Do it by Design: How Usability Brings Value to Risk Controls

Use-errors accounts for the majority of medical devices incident reports. Additionally, according to the World Health Organization, it was also reported that the design of a medical device is often inappropriate for the context in which it is used. Therefore, it is crucial to pay more attention to usability and human factors during medical device development. A strong usability engineering methodology that complies with international standards is needed to address this problem. 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. However, most companies frequently fail to put such a procedure into practice, which impedes the enhancement of usability and consequently increases the danger of errors.

By tackling this subject, we hope to examine the crucial role that usability plays in risk control systems and demonstrate how, despite its limitations, adopting a user-centric approach has a major positive impact on mitigating the risks connected with medical devices. By delving into the International Standard for Application of Usability Engineering to Medical Devices, IEC 62366-1,  and emphasizing the need for a comprehensive usability engineering process, we aim to shed light on the path towards enhancing the safety and effectiveness of medical devices while minimizing the potential for use error-related risks.