SAMINT- MILI 20065
Master’s Thesis 15 credits
December 2020
Development of Medical Device:
A Narrative Literature Review
Azhar Fuadi Siregar
Master’s Programme in Industrial Management and Innovation
Masterprogram i industriell ledning och innovation
Abstract
Development of Medical Device:
A narrative literature review
Azhar Fuadi Siregar
The Stage-gate model has long been used in product development. Alternatives
to Stage-gate such as Design Thinking and other models have been developed
which are flexible and consider users’ needs early on and thus they could be
more suitable for medical device development. This research aims to study and
map how medical device development is treated in the existing research
literature. This master thesis will focus on product development concerning
medical devices. This research aims to conduct a narrative literature review.
Data collection here is a set of articles which were collected through a
database, which will be used for further analysis concerning how different
approaches of models are being utilized in product development, with a specific
focus on the healthcare sector. The goal of the literature review was to study
what models have been utilized in the development has previously been utilized
in the development of medical devices. Other possible alternatives besides
conducting a narrative literature review are conducting one or several cases
with interviews or surveys with companies. Data collection is limited
approximately in the last 15 years (2005 – present), the lookup in the database
was based on keywords applied in the research area. The database used for this
research is Scopus. Articles chosen were selected also from the Scopus
database. The ethical implications based on our findings here are identifying
types of product development models that have been utilized by medical
companies in the healthcare sector. Based on the review, we can identify
several different product development models. Stage-gate and Design Thinking
are not the most popular models utilized in the product development process.
We classify the models based on elements, the element of the models here are
divided into 3 categories which are based on requirements, they are; Regulatory
Aspect, Process Workflow Aspect, and Collaboration Aspect. The regulatory
aspect mainly concerns administrative affairs and how the system as an entity
can control the regulation regarding medical device development. The Process
Workflow Aspect, this element is based on a direct approach toward medical
device development in terms of phases. The Collaboration aspect, this aspect
addresses the stakeholders’ role in policy and decision-making regarding the
production of medical devices. Stage-gate and Design Thinking are not the main
models utilized in medical device development, other than that, various models
are implemented in the healthcare sector, this means other models becoming
alternatives and have been utilized and developed in the product development
process. Other models besides Stage-gate and Design Thinking are alternatives
which do not have significant changes and are just modified forms from the
existing ones.
Supervisor: Anders Brantnell Subject reader: Simon Okwir Examiner: Sofia Wagrell SAMINT- MILI 20065 Printed by: Uppsala Universitet
Faculty of Science and Technology
Visiting address:
Ångströmlaboratoriet
Lägerhyddsvägen 1
House 4, Level 0
Postal address:
Box 536
751 21 Uppsala
Telephone:
+46 (0)18 – 471 30 03
Telefax:
+46 (0)18 – 471 30 00
Web page:
http://www.teknik.uu.se/student-en/
Keywords: Product Development Model, Medical Device, Healthcare
1
Table of Contents
Figures ........................................................................................................................................ 2
Tables ......................................................................................................................................... 3
1 Introduction ........................................................................................................................ 4
1.1 Product Development .................................................................................................. 5
1.1.1 Stage-gate ............................................................................................................. 5
1.1.2 Product Development in the Healthcare Sector ................................................... 6
1.2 Purpose ........................................................................................................................ 7
1.3 Delimitation ................................................................................................................. 7
2 Methods .............................................................................................................................. 8
2.1 Design .......................................................................................................................... 8
2.2 Data Collection ............................................................................................................ 9
2.3 Data Analytics ............................................................................................................. 9
2.4 Ethics ......................................................................................................................... 11
3 Results .............................................................................................................................. 13
3.1 Model Classification .................................................................................................. 16
3.1.1 Regulatory Aspect .............................................................................................. 17
3.1.2 Process Workflow Aspect .................................................................................. 18
3.1.3 Collaboration Aspect .......................................................................................... 19
4 Discussion and Conclusion .............................................................................................. 22
5 References ........................................................................................................................ 24
Appendix .................................................................................................................................. 27
2
Figures
Figure 1. Screenshot of “Stage-Gate Consists of a Set of Information-Gathering Stages
Followed by Go/Kill Decision Gates”, taken from Cooper (2008, p. 214) ................................ 6
3
Tables
Table 1. Keywords and database used for searching articles in conjunction with some
documented findings ................................................................................................................ 11
Table 2. List of articles and studies gathered as data collection for model identification being
used in product development in the healthcare sector .............................................................. 13
Table 3. List of models included in the regulatory aspect. ...................................................... 17
Table 4. List of the model included in the process workflow aspect. ...................................... 19
Table 5. List of examples of models included in the collaboration aspect. ............................. 20
4
1 Introduction
The stage-gate model has long been used in product development in different sectors by various
companies such as 3M, Corning Glass, Guinness, Exxon Chemical, Lego, and Hewlett-Packard
(Cooper, 2001). Medical device development and implementation are difficult since the
healthcare context puts specific requirements for development and implementation. For
instance, the involvement of users is claimed to be essential. Involving users in development is
included in The Stage-gate model but is not an essential part of it (Kuo et al., 2013). Also,
Stage-gate has been claimed to be a rigid and rather bureaucratic process for product
development (Pietszch, 2009). Alternatives to Stage-gate such as Design Thinking and other
models have been developed to be more flexible and also considers the users’ needs early on in
the process. They could thus be more suitable for medical device development. In the current
situation, it is not known to what degree the stage-gate and alternative methods are used in
medical device development.
According to Wood (1996), the specification of a medical device should consider three solid
factors which are; the market needs, the safety considerations, and the process of therapy
mandates. Wood (1996) explained that the first factor is compatible with the means of the new
product either a medical device or not. Derived specifications are vital for creating the device
safe for patients and care providers represent additional analysis and can constrain the
innovation utilized to the principle of engineering design. Wood (1996) mentioned that the
progress of a successful medical device reflects an interesting engineering challenge.
Kuo (2013) stated that a medical device combines interdisciplinary technology and knowledge,
which requires the integration of related fields such as engineering, medicine, materials science,
and clinical medicine. During the new product development (NPD) process, the gain of
important technologies demands distinct expertise and innovative technology. Lu (2012) stated
that among all the industry sectors, healthcare is the fastest growing and plays an important role
in society and the economy.
The development process of medical devices (MDs) means the combination of knowledge and
skills from the fields of engineering and medicine (Ocampo and Kaminski, 2019). According
to Ocampo and Kaminski (2019), product development in the engineering sector is categorized
as an integrated process, which encompasses almost all functional sectors of a firm. This is
based on the Product Development Process (PDP) proposals, in which apart from the structure,
5
phases, and activities, huge mandates are given to strategic aspects, responsibilities per sector,
and composition of the development team.
1.1 Product Development
The importance of customer involvement in product development is vital, in which customers
often give feedback to developers on how their problems are solved and their needs fulfilled.
Lu (2000) mentioned that product description is the details of product requirements to comply
with customer needs with other organizational constraints also taken into account. These
strategic activities take information from all divisions within the organization and external
sources to create corresponding decisions. Kahn et al. (2012) stated that the first move for any
firm aiming to increase its product development process is to acquire an understanding of the
implementations that affect NPD success.
1.1.1 Stage-gate
Cooper introduced the Stage-gate model to form the NPD process in the late 1980s (Smolnik
and Bergmann, 2020). The current trend shows that most firms applying the NPD processes to
enhance and establish their position against competitors in the market. Cooper (2001, p. 129)
stated that “the stage-gate process is a blueprint for managing the product innovation process
to improve effectiveness and efficiency”. Stage-gate divides the innovation process into a set
of stages, each stage consisting of a set of determined, cross-functional, and parallel activities,
in which the next stop to each stage is called a gate (Cooper, 2001). Stage-gate according to
Cooper (2016) is something that sets a means to integrate with other development teams and
deliver functions such as marketing and senior management as seen in figure 1 which shows
the go/kill decision points.
Stage-gate according to Miranda (2016) is famous for its spread out amongst firms around the
world: in the United States, it's been specified by stage-gate founders that more than 80% of
Global 1000 firms apply their model. The stage-gate model is well-known and highly
recognized in companies all over the world as a method of bringing success to the process of
product innovation (Grönlund et al., 2010). Grönlund et al., (2010) added that stage-gate
presents a vital part in product innovation. First, it presents the structure and is mostly utilized
by companies engaged in industrial NPD. Second, some of its inherent restrictions can be
solved by combining the fundamental stances of open innovation. Lastly, gate assessments
facilitate an arena for managers validating and considering main competencies as well as
business models.
