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February 2011
Cables,
Connectors and
Wires Update
page 40
Enabling
Automation
pages 32 and 38
New Frontiers in
Neuromodulation
page 22
Advances in Silicone
Surface Treatments
page 15
Accelerating Ultrasound
Development
page 42
1 EMDT1102 1 1/28/11 8:07:10 AM
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emdt.co.uk European Medical Device Technology February 2011 | 3
CONTENTS
February 2011
Volume 2 Number 2
FEATURES
MATERIALS
15 Advances in Silicone
Surface Treatments
Dispersions that form
a covalent bond with
an elastomer silicone
substrate can prevent
uncontrolled material
migration.
M. Lindberg
MANUFACTURING
18 Ultrasonic Welding from
Pilot to Production
If your proposed
production process will
involve ultrasonic welding
technology, its advisable
to adopt a collaborative
approach with an expert
in the field early in the
design stage.
M. Frost and G. Forward
32 The Rise of the Robots
Automation can help
medtech manufacturers
remain competitive in a
global economy whilst
ensuring consistent
compliance with rigorous
quality standards.
M. Wilson and D. Bradford
DESIGN
22 Advanced Ceramics Help
Open New Frontiers in
Neuromodulation
By enabling the design of
devices that communicate
via ultrasound, advanced
ceramic materials are
contributing to advances
in the development
of implantable pulse
generators.
J. Anatalek and P. Manison
26 The First Million Bucks
Medical device
companies spend around
1 million euros at the
front end of every device
development project.
Some spend it better than
others.
D. Edwards
30 Understanding
Superconductivity
Research in
high-temperature
superconductivity may
lead to more-affordable
MRI scanners.
P. Steffens
COLUMNS
REGULATIONS
AND STANDARDS
12 The Notified Body
Consultation
Procedure: Part 2
This article covers aspects
of the notified body
consultaion process itself,
required documentation
and fees.
M.E. Donawa
FIVE MINUTE
INTERVIEW
46 Rosanna Tarricone,
European Health Technology
Institute for Socio-
Economic Research
Tarricone stresses the
importance of quality in
technological innovation
as well as in life.
REGULARS
6 Online Contents
7 A Note from the Editor
8 NewsTrendsAnalysis
10 Breakthroughs
45 Advertiser Index
38 Engineering Insight:
Motion Control in
Automation
40 Spotlight: Cables,
Connectors and Wires
42 First Look
43 In Focus:
Contract Services
44 In Focus: Moulding
MARKETPLACE
SPECIAL
SECTION
BIOMEDEVICE EUROPE
SHOW PREVIEW
34 Introduction
35 Product Preview
22
Cover materials courtesy of Fischer
Connectors, Saint-Prex, Switzerland.
Cover Photography:
Stephen Hughes Photography
e-mail: sh.photography@btconnect.com
40
3 EMDT1102 3 1/28/11 8:08:45 AM
4 | February 2011 European Medical Device Technology emdt.co.uk
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4 EMDT1102 4 1/28/11 8:10:01 AM
EDITORIAL ADVISORY BOARD
The Editorial Advisory Board of European Medical Device Technology is a distinguished group of specialists
representing various facets of medical device and diagnostics design and manufacturing. Members of the
board review manuscripts, suggest subject matter pertinent to the profession and answer questions when
they arise.
K. Al-Lamee
Managing Director, Aterius Ltd; and
Director, KAL Biomaterials Consulting,
Leeds, UK
S. Dunkerton
Director, HealthTech and Medicines
Knowledge Transfer Network; and
Business Manager, Processes, TWI Ltd,
Great Abington, Cambridge, UK
P. Galavotti
Consultant, Nexion srl,
Mirandola (Modena), Italy
R. Gray
VP Quality and Regulatory,
Donawa Lifescience Consulting,
Rome, Italy
O. Grndahl Hansen
General Manager, PVC Information
Council,
Copenhagen, Denmark
R. Hall
Medical Packaging Consultant,
Shannon, Co. Clare, Ireland
D. Hill
Design Manager, Rocket Medical plc,
Washington, Tyne-and-Wear, UK
D. Hodgins
Managing Director, European Technology
for Business Ltd,
Codicote, UK
C.J. Kirkpatrick
Director, Institute of Pathology,
Johannes Gutenberg University,
Mainz, Germany
U. Kleinkes
Managing Director, IVAM,
Microtechnology Network,
Dortmund, Germany
M.B. Leahey
Executive Director, Medical Device
Manufacturers Association,
Washington, District of Columbia, USA
S. Loznen
Chief Engineer, Electronics and
Telematics Laboratory, Standards
Institution of Israel,
Tel Aviv, Israel
C. Mason
Regenerative Medicine Processing
Unit, Advanced Centre for Biochemical
Engineering, University College,
London, UK
C. Mathews
Director, Team Consulting Ltd,
Ickleton, Cambridge, UK
R. Moore
Manager, Nanomedicine and
Life Sciences, The Institute of
Nanotechnology,
Stirling, UK
W.A. Morton
President, Medical Device Consultants
Inc.,
Attleboro, Massachusetts, USA
A. Schneider
Group Manager, Biomedical Competence
Centres, Fraunhofer IBMT Institute for
Biomedical Engineering,
Sulzbach, Germany
Sulzbach, Germany
S. Sorrel
President, MedPass International,
Paris, France
M. Tavakoli
Consultant and Technology Manager; and
Programme Manager HealthTech and
Medicines Knowledge Transfer Network,
TWI Ltd,
Great Abington, Cambridge, UK
J. Vienken
Vice President Biosciences, Dept.
International Marketing and Medicine,
Fresenius Medical Care,
Bad Homburg, Germany
D.F. Williams
Emeritus Professor, University of
Liverpool, UK, and Partner, Morgan &
Masterson,
Brussels, Belgium
L. Woo
Distinguished Scientist Emeritus, Baxter
Healthcare Corp., and Founder, LWoo
Associates LLC,
Libertyville, Illinois, USA
J.A. Woolston
Director, Astwood Projects,
Redditch, UK
Meeting place for medical technologies
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5 EMDT1102 5 1/28/11 8:11:46 AM
ONLINE CONTENTS
CURRENTLY ON
VIEW AT
emdt.co.uk
New Generation of
Hexapods Deliver
Submicron Resolution
The latest generation of
parallel kinematic positioning
systems known as hexapods
offer an array of advantages
for robotic positional devices
that require precision on the
micron and nanometre level.
Features of the hexapods
include enhanced stability and
reliability, increased flexibility
and improved dynamic
behaviour compared with
older positioning systems.
In addition, they enable the use of high-resolution servo-driven
motors and piezoelectric actuators, freely definable virtual pivot
points and simplified HMI and simulation. The positioning systems
are expected to streamline applications in manufacturing, testing,
bioresearch and medical environments.
Read more about the technology at www.emdt.co.uk/article/
hexapods.
Simplifying IEC 62304 Compliance for Developers
Medical devices have become increasingly sophisticated, often
employing software-controlled applications whose failure to
function correctly could result in death or serious injury to the
patient treated by them. Many of the medical device faults stem
from product upgrades.
An analysis of 3140
medical device recalls
conducted between 1992
and 1998 by US FDA
reveals that 242 of them
are attributable to soft-
ware failures. Of those,
79% were caused by software defects introduced after upgrades.
Many companies are now changing their approach to improve
software processes and are adopting IEC 62304, a standard for
the design of medical products recently endorsed by the European
Union and the United States.
You can learn more about how to achieve compliance by going to
www.emdt.co.uk/article/iec-62304-compliance.
Scan Me By scanning
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6 EMDT1102 6 1/28/11 8:13:53 AM
A NOTE FROM THE EDITOR
Norbert Sparrow
norbert.sparrow@ubm.com
NOW THAT WE HAVE LANDED squarely
in 2011, I thought it might be an opportune
moment to put together a to-do list for
Europes medtech community. Here goes.
Learn Mandarin. Not content with being
the worlds factory, China is ramping up
innovation initiatives. The Medical Technol-
ogy Innovation Scorecard published by PwC
earlier this year forecasts a steady decline in medtech innovation in
developed economies. Meanwhile, China forges ahead. According
to PwC analysts, China will reach near parity with the developed
nations of Europe by 2020. Thats right in less than 10 years!
Moreover, in addition to benefiting from a 15 billion healthcare
stimulus, Chinese medtech companies are venturing abroad in
record numbers. According to a survey of medtech professionals
conducted by the Emergo Group, 83.8% of Asian firms [surveyed]
intend to enter international markets for the first time [in 2011].
Repeat after me: ren shi ni hen gao xing.
Get smarter. Until now, healthcare apps for smartphones have
tended to target fitness fanatics and users seeking to monitor
general health conditions. According to Berlin-based research2guid-
ance, the mobile health apps market is about to undergo a sea
change, as traditional healthcare industry players develop apps for
the chronically ill. Consider the technologys ever-evolving sophis-
tication connecting with a target market of more than 2 billion
patients suffering from a chronic diseasecan you hear me now?
Remember: a hospice is not a home. In about 20 years, one out
of every three people in Europe will be older than 65, and not one
of them will want to spend any part of his or her golden years in an
assisted-living facility. Companies that develop cost-effective tech-
nologies to foster ambient assisted living arrangements will prosper.
Practice frugal engineering. Back in August, I wrote that frugal
engineering will save the world on our medtechinsider blog. The
impetus for that messianic moment was an article titled, The
Importance of Frugal Engineering (www.medtechinsider.com/
archives/16876). The basic idea is that emerging markets dont
need stripped-down versions of wasteful first-world products
frugal engineering seeks to avoid needless costs in the first place.
GE Healthcare is the medtech poster child for this movement. The
company developed a low-cost handheld ultrasound scanner by
incorporating frugal engineering lessons learned in its Indian medi-
cal research and development lab.
Dont follow leaders . . . watch your parking meters. The final
to-do item, courtesy the bard of Minnesota, has nothing to do with
medical technologyat least not in any linear kind of waybut it
is darn good advice that I like to share at every opportunity.
I Was Just Thinking
7 EMDT1102 7 2/2/11 1:30:34 PM
NEWSTRENDSANALYSIS
An international consortium led by
researchers at the Universit Bocconi
(Milan; www.unibocconi.eu) has received a
US$240,000 grant from the US-based Insti-
tute for Health Technology Studies (InHealth;
Washington, DC; www.inhealth.org) to
assess the effects of hip replacement therapy
(HRT) on the employment and retirement
decisions of older adults. This is the first time
that InHealth, a nonprofit organisation sup-
porting research on the social and economic
effects of medical technology, has awarded a
grant to an academic institution outside the
United States.
Ruben Mujica-Mota, PhD, a senior
research fellow at the Centre for Research
in Healthcare Management at the Univer-
sit Bocconi, is the lead investigator for the
study. (The University of York in the United
Kingdom and Johns Hopkins University
School of Public Health in Baltimore, MD,
USA, are also part of the consortium.)
University researchers in partnership with
the European Health Technology Institute for
Socio-Economic Research (Brussels, www.
together4healthinnovation.eu), which formed
the consortium, have been studying the socio-
economic and health effects of orthopaedic
devices, says Mujica-Mota. Resources were
limited, however. The InHealth grant affords
Mujica-Mota and his partners with the
means to broaden the scope of the study. It
provides us with an opportunity to refine our
research [and apply it to] wider economic
opportunities. Even during the grant applica-
tion process, reviewer insights helped us to
fine-tune our ideas, he adds.
Hip replacement has been shown to
improve quality of life by restoring physical
mobility and reducing pain. However, there
is evidence that a substantial number of
patients who might benefit from the proce-
dure do not receive it, according to InHealth.
Currently, between 200,000 and 300,000 hip
replacement procedures are performed in the
United States each year. But in the 2002 US
Health and Retirement Study, nearly 50% of
retired respondents ages 55 to 64 reported
arthritis and other musculoskeletal condi-
tions as the most significant reasons they
could no longer work.
Early retirement triggered by such condi-
tions is a contributing factor to the current
financial crises of Europes pension systems
and of the US Social Security trust fund.
InHealths grant will help assess the impact
of reduced disabilities made possible by hip
replacements on public and private retire-
ment funds.
The 12-month study undertaken by the
consortium can be broken down into two
parts, says Mujica-Mota. We are consult-
ing available literature to determine what
is known about HRT use factors and their
effect on health and employment status, he
explains. The second part will study the use
of HRT in adults 50 and older in the United
States, the United Kingdom and continental
Europe. Data sources for the study will
include the English Longitudinal Study of
Ageing; the Survey of Health, Ageing, and
Retirement in Europe; and the US Health
and Retirement Study.
By comparing patients who received a
hip replacement with those who did not,
researchers will estimate the impact of hip
replacement on national pension and social
security systems, and the potential outcome
of financial incentivessuch as tax breaks
that could encourage working adults to delay
retirement. That, of course, is a hot-button
topic in many countries, and I asked Mujica-
Mota if he had any qualms about how the
mass media might filter this research.
Our study will not be able to shed light
on whether it is optimal or fair from soci-
etys point of view to implement reforms
to social security and pension systems,
says Mujica-Mota. It will, however, seek
to provide an estimate of the economic
benefit that a particular group in society
will derive from access to HRT in the con-
text of pension reforms. It would provide
policy makers with guidance on the extent
to which it would be beneficial for a seg-
ment of the population to couple policy
reform with increased access to healthcare
and the potential benefit to the public
purse, notes Mujica-Mota.
Norbert Sparrow
Consortium Studies Socio-Economic
Impact of Hip Replacement Therapy
Miniaturisation continues to be a driver
in medical technology. And as devices
get smaller, the parts that make up the
devicesand that make them workhave
to shrink accordingly. Enter Freudenberg
engineers, who claim to have developed
and produced the worlds smallest elasto-
mer sealing ring.
The so-called Simmerring can seal shafts
measuring a scant 1 mm in diameter that
achieve rotation speeds up to 10,000 rpm.
The smallest details of this microseal are a
few hundredths
of a millimetre.
Prototypes of the seal have completed
test runs of more than 5000 hours under
operating loads without any visible signs
of wear. The seals will be used inside
miniature devices equipped with com-
plex electronic and mechanical systems.
Pumps in diagnostic systems that require
microseals to function properly are
among the medical applications.
N.S.
