Lower middle Gujarat University
India Lower middle Guru Jambheshwar
University
India Lower middle Indian Institute of Mumbai
Technology, Bombay
India Lower middle Indian Institute of Delhi
Technology, Delhi
India Lower middle Indian Institute Kharagpur
of Technology,
Kharagpur
India Lower middle Indian Institute of Madras
Technology, Madras
India Lower middle Institute of
Engineering
and Technology
Bundelkhand
University
India Lower middle Institute of
Technology, Banaras
Hindu University
India Lower middle J.B. Institute of
Engineering and
Technology
India Lower middle Jadavpur University
India Lower middle Jawaharlal Nehru Telengana
Technological
University
India Lower middle Jerusalem College of
Engineering
India Lower middle K.L.E. Society College
of Engineering and
Technology
India Lower middle Karunya Deemed
University
India Lower middle Khaja Banda
Nawaz College of
Engineering
India Lower middle L.D. Engineering
College, Ahmedabad
India Lower middle Mahatma Gandhi
Mission College of
Engineering and
Technology

WHO Medical device technical series 191


Income Educational Level
Country group institution City Programme BSc MSc PhD Other
India Lower middle Mahavir Institute
of Engineering and
Technology
India Lower middle Manipal Institute of
Technology
India Lower middle Manipal University
India Lower middle Model Engineering
College
India Lower middle Ms Ramaiah
Institute of
Technology
India Lower middle Mvj College of
Engineering
India Lower middle Nagaji Institute
of Technology and
Management
India Lower middle National Institute of
Technology (N.I.T.)
India Lower middle Netaji Subhash Kolkata
Engineering College
India Lower middle Nimt Institute of
Engineering and
Technolgy Riico
Industrial Area
India Lower middle Noorul Islam College
of Engineering
India Lower middle Northern India
Engineering College
India Lower middle Odaiyappa College
of Engineering and
Technology Theni
India Lower middle Osmania University
India Lower middle P.D. Memorial
College of
Engineering
India Lower middle P.S.G. College of
Technology
India Lower middle Padmashree Dr D.Y.
Patil University
India Lower middle Padmasri Dr B.V.
Raju Institute of
Technology
India Lower middle P.D.M. College of
Engineering
India Lower middle P.S.N.A. College of
Engineering and
Technology
India Lower middle Rajalakshmi
Engineering College

192 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
Income Educational Level
Country group institution City Programme BSc MSc PhD Other
India Lower middle Rajiv Gandhi College
of Engineering and
Technology
India Lower middle Rayat and Bahra
Institute of
Engineering and Bio-
Technology
India Lower middle Region of the
Americasita School
of Biotechnology
India Lower middle Region of the
Americasita
University
India Lower middle Sahrdaya College
of Engineering and
Technology
India Lower middle Saroj Institute of
Technology
India Lower middle School of Chemical
and Biotechnology
India Lower middle Sengunthar College
of Engineering for
Women
India Lower middle Shobhit University
India Lower middle Shree Motilal
Kanhaiyalal
Fomra Institute of
Technology
India Lower middle Shri Govindram
Seksaria Institute
of Technology and
Science
India Lower middle Sree Chitra Tirunal
Institute for Medical
Sciences and
Technology
India Lower middle Sri Belimatha
Mahasamasthana
Institute of
Technology
India Lower middle Sri Krishna Institute
of Technology
India Lower middle Sri Ramakrishna
Engineering College
India Lower middle Sri Siddartha
Institute of
Technology
India Lower middle Sri Sivasubramaniya
Nadar College of
Engineering

WHO Medical device technical series 193


Income Educational Level
Country group institution City Programme BSc MSc PhD Other
India Lower middle St Ashok
Technological
Institute
India Lower middle St. Peter's
Engineering College
India Lower middle Sun College of
Engineering and
Technology
India Lower middle Thadomal Shahani
Engineering College
India Lower middle Thangal Kanju
Musaliar Institute of
Technology
India Lower middle Trident Academy of
Technology
India Lower middle U.V. Patel College of
Engineering
India Lower middle Udaya School of
Engineering
India Lower middle University College of
Engineering
India Lower middle Velalar College of
Engineering and
Technology
India Lower middle Veltech Multi Tech
Dr Rangarajan
Dr Sakunthala
Engineering College
India Lower middle Vidyalankar Institute
of Technology
India Lower middle Vinayaka Mission's
Kirupananda Variyar
Engineering College
India Lower middle Watumal Institute
of Electronics
Engineering and
Computer Technology
India Lower middle Yadavrao Tasgonkar
institute of
Engineering and
Technology
Indonesia Lower middle Institut Teknologi Bandung Biomedical X X X
Bandung Engineering
Indonesia Lower middle Universitas Jakarta Biomedical X
Indonesia Engineering
Indonesia Lower middle Universitas Gadjah Yogyakarta Biomedical X
Mada Engineering
Indonesia Lower middle Universitas Surabaya Biomedical X X
Airlangga Engineering
Indonesia Lower middle Institut Teknologi Surabaya Biomedical X X
Sepuluh Nopember Engineering

194 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
Income Educational Level
Country group institution City Programme BSc MSc PhD Other
Indonesia Upper middle Swiss-German Jakarta Biomedical X
University Engineering
Thailand Upper middle Chiang Mai Chiang Mai
University
Thailand Upper middle Chulalongkorn
University
Thailand Upper middle King Mongkut’s Thonburi
University of
Technology
Thailand Upper middle Mahidol University Salaya
Thailand Upper middle Prince of Songkla Songkla
University
Timor-Leste Lower middle National University
of East Timor

Western Pacific Region


Australia High Flinders University of Adelaide Biomedical X X
South Australia Engineering;
Biomedical
Engineering
Technology
Australia High Griffith University Nathan QLD Electronic and X X X
Biomedical
Engineering; Sport
and Biomedical
Engineering
Australia High La Trobe University Melbourne Biomedical X X
Engineering
Australia High Monash University Clayton
Australia High Murdoch University Murdoch
Australia High Queensland Brisbane Medical X
University of Engineering
Technology and Information
Technology; Medical
Engineering and
Mathematics
Australia High RMIT University Melbourne Biomedical X
Engineering
Australia High Swinburne University Hawthorn Biomedical X
of Technology Engineering
Australia High University of Adelaide
Adelaide
Australia High University of Parkville, Biomedical X
Melbourne Melbourne Engineering
Australia High University of New Sydney Biomedical X X X X
South Wales Engineering with or
without Materials
or Engineering
Science
Australia High University of Sydney Sydney Biomedical X X X
Engineering