6
Figure 1. Screenshot of “Stage-Gate Consists of a Set of Information-Gathering Stages
Followed by Go/Kill Decision Gates”, taken from Cooper (2008, p. 214)
1.1.2 Product Development in the Healthcare Sector
According to Songkajorn and Thawesaengskulthai (2014), the innovation process in medical
devices is rather complicated and often displays stoppage. Songkajorn and Thawesaengskulthai
(2014, p. 3) stated that “medical innovative production is lacking suitable new product
development (NPD) related to the innovative development process.” To facilitate the
implementation and embedding of medical devices it is important to consider users’ needs early
on (Von Hippel, 2005).
The term of design thinking has been in the industrial design field since the late 1980s, whilst
the constructs that underlie it have stipulated the industrial design field since its beginning early
in the twentieth century as mentioned by Beale and Cunningham (2018). Beale and
Cunningham (2018) stated that the construct that design thinking is as much a set of “attitudes
and approaches” as it is a set of competencies and methods. Design Thinking could be one
mode that focuses on user needs that Stage-gate does not focus on. Cunningham and Beale
(2018) argued that “design thinking has been popularized in the business world since the year
2000, especially through the work and writings of Tim Brown (Change by Design) and David
Kelley (The Art of Innovation, and The Ten Faces of Innovation) of IDEO, and Roger Martin
of the University of Toronto (Business by Design).”
7
1.2 Purpose
The general aim is to study and map how medical device development is treated in the existing
research literature. The research questions are as follows:
A. What kind of product development models are utilized in medical device development
in the healthcare sector according to the literature?
B. What are the similarities and differences among product development models utilized
in the healthcare sector?
1.3 Delimitation
This master thesis will focus on product development concerning medical devices. All possible
product development models are included but other fields than medical devices will not be
considered.
8
2 Methods
In this chapter, the methods to conduct the study, to answer the research questions, will be
described and discussed. This research aims to conduct a narrative literature review, as Bryman
and Bell (2011, p. 119) mentioned that “narrative review is a more traditional approach that has
advantages of flexibility that can make it more appropriate for inductive research and qualitative
research designs.” Data collection here is a set of articles which were collected through a
database, which will be used for further analysis concerning how different approaches of
models are being utilized in product development, with a specific focus on the healthcare sector.
2.1 Design
Bryman and Bell (2011, p. 94) mentioned that “the literature review must assist you in
developing an argument and bringing in the material of dubious relevance may undermine your
ability to get your argument across”. Bryman and Bell (2011, p. 101) also stated that “the
literature review is for them a means of gaining an initial impression of the topic area that they
intend to understand through their research. The goal of the literature review was to study what
models have been utilized in the development has previously been utilized in the development
of medical devices. Narrative reviews, therefore, tend to be less focused and more wide-ranging
in scope than systematic reviews. They are also less explicit about the criteria for exclusion or
inclusion of studies”. The focus of this study is on secondary data in which a narrative literature
review is conducted using an electronic bibliographic database (Nicolini et al., 2008) covering
a wide range of disciplines from business studies, engineering, healthcare, and the medical
sector.
Other possible alternatives besides conducting a narrative literature review are conducting one
or several cases with interviews or surveys with companies (Bryman and Bell, 2011). Benefits
of conducting a literature review are accessibility of data where numbers of articles or databases
could be set, more wide-ranging in the scope of the area of research, critical review, and in-
depth evaluation of previous studies, specified keywords guided the search of articles during
data collection. The drawbacks of conducting a literature review are the number of references
that must be compiled, so that inclusion and exclusion criteria must be included.
Some pros and cons of types of data gathering are; the review can provide a state-of-art
knowledge on the topic but is time-consuming, interviews can provide in-depth knowledge of
a limited part of the topic and elucidate complex issues, surveys can capture several companies
or individuals but might be difficult to conduct (Bryman and Bell, 2011). Pros of conducting
9
interviews or surveys with companies are getting the up to date information from confirmed
sources. Meanwhile, the cons are the bureaucracy in companies or individuals as well as data
privacy regulation which could be issues that might hinder the progress of the research, in which
companies might hold back from sharing information and performing surveys that are regarded
vital.
The initial assumption is the Stage-gate model has been applied in product development for a
long time in different sectors (Miranda, 2016; Grönlund, 2010). Stage-gate has been claimed to
be a rigid and rather bureaucratic process for product development. Alternatives to Stage-gate
such as Design Thinking and other models have been developed that are flexible and consider
users’ needs early on and thus, they could be more suitable for medical device development.
The data were categorized into tables to draw a wide picture of how models are applied in
product development, particularly the medical device being constructed. As of this, we will be
able to look at the comparison amongst models, for instance, Stage-gate and Design Thinking,
or other alternative models used in product development.
2.2 Data Collection
Data collection is limited approximately in the last 15 years (2005 – present), the lookup in the
database was based on keywords applied in the research area. When the results were generated,
relevant studies and articles were then chosen for more intense research.
In this research, the database used is from Scopus. The motivation why Scopus is because of
the feature where it has widespread findings based on searching of articles gained in its database
and the ability to document the query for article findings. Keywords used for searching articles
in the database are covering; product development, medical device, and healthcare. Once the
articles had been found, the next step is to choose the articles according to the title, abstract,
and keywords used for further examination according to the scoping review (Nicolini et al.,
2008).
2.3 Data Analytics
Filtered articles here could be seen through the first query (A) in the appendix part. In which
the first result showed the original number of documents before the filtering process, there are
3 filtering stages until reaching the final total documents required. Articles chosen were selected
from the Scopus database. Those articles then each filtered first through keywords, look up the
titles, and finally read through the abstracts. Selected articles were mostly subject areas among
10
journals related to healthcare and product development. Meanwhile, the second result showed
the number of documents after filtering into more segmented disciplinary sciences, this could
be seen through the second query (B) in the appendix part. After this, all findings which are
duplicates were removed that did not correspond to the inclusion criteria. Articles here were
limited to journal type of publication. Then, all remaining articles were read based on some
quality criteria on the methodological approach. Quality criteria here refer to the compatibility
of the research area, keywords used, and content of the articles. Finally, we had the final
samples to analyze. After this process, results were executed, in which these areas will be
discussed in the next chapter.
Table 1 below shows the bibliographic search and sampling process in which it was based on
keywords, abstracts, and titles used for gathering articles through a database. Based on table 1,
the query here is listed in the appendix part. In which based on keywords used, research made
in August 2020 resulted in 393 documents, after that filtering is applied for the last 15 years
and delimited into several specific subject areas, this could be seen in the appendix part. The
result then appeared to have a lesser number of documents which were 264 documents. The
next step was filtering based on scanning the titles and read through the abstracts resulted in 81
documents. Then, selecting the articles thoroughly and removed the duplicates. Finally, In the
end, the number of articles that met the criteria was 15.
11
Table 1. Keywords and database used for searching articles in conjunction with some
documented findings
Keywords Database Stage 1
Number of
documents
resulted
before
filtering (A)
Stage 2
Number of
documents
resulted
after first
filtering (B)
Stage 3
Number of
documents
resulted
after second
filtering (C)
Stage 4
Number of
final
documents
chosen after
third
filtering (D)
product
development
model;
medical
device;
healthcare
Scopus 393 264 81 15
A = results based on keywords used to cover the research area
B = first filtering based on year limitation in the last 15 years and specific subject area
C = second filtering after scanning the titles and read all the abstracts
D = third filtering after removing duplicates and thoroughly read the articles
2.4 Ethics
Since no primary data were collected and handled the intrusion of privacy was not a risk.
Furthermore, since no primary data was included informed consent was not applicable (Bryman
and Bell, 2011). The ethical implications based on our findings here are identifying types of
product development models that have been utilized by medical companies in the healthcare
sector. Besides, similarities and differences aspects among models will be analyzed according
to the requirement of product development in the healthcare sector as this will help provide
recommendations regarding choosing the compatible model based on needs in product
development, especially in the healthcare sector.
Ethical considerations should be taken into account in researching for instance, as collecting
data from databases through online search must avoid plagiarism and respect the right of
publishing. Bryman and Bell (2011) mentioned that 4 aspects that should be considered are:
• Data management
12
• Copyright
• Reciprocity and Trust
• Affiliation and conflicts of interest
Research ethics is limited to considering ethical problems that be valid to those taking part in
research most of the time. The area of research ethics requires questions concerning the
relationship between research and ethics, ethical standards for the researcher as well as the goal
and execution of the research (Swedish Research Council, 2017).
Research practices should follow the fundamentals of research integrity, where the principles
here according to All European Academies (2017, p. 4) are: “Reliability in ensuring the quality
of research, reflected in the design, the methodology, the analysis and the use of resources.
Honesty in developing, undertaking, reviewing, reporting and communicating research in a
transparent, fair, full and unbiased way. Respect for colleagues, research participants, society,
ecosystems, cultural heritage and the environment. Accountability for the research from idea
to publication, for its management and organisation, for training, supervision and mentoring,
and for its wider impacts.”
