ABSTRACT
To provide effective and safe care for patients the healthcare industry is dependent upon the provision of well designed medical devices. To achieve this, ergonomists recommend that user-centred design principles are adopted during development and recent changes to medical device regulations support these recommendations. In March 2010 it became a legal requirement for developers to consider the usability of their device before it can be placed on the market in Europe. In the UK, much of the innovation in the medical device industry is performed by Small and Medium Enterprises (SMEs), who often lack specialist ergonomics experts or the resources to bring this in, in the form of consultancy. As a result, the burden for this work frequently falls on the shoulders of the developers themselves. This paper describes the development, testing and validation of an interactive, web-based tool that aims to firstly, inform SME developers of the issues to consider when planning user research in medical device development, and secondly, to assist developers in selecting research methods that are likely to be most effective in answering their specific development questions. Requirementswere defined based on the literature, interviews with medical device developers and the authors’ experience of working in this area. The tool was then developed by a group of user elicitation experts using the Delphi technique. The result was a list of six research methods and nine multiple-choice questions, which when answered by the developer would assign each method to one of three categories according to its applicability to their specific research question: recommended, may be appropriate, and not recommended. The tool was validated and tested by two groups of participants: a group of userelicitation experts and a group of target users (SME medical device developers). Each participant was asked to review a set of user research scenarios and to assign each research method to one of the three categories. Each participant was then asked to repeat this task using the tool. During both of these tasks the participants were observed and asked to describe (think-aloud) their experience with the tool. This paper presents the results of the evaluation and validation of the tool, as well as discussing its potential applications within the medical device industry. We will also use this study as a stimulus for discussing the value and limitations of non specialists conducting ‘ergonomics’ research during medical device development.
