Medtech Matters

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 sfenske@rodmanmedia.com, and we'll see if we want to address your ideas/inquiries/suggestions in a future episode.Send us a textFor 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 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 sfenske@rodmanmedia.com, and we'll see if we want to address your ideas/inquiries/suggestions in a future episode.Send us a textFor 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 sfenske@rodmanmedia.com and we'll see if we want to address your ideas/inquiries/suggestions in a future episode.Send us a textFor more medtech news and information, visit 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 sfenske@rodmanmedia.com and we'll see if we want to address your ideas/inquiries/suggestions in a future episode.Send us a textFor more medtech news and information, visit 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 sfenske@rodmanmedia.com 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.Send us a textFor more medtech news and information, visit www.mpomag.com.

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 sfenske@rodmanmedia.com and we'll see if we want toSend us a textFor more medtech news and information, visit www.mpomag.com.

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 suggestionSend us a textFor more medtech news and information, visit www.mpomag.com.

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 sfenske@rodmanmedia.com and we'll see if we want to address your ideas/inquiries/suggestions in a future episode.Send us a textFor more medtech news and information, visit www.mpomag.com.

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 sfenske@rodmanmedia.com and we'll see if we want to address your ideas/inquiries/suggestions in a future episode.Send us a textFor more medtech news and information, visit www.mpomag.com.

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 sfenske@rodmanmedia.com and we'll see if we want to address your ideas/inquiries/suggestions in a future episode.Send us a textFor more medtech news and information, visit www.mpomag.com.

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 sfenske@rodmanmedia.com and we'll see if we want to address your ideas/inquiries/suggestions in a future episode.Send us a Text Message.For more medtech news and information, visit www.mpomag.com.

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 sfenske@rodmanmedia.com and we'll see if we want to address your ideas/inquiries/suggestions in a future episode.For more medtech news and information, visit www.mpomag.com.

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 sfenske@rodmanmedia.com and we'll see if we want to address your ideas/inquiries/suggestions in a future episode.For more medtech news and information, visit www.mpomag.com.

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 sfenske@rodmanmedia.com and we'll see if we want to address your ideas/inquiries/suggestions in a future episode.For more medtech news and information, visit www.mpomag.com.

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 sfenske@rodmanmedia.com and we'll see if we want to address your ideas/inquiries/suggestions in a future episode.For more medtech news and information, visit www.mpomag.com.

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 sfenske@rodmanmedia.com and we'll see if we want to address your ideas/inquiries/suggestions in a future episode.For more medtech news and information, visit www.mpomag.com.

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 sfenske@rodmanmedia.com and we'll see if we want to address your ideas/inquiries/suggestions in a future episode.

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 sfenske@rodmanmedia.com and we'll see if we want to address your ideas/inquiries/suggestions in a future episode.

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 sfenske@rodmanmedia.com and we'll see if we want to address your ideas/inquiries/suggestions in a future episode.

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 sfenske@rodmanmedia.com and we'll see if we want to address your ideas/inquiries/suggestions in a future episode.

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 sfenske@rodmanmedia.com and we'll see if we want to address your ideas/inquiries/suggestions in a future episode.

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 sfenske@rodmanmedia.com and we'll see if we want to address your ideas/inquiries/suggestions in a future episode.

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we continue to discuss lab developed tests (LDTs) and whether or not the FDA should have the authority to regulate them. How would FDA oversight impact quality and timeliness of care? How do LDTs relate to what happened with Theranos? Specifically, the following questions are addressed between the two parts of this podcast presentation:Can you start today's conversation by explaining why we've selected this topic for today's discussion? Has there been an update to this debate?What is an LDT?Why do labs develop their own LDTs?Can you provide a couple of examples of LDTs?Currently, are LDTs regulated? Why and who is involved?You mentioned LDTs are low risk, but are LDTs truly low risk? What do you mean?Is there precedent we can examine for using enforcement discretion to not regulate LDTs?What is the relationship between LDTs and Theranos?What is your recommendation for companies developing LDTs and/or IVDs?Do you have suggestions for improving the status quo with regard to LDTs?What are the important takeaways from this discussion manufacturers should keep in mind?Listen to this two-part discussion and see how FDA oversight of LDTs could affect your company's products. 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 sfenske@rodmanmedia.com and we'll see if we want to address your ideas/inquiries/suggestions in a future episode.

