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An Ontology Model for the Medical Device Development Process in Europe

Conference Paper · January 2012

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 AN ONTOLOGY MODEL FOR THE MEDICAL
DEVICE DEVELOPMENT PROCESS IN EUROPE

Isa C.T. Santos1*, G. Scott Gazelle2, Luís A. Rocha3, João Manuel R.S. Tavares1
1
Instituto de Engenharia Mecânica e Gestão Industrial /
Faculdade de Engenharia, Universidade do Porto,
2
Institute for Technology Assessment and Department of Radiology,
Massachusetts General Hospital, Harvard Medical School
3
Instituto de Polímeros e Compósitos, Universidade do Minho

ABSTRACT: Product development refers to the transformation process of an idea into a product or service. It can be
applied to any sector, but special attention must be given to each industry particularities. In the case of medical devices,
the development process should consider the multiple definitions of the term ‘medical device’, a vast regulatory
framework as well as numerous organizations that evaluate the devices’ safety and effectiveness before entering the
market. It should also consider various stakeholders and a variety of requirements regarding risk and quality. Currently,
literature regarding product development methodologies applied to medical devices is scarce, and there is no graphical
representation of the process addressing the environment in which it occurs. Here such representation, for the European
market, is made in order to help to understand how medical devices are developed, evaluated and approved. The
development process of medical devices was depicted because it is the most practical, easiest and fastest way to
maintain, understand and communicate information. Furthermore, it facilitates the identification of the elements driving
the process and reduces the complexity of the reality being represented. As the diagram presented is generic, it can be
applied to every segment of the medical device industry. In addition, it can be both used by designers and management
to guide the process, implement quality standards, support decision and select tools.

KEYWORDS: Product development; Concept model; Graphic representation; Europe; Regulations