WHO Medical device technical series 195


Income Educational Level
Country group institution City Programme BSc MSc PhD Other
China Upper middle Academy of Military Beijing X X
Medical Sciences
China Upper middle Anhui Medical Hefei X X X
University
China Upper middle Anhui University of Hefei X
Chinese
China Upper middle Anhui University of Hefei X X
Science
China Upper middle Beijing Institute of Beijing X X X
Technology
China Upper middle Beijing Jiaotong Beijing X X X
University
China Upper middle Beijing Union Beijing X
University
China Upper middle Beijing University Beijing Biomedical X X X
of Aeronautics and Engineering
Astronautics
China Upper middle Beijing University Beijing X X X
of Aeronautics and
Astronautics
China Upper middle Beijing University of Beijing Biomedical X X X
Chemical Technology Engineering
China Upper middle Beijing University Chongqing X X
of Posts and
Telecommunications
China Upper middle Beijing University of Beijing Biomedical X X X
Technology Engineering
China Upper middle Capital Medical Beijing Biomedical X X X
University Engineering
China Upper middle Central South Changsha Biomedical X X X
University Engineering
China Upper middle Changchun Changchun X X X
University of Science
and Technology
China Upper middle Changzhi Medical Changzhi Biomedical X
College Engineering
China Upper middle Chengde Medical Chengde X
University
China Upper middle Chengdu Medical Chengdu X
College
China Upper middle Chengdu University Chengdu X
of Information
Technology
China Upper middle Chengdu University Chengdu X
of TCM
China Upper middle China Jiliang Hangzhou X
University
China Upper middle China Medical Shenyang Biomedical X X
University Engineering

196 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
Income Educational Level
Country group institution City Programme BSc MSc PhD Other
China Upper middle China Medical Shenyang X X X
University
China Upper middle China Nanjing X X
Pharmaceutical
University
China Upper middle Chinese University of Hong Kong Biomedical X X X
Hong Kong Engineering
China Upper middle Chongqing Medical Chongqing Biomedical X X X
University Engineering
China Upper middle Chongqing University Chongqing Biomedical X X X
Engineering
China Upper middle Chongqing University Chongqing X X X
of Posts and
Telecommunications
China Upper middle Chongqing University Chongqing Biomedical X X
of Technology Engineering
China Upper middle Chung Yuan Chung Li, Biomedical X X X
Christian University Taiwan Engineering
China Upper middle Dali University Dali Biomedical X
Engineering
China Upper middle Dalian Medical Dalian X
University
China Upper middle Dalian Ocean Dalian Biomedical X X
University Engineering
China Upper middle Dalian University of Dalian X X X
Technology
China Upper middle Donghua University Shanghai Biomedical X X X
Engineering
China Upper middle East China Normal Shanghai X X
University
China Upper middle East China Shanghai X X X
University of Science
and Technology
China Upper middle Fourth Military Xian Biomedical X X X
Medical University Engineering
China Upper middle Fudan University Shanghai Biomedical X X X
Engineering
China Upper middle Fujian Journal of Fuzhou X
Traditional Chinese
Medicine
China Upper middle Fujian Normal Fuzhou X X
University
China Upper middle Fuzhou University Fuzhou X X
China Upper middle Gannan Medical Ganzhou Biomedical X
University Engineering
China Upper middle Guangdong Medical Guangzhou X
University
China Upper middle Guangdong Guangzhou X
Pharmaceutical
University

WHO Medical device technical series 197


Income Educational Level
Country group institution City Programme BSc MSc PhD Other
China Upper middle Guangxi Medical Nanning X X X
University
China Upper middle Guangxi University of Nanning X
Chinese Medicine
China Upper middle Guangzhou Medical Guangzhou X
University
China Upper middle Guilin University of Guilin Biomedical X
Electronic University Engineering
China Upper middle Guizhou Medical Guiyang Biomedical X
University Engineering
China Upper middle Hangzhou Dianzi Hangzhou X X X
University
China Upper middle Harbin Institute of Harbin Biomedical X X X
Technology Engineering
China Upper middle Harbin Medical Harbin Biomedical X X X
University Engineering
China Upper middle He University Shenyang X
China Upper middle Hebei University Baoding X
China Upper middle Hebei University of Shijiazhuang X
Science
China Upper middle Hebei University of Tianjin X X
Technology
China Upper middle Hebei University of Shijiazhuang X
Technology
China Upper middle Hefei University of Hefei Biomedical X
Technology Engineering
China Upper middle Henan University Luoyang Biomedical X
of Science and Engineering
Technology
China Upper middle Huazhong University Wuhan Biomedical X X X
of Science and Engineering
Technology
China Upper middle Hubei University Xianning Biomedical X
of Science and Engineering
Technology
China Upper middle Hubei University of Wuhan X
Technology
China Upper middle Hunan University Changsha Biomedical X X X
Engineering
China Upper middle Hunan University of Zhuzhou X X
Technology
China Upper middle Inner Mongolia Hohhot X
Medical University
China Upper middle Jiamusi University Jiamusi X
China Upper middle Jiangsu University Zhenjiang Biomedical X X X
Engineering
China Upper middle Jiangxi University of Nanchang Biomedical X
Traditional Chinese Engineering
Medicine

198 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
Income Educational Level
Country group institution City Programme BSc MSc PhD Other
China Upper middle Jilin Medical College Jilin X
China Upper middle Jilin University Changchun Biomedical X X X
Engineering
China Upper middle Jinan University Guangzhou Biomedical X X X X
Engineering
China Upper middle Jinggangshan Ji’an Biomedical X
University Engineering
China Upper middle Jining Medical Jining X
University
China Upper middle Kunming University Kunming Biomedical X
of Science and Engineering
Technology
China Upper middle Kunming University Kunming X
of Science and
Technology
China Upper middle Lanzhou University Lanzhou Biomedical X X X
Engineering
China Upper middle Macao Polytechnic Macau Science in X
Institute Biomedical
Technology
China Upper middle Medical School of Beijing Biomedical X X
Chinese PLA Engineering
China Upper middle Mudanjiang Medical Mudan-jiang X
University
China Upper middle Nanchang Hangkong Nanchang Biomedical X X X
University Engineering
China Upper middle Nanchang University Nanchang X X X
China Upper middle Nanjing Medical Nanjing X X X
University
China Upper middle Nanjing University Nanjing Biomedical X X X
Engineering
China Upper middle Nanjing University Nanjing Biomedical X X X
of Aeronautics and Engineering
Astronautics
China Upper middle Nanjing University Nanjing Biomedical X
of Posts and Engineering
Telecommunications
China Upper middle Nanjing University Nanjing X X
of Science and
Technology
China Upper middle Nankai University Tianjin Biomedical X X
Engineering
China Upper middle Nantong University Nantong X X X
China Upper middle National Cheng Kung Tainan, Taiwan Biomechanics, X X X
University Biomedical
Electronics,
Biomaterials,
Medical
information and
Rehabilitation
technologies

WHO Medical device technical series 199


Income Educational Level
Country group institution City Programme BSc MSc PhD Other
China Upper middle National Chiao Tung Hsinchu, Molecular Medicine X X X
University Taiwan and Bioengineering
China Upper middle National Taiwan Taipei, Taiwan Biomaterials, X X X
University Biomechanical
Engineering,
Bioelectronics,
Clinical
Engineering,
and Biomedical
informatics
China Upper middle National University Changsha X X
of Defense
Technology
China Upper middle North Sichuan Chengdu X
Medical College
China Upper middle North University of Taiyuan Biomedical X X
China Engineering
China Upper middle North University of Taiyuan X X X
China
China Upper middle Northeast Petroleum Daqin X
University
China Upper middle Northeastern Shenyang Biomedical X X X
University Engineering
China Upper middle Northeastern Changchun X X X
University
China Upper middle Northwestern Xi’an Biomedical X X X
Polytechnical Engineering
University
China Upper middle Peking Union Beijing Biomedical X X X
Medical College Engineering
China Upper middle Peking University Beijing Biomedical X X X
Engineering
China Upper middle Putian University Putian X
China Upper middle Qiqihar Medical Qiqihar X
University
China Upper middle Shaanxi Normal Xi’an X X
University
China Upper middle Shandong University Jinan Biomedical X X
Engineering
China Upper middle Shandong University Tsingtao X X X
China Upper middle Shandong University Qingdao X
of Science and
Technology
China Upper middle Shandong University Jinan X X X
of Traditional
Chinese Medicine
China Upper middle Shanghai Jiao Tong Shanghai Biomedical X X X
University Engineering
China Upper middle Shanghai university Shanghai Biomedical X X X
Engineering

