FDA’s Cybersecurity Playbook—Mike on Medtech

FDA’s Cybersecurity Playbook—Mike on Medtech

Mike Drues and Sean Fenske discuss why cybersecurity is important to the Agency and how to address challenges involved with it.

By Sean Fenske, Editor-in-Chief01.20.22
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss a recent offering put out by the FDA in conjunction with the Medical Device Innovation Consortium and MITRE. It is a playbook for device makers to involve threat modeling of medical devices in its approach to cybersecurity. Best practices for addressing cybersecurity of medical devices is also covered. Specifically, the following questions are addressed:

  • Can you start things off by explaining what Threat Modeling is?
  • Regarding this playbook the FDA released, is this purely a type of best practices item or is this something that may have regulatory implications tied to it somewhere down the road?
  • Why is the FDA putting such attention on cybersecurity in medical devices? Is this about patient safety?
  • Are there currently regulatory requirements with regard to cybersecurity?
  • What do you foresee happening with FDA and cybersecurity? Will there continue to be guidance and/or will it become a bigger part of a regulatory review?
  • What are your suggestions or takeaways for device manufacturers when it comes to cybersecurity and the FDA?
You can download the playbook for Threat Modeling Medical Devices discussed in this podcast by clicking HERE.

Listen to this episode and see what you think of the FDA’s interest in cybersecurity. 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 want to 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.

Click here to review other podcasts.