Study of HFE/UE Process Model in Medical Device Development

Recently, importance has been placed on designing medical device based on the concepts of Human Factors Engineering (HFE) and Usability Engineering (UE). In this paper, we considered HFE/UE development process model incorporating human-centered design and safety design. First, in order to practice usability engineering in enterprises based on the relation with human-centered design/safety design, the following three issues were confirmed. (1) Clarification and elaboration of the product development process, (2) Quantification of usability, (3) Improvement of methods, tools, and environment. Next, we focused on “Context Search”, one of the three basic usability tools of the medical product development program. And in designing medical equipment, consideration to the thought circuits of people who actually use the equipment is important as well as performance. Therefore, with reference to the pm - SHELL model of the HFE model, we decided to capture HFE in a wider view. Finally, a new HFE/UE equipment development process model and Usability evaluation process model were examined based on development cases of “medical drivers” and “bone fleas”.