MATCH: A NEW INDUSTRY-FOCUSED APPROACH TO MEDICAL DEVICE DEVELOPMENT (original) (raw)
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Early stage Health Technology Assessment (HTA) of biomedical devices. The MATCH experience
2013
Early stage Health Technology Assessment (HTA) of biomedical devices requires different methods than those usually employed for pharmaceuticals. This paper reviews widely-used methods for HTA, discusses their limits for early stage evaluation of biomedical devices and presents two methods for early stage HTA being developed in the Multidisciplinary Assessment of Technology Centre for Healthcare (MATCH) project: Analytic Hierarchy Process (AHP) to elicit user needs; and early stage economic evaluations using Markov Models.
How does the healthcare industry involve users in medical device development? Pointers for UbiHealth
2004
This paper introduces the Multidisciplinary Assessment of Technology Centre for Healthcare (MATCH) and outlines the problem of integrating a user-centred approach for development of medical devices together with the information and communication technology environments in which they are increasingly required to operate. We highlight some of the regulatory requirements that are relevant to user needs consideration in medical device development. Finally, we reveal a range of limitations in the current practice of the medical device industry in the area of user needs capture, based on responses from interviews with MATCH's industry partners.
The specificities of medical devices - opportunity for a dedicated product development methodology
Expert Review of Medical Devices
The medical sector, similarly to other industries as the aviation industry, has to comply with multiple regulations, guidelines and standards. In addition, there are multiple definitions for the expression 'medical device' and, before entering the market, manufacturers must demonstrate their product's safety and effectiveness. In such a complex and demanding environment it is crucial to know the particularities surrounding the product being developed in order to minimize the chances of a commercial flop. Thus, in this paper, the medical device's specificities are identified and the most relevant legislation is reviewed providing the foundations for a dedicated product development methodology.
Medical device specificities: opportunities for a dedicated product development methodology
Expert review of medical devices, 2012
The medical sector, similarly to other industries as the aviation industry, has to comply with multiple regulations, guidelines and standards. In addition, there are multiple definitions for the expression 'medical device' and, before entering the market, manufacturers must demonstrate their product's safety and effectiveness. In such a complex and demanding environment it is crucial to know the particularities surrounding the product being developed in order to minimize the chances of a commercial flop. Thus, in this paper, the medical device's specificities are identified and the most relevant legislation is reviewed providing the foundations for a dedicated product development methodology.
Representation of the development process of medical devices in Europe
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.
Journal of Materials Science: Materials in Medicine, 2016
The European Society for Biomaterials 2015 Translational Research Symposium focused on 'Innovating in the Medical Device Industry-Challenges & Opportunities' from different perspectives, i.e., from a non-profit research organisation to a syndicate of small and mediumsized companies and large companies. Lecturers from regulatory consultants, industry and research institutions described the innovation process and regulatory processes (e.g., 510K, PMA, combination product) towards market approval. The aim of the present article is to summarise and explain the main statements made during the symposium, in terms of challenges and opportunities for medical device industries, in a constantly changing customer and regulatory environment.
Streamlining medical device design development process from research laboratory to the market
2015 9th International Symposium on Medical Information and Communication Technology (ISMICT), 2015
The objective of this paper is to describe the common conformity assessment procedures to comply with the regulations in certifying devices for medical use. This paper also defines the main aspects of medical devices in general with common key differences between medical devices and consumer products. Furthermore, this paper highlights the role and importance of literature research in medical device development, particularly in shortening the time-to-market and in the certification process. Finally, this paper gives the researchers of institutes and universities suggestions on what could be taken into account at the very early phase of ideation of possible methods and products that are intended to be classified as a medical device
BMC Medical Informatics and Decision Making, 2011
Background: Academic literature and international standards bodies suggest that user involvement, via the incorporation of human factors engineering methods within the medical device design and development (MDDD) process, offer many benefits that enable the development of safer and more usable medical devices that are better suited to users' needs. However, little research has been carried out to explore medical device manufacturers' beliefs and attitudes towards user involvement within this process, or indeed what value they believe can be added by doing so. Methods: In-depth interviews with representatives from 11 medical device manufacturers are carried out. We ask them to specify who they believe the intended users of the device to be, who they consult to inform the MDDD process, what role they believe the user plays within this process, and what value (if any) they believe users add. Thematic analysis is used to analyse the fully transcribed interview data, to gain insight into medical device manufacturers' beliefs and attitudes towards user involvement within the MDDD process. Results: A number of high-level themes emerged, relating who the user is perceived to be, the methods used, the perceived value and barriers to user involvement, and the nature of user contributions. The findings reveal that despite standards agencies and academic literature offering strong support for the employment formal methods, manufacturers are still hesitant due to a range of factors including: perceived barriers to obtaining ethical approval; the speed at which such activity may be carried out; the belief that there is no need given the 'all-knowing' nature of senior health care staff and clinical champions; a belief that effective results are achievable by consulting a minimal number of champions. Furthermore, less senior health care practitioners and patients were rarely seen as being able to provide valuable input into the process.
Medical device development, from technical design to integrated product development
Journal of Medical Engineering & Technology, 2019
The development process of medical devices (MDs) implies the integration of knowledge and skills from the fields of medicine and engineering. Such an integration is difficult because of lack of communication, mismatch of priorities and work-style differences among those fields. Besides, MD development has particularities that make the product development process (PDP) even more complex such as high level of regulations, concurrent technologies application as well as different end users requirements. In addition, these MDs are classified according to the level of risk they offer to userslow, medium and highwhat makes their development project very complex in practice depending on the risk associated. For the specific case of SMEs in the broad mechanical and electronic area that develop physical MD with low and medium-risk levels, PDP models in place have proved to be not well fit to the reality they face. This research objective is to synthesise 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. The methodology used was an extensive bibliographic analysis and field research conducted towards SMEs in the MD industry.