User-Centred Design Methods for Medical Device Development

By Arthur G. Money (Brunel University, UK) and Jennifer L. Martin (University of Nottingham, UK) Designing safe, efficient, effective and usable medical devices is crucial if patients and practitioners are to fully benefit from innovations within the medical device manufacturing sector. Indeed, it is becoming increasingly recognised that the design features of a device are likely to impact on levels of patient safety, and the occurrence of human error, when using a device. Furthermore, designing devices that take into account usability criteria, such as comfort, ease of use, maintainability, storage requirements and aesthetics, are likely to increase the user's willingness to adhere to a given treatment schedule.[1] Involving users in the medical device design and development process is one promising approach that is likely to help ensure that devices are more closely aligned with the needs of the user and hence enable the development of safer, more usable devices that improve treatment outcomes and levels of user satisfaction. User involvement also has clear benefits from a device developer's perspective. For example, providing the opportunity to demonstrate a clear need for a device, and that a device is considered to be highly usable, from a user's perspective is likely to improve the prospects of attracting external funding for further research and development of a given device. Research funding initiatives, such as the UK Health Technology Devices programme, which support collaborative research projects for the development of improved health technology devices, already require developers to involve users in the decision-making processes of device design. This is a departure from more traditional models of participant engagement in which users would typically play a more passive role in the device design process. Given the potential benefits of user involvement, the Engineering and Physical Sciences Research Council has funded Multidisciplinary Assessment of Technology Centre for Healthcare (MATCH) to investigate a range of issues relating to the design, development and assessment of healthcare technologies. Part of this work has involved the development of a National Patient Safety Agency (NPSA) guide, which provides advice on incorporating user testing into the medical device design and development process. [2] The guide aims to provide support in the process of planning and carrying out user testing and deciding which users to involve and deciding which methods to employ when engaging in user testing at each stage of device development pathway. Initially, in terms of planning user testing activity, the guide provides a checklist of questions that the developer may use to help focus their aims and motivations for this activity. Furthermore, it helps to identify what resources will be needed and which users would be most appropriate to involve in the process. The checklist is presented in seven sections under the following headings: What, Why, Who, When, How Much, Where and How. A model of the device development pathway is also presented along with a range of user-centred design (UCD) methods that may be used at each stage of the pathway. UCD is a research approach that puts the user at the centre of the device design, development and evaluation phases. The model indicates how a portfolio of eleven UCD methods may optionally be applied by developers at each stage of the pathway. This provides a prescriptive reference point for device developers for identifying which candidate methods are most appropriate according to which stage of the development lifecycle is taking place. The figure presents the model and associated UCD methods. To provide some insight into what a selection of these methods involve, a brief description of the most frequently occurring methods within the device development lifecycle is now provided. For a detailed description of all methods and how these may be applied, refer to the fullAir Jordans