ABSTRACT
The medical device industry traditionally has focused almost exclusively on system
safety, with little regard to the usability of its products. This is not surprising given that
the Food and Drug Administration’s (FDA’s) regulations have explicitly mandated this
point of view. As a result, many medical devices are complex and extremely difficult to
use, even by those trained in health care and medicine (e.g., medical technologists,
nurses, clinicians). Furthermore, to the extent that the context of use was considered in
the design of medical devices at all, it often was viewed as limited to the hospital
environment.
