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PODCAST

Medtech Matters

Medical Product Outsourcing

A podcast focused on the medical device technology industry, from design and development to outsourcing services and relationships to finished medtech products.

business tech news

All Episodes

55:56

Planning for FDA Shutdowns Now and in the Future

Medtech Matters ·

2025/10/27

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 manufacturers and their submissions. This shutdown is almost one month in, and its conclusion does not seem to be in the near future. So, what do you do if you have a device being submitted to the FDA, already under review, or some other scenario involving the agency? During this conversation, the follow...

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64:30

Should Wellness Products Come with a Warning?

Medtech Matters ·

2025/09/11

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 a warning label on wellness devices about their status as an FDA regulated medical device would be a good idea. Does Mike agree? Do you agree that patients should be provided with an explanation that a wellness product does not get reviewed or approved by the FDA? During this conversation, the fo...

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51:44

3 Most Common Premarket (Postmarket?) Review Issues...

Medtech Matters ·

2025/06/25

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 premarket review issues they see in submissions. First, there is some discussion regarding whether the issues are truly premarket or postmarket concerns. Then, we look at what these are, why they are likely so common, examples of them, and how to avoid running into these issues yourself. During thi...

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56:38

Why Are One-Third of MAUDE Reports a Problem?

Medtech Matters ·

2025/06/10

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. More specifically, we’re digging in to find out why almost a third of the reports are delayed or incomplete. We’ll get insight on what these reports are, if they are important, and what should be done to improve that 30% figure. During this conversation, the following questions are addressed: First...

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55:41

FDA Guidance on Off-Label Communication, Part 2

Medtech Matters ·

2025/05/30

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 the downside or negative aspects of this practice. We cover potential concerns and scenarios to avoid. Specifically, the following questions are addressed: Mike, maybe you can kick things off with a very quick overview of what we previously covered in the first part of the conversation.Now gettin...

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50:08

FDA Guidance on Off-Label Communication, Part 1

Medtech Matters ·

2025/05/30

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 guidance from the FDA that offers insights on how off-label communication can be performed in accordance to the regulation. We get a definition of the topic as well as examples of successful off-label communication efforts. During the discussion, the following questions are addressed: Can you first...

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59:44

Development Considerations for OTC Medtech, Part 2

Medtech Matters ·

2025/01/23

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 haven’t already enjoyed part 1 of the discussion, please be sure to listen to that one first. In this segment, we look at more specific regulatory- and design-related questions that could create some misunderstanding or confusion. Specifically, the following questions are addressed:What is the process...

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47:21

Development Considerations for Over-the-Counter...

Medtech Matters ·

2025/01/23

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 for these devices. A variety of topics are covered, from regulatory questions to human factors design to cleaning protocols. Real-world examples are used to help illustrate several discussion topics. Specifically, the following questions are addressed:What is an OTC device and how do OTC devices ...

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51:34

Device Descriptions in Regulatory Submissions

Medtech Matters ·

2025/01/07

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 this element may seem to be straightforward, an extraordinary number of challenges originate with this portion of a submission. This discussion reviews the role this section plays in a regulatory submission and common mistakes that occur are covered. Specifically, the following questions are addresse...

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53:45

Regulatory Ramifications Due to the Presidential...

Medtech Matters ·

2024/11/26

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 result of the U.S. presidential election. This recording took place two weeks following the election results. In addition, we speak about some recurring themes that are not exclusive to the election, such as the impact of regulatory on innovation. Specifically, the following questions are addressed...

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50:41

Regulatory Considerations with an Assisted Suicide...

Medtech Matters ·

2024/11/20

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 letters. Specifically, I’m referring to the news of an assisted suicide machine that was being considered for introduction in Switzerland, where assisted suicide is legal under certain conditions. However, following the first instance of someone successfully using the device within the country, sever...

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57:41

Predetermined Change Control Plans, Part 2

Medtech Matters ·

2024/09/24

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 for their use are discussed, examples are provided, and role of PCCPs for manufacturing processes are explored. If you haven’t yet listened to Part 1, click here to do so. Specifically, the following questions are addressed in part 2:You have submitted a PCCP with a previous regulatory submissio...

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48:29

Predetermined Change Control Plans, Part 1

Medtech Matters ·

2024/09/24

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 (PCCP). The first guidance addresses PCCPs for artificial intelligence (AI) and/or machine learning (ML) based devices (click here to hear an earlier podcast on this topic). The more recent guidance expands the scope to any medical device, whether it has AI/ML or not. Specifically, the following ...

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58:13

What is a CAPA and How Do You Best Use It?

Medtech Matters ·

2024/09/03

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 other topics we’ve discussed. This episode is focused on CAPA or corrective and preventive action. We’re digging into the CAPA, what it is, its purpose, and how to best implement it. Specifically, the following questions are addressed:Could you please briefly highlight the reasons FDA issues 483 ...

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58:43

You Got a 483 from the FDA. Now what?

Medtech Matters ·

2024/08/22

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 letter from the FDA. Best practices, first steps to take, who is responsible, and potential strategies for avoiding them are shared. Specifically, the following questions are addressed:Could you please explain what a 483 is and what a warning letter is? Are they the same thing?What are some comm...

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54:03

Revisiting Real-World Evidence

Medtech Matters ·

2024/06/18

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 attention. So today, we’re going to look at what’s driving that attention and discuss the reasons behind it. We’ll also talk about how the FDA is seeking to use real-world evidence. Specifically, the following questions are addressed:We’ve discussed real-world evidence previously, in podcasts from 2017...

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40:42

The Most Dangerous Devices to Hit the Market

Medtech Matters ·

2024/06/11

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 though they made it to the market and were used by healthcare professionals. Some of these may have been brought up previously the Netflix documentary, The Bleeding Edge, was discussed but others are new. Specifically, the following questions are addressed:First Mike, can you provide a definiti...

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49:16

Headline-Generating Medical Device Safety Concerns

Medtech Matters ·

2024/05/02

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51:35

Analyzing ECRI’s 2024 Top 10 Health Technology Hazards

Medtech Matters ·

2024/03/19

en-us

51:11

Examining Institutional Review Boards

Medtech Matters ·

2024/03/06

en-us

155 results

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