Medtech Matters

In this Medtech Matters podcast episode 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. Medical device manufacturers need to ensure they are not only satisfying this need, but also fulfilling any potential liability involved. Specifically, we address a number of questions, including:What is human factors as it relates to medical device development?Were human factors always required by the FDA?What is the difference between human factors testing and a clinical trial?What types of medical devices are required to go through human factors validation testing?If you’d like to review the FDA’s Human Factors guidance document before listening to this podcast, you can find it by clicking here. Listen to this episode and see what you think of the FDA’s human factors requirements. If you’d like to share thoughts and comments with us or have questions on the topic, please reach out to me with them at sfenske@rodmanmed