Freudenberg Manufactures
Worlds Smallest Seal
8 EMDT1102 8 1/28/11 8:15:41 AM
Medtech Survey Sees Rosy Outlook for 2011
Expansion into new markets, rising sales
figures and salaries and stepped-up hiring
are among the very positive forecasts
of the 2011 Medical Device Industry
Outlook, an annual survey conducted by
international consultancy Emergo Group.
Here are some highlights of the study; the
full results can be downloaded at www.
emergogroup.com/industry-survey.
International sales increased in 2010 for 0
just over half of the companies partici-
pating in the survey. A little more than
50% of North American and European
companies reported growth; 63% of
Asian survey participants reported
increases.
More than three-quarters of all respon- 0
dents expect overall sales to increase
in 2011, with only 2.8% predicting a
decline.
Almost 70% of European companies 0
responding to the survey intend to enter
international markets for the first time
in 2011. While China and Brazil are
popular destinations for companies
large and small from Europe and North
America, it is interesting to note that
European companies jumping into the
international arena for the first time
find the US market just as appealing as
China.
56% of companies expect to end 2011 0
with more employees than at the start of
the year. An interesting sidelight is that
CEOs are more optimistic about adding
staff in 2011 (65.6%) than their employ-
ees (54.8%). Memo to our C suite
readersstart spreading the news!
N.S. P
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9 EMDT1102 9 1/28/11 8:15:46 AM
BREAKTHROUGHS
GO TO MEDTECHINSIDER.COM FOR DAILY UPDATES ON R&D BREAKTHROUGHS, INDUSTRY
NEWS, REGULATORY UPDATES AND MORE
An international team of physicists and
neuroscientists has reported a break-
through in magnetic resonance imaging
that allows brain scans to be performed
more than seven times faster than what
is currently possible. A physicist from the
University of California, Berkeley, and
colleagues from the University of Minne-
sota and Oxford University describe two
improvements that allow complete 3-D
brain scans to be performed in less than
half a second, instead of the typical two
to three seconds.
When we made the first images,
it was unbelievable how fast we were
going, says David Feinberg, a physicist
and adjunct professor at UC Berkeley
and president of Advanced MRI Tech-
nologies. It was like stepping out of a
prop plane into a jet plane. It was that
magnitude of difference.
For neuroscience, in particular, fast
scans are critical for capturing the
dynamic activity in the brain.
When a functional MRI (fMRI) study
of the brain is performed, about 30 to
60 images covering the entire brain are
repeated hundreds of times like the frames
of a movie. But, in the case of fMRI, its
like a 3-D movie, Feinberg says. By
multiplexing image acquisition for higher
speed, a higher frame rate is achieved,
[capturing] more information faster.
medtechinsider.com/archives/20586
A new type of damage-tolerant
metallic glass that demonstrates
a strength and toughness beyond
that of any known material has
been developed and tested by
researchers at the US Department
of Energys Lawrence Berkeley
National Laboratory (Berkeley Lab)
in collaboration with scientists at the
California Institute of Technology.
Whats more, even better versions of
this new glass may be on the way.
These results mark the first use of a
new strategy for metallic glass fabrica-
tion and we believe we can use it to make
glass that will be even stronger and more
tough, says Robert Ritchie, a materials
scientist who led the Berkeley contribution
to the research.
The metallic glass is a palladium-based
microalloy, which has a high bulk-to-
shear stiffness ratio that counteracts the
intrinsic brittleness of glassy materials.
New Glass Tops Steel in Strength and Toughness
Researchers Achieve Dramatic
Increase in MRI Scanning Speed
10 EMDT1102 10 1/28/11 8:16:42 AM
Synthetic Blood
Vessels Developed
in Hydrogels
Researchers from Rice University and
Baylor College of Medicine (BCM) have
broken one of the major roadblocks on
the path to growing transplantable tis-
sue in the lab. Theyve found a way to
grow the blood vessels and capillaries
needed to keep tissues alive.
The inability to grow blood-vessel
networks, or vasculature, in lab-grown
tissues is the leading problem in regen-
erative medicine today, says researcher
Jennifer West, department chair and the
Isabel C. Cameron Professor of Bioen-
gineering at Rice. If you dont have
blood supply, you cannot make a tissue
structure that is thicker than a couple
hundred microns.
A team of researchers led by West
and BCM molecular physiologist
Mary Dickinson chose polyethylene
glycol as a base material for use in the
research project. The nontoxic plastic
is widely used in medical devices and
as a food additive. Building on 10 years
of research in Wests lab, the scientists
modified the polyethylene glycol to
mimic the bodys extracellular matrix
the network of proteins and polysaccha-
rides that make up a substantial portion
of most tissues.
New Alogorithm Accelerates Medical
ImagingBased Diagnostics
An algorithm for processing three-
dimensional images used in many types
of medical diagnosis is available for
licensing. The technology, which was
developed by researchers at the Univer-
sity of Florida to estimate the volume
of tumours, organs and similar objects
imaged by 3-D scans reduces the time
needed to analyse the object of inter-
est. It can be easily integrated with a
graphic user interface and any imaging
tool or picture archiving and communi-
cation system.
The technology uses polar thin plate
splines in lieu of active contour models,
making it anatomy independent. More-
over, it does not require adjustments
when finding surfaces for different
objects.
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11 EMDT1102 11 1/28/11 8:16:50 AM
REGULATIONS AND STANDARDS
Early review of guidance
The medical device directives specify the
requirements for the Notified Body consulta-
tion procedure, but not the actual process for
meeting the requirements. Thus, manufactur-
ers should begin the consultation process by
reviewing the European MEDDEV guidance
on borderline products, drug-delivery prod-
ucts and ancillary substances.
1
Section C of
the guidance describes the Notified Body
actions that should be taken to initiate the
consultation procedure, the documentation
to be provided by the Notified Body to the
Competent Authority for medicinal products,
and the consultation process itself. Particular
attention should be paid to section C.3; it
outlines the documentation required, which
will be unfamiliar to most medical device
manufacturers. This makes early planning a
necessity for preparing documentation that
will be acceptable to drug regulatory authori-
ties and accurately reflects device safety and performance charac-
teristics, so as to avoid costly delays during the review process.
Equally important is the early identification of guidance
documents from national Competent Authorities, which may
potentially be consulted. The UK Medicines and Healthcare
products Regulatory Agency (MHRA) and the Irish Medicines
Board (IMB) are mentioned in this article and also in Part 1 as
examples of Competent Authorities that provide consultation on
ancillary substances and have developed guidance on how they
manage the process. Other Competent Authorities may have
similar guidance available. If the European Medicines Agency
(EMA) is to be consulted, the current
2
and draft EMA guidance
3

on the consultation procedure should be reviewed. The draft
EMA guidance is useful for planning purposes because it con-
tains updated links and references.
Manufacturers of medical devices incorporating ancillary substances should have a clear
understanding of the consultation procedure that their Notified Body will have to follow.
Part 1 of this article discussed the regulatory requirements and important guidance
documents. Part 2 covers aspects of the process itself, required documentation and fees.
Dr Maria E. Donawa
Physician, pathologist and pharmacist with nearly 30 years
regulatory experience, worked with US FDA before becoming
President of what is now Donawa Lifescience Consulting,
a full-service European CRO and an international consultancy company,
which provides regulatory, quality and European Authorised Representative
services to life science companies.
The Notified Body Consultation
Procedure: Part 2
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12 EMDT1102 12 1/28/11 8:23:35 AM
Selecting a Notied Body
The Notified Body is responsible for contacting the Competent
Authority or EMA to initiate the consultation procedure. As stated
in the MEDDEV guidance document, the Notified Body should
ensure that the data supplied by the manufacturer include a
specific segment on the ancillary medicinal substance or the ancil-
lary human blood derivative incorporated in the medical device.
The Notified Body also must verify the usefulness of the ancillary
substance as part of the medical device, taking into account the
intended purpose of the device. This is a critical responsibility and
step in the consultation procedure because the Competent Author-
ity or EMA will need to take this verification into consideration in
reaching an opinion on the quality and safety of the substance.
If a manufacturer is in the early phase of a project involving a
medical device incorporating an ancillary substance, and has not
yet contracted a Notified Body, the potential benefits of selecting
one with experience and established procedures for managing
the consultation procedure should be considered. For a consulta-
tion on an ancillary medicinal substance, the manufacturer can
select any national Competent Authority to provide an opinion
on the substance and should make this selection in close coop-
eration with the Notified Body. A Competent Authority that is
likely to provide the most efficient and cost-effective consultation
and, if possible, which has experience in authorising a medicinal
product that incorporates the same medicinal substance, should
be selected. A Notified Body with experience in working with
several Competent Authorities will be able to provide an opinion
on this critical aspect of the process.

Timelines
The opinion of the national Competent Authority or the EMA
must be provided within 210 days after the receipt of valid docu-
mentation. This requirement is specified in the Medical Devices
Directive (MDD; 93/42/EEC) in Section 4.3, Annex II, and Section
5, Annex III, and in the Active Implantable Medical Devices Direc-
tive (AIMDD; 90/385/EEC) in Section 4.3, Annex 2, and Section 5,
Annex 3.
It is important to note that this timeframe is based upon the
receipt of documentation that the regulatory authority considers
acceptable for providing an opinion; therefore, project time-
lines should consider the possibility that additional time may be
needed during the submission process to satisfy the authority. A
Notified Body with experience in the consultation procedure is
likely to be more accurate in estimating the actual time needed to
complete this process than one without this experience.
Pre-submission activities and meetings
Although there are similarities among regulatory authorities
on pre-submission activities, some differences exist. For this
reason, if the consultation will be provided by a national Com-
petent Authority, any guidance issued by the authority should
13 EMDT1102 13 1/28/11 8:23:42 AM
REGULATIONS AND STANDARDS
be reviewed in advance of the submission to understand what is
expected during the pre-submission period. For example, section
2.1, Pre-submission meetings and notification, of the MHRA
consultation procedure guidance
4
states that in order to facilitate
allocation of the consultation to assessors in the relevant thera-
peutic assessment team, it is helpful to send a pre-submission
notification email to the contacts on the first page of the guid-
ance when a submission date has been identified. The IMB con-
sultation procedure guidance
5
describes pre-submission activities
in section 3.1 of its guidance document, stating that the Notified
Body should request in writing a consultation with the IMB ide-
ally six months before the intended submission.
If consultation is sought from the EMA, manufacturers should
refer to the section on pre-submission activities of the draft EMA
guidance, which includes a link to the EMA web page on Ancillary
medicinal substances. The EMA also requires that the Notified
Body provide an intention to submit letter at least six months
before the expected date of submission. Both current and draft
versions of the EMA guidance state that the letter should include
the date of expected submission and the scientific explanation that
the action of the medicinal substance incorporated in the medical
device is only ancillary to that of the device. Both versions state
that the scientific explanation should be in line with the MEDDEV
guidance; however, the draft guidance refers to the current ver-
sion2.1/3 rev 3, December 2009instead of the obsolete version.
Depending upon the authority involved with the consultation, a
pre-submission meeting may be required or may be optional. For
example, the EMA strongly recommends a pre-submission meet-
ing at least six months before the expected date of submission.
The IMB requires a pre-submission meeting, which should be held
at least two months before the expected date of submission. The
MHRA states that meetings associated with an imminent consul-
tation may be arranged as part of the consultation procedure. It
also states that a scientific advice meeting to discuss the consulta-
tion at an early stage, which is chargeable, may also be arranged.

Data requirements and format
The documentation that should be provided by the Notified Body
to the Competent Authority or EMA is described in the MEDDEV
guidance on ancillary substances; however, important reference
is made to any relevant national guidance where consultation is
provided by a Competent Authority or to EMA guidance where
consultation is provided by that agency.
As stated in the MEDDEV guidance, the information provided
to the Notified Body should be based upon Annex I of Medici-
nal Products Directive (2001/83/EC), as amended by Directive
2003/63/EC. This latter directive contains a revised Annex I of
Directive 2001/83/EC, Analytical, Pharmacotoxicological and
Clinical Standards and Protocols in Respect of the Testing of
Medicinal Products, which is currently in force.
Although the format requested by the various regulatory authori-
ties may differ, the data requirements and information requested is
consistent with that described in the MEDDEV guidance. For exam-
ple, the first section, General information, should include a general
description of the medical device, including the manufacturers claim
regarding the purpose of incorporation of the ancillary medicinal
substance or the ancillary human blood derivative, together with a
critical appraisal of the results of the risk assessment.
The section Quality documentation is divided into two sec-
tions, the first providing information on the ancillary medicinal
substance or the ancillary human blood derivative. This section
should include relevant parts of the Common Technical Docu-
ment (CTD) Module 3, in accordance with the format described
in Volume 2B, Notice to Applicants, Medicinal products for
human use, Presentation and format of the dossier Common
Technical Document (CTD). Guidance is also provided on how
to provide information on the active substance. The section
should also include CTD Module 2.3, Quality Overall Summary
in accordance with Volume B, Notice to Applicants.
The second section describes the information to be provided
on the ancillary substance as incorporated in the medical device.
The remaining sections cover nonclinical documentation, clinical
evaluation and labeling.
Payment processes and fees
Section 4.5, Fees, of the draft EMA guidance includes updated
links to fees charged for the consultation procedure. For example,
the fee charged for an initial request concerning an ancillary sub-
stance that is new to the EMA centralised procedure is 76,000; a
known ancillary blood derivative from a known source, 57,200;
or a known ancillary medicinal substance from a known source,
38,100. Small and medium enterprises can apply for fee reduc-
tions. Readers should refer to the websites of the Competent
Authority of interest to obtain a current list of fees. 1
References
1. Borderline products, drug-delivery products and medical devices
incorporating, as an integral part, an ancillary medicinal substance or
an ancillary human blood derivative (MEDDEV 2.1/3 Rev. 3, December
2009); http://ec.europa.eu/consumers/sectors/medical-devices/documents/
borderline/index_en.htm
2. EMEA recommendation on the procedural aspects and dossier
requirements for the consultation to the EMEA by a Notified Body on
an ancillary medicinal substance or an ancillary human blood derivative
incorporated in a medical device (Doc. Ref. EMEA/CHMP/401993/2005,
24 April 2008); www.ema.europa.eu/docs/en_GB/document_library/
Regulatory_and_procedural_guideline/2009/10/WC500004337.pdf
3. European Medicines Agency recommendation on the procedural aspects
and dossier requirements for the consultation to the European Medicines
Agency by a Notified Body on an ancillary medicinal substance or an
ancillary human blood derivative incorporated in a medical device or
active implantable medical device (Draft, 21 October 2010); www.ema.
europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_
guideline/2010/10/WC500098403.pdf
4. United Kingdom Medicines and Healthcare products Regulatory Agency
guidance on the consultation procedure; www.mhra.gov.uk/howweregulate/
devices/medicaldevicesdirective/drug-deviceconsultations/index.htm
5. Irish Medicines Board guidance on the consultation procedure; www.
imb.ie/en/medical-devices/premarket-activities/drugdevice-combination-
products.aspx
14 EMDT1102 14 1/28/11 8:23:46 AM
MATERIALS
Altered functionality
Advances in silicone technology have
enabled a number of breakthroughs.