13
3 Results
In table 2, several articles are presented with models utilized in product development in the
healthcare sector. Following in the appendix section, 2 tables elaborate more on further details
and descriptions among models applied in medical device in the healthcare sector which are
based on literature review.
Based on the review, we can identify several different product development models. Stage-gate
and Design Thinking are not the most popular models utilized in the product development
process. All models being utilized in product development are shown in table 2.
Table 2. List of articles and studies gathered as data collection for model identification being
used in product development in the healthcare sector
Title Author Year Focus Model
Utilized
Source
New product
development for
the healthcare
industry: A case
study of diet
software
Basoglu et
al.
2012 The study investigates
the design parameters
and product
specifications for
product development
concerning the health
industry in Istanbul
Technology
Acceptance
Model
Health Policy
and Technology
Integrated
Fuzzy-Based
Modular
Architecture for
Medical Device
Design and
Development
Aguwa et
al.
2010 This study aims to
bring collaboration
between several
engineering concepts
and the medical sector
with the overall goal to
improve patient’s
quality of medical
treatment and safety
Integrated
fuzzy-based
Model
Journal of
Medical
Devices
Rules
modification on
a Fuzzy-based
modular
architecture for
medical device
design and
development
Aguwa et
al.
2012 The focus of the study
is to specify the effect
or impact of “rules
changes” on the
optimal number of
modules in medical
device design and
development
Fuzzy-based
Model
IIE Transactions
on Healthcare
Systems
Engineering
Barco
Implements
Platform-Based
Boute et al. 2018 This paper presents
Barco, a global
technology company,
operations
research
INFORMS
Journal on
14
Product
Development in
Its Healthcare
Division
who applied an
operations research
optimization model,
which was supported
by an efficient solution
method, to implement
platforms for the
design and production
of its high-tech medical
displays.
optimization
model
Applied
Analytics
Capturing User
Requirements in
Medical Device
Development:
The Role of
Ergonomics
Martin et
al.
2006 This study marks the
importance of a good
design of medical
devices and the role
that medical device
developers can involve
in improving patient
safety
Ergonomics Physiological
Measurement
Value Driven
Innovation in
Medical Device
Design: A
Process for
Balancing
Stakeholder
Voices
De Ana et
al.
2013 This study depicts the
application of a spiral
innovation process in
medical device
development of a
medical device that
considers three
different stakeholder
voices: the voice of the
customer, the voice of
the business, and the
voice of the technology
Value driven
innovation
Annals of
Biomedical
Engineering
Using design
thinking to
improve patient
experiences in
Japanese
hospitals: a case
study
Uehira and
Kay
2009 This article gives a
case study of the use of
qualitative research
tools to help a large
Japanese company
generate innovations
while Japan’s business
history and culture
hinder the process
Design
thinking
Journal of
Business
Strategy
The Use of
Control Systems
in New Product
Development
Innovation:
Advancing the
‘Help or Hinder’
Debate
Akroyd et
al.
2009 In past research, it is
shown that the role and
style of MCS used to
provide explanations
on why MCS can both
help and hinder NPD
innovation. This study
Stage-gate The IUP Journal
of Knowledge
Management
15
gives another
explanation by testing
the relationship
between three models
of a commonly used
MCS, known as the
Stage-Gate Process
Exploring an
effective model
of new product
development in
medical devices:
a knowledge
cluster approach
Kuo et al. 2013 This study proposes a
knowledge cluster that
improves the
integration of
interdisciplinary human
resources and increases
the acquirement of
innovative technologies
A knowledge
cluster
approach
International
Journal of
Technology
Management
Interpretive
structural
modelling of
risk sources in
medical device
development
process
Rane and
Kirkire
2015 This study investigates
risk sources in the
MDD process, the risk
sources which can
harm the MDD
processes in terms of
cost, time of
development, and
quality of the device
Interpretive
structural
modelling
International
Journal of
System
Assurance
Engineering and
Management
Medical device
development,
from technical
design to
integrated
product
development
Ocampo
and
Kaminski
2019 The objective of this
paper is to integrate a
PDP model for SMEs
in the specific medical
sector, by incorporating
the best practices of the
engineering area and
particularities of the
medical area
Engineering
area product
development
Journal of
Medical
Engineering &
Technology
Stage-Gate
Process for the
Development of
Medical Devices
Pietszch et
al.
2009 This study investigates
existing model
representations and
presents a new
comprehensive
development model
that seizes all aspects
of medical device
development and
commercialization
from early-concept
Stage-gate Journal of
Medical
Devices
16
3.1 Model Classification
Common similarities between models here are the needs of specific requirements on product
development and its practice, mainly users’ experience as one of the stakeholders as well as
their involvement are considered vital in PDP. Users here are stakeholders who should be
addressed during the PDP, for instance, patients, governmental agencies, hospitals. Because
once a stakeholder’s voice is not heard, this could lead to hinder the process of product
development and lead to ineffective and inefficient PDP (De Ana et al., 2013).
preference to
postmarket supervision
Supporting
medical device
development: a
standard product
design process
model
Medina et
al.
2012 This study depicts the
complex nature of the
medical device
development (MDD)
process and presents a
product design process
model to assist
designers engaged in
the MDD
Product
design
process
model
Journal of
Engineering
Design
Design Thinking
in Healthcare:
Innovative
Product
Development
through the
iNPD Process
Cheung 2012 This study presents the
design process of an
innovative surgical
product named the non-
invasive patient
tracker, based on user-
centered research
implemented in the
operating rooms of a
hospital in Hong Kong
Design
thinking
The Design
Journal
A real-world
perspective:
Building and
executing an
integrated
customer
engagement
roadmap that
bridges the gaps
in traditional
medical device
development
processes
Goldenberg
and
Gravagna
2018 This study will mention
the gaps that have been
observed in the
traditional stage-gate
new product
development process in
the current healthcare
landscape and will
elaborate the marketing
best practices that have
been applied to bridge
those gaps
Integrated
customer
engagement
roadmap
Journal of
Medical
Marketing:
Device,
Diagnostic and
Pharmaceutical
Marketing
17
Integrated customer engagement roadmap (Goldenberg and Gravagna, 2018), for instance, is
the model being used to bridge the gaps between the complexities of the external healthcare
landscape and the often indifferent and formulaic internal processes for new product
development (NPD). As it has been seen that the linear stage-gate approach to NPD results in
product development derailment. The element of the models here are divided into 3 categories
which are based on requirements, they are; Regulatory Aspect, Process Workflow Aspect, and
Collaboration Aspect.
3.1.1 Regulatory Aspect
This element mainly concerns administrative affairs and how the system as an entity can control
the regulation regarding medical device development. Also, this element focuses on the risk
and impact that hinder the product development process from the organizational dynamics point
of view. There are 3 models included in this aspect, they are; Engineering Area Product
Development, Stage-gate, and Product Design Process. By this, the goals of the new product
development will be delivered and expectations on creating more flexible regulations which are
less complicated bureaucracy.
Table 3. List of models included in the regulatory aspect.
Title Author Year Focus
Medical device
development, from
technical design to
integrated product
development
Ocampo
and
Kaminski
2019 The objective of this paper is to integrate a
PDP model for SMEs in the specific medical
sector, by incorporating the best practices of
the engineering area and particularities of the
medical area
Stage-Gate Process
for the Development
of Medical Devices
Pietszch et
al.
2009 This study investigates existing model
representations and presents a new
comprehensive development model that
seizes all aspects of medical device
development and commercialization from
early-concept preference to postmarket
supervision
Supporting medical
device development: a
standard product
design process model
Medina et
al.
2012 This study depicts the complex nature of the
medical device development (MDD) process
and presents a product design process model
to assist designers engaged in the MDD
18
Ocampo and Kaminski (2009) mentioned that MD development has particular things that make
the product development process (PDP) even more complicated such as a high level of
regulations, concurrent technologies application, and different end-users’ requirements. The PD
models available within the medical knowledge sector are too much regulatory oriented and do
not make use of some of the best practices and tools that are available within the PD in the
engineering area. Also, following the regulatory aspects other attributes such as users’ safety
and product’s effectiveness, all considered crucial to the medical sector.
The study results by Pietszch (2009) recommend that stage-gate processes are the predominant
development model applied in the medical device industry and the regulatory requirements such
as the food and drug administration (FDA’s) Quality Systems Regulation perform a substantive
role in shaping activities and making decisions in the process. Control and reporting of product
performance in the area have gained increasing attention from the FDA, partly in consequence
of information regarding product recalls. Besides, design verification describes a device
through feasibility studies and verification testing and confirms that device development meets
the quality system (QS) regulation.
The model proposed by Medina et al. (2013) depicts the phases of MDD and their relationships,
this includes the testing and approval environment that impacts this process. The Food and Drug
Administration (FDA) is an important part of this environment, acting as the regulatory agency
for medical devices in the USA. FDA consent is a significant milestone that industry developers
must achieve before the actual launch of their medical devices in the US market. The FDA’s
role related to medical devices can be described as one of the risk assessments intended to create
equilibrium between confirming the complete safety and effectiveness of the products.
