Medtech Matters

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences , we review the list of guidances FDA expects to begin to focus on in 2027. The list really represents the guidance it expects to roll out in the coming years, but may be seen by the public as early as next year. What are the notable areas of focus for the agency? What are they missing? Gain...

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences , we’re continuing the conversation of guidance documents that are expected to gain the attention of the agency in 2027. While some of the guidance topics outlined may not see an official release for a few years, several will come into effect in the next year. Are these the highest priority a...

In 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 Medical Device User Fee Act, MDUFA VI, which would come into use in September 2027. In this portion of the discussion, the lack of details in major deficiency letters is covered. We also take a look at review times and see wha...

In 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 User Fee Act, MDUFA VI, which would go into effect in September 2027. The conversation involves changes to the pre-sub (or Q-sub) meeting with the agency as well as the possible addition of a fee associated with it. There’...

In this Medtech Matters podcast episode, sponsored by Nelson Labs , two representatives from the company offer their expertise and insights on sterility testing. Amina Rahmoune, Laboratory Operations Manager – Sterility Assurance, and Martell Winters, Director of Science, join Sean Fenske, Editor-in-Chief of MPO , to explain why sterility testing takes place, what makes it challenging for medical...

In 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 by ECRI. ECRI is an independent, nonprofit organization that improves the safety, quality, and cost-effectiveness of care across all healthcare settings. Each year, they publish this Top 10 list to help bring awareness to...

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 members. A variety of real-world examples are provided that demonstrate the need to “trust but verify” the actions of these team members. During this conversation, the following questions are addressed: W...

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 510k reviews. It is performed through an independent organization that is not part of the agency. As such, there are additional costs involved but the time savings could potential make up for that ad...

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 and replaced 21 CFR Part 820. The regulation incorporates ISO 13485:2016, which is expected to help align medical device regulations globally. In this podcast, we focus on what device manufacturers sho...

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 devices. The pair from Nelson Labs—Audrey Turley, B.S., Director of Lab Operations – Biosafety, and Kristin Treece, Ph. D., Principal Scientist - Analytical Chemistry—bring their expertise to the conversat...

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, alrea...

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...

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 l...

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...

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...

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...

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....

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 misu...

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 submiss...

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, s...

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. Howev...

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 followi...

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...

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, th...

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 pl...