Episodes

  • Development Considerations for OTC Medtech, Part 2

    Development Considerations for OTC Medtech, Part 2

    · Medtech Matters
    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 for bringing a novel OTC device to market?Under what circumstances would a switch from Rx to OTC require a De Novo or premarket approval application (PMA) in lieu of a 510(k) submission?What considerations may be relevant when designing an OTC device?What is the mechanism for obtaining feedback from the FDA on the necessary data to support a premarket submission for an OTC device??What are the requirements for clinical trials of OTC devices?What is the role of human factors testing for OTC devices?What are the labeling considerations for OTC devices?What are the cleaning or disinfection considerations for OTC devices?What are the Unique Device Identifier (UDI) requirements for OTC devices?What else is important?Are OTC devices searchable in the FDA’s medical device databases?When are OTC digital health solutions or software regulated as devices?What considerations apply to OTC software devices or connected devices?What are todays take-aways?

    After listening to both parts of the discussion, do you have a better understanding of OTC devices and are you evaluating your own products to see if any should be considered for this expansion? 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 we want to address your ideas/inquiries/suggestions in a future episode.

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    For more medtech news and information, visit www.mpomag.com.

  • Development Considerations for Over-the-Counter Medtech, Part 1

    Development Considerations for Over-the-Counter Medtech, Part 1

    · Medtech Matters

    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 compare to prescriptive devices?Can you provide some examples of OTC devices?What types of devices are potential candidates for OTC status, including a switch from prescription (Rx) to OTC?Does a switch from Rx to OTC for a 510(k)-cleared device require a new premarket submission?Can real-world evidence (RWE) be used to support a premarket submission for an OTC device, including a switch from Rx to OTC use?

    After you listen to this discussion, move on to part 2 to gain more specific insights as we narrow down on particular factors. 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 we want to address your ideas/inquiries/suggestions in a future episode.

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    For more medtech news and information, visit www.mpomag.com.

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  • Device Descriptions in Regulatory Submissions

    Device Descriptions in Regulatory Submissions

    · Medtech Matters

    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 addressed:

    Of all the potential topics we could be covering, why has device descriptions come up as one we should discuss?What support do you have to say device descriptions are one of the most poorly written sections of a pre-sub or final regulatory submission?What is the point of the device description in a regulatory submission? Why would it be so important to get it right?How can you verify your device description does its job? How do you know?How do you balance technical detail with simplicity in a device description, especially when you’re describing a complex device?Is it worthwhile to reiterate the device description in a pre-sub meeting? Shouldn’t the reviewers already be familiar with it if it was included in the pre-sub submission.Can you share specific recommendations on how to best write or design a device description?Do you have an example you can share?What else is important and/or what should listeners take away from this episode?

    Listen to this discussion and see if you think you may have submitted device descriptions incorrectly in the past. 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 we want to address your ideas/inquiries/suggestions in a future episode.

    Listen to the podcast streaming via the player or get the podcast on the Medtech Matters channel via your preferred vendor of podcasts, such as Apple Podcasts (iTunes) or Spotify.

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    For more medtech news and information, visit www.mpomag.com.

  • Regulatory Ramifications Due to the Presidential Election

    Regulatory Ramifications Due to the Presidential Election

    · Medtech Matters

    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:

    Based on the fact things can continue to change, why discuss this now?Would it be possible to eliminate the FDA? What might replace it?Is there too much regulation of medical devices? Or is it just the opposite—too little? What’s the sweet spot?There are some who believe the more regulation we have, the less innovation that’s possible. Do you agree? Are these directly impacted by each other?Is it possible to separate regulation and politics?Other than AdvaMed, which said it was looking forward to working with the new administration for what that’s worth, why isn’t the FDA or industry speaking about the possible eliminations at FDA?Do you agree that safety and efficacy should NOT be a function of politics?Without naming specific people, who is the type of person you’d want heading HHS or the FDA?Does this discussion have implications related to reimbursement or CMS?If you were serving as a regulatory consultant for a company looking at what’s potentially coming down the road, how would you advise them today?Any final thoughts on what’s important for this discussion/topic?

    Listen to this discussion and see if you agree with our assessments. 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 we want to

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    For more medtech news and information, visit www.mpomag.com.

