See

discussions, stats, and author profiles for this publication at: https://www.researchgate.net/publication/4368923

A Survey of Success Factors in New Product

Development in the Medical Devices Industry
Conference Paper July 2008
DOI: 10.1109/IEMCE.2008.4617987 Source: IEEE Xplore

CITATIONS

READS

14

181

5 authors, including:
Alan Brown

Dorian Dixon

Ulster University

Ulster University

14 PUBLICATIONS 117 CITATIONS

57 PUBLICATIONS 312 CITATIONS

SEE PROFILE

SEE PROFILE

Julie Eatock

Brian J Meenan

Brunel University London

Ulster University

32 PUBLICATIONS 206 CITATIONS

139 PUBLICATIONS 1,491 CITATIONS

SEE PROFILE

All in-text references underlined in blue are linked to publications on ResearchGate,

letting you access and read them immediately.

SEE PROFILE

Available from: Dorian Dixon

Retrieved on: 08 October 2016

A Survey of Success Factors in New Product

Development in the Medical Devices Industry
Alan Brown, Dorian Dixon, Julie Eatock, Brian J. Meenan and Terry Young

AbstractThis study of the factors that are correlated with

success in New Product Development (NPD) is based on 68
responses to a survey of medical device companies in the UK and
Ireland. It was found that the degree of technological innovation,
the involvement of end users in the development process, the
dissemination of NPD priorities to staff, and the use of financial
analysis throughout the development process were all correlated
with success in a statistically significant manner. These findings
demonstrate the importance of innovation, integration and the use
of financial metrics to sustained product development success. In
addition, this survey found that new-to-the world innovations
made up only 4.4% of NPD projects in larger companies and
9.3% of NPD projects in small and medium sized enterprises.

one reason for this ongoing success [3]. The management of

innovation and the related processes of new product
development (NPD) will play a key role in the future success
of this industry. It is therefore of real importance to understand
the mechanisms by which new innovations are most
successfully commercialised. The research reported here aims
to identify factors that are correlated with the commercial
success of a product in a statistically significant manner. This
paper describes a benchmarking survey of NPD in medical
device companies in the UK and Ireland, and discusses the
implications of these findings for the sector.
II. LITERATURE REVIEW

Index TermsMedical devices, Product development,

Research and development management, Technological
innovation,

I. INTRODUCTION

OMMERCIAL success of new products is the ultimate

benchmark of new product development and innovation.
The medical devices industry is viewed as being an innovative
[1,2] and commercially successful manufacturing sector. The
increasing spending on healthcare in developed countries is

Manuscript received January 25 , 2008. The authors acknowledge support

of this work through the UK MATCH Programme (EPSRC Grant
GR/S29874/01), although the views expressed are entirely their own.
A. Brown is with the Multidisciplinary Assessment of Technology Centre
for Healthcare (MATCH), in the Nanotechnology and Integrated
Bioengineering Centre at the University of Ulster, Shore Road,
Newtownabbey, BT37 0QB (Tel: =442890368925, Fax:=442890366863,
email: a.brown@ulster.ac.uk).
J. Eatock is with the Multidisciplinary Assessment of Technology Centre
for Healthcare (MATCH), in the School of Information Systems, Computing
and Mathematics at Brunel University, Uxbridge UB8 3PH. (email.
Julie.eatock@brunel.ac.uk)
D. Dixon is with the Multidisciplinary Assessment of Technology Centre
for Healthcare (MATCH), in the Nanotechnology and Integrated
Bioengineering Centre at the University of Ulster, Shore Road,
Newtownabbey, BT37 0QB (email: d.dixon@ulster.ac.uk).
B.J. Meenan is with the Multidisciplinary Assessment of Technology
Centre for Healthcare (MATCH), in the Nanotechnology and Integrated
Bioengineering Centre at the University of Ulster, Shore Road,
Newtownabbey, BT37 0QB (email: bj.meenan@ulster.ac.uk).
T. Young is with the Multidisciplinary Assessment of Technology Centre
for Healthcare (MATCH), in the School of Information Systems, Computing
and Mathematics at Brunel University, Uxbridge UB8 3PH. (email.
terry.young@brunel.ac.uk)