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we look at the debate over lab developed tests (LDTs) and whether or not the FDA should have the authority to regulate them. What would this type of oversight do to the need for speed with these types of tests? Would FDA supervision make things safer and also avoid future situations like the Theranos debacle? Specifically, the following questions are addressed between the two parts of this podcast presentation:Can you start today's conversation by explaining why we've selected this topic for today's discussion? Has there been an update to this debate?What is an LDT?Why do labs develop their own LDTs?Can you provide a couple of examples of LDTs?Currently, are LDTs regulated? Why and who is involved?You mentioned LDTs are low risk, but are LDTs truly low risk? What do you mean?Is there precedent we can examine for using enforcement discretion to not regulate LDTs?What is the relationship between LDTs and Theranos?What is your recommendation for companies developing LDTs and/or IVDs?Do you have suggestions for improving the status quo with regard to LDTs?What are the important takeaways from this discussion manufacturers should keep in mind?Listen to this two-part discussion and see how FDA oversight of LDTs could affect your company's products. 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 sfenske@rodmanmedia.com and we'll see if we want to address your ideas/inquiries/suggestions in a future episode.

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we look at what happens to products on the market under the FDA's emergency use authorization (EUA). Once the EUA period ends, what happens to these products? As President Biden has already declared the pandemic to be over, this timeframe will be approaching quickly. Specifically, the following questions are addressed:Could you please explain what an EUA is within the regulatory context of the pandemic?Under whose authority is the pandemic deemed over such that the status of devices on the market under EUAs become a concern?How will the FDA handle these EUA products?What should companies be doing now if they want to keep their products on the market after the EUAs expire?Are there any considerations companies should keep in mind with an EUA product?Are there any reasons a company may not want an EUA product to go through a full regulatory review?What are the most important takeaways with all of this for medical device manufacturers?Listen to this episode and see if the end of EUAs impacts your company. 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 sfenske@rodmanmedia.com and we'll see if we want to address your ideas/inquiries/suggestions in a future episode.

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we look at the FDA's use of the word “exempt” and what it means for medical device manufacturers. During this discussion, we look at the relationship between 510k exempt and Class of device. Specifically, the following questions are addressed:Could you please explain what 510k exempt actually means?Are all Class I medical devices exempt and all Class II devices not exempt?What's the difference between Class I exempt and Class II exempt?What is the difference between general controls and special controls? How are these relevant to exempt status?Could you give some examples of products that are Class I exempt and explain why they are afforded that status?Now could you do the same for Class II products that are exempt and give reasons why?What are the most important takeaways with all of this for medical device manufacturers?Listen to this episode and see how 510k exempt may affect your company's products and future regulatory submissions. 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 sfenske@rodmanmedia.com and we'll see if we want to address your ideas/inquiries/suggestions in a future episode.

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we look at how a company can promote the off-label use of a medical device. It would seem to go against FDA regulation to do so, but there are acceptable methods that can be utilized that essentially promote the off-label use. Specifically, the following questions are addressed:Since this discussion came out of the last podcast on intended use, can you give a very quick summation of that rule?Can you speak to the relationship between intended use and off-label use?When it comes to a medical device manufacturer promoting the off-label use of a device, how can that happen without raising a red flag with the FDA?To what degree can a promotion take place? Could it be an advertisement, collateral material provided to a doctor, or messaging from a sales person? Or all of the above?Can you share a couple real-world examples of acceptable off-label promotion?Where is the cut-off? In other words, what should companies be sure they AREN'T doing with regard to off-label promotion?What are the most important takeaways with all of this for medical device manufacturers?Listen to this episode and see if you're able to promote an off-label use of one of your devices. 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 sfenske@rodmanmedia.com and we'll see if we want to address your ideas/inquiries/suggestions in a future episode.

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we look at the FDA's Intended Use rule and how it impacts device labeling. It is also revealed how labeling can be used by medical device OEMs as a competitive advantage. Specifically, the following questions are addressed:Could you please explain exactly what we mean by labeling, and further, clarify the difference between high level and low level labeling?How can labeling, both high level and low level, be used as a strategic advantage?Could you please explain the difference between intended use and indications for use?What is this intended use rule and why is it important to medical device manufacturers?What is meant by manufacturer's objective intent?Do you have examples you can provide?What are the most important takeaways with all of this for medical device manufacturers?Listen to this episode and see how Intended Use affects your device labeling. 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 sfenske@rodmanmedia.com and we'll see if we want to address your ideas/inquiries/suggestions in a future episode.