200 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
Income Educational Level
Country group institution City Programme BSc MSc PhD Other
China Upper middle Shanghai University Shanghai X
of medical and
Health Science
China Upper middle Shanghai University Shanghai X
of Traditional
Chinese Medicine
China Upper middle Shenyang Shenyang Biomedical X
Pharmaceutical Engineering
University
China Upper middle Shenyang University Shenyang Biomedical X X X
of Technology Engineering
China Upper middle Shenzhen University Shenzhen X X X
China Upper middle Sichuan Agriculture Chengdu X
University
China Upper middle Sichuan Medical Chengdu X
University
China Upper middle Sichuan University Chengdu Biomedical X X X
Engineering
China Upper middle Sichuan University Zigong X
of Science and
Engineering
China Upper middle Soochow University Soochow X X
China Upper middle South China Guangzhou Biomedical X X X
University of Engineering
Technology
China Upper middle South University Shenzhen X
of Science and
Technology of China
China Upper middle South-central Wuhan Biomedical X X
University for Engineering
Nationalities
China Upper middle South-central Wuhan X X X
University of
Technology
China Upper middle Southeast University Nanjing Biomedical X X X
Engineering
China Upper middle Southern Medical Guangzhou Biomedical X X X
University Engineering
China Upper middle Southwest Jiaotong Chengdu Biomedical X X X
University Engineering
China Upper middle Southwest University Mianyang Biomedical X
of Science and Engineering
Technology
China Upper middle Sun Yat-sen Guangzhou Biomedical X X X
University, SYSU Engineering
China Upper middle Taishan Medical Taishan X
University
China Upper middle Taiyuan University of Taiyuan Biomedical X X X
Technology Engineering

WHO Medical device technical series 201


Income Educational Level
Country group institution City Programme BSc MSc PhD Other
China Upper middle The fourth Military Xi’an X X X
Medical University
China Upper middle The Hong Kong Hong Kong Biomedical X X X
Polytechnic Engineering
University
China Upper middle The Second Military Shanghai Biomedical X X
Medical University Engineering
China Upper middle The University of Macau Biomedical X X X
Macau Instrumentation
Design; Biomedical
Imaging;
Bioinformatics
China Upper middle Third Military Chongqing Biomedical X X X
Medical University Engineering
China Upper middle Tianjin Medical Tianjin Biomedical X X X
University Engineering
China Upper middle Tianjin Polytechnic Tianjin X X X
University
China Upper middle Tianjin University Tianjin Biomedical X X X
Engineering
China Upper middle Tianjin University of Tianjing X X
Traditional Chinese
Medicine
China Upper middle Tongji University Shanghai Biomedical X X X
Engineering
China Upper middle Tsinghua University Beijing Biomedical X X X
Engineering
China Upper middle University of Chinese Beijing X X
Academy of Sciences
China Upper middle University of Chengdu Biomedical X X X
Electronic Science Engineering
and Technology of
China
China Upper middle University of Science Hefei X X
and Technology of
China
China Upper middle University of Shanghai Biomedical X X X
Shanghai for Science Engineering
and Technology
China Upper middle Wannan Medical Qianghu X
College
China Upper middle Weifang Medical Weifang X
University
China Upper middle Wenzhou Medical Wenzhou X X
College
China Upper middle Wenzhou Medical Wenzhou Biomedical X X
University Engineering
China Upper middle Wuhan University Wuhan Biomedical X X
Engineering
China Upper middle Wuhan University of Wuhan X X
Technology

202 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
Income Educational Level
Country group institution City Programme BSc MSc PhD Other
China Upper middle Xi`an International Xi’an X
University
China Upper middle Xi`an Technological Xi’an X
University
China Upper middle Xi’an Jiaotong Xi’an Biomedical X X X
University Engineering
China Upper middle Xiamen University Xiamen Biomedical X X
Engineering
China Upper middle Xi'an Jiaotong Xi’an X X X
University
China Upper middle Xidian University Xi’an Biomedical X X
Engineering
China Upper middle Xinxiang Medical Xinxiang Biomedical X X X
University Engineering
China Upper middle Xuzhou Medical Xuzhou X
University
China Upper middle Yancheng Teachers Yancheng X
University
China Upper middle Yangtze Normal Chongqing X
University
China Upper middle Yanshan University Qinhuangdao Biomedical X X X
Engineering
China Upper middle Yunnan University Yunnan X X
China Upper middle Zhejiang Chinese Hangzhou X
Medical University
China Upper middle Zhejiang Gongshang Hangzhou X
University
China Upper middle Zhejiang University Hangzhou Biomedical X X X
Engineering
China Upper middle Zhejiang University Hangzhou X
of Technology
China Upper middle Zhengzhou University Zhengzhou Biomedical X
Engineering
Japan High Chiba Institute of Chiba
Science
Japan High Chubu University Nagoya
College of Medical
Technology
Japan High Fujita Health Toyoake
University
Japan High Hokkaido Institute of Hokkaido
Technology
Japan High Kanazawa University Kanazawa
Japan High Kawasaki University Kurashiki
of Medical Welfare
Japan High Kitasato University Sagamihara

WHO Medical device technical series 203


Income Educational Level
Country group institution City Programme BSc MSc PhD Other
Japan High Kumamoto Institute Kumamoto
of General Medical
Welfare
Japan High Kyoto College of Kyoto
Health and Hygiene
Japan High Nagasaki Institute of Nagasaki
Applied Sciences
Japan High Nippon Buri Oita
University Medical
College
Japan High Okayama University Okayama
of Science
Japan High Osaka College of Osaka
High Technology
Japan High Osaka Electro- Osaka
Communication
University
Japan High Ota College of Ota
Medical Technology
Japan High Saitama Medical Saitama
University
Japan High Suzuka University of Suzuka
Medical Science
Japan High Tenri School of Tenri
Medical Technology
Japan Upper middle Toin University of Yokohama
Yokohama
Japan High Tokai University Numazu
Japan High University of East Shimonoseki
Asia
Japan High Yomiuri Institute of Tokyo
Technology
Malaysia Upper middle Cyberjaya University Selangor
College of Medical
Sciences
Malaysia Upper middle HELP University Kuala Lumpur
Malaysia Upper middle International Islamic Kuala Lumpur
University Malaysia
(IIUM)
Malaysia Upper middle MAHSA University Kuala Lumpur
Malaysia Upper middle Politeknik Shah Alam Selangor
Malaysia Upper middle Politeknik Sultan Selangor
Salahuddin Abdul
Aziz Shah
Malaysia Upper middle Universiti Malaysia Perlis
Perlis
Malaysia Upper middle Universiti Putra Selangor
Malaysia (UPM)