978-1-4244-2289-0/08/$25.00 2008 IEEE

For some time improving the process used to develop new

products has been viewed as a way to increase revenue and
profit. To this end, the statistical analysis of data sets from
questionnaires has been used to identify those factors that
differentiate between success and failure in NPD. One early
study published in 1974, adopted the approach of investigating
success and failure pairs to ascertain the differentiating factors
[4]. This study concluded that product success was related to
understanding user needs, attention to marketing, efficiency in
development, effective use of outside technology and
management seniority and authority. Other more recent studies
investigated successful and unsuccessful product pairs in an
attempt to relate success to the proficiency of various
development activities [5,6].
A second approach that has been adopted is to focus on the
proficiency of the development process itself. This approach
was adopted by Cooper and Kleinschmidt [7] who reported
that a complete NPD process was more likely to produce a
successful product. In addition they found that success was
particularly influenced by the predevelopment activities
including preliminary market assessment and technical
analysis. Rochford and Rudelius [2], in their survey of 79
medical device companies, found that preliminary technical
analysis and initial market activities were more likely to be
carried out for successful products. Millson and Wilemon [8]
reported that proficient NPD was related to product success
and in particular highlighted the importance of customer
integration during the early stages of development.
In this study the effects of company factors, product factors
including innovation and regulatory class, together with the
use of particular development tools and strategies on market
success are investigated. The study has a number of novel

2
aspects including the investigation of a comprehensive range
tools & strategies and the influence of innovation on product
success. While factors such as the regulatory class of the
product have specific relevance in the medical devices sector,
many of the general findings also have application across a
range of industries.
III. METHODOLOGY
The aim of this study was to identify those factors that
contributed most to the perceived commercial success of new
products in the medical devices sector. These factors, the
inputs into the NPD process that were investigated were split
into the three categories namely, NPD tools and strategies,
product factors, and company factors. Fig. 1 contains a flow
chart model of the NPD process that is the basis of this study
and illustrates the inputs into new product development
studied in this survey split into three categories as described,
and the output metric used in this study, namely perceived
success.

details of these tools will not be discussed in detail in this

article. However, a wealth of published information exists on
these methods and their practical application. Reviews of the
literature are available from Griffin [10] and Langerak et al.
[11]
The use of these tools and strategies across the medical
device sector, and their correlations with perceived product
success were investigated.
B. Product Factors
In addition to investigating the influence of a wide range of
tools and strategies this study also examines three important
product factors, namely the regulatory class, the technological
innovativeness and the market innovativeness of the device.
To give a measure of the regulatory factors involved with
developing the device, respondents were asked to identify the
EU and /or the FDA regulatory classification of the device.
To determine the technological innovativeness of the device
the respondents rated the complexity / technical challenge of
the new product. Respondents were asked to select from four
categories: minor upgrade, major upgrade, new productexisting technology and new product-new technology.
The market innovativeness of the device was determined by
assessing the relationship of the new product to the market.
Respondents were asked to select from four categories: new
market to the world, new market to the company, extension to
an existing market or in an existing market.
C. Company Factors
A number of company factors were recorded, for example
the number of employees, number of units produced per year,
years of operation and whether the company is an OEM
supplier. These questions provided an indication of the size
and experience of the company, as well as an indication of
whether they produced commodity units, or made-to-order

Fig. 1. NPD flow chart model

A. NPD tools and strategies

Table I depicts the range of current management tools and
strategies which were investigated in this study. These
tools/strategies can be divided into a number of distinct
categories namely, NPD process strategies, Financial analysis,
integration strategies and quality strategies.
TABLE 1
TOOLS AND STRATEGIES INVESTIGATED
NPD process
Financial
Integration
Quality
Analysis
Formal process
Stage-gate
QFD
Concurrent
Lean

Financial
Analysis

Customer/end user
Part Supplier
NPD priorities
Cross functional
Dedicated team

DOE
FMEA
TQM
Six-Sigma

The tools investigated were chosen based on a literature

review and several industrial case studies [9]. The specific

D. Questionnaire
The questionnaire consisted of three parts. The first part
consisted of general questions relating to the business. Parts II
& III contained questions relating to the development of the
examples of a more, and less, commercially successful product
launched by the company in the previous five years. The same
questions were presented for both the more and less successful
devices. In this manner information was sought on products
which had a wide range of commercial fates in order to
provide a more comprehensive data set. While a degree of self
selection is an inherent aspect of questionnaires of this nature,
analysis was conducted in to ensure that asking for data on two
products in manner described did not unduly skew the
findings. Correlations were conducted on the less and more
successful product independently and then compared to the
results of the analysis of the complete data set.
The output metric chosen for this study is the commercial
success of the product. Respondents were asked to rate the
commercial success of the product against their expectations.
This was done on a five point scale of much more successful
than anticipated, slightly more successful than anticipated,