The difference between the regulatory aspect and the other aspects is that this aspect focuses
more on regulation and policies that cover the set of standards applied in product development
in the healthcare sector in which the other aspects do not, this could impact another aspect such
as the economics of medical device manufacturers. Furthermore, through the verification and
approval process, this aspect aims to make sure the safety and effectiveness of new products.
3.1.2 Process Workflow Aspect
This element is based on a direct approach toward medical device development in terms of
phases. This element mainly concerns process improvement, product specification, and
breakthroughs in the healthcare sector such as a new proposal for improved medical products.
19
This also includes the testing and approval of the medical device product. According to the
literature review, there is only 1 model included in this aspect, which is Design Thinking.
Table 4. List of the model included in the process workflow aspect.
Cheung (2012) applied Cagan and Vogel’s integrated New Product Development (iNPD)
process. The iNPD process comprehends four phases, starting from product planning to
program approval. The study deals with the invention of the non-invasive patient tracker by
testing the first two phases of this process and addressing slightly on the third. Phase I focuses
on identifying product opportunities for a particular user group. Phase II is the understanding
of product opportunities. In phase III, product opportunities are finally conceptualized. The last
phase is regarding realizing and detailing.
The difference between the process workflow aspect and the other aspects is that this aspect
focuses more on the product development process compared to the other models in which the
other models do not, for instance, the shifting from conventional medical treatment to
innovation. New technology such as surgical innovation also becomes an important part of the
aspect as innovation emerges as a part of the success rate of new product development.
Moreover, this aspect is related to the end-users who are directly impacted based on needs to
provide solutions according to diagnosis.
3.1.3 Collaboration Aspect
This aspect addresses the stakeholders’ role in policy and decision making regarding the
production of medical devices. Besides, this aspect is related to user needs that also cover the
stakeholders’ interests from the beginning of the product development process until the launch
to the marketplace. Stakeholders here involving payers, patients, hospitals/healthcare systems,
and governmental agencies. Also, this aspect distributes each role according to its functionality
so that everyone will be responsible for their own, and in the end, the objectives could be
achieved without overlapping power. There are 7 models included in this aspect, they are;
Title Author Year Focus
Design Thinking in
Healthcare: Innovative
Product Development
through the iNPD Process
Cheung 2012 This study presents the design process of an
innovative surgical product named the non-
invasive patient tracker, based on user-
centered research implemented in the
operating rooms of a hospital in Hong Kong
20
Knowledge Cluster, Integrated Fuzzy-based Model, Fuzzy-based Model, Ergonomics, Value
Driven Innovation, Design Thinking, and Integrated Customer Engagement Roadmap. Table 5
below presents a list of examples of models included in this aspect.
Table 5. List of examples of models included in the collaboration aspect.
Integrated Customer Engagement Roadmap (Goldenberg and Gravagna, 2018) has the main
focus on addressing stakeholders in PDP. Stakeholders should be involved in the life of medical
devices from the very beginning until the release of the product as this also includes the process
of commercialization, funding requirements of developing projects, and technology transfers.
Stakeholders here involving payers, patients, hospitals/healthcare systems, and governmental
agencies. Stakeholders also have different and unique requirements associated with the medical
device improvement and are not limited only to non-technical aspects for instance their
involvement in the decision making during the PDP.
Title
Author Year Focus
A real-world perspective:
Building and executing an
integrated customer
engagement roadmap that
bridges the gaps in
traditional medical device
development processes
Goldenberg
and
Gravagna
2018 This study will mention the gaps that
have been observed in the traditional
stage-gate new product development
process in the current healthcare
landscape and will elaborate on the
marketing best practices that have
been applied to bridge those gaps
Integrated Fuzzy-Based
Modular Architecture for
Medical Device Design and
Development
Aguwa et al. 2010 This study aims to bring collaboration
between several engineering concepts
and the medical sector with the
overall goal to improve patient’s
quality of medical treatment and
safety
Exploring an effective
model of new product
development in medical
devices: a knowledge
cluster approach
Kuo et al. 2013 This study proposes a knowledge
cluster that improves the integration
of interdisciplinary human resources
and increases the acquirement of
innovative technologies
21
The fuzzy-based model proposed by Aguwa et al. (2010) had the goal to verify the effect of
rules modification on the final number of product modules. This model concerns with analyzing
the input of stakeholders’ data from available products and components to get an optimal
number of product modules for medical devices. These models lower product cycle time,
therefore increase market competitiveness. This depends on stakeholders’ inputs that affect
both product quality and reliability, which is also influenced by rules change based on
stakeholders’ constraints.
Kuo et al. (2013) propose a new product development (NPD) model that intends to improve the
effectiveness of innovative NPD in medical devices. An approach called a knowledge cluster
then assists in gathering, managing, integrating, and accumulating knowledge to become the
impulse for innovation. The model offers collaboration in PDP and offers an integration
platform to combine expertise and required knowledge into the integrated new product
development (iNPD). This will also improve the integration of interdisciplinary human
resources from diverse people with diverse backgrounds, experiences, and skillsets and
increases the acquirement of innovative technologies. To support an effective NPD model,
firms must provide sufficient incentives and trust to external individuals or groups willing to
contribute by sharing their skills, expertise, and knowledge to this knowledge cluster platform.
The difference between the collaboration aspect and the other aspects is that this aspect focuses
more on taking on responsibility based on each stakeholders’ interest. What distinguishes this
aspect in which other aspects do not concern of is the communication process, especially
connecting cross-functional teams. By this, the collaboration between parties will result in the
success of medical device development and reduce failures, this will also reduce uncertainties
and optimize workflow process. This aspect gives a different approach to integration with
stakeholders from different background and break down barriers. Moreover, this aspect
emphasizes the contribution towards common goals and agreements to be achieved in the
medical device development from the very beginning until the release of the product.
22
4 Discussion and Conclusion
This study is about medical device development in the healthcare sector. It is based on
conducting a narrative literature review in which research between models being applied in
product development will be compared. Models here are not limited to Stage-gate and Design
Thinking but also other possible alternatives. Each model is analyzed according to the needs of
product development in the healthcare sector, in which different approaches of models have
their focus based on needs in the product development process. Models are classified into 3
elements, they are; regulatory aspect, model configuration aspect, and collaboration aspect.
Initial knowledge is that the Stage-gate model has been applied in product development for a
long time in different sectors (Miranda, 2016; Grönlund, 2010). In the current situation, it is not
known to what degree Stage-gate and alternative methods are used in medical device
development. The guiding assumption could be that Stage-gate is the most popular model.
Based on the results section, there are several key findings identified. The key finding in the
process workflow aspect, according to the literature, the only model that describes development
phases is Design Thinking, which is proposed by Cheung (2012), the model applied Cagan and
Vogel’s integrated New Product Development (iNPD) process. The iNPD process
comprehends four phases, starting from product planning to program approval, it covers things
which are; identifying, understanding, conceptualizing, and realizing.
Key findings in the regulatory aspect as mentioned by Ocampo and Kaminski (2009) is that the
PD models in the medical sector are too regulatory oriented. Pietszch (2009) mentioned that
the control and reporting of product performance in the area have gained increasing attention
from the FDA, partly in consequence of information regarding product recalls. Medina et al.
(2013) also added that the FDA’s role related to medical devices can be described as one of the
risk assessments intended to create equilibrium between confirming the complete safety and
effectiveness of the products.
Key findings in the collaboration aspect, Goldenberg and Gravagna (2018) mentioned that
stakeholders should be involved in the life of medical devices from the very beginning until the
release of the product. Aguwa et al. (2010) mentioned that stakeholders’ inputs affect both
product quality and reliability, which is also influenced by rules change based on stakeholders’
constraints. Kuo et al. (2013) also added that a cluster knowledge approach model offers
23
collaboration in PDP and offers an integration platform to combine expertise and required
knowledge into the integrated new product development (iNPD).
Stage-gate and Design Thinking are not the main models utilized in medical device
development, other than that, various models are implemented in the healthcare sector, this
means other models becoming alternatives and have been utilized and developed in the product
development process. Other models besides Stage-gate and Design Thinking are alternatives
which do not have significant changes and are just modified forms from the existing ones. There
is no urgency to create such a new model in the medical device development, as alternative
models here are just upgrades and modified from the conventional one which is the Stage-gate
model.
