Exploring the Variability of Human Factors and Usability Testing Methods for Evaluating Medical Devices - Preliminary Results

The success of a medical device is based on its ability to be deployed according to its use specification to safely achieve the intended outcome. Central to this is the design of the device which, if poorly executed, contributes to 'use error' which affects the efficacy, safety, and user experience of a medical device. Human factors guidance provides recommendations to evaluate the user experience in a bid to improve design efforts and ultimately the safety and usability of medical devices. The heterogeneity of the industry means that the interpretation of these guidelines is subjective and adapted differently to suit the use specification of the devices. The aim of this study is to explore the perceptions of medical device industry professionals on factors influencing the evaluation of the user experience in the design of medical devices. A bespoke survey approach is currently being undertaken to achieve this objective and to interrogate the key issues. There is a lack of substantial evidence in the literature that indicates which user experience testing methods are most favoured and widely used in practice, across all stages of device development from concept to post-sales testing. This study is designed to shed light on industry practices; the variability of user experience testing methods of medical devices, as well as the preferred methods, and the aspects of user experience considered in medical device design.