COVID-19, Part 1—Mike on Medtech

COVID-19, Part 1—Mike on Medtech

Mike Drues and Sean Fenske discuss Emergency Use Authorization and the potential problems with non-medical device manufacturers producing ventilators.

By Sean Fenske, Editor-in-Chief04.01.20
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss questions raised by news of medical technology being rolled out to help battle the COVID-19 virus. Topics such as what Emergency Use Authorization means to how non-manufacturers of medical devices can now produce products for the effort such as ventilators. Specifically, we address a number of questions, including:

  • What is coronavirus?
  • We’re hearing quite a bit about Emergency Use Authorization, primarily around tests for COVID-19. What does that mean exactly?
  • Does EAU lower the regulatory burden compared to other pathways to market?
  • To address the need for ventilators, companies like Ford and GM are changing over production to help. How does this happen when the FDA has likely never stepped foot into these facilities?
  • With all the rushed approvals/clearances of new medical supplies, is there a concern regarding safety?
  • What is the situation for companies with existing devices (already on market) that can be modified to help with the battle against COVID-19?

Listen to this episode and see what you think of the concerns brought up regarding the effort against COVID-19. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com and we’ll see if we can address your ideas/inquiries/suggestions in a future 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.

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