Areas for further research could cover wider subject areas, for instance, project management,
agile manufacturing, and scrum master. Also, these subject areas are varied in terms of
approach, for instance, project management has been applied by industries like manufacturing
and engineering which produce physical products (Tonnquist, 2018). Agile manufacturing has
also been developed to embrace flexibility and continuous improvement based on feedback as
the project advances, its capability to adapt innovations quickly also makes it possible to be
applied in the current project (Gunasekaran et al., 2018). Meanwhile, the scrum master is a new
thing to most firms, it functions as a leader and facilitator and helps the team to proceed faster,
in which speed plays an important role in transforming parameters and productivity (Noll et al.,
2017). These areas will help improve the process of commercialization, funding requirements
of developing projects, and technology transfers. This will increase productivity and efficiency
in the product development process. Moreover, the rate of product failure will be reduced and
improve product effectiveness.
Time limitation for next research could be extended to study the development of product
development in the healthcare sector throughout the time thoroughly, for instance, getting
articles from the year 2000 and look upon other databases such as PubMed, Web of Science,
Business Source Complete, and IEEE Explore Digital Library. Other possible alternatives
besides conducting a narrative literature review are performing a case study with interviews or
surveys with companies.
24
5 References
Aguwa, C. C. et al. (2010) ‘Integrated Fuzzy-Based Modular Architecture for Medical Device
Design and Development’, Journal of Medical Devices, 4(3). doi: 10.1115/1.4002323.
Aguwa, C. C., Monplaisir, L. and Sylajakumari, P. A. (2012) ‘Rules modification on a Fuzzy-
based modular architecture for medical device design and development’, IIE Transactions on
Healthcare Systems Engineering, 2(1), pp. 50–61. doi: 10.1080/19488300.2012.666630.
Akroyd, C., Narayan, S. and Sridharan, V. G. (2009) The Use of Control Systems in New
Product Development Innovation: Advancing the ‘Help or Hinder’ Debate. SSRN Scholarly
Paper ID 1483565. Rochester, NY: Social Science Research Network. Available at:
https://papers.ssrn.com/abstract=1483565 (Accessed: 25 September 2020).
‘ALLEA-European-Code-of-Conduct-for-Research-Integrity-2017.pdf’ (no date). Available
at: https://allea.org/wp-content/uploads/2017/05/ALLEA-European-Code-of-Conduct-for-
Research-Integrity-2017.pdf (Accessed: 25 September 2020).
de Ana, F. J. et al. (2013) ‘Value driven innovation in medical device design: a process for
balancing stakeholder voices’, Annals of Biomedical Engineering, 41(9), pp. 1811–1821. doi:
10.1007/s10439-013-0779-5.
Başog˘lu, A. N. et al. (2012) ‘New product development for the healthcare industry: A case
study of diet software’, Health Policy and Technology, 1(2), pp. 93–104. doi:
10.1016/j.hlpt.2012.04.003.
Beale, M. and Cunningham, T. (2018) ‘Design Thinking at Daedalus’, Journal of Commercial
Biotechnology, 24(1). doi: 10.5912/jcb854.
Boute, R. N., Van den Broeke, M. M. and Deneire, K. A. (2018) ‘Barco Implements Platform-
Based Product Development in Its Healthcare Division’, INFORMS Journal on Applied
Analytics, 48(1), pp. 35–44. doi: 10.1287/inte.2017.0917.
Bryman, A. and Bell, E. (2011) Business research methods. Cambridge; New York, NY:
Oxford University Press.
Cheung, M. (2012) ‘Design Thinking in Healthcare: Innovative Product Development through
the iNPD Process’, The Design Journal, 15(3), pp. 299–324. doi:
10.2752/175630612X13330186684114.
Cooper, R. G. (2001) Winning at New Products: Accelerating the Process from Idea to Launch,
Third Edition. 3rd Edition. Cambridge, Mass: Basic Books.
Cooper, R. G. (2016) ‘Agile–Stage-Gate Hybrids’, Research-Technology Management, 59(1),
pp. 21–29. doi: 10.1080/08956308.2016.1117317.
Goldenberg, S. J. and Gravagna, J. (2017) ‘A real-world perspective: Building and executing
an integrated customer engagement roadmap that bridges the gaps in traditional medical device
25
development processes’, Journal of Medical Marketing, 16(2), pp. 41–49. doi:
10.1177/1745790418770598.
‘Good-Research-Practice_VR_2017.pdf’ (no date). Available at:
https://www.vr.se/download/18.5639980c162791bbfe697882/1555334908942/Good-
Research-Practice_VR_2017.pdf (Accessed: 26 November 2020).
Grönlund, J., Sjödin, D. R. and Frishammar, J. (2010) ‘Open Innovation and the Stage-Gate
Process: A Revised Model for New Product Development’:, California Management Review.
doi: 10.1525/cmr.2010.52.3.106.
Gunasekaran, A. et al. (2019) ‘Agile manufacturing: an evolutionary review of practices’,
International Journal of Production Research, 57(15–16), pp. 5154–5174. doi:
10.1080/00207543.2018.1530478.
Kahn, K. B. et al. (2012) ‘An Examination of New Product Development Best Practice’,
Journal of Product Innovation Management, 29(2), pp. 180–192. doi: 10.1111/j.1540-
5885.2011.00888.x.
Kuo, Y.-S. et al. (2013) ‘Exploring an effective model of new product development in medical
devices: a knowledge cluster approach’, International Journal of Technology Management,
63(3–4), pp. 295–312. doi: 10.1504/IJTM.2013.056902.
Lane, B. et al. (2019) ‘Development of a clinician–parent home care education intervention’,
Cardiology in the Young, 29(10), pp. 1230–1235. doi: 10.1017/S1047951119001318.
Lu, B. et al. (2012) ‘Can health economics aid decision making in healthcare innovation in
academia?’, International Journal of Technology Transfer and Commercialisation, 11(1/2), p.
70. doi: 10.1504/IJTTC.2012.043911.
Lu, R. M. T. and Mazouz, K. A. (2000) ‘A conceptual model of data warehousing for medical
device manufacturers’, in Proceedings of the 22nd Annual International Conference of the
IEEE Engineering in Medicine and Biology Society (Cat. No.00CH37143). Proceedings of the
22nd Annual International Conference of the IEEE Engineering in Medicine and Biology
Society (Cat. No.00CH37143), pp. 1279–1284 vol.2. doi: 10.1109/IEMBS.2000.897970.
Martin, J. L. et al. (2006) ‘Capturing user requirements in medical device development: the role
of ergonomics’, Physiological Measurement, 27(8), pp. R49-62. doi: 10.1088/0967-
3334/27/8/R01.
Medina, L. A., Kremer, G. E. O. and Wysk, R. A. (2013) ‘Supporting medical device
development: a standard product design process model’, Journal of Engineering Design, 24(2),
pp. 83–119. doi: 10.1080/09544828.2012.676635.
Miranda de Souza, V. and Borsato, M. (2016) ‘Combining Stage-GateTM model using Set-
Based concurrent engineering and sustainable end-of-life principles in a product development
assessment tool’, Journal of Cleaner Production, 112, pp. 3222–3231. doi:
10.1016/j.jclepro.2015.06.013.
26
Nicolini, D. et al. (2008) ‘Managing knowledge in the healthcare sector. A review’,
International Journal of Management Reviews, 10(3), pp. 245–263. doi: 10.1111/j.1468-
2370.2007.00219.x.
Noll, J. et al. (2017) ‘A Study of the Scrum Master’s Role’, in Felderer, M. et al. (eds) Product-
Focused Software Process Improvement. Cham: Springer International Publishing (Lecture
Notes in Computer Science), pp. 307–323. doi: 10.1007/978-3-319-69926-4_22.
Ocampo, J. U. and Kaminski, P. C. (2019) ‘Medical device development, from technical design
to integrated product development’, Journal of Medical Engineering & Technology, 43(5), pp.
287–304. doi: 10.1080/03091902.2019.1653393.
Pietzsch, J. et al. (2009) ‘Stage-Gate Process for the Development of Medical Devices’, Journal
of Medical Devices, 3. doi: 10.1115/1.3148836.
Press, T. M. (no date) Democratizing Innovation | The MIT Press. The MIT Press. Available
at: https://mitpress.mit.edu/books/democratizing-innovation (Accessed: 30 September 2020).
Rane, S. B. and Kirkire, M. S. (2017) ‘Interpretive structural modelling of risk sources in
medical device development process’, International Journal of System Assurance Engineering
and Management, 8(1), pp. 451–464. doi: 10.1007/s13198-015-0399-6.
Sanchez, L. M. and Nagi, R. (2001) ‘A review of agile manufacturing systems’, International
Journal of Production Research, 39(16), pp. 3561–3600. doi: 10.1080/00207540110068790.
Smolnik, T. (2020) ‘Structuring and managing the new product development process – Review
on the evolution of the Stage-Gate® process’, Journal of Business Chemistry.
Songkajorn, Y. and Thawesaengskulthai, N. (2014) ‘Medical Device Innovation Development
Process’, International Journal of Innovation and Technology Management, 11(04), p.
1450027. doi: 10.1142/S0219877014500278.