1 INTRODUCTION This paper presents the differentiating characteristics of

medical devices and suggests a dedicated product
Product development refers to the transformation process development methodology. The procedure is presented
of ideas into commercial products [1]. Typically, it starts graphically because that is the most practical, easiest and
with the recognition of a need. Then, the problems that fastest way to maintain, understand and communicate
customers aim to solve by buying new products are information. Furthermore, it facilitates the identification
identified (customer needs). Following, numberless ideas of the elements driving the process and reduces the
to satisfy the needs are generated but usually only one is complexity of the reality being represented. This
developed and optimized. Prototypes or pre-series are representation, besides helping to understand how
produced and evaluated by a restricted number of clients medical devices are developed, evaluated and approved,
and, if they perform well, the process ends with the will guide both managers and designers during the
launch into the market. development process. It will also support decision
In spite of the differences among product development making, the selection of tools and the implementation of
processes, it is possible to define a generic procedure quality standards.
since they share common tasks and features. The This article is organized as follows. After the
application of such a procedure has many advantages presentation of the particular characteristics of medical
such as facilitate planning, increase predictability, help devices, a review regarding medical devices
to improve quality, reduce costs, and compress cycle development methodologies is made. Following, the new
times [2-4]. However, is possible to obtain further representation for the development process of medical
benefits if a dedicated procedure is used, that is, a devices is described. Finally, conclusions are drawn, and
procedure that considers the characteristics of the possible future perspectives are indicated.
product being developed and the environment in which
the development occurs.
____________________
* Rua Dr. Roberto Frias, s/n 4200-465 Porto, Portugal, email: [email protected]
2 CHARACTERISTICS OF MEDICAL has available online free-to-use tools to support the
DEVICES development of innovations [8]. Using the ‘Scorecard’ it
is possible to rank ideas and, by browsing through
Medical devices encompass distinct apparatuses ranging ‘Navigator’, one can structure the development of a
from dental floss to lab-on-a-chip technology and are novel device.
used in different settings, such as our homes and In 1997, the FDA (Food and Drug Administration)
hospitals. They also have several users, i.e., clients, who presented in the document “Design Control Guidance for
use the devices differently and with dissimilar Medical Device Manufacturers” the waterfall model as a
expectations [5]. tool for introducing new product design controls. Some
Despite the fact that different definitions for the term years later, the same institution encouraged
‘medical device’ coexist, overall, it refers to any manufacturers to shift to the total product life cycle
apparatus, software or material intended to be used in the (TPLC) model, a holistic approach to managing products
diagnosis, prevention, monitoring, treatment or through their lifecycle and making improvements to new
alleviation of a disease or an injury [6]. The differences products based on experiences with current products [9].
in the definition reflect the regulatory system with which In their work, Aitchison et al. [10] described the design
the devices must comply, which in turn affect the process for implantable orthopedic medical devices. The
industry performance. process was represented sequentially with 7 stages
It is possible to classify medical devices according to separated by design reviews to evaluate design
several criteria. While some categorizations have no requirements, assess the capability of the design and
impact on the device, others, like the risk classification, identify problems.
determine the legislation the device must comply with Aguwa et al. [11] proposed an integrated fuzzy-based
and its path to market. modular architecture for medical device design and
Medical devices interact with human fluids and tissue development. In their work, the development of medical
and as such cannot be disposed like other products. This devices involves 4 steps. The first step refers to the
is one of the reasons for considering carefully the entire functional and physical decomposition analyses of a
lifecycle of the devices during the product development. medical device or system. The second step includes the
To ensure the safety of both patients and healthcare selection of the performance parameters and the
providers, medical devices are highly regulated. During identification of the key metrics. Then, there is the
their development regulations, standards and guidelines evaluation of candidate modules. This is a phase that
regarding safety, quality, effectiveness, materials and consists of two tasks: the development of a formal,
others requirements must be considered. Besides these structured process for engineering judgment of candidate
documents, there are entities responsible to evaluate if modules with respect to the selected design objective
the devices conform. After the device enters the market, metrics, and the development of a fuzzy logic model for
monitoring continues to evaluate the risk the device transforming the subjective judgments into a set of
actually poses and to record adverse events; analyses are performance indices. The fourth and final stage is
conducted to determine coverage and reimbursement product modularization using a multi-optimization
policies. model.
A stage-gate process is proposed by Pietzsch et al. [12].
3 DEVELOPMENT OF MEDICAL The process includes the following 6 phases:
DEVICES predevelopment activities; opportunity and risk analysis;
concept and feasibility; design, development,
The development of medical devices is both capital and verification and validation; product launch preparation;
technologically intensive requiring highly qualified and product launch and post launch assessment.
personnel with different backgrounds ranging from Das et al. [13] propose an attribute-driven concurrent
medical doctors to engineers. It is often the case that engineering (ADCE) process for the development of
design requirements are incomplete and complex, and medical devices.
result from ambiguous situations. Furthermore, the Medical devices are a regulated product and, as such,
