Capturing User Requirements in Medical Device Development: The Role of Ergonomics

Measuring and fulfilling user requirements during medical device development will result in successful products that improve patient safety, improve device effectiveness and reduce product recalls and modifications. Medical device users are an extremely heterogeneous group and for any one device the users may include patients, their carers as well as various healthcare professionals. There are a number of factors that make capturing user requirements for medical device development challenging including the ethical and research governance involved with studying users as well as the inevitable time and financial constraints. Most ergonomics research methods have been developed in response to such practical constraints and a number of these have potential for medical device development. Some are suitable for specific points in the device cycle such as contextual inquiry and ethnography, others, such as usability tests and focus groups may be used throughout development. When designing user research there are a number of factors that may affect the quality of data collected including the sample of users studied, the use of proxies instead of real end-users and the context in which the research is performed. As different methods are effective in identifying different types of data, ideally more than one method should be used at each point in development, however financial and time factors may often constrain this.

Public and user participation in public service delivery: tensions in policy and practice

Social-scientific analysis of public-participation initiatives has proliferated in recent years. This review article discusses some key aspects of recent work. Firstly, it analyses some of the justifications put forward for public participation, drawing attention to differences and overlaps between rationales premised on democratic representation/representativeness and those based on more technocratic ideas about the knowledge that the public can offer. Secondly, it considers certain tensions in policy discourses on participation, focusing in particular on policy relating to the National Health Service and other British public services. Thirdly, it examines the challenges of putting a coherent vision for public participation into practice, noting the impediments that derive from the often-competing ideas about the remit of participation held by different groups of stakeholders. Finally, it analyses the gap between policy and practice, and the consequences of this for the prospects for the enactment of active citizenship through participation initiatives.