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we look at the Special Controls that are part of the FDA's regulatory requirements for Class II devices. During the conversation, the purpose of these Special Controls is presented. Additionally, ways to use these regulatory requirements to gain a competitive advantage is also discussed. Specifically, the following questions are addressed:Would you please explain what we mean by Special Controls? What are they, and how and when are they used?What makes these “special”?Would you mind providing some real-world examples of Special Controls?How do Special Controls vary based on the regulatory pathway? In other words, how are they different from 510k vs a de novo?With regard to Special Controls, what are the most important takeaways to keep in mind?Listen to this episode and see if you can leverage Special Controls to gain a competitive advantage. 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 sfenske@rodmanmedia.com and we'll see if we want to address your ideas/inquiries/suggestions in a future episode.

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we look at the FDA's policy known as Refuse to Accept (RTA) as it relates to 510k submissions. Sadly, some companies are rejected due to Refuse to Accept as many as three times, which is a completely avoidable problem. Specifically, the following questions are addressed:Please start with an explanation of the FDA's review process. What happens after the agency receives a submission?This is the third Refuse to Accept guidance from FDA. Can you provide an overview of all three and explain how they should be used?What was the agency's goal in releasing these guidance documents?Do you have examples you can share of submissions rejected on RTA review?The agency has tried to modernize with the offering of some etools. Can you explain what these are and what advantages and disadvantages there are to using them?How should a medical device manufacturer view these documents and how should they use them?What are the options for a device maker upon the rejection of a submission?What are today's takeaways with regard to Refuse to Accept guidance from the FDA?Listen to this episode and see if you better understand how to avoid a Refuse to Accept rejection. 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 sfenske@rodmanmedia.com and we'll see if we want to address your ideas/inquiries/suggestions in a future episode.

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we examine medical device recalls. More specifically, the focus of the discussion is on voluntary recalls, why they occur, and why companies need to be ready to conduct a recall. The FDA's involvement with a recall is also presented as well as what “recall ready” means. Specifically, the following questions are addressed:Can you start by explaining what a voluntary recall is and why or when it's used?Is there any differences in the process for a voluntary recall across any of FDA's categories, such as pharma, medical device, food, etc.?Is there a non-voluntary recall (or one that is ordered)? If so, how is that different?The FDA states a company within a product distribution chain needs to be “recall ready.” What does this mean?What are the steps in a voluntary recall?Is the FDA involved in a voluntary recall beyond being notified? If so, how?How do you ensure everyone who needs to be contacted about a recall is reached?What are the most important takeaways companies need to keep in mind about voluntary recalls?Listen to this episode and see if you better understand voluntary recalls. 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 sfenske@rodmanmedia.com and we'll see if we want to address your ideas/inquiries/suggestions in a future episode.

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we take a deep dive on the letter to file tool that companies can use for certain situations. But what are those situation and how do you know when it's appropriate to use this pathway? Also, how do you ensure you are using a letter to file correctly so as to avoid challenges that could arise with the FDA? Specifically, the following questions are addressed:While we've mentioned letter to file a number of times in other podcasts, can you please take a minute to explain exactly what a letter to file is and when it should be used?Why is a letter to file important?When does a medical device company submit a letter to file to the FDA?Does the FDA provide any guidance on a letter to file or offer a template to use for it?What goes into a Letter to file?Can you provide some real-world examples of when to consider using a letter to file versus not using one? Does the type of change matter?Are there situations where using a letter to file could result in an adverse effect to what was intended?When it comes to a letter to file, what are the most important takeaways for listeners to keep in mind?Listen to this episode and see if you better understand the point of the letter to file and when to use it. 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 sfenske@rodmanmedia.com and we'll see if we want to address your ideas/inquiries/suggestions in a future episode.

In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Dr. Juliana Blum, Co-founder and Executive Vice President of Corporate Development at Humacyte. She speaks to the technology behind their regenerative solution and how it can be leveraged as a technology platform to fulfill a variety of bioengineered tissue needs. Specifically, the following questions are addressed.What is Humacyte and tell us a bit about your technology?What are the applications for bioengineered tissue?Obviously without giving away trade secrets, can you tell us a bit about how it is fabricated?What were the major challenges that needed to be overcome to develop this?What's ahead for Humacyte?Listen to this episode and see what you think of the company's bioengineered tissue technology platform. If you'd like to share thoughts, ask questions, or suggest a future participant for Medtech Matters, please reach out to me at sfenske@rodmanmedia.com.