Although silicone has been part of the
innovation process in many industries, its
contribution to the healthcare industry
arguably has been especially beneficial.
By means of various surface modi-
fications, silicone can be manipulated
physically and chemically to alter its
functionality. For instance, using a silicone
primer can change the bond and energy
levels of a variety of different substrates
to promote adhesion. Alternatively, many
medical devices depend on minimising
friction at the interface between various
components and between components and
human tissue. In the past, silicone gels or
even self-lubricating elastomers were used
in these situations; however, both of these
applications carry the potential for uncon-
trolled migration of the lubricious compo-
nent. This concern has paved the way for
the newest development in silicone technol-
ogyheat-curable silicone dispersions that
covalently bond to a silicone substrate and
result in a dry yet low-tack finish.
Silicone polymer fundamentals
Understanding the basic structure of a sili-
cone polymer is the first step in developing
new methods of surface modification. First,
there are nonfunctional silicone polymers.
Silicone polymers are chains (backbones)
comprised of repeating Si-O units, termed
siloxane, with organic groups occupying
any of the remaining bonding sites (R)
on the silicon atom not already occupied
by oxygen atoms. (See Figure 1.) Carbon
does not play a part in the backbone of
these polymersthe substituents (R) often
contain a carbon-silicon bondand for
this reason silicone polymers are described
as polyorganosiloxanes.
During the polymerisation process, two
main factors are controlled: the substitu-
ent groups and the degree of polymerisa-
tion. Although many combinations are
possible, the main nonfunctional pendant
groups (R) attached to the polymer back-
bone can be methyl, phenyl or trifluoro-
propyl. Generally, a material is referred to
as a polymer if a molecule contains only
one type of substituent group; a copoly-
mer has a molecule that contains a combi-
nation of substituent groups. Furthermore,
all silicone polymers can be synthesised
to a specific degree of polymerisation.
The degree of polymerisation dictates the
average molecular weight, which, in turn,
governs the viscosity. A silicone polymer
can have a viscosity close to that of water
(20 cP) or it can be so dense as to be a
solid (several million centipoise).
R R R R R R
o o o o o o
R
Si
R
Si
R
Si
R
Si
R
Si
R
Si
FIGURE 1: A silicone polymer backbone.
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Advances in Silicone
Surface Treatments
Silicone coatings promote adhesion or lubricity, but they can cause uncontrolled
material migration in the process. Dispersions that form a covalent bond with an
elastomer silicone substrate can prevent that from happening.
M. Lindberg, NuSil, Sophia Antipolis, France
15 EMDT1102 15 1/28/11 8:24:35 AM
MATERIALS
Adhesion
Historically, the main reason for modify-
ing silicone surfaces has been to improve or
allow adhesion to various substrates. Bond-
ing any type of silicone requires an under-
standing of the mechanisms necessary for
a good bondsurface energy and chemical
reactivity. Surface energy is the thermo-
dynamic effect related to a materials
intramolecular forces, and it is a determin-
ing factor in how an adhesive will spread
across a substrate surface. It is commonly
accepted that the substrates surface energy
must exceed that of the adhesive to achieve
adequate contact.
1
Moreover, the better an
adhesive spreads, the more intimate will be
the contact between molecules, allowing
more reactive groups to interact or bond.
In aggregate, the interactions between
the adhesive and the substrate produce a
stronger bond.
Low-surface-energy materials, such as
some plastics, do not allow silicone adhe-
sives to spread out, which means they are
generally poor candidates for bonding.
However, it is possible to raise the surface
energy of some plastics through processes
such as UV radiation, plasma and corona
discharge or by flame or acid treatments.
The presence of oxygen-containing spe-
cies, such as OH groups, on the surface of
plastics provides reactive sites for silicone
adhesives and primer systems. These proc-
esses affect chemical adhesion, or chemical
bonding such as covalent, hydrogen or other
weaker forces, between the silicone and
substrate. Substrates with reactive groups
available for bondingOH groups on
glass, and oxide layers on metals such as
aluminiummake this chemical bond easier
to achieve. Substrates with inert surfaces
lacking reactive sites, such as graphite and
polytetrafluoroethylene, can make adhesion
difficult.
Lubrication
Regardless of chemistry, silicone polymers
will have varying levels of success as a lubri-
cant or hydrophobic coating on a variety of
substrates including moulded silicone parts,
metal, glass and many plastics. Methods
of applying the polymer include dipping,
spraying, brushing or wiping. If a very thin
film is desired, silicone polymers may be
further diluted to as little as 15% silicone
solids in a compatible solvent. Methyl poly-
mers may be dispersed in nonpolar organic
solvents, whereas fluoropolymers and
copolymers may be dispersed in chlorinated
hydrocarbons and ketones and, to a lesser
extent, aromatic hydrocarbons, mineral
spirits and isopropyl alcohol. For ease of
use with minimal processing, some medical
device manufacturers select polymers that
are predispersed to a specified percentage of
solids content.
When coating or lubricating a moulded
part, it is important to consider the
chemistry of the moulded part versus the
chemistry of the lubricant. At the time of
application, if more than a few hours of
lubrication are needed, select a fluoropoly-
mer or copolymer silicone lubricant. Oth-
erwise, the silicone fluid will diffuse into
the elastomer, both swelling the moulded
component and depleting the fluid on the
elastomers surface, effectively reducing
or eliminating the lubricating charac-
teristics. Since a fluids rate of diffusion
into a silicone elastomer decreases as the
fluids molecular weight increases, higher-
viscosity fluids lubricate a silicone elasto-
meric surface for a slightly longer period
compared with a lower-viscosity fluid. On
temperature-resistant materials such as
glass, ceramic and metal, silicone polymers
and copolymers can be converted to highly
durable hydrophobic films by heating the
treated surfaces.
Beyond polymers (predispersed and
otherwise), some dispersed silicone for-
mulations are designed to cure at ambi-
ent conditions. These formulations yield
a minimal crosslink density that results
in a slippery finish similar to the afore-
mentioned polymers. Unlike polymers,
however, dispersed silicone formulations
minimally bond to the substrate they coat.
This feature makes these products ideal for
lubricating cutting edges, needle cannulae
and so forth. These silicone formulations
are one-part dispersions that devolatilise
and cure at ambient conditions. They may
be applied by dipping or wiping. When
working with these formulations, it is
important to remember that they tend to
be moisture sensitive. Consequently, if
adjustment to the percent solids or vis-
cosity is needed, it is important to use a
moisture-free organic solvent.
FIGURE 3: A silicone slab, half of which is coated with a low coefcient of friction coating (matte side);
the other half (glossy) is uncoated.
FIGURE 2: A self-lubricating liquid silicone rubber slab. The middle portion has been wiped to show the
lubricant on the sides.
16 EMDT1102 16 1/28/11 8:24:40 AM
MATERIALS
when coated, will bend, twist and elongate
without cracking, flaking or peeling.
Conclusion
Silicones offer diverse and emerging solu-
tions to the challenges of the healthcare
industry. Silicone polymers and low-cross-
link-density coatings are well-established
performers that routinely deliver critical
criteria in a host of applications. The newest
friction minimising silicone coating will
revolutionise applications where the migra-
tion of greases or oils historically has been a
problem. Silicones will continue to play an
important role in an industry determined
to meet demand for ever-more effective
products. 1
Matthew Lindberg
is Technical Sales at NuSil. NuSil Technology -
Europe is located at Parc dActivits de Sophia
Antipolis, Le Natura Bt2, 1198, avenue Maurice
Donat, F-06250 Mougins, France
tel. +33 4 9296 9331; e-mail: silicone@nusil.com
www.nusil.com

References
1. J. Comyn, Adhesion Science, Royal Society of
Chemistry, Cambridge, UK; 1997.
Advanced formulations
Technological advances have resulted in
novel formulations and improvements on
friction-minimising surface treatments. For
example, some silicone elastomers that are
designed for moulding will self-lubricate.
Self-lubricating liquid silicone rubbers do
not require the additional processing step
of adding a lubricant, lubricious coating or
grease. Instead, the lubricity is built into
the silicone elastomer system, yielding a
lubricious coating on the moulded surface.
This is caused by the elution of additives
over time after the vulcanisation process is
complete. However, with this formulation,
as with all of the above, there is potential
for uncontrolled migration of the lubricious
component.
Addressing this concern has brought
about the most recent breakthrough in
the evolving technology of silicone coat-
ings: a heat-curable silicone dispersion that
covalently bonds to the silicone elastomer
substrate and results in a dry, friction-
minimising finish.
The development of this formulation is
the result of two industry goals: finding a
coating for moulded or extruded silicone
parts that overcomes the materials inherent
blocking characteristic and achieving this
without creating potential for migration
of any formulary components. Over time,
hydrogen bonding causes cured silicones to
develop an affinity for themselves and other
surfaces such that they want to stick rather
than slide. This presents obvious problems
in a host of applications where a moulded
or extruded silicone part must move or slide
with a modicum of friction.
By spraying or dipping the friction-
diminishing silicone coating on a substrate,
there is a dramatic reduction in the parts
coefficient of friction. The result is a dura-
ble yet flexible coating that resists abrasion
from moving, sliding and rubbing parts.
This silicone formulation meets critical
performance goals with negligible impact
on the mechanical properties of the silicone
substrates it coats. Once cured, the coating
will chemically bond to the silicone elas-
tomer substrate and mimic its mechanical
properties, achieving a final product that,
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17 EMDT1102 17 1/28/11 8:24:48 AM
MANUFACTURING
Join together: if your proposed production process will involve ultrasonic welding technology, adopt a
collaborative approach with an expert in the field early in the design stage to ensure a successful outcome.
Design for assembly
Ultrasonic welding has become the pre-
ferred joining method for many manu-
facturers of precision moulded parts.
The process is clean, fast, repeatable and
controllable with process control feedback.
At first glance, the technology may seem
simplejust one link in a full-scale medical
device production chain otherwise com-
posed of complex mechanisms and automa-
tion elements. Look more closely, however,
and you will discover that it is at the hub of
an important working partnership between
the design engineer, mould tool manufac-
turer, assembly line builder and supplier of
the ultrasonic joining systems. Making the
right decisions at the design stage of a proj-
ect is essential to ensure that the functional-
ity and performance of both the product
and the assembly line meet the intended
specifications.
The most effective way of ensuring that
the ultrasonic welding process will be
consistent and predictable is to design for
assembly. Pay close attention to the poly-
mers that will be used and to part geom-
etry and tolerances early on. This will
simplify the assembly and welding process
and enhance reliability. These important
inputs need to be based on sound advice
gathered through a collaborative partner-
ship with the supplier of the ultrasonic
welding system.
Material selection and joint design
Ultrasonic welding is affected by the
response of the materials that are being
joined. Amorphous materials such as ABS
and its derivatives, typically used in the
production of medical device components,
respond extremely well to ultrasonic energy.
Crystalline materials such as POM, PBT
and PP also can be welded with relative
ease, although a little more attention must
be paid to material response. The best
results will always be obtained when the
components being welded are produced
from the same material. Dissimilar materi-
als can be joined using ultrasonic technol-
ogy providing they are from a compatible
family of materials and have similar melting
points. It is also possible to weld completely
dissimilar materials using a joint design, by
which one material is reformed and encap-
sulates the other mechanically, thus secur-
ing it in place.
Next to material selection, the key
elements in creating a robust and repeat-
able weld are part design and, especially,
joint design. Although basic information
on joint designs is readily available from
numerous sources, this information should
be treated as an overviewcomplex, deli-
cate and high-specification components
may require a more nuanced approach
to welding. In such cases, it is important
to establish that the parts to be welded
are actually capable of holding up to the
forces applied by the process, however
small they may be. The designer also must
ensure that a joint can be reliably achieved
at a given speed and with a sufficiently
wide process window. A process window
that is too narrow will result in repeated
machine adjustments and possibly higher
reject rates. The final production method,
especially if it is highly automated, can
also have an influence on both the product
design and welding process.
The presence of other components,
especially delicate parts or electronics, in
the final assembly also must be taken into
consideration. At this level it is important
to have more than just a basic apprecia-
tion of the ultrasonic welding process,
and manufacturers would do well to seek
advice from a supplier with experience
applying ultrasonic welding technology
to applications of this nature. For exam-
ple, the creation of joint designs and part
preparation, where the ultrasonic energy
Ultrasonic Welding from
Pilot to Production
Ultrasonic welding is a clean, fast, repeatable
and controllable process.
M. Frost and G. Forward, Telsonic UK Ltd, Poole, UK
18 EMDT1102 18 1/28/11 8:45:44 AM
is focused into the joint efficiently and the
weld is completed swiftly without dis-
sipation to other areas of the component
or even consideration in the selection of
weld frequency because of part geometry,
require a high level of expertise. The
new torsional ultrasonic welding proc-
ess, which works in the horizontal plane,
can also be employed to eliminate normal
directional vibration in the part, reduce
particle production and enable thin wall
joining and forming. These principles not
only result in a successful weld but elimi-
nate the risk of damage to any internal
components.
In regards to parts that have more than
one weld, both the component and joint
design should be reviewed to ensure that
the energy from multiple weld sequences
does not produce an adverse effect on
other weld points.
Putting the theory to the test
Having evaluated the component design,
materials and specific joint design recom-
mendations, it is time to put the theory to
the test.
Proof of principle can be established
by performing a series of test welds on
prototype parts. If these parts are not
yet available, tests can be conducted on
materials of the same type and thick-
ness. The tests also allow consideration
of the proposed assembly orientation
of the welding operationhorizontal
or verticaland the proposed welding
methodlinear or torsional. These ini-
tial tests are useful in helping to establish
process parameters, process capability
and weld cycle times, all of which is valu-
able information for the manufacturer
of the assembly line when considering
concept design and assembly sequencing.
The resulting welded assemblies are then
tested for strength and seal integrity.