204 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
Income Educational Level
Country group institution City Programme BSc MSc PhD Other
Malaysia Upper middle Universiti Teknologi Johor
Malaysia (UTM)
Malaysia Upper middle Universiti Teknologi Perak
PETRONAS (UTP)
Malaysia Upper middle Universiti Tunku Selangor
Abdul Rahman
(UTAR)
Malaysia Upper middle University Kuala
Lumpur - British
Malaysian Institute
Malaysia Upper middle University of Malaya Kuala Lumpur Biomedical X X
Engineering
Malaysia Upper middle University of Malaya Kuala Lumpur Biomedical X
Engineering
(Prosthetics and
Orthotics)
Malaysia Upper middle University of Iskandar
Southampton Puteri, Johor
(Malaysia Campus)
Marshall Upper middle Kolej Kemahiran Ledang, Johor
Islands Tinggi Mara Ledang
(KKTM)
New Zealand High University of Auckland Biomedical X
Auckland Engineering
New Zealand High University of Otago Dunedin Bioengineering X
Philippines Lower middle De La Salle Manila
University
Republic of High Hanyang University Seoul
Korea
Republic of High Kyung Hee University Wonju
Korea
Republic of High Sangji University Seoul
Korea
Republic of High Seoul National Suwon
Korea University
Republic of High Sungkyunkwan Seoul
Korea University
Singapore High Nanyang Polytechnic Singapore Biomedical X
Engineering
Singapore High National University Singapore Biomedical X
of Singapore Engineering
Singapore High Ngee Ann Polytechnic Singapore Biomedical X
Engineering
Singapore High Republic Polytechnic Singapore Biomedical X
Electronics
Singapore High SIM University Singapore Biomedical X X
Engineering
Singapore High Singapore Singapore Bioengineering X
Polytechnic

WHO Medical device technical series 205


Income Educational Level
Country group institution City Programme BSc MSc PhD Other
Singapore High Temasek Polytechnic Singapore Biomedical X
Engineering
Viet Nam Lower middle International Ho Chi Minh
University of Vietnam City
National Universities

206 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
Annex 3 National and international
professional biomedical engineering
associations

Reported
number of
Country Name of society Acronym members Income grouping
African Region
Burkina Faso L'ASSOCIATION BURKINABE DES TECHNICIENS ATBIB … Low income
ET INGENIEURS BIOMEDICAUX
Burundi ASSOCIATION BURUNDAISE DE L'INGENIERE ABIB … Low income
BIOMEDICALE ET HOSPITALIERE
Cameroon CAMEROONIAN ASSOCIATION OF CAP-BME … Lower middle
PROFESSIONAL BIOMEDICAL ENGINEERING income
Côte d’Ivoire SYNDICAT NATIONAL DES BIOMEDICAUX DE SYNABIOCI … Lower middle
COTE D'IVOIRE income
Democratic ASSOCIATION DES INGENIEURS ET … Low income
Republic of the TECHNICIENS BIOMEDICAUX
Congo
Ethiopia ETHIOPIAN BIOMEDICAL ENGINEERING EBEA 80 Low income
ASSOCIATION
Gambia (The) GAMBIA BIOMEDICAL ENGINEERING GAMbeta … Low income
TECHNOLOGISTS ASSOCIATION
Ghana GHANA SOCIETY OF BIOMEDICAL ENGINEERS … Lower middle
income
Kenya ASSOCIATION OF MEDICAL ENGINEERING OF AMEK … Lower middle
KENYA income
Nigeria NIGERIAN INSTITUTE FOR BIOMEDICAL NIBE … Lower middle
ENGINEERING income
Rwanda RWANDA MEDICAL ENGINEERING ASSOCIATION RMEA Low income
South Africa BIOMEDICAL ENGINEERING SOCIETY OF SOUTH … … Upper middle
AFRICA income
South Africa CLINICAL ENGINEERING ASSOCIATION SOUTH CEASA … Upper middle
AFRICA income
Uganda UGANDA NATIONAL ASSOCIATION FOR MEDICAL UNAMHE 49 Low income
AND HOSPITAL ENGINEERING
United Republic ASSOCIATION OF MEDICAL ENGINEERS AND AMETT Low income
of Tanzania TECHNICIANS TANZANIA
Zambia BIOMEDICAL ENGINEERING ASSOCIATION Lower middle
ZAMBIA income
Eastern Mediterranean Region
Iran (Islamic IRANIAN SOCIETY FOR BIOMEDICAL ISBME … Upper middle
Republic of) ENGINEERING income
Jordan JORDAN BIOMEDICAL ENGINEERING SOCIETY JBMES … Upper middle
income

Source: January 2015 Global Survey - Professional and Academic Profiles on Biomedical Engineers and Technicians, WHO.

WHO Medical device technical series 207


Reported
number of
Country Name of society Acronym members Income grouping
Kuwait KUWAIT ASSOCIATION OF BIOMEDICAL KABME … High income
ENGINEERS
Libya LIBYAN SOCIETY OF BIOMEDICAL ENGINEERS LSBE … Upper middle
income
Saudi Arabia SAUDI SCIENTIFIC SOCIETY FOR BIOMEDICAL SSSBE 300 High income
ENGINEERING
United Arab SOCIETY OF ENGINEERS UNITED ARAB SOEUAE … High income
Emirates EMIRATES
European Region
Austria AUSTRIAN SOCIETY FOR BIOMEDICAL OEGBMT … High income
ENGINEERING
Belgium BELGIAN SOCIETY FOR MEDICAL AND … … High income
BIOLOGICAL ENGEINEERING AND COMPUTING
Bulgaria BULGARIAN SOCIETY OF BIOMEDICAL PHYSICS BSBPE 28 Upper middle
& ENGINEERING income
Croatia CROATIAN MEDICAL & BIOLOGICAL CROMBES 136 High income
ENGINEERING SOCIETY
Cyprus CYPRUS ASSOCIATION OF MEDICAL PHYSICS & CAMPBE … High income
BIOMEDICAL ENGINEERING
Czech Republic CZECH SOCIETY FOR BIOMEDICAL SBMILI … High income
ENGINEERING & MEDICAL INFORMATICS
Denmark DANISH SOCIETY FOR BIOMEDICAL DMTS … High income
ENGINEERING
Estonia ESTONIAN SOCIETY FOR BIOMEDICAL … … High income
ENGINEERING & MEDICAL PHYSICS
Finland FINNISH SOCIETY FOR MEDICAL PHYSICS & … … High income
BIOMEDICAL ENGINEERING
France SOCIETE DES ELECTRICIEN ET DES … … High income
ELECTRONICIENS
France SOCIETE FRANCAISE DE GENIE BIOLOGIQUE ET SFGBM … High income
MEDICAL
Germany DEUTSCHE GESELLSCHAFT FUR DGBMT … High income
BIOMEDIZINISCHE TECHNIK E.V.
Greece GREEK SOCIETY FOR BIOMEDICAL … … High income
ENGINEERING
Hungary SOCIETY OF MEASUREMENT & AUTOMATION … … Upper middle
SECTION BIOMEDICAL ENGINEERING income
Iceland ICELANDIC SOCIETY FOR BIOMEDICAL … … High income
ENGINEERING
Ireland BIOMEDICAL ENGINEERING ASSOCIATION OF BEAI … High income
IRELAND
Israel ISRAEL SOCIETY FOR MEDICAL & BIOLOGICAL ISMBE … High income
ENGINEERING
Italy ASSOCIAZIONE ITALIANA DI INGEGNARIA AIIMB … High income
MEDICA E BIOLOGICA
Italy ITALIAN ASSOCIATION OF CLINICAL ENGINEERS AIIC 1366 High income
Latvia LATVIAN MEDICAL ENGINEERING AND PHYSICS … … High income
SOCIETY

