Change Management, Part 2—Mike on Medtech

Change Management, Part 2—Mike on Medtech

Mike Drues and Sean Fenske discuss the potential implications for a medical device manufacturer who mishandles the reporting of a change to a device.

By Sean Fenske, Editor-in-Chief01.20.20
In the second part of this two-part Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss change management with regard to how to address it with the FDA. The type of change and the overall implications of it to the functionality and efficacy of the device should dictate which route a company should take—letter-to-file or a Special 510k. Specifically, we address a number of questions, including:

  • What is change management and why is it important?
  • How does a company or regulatory individual decide when to handle the change internally, such as via a letter-to-file, vs. notifying the FDA with a special 510k or PMA supplement?
  • Does it matter what type of change is being made? And I have a list of examples. Perhaps we can take these one at a time?
    • Aesthetic change, such as color or size of a font?
    • Design change, such as the shape or size of the device?
    • Material change, such as the replacement of one material with another or the combination of two materials?
    • Labeling change, such as modifying an existing claim or adding a new one?
    • Change in the manufacturing process, such as for improving efficiency or reducing rejection rate or what about if the product is sent to a contract manufacturer?
    • Software change, such as for a security update or to add functionality?
    • Supply chain change, such as a testing vendor or something many may need to address, sterilization change?
  • How does change management for medical devices differ from those for drugs and which is used for combination products (drug/device)?
  • Do you have a suggested process to handle change and more importantly, can you defend it?
  • What is the relationship between change management and product liability?
  • What can happen if a company mishandles their change management procedures?
  • What are the most important takeaways for listeners concerned with change management?

Listen to this episode and see what you think of the tips and best practices for handling change management. 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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