Other considerations for the overall
specification at this stage include the
environment where the equipment will
be used: cleanroom specifications, for
example, and the likely configuration of
the ultrasonic welding modules, includ-
ing how they might integrate within the
overall production line. This initiates a
detailed evaluation of equipment sur-
face coatings, any approved grease that
may be used, potential dirt traps and,
of course, the cleanliness of the welding
process itself, ensuring that no unaccept-
able debris is produced during the weld
cycle in line with GAMP procedures.
The knowledge acquired during these
initial tests enables the supplier of the
ultrasonic joining technology to make
a valuable contribution to the develop-
ment of the user requirement specifica-
tions (URS) for the production system.
Ultimately, the supplier of the assembly
machine also benefits from the process
knowledge gained from these trials by
gaining complete confidence in both the
process and the cycle time.
From planning to pilot production
Once the feasibility and process parameters
have been developed and confirmed during
the design of experiment phase, customers
sometimes will commission a semi-auto-
mated machine for pilot production of the
Twin ultrasonic heads are integrated into a
device automation process.
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19 EMDT1102 19 1/28/11 8:45:48 AM
20 EMDT1102 20 1/28/11 8:45:53 AM
MANUFACTURING
component. The pilot machine is, in effect,
a fully functional unit that will replicate the
actual welding operations in the proposed
production system.
The pilot system is subject to stringent
design failure mode effect analysis and the
development of functional design speci-
fications (FDS) covering machine opera-
tion, safety, ergonomics, reject handling
and so forth. On machine build comple-
tion and before delivery to the customer,
installation qualification documentation
will be prepared, including calibration
certificates for the machine and certifica-
tion of conformity for tooling that comes
into contact with the device. Operational
qualification, in line with the FDS and
URS, will test the machine for reliability,
safety and consistency of quality.
Once a formal factory acceptance
test (FAT) at the customer site has been
completed, the pilot production machine
becomes a valuable asset allowing small
batch production runs using components
from the prototype moulding tool. This
also provides the opportunity to use an
analytical tool to log data from each and
every weld cycle and subsequently moni-
tor process capability over time. The data
stored by this system can also be used
for documentation purposes or to moni-
tor any subtle changes made to welding
parameters. Standard deviation can be
applied to set and prove the upper and
lower control limits for reject assemblies.
By the time the pilot machine is in
operation and the production assembly
machine is in build, with production
mould tooling underway, the parties
involved in the project have come a long
way. At every stage in this design and
development process, however, the exper-
tise, knowledge and commitment of the
joining technology supplier will have
played a significant part in determining
the optimal production solution. 1
Martin Frost
is Area Sales Manager and
Geoff Forward
is Technical Support Manager
at Telsonic UK Ltd, Units 14 & 15, Birch Copse,
Technology Road, Poole, Dorset BH17 7FH, UK
tel. +44 1202 697 340
e-mail: sales@telsonic.co.uk
www.telsonic.com
Typical weld joint congurations
A: Metallic part insertion or encapsulation into
component. B: Direct-contact spot welding.
C: Part interface joining (transmission through
the part). D: Direct-contact swaging.
A
B
C
D
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DESIGN
By enabling the design of hermetically sealed feed throughs, ultrathin housings and devices that
communicate via ultrasound, advanced ceramic materials are contributing to the development
of next-generation implantable pulse generators.
A shock to the system
The use of neuromodulation to treat an
array of medical conditions and diseases
has generated a lot of excitement in recent
years. Adapting cardiac rhythm manage-
ment techniques, neuromodulation uses
electrical signals to stimulate or block dif-
ferent nerve impulses in the body. It holds
promise for reducing or eliminating back
pain, curing obesity, lowering high blood
pressure and controlling diabetes, among
many other conditions.
Advanced ceramic materials play an
important role in this technology, and they
are poised to play an even greater one as
these medical devices continue to evolve.
Advanced ceramics enable the manufacture
of brazed assemblies for hermetically sealed
electrical feed throughs, for example, and
piezocomposite materials facilitate ultrasonic
communication in devices. Biocompatible
ceramics can be a desirable alternative to
titanium for the fabrication of device casings.
New ceramic composite materials and
assemblies as well as high-pin-density feed-
through assemblies will enable the next
generation of neuromodulation devices. This
new generation will improve treatment and
communicate more effectively with other
devices and be even safer and more conven-
ient for patients than existing products.
Implantable pulse generators
Central to the technology is a neurostimu-
lator, usually referred to as an implant-
able pulse generator (IPG). The IPG is a
battery-powered micro-electronic device,
implanted in the body, which delivers elec-
trical stimulation to the nervous system.
An essential part of surgically implanted
systems designed to treat a wide array of
conditions, the IPG delivers very small
pulses of electricity to block or stimulate
nerve signals (or impulses), depending
upon the condition. Figure 1 shows some
of the approved and future uses for this
groundbreaking technology.
Wires that control the IPG and transmit
and receive electrical signals are attached
to the nerve that is being stimulated or
blocked. In some cases, the devices are
applied to conditions for which medica-
tion either has not been completely effec-
tive or has caused unpleasant side effects.
In other cases, nerve stimulation is con-
sidered to be a more convenient way to
control a condition, either by itself or in
combination with medicine.
The feed through
An important component of an IPG device
is the feed through, the mechanical struc-
ture that provides the electrical connection
for the leads to get in and out of the device
housing.
J. Anatalek and P. Manison, Morgan Technical Ceramics,
Stourport-on-Severn, UK
Advanced Ceramics Help Open
New Frontiers in Neuromodulation
Improving feed through design and expanding capabilities is central to the development of next-
generation implantable pulse generators.
22 EMDT1102 22 1/28/11 8:49:39 AM
This tiny component, typically no more
than 2 cm long by 1 cm wide, performs
some key functions. First, the feed
through provides a conduit for the com-
munication of signals between the IPG
and the body. Second, the feed throughs
hermetic seal keeps body fluids away from
the IPG device and prevents electricity and
battery materials from leaking into the
body. The feed through must be abso-
lutely leak-free and be robust enough to
withstand radiofrequency and eliminate
interference from MRI equipment and
antitheft scanners. The tiny device can
contain from two to 30+ leads.
Figure 2 shows a feed through used in
the Eon Mini Rechargeable IPG System, a
device developed for chronic pain manage-
ment by St. Jude Medical Inc. The feed
through, manufactured by Morgan Tech-
nical Ceramics Alberox business (MTC-
Alberox), serves as the bridge between the
outside and inside of the case and carries the
signal from inside the titanium package to
the wires. It is a ceramic-to-metal assembly,
made of weldable titanium flanges, with
platinum or platinum/iridium pins, poly-
crystalline alumina and 99.99% gold braze.
The ceramic serves as an insulator for the
feed through. Alberox uses a die pressing
process to make its own alumina ceramic
components and brazes the assembly to seal
the electrical wires into the ceramic compo-
nents to make the electrical feed throughs.
IPG applications from head to toe
New medical uses for IPG devices are
patented frequently. The conditions that
show the most promise for these devices
are chronic back pain, hypertension and
diabetes. Examples of devices focused on
these conditions (either available now or
in development) are described below.
For the treatment of chronic back pain,
IPG devices deliver mild electrical pulses
to the spinal cord, which interrupt or mask
the transmission of pain signals to the
brain. For example, the Eon Mini treats
chronic pain of the trunk or limbs and
pain from failed back surgery. It is slightly
larger than the circumference of a 2 coin;
the device has a 10-mm profile and weighs
about 28 grams. Its small size allows for
a smaller incision, which gives physicians
increased flexibility in selecting the implant
location and also makes the site less visible
and more comfortable for patients.
In this application, the IPG is implanted
in the back, in close proximity to the
nerve that doctors are trying to block.
This particular device has a 16-channel
feed through, containing a ground wire
and pins arranged on a long thin oval. The
feed through can send sixteen different
signals at a time, which doctors place in
different locations. They then go through
a process of elimination, stimulating one
nerve at a time and in combination, work-
ing with the patient until they get a combi-
nation that effectively treats the pain.
Most patients with high blood pressure
control their condition by using a regi-
men of anti-hypertensive drugs. However,
many studies have reported a persist-
ence of refractive hypertension (elevated
blood pressure despite the use of at least
two anti-hypertensive drugs) in as much
as 18% of the patient population. IPG
devices are being developed to treat hyper-
tension in a manner that is not only safe
and effective, but avoids the undesirable
side effects of drug therapy.
The system includes an IPG, sensors
and leads, and external electronics for
Spinal cord implants
IPG devices deliver mild electrical
pulses to the spinal cord, interrupting
or masking the transmission of pain
signals to the brain. The IPG is
implanted in the back, in close
proximity to the nerve that is being
blocked.
Diabetes
IPGs can be an option for patients with
diabetes who are unresponsive to drug
therapy. The implanted device stimu-
lates or inhibits the patients vagus
nerve to modulate its electrical activity
and increase or decrease secretion of
natural insulin by the pancreas.
Obesity
In addition to the IPG, the system
includes sensors and leads, and
external electronics for calibration,
programming and periodic adjustment
of parameters by the attending
physician. A device that stimulates the
vagus nerve to control obesity is under
investigation.
Hypertension
IPG devices under development are
safe and effective, avoiding the
undesirable side effects of drug
therapy. One clinical trial is investigat-
ing whether an implanted device can
help control blood pressure by stimulat-
ing pressure sensors called barorecep-
tors on the carotid artery and carotid
sinus. These sensors measure and
report blood pressure to the brain.
The future
The general trend in implantable
devices is miniaturisation. New
devices tend to be smaller, but with
a greater number of leads that send
more signals to and from a single
device. Improving feed-through
design and expanding capability is
central to next-generation IPGs.
Future applications will require 100
to 200 leads, which will allow
device manufacturers to add further
treatments to implantable systems.
New high-density feed throughs
could contain 10 times the number
of leads in current systems without
increasing device size or spacing.
Body communications is also an
emerging eld: ultrasonic devices
are placed within a medical device
casing and used to remotely power
and communicate with other
devices in the body.
FIGURE 1: By applying small pulses of electricity to block or stimulate nerve signals,
implantable pulse generators can treat an array of conditions. This graphic shows current
and emerging uses of this technology.
23 EMDT1102 23 1/28/11 8:49:44 AM
DESIGN
calibration, programming and periodic
adjustment of parameters by the attending
physician.
One clinical trial is investigating
whether an implanted device can help
control high blood pressure by stimulat-
ing pressure sensors, called baroreceptors,
located on the carotid artery and in the
carotid sinus. These sensors measure the
blood pressure and report the results to
the brain, where they are compared with
the needs of the body.
Other investigations are being con-
ducted on a device that stimulates the
vagus nerve to control obesity. Research-
ers testing the device have seen a dramatic
drop in hypertension as an unexpected
benefit of the therapy.
Several devices are being used or are
under development for diabetics, especially
as an option for patients who are unre-
sponsive to drug therapy. For example,
an implanted IPG can stimulate or inhibit
a patients vagus nerve and modulate its
electrical activity to increase or decrease
secretion of natural insulin by the patients
pancreas. The stimulator might be selec-
tively activated in response to direct meas-
urement of blood glucose or symptoms,
or it could be activated automatically at
predetermined times or intervals. Alterna-
tively, it could be automatically activated
by means of an implanted sensor to detect
blood glucose concentrations.
One implantable system, originally tested
to control obesity and other gastro-intestinal
disorders, is showing some promise in
controlling diabetes. The device is designed
to precisely control nerve and organ func-
tion using the vagal nerves, which regulate
much of the activity of the stomach and the
pancreas. The device being studied delivers
high-frequency, low-energy electrical signals
through laparoscopically implanted leads to
block vagal nerve transmission. The delivery
of energy to the nerves is intermittent and
the effects of the therapy on the nerves and
end organs are intended to be reversible. The
system is designed to be noninvasively adjust-
able to meet individual needs.
Headaches, obesity, epilepsy, depres-
sion, Parkinsons, syncope, sleep apnea
and restless leg syndrome are a few of
the many other conditions for which this
treatment is being investigated.
A stimulating future
The general trend in implantable devices
is miniaturisation. New devices tend to
be smaller, but they must accommodate a
greater number of leads to transmit more
signals into and out of a single device.
Therefore, improving feed through design
and expanding its capabilities is central to
the development of next-generation IPGs.
Future neurostimulator applications are
currently looking at 100 to 200 leads,
which will give device manufacturers
opportunities to add further treatments to
an implantable system.
The evolution of pacemakers is a good
example of where IPGs are headed. Just a
few years ago, pacemakers were the size of
a Blackberry and had just two leads. Now,
the typical pacemaker is about the size of
a lighter and can have as many as 10 leads,
some of which enhance communication
to the device, allow monitoring of other
patient information, and transmit informa-
tion directly from the device to a doctor.
Additional leads could build in inten-
tional redundancy, which would reduce
device downtime and eliminate the need
for revision surgery should any leads fail.
One of the most exciting avenues of
research in this regard is the develop-
ment of high-density feed throughs that
can increase the number of leads tenfold
without altering the current device size
or spacing. Todays feed throughs are
constructed by assembling many differ-
ent parts, stacking them into complicated
arrays with braze materials and putting
them in a furnace, where the parts are
joined. To pack together more wires in a
smaller space, researchers are developing
high-density feed throughs using alumina
ceramics, cofired platinum leads and
patent-pending processing technologies.
Body talk
Another interesting development in the
IPG arena is the development of body
communications: the use of ultrasonic
devices within the casing of a medical
product to remotely power and com-
municate with other devices in the body.
This next level of improvement has great
advantages, because it could mean that no
wires would have to be implanted.
Implanting wires in the body can be a
challenge. They may eventually fail, and
subsequent removal and replacement can
be difficult. Also, using ultrasound rather
than radiofrequency means the communi-
cation stays within the body.
The use of ultrasound both to power
and interrogate remote sensors is probably
coming to many implantable devices, but
wiring will still be needed for neuro-
stimulators, where leads are attached to
the skull, brain or spine. However, in
the future, the main implant might be
able to communicate with other devices
implanted in the body or with the external
programmer via ultrasound.
Applying technology developed for
cochlear implants and using piezo-
ceramic components that enable increased
resolution, the ElectroCeramics business of
Morgan Technical Ceramics has researched
a custom assembly for an annunciator that
could be inserted into a main IPG. The
implant could use intelligible speech to
warn the user that an event is occurring.