208 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
Reported
number of
Country Name of society Acronym members Income grouping
Lithuania LITHUANIAN SOCIETY FOR BIOMEDICAL LBID … High income
ENGINERING
Montenegro THE SOCIETY OF BIOMEDICAL ENGINEERING … … Upper middle
AND MEDICAL PHYSICS, SERBIA AND income
MONTENEGRO
Netherlands THE NETHERLANDS SOCIETY FOR BIOPHYSICS BIOPM … High income
AND BIOMEDICAL TECHNOLOGY
Norway NORWEGIAN SOCIETY FOR BIOMEDICAL … … High income
ENGINEERING
Poland POLISH SOCIETY FOR BIOMEDICAL PTIB … High income
ENGINEERING
Poland POLISH SCIENTIFIC AND TECHNICAL … … High income
COMMITTEE FOR BIOMEDICAL ENGINEERING
OF SEP
Portugal SOCIEDADE PORTUGUESA DE EGENHARIA SPEB 65 High income
BIOMEDICA
Romania SOCIETATEA NATIONALA DE INGINERIE SNIMTB … Upper middle
MEDICALA SI TECHNOLOGIE BIOLOGICA income
Slovakia SLOVAK SOCIETY OF BIOMEDICAL SBIMI … High income
ENGINEERING AND MEDICAL INFORMATICS
Slovenia SLOVENE SOCIETY FOR MEDICAL & DMBTS … High income
BIOLOGICAL ENGINEERING
Spain SPANISH SOCIETY OF BIOMEDICAL SEIB … High income
ENGINEERING
Sweden SWEDISH SOCIETY FOR MEDICAL ENGINEERING MTF … High income
& PHYSICS
Switzerland SWISS SOCIETY FOR BIOMEDICAL SSBE … High income
ENGINEERING
Turkey BIOMEDICAL ENGINEERS ASSOCIATION BIYOMED 95 Upper middle
income
Ukraine INSTITUTE OF MEDICAL ENGINEERING AND … … Lower middle
CLINICS income
United Kingdom INSTITUTION OF PHYSICS AND ENGINEERING IN IPEM … High income
MEDICINE
Region of the Americas
Argentina SOCIEDAD ARGENTINA DE BIOINGENIERA SABI … Upper middle
income
Brazil SOCIEDADE BRASILEIRA DE ENGENHARIA SBEB 250 Upper middle
BIOMÉDICA income
Canada CANADIAN MEDICAL & BIOLOGICAL CMBES … High income
ENGINEERING SOCIETY
Chile SOCIEDAD CHILENA DE INGENIERIA BIOMEDICA SOCHIB 65 Upper middle
income
Colombia COLOMBIAN ASSOCIATION OF BIOENGINEERING … … Upper middle
AND MEDICAL ELECTRONICS income
Costa Rica ASOCIACION COSTARRICENSE DE ACOBEM … Upper middle
BIOINGENIERIA Y ELECTROMEDICINA income
Cuba SOCIEDAD CUBANA DE BIOINGENIERIA SOCBIO … Upper middle
income

WHO Medical device technical series 209


Reported
number of
Country Name of society Acronym members Income grouping
Mexico COLEGIO DE INGENIEROS BIOMEDICOS CIB 105 Upper middle
income
Mexico SOCIEDAD MEXICANA DE INGENIERÍA SOMIB … Upper middle
BIOMÉDICA income
Peru ASOCIACION PERUANA DE BIOINGENERIA APBIO … Upper middle
income
United Republic ASSOCIATION OF MEDICAL ENGINEERS AND AMETT … Low income
of Tanzania TECHNICIANS TANZANIA
United States of AMERICAN INSTITUTE FOR MEDICAL & AIMBE … High income
America BIOLOGICAL ENGINEERING
Venezuela BIOENGINEERING VENEZUELAN SOCIETY SOVEB … Upper middle
(Bolivarian income
Republic of)
South-East Asia Region
India BIOMEDICAL ENGINEERING SOCIETY OF INDIA BMESI … Lower middle
income
Western Pacific Region
Australia AUSTRALIAN FEDERATION FOR MEDICAL & SMBE … High income
BIOLOGICAL ENGINEERING
Australia COLLEGE OF BIOMEDICAL ENGINEERS, … … High income
ENGINEERS AUSTRALIA
China CHINESE SOCIETY FOR BIOMEDICAL CSBME … Upper middle
ENGINEERING income
China MACAU SOCIETY OF BIOMEDICAL ENGINEERING … … Upper middle
income
China HONG KONG INSTITUTION OF ENGINEERS HKIE … Upper middle
income
China TAIWANESE SOCIETY OF BIOMEDICAL BMES 660 Upper middle
ENGINEERING income
Japan JAPAN SOCIETY OF MEDICAL & BIOLOGICAL JSMBE … High income
ENGINEERING
Japan JAPAN ASSOCIATION FOR CLINICAL ENGINEERS JACE 15719 High income
Malaysia MALAYSIAN SOCIETY OF MEDICAL AND MSMBE … Upper middle
BIOLOGICAL ENGINEERING income
Malaysia MALAYSIA MEDICAL DEVICE ASSOCIATION MMDA … Upper middle
income
Malaysia ASSOCIATION OF MALAYSIAN MEDICAL AMMI … Upper middle
INDUSTRIES income
Malaysia BIOMEDICAL ENGINEERING ASSOCIATION BEAM … Upper middle
MALAYSIA income
Malaysia ASSOCIATION OF PRIVATE HOSPITALS OF APHM … Upper middle
MALAYSIA income
Malaysia FEDERATION OF MALAYSIA MANUFACTURERS FMM … Upper middle
income
Mongolia MONGOLIAN SOCIETY OF BIOMEDICAL … … Lower middle
ENGINEERING income
Republic of Korea KOREAN SOCIETY OF MEDICAL & BIOLOGICAL KOSOMBE … High income
ENGINEERING