devices’ lifecycle is similar to or even longer than the have to comply with multiple standards, regulations and
development cycle, and research happens in every also guidelines regarding varied topics like safety,
direction. These reasons can explain why most quality, risk management and others. To overcome this
commonly the development of novel devices is fact, Alexander et al. [14] recommend, along with a
incremental with each model slightly different from its concurrent engineering approach, the application of
previous generation [7]. In this section, some of the design for X methods. Medina et al. [15] go further
research regarding methodologies for the development of suggesting guidelines to design for FDA (DfFDA) that
medical devices is presented. should be used, when appropriate, with another design
As the development of medical devices is complex, it is for X methods such as design for assembly (DfA),
common for regulatory bodies to offer consultancy design for manufacturing (DfM), design for reliability
services to help manufacturers deal with regulations and (DfR), design for quality (DfQ), design for validation
standards. For example, the British National Health (DfV) and design for usability (DfU). Design for FDA
Service (NHS) of the National Innovation Centre (NIC)
aims to increase awareness about regulatory compliance Idea creation can be decomposed into several tasks
and promote designers to consider the regulations (Figure 2). It can start in various ways ranging from the
throughout the development process of medical devices. identification of a clinical need to the identification of a
Literature shows that there is a concern in addressing the capability, i.e., new knowledge or technology. In order
medical device specificities. However, each author to proceed, not only does the commercial potential of the
focuses in a single aspect. In the following section, it is market opportunity have to be assessed, but also its
suggested an integrated methodology for the readiness or, in other words, whether there is suitable
development of medical devices. technology, the manufacturing process is feasible or the
market is prepared. If the opportunity has potential, the
4 PROPOSED MODEL development of the medical device has to be planned and
a decision regarding the markets in which the device will
Regardless its complexity, every medical device must be commercialized has to be made. This decision will
comply with similar requirements regarding quality, dictate the regulatory framework; here, it is addressed
safety and effectiveness. The model proposed here is the European one.
generic and, as long as it is custom-tailored, it can The next phase, concept development (Figure 3), is an
accommodate the specificities of any device. This model iterative process that starts with the analysis of
aims to describe the European environment in which competitive products and the voice of the customer, i.e.,
medical devices are developed, i.e., indicate the the process of capturing the customers’ expectations,
development process’ inputs and outputs. preferences and aversions (Figure 4). The latter is a sub-
The representation of the development process of process that starts with the identification of the customer;
medical devices was accomplished in two phases. in this context, ‘customer’ represents those that are
During the first phase, information was gathered from involved in the development of the medical device, from
literature on product development methodologies and the maker to the user. During this stage, the management
medical devices, and the process was implemented using of intellectual property (Figure 5) must be considered
Business Process Model and Notation (BPMN) [16]. constantly to protect new ideas/inventions and not to
During the second phase, the first version of the infringe on existing patents or utility models.
graphical representation was discussed; several During the design phase (Figure 6), both product (Figure
structured interviews were conducted, and an online 7) and manufacture (Figure 8) design can be performed
survey (based on the work of Medina et al. [17]) was either sequentially or concurrently. The management of
created and made available among members of intellectual property is once again a constant, and the
academia, industry and regulatory bodies. With the hazard analysis (Figure 9) should be conducted
feedback obtained, the model was completed. frequently to minimize risks and also to prepare post-
As Figure 1 shows, the development of a medical device market surveillance.
can be described as a cycle composed of the following The approval process differs from country to country;
phases: idea creation, concept development, design, Figure 10 shows the European process.
regulatory approval and clearance, and post-market Post-market activities are divided into two categories:
surveillance and vigilance. The process is highly post-market surveillance (PMS) and vigilance. The first
iterative and the borders of the phases are blurred. In is a proactive measure that consists in the collection of
Europe, in order to start the regulatory approval and data regarding the quality, safety and performance of
clearance stage, one has to have the medical device and medical devices once they have entered the market.
its manufacturing process completely defined because Vigilance, on the other hand, is a reactive measure that
both the quality of the product and production are consists in the report of incidents that may occur when
assessed. medical devices do not perform as intended, leading to
injury or, in the worst case, to death. With vigilance, one
aims to protect the health and safety of both patients and
healthcare professionals, evaluate incidents and avoid
relapses, and learn from experience.
Post-market activities, besides being a regulatory
obligation, are a good business practice because they
help manufacturers to understand the performance of
medical devices once they enter the market.
Furthermore, they provide feedback that is essential to
maintain quality and consumer satisfaction and allow the
promptly deployment of warning and product recall
procedures in case of incidents.
The requirements for PMS can be found in the European
Unions' Medical Device Directives, the quality standards
ISO 9001 and ISO 13485, and the risk management
standard ISO 14971. This information can be
Figure 1: Medical device development process.
complemented by two guidelines published by the The responsibility over post-market surveillance lies
European Commission: MEDDEV 2.12-1 rev 6 from over manufacturers as well as competent authorities,
December 2009 and NB-MED/2.12/Rec1. custom officials, notified bodies, authorized
representatives, importers/distributers and users.

