Medtech Matters

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the use of human factors (or ergonomics or useability) in medical device design, the FDA’s increased interest in its use, and how different users impact the device development (such as patient/home use versus physican/hospital use). Specifically, the following questions are addressed in this discussion: What exactly are human factors with regard to the development of medical devices?Last year, the FDA put out human factors guidance for medical device manufacturers. Have human factors always been a part of the FDA’s processes in some way or is it a relatively new element?How do manufacturers or how should manufacturers conduct human factors testing?As more devices are being sent home and used outside a healthcare environment, can you share the considerations for human factors development with devices used directly by patients? Also, during this discussion, reference is made to two FDA guidance