Usability and Safety of Software Medical Devices: Need for Multidisciplinary Expertise to Apply the IEC 62366: 2007

Software medical devices must now comply with the "ergonomics" essential requirement of the Medical Device Directive. However, the usability standard aiming to guide the manufacturers is very difficult to understand and apply. Relying on a triangulation of methods, this study aims to highlight the need to combine various expertises to be able to grasp the standard. To identify the areas of expertise on which the usability standard relies, an analytical review of this document was performed as well as an analysis of a discussion forum dedicated to it and an analysis of a case study of its application for CE marking. The results show that the IEC 62366 is a usability standard structured as a risk management one. It obviously requires Human Factors/Ergonomics expertise to be able to correctly identify and prevent risks of use errors, but it also requires risk management expertise to be able to grasp the issues of the risk analysis and master the related methods.