Medical Device Development: the challenge for ergonomics

High quality, well designed medical devices are necessary to provide safe and effective clinical care for patients as well as to ensure the health and safety of professional and lay device users. Capturing the user requirements of users and incorporating these into design is an essential component of this. The field of ergonomics has an opportunity to assist, not only with this area, but also to encourage a more general consideration of the user during medical device development. A review of the literature on methods for assessing user requirements in engineering and ergonomics found that little published work exists on the ergonomics aspects of medical device development. In particular there is little advice available to developers on which issues to consider during design and development or recommendations for good practice in terms of the methods and approaches needed to capture the full range of user requirements. The Multidisciplinary Assessment of Technology Centre for Healthcare (MATCH) is a research collaboration that is working in conjunction with industrial collaborators to apply ergonomics methods to real case study projects with the ultimate aim of producing an industry-focused guide to applying ergonomics principles in medical device development.

MATCH: a new industry-focused approach to medical device development

MATCH (Multidisciplinary Assessment of Technology Centre for Healthcare) is a new collaboration in the UK that aims to support the healthcare sector by creating methods to assess the value of medical devices from concept through to mature product. A major aim of MATCH is to encourage the inclusion of the user throughout the product lifecycle in order to achieve devices that truly meet the requirements of their users. A review of the published literature indicates that user requirements are mainly collected during the design and evaluation stage of the product lifecycle whilst other areas, including the concept stage, have less user involvement. Complementing the literature review is an in-depth consultation with the medical device industry, which has identified a number of barriers encountered by companies when attempting to capture user requirements. These will be addressed by a number of case study projects, performed in collaboration with our industrial partners, that will examine the application and utility of different approaches to collecting and analysing data on user requirements. MATCH is focused on providing advice to device developers on how to select and apply methods that have maximum theoretical strength, practical application, cost-effectiveness and likelihood of wide sector acceptance. Feedback will be sought in order to ensure that the needs of the diverse medical device sector are met.

How does the healthcare industry involve users in medical device development? Pointers for UbiHealth

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.