Figure 2: Idea creation process.

Figure 3: Concept development process.

Figure 4: Voice of the customer process.

Figure 5: Management of the intellectual process.

Figure 6: Design process.

Figure 7: Product design.

Figure 8: Manufacture design.

Figure 9: Hazard analysis process.

Figure 10: Flowchart with the European path to market.
[2] Sheridan N., Gustavson P., Smith K.: Product
5 CONCLUSIONS development as a competitive advantage.
Engineering Management, 13(2):38-41, 2003.
In spite of the graphic representation of the product [3] Owens J., Cooper R.: The importance of a structured
development process not being new, so far, there is not a new product development (NPD) process: a
representation specific to medical devices. These methodology. In: Engineering Education:
products justify such a representation because they have Innovations in Teaching, Learning and Assessment
features that make them peculiar. In this paper, those (Ref. No. 2001/046), IEE International Symposium:
features were presented together with a representation of 10/1-10/6, 2001.
the European environment in which medical devices are [4] Brown A., Dixon D., Eatock J., Meenan B. J.,
developed. In the future, it is relevant to repeat this Young T.: A survey of success factors in New
exercise to the American market since it is the world's Product Development in the medical devices
largest. industry. In: 2008 IEEE International Engineering
Management Conference, 1-5, Jun. 2008.
ACKNOWLEDGEMENT [5] Shah S. G. S., Robinson I.: Medical device
The first author wishes to thank Fundação para a Ciência technologies: who is the user? International Journal
e Tecnologia (FCT), in Portugal, for its financial support of Healthcare Technology and Management, 9(2):
provided by the grant SFRH/BD/42967/2008. 181-197, 2008.
The work was partially supported by the project [6] WHO: Medical device regulations: global overview
“SenseCardioHealth: New technological solutions for and guiding principles. vol. 24, no. 3. Geneva:
smart cardiovascular medical devices” - MIT-Pt/EDAM- WHO, 2003.
EMD/0007/2008, sponsored by FCT. [7] Altenstetter C.: EU and member state medical
devices regulation. International Journal of
REFERENCES Technology Assessment in Healthcare, 19(1):228-
[1] Ulrich K., Eppinger S.: Product design and 48, 2003.
development. 5th ed. McGraw-Hill/Irwin, 2011. [8] “National Innovation Centre.” [Online]. Available:
http://www.nic.nhs.uk/. [Accessed: 21-Sep-2011].
 [9] Axendia Inc. & Cambashi Inc., Total Product
Lifecycle Management : Lowering costs while
Increasing quality, 1:1-36, 2009.
[10] Aitchison G., Hukins D., Parry J., Shepherd D.,
Trotman S.: A review of the design process for
implantable orthopedic medical devices. The Open
Biomedical Engineering Journal, 3:21-27, 2009.
[11] Aguwa C. C., Monplaisir L., Sylajakumari P. A.,
Muni R. K.: Integrated fuzzy-based modular
architecture for medical device design and
development. Journal of Medical Devices, 4(3): 1-
10, 2010.
[12] Pietzsch J. B., Shluzas L. a, Paté-Cornell M. E.,
Yock P. G., Linehan J. H.: Stage-gate process for
the development of medical devices. Journal of
Medical Devices, 3(2):1-15, 2009.
[13] Das S. K., Almonor J. B.: A concurrent engineering
approach for the development of medical devices.
International Journal of Computer Integrated
Manufacturing, 13(2):139–147, 2000.
[14] Alexander K., Clarkson P. J.: Good design practice
for medical devices and equipment, Part I: A review
of current literature. Journal of medical engineering
technology, 24(1):5-13, 2000.
[15] Medina L. A., Wysk R. A., Kremer G. E. O.: A
review of design for X methods for medical devices:
The introduction of a design for FDA approach. In:
Proceedings of the ASME 2011 International
Design Engineering Technical Conferences &
Computers and Information in Engineering
Conference IDETC/CIE 2011, 2011.
[16] Briol P.: BPMN the business process modeling
notation. 2008.
[17] Medina L. A., Wysk R. A., Kremer G. E. O.: An
ontology model for the medical device product
development. In: Proceedings of the 2011 Design of
Medical Devices Conference, 2011.

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