E. Hypotheses
This questionnaire was designed to test three main
hypotheses, essentially that the inputs to the model shown in in
Fig. 1 will be correlated with the output of the model
considered in this paper, namely the perceived success of the
product. These hypotheses are summarized in Table II.
TABLE II
HYPOTHESES RELATED TO PERCEIVED SUCCESS
Hypothesis
H1
The use of NPD tools and strategies have a
significant effect on product success
H2
Product factors have an impact on product success
H3

Company factors have an impact on product

success

manner in which the products were selected did not unduly

bias the findings.
TABLE III
FACTORS AND THEIR CORRELATIONS WITH PRODUCT SUCCESS
Correlation with success
More
Less
successful successful
0.29+
0.30

Complexity/technical
challenge
n

n
Financial analysis used
throughout the
development

0.35+++

37
0.27

30
0.21

(p=0.15)

(p=0.32)

31
0.27

24
0.36+

67
0.31++
55
0.34+++

(p=0.11)

+++

All

(p=0.104)

End user/customer
involvement

36

26

62

NPD dissemination
among staff

0.39++

0.46++

0.32++

n
p<0.01, ++p<0.05, +p<0.1

35

26

61

A. Tools and Strategies

1) Financial Analysis
Using financial analysis throughout the development was
found to have a statistically significant correlation with success
(r=0.34, p<0.01). In this study 78% of companies which
responded used financial analysis for the initial business case
and 55% of responding companies continued to use financial
analysis throughout the development process. 21% did not use
financial analysis at any stage. Fig. 2. shows the median
perceived success, with the upper and lower quartiles, of
products where financial analysis was not used, used for the
initial business case only or used throughout. Using financial
analysis throughout shows higher levels of success than either
not using financial analysis at all or using it for the initial
business case only, but this study shows no significant
difference between not using financial analysis at all and using
it for the initial business case only.
6

perceived success

as successful as anticipated, slightly less successful than

anticipated, and much less successful than anticipated. This
metric of product success was chosen as it permits
comparisons to be made across of a wide range of companies
and products. Alternative numeric measures of success such as
revenue, profit or number of items shipped do not permit
meaningful comparison across disparate products. For
example, a small firm shipping 10 units of a complex
diagnostic device per annum might be deemed as highly
successful.
After testing a draft version of the questionnaire with a
small group of respondents, the questionnaire was distributed
through a UK medical device trade magazine and was sent
directly to a number of UK and Irish medical device
manufacturers. The questionnaire was also made at a number
of events and was available online through the project website.
Data were obtained using the questionnaire relating to 68
medical device products launched by 38 UK and Irish
companies within the last 5 years. A number of respondents
only completed the survey for one product, either through
preference or because only one product had been launched in
the previous 5 years.
The survey results for each product were coded and entered
into a statistical package. Descriptive statistics and a
Spearmans bivariate correlation were evaluated to identify
those factors which had a statistically significant influence on
the perceived success of the product. Correlations were
performed on the less successful and more successful product
data independently and these were then compared to the results
obtained from the complete data set.

IV. RESULTS AND DISCUSSION

1

Ultimately the most important output from the NPD process

is the commercial success of the new product in the market
place. Table III illustrates those factors that were found to be
correlated with success in a statistically significant manner
(p<0.1). The results of these correlations can be seen in Table
3. Of the correlations that are statistically significant for the
whole population, only that for End user / customer
involvement shows a difference in the statistical significance
between the two sub-groups. This provides evidence that the

0
N=

13

14

34

not used

Initial case

throughout

financial analysis

Fig. 2. Boxplot of perceived success of a product according to the use of

financial analysis during the NPD process., showing the median values, the
upper and lower quartiles and the extreme values of perceived product
success for each level of use of financial analysis.

Rochford and Rudelius [2] reported that approximately 75%

of companies carried out a preliminary financial analysis

4
one might have expected the NPD strategies such as StageGate or concurrent engineering to have an effect.
B. Product Factors
1) Technological Innovativeness
The complexity / technical challenge of the device was
correlated with higher levels of success (r=0.35, p<0.01).
Technological innovation will often carry higher levels of risk
and cost. Hence it may only be undertaken by an organisation
if the potential returns on this investment are also high. In this
study 14.7% of products were new products using new
technology, 42.6% were new products using existing
technology, 20.6% were major upgrades and 22.1% were
minor upgrades.
2) Market Innovativeness
In terms of market innovation 7.6% of products were
described by respondents as for new to the world markets, an
additional 12.1% were new markets for the company and the
vast majority of products (80.3%) were aimed at existing
markets or extensions to existing markets. Fig. 3.shows that
Small and Medium Enterprises (SMEs), those with fewer than
250 employees [15], were more than twice as likely to launch
new to the world products than larger companies (9.3% of
products launched by SMEs compared with 4.4 % of products
launched by large companies). No statistically significant
correlation was seen between the perceived success of the
product and whether this was a new or existing market to the
company.
60.00%
50.00%
Percentage

