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Reminiscing about past and present lessons learned from listening to conversations with this show’s most frequent guest, one important principle emerged: Teach others how to think, not what to think.
In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues, president of the medical device consultancy firm, Vascular Sciences.
Anyone who’s listened to the show knows that Jon and Mike are passionate about the world of medical devices, particularly design controls, regulatory affairs, and prudent engineering practices. Listen to this episode where they revisit how they met in December 2014 and what they have shared and learned through the years.
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Some highlights of this episode include:
- Do you make these design control mistakes? Original podcast content triggered a reaction by Jon to connect with Mike, only to discover they shared more similarities than differences.
- Medical device companies continue to make mistakes and get in trouble with the FDA by focusing more on what regulations say, rather than understand and follow the intent of design controls.
- Design controls are vague and purposely written that way to be applied to the broad medical device industry—from Band-Aids to artificial hearts.
- Biocompatibility Testing: What’s that? Medical device professionals should know what and how to do things, not be spoon fed to follow a recipe.
- How can a sponsor prove that a medical device’s design inputs/outputs and verification/validation are correct? Ask the right question to solve the right problem that meets users’ needs, but don’t assume users know what they need.
- Different Pathways: Why take the easier and straightforward path to market? Design controls and regulations tend to encourage evolutionary, not revolutionary product development.
- Design Changes: As products are in use, keep learning, iterating, and evolving to make products safer, better, and more effective for patients.
- Risk: How it relates to off-label use and anticipated misuse is a major benefit of following design controls and risk management practices.
Links:
FDA - Medical Devices
820.30 Design Controls - Code of Federal Regulations (CFR)
Design Control Guidance For Medical Device Manufacturers - FDA
Premarket Notification 510(k)
Webinar: Why Design Validation is more than Testing: How do we validate our validation?
Mike Drues on LinkedIn
Vascular Sciences
The Greenlight Guru True Quality Virtual Summit
Greenlight Guru YouTube Channel
MedTech True Quality Stories Podcast
Greenlight Guru
Memorable Quotes from this episode:
“What I appreciate most about my relationship with Mike Drues is that he has caused me to think about the world a lot differently, specifically within the med device space.” Jon Speer
“We are passionate about medical device product development and design controls and prudent engineering.” Jon Speer
“Companies getting in trouble with the FDA is because they try to focus more on what the regulation says, as opposed to trying to understand and follow the intent of the regulation.” Mike Drues
“Design controls were very vague, and they were written purposely very vague because the medical device industry is a very broad industry.” Mike Drues
“I’m not saying, don’t follow the rules. I’m not advocating anarchy.” Mike Drues
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