FIGURE 2: The mechanical structure, called
a feed through, that provides the electrical
connection for the leads to get to and from
the device housing is a key component of an
implantable device. Pictured here is a feed
through used in the Eon Mini Rechargeable IPG
System, a device developed for chronic pain
management by St. Jude Medical Inc.
24 EMDT1102 24 1/28/11 8:50:07 AM
Next steps
The market for neuromodulation is valued
at more than 1.3 billion, with a compound
annual growth rate estimated at 18 to 22%
and a seemingly never-ending parade of
new applications for the basic technology.
IPGs are increasingly accepted by regula-
tory authorities and insurers and are often
preferred by patients and physicians over
some drug therapies. As the next generation
of devices is developed, advanced ceram-
ics will play a fundamental role. The same
robust biocompatible materials being used
to make implantable drug delivery devices
may now be used to develop a feed through
for next-generation IPGs. 1
John Anatalek
is Business Unit Manager, Medical Products, and
Paul Manison
is Sales Manager at Morgan Technical
Ceramics, Bewdley Road, Stourport-on-Severn,
Worcestershire DY13 8QR, UK
tel: +44 1299 872 210
e-mail: mtcuksales@morganplc.com
www.morgantechnicalceramics.com
Biocompatible materials
Most IPGs are currently made of tita-
nium. Research is being done on the use
of ceramic injection moulding (CIM) to
develop a thin-walled ceramic case that is
smaller and simpler than current designs
and that enables more efficient communica-
tion with the electronics in the device. CIM
enables production of small components
with very high precision and without a
secondary grinding process.
MTCs Stourport UK CIM facility is
currently in the early stages of developing
an implantable housing moulded from zir-
conia for use in the treatment of migraine
and cluster headaches. The proposed use
of ceramic in this device requires zirconia
rather than alumina because the com-
ponent is very thin and zirconia is much
stronger than alumina. The CIM ceramic
would then be brazed and hermetically
sealed to the feed through.
The zirconia ceramic casing is stronger
than titanium, allowing for a mechani-
cally robust structure in a smaller housing.
An alumina equivalent would be strong,
but twice as thick. Both zirconia and
alumina are transparent to radiofrequency
energy, so signals can be passed through
the wall for communication and possible
charging. The hope is that developing a
device casing out of zirconia would mean
that no feed-through wires would be
needed to connect to an antenna. Keeping
the antenna within the device improves
functionality for the patient. The zirco-
nia material is also inherently insulating,
so electrical wires can be placed closer
together than they would be in a metal
flanged feed through brazed into a metal
housing. Such a device would have no
need for a battery; it would not require
replacement as long as it retains its her-
metic seal. Finally, zirconia is a biocom-
patible material that complies with ISO
13356 implants for surgery.
Many more articles on medical
technology design issues are
archived on our website. They
can be accessed by going to www.emdt.co.uk/
categories/design.
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DESIGN
Understanding the innovation mandate
At Sagentia, we recently conducted
research amongst 20 big-name medi-
cal device companies to identify areas
of best practice in front end innovation.
Our intent is to share that insight and
help companies get the most out of their
investment. First, we should clarify
our definition of front end: it is the set
of activities that deliver a bulletproof
investment case around a product con-
cept that will release the multimillion
euro budgets required for downstream
product development (system design,
detail design, prototyping, clinical trials,
transfer to manufacture and so forth).
Although everybody agrees that
innovation is a major contributor to
competitive edge, it doesnt follow that
everybody does it well. Some organisa-
tions are innovation sophisticates, whilst
others struggle to make sense of how to
nurture opportunities into strong prod-
uct concepts that warrant further invest-
ment. Sophistication is required of both
market and technology research meth-
ods. Importantly, being good at one is no
indicator of being good at the other.
So, how can a medical device company
achieve the best value from its first million
euros? In this article, we discuss a series of
best practices to answer that question.
Executives who operate at the front end
need to recognise what type of innova-
tion mandate they have so that they can
put in place an appropriate structure to
support it. Although all companies have
an underlying innovation mandate that is
part of their corporate strategy, not all can
articulate their mandate well. So whilst
all front end executives are usually able
to directly relate their role to an over-
all financial growth agenda, only some
are able to point to a link between their
companys competitive position and their
particular innovation programme. An
example of such a link would be we aim
to be number one in Chinese laparoscopic
surgery, and hence we are undertaking
this kind of research.
Businesses that have a competitive
strategy that requires them to be number
The First Million Bucks
Medical device companies spend around 1 million euros at the front end of every
device development project to get to a product concept that they believe in (at least
on paper). Some spend it better than others.
D. Edwards, Sagentia, Harston Mill, UK
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26 EMDT1102 26 1/28/11 8:51:41 AM
one or two in a given medical market must
deliver product and service differentia-
tion to that market. In this situation, the
group or individual operating at the front
end needs to be a front end sophisticate
and should both understand the challenge
and feel confident and justified in seek-
ing funds for projects that dont have a
guaranteed outcome. The best front end
innovators in these types of businesses
will operate in that zeitgeistthey live it,
breathe it and feel entirely comfortable
with it.
Recognising radical
A sophisticated approach is an absolute
prerequisite for any front end innovation
that hopes to deliver a new market ben-
efit or technology. The data upon which
these breakthrough products are based,
and upon which decisions are made, are
usually very thin. This is the nature of
disruptionif a precedent existed, the
innovation wouldnt be radical.
If usual screening rules were applied in
these situations, budget requests to sup-
port these endeavours would be rejected
out of hand. Consequently, governance of
high-risk activities calls for an alternative
approach, and it needs to be recognised
from the outset that the project being
evaluated will need to be handled differ-
ently. We believe that three elements are
necessary to ensure this happens: people,
tools and processes.
First, it is essential that the leaders of
front end work are people with experience
and an understanding of the high-risk
profile and decision-making required.
Moreover, we need these individuals to
sympathise with both marketing and
R&D. Such individuals are rare. Second,
a correct set of tools must be used, and we
have a toolbox to share later in this arti-
cle. And last, processes must be designed
both to nurture and adequately vet a high-
risk project portfolio.
People: marketing vs R&D
Most executives come with either an R&D
sensibility or are rooted in marketing. Few
R&D innovators cross the floor into mar-
keting; those that do are a rare breed and
are to be treasured. Even fewer marketers
move into R&D. This lack of common
ground has been a problem for years and
it remains so today.
The shortfalls apparent in both mar-
keting-led and R&D-led innovation are
all too obvious. Marketing-led innovation
falls short in generating solutions and,
in some cases, relies too much on two-
day creativity workshops to respond to
months of careful market research. There
are better tools available, as outlined in
Table I. The corollary is also true: R&D-
heavy teams leading innovation efforts are
often blind to the range of market research
tools available at either the opportunity-
scanning or topic-specific market research
steps. Awareness and acceptance of these
gaps is critical, and efforts to share tools
and bridge gaps will significantly improve
outcomes.
Process 1: a four-step programme
Are organisations systematic or seren-
dipitous about how they initiate a pro-
gramme? Anecdotal evidence tells us
that the use of systematic analysis is very
much on the increase in the medical device
industry. The stereotypical image remains
of a CEO popping his head around the
door to R&D, scratching his chin and
proclaiming, We need to be bigger in
imaging (in a small number of instances,
this is still the case). However, it is encour-
aging that this haphazard approach is
diminishing rapidly. The CEO instruction
was, in reality, filling a void. Now that the
analytical tools exist, they are being used
at the expense of top-down instruction.
Developing this point further, a better
approach is to follow a simple but clearly
defined four-step programme.
1. Opportunity scanning. Information
is sampled across a range of topics (clinical
procedure, clinician group, market trend
or even technology opportunity) with the
goal of identifying a theme to exploit.
This is the stage which, until recently, was
fulfilled by the visionary CEO.
2. Topic-specific market research. Hav-
ing settled on a topic, data is sought to
qualify the opportunity hypothesis. This
data takes two forms: quantitative data
on the size and growth of the topic and
qualitative data on the target users subtle
needs relating to it.
3. Solution generation. In solution
generation and filtering, we explore both
technology and design.
4. Concept profiling. This is the final
stage, when the concept is bullet-proofed
prior to governance scrutiny, ensuring that
all stage exit criteria are addressed.
Process 2: a bullpen of opportunities
Our research indicates a shift in the medi-
cal device industry (and other sectors such
as consumer products) towards a bullpen,
where projects are gathered together and
viewed as a whole. The bullpen portfolio
approachas opposed to a traditional
process that considers individual projects
in isolation and on their own merithas
been shown, on aggregate, to improve suc-
cess rates. Heres why:
Competition (not between teams, per 0
se, but between market opportunities)
should be encouraged in order to get the
best results out of projects .
A discipline is established that kills 0
foundering projects and swiftly reassigns
budgets into awaiting projects.
It will help ensure that R&D budgets are 0
fully spent. A common misconception
among middle managers is that under-
spending R&D budget is a good thing.
We disagree with this position, arguing
that an underinvestment in R&D is an
underinvestment in growth.
Marketing-led
innovation falls short in
generating solutions
R&D-heavy teams
leading innovation
efforts are often blind
to the range of market
research tools available
27 EMDT1102 27 2/2/11 1:33:41 PM
DESIGN
Tools
Organisations seem to focus on those
areas of front end innovation, where
they have internal resources and proven
strengths. For example, depending on who
is running the showi.e., marketing or
R&Dthe focus will be weighted accord-
ingly. This approach is limiting and forces
sponsors to make decisions with incom-
plete evidence. Companies should consider
their areas of weakness and explore the
full range of tools available to address
them.
Table I shows an aggregation of tools
that may be used by front end innovation
executives in large, sophisticated medical
device organisations.
It is encouraging to note the sheer diver-
sity of tools that are now available, cou-
pled with the fact that many of these tools
are new to the medical device industry.
On the market research side, for example,
CarePath mapping is a tool to determine
triggers for replacing entire medical
procedures in light of the move towards
preventative rather than curative inter-
ventions. On the R&D side, technology
landscaping is a means to explore technol-
ogy solutions from adjacent industries for
application in a medical setting.
In some instances, these tools are
deployed and managed directly by the
medical device company. For some of the
more specialist tools, or where adequate
in-house expertise and resources do not
exist, outside consulting services are being
retained. Indeed, the ratio of internal
spend (salary and benefits) to external
spend (consultancy) averages 1:3. In other
words, of that 1 million euros described
earlier, 750,000 is being incurred as a
direct expense.
Beyond VoC research
All companies point to needs as the single
most important innovation driver. Over
the past 20 years, Voice of the Customer
(VoC) has become the established indus-
try mantra. Questioning its validity was
seen as verging on the heretical. Change,
however, is on the horizon.
While there is still appropriate rever-
ence for the opinions and insights voiced
by clinicians, there are definite shortcom-
ings associated with listening only to
customers:
Clinicians are sometimes poor at 0
self-reporting. Recognising that most
thought is unconscious, what amount
of false reporting or noise do we intro-
duce when we interview (rather than
observe) a clinician?
Practitioners are often blind to disrup- 0
tion. Clinicians intellectual invest-
ment in the current standard of care
(a given procedure) will often render
them blind to, or simply unaware of,
the potential for disruption at a proce-
dural level.
Key opinion leadersa particular 0
segment of the clinical population that
is commonly sought outare some-
times the wrong voices to listen to.
Less skilled clinicians and users are an
overlooked constituency and a larger
market segment.
The overarching point is that the tool
and its applicability need to be fully
understood. Before initiating any research,
a prudent innovator should have a hypoth-
esis as to where insight will come from
and choose a research method (or meth-
ods) accordingly.
Take laparoscopic gall stone removal
for example. If ethnographic research
is undertaken in isolation, insights will
be gained into the limitations of current
technologies. This will lead to ideas for
new gall stone removal technologies. But
there may well be an entire procedure-dis-
ruption angle. There may be a yet-to-be-
discovered drug that will obviate the need
for surgery entirely by preventing a stone
TABLE I: Toolbox by category
1. Opportunity scanning 2. Topic-specic market
research
3. Solution generation 4. Concept proling
Buy and peruse industry reports
Ad hoc clinician chats
Scan call centre logs
Scan competitor recalls
Drinking fountain innovation topics
Scan FDA logs
Scan blogs/chat rooms
Medical advisory panels
Scan clinical outcome data by
disease and therapy
KOL interviews
Ethnographies
University alliance
CarePath mapping
Human factors analysis
Advisory panels
Cross-functional internal team
assessments
Market size assessment (using
secondary data)
Market size assessment (build bottom
up with primary data)
Validate customer-need assumptions
with VoC
Ideation sessions
University alliance
Technology landscaping
IP white spaces
Technology selection
Concept embodiment using
morphological mapping
Preliminary concept vision (graphics)
For high-risk technologyproof
of principle demonstrator (not full
prototypes)
IP check
Regulatory check
Reimbursement check
Business case
Paper prototypes (storyboard) test
with VoC
Proof-of-concept prototyping
Preclinical with animal models
Prepare evidence collection request
Concept lock-write spec
Go to market strategy
Pilot (get customer to pay)
Materials testing
28 EMDT1102 28 1/28/11 8:51:49 AM
from forming in the first place. If you
have a surgical tools franchise that serves
this market, you may miss a billion-euro
disruption to your annual revenue.
Conclusion
With typical medical device budgets for
front end work around the 1 million euro
mark, it is clear that industry recognises
the crucial position this early activity
occupies within the innovation function.
The key, however, is to make this invest-
ment valuable.
Perhaps the single largest determinant
of the practices one ought to adopt is
competitive stance. Put bluntly, a company
aspiring to lead in its sector will need
to be more sophisticated in its front end
execution than a company adopting a fast-
follower competitive strategy.
If a business unit expects to be the dis-
ruptor in its market niche, it will need to
consider many of the practices and tools
described here. The tools can be broken
into groups: those that will take you to
new needs and procedures (markets) and
those that will take you to new solutions
(technologies).
If an innovation function is being led
by a marketing executive, it would behove
said executive to consider sophisticated
solution research and creation tools. It is
not enough to simply hand off a market-
ing brief to the companys line extension
technology teamits likely that they will
dilute the opportunity with business-as-
usual solutions. There is more to solution
building than brainstorming workshops.
Similarly, R&D-led functions should chal-
lenge their own level of market interroga-
tion wisdom to see how aware they really
are of the unmet needs of their customers.
There is more to market research than
clinician interviews.
