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 SiregarThe 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:
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Telephone:
+46 (0)18 – 471 30 03
Telefax:
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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
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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
