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
156 episodes
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...
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Episode 157
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22:09
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...
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Episode 156
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57:28
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...
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Episode 155
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1:06:02
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...
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Episode 154
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53:16
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...
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Episode 153
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58:10
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...
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Episode 152
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57:13
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...
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Episode 151
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51:40
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...
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Episode 150
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1:01:16
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...
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Episode 149
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48:53
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...
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Episode 148
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53:06
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...
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Episode 147
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55:17
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
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Episode 146
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52:13
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...
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Episode 145
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59:13
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...
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Episode 144
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50:01
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...
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Episode 143
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59:45
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...
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Episode 142
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1:00:15
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...
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Episode 141
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55:35
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 ...
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Episode 140
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42:13
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, ...
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Episode 139
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50:48
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...
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Episode 138
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53:07
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, ...
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Episode 137
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52:43
Reimbursing Breakthrough Designation Products
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we examine the journey that’s occurred with regard to getting reimbursement tied to the FDA’s ...
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Episode 136
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52:50
Strengthening the 510k Program
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we take a look at guidances published by FDA regarding the 510k regulatory pathway. The subjec...
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Episode 135
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39:38