during product development. Fewer companies conducted

market analysis later in a products development yet doing so
was found to be significantly correlated with success. Cooper
and Kleinschmidt [7] found that the proficient implementation
of NPD metrics was correlated with product success. In the
medical devices industry, as well as evaluating the commercial
implications of the new product to the company, Health
Technology Assessment is becoming increasingly important
for companies to consider, where cost-benefit analysis of new
products, comparing both cost and clinical performance to
existing alternatives, is often required before a new product
will be reimbursed. This analysis focuses the development
activity on both the clinical performance of the device and the
financial benefits to the company.
2) Integration Strategies
NPD dissemination among staff is correlated with greater
success (r = 0.32. p<0.05). The proficiency with which NPD
priorities are disseminated amongst staff can be viewed as a
measure of internal integration. In surveys in the automotive
industry, Calantone and Di Benedetto [12] and Clark and
Fujimoto [13] both reported positive correlations between
internal integration and product performance.
Involving the customer/end user in new product
development, a form of external integration, was also
correlated with increased success (r=0.31, p<0.05). It is
necessary to exercise a degree of caution when interpreting
this correlation as the factor was not found to be statistically
significant for the sub-group of less successful products. In
this survey end user/customer involvement was cited in 65% of
all products. Although this figure illustrates substantial end
user integration during NPD within the sector, further
opportunities exist for more comprehensive and timely input
from users. The findings here agree with several previous
studies which highlighted identifying and understanding user
need as a critical factor in NPD [4,5,8].
Involving the end user or customer in design and
development is important to ensure that the product meets real
needs and increase the likelihood that it will be a market
success. Within the medical device sector the users can be
doctors, nurses and other healthcare professionals, carers or
indeed the patients themselves. It is therefore crucial that end
user engagement and requirements capture within the medical
devices sector takes account of the needs of these often
disparate groups. Product development managers should
encourage user involvement to increase the likelihood of a
products ultimate success. A range of techniques are available
for engaging with the various types of end user including,
patient interviews and focus groups [14].
3) NPD Process and Quality Strategies
None of the NPD process strategies such as Stage-Gate
NPD, concurrent engineering, or the quality strategies such as
TQM or Six Sigma, listed in Table I were found to be
correlated with success in a statistically significant manner.
This finding is interesting, as many of these strategies are
highlighted as best practice in product development. For some
of these strategies, NPD performance is not the main aim, but

40.00%
SME

30.00%

Large

20.00%
10.00%
0.00%
existing
market

extension

new market new market

for company for world

Category

Fig. 2. Chart of Market Innovation for respondents from SMEs and Large
companies, showing that a higher percentage of products developed by SMEs
are new to the world and new to the company.

The conservative approach to innovation concurs with a

recent survey of business executives, which found that true
new to the world innovations have fallen from 20.4% of
product launches to 11.5% over a five-year period to 2004
[16]. It is important that this is considered when selecting
which initial ideas should be developed into new products. A
reliance on short term financial metrics when selecting new
products for development for example can lead to a product
portfolio with too many, low risk, short term projects. These
issues are also prevalent in the pharmaceutical sector, were
only a small percentage of new products are actually based on
new chemical entities. For example, in 2005 only 15 new
chemical entities were approved with the vast majority of new
products being generics, new dosages, etc [17]

5
3) Regulatory Class
In terms of the regulatory class of the new products, no
statistically significant correlation was observed between
product success and the regulatory classification of the device.
Previously published work has shown that products in higher
regulatory classes take longer to develop than those in lower
classes [18].
C. Company Factors
None of the company factors, such as the size of the
company or the number of new products that had been
launched in the preceding five years were correlated with the
perceived success of the product in a statistically significant
manner.
V. CONCLUSIONS
This paper reports an investigation into factors which
impact product success. A survey of medical device
manufacturers in the UK and Ireland was undertaken and
respondents were asked a series of questions concerning a
more and less successful product released in the previous five
years. The main outcomes of this research are described in
relation to the hypotheses outlined in Table II:
H1. The use of NPD tools and strategies have a significant
effect on product success
Three of the NPD tools and strategies were found to be
correlated with success. Customer/End user involvement
during a products development was found to be correlated
with its degree of market success. The survey also showed that
the use of financial analysis methods throughout the NPD
process was correlated with increased success. Interestingly,
the survey found that using financial analysis methods for the
initial business case was no better than not using financial
analysis at all. Finally, NPD priorities such as performance
requirements and launch date need to be disseminated to the
appropriate staff as this was found to be related to success.
H2. Product factors have an impact on product success
This survey found that technologically innovative products
were more likely to exceed the companys commercial
expectations when compared to those based on incremental
development of existing lines. No correlation was observed
between the market innovativeness of a product and its
commercial success. The survey suggested that the
respondents, especially the large companies, were conservative
in their approach to market innovativeness, with only 7.6% of
products being for new to the world markets. SME
respondents were more likely to launch new to the world
products than those from larger companies
H3. Company factors have an impact on product success
This hypothesis was not supported by the results of this
research. None of the company factors studied were found to
be correlated with product success in a statistically significant
manner.
This study undertook a comprehensive investigation of a

