Medtech Matters
A podcast focused on the medical device technology industry, from design and development to outsourcing services and relationships to finished medtech products.
Episodes
158 episodes
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...
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 biocompatibi...
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 manufac...
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 wh...
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 p...
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. M...
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 g...
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...
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...
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 thi...
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...
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
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 scenarios f...
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 (P...
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 ot...
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 warning l...
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 attentio...
The Most Dangerous Devices to Hit the Market
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re taking a look at several devices that unfortunately ended up being quite dangerous even ...
Headline-Generating Medical Device Safety Concerns
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re reviewing a few stories in the news that tie into the safety of medical devices. First, ...
Analyzing ECRI’s 2024 Top 10 Health Technology Hazards
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re looking at the latest annual list put out by ECRI, an independent authority on healthcar...
Examining Institutional Review Boards
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re looking at IRBs, or institutional review boards. We’re taking a look at what these are, ...