MeD UD – A process reference model for usability design in medical devices

A critical component to the success of software systems is the incor-poration of the end user. Ensuring that the end user can use the system effec-tively and efficiently is an important consideration. Failure to do this can lead to user error which in turn can have serious or even fatal consequences. To ad-dress this issue in the medical domain, where the risk to patient and user safety is quite high, a number of standards and guidance documents promote the use of Human Factors and Usability Engineering techniques during the develop-ment of devices. In this paper we introduce MeD UD (Medical Device Usabil-ity Design) – A Process Reference Model (PRM) for evaluating usability engi-neering in the medical device domain. Through a process assessment utilising the MeD UD PRM, medical device organisations can improve their usability design processes to achieve more usable products, reduce the risks associated with user errors and efficiently meet the medical device regulatory require-ments.