Medtech Matters
Medical Product Outsourcing
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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.
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Recent Episodes
Measuring Regulatory/Quality Team Member Performance
In 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 and quality team…
FDA's Third-Party Review Program
In 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 available for certain…
Triaging Your QMS: Considerations Based on the New QMSR
In 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 effect on February 2nd…
A Deep Dive into E&L and Biocomp Testing
In 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 of medical…
Planning for FDA Shutdowns Now and in the Future
In 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 medical device…
Should Wellness Products Come with a Warning?
In 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 gave reasons why placing…
3 Most Common Premarket (Postmarket?) Review Issues FDA Sees
In 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 about the most common…
Why Are One-Third of MAUDE Reports a Problem?
In 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 issues are with them.…
FDA Guidance on Off-Label Communication, Part 2
In 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 part, we’re examining…
FDA Guidance on Off-Label Communication, Part 1
In 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 reviewing a recent…
Development Considerations for Over-the-Counter Medtech, Part 1
In 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 need to keep in mind…
Development Considerations for OTC Medtech, Part 2
In 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 devices. If you…
Device Descriptions in Regulatory Submissions
In 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 description. While…
Regulatory Ramifications Due to the Presidential Election
In 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 sector as a…
Regulatory Considerations with an Assisted Suicide Machine
In 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 of my MPO editor’s…
Predetermined Change Control Plans, Part 2
In 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 plans. Potential…
Predetermined Change Control Plans, Part 1
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we examine the FDA’s recent guidance documents regarding predetermined change control plans…
What is a CAPA and How Do You Best Use It?
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re focusing in on a regulatory piece that’s been mentioned numerous times with regard to…
You Got a 483 from the FDA. Now what?
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re discussing what the process should be for a company once they receive a 483 or…
Revisiting Real-World Evidence
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re revisiting real-world evidence (RWE), which is a topic that’s been getting some…
Frequently Asked Questions
Medtech Matters has published 159 episodes since February 2017, covering topics in Business, News.
Medtech Matters is currently highly active with new episodes monthly. Average episode length is 33m.
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