In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Andy Doraiswamy, founder and CEO of Koya Medical. He highlights the benefits of his company's compression therapy solution, which can be accomplished while the patient remains mobile and active. Specifically, the following questions are addressed.What is Koya Medical and what is your clinical focus area?You recently gained clearance for the Dayspring Lite. What is this and how does it differ from the Dayspring?Is this device only used to address lymphedema in cancer patients or can it be used to treat other conditions that could benefit from compression therapy?What is the feedback from patients? Have you had patients who went through more traditional treatments to address lymphedema and then used the Dayspring and can compare the two?What's next for Koya Medical?Listen to this episode and see what you think of compression therapy technology that enables mobility to be restored. If you'd like to share thoughts, ask questions, or suggest a future participant for Medtech Matters, please reach out to me at sfenske@rodmanmedia.com.

In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Mike Favet, CEO of NeuroPace. He offers insights into how his technology helps those suffering with epilepsy. In addition, he provides an explanation of the firm's nSight Platform. Finally, he talks about the partnership with another organization focused on epilepsy and how it integrates with his firm's technologies. Specifically, the following questions are addressed.Can you please explain what the focus of your company NeuroPace is?What is the nSight Platform and how does it lead to a better treatment protocol for patients with epilepsy?Why have you partnered with Seizure Tracker?With the three of these systems combined and working together, what is the impact to those with epilepsy?What's next for NeuroPace? What are the next steps?Listen to this episode and see what you think of these epilepsy solutions. If you'd like to share thoughts, ask questions, or suggest a future participant for Medtech Matters, please reach out to me at sfenske@rodmanmedia.com.

In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Elad Walach, Co-Founder and CEO of Aidoc. He explains how artificial intelligence is being leveraged to assist radiologists in diagnosing conditions that weren't originally even being sought. The Aidoc software constantly runs in the background of the imaging system to examine all patient scans without any further direction or commands. Specifically, the following questions are addressed.Can you please tell us what Aidoc is and what your focus is?How much time is saved for a radiologist in leveraging Aidoc versus the more traditional review method?What is the accuracy level with detection and how does it compare to the average for human error?Can this system function as a training or educational tool just as well as being a clinical tool?What's next for Aidoc?Listen to this episode and see what you think of Aidoc's ability to scan beyond the original condition. If you'd like to share thoughts, ask questions, or suggest a future participant for Medtech Matters, please reach out to me at sfenske@rodmanmedia.com.

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we highlight a number of areas in which the agency's regulatory oversight could be considered lacking. If the agency incorporated the highlighted ideas from this podcast, might it smooth the pathway to market for some products? Might it enhance communication with the FDA? Could they be welcome additions? Specifically, the following questions are addressed:Can you please take a minute to explain why we are dedicating an episode to what's missing from regulatory and quality systems?First topic on the list is communicating with the FDA. Do we need a Wellness Device registration, wellness pre-sub, or wellness device database?What about a catch-up 510k and letter to file pre-sub?How about a pre-sub for manufacturing issues or to resolve 483s and/or warning letters?Let's jump to regulatory pathway. Is a pathway needed that provides a de novo like version of the PMA?Staying in this realm, what about the idea of having substantial equivalence in the Class III and PMA realm?What are today's takeaways in what we may be missing in regulatory and quality systems?Listen to this episode and see what you think of these regulatory ideas. 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 sfenske@rodmanmedia.com and we'll see if we want to address your ideas/inquiries/suggestions in a future episode.

In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with David Fischel, CEO of Stereotaxis. He explains how his robotic surgical system works and what makes it unique from other systems on the market. He also speaks about the additional benefits that could be realized for interventional technology as a result of his system's ability to “pull” the catether through the patient's vasculature. Specifically, the following questions are addressed.What type of technology does Stereotaxis offer and what is the target clinical area?How does your system improve upon the traditional methods of performing interventional procedures?Many of my listeners are familiar with robotic systems as it relates to automation or minimally invasive surgical systems. How does your system compare to the more traditional thought of a robotic system?What is the learning curve for doctors seeking to learn how to use your system who are accustomed to more traditional procedures?What's ahead for Stereotaxis? What's on the horizon?Listen to this episode and see what you think of the unique robotic surgical system from Stereotaxis. If you'd like to share thoughts, ask questions, or suggest a future participant for Medtech Matters, please reach out to me at sfenske@rodmanmedia.com.

