Medtech Matters

In the second part of this Medtech Matters podcast series of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the FDA’s emphasis on human factors (or ergonomics or usability) testing. We mention what medical device manufacturers should be concerned with for less than satisfactory testing protocols, and how the FDA may not even be the worst thing they should be worried about. Specifically, we address a number of questions, including:  Are there certain areas of human factors the FDA is emphasizing or paying closer attention to? Do you have suggestions or real-world examples on how a company may perform human factors testing? How does human factors testing for a medical device differ based on where the product is intended to be used (for example, in the home versus in a hospital room or used by a physician versus the patient directly)? What type of trouble with the FDA can a company get into for not accomplishing human factors testing in a satisfactory manner? What are the key takeawa