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Mike on Medtech: Human Factors/Usability, Part 2

Mike on Medtech: Human Factors/Usability, Part 2

Mike Drues and Sean Fenske discuss the implications of not meeting with the FDA’s requirements for human factors testing.

By Sean Fenske, Editor-in-Chief02.03.20
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 takeaways device manufacturers should consider with regard to human factors/usability?

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@rodmanmedia.com so I can consider discussing them with Mike in an upcoming episode.

Listen to the podcast streaming via the player or get the podcast on the Medtech Matters channel via your preferred vendor of podcasts, such as Apple Podcasts (iTunes) or Spotify.

Once you’ve had a chance to listen to the podcast, if you have any questions or comments you’d like us to discuss or share with other Mike on Medtech listeners about this topic or any other topic we’ve addressed, or you have a suggestion for a future topic for us to cover, email me and we’ll try to respond in an upcoming Mike on Medtech podcast.

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