In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Dr. Deepak Khuntia, chief medical officer and senior VP of Medical Affairs at Varian. He offers insights on the company's FLASH technology* and the significant differences between it and other radiation treatment systems. Dr. Khuntia also provides information about a clinical trial taking place to better understand the effect the FLASH system has on surrounding tissue. Specifically, the following questions are addressed.You're currently conducting a clinical trial on your FLASH therapy. Can you explain what the technology is and what it's used for?How does this treatment compare with more traditional methods for addressing this condition?Are there future potential applications where the FLASH technology could be used?Is this the first clinical trial incorporating the technology? I'm curious as to the response/feedback from physicians.In terms of the Flash technology, or Varian on the whole, what's ahead? What are the next steps?Listen to this episode and see what you think of Varian's FLASH technology. If you'd like to share thoughts, ask questions, or suggest a future participant for Medtech Matters, please reach out to me at sfenske@rodmanmedia.com.*Note: FLASH therapy is under development and is not available for commercial sale.

In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Moshe Safran, CEO of RSIP Vision U.S. He shares technology advancements and his thoughts about them as related to the imaging field. Of note is his comments on 3D reconstruction as well as the impact artificial intelligence is having on the space. Specifically, the following questions are addressed.What is RSIP Vision and what is your area of focus?Medical imaging technology is rapidly advancing in several ways. Let's start with 3D reconstruction. How is this being used today and how is it transforming medical imaging?Imaging advancements are also impacting joint replacement procedures. What are the real innovations here and how are they enhancing treatment?How about the use of AI in image capture? What's happening here to improve processes?What are the key takeaways in terms of using AI in medical technology? Why is it important?What's ahead for RSIP? What can we expect or where is your focus?Listen to this episode and see what you think of emerging imaging technology. If you'd like to share thoughts, ask questions, or suggest a future participant for Medtech Matters, please reach out to me at sfenske@rodmanmedia.com.

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss a recent offering put out by the FDA in conjunction with the Medical Device Innovation Consortium and MITRE. It is a playbook for device makers to involve threat modeling of medical devices in its approach to cybersecurity. Best practices for addressing cybersecurity of medical devices is also covered. Specifically, the following questions are addressed:Can you start things off by explaining what Threat Modeling is?Regarding this playbook the FDA released, is this purely a type of best practices item or is this something that may have regulatory implications tied to it somewhere down the road?Why is the FDA putting such attention on cybersecurity in medical devices? Is this about patient safety?Are there currently regulatory requirements with regard to cybersecurity?What do you foresee happening with FDA and cybersecurity? Will there continue to be guidance and/or will it become a bigger part of a regulatory review?What are your suggestions or takeaways for device manufacturers when it comes to cybersecurity and the FDA?You can download the playbook for Threat Modeling Medical Devices discussed in this podcast by clicking  HERE. Listen to this episode and see what you think of the FDA's interest in cybersecurity. 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 sfenske@rodmanmedia.com and we'll see if we want to address your ideas/inquiries/suggestions in a future episode.

In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Dr. Tamir Wolf, CEO and Co-Founder of Theator. He discusses his company and why capturing a video record of a surgery is beneficial to physicians. He speaks to the educational advantages that can be realized and also talks about the legal implications of using his technology in a malpractice suit. Specifically, the following questions are addressed.Can you please provide a brief overview of Theator?Is this technology used for surgical training, surgical planning, or both?Does this technology function in real time or is it only outside of the OR?What if a surgeon was sued for a mistake during a surgical procedure. Could this technology be used as evidence?What's next for Theator? Where is the company headed?Listen to this episode and see what you think of capturing surgeries on video with Theator. If you'd like to share thoughts, ask questions, or suggest a future participant for Medtech Matters, please reach out to me at sfenske@rodmanmedia.com.

In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Amit Phadnis, chief digital officer at GE Healthcare. He makes several predictions for the new year about how technology will impact the delivery of healthcare. Topics of discussion include the reduction of burnout among healthcare workers, continued integration and understanding of AI, reduction of healthcare inequalities, acceleration of telehealth, and other related areas. Specifically, the following questions are addressed.You have a number of predictions for 2022 that I'd like to explore. Let's start with a continued emergence of innovations to reduce burnout. Why are these important and do you have examples of some more recent ones?Talk to me about physicians become more particular about AI. Are they overwhelmed or beginning to recognize what's valuable and what's not?Another prediction you have is that technology will help the workforce reduce healthcare inequalities. What does that mean?The pandemic resulted in an incredible acceleration of telehealth. How will we grow from that and find the real value play for it?You say that precision health will revolutionize healthcare delivery. What does that mean specifically?In what other ways do you see AI and other advanced medical technologies making an impact in 2022?Listen to this episode and see what you think of Phadnis' predictions of healthcare and technology in 2022. If you'd like to share thoughts, ask questions, or suggest a future participant for Medtech Matters, please reach out to me at sfenske@rodmanmedia.com.

