Commentary: Ethnographic field research for medical-device design

摘要

I was gratified to see in the standard, AAMI/ ANSI/IEC 62366:2007, Medical Devices-Application of usability engineering to medical devices, that, for the first time, a human-factors related, medical device standard called explicitly for user research. Annex D of the standard (Guidance on the Usability Engineering Process) lists user research as the first step of the "user interface design cycle." While the annex says that "user input can be obtained in a variety of ways," it also says that the approach advocated in the standard "necessitates an understanding of how users interact with the medical device in the actual use environment.