  • Regulatory Considerations with an Assisted Suicide Machine

    Regulatory Considerations with an Assisted Suicide Machine

    · Medtech Matters

    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, several people involved were arrested and the situation is being investigated further. Specifically, the following questions are addressed:

    Should this be a device that goes through a regulatory review? Given its purpose, should it be treated as a regulated device?If it were a regulated medical device, what would its classification be?What would be its pathway to market?Does risk have the same definition for a device like this?Similarly, what about safety and efficacy? Is testing or a clinical trial required or even appropriate?Is there a precedent for this type of product? Not talking about a predicate here but a precedent.Any final thoughts on what’s important for this discussion/topic?

    Listen to this discussion and see if you have a better understanding of CAPAs. If you’d like to share thoughts, ask questions, or have a suggestion

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    For more medtech news and information, visit www.mpomag.com.

  • Predetermined Change Control Plans, Part 2

    Predetermined Change Control Plans, Part 2

    · Medtech Matters

    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 submission, but you have not yet made the actual, real-world change to the device. Can that PCCP submission, assuming it was approved, be used as a predicate for a 510k submission?For what types of devices should I consider a PCCP?Can you provide a few examples of PCCPs?Can PCCPs be used for manufacturing?Since the use of a PCCP is relatively new, can you think of what questions could potentially arise? What questions might we not have just yet?Anything else you’d like to say about the use of a PCCP we haven’t covered?What are the important takeaways?


    After both parts, do you have a better understanding of PCCPs? 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 we want to address your ideas/inquiries/suggestions in a future episode.

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    For more medtech news and information, visit www.mpomag.com.

  • Predetermined Change Control Plans, Part 1

    Predetermined Change Control Plans, Part 1

    · Medtech Matters

    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 questions are addressed:

    What is a predetermined change control plan and why is it important?FDA published two guidances on PCCPs (one last year in April and one just this past August). These two guidances sound similar (maybe substantially equivalent), so what’s the difference?What’s the difference between a PCCP for a SaMD with ML or AI different from a PCCP for a non-SaMD device, like a catheter or stent?Are there any limits on changes in a PCCP?How and when do I submit a PCCP?What are the advantages of submitting a PCCP?Are there any disadvantages of submitting a PCCP?


    Listen to part 2 of this discussion and then see if you have a better understanding of PCCPs. 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 we want to address your ideas/inquiries/suggestions in a future episode.

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    For more medtech news and information, visit www.mpomag.com.

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

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

    · Medtech Matters

    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 observations and warning letters?What is a CAPA and when should it be used?What are the most common reasons for 483s and warning letters involving a CAPA?How do you know if your CAPA is doing what it’s supposed to do?Is industry taking the wrong approach with a CAPA? Is there a better way we could be looking at this issue?How are CAPAs related to other aspects of the QMS, such as risk, post-market surveillance, or complaint handling?Do you have examples that might help illustrate what we’ve discussed?What else is important and/or what are the most important takeaways?


    Listen to this discussion and see if you have a better understanding of CAPAs. 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 we want to address your ideas/inquiries/suggestions in a future episode.

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    For more medtech news and information, visit www.mpomag.com.

  • You Got a 483 from the FDA. Now what?

    You Got a 483 from the FDA. Now what?

    · Medtech Matters

    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 common reasons or examples of why a company would get a 483 or warning letter?What are the first steps for a company that has just received a warning letter or 483?Who is responsible for the response to a 483 or warning letter? Does this fall to regulatory? Quality? Who really should be responsible for addressing it?Is it common for a company to get a warning letter or 483 for the same issue? If that happens, what then should the company do?What’s worse than a 483 or warning letter? Is there a higher level that really causes a concern for the company involved?What should be considered in terms of the PR hit as a result of a 483 or warning letter?Do you have suggestions with regard to preventing a 483 or warning letter?Anything more a company should consider and after that, please share what you consider to be the most important takeaways?


    Listen to this discussion and see if you have a better handle on what to do if you get a 483 or warning letter. 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 we want to address your ideas/inquiries/suggestions in a future episode.

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    For more medtech news and information, visit www.mpomag.com.

