Medtech Matters
by Medical Product Outsourcing
Latest episode
A Preview of MDUFA VI: Changes and Highlights, Part 2
A Preview of MDUFA VI: Changes and Highlights, Part 2
About this podcast
A podcast focused on the medical device technology industry, from design and development to outsourcing services and relationships to finished medtech products.
Episodes
The newest 20 of 163 episodes
- A Preview of MDUFA VI: Changes and Highlights, Part 2 · 51 min · Episode 164In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re into part 2 of the discussion in an early look at the next…
- A Preview of MDUFA VI: Changes and Highlights, Part 1 · 49 min · Episode 163In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re taking an early look at the next version of the Medical Device…
- The Value in Partnering for Sterility Testing · 26 min · Episode 162In this Medtech Matters podcast episode, sponsored by Nelson Labs, two representatives from the company offer their expertise and insights on sterility testing. Amina Rahmoune…
- ECRI's 2026 Top 10 Health Technology Hazards · 57 min · Episode 161In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re reviewing the list of top health technology hazards identified…
- Measuring Regulatory/Quality Team Member Performance · 1 h 2 min · Episode 160In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re speaking about how to best determine the efficacy of regulatory…
- FDA's Third-Party Review Program · 1 h 1 min · Episode 159In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re discussing the FDA’s third-party review program. This option is…
- Triaging Your QMS: Considerations Based on the New QMSR · 59 min · Episode 158In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re discussing the FDA’s recently implemented QMSR. It went into…
- A Deep Dive into E&L and Biocomp Testing · 22 min · Episode 157In this Medtech Matters podcast episode, sponsored by Nelson Labs, we’re discussing the importance of E&L (extractables and leachables) and biocompatibility testing for a variety…
- Planning for FDA Shutdowns Now and in the Future · 57 min · Episode 156In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re discussing the government shutdown and its potential impact on…
- Should Wellness Products Come with a Warning? · 1 h 6 min · Episode 155In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re speaking about a recent Editor’s Letter I wrote for MPO that…
- 3 Most Common Premarket (Postmarket?) Review Issues FDA Sees · 53 min · Episode 154In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re highlighting comments made by FDA representatives at an event…
- Why Are One-Third of MAUDE Reports a Problem? · 58 min · Episode 153In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re discussing MAUDE safety reports and taking a look at what the…
- FDA Guidance on Off-Label Communication, Part 2 · 57 min · Episode 152In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re continuing our conversation on off-label communication. In this…
- FDA Guidance on Off-Label Communication, Part 1 · 52 min · Episode 151In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re speaking about off-label communication. More specifically, we’re…
- Development Considerations for OTC Medtech, Part 2 · 1 h 1 min · Episode 150In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re continuing our conversation about over-the-counter (OTC) medical…
- Development Considerations for Over-the-Counter Medtech, Part 1 · 49 min · Episode 149In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re discussing over-the-counter (OTC) devices and aspects developers…
- Device Descriptions in Regulatory Submissions · 53 min · Episode 148In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re discussing a common part of a regulatory submission—the device…
- Regulatory Ramifications Due to the Presidential Election · 55 min · Episode 147In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re looking at the potential implications for the medical device…
- Regulatory Considerations with an Assisted Suicide Machine · 52 min · Episode 146In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re drawing inspiration from an item I wrote about recently in one…
- Predetermined Change Control Plans, Part 2 · 59 min · Episode 145In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we continue speaking on the topic of predetermined change control…