210 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
Reported
number of
Country Name of society Acronym members Income grouping
Singapore BIOMEDICAL ENGINEERING SOCIETY BES … High income
(SINGAPORE)
International societies (includes national societies with international membership)
International AMERICAN COLLEGE OF CLINICAL ACCE 300 N/A
ENGINEERING
International COMMISSION FOR THE ADVANCEMENT OF CAHTMA 28 N/A
HEALTHCARE TECHNOLOGY MANAGEMENT IN
ASIA
International EUROPEAN ALLIANCE FOR MEDICAL AND EAMBES 8000 N/A
BIOLOGICAL ENGINEERING & SCIENCE
International EUROPEAN SOCIETY FOR ENGINEERING AND ESEM … N/A
MEDICINE
International IEEE ENGINEERING IN MEDICINE AND BIOLOGY EMBS 10000 N/A
SOCIETY
International INTERNATIONAL COUNCIL ON MEDICAL AND ICMCC … N/A
CARE COMPUNETICS
International INTERNATIONAL FEDERATION FOR MEDICAL IFMBE 27538 N/A
AND BIOLOGICAL ENGINEERING
International INTERNATIONAL UNION FOR PHYSICAL AND IUPESM 40000 N/A
ENGINEERING SCIENCES IN MEDICINE
International ASSOCIATION FOR THE ADVANCEMENT OF AAMI 7000 N/A
MEDICAL INSTRUMENTATION
International AUSTRALASIAN COLLEGE OF PHYSICAL ACPSEM 649 N/A
SCIENTISTS AND ENGINEERS IN MEDICINE
International ASSOCIATION FRANCOPHONE DES AFPTS-RD 20 N/A
PROFESSIONNELS DE TECHNOLOGIES DE CONGO
SANTE©

WHO Medical device technical series 211


Annex 4 Survey respondents

Organization Contact
Auckland Clinical Practice Committee (Auckland CPC) Stephen Munn
Adelaide HTA Tracy Merlin
Singapore Ministry of Health Pwee Keng Ho
NECA, Republic of Korea Jeonghoon Ahn
CENETEC, Centro Nacional de Excelencia Tecnológica Rosa Maria Ceballos
en Salud, Mexico
Toronto, Canada (Centre for Global eHealth Innovation, Tony Easty
Toronto General Hospital)
Osteba, Osasun Teknologien Ebaluazioaren Zerbitzua/ Iñaki Gutiérrez-Ibarluzea
Basque Office for HTA
GÖG – Gesunheit Österreich GmbH, Austria Ingrid Rosian-Schikuta
CEDIT, Comité d´Evaluation et de Diffusion des Alexandre Barna
Innovations Technologiques, France
IETS – Instituto de Evaluación Tecnológica en Salud, Aurelio Mejía
Colombia
University Hospital Centre Zagreb, Department of Mario Medvedec
Nuclear Medicine and Radiation Protection, Croatia
CGATS Departamento de Ciência e Tecnologia, Brazil Eduardo Coura Assis (translated from Portuguese)
ASERNIP-S – Australian Safety and Efficacy Register of Alun Cameron, Senior Research Officer
New Interventional Procedures – Surgical
CENGETS, Pontifical Catholic University of Peru Luis Vilcahuaman
CENGETS, Healthcare Technopole, Peru Rossana Rivas
Neuquén, Argentina Santiago Hasdeu
Biomedical Technology Unit, BITU, Greece Nicolas Pallikarakis
PathCare Laboratories, Nigeria Gbemileke Ogunlana
VASPT, State Health Care Accreditation Agency under Irena Zujiene
the Ministry of Health of the Republic of Lithuania
AdHopHTA, Spain Laura Sampietro-Colon
Agency for Healthcare Research and Quality AHRQ, Elisabeth U Kato
United States of America
University of Warwick Leandro Pecchia
AETSA, Andalusia, Spain Eduardo Briones
CADTH, Canada Michelle Mujoomdar

212 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
Annex 5 Global Strategy on Human
Resources for Health: Workforce 2030 –
summary

Vision
Accelerate progress towards universal health coverage and the UN Sustainable
Development Goals by ensuring equitable access to health workers within strengthened
health systems.

Overall goal
To improve health, social and economic development outcomes by ensuring universal
availability, accessibility, acceptability, coverage and quality of the health workforce
through adequate investments to strengthen health systems, and the implementation
of effective policies at national, a regional and global levels.

Principles
• Promote the right to the enjoyment of the highest attainable standard of health.
• Provide integrated, people-centred health services devoid of stigma and
discrimination.
• Foster empowered and engaged communities.
• Uphold the personal, employment and professional rights of all health workers,
including safe and decent working environments and freedom from all kinds of
discrimination, coercion and violence.
• Eliminate gender-based violence, discrimination and harassment.
• Promote international collaboration and solidarity in alignment with national
priorities.
• Ensure ethical recruitment practices in conformity with the provisions of the WHO
Global Code of Practice on the International Recruitment of Health Personnel.
• Mobilize and sustain political and financial commitment and foster inclusiveness
and collaboration across sectors and constituencies.
• Promote innovation and the use of evidence.

Objectives
1. To optimize performance, quality and impact of the health workforce through
evidence informed policies on human resources for health, contributing to healthy
lives and well-being, effective universal health coverage, resilience and strengthened
health systems at all levels.
2. To align investment in human resources for health with the current and future
needs of the population and of health systems, taking account of labour market
dynamics and education policies; to address shortages and improve distribution
of health workers, so as to enable maximum improvements in health outcomes,
social welfare, employment creation and economic growth.
3. To build the capacity of institutions at sub-national, national, regional and global
levels for effective public policy stewardship, leadership and governance of actions
on human resources for health.

WHO Medical device technical series 213


4. To strengthen data on human resources for health, for monitoring and ensuring
accountability for the implementation of national and regional strategies, and the
Global Strategy.

Global milestones (by 2020)


• All countries have inclusive institutional mechanisms in place to coordinate an
intersectoral health workforce agenda.
• All countries have a human resources for health unit with responsibility for
development and monitoring of policies and plans.
• All countries have regulatory mechanisms to promote patient safety and adequate
oversight of the private sector.
• All countries have established accreditation mechanisms for health training
institutions.
• All countries are making progress on health workforce registries to track health
workforce stock, education, distribution, flows, demand, capacity and remuneration.
• All countries are making progress on sharing data on human resources for health
through national health workforce accounts and submit core indicators to the WHO
Secretariat annually.
• All bilateral and multilateral agencies are strengthening health workforce assessment
and information exchange.

Global milestones (by 2030)


• All countries are making progress towards halving inequalities in access to a health
worker.
• All countries are making progress towards improving the course completion rates
in medical, nursing and allied health professionals training institutions.
• All countries are making progress towards halving their dependency on foreign-
trained health professionals, implementing the WHO Global Code of Practice.
• All bilateral and multilateral agencies are increasing synergies in official development
assistance for education, employment, gender and health, in support of national
health employment and economic growth priorities.
• As partners in the UN Sustainable Development Goals, to reduce barriers in access
to health services by working to create, fill and sustain at least 10 million additional
full-time jobs in health- and social care sectors to address the needs of underserved
populations.
• As partners in the United Nations Sustainable Development Goals, to make progress
on Goal 3c to increase health financing and the recruitment, development, training
and retention of the health workforce.

Core WHO secretariat activities in support of implementation of the Global


Strategy on Human Resources for Health: Workforce 2030
Develop normative guidance; set the agenda for operations research to identify evidence-
based policy options; facilitate the sharing of best practices; and provide technical
cooperation on – health workforce education, optimizing the scope of practice of different
cadres, evidence-based deployment and retention strategies, gender mainstreaming,
availability, accessibility, acceptability, coverage, quality control and performance
enhancement approaches, including the strengthening of public regulation.

214 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
Provide normative guidance and technical cooperation, and facilitate the sharing of best
practices on health workforce planning and projections, health system needs, education
policies, health labour market analyses, and costing of national strategies on human
resources for health. Strengthen evidence on, and the adoption of, macroeconomic
and funding policies conducive to greater and more strategically targeted investments
in human resources for health.