Tonnquist, B., 2018. Project Management; A Guide to the Theory and Practice of Project
Methodology and Agile Methods. Stockholm: Bo Tonnquist and Sanoma Utbildning AB,
Stockholm.
Uehira, T. and Kay, C. (2009) ‘Using design thinking to improve patient experiences in
Japanese hospitals: a case study’, Journal of Business Strategy. Edited by V. Kumar, 30(2/3),
pp. 6–12. doi: 10.1108/02756660910942418.
Wood, B. (1996) ‘Characterizing medical device development’, in IEEE Technical
Applications Conference. Northcon/96. Conference Record. IEEE Technical Applications
Conference. Northcon/96. Conference Record, Seattle, WA, USA: IEEE, pp. 254–259. doi:
10.1109/NORTHC.1996.564919.
27
Appendix
Query:
A (393 document results):
( TITLE-ABS-KEY ( product AND development ) AND TITLE-ABS-KEY ( medical AND
device ) AND TITLE-ABS-KEY ( healthcare ) )
B (264 document results):
( TITLE-ABS-KEY ( product AND development ) AND TITLE-ABS-KEY ( medical AND
device ) AND TITLE-ABS-KEY ( healthcare ) ) AND ( LIMIT-TO ( SUBJAREA , "MEDI"
) OR LIMIT-TO ( SUBJAREA , "ENGI" ) OR LIMIT-TO ( SUBJAREA , "BUSI" ) OR
LIMIT-TO ( SUBJAREA , "HEAL" ) ) AND ( LIMIT-TO ( PUBYEAR , 2020 ) OR LIMIT-
TO ( PUBYEAR , 2019 ) OR LIMIT-TO ( PUBYEAR , 2018 ) OR LIMIT-TO ( PUBYEAR
, 2017 ) OR LIMIT-TO ( PUBYEAR , 2016 ) OR LIMIT-TO ( PUBYEAR , 2015 ) OR
LIMIT-TO ( PUBYEAR , 2014 ) OR LIMIT-TO ( PUBYEAR , 2013 ) OR LIMIT-TO (
PUBYEAR , 2012 ) OR LIMIT-TO ( PUBYEAR , 2011 ) OR LIMIT-TO ( PUBYEAR ,
2010 ) OR LIMIT-TO ( PUBYEAR , 2009 ) OR LIMIT-TO ( PUBYEAR , 2008 ) OR
LIMIT-TO ( PUBYEAR , 2007 ) OR LIMIT-TO ( PUBYEAR , 2006 ) OR LIMIT-TO (
PUBYEAR , 2005 ) )
28
Table 1. List of articles and studies gathered as data collection for model identification being
used in product development in the healthcare sector
Title Author Publicatio
n year
Model
utilized
Concern Description
New product
development
for the
healthcare
industry: A
case study of
diet software
Basoglu et
al.
2012 Technology
Acceptance
Model
Recent product
promotion is
crucial to a firm’s
survival and
growth. A firm
must expand a
process to specify
how to find and
promote new
product ideas, and
how to
successfully make
them recognized
into the
marketplace.
In this
problem, this
research
explores the
design
parameters and
product
specifications
for product
development
concerning the
health industry
in Istanbul
Integrated
Fuzzy-Based
Modular
Architecture
for Medical
Device
Design and
Developmen
t
Aguwa et
al.
2010 Integrated
fuzzy-
based
The focus of this
study is to bring
collaboration
amongst
engineering
concepts and the
medical
profession with
the overall aim to
increase patient’s
quality of medical
treatment and
safety.
During the
study, an
integrated
fuzzy-based
system to
reach optimal
product
modules for
medical
devices has
been
presented. This
built upon
stakeholders’
inputs that
affect both
product quality
and reliability
Rules
modification
on a Fuzzy-
based
modular
architecture
Aguwa et
al.
2012 Fuzzy-
based
The focus of this
study is to define
the effect or
impact of “rules
changes” on the
best number of
Besides cost
implication,
quality is a key
problem. As of
this, an
integrated,
29
for medical
device
design and
development
modules in
medical device
design and
development.
The aim of the
research is to
reach an overall
improvement in
medical devices
by finding the
effect of “rules
change” on the
best number of
modules.
collaborative
modular
architecture
method for
medical device
design and
development is
presented. The
methodology
concerns
analyzing the
input of
stakeholders’
data from
current
products and
components to
obtain an
optimal
number of
modules. The
goal of this
research is to
verify the
effect of rules
modification
on the final
number of
product
modules.
Barco
Implements
Platform-
Based
Product
Developmen
t in Its
Healthcare
Division
Boute et
al.
2018 operations
research
optimizatio
n model
The model is a
tool that enables
firms in diverse
industries to
objectively
evaluate the
monetary impact
of the platform
strategy, making
it easier for the
different
departments
involved in
platform decisions
to approve the
The research
shows how
Barco, a global
technology
company,
utilized an
operations
research
optimization
model, which
was supported
by an effective
yet efficient
solution
method, to
30
optimal design.
The
implementation
can also provide a
company key
insights on
whether a
platform strategy
would be
beneficial in its
business
environment.
perform
platforms -
general
structures from
which sets of
products could
be created - for
the design and
production of
its high-tech
medical
displays.
Capturing
User
Requirement
s in Medical
Device
Developmen
t: The Role
of
Ergonomics
Martin et
al.
2006 Ergonomic
s
Developers of
medical devices
are progressively
subject to
demands that they
combine valuation
of user needs into
their development
processes. Those
demands come,
on the one hand,
from institutions
funding medical
device research,
many of those
now need some
proof in grant
applications that
user requirements
have been or will
be addressed
Most
ergonomics
research
methods have
been expanded
in response to
such practical
barriers and
these could
have potential
for medical
device
development.
Some are
compatible for
specific points
in the device
cycle for
instance,
contextual
inquiry and
ethnography,
the rests such
as usability
tests and focus
groups may be
utilized
throughout
development
31
Value
Driven
Innovation
in Medical
Device
Design: A
Process for
Balancing
Stakeholder
Voices
De Ana et
al.
2013 Value
driven
innovation
In the medical
device industry,
there are a
number of
stakeholders who
demand to have
their voices heard
throughout the
innovation
process. Each
stakeholder has
different and
unique
requirements
associated with
the medical
device, the
requirement of
one may
extremely
influence the
requirement of
another, and the
relationships
among
stakeholders may
be poor
The paper
describes the
application of
a spiral
innovation
process to the
development
of a medical
device which
examines three
distinct
stakeholder
voices: the
Voice of the
Customer, the
Voice of the
Business and
the Voice of
the
Technology.
Using design
thinking to
improve
patient
experiences
in Japanese
hospitals: a
case study
Uehira
and Kay
2009 Design
thinking
This research
underscored the
potential value of
deep user research
in product
development for
the entire medical
market
The article
provides a
brief case
study of the
use of
qualitative
research tools
by K.K.
Daishinsha, a
Japan-based
marketing
consulting
firm, to assist a
large Japanese
firm expand an
attractive
32
offering in a
new category.
The Use of
Control
Systems in
New Product
Developmen
t Innovation:
Advancing
the ‘Help or
Hinder’
Debate
Akroyd et
al.
2009 Stage-gate Main key
argument of the
study is that the
MCS design
should be
corresponding to
the nature of NPD
innovation.
The objective
of this paper is
to bring
forward this
help or hinder
debate by
inspecting the
potential
reasons as to
why MCS can
be thought to
deter the NPD
innovation
efforts.
Writers
identify
different types
of stage-gate
process
models which
can fit in with
different levels
of NPD
innovation.
The fairness of
the match
decides
whether MCS
help or hinder
NPD
innovation.
Exploring an
effective
model of
new product
development
in medical
devices: a
knowledge
Kuo et al. 2013 A
knowledge
cluster
approach
The establishment
of a KC and the
role that the KC
demonstrates in
the outside-in
innovative
process will be
the focus of this
study in order to
simplify breaking
The study
suggests a new
product
development
(NPD) model
that intends to
improve the
effectiveness
of innovative
NPD in the
33
cluster
approach
through the
innovation gap
and bringing the
maximum
advantage as well
as a new model
for NPD
medical
devices.
By adopting
open
innovation
(OI) theory
and utilizing
an in-depth
investigation
methodology,
this paper
argues a
knowledge
cluster that
improves the
integration of
interdisciplinar
y human
resources and
increases the
acquirement of
innovative
technologies
Interpretive
structural
modelling of
risk sources
in medical
device
development
process
Rane and
Kirkire
2015 Interpretive
structural
modelling
This study is
concerned on risk
sources in MDD
process but can be
practiced to
product
development in
other areas to
increase the
development
processes
The paper
investigates
risk sources in
medical device
development
(MDD)
process. A
model of
interaction
among these
sources is
promoted
based on
contextual
mutual
relationships
among them.