  • Revisiting Real-World Evidence

    Revisiting Real-World Evidence

    · Medtech Matters

    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 and 2020, but what’s the cause for us to do so today?Without requiring people to go back and relisten to those previous podcasts—not that I’d object—can you please briefly explain what real-world evidence is? Could you also mention how it compares and contrasts with real-world data?How does real-world evidence compare to what’s deemed the gold standard—randomized clinical trials?Do you have any examples of how real-world evidence has been used in regulatory submissions?FDA has a new draft guidance around real-world evidence. What’s actually new in this?In your estimation, what are the limitations of the new guidance? Is it falling short of what its goal should be or is supposed to be?Does the real-world data or evidence need to come from use within the U.S.?In discussing the possibility of doing this topic, you mentioned manufacturers may be missing a real opportunity with real-world evidence. What do you mean by that?What are the takeaways?


    Listen to this discussion and see what you think of the use of real-world evidence. 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 we want to address your ideas/inquiries/suggestions in a future episode.

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    For more medtech news and information, visit www.mpomag.com.

  • The Most Dangerous Devices to Hit the Market

    The Most Dangerous Devices to Hit the Market

    · Medtech Matters

    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 definition of what a dangerous device is?As I mentioned in the introduction, we previously discussed the 2018 documentary The Bleeding Edge, which featured some dangerous devices. How far back do dangerous devices go though? Are these a relatively newer problem?Another publisher’s website featured a slideshow of four dangerous devices. But do you have any sort of idea of how many others there may have been?With all the regulations in place, regulatory professionals that work in this industry, and FDA oversight, how do any “dangerous devices” make it to the market?Should we be adding regulations to address these devices so they don’t happen again?What are the takeaways?


    Listen to this discussion and see what you think of the system we have to attempt to prevent these types of devices from getting to market. 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 we want to address your ideas/inquiries/suggestions in a future episode.

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    For more medtech news and information, visit www.mpomag.com.

  • Headline-Generating Medical Device Safety Concerns

    Headline-Generating Medical Device Safety Concerns

    · Medtech Matters

    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, a story regarding plastic syringes made in China that were deemed not to be used by the FDA. The other story is about a report indicating third-party testing lab data may be unreliable and, in some cases, falsified. Specifically, the following questions are addressed:

    Can you give some additional insights into each of these news items and explain how they are connected?Given the medtech universe and all the different types of devices it encompasses, a syringe seems somewhat low on the list of advanced devices. What can we learn from this device?If a basic device like a syringe cracks or doesn’t function properly, how realistic is it that the issue is reported to the manufacturer or FDA?If my device includes a syringe but it’s not manufactured by one of the companies that received a warning letter (or maybe it’s not even made in China), do I have anything to worry about?Do you have an example to help illustrate this?Looking beyond syringes, obviously virtually all device manufacturers rely on testing data. If the FDA is warning makers about third-party labs providing fabricated, duplicated, or otherwise unreliable data, what should companies do who use third-party testing labs?What are the takeaways?


    Listen to this discussion and see what you think of these concerns regarding device safety. 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 we want to address your ideas/inquiries/suggestions in a future episode.

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    For more medtech news and information, visit www.mpomag.com.

  • Analyzing ECRI’s 2024 Top 10 Health Technology Hazards

    Analyzing ECRI’s 2024 Top 10 Health Technology Hazards

    · Medtech Matters

    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 healthcare technology and safety, on their top 10 health technology hazards for 2024. The full list is available at the organization’s website, which is at www.ecri.org. Specifically, the following questions are addressed:

    What is ECRI and what is the purpose of this list?Number one on the list is medical devices for the home. Specifically, they indicate medical devices may pose usability challenges for home users, risking misuse and patient harm. Can you please explain why this would be number one on the list? What’s the issue with usability?The second item on the list involves inadequate or onerous device cleaning instructions. So this isn’t really about cleaning protocols, but rather the instructions that indicate how the device should be cleaned. What’s the concern here?The fourth item is regarding the sustainability trend. Specifically, ECRI states this one as overlooked environmental impacts of patient care endanger public health. This is more of a product design issue, correct?Another hot topic item, number five calls out insufficient governance of AI used in medical technologies risks inappropriate care decisions. Is this indicating we should avoid relying too heavily on decisions indicated by AI and ensure clinician overview of findings?Still another hot button, cybersecurity issues ranks at number six on the list. Specifically, it is listed as ransomware targeting the healthcare sector remains a critical threat. This ties in directly to the significant efforts being put forth to ensure connected devices have a cybersecurity plan in place, correct?What are the takeaways?


