Medtech Matters

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 areas that require guidance? Has FDA missed out by not including certain focus areas? During this conversation, the following questions are addressed:

• Can you provide a quick review of part 1 of this discussion?
• What can we expect with regard to guidance in 2027 from FDA?
• What’s on FDA’s A-List of Guidance Topics for 2027?
• What’s on the B-List of Guidance Topics for 2027?
• What’s on the “Under Construction List” of Guidance Topics for 2027?
• How do topics get on these lists?
• What topics are NOT on these lists but probably should be?
• Do you have suggestions for FDA regarding guidance documents?
• Should FDA even be in the business of writing guidance documents? Is that really their job?
• What else is important?
• What are the takeaways?

Listen to this discussion and see what you think of the upcoming FDA guidance. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, plea

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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 insight on the list they’ve published and see what you think of these potential guidance topics as well as areas they should have included. In this podcast, the following questions are addressed.

• Can you offer a primer on what FDA guidance documents are?
• What’s the difference between regulation, such as what’s in the Code of Federal Regulations (or CFR, as some know it), and a guidance document?
• Who is the intended user of the guidance document? Or is the FDA or device manufacturer required to follow a guidance document?
• Can you please explain why some guidance documents are final while others are indicated as draft? What’s the difference?
• Is there a central resource for guidance documents? Are these all online or is there another way to review them?

Listen to this discussion and then check out part 2 to hear the rest of the discussion. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at [email protected], and we’ll see if your ideas/inquiries/suggestions align with a future episode.

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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 what the potential impact is to them. During the conversation, the following questions are addressed:

• Can you give a brief summary of the items we discussed in part 1?
• Industry has long complained of a lack of detail in major deficiency letters. What can or should FDA do to address this complaint?
• Does MDUFA VI address FDA review times (i.e., the amount of time FDA has to make a decision) and if so, how?
• Is there anything else in MDUFA VI worth noting?
• What else is important?
• What are today’s takeaways?

Listen to this discussion and see if you have questions about MDUFA VI. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at [email protected], and

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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’s also talk around potential changes for the de novo pathway. During this conversation, the following questions are addressed:

• What is the Medical Device User Fee Act (a.k.a., MUDFA) and why do we have it?
• Is there a downside to MUDFA?
• Medical device user fees have been around since 2003. So, what is new or noteworthy in the 2027 version?
• One update to the program would be to create a “focused follow-up pre-submission process” by the end of 2027, allowing sponsors to receive responses faster than with a traditional pre-submission request. Any comments on that?
• We have previously discussed in depth the de novo pathway to market, how it compares to the 510k, and the reasons why the de novo’s popularity has increased significantly over the past decade. Does MDUFA VI include any changes to the de novo?

Listen to this discussion and then check out part 2 to hear the rest of the discussion. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at [email protected], and we’ll see if your ideas/inquiries/suggestions align with a 

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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 device manufacturers, why partnering with a testing expert can ease the process, and the important factors to keep in mind regarding sterility testing.

In this episode of Medtech Matters, the following questions are addressed.

• Can you please explain what Nelson Labs does?
• What is sterility testing and why does it matter to medical device manufacturers?
• What are the different types of sterility testing?
• Is there regulatory guidance for sterility testing?
• Why would a company have sterility testing performed by a testing partner rather than doing it in-house?
• What are the challenges involved with sterility testing?
• Is sterility testing for the device, the packaging, or both?
• What are the most important factors for device manufacturers to keep in mind involving sterility testing?

Listen to this discussion and see if you still have questions about sterility testing. If you do, reach out to Nelson Labs to get answers.

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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 problem technology concerns and encourage improvement. During this conversation, the following questions are addressed:

• We discussed this in a podcast in March 2024. Why are we discussing this again?
• What is ECRI, and what is the purpose of this list?
• Why is this topic important to device manufacturers and to patients?
• What’s on the current 2026 hazards list?
• How do the hazards in the 2026 list compare to previous years?
• At the end of the day, what, if anything, have we learned? Are we going in the right direction or simply treading water?
• What are today’s takeaways?

Listen to this discussion and see if you have issues you should address based on this list. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at [email protected], and we’ll see if your ideas/inquiries/suggestions align with a future episode.

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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:

• Why the need to measure the safety and efficacy of the regulatory and quality team?
• What can happen if you put too much trust or reliance on your regulatory consultant?
• Can you give a specific example where there was too much trust?
• Can you give us another regulatory example, perhaps involving clinical trials?
• Can you provide a quality or manufacturing example, perhaps involving AI?
• What are today’s takeaways?

Listen to this discussion and see if you need a plan to verify your regulatory and quality team members’ actions. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at [email protected], and we’ll see if your ideas/inquiries/suggestions align with a future episode.

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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 added expense. Other factors and considerations are also reviewed. During this conversation, the following questions are addressed:

• If I need to get a 510k clearance on my new medical device, is going through the FDA my only option?
• Under what circumstances should a sponsor consider using the third-party review program?
• Under what circumstances should a sponsor not consider using the third-party review program?
• How popular is the third-party review program, i.e., why are many people not familiar with it?
• Can you provide some examples of devices that have gone through the third-party review program.
• What advice would you provide in choosing which third-party review organization to work with?
• What are the key steps when considering using the third-party review program?
• When evaluating potential third-party review organizations, do you have recommendations on what questions to ask?
• Is there anything like the third-party review program outside the US, i.e. is there any regulatory precedent?
• What else is important, and what are today’s takeaways?

Listen to this discussion and see if you may have interest in the third-party review program. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at [email protected], and we’ll see if your ideas/inquiries/suggestions align with a future episode.

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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 should be doing now and what can wait for a later time. During this conversation, the following questions are addressed:

• As most are already familiar with QMS and now QMSR, we’ll dive deeper. Can you tell me if all sections of the QMSR listed in the QSR are required for all medical devices?
• Is a full QMS required to be in place in order to secure FDA clearance or approval?
• What about the sections of the QMSR? Are all of them equal in terms of importance? Are some sections more important than others?
• When do I need to have a QMS in place?
• What if I never intend to market my device? First, maybe provide an example of when that would be the case, and then address the first part.
• Should all QMS systems look the same?
• Are there differences with the QMSR with premarket vs. postmarket?
• How do you know the QMS is working? How can you be sure?
• What are the important takeaways from today’s session?

Listen to this discussion and see if you are compliant with the new QMSR. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at [email protected], and we’ll see if your ideas/inquiries/suggestions align with a future episode.

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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, where a number of issues are resolved. During this episode, the following questions are addressed:

• First, what is Nelson Labs? What do you do? 
• What is E&L testing?
• Why is it important? 
• What is being tested? 
• Is this done on all medical devices?
• Are there different tests for E&L depending on the device and/or application?
• When is E&L testing performed?
• What is biocomp testing? 
• Why is it important?
• When is it performed?
• How do you perform in vivo testing? (and what does in vivo mean?)
• Anything else device manufacturers need to know about E&L and/or biocomp testing?

Listen to this discussion and see if you still have questions about E&L and/or biocompatibility testing. If you do, reach out to Nelson Labs to get answers. Feel free to use the links or contact mechanism here.

Click here to learn more about Nelson Labs >>>>>

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