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 this conversation, the following questions are addressed:

• Recently, three medical device senior operations officers from FDA’s Office of Inspections and Investigations spoke at a conference about the most common “issues” FDA encounters during the premarketing review of medical devices. Can you give a recap of what they said?
• In your 30+ years of experience working in the medical device industry, would you agree with FDA that these are the three most common issues?
• Before discussing the three specific common problems individually, what do you think is the “root cause” of these problems?
• Can you provide some examples?
• How can design change and design creep get companies in trouble with FDA?
• What does “marketing beyond authorized intended use” mean?
• Do you have suggestions and/or best practices to avoid running into problems around these issues?
• What else is important?
• What are today’s takeaways?

Listen to this discussion and see if you've run into these issues yourself. 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 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, Mike, if you would, please explain what the Manufacturer and User Facility Device Experience (MAUDE) Database is.
• What are the MAUDE reporting requirements?
• How well does the MAUDE reporting system work?
• Are there consequences for a delayed or incomplete report?
• Given the statistics, is the MAUDE database a reliable source of information for medical device manufactures? for clinicians? for patients? for anyone?
• What should manufacturers do?
• What should the FDA do?
• What else is important?
• What are today’s takeaways?

Listen to this discussion and see if your company might have an issue with submitting a correct MAUDE report. 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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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 getting into that downside I mentioned in my opening, what are the disadvantages of off-label communication? In other words, what’s potentially wrong with allowing manufacturers to advertise uncleared or unapproved product claims?
• Why are some (including some within the industry) opposed to giving manufacturers permission to advertise off-label claims?
• Do you have any examples you can share?
• Is it possible to find an appropriate balance between what claims should be vetted through the FDA and those that don’t need to be?
• What happens when a company makes unsupported, deceptive, or completely false claims about a product?
• In your professional opinion, should we allow a company to advertise unapproved claims that haven’t gone through a formal review process? Is it a good thing or a bad thing?
• What else is important?
• What are the most important takeaways?

Listen to this discussion after you’ve heard Part 1 and see what you think of off-label communication and the guidance. 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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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 please provide an explanation of what “off-label” is in terms of the FDA?
• Before getting into the details of this “new” guidance, what is the difference between Off-Label Use vs. Off-Label Communication?
• What’s new in this “final” guidance?
• What is meant by firm-initiated communication containing scientific information on unapproved uses?
• If you communicate with an organization about unapproved (or off-label) uses, what will happen?
• If you send such a communication, are you acknowledging the off-label use and then need to submit it to FDA for a label expansion?
• Does FDA need to know about the communication?
• What else is important?
• What are the most important takeaways?

Listen to this discussion and see if you can benefit from off-label communication. Then check out part 2 of this 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 we want to address your ideas/inquiries/suggestions in a future episode.

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

• 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 https://www.mpomag.com.

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 https://www.mpomag.com.

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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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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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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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 https://www.mpomag.com.