Provide technical cooperation and capacity building to develop core competency in


policy, planning and management of human resources for health focused on health
system needs. Foster effective coordination, alignment and accountability of the
global agenda on human resources for health by facilitating a network of international
stakeholders. Systematically assess the health workforce implications resulting from
technical or policy recommendations presented at the World Health Assembly and
regional committees. Provide technical cooperation to develop health system capacities
and workforce competency, including to manage the risks of emergencies and disasters.

Review the utility of, and support the development, strengthening and update of tools,
guidelines and databases relating to data and evidence on human resources for health
for routine and emergency settings. Facilitate yearly reporting by countries to the WHO
Secretariat on a minimum set of core indicators of human resources for health, for
monitoring and accountability for the Global Strategy. Support countries to establish and
strengthen a standard for the quality and completeness of national health workforce
data. Streamline and integrate all requirements for reporting on human resources for
health by WHO Member States. Adapt, integrate and link the monitoring of targets in
the Global Strategy to the emerging accountability framework of the UN Sustainable
Development Goals. Develop mechanisms to enable collection of data to prepare and
submit a report on the protection of health workers, which compiles and analyses the
experiences of Member States and presents recommendations for action to be taken
by relevant stakeholders, including appropriate preventive measures.

For further information, see: http://apps.who.int/iris/bitstream/10665/250368/1/9789


241511131-eng.pdf?ua=1

WHO Medical device technical series 215


Annex 6 UN High-Level Commission on
Health Employment and Economic Growth

10 recommendations to strengthen health and social protection systems


and to meet the targets of the SDGs

1. JOB CREATION
Stimulate investments in creating decent health sector jobs, particularly for women and
youth, with the right skills, in the right numbers and in the right places.

2. GENDER AND WOMEN'S RIGHTS


Maximize women’s economic participation and foster their empowerment through
institutionalizing their leadership, addressing gender biases and inequities in education
and the health labour market, and tackling gender concerns in health reform processes.

3. EDUCATION, TRAINING AND SKILLS


Scale up transformative, high-quality education and lifelong learning so that all health
workers have skills that match the health needs of populations and can work to their
full potential.

4. HEALTH SERVICE DELIVERY AND ORGANIZATION


Reform service models concentrated on hospital care and focus instead on prevention
and on the efficient provision of high-quality, affordable, integrated, community-based,
people-centred primary and ambulatory care, paying special attention to underserved
areas.

5. TECHNOLOGY
Harness the power of cost-effective information and communication technologies to
enhance health education, people-centred health services and health information
system

6. CRISES AND HUMANITARIAN SETTINGS


Ensure investment in the International Health Regulations core capacities, including
skills development of national and international health workers in humanitarian settings
and public health emergencies, both acute and protracted. Ensure the protection and
security of all health workers and health facilities in all settings.

7. FINANCING AND FISCAL SPACE


Raise adequate funding from domestic and international sources, public and private
where appropriate, and consider broad-based health financing reform where needed,
to invest in the right skills, decent working conditions and an appropriate number of
health workers.

216 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
8. PARTNERSHIP AND COOPERATION
Promote intersectoral collaboration at national, regional and international levels; engage
civil society, unions and other health workers’ organizations and the private sector; and
align international cooperation to support investments in the health workforce, as part
of national health and education strategies and plans.

9. INTERNATIONAL MIGRATION
Advance international recognition of health workers’ qualifications to optimize skills use,
increase the benefits from and reduce the negative effects of health worker migration,
and safeguard migrants’ rights.

10. DATA, INFORMATION AND ACCOUNTABILITY


Undertake robust research and analysis of health labour markets, using harmonized
metrics and methodologies, to strengthen evidence, accountability and action.

WHO Medical device technical series 217


Annex 7 Current and proposed profiles
for biomedical engineers and biomedical
engineering technicians (206)
Current profile for biomedical engineers Proposed profile for biomedical engineers
ISCO 08 Code ISCO 08 Code
Unit group 2149 Unit group NEW NUMBER
Engineering professionals not elsewhere classified Biomedical engineers

This unit group covers engineering professionals not This unit group covers engineering professionals that
classified elsewhere in Minor group 214, Engineering apply knowledge of engineering and medical field to
Professionals (excluding electrotechnology) and 215: health-care systems to optimize and promote safer,
Electrotechnology engineers. higher quality, effective, affordable, accessible,
appropriate, available, and socially acceptable health
For instance, the group includes those who conduct technology to populations.
research, advise on or develop engineering procedures
and solutions concerning workplace safety, biomedical In such cases tasks would include:
engineering; optics; materials; nuclear power a) Conducting research, advise or development
generation and explosives. of medical devices for prevention, diagnosis,
treatment, rehabilitation and palliative care across
In such cases tasks would include: all levels of the health-care delivery;
a) applying knowledge of engineering to the design, b) Innovating, designing, developing, regulating,
development, and evaluation of biological and managing, assessing, installing, and maintaining
health systems and products, such as artificial such medical devices or health technologies.
organs, prostheses, and instrumentation;
c) Applying engineering principles and design
b) designing devices used in various medical concepts to medicine and biology for the pursuit of
procedures, imaging systems such as magnetic new knowledge and understanding at all biological
resonance imaging (MRI), and devices for scales;
automating insulin injections or controlling body
d) Designing medical devices, software, processes
functions;
and techniques to be used in health care, including
c designing components of optical instruments such consumables, artificial organs, diagnostic and
as lenses, microscopes, telescopes, lasers, optical therapeutic instrumentation and related systems
disc systems and other equipment that utilize the such as magnetic resonance imaging, and devices
properties of light; for automating insulin injections or controlling
d) designing, testing, and coordinating the body functions;
development of explosive ordnance material to e) Designing, developing, evaluating and managing
meet military procurement specifications; technologies used to promote and support life
e) designing and overseeing construction and quality and longevity, including assistive products
operation of nuclear reactors and power plants and technologies for monitoring or rehabilitating
and nuclear fuels reprocessing and reclamation activities of daily living; such as wheelchairs,
systems; prosthesis leg, hearing aid and personal
f) designing and developing nuclear equipment emergency response systems;
such as reactor cores, radiation shielding, f) Designing, developing and managing medical
and associated instrumentation and control technologies for focus disease areas such as
mechanisms; reproductive, maternal, neonatal and child health;
g) assessing damage and providing calculations for infectious and noncommunicable diseases;
marine salvage operations; g) Designing, developing and managing systems
h) studying and advising on engineering aspects for optimal sustained healthcare operations in
of particular manufacturing processes, such as both resource-scarce and well-resourced settings
those related to glass, ceramics, textiles, leather as well as during challenging events such as
products, wood, and printing; disasters and emergencies;
i) identifying potential hazards and introducing h) Designing, developing and applying safety
safety procedures and devices. programme methodologies to mitigate risks when
dealing with medical devices throughout their life
cycle. Including biosafety, patient and health-care
Included occupations worker safety and personal protection;
Examples of the occupations classified here:
- Biomedical engineer
- Explosive ordnance engineer

