Abstract
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 ergonomic 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 Health care (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.
Highlights
To provide safe and high quality care for patients the healthcare industry requires clinically effective and well designed medical devices
In addition to access to users, the intrusiveness of some methods discussed in this paper may mean that they are unsuitable for use within a medical setting or may have to be modified: for example when using contextual inquiry it may be inappropriate for the researcher to ask questions of the users whilst they are performing tasks or during patient consultations or certain surgical procedures
Apart from the recent focus on usability of devices, in particular of infusion pumps, little published work exists on the ergonomics aspects of medical device development
Summary
To provide safe and high quality care for patients the healthcare industry requires clinically effective and well designed medical devices. The healthcare sector is extremely complex and characterised by multiple users; varied healthcare settings from emergency to acute to home; remote purchasing and patient variability where factors such as type of clinical condition, health status and disability are added to the usual multiplicity of individual characteristics. Developers, including those with a clinical background, may struggle to appreciate that user requirements encompass more than just clinical effectiveness and that for any one device there will be a number of different users to consider, including doctors, nurses, technicians, maintenance staff, patients and carers. There may be scope for these organisations to encourage device developers to adopt ergonomic principles more thoroughly by considering usability and other user issues when making purchasing decisions
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