To front end sponsors perhaps reading
this, we would counsel to let your front
end innovation function mature into the
delivery engine it needs to be to address
your competitive agenda. Perhaps there
are some governance and operational
practices that can be adopted from those
discussed here. A strong message from
our research is that we ought not allow
organisational structure legacy and tradi-
tion impede performance.
To the front end doer, we would rec-
ommend looking at the toolbox you are
drawing from and the bias that your
background brings to the challenge. There
are several tools listed in this report that
might warrant a trial run. 1
Dan Edwards
is Vice President at Sagentia, Harston Mill,
Harston, Cambridge CB22 7GG, UK
tel. +44 1223 875 200
e-mail: dan.edwards@sagentia.com
www.sagentia.com
If you are interested in receiving the
complete Sagentia research report, please
contact Dan Edwards by e-mail, dan.
edwards@sagentia.com.
Dozens of articles on medical
product design and related
topics are archived on our
website. To access them, go to
www.emdt.co.uk/categories/design.
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Leveraging expertise in quality standards and design for manufacturability, Vesta infuses value
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Meet Vesta at MEDTEC Europe 2011
in March, stand #4464, or visit
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29 EMDT1102 29 1/28/11 8:51:53 AM
DESIGN
MRI trade offs
Its been 100 years since the discovery
of superconductivitythe phenomenon
that allows certain materials to conduct
electricity without resistance and, there-
fore, transport electrical energy without
loss. It is critical to the operation of MRI
scanners but, despite decades of research,
maintaining the superconductive mag-
nets to run these state-of-the-art imaging
machines still puts hospital resources
under significant strain.
This is because MRI scanners use low-
temperature superconducting magnets
made of niobium alloys to generate the
strong 1- to 2-T magnetic fields that line
up the spins of hydrogen atoms in the
body. These have to be kept below a criti-
cal temperature of around 5 K (2680C)
and that requires expensive liquid helium
cooling. Maintenance of these magnets has
driven the cost of MRI machines into mil-
lions of euros, limiting their use in finan-
cially constrained healthcare settings.
In response, manufacturers have devel-
oped less-expensive, low-magnetic-field-
strength (0.2 T and lower) MRI scanners.
Most of the cost savings come from using
an electromagnet instead of a supercon-
ducting one. However, the lower field
strength results in poorer quality images
and longer scan times.
In 1986, hopes for more easily usable
and, therefore, more affordable supercon-
ductors were raised with the discovery of
superconductivity in copper oxide com-
pounds at up to 138 K (135C). These
temperatures can be achieved using liquid
nitrogen cooling. As nitrogen is a far more
abundant resource than helium, the whole
process is less costly. With potential for
even higher temperatures and, therefore,
significant savings for industry, academic
interest in superconductivity was renewed.
Whilst considerable progress has been
made in the study of high-temperature
superconductors, an understanding of the
mechanism driving their superconductivity
remains elusive and is holding back their
commercial deployment.
The latest step forward was made at the
Institut Laue-Langevin (ILL) in Grenoble,
France, the worlds flagship centre for neu-
tron science. Using neutron spectroscopy,
an international team of researchers from
the Laboratoire Lon Brillouin (France)
and the University of Minnesota (USA)
have proved experimentally the existence
of unusual magnetic excitations that pre-
cede the transition to superconductivity at
high temperatures.
Pseudo-gap phase
The magnetic excitations observed in
these copper-oxide superconductors occur
in a transition state, known as the pseudo-
gap phase. In this phase, the materials
demonstrate unusual properties that
deviate considerably from the behaviour of
normal metals. It is considered that under-
standing this state is the key to under-
standing superconductivity.
Several theoretical models have been
proposed to describe the pseudo-gap
phase. One of them, put forward by Pro-
fessor C. M. Varma (Riverside) in 1997
1

claims that the superconducting state
P. Steffens, Institut Laue-Langevin, Grenoble, France
Understanding Superconductivity
Research in high-temperature superconductivity may lead to more-affordable MRI scanners.
I
m
a
g
e

b
y

D
a
v
i
d

M
a
r
c
h
a
l
/
i
S
t
o
c
k
p
h
o
t
o
.c
o
m
30 EMDT1102 30 1/28/11 8:52:44 AM
emerges from a spontaneous formation
of microscopic electrical current loops,
thereby creating microscopic magnetic
moments. The pseudo-gap phase results
from the appearance of these loops of
current. The team at ILL have for the first
time observed magnetic behaviour in a
copper-oxide high-temperature supercon-
ductor consistent with this spontaneous
formation of tiny loops of current.
The results from ILL, published in
Nature
2
, are furthering our understanding
of the high critical temperatures for super-
conductivity observed in some copper-
oxides and what creates this phenomenon
in the first place.
Designing a better MRI
Armed with more accurate theoretical
models, future research stands a better
chance of discovering the ideal supercon-
ductoravailable at low production cost
and with the right mechanical properties
and critical temperatures. Looking further
into the future, we may even hope to have
superconducting magnets operating in
MRI machines at room temperature, thus
completely removing the need for cooling
and reducing the size and running costs of
the scanner.
Though we have some way to go,
continuing industry and academic interest
means we can realistically expect to see
further progress in this area as research-
ers look to make the application of high-
temperature superconductors easier and
less costly. The first step is a fuller under-
standing of this unique phenomenon.
In the 100 years since its discovery,
the commercial applications of super-
conductivity have intrigued designers
and technicians from various industries.
MRI scanners represent one of the most
successful applications so far, but, as
we have seen, there are still challenges
to overcome. The world class research
taking place at ILL is helping solve this
significant challenge and is giving us the
best possible chance of fully understand-
ing superconductivity and unlocking its
true potential. 1
References
1. C. M. Varma, Non-Fermi-liquid states and
pairing instability of a general model of copper
oxide metals, Phys. Rev., B 55, 1455414580
(1997).
2. D. van der Marel, Superconductivity: Beware
of the pseudogap, Nature Physics, 7, 1011
(2011).
Paul Steffens, PhD,
is a scientist at Institut Laue-Langevin, BP 156,
F-38042 Grenoble, France
tel. + 33 4 7620 7111
e-mail: steffens@ill.fr
www.ill.eu
More articles about medical
device design issues can be
accessed at www.emdt.co.uk/
categories/design.
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31 EMDT1102 31 1/28/11 8:52:49 AM
MANUFACTURING
Automation can help medtech manufacturers remain competitive in a global economy
whilst ensuring consistent compliance with rigorous quality standards. However, traditional
product-specific automation systems can be inflexible. Enter the robots.
Quality and traceability
The production of medical devices is subject
to stringent standards related to product
quality as well as traceability. Companies
operating in this sector also face increasing
pressure to reduce costs and continuously
improve delivery performance.
Automation has been recognised as a solu-
tion to these issues. It enables the consistent
production of high-quality parts and serves
as a traceability tool, as it makes it relatively
simple to maintain control of components
during the production process. Traditional
automation systems are product specific.
Because system design and operations are
optimised for the production of a specific
part, these machines provide consistent qual-
ity at potentially high production rates.
However, these dedicated automation
solutions are often expensive investments
and may require significant expenditure
when modifications are required to accom-
modate changes in product design. It is not
uncommon for a completely new system
to be designed when new products are
introduced. To meet commercial pressures,
manufacturers are turning to robot-based
automation systems that combine quality
and consistency with flexibility. Robotics
can provide the capability to process dif-
ferent products through the same system
and are reconfigurable for new products,
thereby reducing costs and improving deliv-
ery flexibility.
The use of vision systems is also increas-
ing as their cost comes down and ease of
operation increases. Vision is often used
to assist automated assembly and packing
operations by finding randomly positioned
parts. It is also used very effectively as a
key element of quality control, as it pro-
vides a quick and simple inspection tool for
measuring critical dimensions and verifying
features. Vision is also simple to integrate
within an overall control system and there-
fore can become a key element of product
validation and traceability.
Automating orthopaedics production
Because of their inherent dexterity, robots
lend themselves to manufacturing opera-
tions that otherwise would be difficult to
automate. The production of orthopaedic
implants is a case in point. These devices
are manufactured from high-strength bio-
compatible materials, such as titanium and
stainless steel, and a consistent defect-free
surface finish is critical. Irregularities can
lead to excessive wear and reduced
joint life.
Six-axis robots are used by a
growing number of implant man-
ufacturers to perform grinding,
polishing and buffing operations.
Typically, the robots present the
implant to a series of belts. Vary-
ing grades of structured abrasives
remove material to achieve the
required shape and finish; polish-
ing mops complete the operation.
The combination of automation
and enhanced abrasives achieves a
more consistent finish and extends
media life. By comparison with
manual production, robotics typi-
cally reduces the number of indi-
vidual finishing operations from
eight to six. The major benefit is
an increase in productivity. It can
take 45 to 90 minutes to hand
polish and buff a hip implant; a
robot can do it in 8 minutes.
Contact lens packaging
A key challenge in packing contact lenses
is handling the lenses and placing them
in blister packs. A manual line normally
consists of a series of bespectacled opera-
tors using tweezers to pick up lenses from
water baths and place them in packs. An
automated system has been developed to
replace this manual operation.
In this application, the lenses are deliv-
ered to the robot in trays. Multiple trays
are carried in a basket. The trays have 24
pockets, each of which has drain holes,
containing a single moulded lens. The first
robot takes the baskets and places them in
M. Wilson and D. Bradford, Automation Advisory Service Ltd, Banbury, UK
The Rise of the Robots
32 EMDT1102 32 1/28/11 8:53:46 AM
tanks of de-ionised water to keep the lenses
wet. The lenses float in their pockets but
are trapped in the cavity by an empty tray
placed above.
The robot then removes two trays from
the basket. In the process, most of the water
drains out of each pocket, leaving just the
lens. The trays are then passed to three other
robots, which pick the lenses and place them
in blister packs that are accurately fed to
the robots via a conveyor system. A special
vacuum-based gripper was developed to
enable the damp lenses to be picked at high
speed and placed in the packaging.
The precise position of the lens within the
pocket is unknown; consequently, a vision
system is used to identify its location so the
robot can accurately pick it. Appropriate
lighting is a key element of the system, as the
vision technology needs to differentiate the
clear contact lens from a clear background.
The vision system also performs quality
control because it ignores any lenses that
have become folded. A downstream vision
system ensures that a lens is present in every
blister pack. Data from the vision systems is
consolidated in the control system to ensure
that the output matches the number of
lenses fed into packaging minus any defects.
This system processes 300 lenses per
minute. Initially, it was estimated that seven
systems would need to be installed. The line
was found to be so effective that only two
were needed to meet the companys produc-
tion requirements.
Automated assembly and testing
Medical device assembly covers a broad
range of products from sutures and cannu-
lae to inhalers. Assembly systems are often
high-volume dedicated machines based on
a linear index or rotary table approach.
Items such as syringes and needles can be
produced at 1000 parts per minute. More
difficult parts such as catheters are typically
assembled at about 60 parts per minute.
Inspection and testing, often at 100% of
production, is incorporated within the sys-
tem. There is generally little flexibility built
into these systems.
However, the initial design of these
machines presents a problem. A new prod-
uct must undergo a lengthy and stringent
testing programme before it can be placed
on the market. A significant number of
sample parts, which could be on the order
of 200,000, are required for testing by
the company as well as various regulatory
bodies. It is not cost effective to build the
final assembly system for a limited run, and
manual production is not an alternative.
Therefore, low-volume pilot manufacturing
systems are built, which are increasingly
reliant on robots. Although robots are
slower than dedicated automation, they are
easier to set up to perform multiple tasks
and are better suited to low-volume prepro-
duction systems.
Even in some high-volume applications,
robots can be a cost-effective alternative to
special-purpose automation. Robotic motion
is defined by software, whereas the motion
of special-purpose automation is normally
defined by mechanical design. The robot
accommodates changes late in the design
and manufacturing cycles and provides a
low-risk alternative to conventional automa-
tion, which is not as nimble in adapting to
product or system design revisions.
Vision is increasingly used for product
inspection. As mentioned earlier, this can
include measurement of critical dimensions
as well as inspection of product features.
For example, vision technology can be used
to check mouldings for the absence of flash,
which could affect product performance
and generate contamination during use.
Final packing
Automation is widely used in final packing
operations. Packaging is not subject to the
same approvals as the actual products and
can change much more frequently to meet
customer demands. Packing systems often
include robots because of the flexibility
they provide. For example, a robotic sys-
tem automates the pick-up of flow-packed
droppers from a conveyor, using vision
technology to identify the positions of the
droppers. The robots place the droppers in
a carton along with a bottle containing pen-
icillin. These packing systems are relatively
standard robot applications and, therefore,
proven solutions are commonly available.
System design and implementation
Some companies specialise in automated
systems for medtech applications. However,
they typically have more experience design-
ing high-volume, dedicated systems rather
than robots. Conversely, there are many
robot system integrators, but they often
have limited experience meeting the unique
requirements of the medtech sector. To find
the optimal solution, OEMs should discuss
their requirements with a range of suppliers.
To communicate effectively with suppliers,
the customer must develop detailed user
requirement specifications. The specs should
itemise appropriate information such as the
tasks to be performed, required throughput,
product details including tolerances and
details of the component input methods and
required presentation at the output.
Development of the specification can be
time consuming, but it provides the key to
successful system implementation. The lack
of clear and detailed specs at the outset of a
project can result in a system that does not
perform to user expectations.
Good specifications also provide the
opportunity to consider suppliers who may
have less experience working in the medical
device arena but who have gained expertise
in other sectors that could lead to valuable
insights and foster new ideas. They may
need additional support during the project
to ensure they understand and achieve
compliance with the relevant standards,
but if they come up with a fresh approach
and better solution, the initial investment in
time may yield a lower overall cost.
To achieve compliance with standards and
validation, automation is almost becoming
mandatory in the medtech industry. Height-
ened cost pressure will drive manufactur-
ers to use the most cost-effective solutions.