218 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
- Marine salvage engineer i) Supporting and training health-care workers on the
- Materials engineer appropriate and safe use of medical technologies;
- Optical engineer j) supporting the design of health-care facilities.
- Safety engineer
Examples of the occupations classified here:
Excluded occupations - Biomedical engineer
- Electro medical engineer
Some related occupations classified elsewhere: - Clinical engineer
- Industrial and production engineer - 2141
- Medical engineer
- Environmental engineer - 2143
- Surveyor - 2165 Excluded occupations

Note: it should be noted that, while they are Some related occupations classified elsewhere:
appropriately classified in this unit group with other - Industrial and production engineer - 2141
engineering professionals, biomedical engineers - Environmental engineer - 2143
are considered to be an integral part of the health
- Surveyor - 2165
workforce alongside those occupations classified in
Sub-major Group 22: Health Professionals, and others
classified in a number of other unit groups in Major Note: it should be noted that, while they are
Group 2: professionals. appropriately classified in this unit group with other
engineering professionals, biomedical engineers
are considered to be an integral part of the health
workforce alongside those occupations classified in
Sub-major Group 22: Health Professionals, and others
classified in a number of other unit groups in Major
Group 2: professionals.
Current profile for ILO for biomedical engineering Proposed profile for ILO for biomedical
technician engineering technician
Unit Group 3119. Unit Group 311X
Biomedical engineering technicians
Physical and engineering science technicians not
elsewhere classified (considering information from Biomedical engineering science technicians
Unit Group 3111 to 3119). perform technical tasks to aid in research, design,
manufacture, assembly, operation, maintenance and
repair of medical equipment, and in the development
of medical applications of research results;

Organizing maintenance and performing repairs of


medical equipment;

Assisting engineers in testing, designing and


maintaining medical equipment;

Preparing and revising technical manuals dealing


with assembly, installation, operation, maintenance
and repair of medical equipment that has electronic,
optical or mechanical components;

Assisting biomedical engineers and monitoring


technical aspects of manufacturing, use, maintenance
and repair or mechanical, optical or electronic
equipment used for patient care;

Assisting health-care workers in the appropriate use of


medical technologies.

WHO Medical device technical series 219


Annex 8 Declaration of interests
All collaborators provided conflict of interest statements, which were reviewed in
accordance with WHO requirements. The declared interests are listed in the table below.

Name Institution Email Conflict of interests


Saleh Al Tayyar King Saud University, Saudi stayyar@ksu.edu.sa None
Arabia
Roberto Ayala CENETEC; Ministry of Health, rap6701@gmail.com None
Mexico
Reiner Banken University of Ottawa, Canada reinerbanken@gmail.com None
Stefano Bergamasco Italian Association of Clinical stbergamasco@gmail.com None
Engineers, Italy
Saide Calil Retired, Brazil calil.saide@gmail.com None
Anthony Chan British Columbia Institute of anthony_chan@bcit.ca None
Technology, Canada
Tobey Clark University of Vermont, United tobey.clark@its.uvm.edu None
States of America
Yadin David Biomedical Engineering david@biomedeng.com None
Consultants, LLC, United
States of America
Valerio Di Virgilio United Nations Office for Valeriod@unops.org None
Project Services
Karin Diaconu Institute for Global Health kdiaconu@qmu.ac.uk None
and Development Queen
Margaret University,
Edinburgh, United Kingdom
Michael Flood Locus Consulting Pty Ltd, mike@locusconsulting.net.au None
Australia
Corrado Gemma Fondazione IRCCS Policlinico c.gemma@smatteo.pv.it None
San Matteo, Italy
Michael Gropp None mxbgropp7@gmail.com Previously employed
by Medtronic, Inc, until
2013. Invited speaker
advisor and trainer to
AHWP, RAPS, Saudi FDA,
AAMI, Stanford and Duke
universities and WHO
Erin Holmes National Health Committee, erin.holmes@gmail.com None
Ministry of Health, New
Zealand
Fred Hosea Yachay Tech University, fhosea@yachaytech.edu.ec None
Ecuador
Tom Judd IFMBE CED judd.tom@gmail.com None
Einstein Albert Kesi Maker & Finisher, India mecei@yahoo.com None
Niranjan Khambete Deenanath Mangeshkar niranjan.d.khambete@gmail.com None
Hospital, Pune, India
Zheng Kun Children's Hospital of zhengkun@zju.edu.cn None
Zhejiang University School of
Medicine, China

Paul LaBarre UNICEF Supply Division, plabarre@unicef.org Received research grants


Denmark from Case Western,
JPIEGO, BMGF and NIH,
all which ceased in 2016.

220 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
Name Institution Email Conflict of interests
Paolo Lago Fondazione IRCC Policlinico p.lago@smatteo.pv.it None
San Matteo, Italy
Kang Ping Lin Chung Yuan Christian kplin@cycu.edu.tw None
University
Ratko Magjarevic FMBE and University of ratko.magjarevic@fer.hr As officer of IFMBE
Zagreb and IUPESM partially
supporting travel to
conferences.
Mario Medvedec University Hospital Centre mmedvede@kbc-zagreb.hr None
Zagreb
Debjani Mueller Charlotte Maxeke Medical dbmueller7@yahoo.de None
Research Cluster
Shauna Mullally UNICEF/Government of the shaunamullally@gmail.com Consultant to THET,
Northwestern Territories, NGO in Zambia during
Canada 2011–2013
Valentino Mvanga Ministry of Health, United vmvanga@yahoo.com None
Republic of Tanzania
Kenneth I Nkuma- Association of Biomedical drkinkumaudah@gmail.com None
Udah Engineers and Technologists
of Nigeria
Ebrima Nyassi Medical Research Council enyassi@mrc.gm None
Unit, the Gambia
Nicolas Pallikarakis University of Patras, Greece nipa@upatras.gr None
Leandro Pecchia University of Warwick, United l.pecchia@warwick.ac.uk None
Kingdom
Ledina Picari Ministry of Health of Albania ledinapicari@yahoo.com None
Mladen Poluta Western Cape Government mladen.poluta@uct.ac.za Consultant to University
Department of Health, South of Cape Town, to WHO
Africa and to Northwestern
University
Daniela Rodriguez- Swiss Tropical and Public daniela.rodriguez@unibas.ch None
Rodriguez Health Institute
Amir Sabet University of Michigan, asabet@umich.edu None
Sarvestani United States of America
Mario Secca IFMBE marioforjazsecca@mac.com None
Elliot Sloane Center for Healthcare ebsloane@gmail.com None
Information Research and
Policy
Megan Smith University of Guelph, Canada msmith32@mail.uoguelph.ca None
Consuelo Varela Centro para el Control consuelo.varela@infomed.sld.cu None
Corona Estatal de Medicamentos,
Cuba
Herb Voigt Boston University, United hfv@bu.edu Served as President of
States of America IUPESM with invited
participation conferences
in various countries
James O Wear None, United States of james.wear@gmail.com None
America
Anna Worm THET, Benin anna@worm.nl None
Martha Zequera Pontificia Universidad mzequera@javeriana.edu.co None
Javeriana, Colombia

WHO Medical device technical series 221


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234 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
Department of Essential Medicines and Health Products
Innovation, Access and Use unit
World Health Organization
20 Avenue Appia ISBN 978 924 156 547 9
CH-1211 Geneva 27, Switzerland
Tel: +41 22 791 1239
E-mail: medicaldevices@who.int
http://www.who.int/medical_devices/en/

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