In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Andrew Ekdahl, worldwide president of joint reconstruction at DePuy Synthes. He offers insight on the company's approach to knee replacement, blending a number of technologies to achieve a restoration. Ekdahl also speaks to the impact newer innovations, such as robotic-assisted surgical technologies and data driven solutions, have on knee implants. Specifically, the following questions are addressed.I understand DePuy is taking a different approach to total knee replacement. Instead, it's being looked at as knee restoration. Can you explain what that is and why the differentiation in language?How is data driven technologies being used to help with this mission?What's happening in terms of implant development? Are the implants changing to meet with this effort?To further enhance this mission to restore the knee, how is personalized medicine (a term we hear often) playing a role here?How does this effort meet with the needs (and wants) of surgeons? Is this speeding up surgical procedures?What about the instrumentation? Any changes and/or advancements in that space?What is this leading to? Where is DePuy headed in terms of the knee, joints, or the larger orthopedic space?Listen to this episode and see what you think of DePuy's knee restoration strategy. If you'd like to share thoughts, ask questions, or suggest a future participant for Medtech Matters, please reach out to me at sfenske@rodmanmedia.com.

In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Kathy Lee-Sepsick, founder and CEO of Femasys. She provides an overview of how the company's technology is helping women who are dealing with infertility. She also speaks about a device that enables a non-surgical means of permanent birth control. Specifically, the following questions are addressed.Can you please start off by giving us a little insight on what Femasys is?So your technologies are at both end of the spectrum, addressing infertility and also helping to prevent pregnancy. Can you talk a bit about the FemaSeed and how it different from other available infertility technologies?What is FemBlock and how does it work?What is FemVue and how did it change the current standard for this type of medicine?What's next for Femasys? Where is the firm headed?Listen to this episode and see what you think of the women's health technologies from Femasys. If you'd like to share thoughts, ask questions, or suggest a future participant for Medtech Matters, please reach out to me at sfenske@rodmanmedia.com.

In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Dr. Asha Parekh, a biomedical engineer and CEO of Front Line Medical. She explains how the COBRA-OS can stop internal bleeding to prevent patients from dying due to loss of blood. She also explains how the technology differs from current treatment methods. Specifically, the following questions are addressed.Can you please start by telling us a little about Front Line Medical Technologies and your COBRA-OS technology?How does the COBRA-OS technology differ from other available solutions?When is the COBRA-OS used? Is this used in a hospital or in an emergency situation at the scene (of say an accident)?Can you share some of the stats associated with this technology? In other words, how does it measure up to other technologies in survival rate, success rate, etc.?What's next for Front Line Medical Technologies?Listen to this episode and see what you think of Front Line's COBRA-OS technology. If you'd like to share thoughts, ask questions, or suggest a future participant for Medtech Matters, please reach out to me at sfenske@rodmanmedia.com.

In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Bryan Lord, CEO and co-Founder of Pristine Surgical. He provides a number of reasons why disposable endoscopes should be indicated for medical procedures. Lord also highlights some of the challenges with reusable scopes and how single-use solutions help to eliminate them. Specifically, the following questions are addressed.Let's start with a quick overview of what Pristine Surgical is about. Can you tell us about the company and technology?Why have there been such problems with the cleaning and sterilization of endoscopes?I understand safety in terms of instrument cleaning shortcomings, but has COVID had an impact as well?Do you encounter questions regarding durability and/or functionality of single-use scopes? If so, how do you address them?When compared to reusable scopes, are there any tasks that can't be performed with a single-use scope?Are the images and videos able to be shared in a similar manner to most companies' scope offerings?When people hear about a single-use product, they think of the trash created. Have you looked at the environmental impact of single-use versus reusable scopes?What's next for Pristine Surgical?Listen to this episode and see what you think of Pristine's single-use scope technology. If you'd like to share thoughts, ask questions, or suggest a future participant for Medtech Matters, please reach out to me at sfenske@rodmanmedia.com.

