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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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:…
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…
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…
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 conversation,…
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,…
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…
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 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…