Increasingly, these will be flexible systems
based on robots and they may well be deliv-
ered by integrators new to the sector. 1
Mike Wilson and David Bradford
are Directors, Automation Advisory Service Ltd,
28 Hightown Road, Banbury OX16 9BY, UK
tel. +44 7812 766 639
e-mail: mike.wilson@automationadvice.co.uk
www.automationadvisoryservice.com
33 EMDT1102 33 1/28/11 8:53:51 AM
SHOW PREVIEW: BIOMEDEVICE
2324 February 2011
Paris, France
www.biomedevice-europe.com
BIOMEDevice
Returns to Paris
The event will attract professionals from
the biotechnology, medical device and
pharmaceutical industries
Now in its second year, BIOMEDevice Europe is a com-
bined trade show and conference dedicated to furthering
the development of combination devices. Scheduled for 23
24 February, the event will be held jointly with Pharma-
pack at the Grande halle de la Villette in Paris. More than
40 companies will present their products and services at
the event. Show organiser UBM Canon, which also pub-
lishes this magazine, expects the event to attract approxi-
mately 2800 visitors, including executives, engineers and
researchers looking for new partnership opportunities and
sourcing innovative technologies.
Topics to be discussed during the conference programme
include market trends and opportunities for combination
products, new materials and technologies, and regulatory
updates pertaining to France, the United Kingdom and the
United States. The frst day of the conference will highlight
the observations of experts from US FDA, Afssaps, MHRA
and notifed bodies. The second day of the conference will
focus on technological challenges linked to the development
of combination products. Presentations will be given by
experts from academia and the industry. A complete confer-
ence schedule is available at www.biomedevice-europe.com
and www.pharmapack.fr.
34 EMDT1102 34 1/28/11 9:15:25 AM
IMPIANTI SOLARI
EXPO
MECSPE PLASTIXEXPO EUROSTAMPI SUBFORNITURA CONTROL ITALY MOTEK ITALY AUTOMOTIVE LOGISTICA TRATTAMENTI
& FINITURE
35 EMDT1102 35 2/2/11 1:34:41 PM
SHOW PREVIEW: BIOMEDEVICE
Gas filters
Gas filters from Pall provide protection
from the risks of cross-contamination
between patient and equipment. The
Intervene filters are designed to support
high air flow rates. Built using a
lightweight housing construction, the
filters offer bidirectional flow capabilities
to eliminate orientation concerns.
They are manufactured in an ISO
13485certified production facility and
tested for particle retention efficiency
using EN 1822 and IEST-RP-CC001.5
guidelines. Intervene filters with a 1-m
PTFE membrane meet ULPA standards.
Pall Medical
www.pall.com
Stand 370
Assembly system
Mikron Automation has developed
an assembly system that is designed to
accommodate large production volumes.
The assembly system meets GMP norms
and complies with current safety directives.
When designing the G05 assembly system,
the manufacturer endeavoured to meet its
customers evolving requirements in terms
of ergonomics and to minimise noise levels
on conveyors and pallets.
Also available from the company is the
EcoLine automation platform, which is
designed to accommodate manual, semi-
and fully automatic standard modules.
The linear system allows work to be
performed on both sides of the machine,
thus maximising floor space. Designed by
the firms Singapore-based subsidiary, this
platform is a suitable production unit for
the assembly and testing of products for
emerging markets and for low to medium
production volumes.
The software and hardware of
the above two assembly systems are
compatible and complementary, enabling
them to be conjoined to develop assembly
systems that address the needs of the
pilot line as well as applications requiring
complete automation.
Mikron Automation
www.mikron.com
Stand 255
Flexible and rigid packaging
Manudo Medical processes plastic
sheets using high-frequency welding and
thermoforming to produce packaging for
the medical device and pharmaceutical
sectors. The company designs and
manufactures flexible and rigid containers
and bags for biotechnology, cell culture
and implant applications. Drainage bags
and flexible packaging also are available.
Furthermore, the firm offers a number
of additional services including design,
prototyping, bacteriological testing,
process implantation, validation and
traceability control. An array of packaging
materials suited for medical applications
are available from the company, which
operates Class 10,000 and Class 100,000
cleanrooms.
Manudo Medical
www.manudo.fr
Stand 281
Exhibition Highlights
Cleanroom-Compatible Sealing System
Offers Versatility
Headquartered in the village of Peschadoires in the centre of France, Top Clean
Packaging Group has developed a novel sealing system at its facility in Suzhou,
China. The company had been using sealers made by other companies but, notes
Franois Berry, President of Top Clean
Packaging Group, they never quite
satisfied the companys demands. Berry
tasked his engineers and development
staff to come up with an alternative.
The resulting machine, the Cartolux 500,
is built on a solid frame and provides 6 bar
of air pressure. Designed for cleanroom
use, the sealing machine does not use pins on the sealing frame. Instead, a silicone
plate is wedged between two metal sealing plates. Sealing parameters such as pressure,
temperature and cycle time can be set by means of a PLC with a touch screen and stored
for future use. The tools and machine comply with IQ, OQ and PQ protocols.
The compact sealing machine is available either as a standalone unit; with tools,
settings and sealing qualification tests and controls; or as a complete package that
includes the blister packs and lids and a variety of services from the firm, including
packaging qualification and on-demand outsourcing to help manufacturers to
accommodate production peaks.
Top Clean Packaging Group
www.topcleanpackaginggroup.com
Stand 340
CLOSE UP
36 EMDT1102 36 2/2/11 1:35:38 PM
TABLE OF CONTENTS
MARKETPLACE
43 44
42 38
Find a wealth of additional sourcing
information, article archives and original
content on our website, emdt.co.uk.
38 Engineering Insight
40 Spotlight on Cables, Connectors
and Wires
42 First Look
43 In Focus: Contract Services
44 In Focus: Moulding
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37 EMDT1102 37 1/28/11 9:21:39 AM
MARKETPLACE: ENGINEERING INSIGHT
HYBRID STEPPER MOTORS can produce a tremendous number
of stepsoften as many as 200per revolution. Because of this
capability, hybrid motors offer the technical advantage of high
torque at start and at low speeds. Resolution can be increased by
driving the motor in micro-steps, resulting in smoother movement
and more precise positioning. These characteristics enable engi-
neers to reduce the size of the gearbox or even eliminate it entirely,
which can represent a considerable gain in the end systems reli-
ability and compactness. Additionally, hybrid steppers are based
on brushless technology. Parts do not exhibit wear, resulting in a
longer service life than alternative technologies. Because of these
features, hybrid stepper motors are widely used in medical auto-
mation applications requiring less than 50-W mechanical power.
Hybrid steppers need to be electronically commutated. Tra-
ditionally, these motors have been driven in open-loop mode,
which results in a size handicap: this type of motor typically
is supersized to ensure correct operation with no step loss
or stalling. Even though this is a cost-effective solution that is
widely used and has been proven in many applications, it still
carries an inherent risk of malfunction. The use of a physi-
cally larger motor does not guarantee that the machine will not
occasionally block for unknown reasons. When a motor runs
in open loop, this malfunction will not be detected and could
cause severe damage to the load or the machine itself. For this
reason, most hybrid stepper motors used in medical or labora-
tory devices are linked to an encoder, which enables permanent
and precise angle measurements.
The encoder is used by the motor driver or machine control
unit to check the actual operation of the motor. Depending on
the sensitivity of the application, different types of encoders may
be specified. For critical applications, the encoder resolution has
to be quite high and accurate, especially when the motor oper-
ates in direct drive with no reduction factor. Optical encoders are
often back-mounted on the motors for these types of applications.
Standard motors are also available with a double shaft to permit
different types of assembly. It should be noted that expertise and
attention to detail are required when performing the final assem-
bly of such a delicate component.
Specifying encoders
Encoders typically are quite expensive, difficult to assemble and
tend to be unprotected. Moreover, they require open space along
the length of the drive axis. To minimise these technical draw-
backs, a hybrid stepper motor with integrated encoder has been
developed. The encodera rotary sensorcan replace many
optical encoders in most automation devices advantageously
whilst helping customers to reduce costs. Its technical character-
istics can fulfill many requirements of the medtech industry. This
newly developed system offers high resolution, 5920 counts per
revolution1480 pulses 2 channelsas well as an index signal
mechanically referenced to the motor shaft. The system not only
provides fine resolution accuracy but also exhibits less than 0.3
linearity and costs less than a comparable optical solution. High-
lights include:
Ruggedised engineeringvibration and wide temperature ranges 0
will not affect operation.
Wear-free operation that guarantees a long service life. 0
Encoders are directly mounted on the motor and fully tested on 0
the production line. The encoder is encapsulated in a metal and
plastic housing that protects sensitive elements.
Component integration that saves spacethe actual design is 0
suitable for NEMA 23 and 34 motors but is small enough to be
integrated in a NEMA 17 upon customer request.
This electromagnetic system also can run in a true closed loop
using the latest generation of drivers from Sonceboz, resulting in
a fully integrated motion system. The LoadSense driver estimates
J. Antille and Y. Meyer, Sonceboz SA,
Sonceboz, Switzerland
Hybrid stepper motors with integrated encoders that combine performance and precision are
suitable for a range of medical automation applications.
A Step Up in Motion Control
The motor, encoder and electronics can be encapsulated in a single unit.
38 EMDT1102 38 1/28/11 9:48:56 AM
the payload, i.e. the torque
required by the motor in
real time. Driver parameters
adapt instantly, thus ensur-
ing that the hybrid stepper
is free of any step loss. If
required for security reasons,
the encoder signals still can
be output independently.
When motion is auto-
mated, the motor controls
its acceleration ramps in
relation to the actual forces
in playand, thus, for
every single movementin
real time. This technology does not require a safety margin:
instantly knowing the payload that is being applied to the motor
makes it possible to achieve optimal performance. Under these
circumstances, the maximum speed depends on the real forces
affecting the motor, and not simply on a theoretical payload.
The system enables permanent controls in real time and pro-
duces acceleration without an increase in inertia. In most
cases, the technology can be a key driver in increasing pro-
ductivity of an overall system. Gains of nearly 30% have been
observed. The closed-loop technology is currently available for
NEMA 23 and 34 motors but is adaptable for NEMA 17 sizes
upon request.
Hybrid stepper motors with integrated encoders come into
their own where torque at low speed, positioning and accu-
racy are determining factors. Their intrinsic electromagnetic
attributes make them suitable for a range of medical and labora-
tory automation applications. 1
*Jacques Antille
is Key Account Manager and
Yvan Meyer
is Business Unit Manager at Sonceboz SA, 5, Rue Rosselet Challandes,
CH-2605 Sonceboz, Switzerland
tel. +41 32 488 1317
jacques.antille@sonceboz.com
www.sonceboz.com
* to whom all correspondence should be addressed
Hybrid stepper motors with integrated
encoders combine accuracy and
compact dimensions.
www.medteceurope.com
Sponsored by:
16340_EU_MT1 T11
For more information and to register, please visit:
22-24 March 2011
Messe Stuttgart, Stuttgart, Germany
10th Edition of the International Exhibition of Manufacturing and Automation
Technology, Materials and Outsourcing for European Medical Device Manufacturers
39 EMDT1102 39 1/28/11 9:49:03 AM
Spotlight
MARKETPLACE
4
2
3
1
Cables, Connectors and Wires
1 Cables and wires
The Xtra-Guard Flex cable line
available from AlphaWire can
withstand continuous flexing,
including multiaxis torsional
movements, making it suit-
able for linear motion systems
and Cartesian and articulated
robotics. The manufacturer
also offers hook-up wire in a
variety of insulations to meet
requirements related to temper-
ature, wear and abrasion resis-
tance, electrical performance or
resistance to oil, solvents and
chemicals.
AlphaWire
Sunbury-on-Thames, UK
+44 8002 888 809
www.alphawire.com
2 Push-pull cylindrical
connectors
Connectors specialist ODU
Steckverbindungssysteme has
introduced an online product
configurator for its Medi-Snap
cylindrical connectors, which
feature plastic push-pull locking
components. Accessible from the
website listed below, the product
configurator enables users to
select from various parameters
such as current, voltage and
coding to configure the push-
pull cylindrical connectors for
specific applications.
ODU Steckverbindungssysteme
GmbH & Co. KG
Mhldorf, Germany +49 8631 615 640
www.odu.de
3 Rugged connectors
The UltiMate series of connec-
tors from Fischer Connectors is
designed for use in harsh envi-
ronments. Suited for various
medical device applications,
the connectors line features
EMC 360 high-performance
shielding and high shock and
vibration resistance. It sup-
ports an operating temperature
of 55 to 135C. The connec-
tors are rated for 10,000 mat-
ing cycles and are available in
a variety of body styles, sizes
and configurations.
Fischer Connectors SA
Saint-Prex, Switzerland
+41 21 800 9595
www.fischerconnectors.ch
4 Surface mount
connectors
A line of custom surface mount
connectors minimises board
space by using the perimeter of
circular and other odd-shaped
PC boards. The manufacturer
can provide an affordable design
and rough sample for electrical
and mechanical testing. SMT
perimeter connectors are created
from FR-4 insulators on driller
and routing machines and incor-
porate screw-machined solder
ball terminals on both the male
header and the mating female
connector.
Advanced Interconnections
West Warwick, RI, USA +1 401 823 5200
www.advanced.com
40 EMDT1102 40 1/28/11 9:50:55 AM
6
8 7
5
5 Push-pull connector
The Redel XP patented plastic
push-pull connector line fea-
tures a latching system that is
embedded in the shell, offering
high impact resistance and con-
tact density. The connectors
self-latching system is designed
to facilitate quick mating and
unmating. The connector line
offers multiple contact and
colour configurations and suits
a variety of medical or mea-
surement applications, from
catheters to surgical instru-
ments. The manufacturer is
certified to ISO 9001:2000.
LEMO SA
Ecublens, Switzerland +41 21 695 1600
www.lemo.com
6 RF connector
The MedEasyLock connector
series is designed specifically
for use in medical equipment.
Instead of using a threaded
mechanism, the connectors
have a quick-lock coupling
mechanism that enables fast
mounting while maintaining
a reliable connection. The
connectors also have an
extended connector housing
that provides strain relief and
prevents bending and damage to
the cable, thus ensuring reliable
electrical performance during
the entire product life.
Quadrant Connections
Radlett, UK +44 1923 851 400
www.quadrantconnections.com
7 Radiopaque wire
Custom-manufactured clad
composite radiopaque wires
for use with catheters, stents,
implantable coils and related
devices are available from
Anomet Products Inc. The wires
feature platinum and platinum-
iridium, tantalum and tantalum-
tungsten, and similar alloys
in clad composite with high
strength wires such as 316LVM
stainless steel, nitinol and
MP35N. An alternative to solid
wires with marker bands, the
clad composite wires improve
visibility under fluoroscopy.
Anomet Products Inc.