    Listen to this discussion and see what you think of these items on the list or what was missed and should have been on the 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 we want to address your ideas/inquiries/suggestions in a future episode.

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    For more medtech news and information, visit www.mpomag.com.

  • Examining Institutional Review Boards

    Examining Institutional Review Boards

    · Medtech Matters

    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, how they relate to medical device approvals, and why they are important. Specifically, the following questions are addressed:

    Could you please explain what an IRB or institutional review board is?If I’m a device maker and am looking to conduct a clinical trial for one of my devices, do I need IRB approval?Are there situations in which I would not need an IRB approval prior to a clinical trial?Do you have suggestions on selecting an IRB? What I would want to look for and perhaps what I’d want to avoid?What information do I need to provide to the IRB for its review?What kind of timeline should I expect with the IRB review process?Do I have any recourse if the IRB review comes back not in my favor?What are the takeaways?


    Listen to this discussion and see if you’ve gained insight for your next interaction with an IRB. 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 we want to address your ideas/inquiries/suggestions in a future episode.

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    For more medtech news and information, visit www.mpomag.com.

  • Reimbursing Breakthrough Designation Products

    Reimbursing Breakthrough Designation Products

    · Medtech Matters

    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 Breakthrough Designation Program (BDP). It’s been planned, called off by CMS, put into proposed legislation, but we still don’t have a definitive solution. Specifically, the following questions are addressed:

    Can you please explain what the Breakthrough Device Designation program is?When did the reimbursement component come into play with regard to the BDP?Why is it important for a BDP device to have reimbursement tied to it upon regulatory approval/clearance?What concerns did CMS have regarding the reimbursement portion of the BDP?This year, we’ve seen proposed legislation from Congress to force CMS to pay for devices that gain the BDP designation. What’s going on with these?Does the ridiculously low number of devices associated with the TCET demonstrate an underlying problem with all of this?What about the proposed “reasonable and necessary” caveat that’s also associated with the TCET? Do we need to clarify what this means or just replace it entirely?What are the takeaways?


    Listen to this discussion and see how you feel about the latest proposed reimbursement plan. 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 we want to address your ideas/inquiries/suggestions in a future episode.

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    For more medtech news and information, visit www.mpomag.com.

  • Strengthening the 510k Program

    Strengthening the 510k Program

    · Medtech Matters

    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 subject matter of the three were: best practices for selecting a predicate device, the need for clinical data in a submission, and evidentiary expectations with implanted devices. Specifically, the following questions are addressed:

    Can you please provide a brief explanation of the 510k pathway?Why is the agency attempting to strengthen the program? What is their ultimate goal?With the predicate device, we recently had a podcast on using a recalled device for a predicate. When they say “best practices,” are they suggesting avoiding doing that?What other best practices are tied to the predicate device selection?How do you gather clinical data on a device that’s not cleared or approved and just being submitted to the FDA?For what situations is the agency considering clinical data in a submission and why?For the third guidance, can you explain what this is? What are evidentiary expectations with implanted devices?What do these mean to you? What will they mean to medical device manufacturers?What are the takeaways?


    Listen to this discussion and let us know what you think of any or all of these guidances. 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 we want to address your ideas/inquiries/suggestions in a future episode.

    Send us a text

    For more medtech news and information, visit www.mpomag.com.