The risk
sources which
can
compromise
34
the MDD
processes in
terms of cost,
time of
development
and quality of
device are
identified
mainly
through
experts’ point
of views and
literature
review
Medical
device
development
, from
technical
design to
integrated
product
development
Ocampo
and
Kaminski
2019 Engineerin
g area
product
developme
nt
The goal of this
research is to
blend a PDP
model for SMEs
in the specific
medical sector, by
integrating the
best practices of
the engineering
area and
specialities of the
medical sector
Medical
Device (MD)
development
has specialities
that make the
product
development
process (PDP)
even more
complicated
for instance
high level of
regulations,
concurrent
technologies
application as
well as
different end
users
requirements.
Moreover,
these MDs are
characterized
according to
the level of
risk they
propose to
users – low,
medium and
high – what
makes their
35
development
project very
complex in
implementatio
n depending
on the
connecting
risk
Stage-Gate
Process for
the
Developmen
of Medical
Devices
Pietszch et
al.
2009 Stage-gate The paper
observes existing
model
representations
and provides a
new
comprehensive
development
model that seizes
all aspects of
device
development and
commercializatio
n from early-
concept selection
to post-market
control
The study
outcomes
proposes that
stage-gate
processes are
the
predominant
development
model used in
the medical
device
industry and
that regulatory
requirements
such as the
food and drug
administration
(FDA’s)
Quality
Systems
Regulation
present an
absolute role
in establishing
activities and
decisions in
the process.
The results
also emphasize
the significant
differences
between
medical device
innovation and
drug discovery
and
36
development,
and underscore
current
challenges
associated
with the
successful
development
of the
increasing
number of
combination
products
Supporting
medical
device
development
: a standard
product
design
process
model
Medina et
al.
2012 Product
design
process
model
In the article,
writers pick for a
more
comprehensive
description of the
MDD area and
thereby counter to
this fragmented
view in the
literature, a
viewpoint
referred with
potential negative
implications about
MDD’s
effectiveness
The article
depicts the
complex
nature of the
medical device
development
(MDD)
process and
performs a
product design
process model
to help
designers
participated in
MDD.
Basically, the
model sets as a
conceptual
framework and
provides a set
of formalisms
to stipulate the
development
area for
medical
devices.
Particularly,
the model
describes the
phases of
MDD and their
relationships,
37
including the
examining and
approval
environment
that affects this
process.
Design
Thinking in
Healthcare:
Innovative
Product
Developmen
t through the
iNPD
Process
Cheung 2012 Design
thinking
Innovative
surgery sways on
the horns of a
dilemma. While a
surgical
innovation may
propose major
improvement over
conventional
treatment
strategies on the
other hand, it may
be viewed by both
the surgeon and
the patient as
involving
significant risk on
the other
This paper
analyzes the
design process
of an
innovative
surgical
product called
the non-
invasive
patient tracker,
based on user-
centred
research
implemented
in the
operating
rooms of a
hospital in
Hong Kong.
The author
says that
surgical
innovation, as
well as the
responses to it,
promotes
through a
process of
‘nested’
circular
causalities that
emerge from a
linearly
directed
intention, i.e.
38
the purpose to
cure disease.
A real-world
perspective:
Building and
executing an
integrated
customer
engagement
roadmap that
bridges the
gaps in
traditional
medical
device
development
processes
Goldenber
g and
Gravagna
2018 Integrated
customer
engagemen
t roadmap
It is obvious, the
traditional stage-
gate process
engaged in new
product
development is
not dynamic
enough, nor
tactical enough, to
facilitate a
product’s success.
The new product
development
process should
address each
stakeholder’s
perspective (i.e.
payers, patients,
hospitals/healthca
re systems, and
governmental
agencies) and
produce data and
corresponding
messaging that
expresses to them
The benefits of
utilizing the
integrated
customer
engagement
roadmap
approach:
1. De-risks
failure to
launch
2. De-risks
commercial
vulnerability
3. Provides an
efficient NPD
process
4. Uncovers
unique
opportunities
in the market
39
Table 2. Details and advantages amongst models used by medical device studies to develop
medical device in the healthcare sector
Title Author Publicatio
n year
Model
utilized
Details Advantages
New
product
developmen
t for the
healthcare
industry: A
case study
of diet
software
Basoglu et
al.
2012 Technolog
y
Acceptance
Model
The study
focuses on
assuring the
TAM model and
establishing
external
parameters from
previous studies
to measure the
attitude and
intention of
health doctors
towards utilizing
Nutrition
Software
Outcomes of this
study show that
doctors’ positive
attitudes towards
utilizing
nutrition
software depends
on utility. Ease
of use, on the
other hand, does
not have a
prominent
impact on the
decisions to have
an intention to
use
Integrated
Fuzzy-
Based
Modular
Architecture
for Medical
Device
Design and
Developmen
t
Aguwa et
al.
2010 Integrated
fuzzy-
based
Model
an integrated
collaborative
modular
architecture
method for
medical device
design and
development is
presented in this
research. The
methodology is
concerning
analyzing the
input of
stakeholders’
data from
available
products and
components to
get an optimal
number of
modules. The
methodology
starts by
establishing a
product’s
The improved
quality of patient
care by bringing
through cost
reductions in
product design
and
development, as
of that increasing
patient safety.
This
methodology
helps lower
product cycle
time, then
increasing
market
competitiveness
among other
factors. All in
all, things
improved are
higher
flexibility, less
40
functional and
physical
decompositions.
Product
parameters are
picked for
instance quality,
reliability, ease
of
development, and
cost
product
development
time, reduced
material and
purchase cost,
and shorter
delivery time
Rules
modification
on a Fuzzy-
based
modular
architecture
for medical
device
design and
developmen
t
Aguwa et
al.
2012 Fuzzy-
based
Model
The specific
objectives of this
research are to:
specify design
criteria by
collaborating
with users and
manufacturers of
medical
equipment;
construe those
stakeholders’
inputs into
specific design
targets; expand a
preliminary
modular design
framework
utilizing multi-
criteria
optimization
methods;
examine the
preliminary
modular
architecture
utilizing a simple
medical device
and finally,
acquire the
impact of number
of “rules change”
on the best
number of
modules and
Future field
areas involve
researching
stakeholders’
data
management, for
instance,
factoring
anthropology
data into the
algorithm. The
effect of ranking
input to the best
number of
modules will be
investigated.
This study will
be widened to
include invasive
medical devices,
for instance an
artificial heart
and minimally
invasive devices.
41
minimum
deviation, ‘d’.
Barco
Implements
Platform-
Based
Product
Developmen
t in Its
Healthcare
Division
Boute et
al.
2018 operations
research
optimizatio
n model
The optimization
model seizes all
cost aspects
related to the
utilization of
platforms; so, it
is an objective
tool that
examines the
input from
marketing, sales,
research and
development
(R&D),
operations, and
the supply chain.
This
comprehensive
view enabled
Barco to prevent
the excessive
costs that may
generate from the
execution of an
incorrect
platform
The outcomes of
the project led to
decrease in
safety stock and
improved
flexibility due to
the use of
platforms: R&D
enable to
introduce twice
as many
products
utilizing the
same resources,
as it increases
Barco’s income
by more than
five million
euros annually
and reducing
product
introduction time
by narrowly 50
percent.
Capturing
User
Requiremen
ts in
Medical
Device
Developmen
t: The Role
of
Ergonomics
Martin et
al.
2006 Ergonomic
s
This study has
two goals. First,
it inspects the
potential benefits,
in terms of
improved patient
safety and device
effectiveness,
lower need for
product
withdrawals and
modification and
greater
commercial
success, of
incorporating
Evaluating and
meeting user
needs during
medical device
development will
generate
in successful
products that
improve patient
safety, improve
device
effectiveness and
efficiency, and
reduce product
withdrawals, and
modifications.
42
‘user needs’ at all
phases of the
design process.
Second, it
analyzes existing
methods for
evaluating user
requirements,
drawing upon a
newly done
review of the
literature on
methods for
evaluating user
needs in
engineering and
ergonomics
Ergonomics
research methods
are in particular
suitable.
Value
Driven
Innovation
in Medical
Device
Design: A
Process for
Balancing
Stakeholder
Voices
De Ana et
al.
2013 Value
Driven
Innovation
The innovation
process as a
spiral with
several phases
that cover a
divergent stage
followed by a
convergent stage.
The project
team’s
recommendation
s were executed
as they related to
the device design
for the most part.
Other initiatives
that influenced
process
management,
operations, etc.,
were discussed
and transferred
to the
appropriate
departments for
further
consideration
and decision
making.
