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Medtech Matters

Human Factors—Mike on Medtech

Mike Drues and Sean Fenske discuss the importance and benefits of human factors design in medical device development.

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By: Sean Fenske

Editor-in-Chief, MPO/ODT
Human Factors—Mike on Medtech

In this 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 documents relevant to the use of human factors with medical device development. You can find those here:


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 at sfenske@rodmanmedia.com and we’ll try to respond in an upcoming Mike on Medtech podcast.

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