Shrewsbury, MA, USA +1 508 842 3069
www.anometproducts.com
8 Metallic wire
and tubing
Euroflex offers tubing, wire and
sheet from a variety of materials
in an array of sizes and con-
figurations with various sur-
face options. Material options
include nitinol, stainless steel,
cobalt-based alloys, titanium
alloys, tantalum, platinum
alloys and magnesium. The
materials are manufactured to
high standards and are primar-
ily used in the medical industry.
Typical applications include
stents, filters, baskets and
guidewires.
Euroex GmbH
Pforzheim, Germany +49 7231 208 210
www.euroflex-gmbh.de
41 EMDT1102 41 1/28/11 9:51:02 AM
MARKETPLACE
First Look
A roundup of noteworthy new materials, components and
equipment suited for medical technology applications
RF capacitor series includes
nonmagnetic terminations
AVX Ltd, a manufacturer of advanced passive components and
interconnect products, has expanded its porcelain and ceramic dielectric
multilayer capacitor chip product offerings to include nonmagnetic
termination versions. Designated the SQ Series, the RF capacitors are
rated at 50 to 500 V dc with capacitance values ranging from 0.1 to
1000 pF. Suitable for medical devices such as MRI coils, the SQ Series
capacitors offer low equivalent series resistance and high Q, current and
self-resonance frequency values.
AVX Ltd
Fleet, UK +44 1252 770 000
www.avx.com
LED light source offers reliability
Asetronics has introduced the ASELight Star, a replacement product for
Osram Ostar Lighting. The successor product has been developed in
collaboration with Osram Opto Semiconductors on the proven basis of
the previous LED and is produced and sold exclusively by Asetronics.
The Ostar Lighting Plus LED light source is the basis for the ASELight
Star. The module is based on the identical hexagonal platform as the
product it is replacing, making it possible to use the ASELight Star as a
1:1 replacement in existing systems. The new four-chip version achieves
a brightness of 700 lm at 700 mA. The proven hexagonal design allows
high packing density: several ASELight Star modules can be combined
in a mosaic pattern to achieve large lighting surfaces with a broad range
of contours.
Asetronics
Bern, Switzerland +41 31 329 3111
www.asetronics.ch
Medical ultrasound development kit
accelerates time to market
An ultrasound beam-forming development kit has been introduced
by Samplify Systems Inc. Based on the companys AutoFocus beam-
forming technology, the SMK9130 is described as a complete hardware
solution for the ultrasound front end, reaching from probe connector to
PCIe connector. The kit allows OEMs to start developing their image
processing algorithms with known good hardware in advance of the
availability of their production systems. Software development and
system integration time is minimised, and OEMs gain a competitive
advantage by bringing product to market more quickly and cost-
effectively, according to the firm.
Samplify Systems Inc.
Santa Clara, CA, USA +1 408 249 1500
www.samplify.com
42 EMDT1102 42 1/28/11 10:27:19 AM
MARKETPLACE
In Focus
Contract Services
Contract engineering services
ISO 13485:2003certified contract medical
device and diagnostic developer and US
FDAregistered contract manufacturer
Inteprod provides engineering and
manufacturing services to the medical
device industry. The manufacturer
supports medical technology and life
science companies with a strategy that
begins with a concept and ends with a
finished product. The firm explains that
this approach provides customers with a
strategic advantage in reduced costs and
faster time to market. Experienced and
proficient in the design, development and
manufacture of advanced technologies, the
company states that it has a direct impact
on the progress, application and success of
new technologies.
Inteprod
Eagleville, PA, USA +1 610 650 9002
www.inteprod.com
Surface modification services
Biomat specialises in developing products
and surface modifications for biomedical
applications. The company offers coating
services that employ biological molecules
ranging from Biotin to various proteins.
The firm offers R&D, engineering and
biological coating services. The company
also can produce plastic parts for
applications such as immunoassays and
offers research with modified surfaces. It
processes more than 20,000,000 pieces
per year.
The firm has more than 15 years of
experience developing surface modification
and coating technologies. Its production
capability enables it to serve a variety of
customers ranging from researchers to
pharmaceutical industries.
Biomat srl
Rovereto, Italy +39 0 4644 43320
www.immunosurface.com
Contract services
Donatelle provides contract medical device
manufacturing services to a global
customer base. The companys capabilities
include assembly, packaging and
sterilisation management. Certified to ISO
9001 and ISO 13485, the company
complies with US FDA guidelines. Available
services include engineering; rapid
prototyping; in-house tooling design and
fabrication; micromoulding, insert
moulding and overmoulding; white room
and cleanroom moulding and assembly;
liquid silicone injection moulding; and the
precision machining of metal and plastic
components.
Donatelle
New Brighton, MN, USA +1 651 633 4200
www.donatellemedical.com
Bespoke Plastic Parts
Offered for Microfluidic
Devices
Carville is an ISO 9001certified
contract services provider
offering custom plastic
components to the medical
sector. The company produces
a variety of components
ranging from microfluidic
devices to manifolds for
clinical diagnostics and quality
assurance phantoms for use in x-ray, CT and MRI scanners.
The manufacturer also offers a range of manufacturing and machining services
including heat treatment and preparation of plastic materials, autoclave casting of
special materials in controlled environments, CNC milling, CNC turning, plastics
bonding and cementing, plastic polishing and finishing, and product assembly and
final testing. As a contract manufacturer, the company can support customers with
single-unit prototypes as well as high-volume production quantities.
Carville Ltd
Dorking, UK +44 1306 881 681
www.carville.co.uk
43 EMDT1102 43 1/28/11 11:34:56 AM
MARKETPLACE
In Focus
Moulding
Custom-moulded spacers
High strength and heat resistance as
well as unique electrical properties
are among the features of bantam
jack spacers and similar electrical and
electronic components custom moulded
by Minnesota Rubber and Plastics. The
PEI bantam jack spacers also offer high
hydrolytic and UV stability as well as
radiation resistance. The PEI material
that is used in the spacers is suited for
repeated steam, hot-air and cold chemical
sterilisation. It is inherently flame
retardant and can be used at continuous
temperatures up to 375F. To add extra
strength to the spacer design, the PEI
resin can be reinforced with glass fibres
as well as other materials such as carbon.
The custom bantam jack spacers can be
combined with other high-performance
plastic and elastomer components to form
a complete assembly.
The company also offers compre-
hensive design services, which include
preliminary engineering assistance and
mechanical design review as well as
materials engineering. Furthermore,
the firm provides rapid mould design
and development, FEA analysis, proto-
type services, process engineering, and
injection, compression, transfer and
liquid-silicone-rubber moulding. The
manufacturer also can assist with metal-
to-plastic conversions.
Minnesota Rubber and Plastics
Pacy-sur-Eure, France +33 2 3222 2410
www.mnrubber.com
Plastic injection moulding
services
Specialising in the engineering of
thermoplastic and silicone, MediConcepts
is a medical device contractor that provides
a variety of cleanroom manufacturing
services including plastic injection
moulding, double injection moulding,
overmoulding and insert moulding. It
routinely processes common thermoplastics
such as polycarbonate, nylon and
polyurethane. The company also processes
advanced thermoplastics such as PEEK,
PEI, and liquid silicone rubber. Moulded
parts produced by the firm include silicone
valves and plastic parts used in
laparoscopic products such as tissue
retrieval bags, and handheld instruments
and trocars. The company is certified to
ISO 13485 and compliant with QSR and
US FDA requirements.
MediConcepts Ltd
Hong Kong +852 2838 0300
www.mediconcepts.com.hk
Precision Moulds Comply with CGMP Guidelines
High-precision moulds for preproduction and multicavity applications that are
compliant with CGMP guidelines are available from IGS GeboJagema, a manufacturer
certified to ISO 9001:2008 and ISO 14001. The company also offers project tooling
and moulds that are suitable for the production of precision plastic parts used in
products such as multicomponent medical devices or single-use medical disposables.
The moulds are typically used to manufacture components for metered-dose and
dry-powder inhalers, blood-monitoring devices and single-use medical disposables.
The Dutch company has recently invested in an Engel 300-ton injection moulding
machine, which has been installed in
an on-site cleanroom.
According to the company, its
manufacturing standards ensure
that millions of components per
cavity can be obtained before a
major refurbishment is required.
The manufacturer employs quality
assurance procedures such as 3-D
computerised measurement during
the entire manufacturing process. Its
technical centre also has the moulding
machines and process operators
required to run factory acceptance tests. The company routinely works with its
customers throughout the entire production process. It offers project management,
engineering services and consultancy, prevalidation, and service, maintenance and
global support for its products. Early engineering assistance is also available to help
ensure an efficient mould approval process.
IGS GeboJagema
Tilburg, Netherlands +31 13 467 2950
www.igsgebojagema.nl
44 EMDT1102 44 1/28/11 11:40:53 AM
Advertiser Page Advertiser Page
C L A S S I F I E D S
To advertise in this section please contact
Helene Beck, e-mail: helene.beck@ubm.com
tel. +1 732 970 8960 fax. +1 732 970 0334
CLASSIFIEDS
ADVERTISERS INDEX
This index is offered as a service. The Publisher cannot be held
responsible for errors or omissions.
25 Edicott St., Norwood, MA 02062
general@appliedplastics.com
www.appliedplastics.com
Senaf srl .....................................................................................35
www.senaf.it
Schober GmbH ............................................................................... 7
www.schober-gmbh.de
Siams SA ....................................................................................... 5
www.medisiams.ch
Taipei Trade Show ....................................................................... 20
www.taihealth.com
TechDevice Corp.......................................................................... 19
www.techdevice.com
Unimed SA .................................................................................... 6
www.unimed.ch
Vesta Inc..................................................................................... 29
www.vestainc.com
AdvanSource Biomaterials ........................................................... 11
www.advbiomaterials.com
Alpha Wire Co. .............................................................................. 6
www.alphawire.com
Applied Plastics Co. ......................................................... Classified
www.appliedplasticsinc.com
Ark-Plas Products Inc. ................................................................... 4
www.ark-plas.com
CSA International .......................................................................... 2
www.csa-international.org
Foster Printing ............................................................................ 21
www.fosterprinting.com
Lemo SA ...................................................................................... 47
www.lemo.com
Machine Solutions Inc. ................................................................ 13
www.machinesolutions.com
Master Bond Inc. ........................................................................... 4
www.masterbond.com
maxon motor AG .......................................................................... 25
www.maxonmotor.com www.maxonmedical.com
Medilingua Medical Translation ................................................... 31
www.medilingua.com
Nordson EFD ................................................................................48
www.nordsonefd.com/ads/emdt-0211
Protomed ...................................................................................... 9
www.protomed.fr
Raumedic AG ............................................................................... 17
www.raumedic.com
www.MDEAwards.com
VISIT OUR WEB SITE FOR COMPLETE INFORMATION.
Transforming Healthcare One Innovation at a Time
ENDORSED BY:
1
7
8
5
1
_
M
D
E
A
1
1
SPONSORED BY: PRESENTED BY:
45 EMDT1102 45 2/2/11 1:37:03 PM
FIVE MINUTE INTERVIEW
Q If I were not talking to you right now, what would you
be doing?
A I would be working with my colleagues on one of the research
projects Im currently carrying out that focuses on developing
health economics for medical devices. These days, I am mainly
involved in areas such as funding and access to technological
innovation in healthcare systems, procurement of medical devices
in hospitals, and assessment of the broad socio-economic value of
medical technologies for European economies.
Q How did you get in the industry?
A A headhunter asked me whether I would be interested in
working for Eucomed, the European Medical Technology
Industry Association. After several requests, I decided to go
ahead with interviews. Why? Because I was intrigued by the
challenges that would come with the position. Challenges
always excite me!
Feeling the need for more reputable, evidence-based data on
the value of medical technology, the European Health Technol-
ogy Institute for Socio-Economic Research (EHTI) was founded
in 2006 and it was consequently an exciting step to go from my
position at Eucomed to becoming Executive Director of EHTI.
Q What is the best thing about your work?
A It is never the same. I never get bored and never get tired.
My work always recharges my batteries! My previous work at
Eucomed and what I do now at EHTI is fascinating because medi-
cal technology has such a profound impact on peoples health and
well-being. It is particularly motivating to know that the work we
do helps to improve the quality of life for millions of people.
Q What do you think is the most important medical device
invention ever?
A The invention of the invention! The high dynamism of this sector
is very promising and gives people peace of mind knowing that our
industry is already at work today to prevent or cure disease that
may affect our health tomorrow. On average, a new and improved
iteration of a medical technology is developed every 18 months,
and procedures that would have required days of hospitalisation,
such as cataract surgery, are now performed in an outpatient set-
ting. All these inventions and innovations truly impact peoples
lives for the better
Q What should people give more attention to?
A Quality! Quality is what makes the difference between just
living and living well. Technological innovation is one of
the most important drivers of quality of life and it is therefore
EHTIs and my personal commitment to carry out qualitative
and robust research projects. Only then can we make this still
too-green field of economic science as relevant as more mature
health economics applications and put it high on the agenda of
policy-makers.
Q What is the most exciting development on the horizon?
A Increased well-being at an older age. Nowadays, retirement
means being healthy enough to enjoy the things you love. And
this is possible thanks to medical technology. What is available
today could only be dreamt of yesterday, and the pace of inno-
vation is increasing evermore. It is EHTIs job to demonstrate
and quantify how relevant this evolution is to all of us.
Q What is the measure of success for EHTI as an independent
research institute?
A The success of EHTI lies in its components. The best
researchers in Europe are committed to pursuing high-level
research in collaboration withand driven byindustry and
policy makers. EHTIs work can be defined as actionable
research, because it not only aims to be published in peer-
reviewed journals but also, and more importantly, it wants to
support the health-related decision-making process in Europe.
In that regard, EHTI is truly unique! 1
EMDTs series of interviews offers personal perspectives on the diverse and
dynamic medical device technology industry. Here, we talk to Professor
Rosanna Tarricone.
Professor Rosanna Tarricone is
Executive Director of the European Health
Technology Institute for Socio-Economic
Research (EHTI), an independent research
institute aimed at developing data and evidence on the
social and economic value of medical technology and
its impact on the economy and welfare of European
countries. EHTI is composed of prestigious European
universities (Universit Bocconi and the London School
of Economics), policy-makers and industry (Eucomed). She can be contacted at
214d Chausse de Wavre, B-1050 Brussels, Belgium
tel. +32 2 626 9575
e-mail: rosanna.tarricone@ehti.info
www.ehti.info
The Metrics of Living Well
46 EMDT1102 46 1/28/11 11:44:10 AM

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