Using
design
thinking to
improve
patient
experiences
Uehira
and Kay
2009 Design
thinking
While firms
worldwide deal
with increased
pressure to
produce
innovations on a
A strategy of
constant
incremental
escalations of
existing products
and business
43
in Japanese
hospitals: a
case study
predictable basis
through
disciplined
processes, many
firms in Japan
meet specific
challenges due to
Japan’s business
history and
culture
A manufacturing-
driven mindset
controls and
impedes Japanese
firms as services
become
increasingly
central to growth
even in industries
historically
centered on
manufacturing
goods.
models which
has in many
cases brought
great success to
Japanese firms –
is deeply
ingrained.
Organizational
dynamics in
Japan further
drive a thorough
and detailed
approach to
work, with the
sacrifice of risk-
taking and
championing of
breakthrough
ideas.
The Use of
Control
Systems in
New
Product
Developmen
t
Innovation:
Advancing
the ‘Help or
Hinder’
Debate
Akroyd et
al.
2009 Stage-gate Thus, during
NPD innovation,
management
controls systems
(MCS) may play
more of an
information role
which is used to
enhance learning
and coordination
to reduce
uncertainty.
In this study we
define MCS in
relation to the
stage-gate
process which
firms use to
manage the flow
In summary,
writers’ review
argues that each
NPD innovation
project faces a
different level of
uncertainty.
By this, each
NPD innovation
project type may
require the use of
a stage-gate
process
characterized by
various features.
Different stage-
gate process
models are
examined to
44
of new products
from idea
generation to
their launch into
the market.
better know how
firms can
manage NPD
innovation
projects.
The features of
each stage-gate
process model
are necessary for
managing
various types of
NPD innovation
projects in
practice.
Exploring
an effective
model of
new product
developmen
t in medical
devices: a
knowledge
cluster
approach
Kuo et al. 2013 A
knowledge
cluster
approach
This study
contributes to the
literature by
describing how to
develop a
knowledge
cluster (KC)
utilizing external
resources,
providing the
professional and
key technologies
needed by
enterprises, and
developing a new
NPD
management
model through a
cross-
organizational
management
platform that
solves the
challenges to OI
(open
innovation).
The KC proceeds
as a platform to
combine the
Five key factors
in the product
development
process influence
the benefits of
NPD.
First, developing
a KC as a
platform for
collaborative
R&D is
conducive to
getting core
technology.
Second,
enterprises must
establish
symbiotic and
complementary
partnerships with
external
technology
providers.
Third, firms
must construct
an innovative
management and
feedback
45
required
knowledge,
expertise and
know-how from
various resources
for successful
NPD. This study
not only ensures
OI as an efficient
approach to NPD
but also enhances
writers’
understanding of
the innovation
process.
mechanism to
look for
consensus based
on mutual trust
and recognition.
Fourth, they
must create
R&D product
design more
user-oriented.
Fifth, enterprises
should direct to
strengthen their
integration
capabilities
across the
organization for
internal R&D to
become
commercialized
R&D.
Interpretive
structural
modelling
of risk
sources in
medical
device
developmen
t process
Rane and
Kirkire
2015 Interpretive
structural
modelling
This research is a
unique effort and
will be a guide
for the
developers,
decision makers
and researchers
to focus and
reckon with the
risk sources
which can hinder
the processes and
may even result
in harmful events
connected to
devices.
ISM is:
• Interpretive, as
the relations
among variables
are determined
This research
creates three
significant
contributions to
the Medical
Device
Development
(MDD) domain
based on the
opinions of
experts in MDD
industry and
literature review.
Firstly, ten most
critical risk
sources which
lead to
obstruction
during MDD
process have
been identified.
46
based on the
experts’ opinions.
• Structural, as
overall structure
of the system is
established based
on the
relationships
promoted.
• A modelling
technique, as a
diagraph model
describes the
overall
relationships
among the
variables and the
arrangement of
the system under
consideration
Second, all the
risk sources
identified have
been explained
and indicated in
detail.
And third, a
contextual
relationship
among identified
sources has been
built.
Medical
device
developmen
t, from
technical
design to
integrated
product
developmen
t
Ocampo
and
Kaminski
2019 Engineerin
g area
product
developme
nt
The present
research aims to
propose a PDP
model, which is
specific to SMEs
in the medium-
risk medical
devices (MRMD)
sector by
combining the
best practices of
the engineering
area, which leans
to the technical
and economic
success, with the
regulatory
aspects and, also
with other
attributes such as
users’ safety and
product’s
effectiveness, all
considered very
Increase the
success rate of
new product
developments
(PDs) as well as
decrease the
enterprise’s risks
when developing
new products.
The results
gained will
permit SMEs in
the MRMD
sector to carry
out their projects
of new MD
faster and more
successful by
making possible
the integration of
diverse
knowledge areas
within the
enterprise as
47
important to the
medical area
In short, by
addressing the
engineering area
PD models and
by bringing the
necessary MD
aspects into it
such as
regulations and
other safety
aspects, it is
considered that
the unification of
the different
sources that were
merged into the
proposed model,
will simplify the
MRMD
enterprises. With
this new model in
hands they will
be able to direct
more innovative
projects of new
PDs, even to
evolutionary ones
by scaling the
model in order to
ease these type of
projects.
well as by
incorporating
new
development
project aspects
such as
accessing end
users’ real needs,
entrepreneurial
strategies,
regulations, new
technologies,
intellectual
property, and so
on
Stage-Gate
Process for
the
Developmen
t of Medical
Devices
Pietszch
et al.
2009 Stage-gate The objective of
the empirical
study provided is
to give a detailed
overview and
model
representation of
the medical
device
development
process and its
The linear stage-
gate model
provides an
extensive
description of
the various
activities and
decisions related
to the
development of
medical devices.
48
various activities
and decisions.
The model is
delivered in
linear-form as a
stage-gated
process,
according to the
feedback and
information
gained in the
field study. In
reality, many of
the established
processes within
the model are
likely to be
iterative. The
linearity of the
model is thus a
simplified
representation of
the proper
process.
A well concept
of this process
can benefit all
stakeholders in
the bench-to-
bedside process
of device
commercializatio
n: investors, who
want to serve
their resources in
the most
efficient way,
and who need to
understand the
funding
requirements of
different types of
development
projects;
engineers and
researchers who
aim at improving
the design and
benefit of a
technology; and
regulators who
need to make
sure the safety
and effectiveness
of new products
in the most
efficient way
Supporting
medical
device
developmen
t: a standard
product
design
process
model
Medina et
al.
2012 Product
design
process
model
This article
delivers a
validated product
design process
model as a
conceptual tool
and a
visualization
approach for the
development of
medical devices.
The model
provided can
have diverse
applications.
First, it can be
used as training
material for best
practices of
MDD.
Second, the
model can
49
To summarize,
this research
presents a
product design
process model as
a visualization
aid for designers
to use proactively
in dealing the
complexities of
MDD. The model
serves a set of
formalisms to
stipulate the
critical factors for
MDD, along with
their
relationships.
Including
information
about the medical
device
environment
(regulations,
patents and
standards) at a
high level.
Together, the
development and
introduction
processes are
specified with
great detail for
ease of
application with
MDD in general.
support as a
framework for
enhancing a
holistic view of
the MDD
process.
Third, the model
can set process
guidelines for
implementing
MDD the model
can offer
assistance for
regulatory
compliance.
Design
Thinking in
Healthcare:
Innovative
Product
Developmen
t through the
Cheung 2012 Design
thinking
This paper
depicts the design
process of an
innovative
surgical product
called the
noninvasive
patient tracker,
based on user-
The development
of an innovative
design for a non-
invasive patient
tracker through
the iNPD
process
discussed in the
paper expresses
50
iNPD
Process
centred research
performed in the
operating rooms
of a hospital in
Hong Kong and
informed by the
first two phases
of Cagan and
Vogel’s
integrated New
Product
Development
(iNPD) process
that surgical
innovation and
its correlated
constructs
expand through a
gradual spectrum
of ‘nested’
circular
causalities that
arise from a
linearly directed
purpose.
Through
validation of the
iNPD process,
the witer makes
an investigation
into design
thinking in the
healthcare
sector.
A real-
world
perspective:
Building
and
executing an
integrated
customer
engagement
roadmap
that bridges
the gaps in
traditional
medical
device
developmen
t processes
Goldenber
g and
Gravagna
2018 Integrated
customer
engagemen
t roadmap
It is obvious, the
traditional stage-
gate process
engaged in new
product
development is
not dynamic
enough, nor
tactical enough,
to facilitate a
product’s
success. The new
product
development
process should
address each
stakeholder’s
perspective (i.e.
payers, patients,
hospitals/healthca
re systems, and
governmental
agencies) and
The benefits of
utilizing the
integrated
customer
engagement
roadmap
approach:
1. De-risks
failure to launch
2. De-risks
commercial
vulnerability
3. Provides an
efficient NPD
process
4. Uncovers
unique
51
produce data and
corresponding
messaging that
expresses to them
opportunities in
the market