  • Medical Device Manufacturing Recalls

    Medical Device Manufacturing Recalls

    · Medtech Matters

    In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we take a look at the recent rise in recalls that are being tied back to manufacturing issues. The discussion explores the recall mechanism itself and then move to the details behind the numbers. Finally, a strategy for mitigating risk is shared to help manufacturers avoid the potential for recalls. Specifically, the following questions are addressed:

    Before we get into the reasons around why, can give a very brief overview of what exactly a device recall is?Medical device recalls aren’t new, so why are we taking a closer look at them today?Should we have been able to see this coming? Was this foreseeable?Are all of these recalls, or really any recalls, equal in terms of how serious they are?Can you explain what is meant by faulty manufacturing? Are machines making bad parts and it’s not being recognized?Who’s job is it to set the specs?Why the sudden increase? In 2022, recalls hit their lowest level in a decade. So what changed that now in 2023, they are at such a high level?Moving forward, what could we do/should we do to mitigate these risks and minimize residual risk for devices in the future?What are the takeaways?


    Listen to this discussion and see if you feel more comfortable about avoiding a recall. 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 we want to address your ideas/inquiries/suggestions in a future episode.

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    For more medtech news and information, visit www.mpomag.com.

  • AI Predetermined Change Control Plan

    AI Predetermined Change Control Plan

    · Medtech Matters

    In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we take a look at a guidance from the FDA that explains how product sponsors can submit a predetermined change control plan for artificial intelligence and machine learning technologies. These are critical as these types of software evolve over time to enhance the benefits they bring. Specifically, the following questions are addressed:

    Can you please give a brief overview of what an AI or ML product is?Can you explain how this product can, quote evolve, as the FDA puts it?Now can you cover what a predetermined change control plan is and how it relates to the AI/ML product in this discussion?So why is this important? Why is it important to enable an AI or ML device to evolve?Can you offer real world examples of how this all works?What are the takeaways? Or in this instance, perhaps you could reiterate the most important tasks a company needs to keep in mind for their AI/ML products.


    Listen to this discussion and see if you think this guidance addresses the issues associated with AI/ML. 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 we want to address your ideas/inquiries/suggestions in a future episode.

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    For more medtech news and information, visit www.mpomag.com.

  • Can You Use a Recalled Device as a Predicate?

    Can You Use a Recalled Device as a Predicate?

    · Medtech Matters

    In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we examine the FDA policy regarding the use of a recalled device as a predicate in a 510k submission. Is it a good idea? What considerations are there for doing so? Specifically, the following questions are addressed:

    First, would you please explain the various levels of a recall as it relates to a medical device and what each level means?Can you quickly remind us of how a predicate device is used in a 510k submission?Given we’ve laid the groundwork, can you now please explain how a recalled device can be used as a predicate device?Is there any argument that can be made for having it be valid to use a Class 1 recall device as a predicate?Do you think a recall should invalidate a device from being used as a predicate? Or, would you ever suggest a recalled device to a client to be used as a predicate?I know some have argued for a “cap” to a device being used as a predicate, for example, nothing older than 10 years. Should there be a minimum amount of time a device should be on the market in clinical use to be able to be used as a predicate?What are the most important takeaways?


    Listen to this discussion and see if you think using a recalled device as a predicate is a good regulatory strategy. 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 we want to address your ideas/inquiries/suggestions in a future episode.

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    For more medtech news and information, visit www.mpomag.com.

  • Leading Issues from FDA Inspections (or History Repeating Itself)

    Leading Issues from FDA Inspections (or History Repeating Itself)

    · Medtech Matters

    In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we look at the 483s and warning letters that resulted from FDA inspections in 2022. The list is alarmingly similar to previous years and the discussion explores why that’s the case. The discussion also centers around ways device manufacturers can avoid making many of these same mistakes that get other companies into trouble with the agency. Specifically, the following questions are addressed:

    Can run through the top reasons for 483s and warning letters?Can you provide some examples of CAPA problems and offer suggestions for avoiding them?Like CAPAs, design controls accounted for more than 12% of the list. Can you provide examples of these violations and suggestions on how to avoid them?Third among the top was complaint handling, almost 11% of all violations. Do you have examples of these and tips for avoiding them?Are these top three problems really identical to what we’ve seen in previous years? Are these the same mistakes again?What are the most important takeaways with regard to today’s discussion?


    Listen to this discussion and see if you might be vulnerable to a 483 upon your next inspection. 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 we want to address your ideas/inquiries/suggestions in a future episode.

    Send us a text

    For more medtech news and information, visit www.mpomag.com.

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