Design for risk control: the role of usability engineering in the management of use-related risks.

The majority of medical device incident reports can primarily be attributed to use error. Greater attention to human factors and usability during development of a medical device could improve this situation. However, recent studies have shown that companies do not find the application of a sound usability engineering process according to international standards a simple task. The purpose of this collaborative research project between a medical device company, two universities and a university hospital was to study the practical application of the International Standard for Application of Usability Engineering to Medical Devices, IEC 62366, by means of a case study in industrial practice. This paper describes the user studies in the case and reveals the factors important to success. Also, the paper demonstrates how to apply an iterative usability engineering process within a linear product development process in industry. Management support and careful planning of resources and activities proved essential. To control use-related risks, the usability engineer should 'design for risk control' in a structured manner, while the risk manager should remain responsible for acceptable levels of residual risk. The paper concludes with recommendations for the improvement of IEC 62366 and ISO 14971, the standard for the risk management of medical devices.