In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Carlton Weatherby, vice president and general manager of Spine and Biologics at Medtronic. He provides insight on why the organization acquired Mazor and Titan Spine, the strategy for the division to address more of the care continuum, and how trends are being addressed such as AI, data, and MIS. Specifically, the following questions are addressed.Medtronic has made two interesting acquisitions in the Spine space. Can you tell us what made Mazor and Titan Spine attractive targets?Medtronic has demonstrated an interest in providing a solution for the entire care chain in other therapy areas, such as in diabetes. Is Spine headed in a similar direction?As you know, minimally invasive in spine is the trend. How is Medtronic addressing this?Another significant trend in medtech is the incorporation of data and artificial intelligence. What is Medtronic doing in these areas with regard to spine?What's ahead? What can you share with regard to Medtronic's spine future?Listen to this episode and see what you think of Medtronic's approach to spine. If you'd like to share thoughts, ask questions, or suggest a future participant for Medtech Matters, please reach out to me at sfenske@rodmanmedia.com.

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we look at ways in which medical device manufacturers can benefit from a commercial strategy standpoint through the leveraging of its regulatory strategy. Knowing how to make the regulatory process more challenging to help prevent “me too” products to reach the market can be a commercial advantage for medtech firms. Specifically, the following questions are addressed:First, why don't we begin with you describing exactly what you mean when you say a company's regulatory strategy? And is that strategy company-wide or does a regulatory strategy change with each product?Who should be involved with the creation of a regulatory strategy if anyone beyond the regulatory representative?So how does the regulatory strategy and commercial strategy intertwine?What benefits can be realized from this approach?Would you please provide some real world example to further help illustrate the relationship between the two when it's successful?What should be the most important considerations for medical device firms to keep in mind regarding their commercial strategy when identifying their regulatory strategy?In addition, several previous podcasts were mentioned. To listen to those, click on the podcast title below.Breakthrough Designation Program Update—Mike on MedtechBeyond 510(k)/PMA: Breakthrough Devices Program—Mike on MedtechBreakthrough Designation Program—Mike on MedtechReimbursement Debate Over FDA Breakthrough Device DesignationDe Novo Final Rule—Mike on MedtechBeyond 510(k)/PMA: De Novo 101—Mike on Medtech Listen to this episode and see what you think of the intermingling of regulatory and commercial 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 sfenske@rodmanmedia.com and we'll see if we want to address your ideas/inquiries/suggestions in a future episode.

In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Jackie Butler, director of BIO El Paso – Juarez, and Philip Morton, product development lab manager at MCA. They offer insights on how strong the region has been in supporting medical device manufacturers and how their organizations is only building upon that foundation. They explain the benefits of the organizations and the services they provide—free of charge—to U.S.-based companies. Specifically, the following questions are addressed.What is Bio El Paso?Can you tell me what MCA is?What is the connection between BIO El Paso and MCA?What's the impact you are making on the medical device industry?The Devise Product Realization Hub offers a variety of services free of charge to companies. Can you discuss these?Do you have any success stories you could share?What are the next steps for this program and your organizations as they remain relevant to the medical device industry?Listen to this episode and see what you think of the El Paso/Juarez region. If you'd like to share thoughts, ask questions, or suggest a future participant for Medtech Matters, please reach out to me at sfenske@rodmanmedia.com.

In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Tom O'Brien, worldwide president of Endomechanical at Ethicon. He shares insights on the company's approach to the development of surgical instrumentation and reducing surgical complications. O'Brien also offers data from a recent study on the new Echelon Circular Powered Stapler and the improvements it offers for clinicians. Specifically, the following questions are addressed.Can you start by explaining what is encompassed within the Endomechanical unit at Ethicon?When it comes to the design and development of a surgical device, what are the key priorities for Ethicon and why?When companies talk about reducing surgical complications, what do they really mean and how is Ethicon trying to do this?Speaking of complications, Ethicon recently had data on a new stapler, the Echelon Circular Powered Stapler. Can you speak to the study about this device and what benefits it provides?Are there clinical areas on the horizon you are looking to address (that you can speak about, that is)?Listen to this episode and see what you think of Ethicon and its approach to surgical instrumentation. If you'd like to share thoughts, ask questions, or suggest a future participant for Medtech Matters, please reach out to me at sfenske@rodmanmedia.com.