range of different factors which have the potential to impact

new product success within the medical device sector in the
UK and Ireland. A number of these factors have been shown to
be correlated with success in a statistically significant manner.
The results of this study will assist companies in adopting an
evidence based approach when selecting products to develop
and when improving their NPD process. We close by noting
the need to base NPD decision making on quantifiable
evidence and the requirement for further objective research in
this area.
REFERENCES
[1]

[2]
[3]
[4]
[5]

[6]
[7]

[8]

[9]

[10]

[11]

[12]

[13]

[14]

[15]

[16]
[17]
[18]

B. Shaw , The Role of the Interaction between the User and the
Manufacturer in Medical Equipment Innovation, R&D Management,
vol 15, pp 283-292, 1985.
L. Rochford and W. Rudelius, "New product development process,"
Industrial Marketing Management, vol. 26, pp. 67-84, 1997
B. Wood, Characterising medical device development, Northcon
Conference Record, pp 254-259, Seattle, 1986
R. Rothwell, "The Hungarian SAPPHO: some comments and
comparisons," Research Policy, vol. 3, pp. 30-38, 1974.
B. J. Zirger and M. A. Maidique, "A Model of New Product
Development: An Empirical Test," Management Science, vol. 36, pp.
867-883, 1990.
M. Parry and M. Song, "Identifying new product successes in China,"
Journal of Product Innovation Management, vol. 11, pp. 15-30, 1994.
R. G. Cooper and E. J. Kleinschmidt, "An investigation into new
product process: steps deficiencies and impact," Journal of Product
Innovation Management, vol. 3, pp. 71-85, 1986.
M. R. Millson and D. Wilemon, "Managing innovation in the medical
device industry," presented at IEMC (International Engineering
Management Conference), San Juan, 1998.
J.Eatock, D.Dixon, B.J. Meenan, T. Young, J.Anderson, Report on
Medical Device Product Development Processes: Some Illustrative
Examples, MATCH, 2005
http://www.match.ac.uk/downloads/Deliverable%205%20_P2_D5_V2_
051031_.pdf, accessed Jan 2008
A. Griffin, "Modeling and measuring product development cycle time
across industries," Journal of Engineering and Technology
Management, vol. 14, pp. 1-24, 1997.
F. Langerak, E. Peelen, and E. Nijssen, "A Laddering Approach to the
Use of Methods and Techniques to Reduce the Cycle Time of New-tothe-Firm Products," Journal of Product Innovation Management, vol.
16, pp. 173-182, 1999.
R. J. Calantone and C. A. Di Benedetto, "Performance and time to
market: accelerating cycle time with overlapping stages," IEEE
Transactions on Engineering Management, vol. 47, pp. 232-244, 2000.
K. B. Clark and T. Fujimoto, Product development performance :
strategy, organization, and management in the world auto industry:
Harvard Business School Press, 1991.
S. G. S. Shah and I. Robinson, "User Involvement in Medical Device
Technology Development and Assessment: A Structured Literature
Review," International Journal of Health Care Quality Assurance, vol.
19, pp. 498-513, 2006.
European Commission, The new SME definition, 2005
http://ec.europa.eu/enterprise/enterprise_policy/sme_definition/sme_use
r_guide.pdf, accessed Jan 2008.
R. G. Cooper, "Your NPD portfolio may be harmful to your business
health," vol. 29: Visions Magazine, 2005.
T. CenterWatch, "Drugs Approved by the FDA (2005)," Thomson
CenterWatch, 2006.
D. Dixon, A. Brown, B. Meenan, and J. Eatock, "Experiences of New
Product Development in the Medical Device Industry," in Medical
Device Technology, vol. 17, 2006, pp. 20-22.