Podcast appearances and mentions of mike drues

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 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 episode of the Global Medical Device Podcast, Etienne Nichols and regulatory expert Mike Drues take a critical look at the FDA's Manufacturer and User Facility Device Experience (MAUDE) database. While intended to serve as a vital tool for post-market surveillance, the MAUDE database is fraught with issues—from late reporting and missing data to unclear mission alignment. Mike challenges MedTech professionals to rethink how we engage with the system, exposing how widespread underreporting and data hygiene problems not only weaken safety efforts but also increase legal risk. This eye-opening discussion reveals where the breakdowns are occurring, who's responsible, and what industry and regulators can do to fix it.Key Timestamps[02:30] What is the MAUDE database, and why does it matter?[06:10] The critical difference between reportable and non-reportable adverse events[11:20] Limitations of MAUDE: Why FDA warns against using it for rate comparisons[17:45] Underreporting, late submissions, and missing data: The disturbing stats[25:00] High-profile companies dominating late reporting violations[32:10] Legal consequences: What expert witnesses look for in MAUDE data[38:50] Is it poor systems or lack of regulatory understanding causing failures?[46:00] Recommendations for manufacturers: What responsible reporting looks like[53:20] How FDA could modernize the MAUDE database to better serve patients[1:01:30] Carrots or sticks: Creating incentives vs. penalties for compliance[1:09:00] Final thoughts: The true mission of MAUDE and how to fulfill itStandout Quotes"A report in the MAUDE database is just a historical record. It doesn't say why it happened or who's at fault—just that it happened."— Mike DruesThis quote underscores the limited utility of MAUDE reports and why interpretation requires caution."If you're not a medical device professional without your tools, then you're not really a medical device professional."— Etienne NicholsA poignant reminder that compliance and quality are human-led, not software-enabled by default.Top TakeawaysLate Reporting is Widespread and RiskyNearly 30% of MAUDE reports are filed late, with 10% submitted more than six months past due. This creates legal exposure and potential patient harm.MAUDE Is Misused—Despite FDA WarningsManufacturers commonly use MAUDE for competitive analysis or trend detection, even though the FDA explicitly warns against it.Three Companies Account for Over Half of Late ReportsLarge, well-resourced companies like Medtronic and Becton Dickinson are responsible for a disproportionate share of noncompliance.Electronic Tools Help, but Culture Matters MoreSoftware can support MDR timelines, but organizations still need internal processes and urgency to act responsibly.FDA and Industry Both Need to EvolveSuggestions include AI-driven cross-referencing, tiered reporting urgency, and incentive-based compliance recognition.ReferencesFDA MAUDE Database21 CFR 803.16 – MDR Reporting RequirementsEtienne Nichols on LinkedInMedTech 101: What Is MAUDE and Why Should You Care?Think of the MAUDE database as a public logbook of adverse events involving medical

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 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 part 2 of a critical two-part series, Etienne Nichols and regulatory affairs expert Mike Drues explore the nuanced pathway of switching a medical device from prescription (Rx) to over-the-counter (OTC). This episode dives deep into what triggers a new submission, how usability testing and human factors play an expanded role for lay users, and the regulatory logic that guides these transitions. The conversation highlights the importance of aligning regulatory strategy with business goals, and offers practical insights on leveraging real-world evidence, understanding the limits of FDA databases, and optimizing pre-submission meetings.Key Timestamps02:10 – Starting from a cleared 510(k): Do you need a new submission for OTC?06:45 – Implications of removing the healthcare provider from the equation12:00 – Risk management: Expanding risk profiles when lay users are involved18:15 – When a 510(k) becomes a De Novo or PMA22:50 – Usability testing and the risk of user error in OTC devices31:20 – Clinical investigations and good clinical practices (GCPs)36:00 – Real-world evidence vs. real-world data—what's usable?41:30 – Using Pre-Subs effectively and what “quality data” really means47:10 – Labeling, cleaning, and UDI for OTC products53:40 – OTC software and digital health—when is it a regulated device?01:00:00 – Summary: Aligning regulatory logic with common sense and business strategyQuotes“With an OTC device, we are taking the healthcare professional totally, completely, and utterly out of the loop.”– Mike DruesThis quote encapsulates the core regulatory challenge in moving a device to OTC: every element, from labeling to usability, must assume zero clinical supervision.“If the clinical trial won't tell you anything you don't already know from good real-world evidence, why spend the time and money?”– Mike DruesA powerful argument for using well-documented real-world evidence over unnecessary trials—provided the data truly meets evidentiary standards.Top TakeawaysLabel Expansion ≠ Shortcut: Moving from prescription to OTC usually requires a new submission—especially when removing the healthcare provider introduces new risks.Usability Testing Is Critical: OTC usability studies must go beyond IFU comprehension to include risk of misuse, poor device selection, and user decision-making.Real-World Evidence Can Help—If It's Clean: Real-world data isn't always usable. FDA will expect reproducibility, traceability, and strong justifications.Labeling & Design Must Assume No Clinical Oversight: Cleaning procedures, warnings, and directions must all be validated for home use and layperson comprehension.Use Pre-Subs Wisely: Especially for label expansions or gray-area digital health tools, pre-subs provide critical alignment with FDA and prevent costly errors.References & ResourcesEtienne Nichols on LinkedInFDA Guidance on Real-World Evidence for Regulatory Decision-MakingGreenlight Guru Webinar: What is and Isn't a Regulated Medical Device (feat. Mike Drues)FDA Guidance: Clinical Decision Support SoftwareMedTech 101: OTC vs Prescription DevicesAnalogy: Think of prescription vs. OTC devices like driving a manual vs. automatic car. Prescription devices assume a trained “driver” (the healthcare provider), while OTC devices must be intuitive and safe enough for anyone to “drive”...

In Part 1 of this two-part series, Etienne Nichols sits down with regulatory strategist Dr. Mike Drues to explore the nuanced differences between prescription (Rx) and over-the-counter (OTC) medical devices. They demystify key terms, regulatory classifications, and the growing trend of label expansions from Rx to OTC—highlighting real-world examples like CPAP machines and continuous glucose monitors (CGMs). This episode unpacks how intended users, environments, and risk tolerances shape device categorization, and why usability testing is far more complex than many realize. Whether you're developing a consumer health product or preparing a label expansion strategy, this is a must-listen for your regulatory roadmap.Key Timestamps[03:05] – What defines an OTC vs. prescription medical device?[06:45] – Market size of OTC devices and major product categories10:00 – Label expansion: moving from Rx to OTC status13:22 – The role of intended use environment in OTC classifications20:40 – Examples of devices in each FDA class that are OTC26:30 – Prescription devices used in home settings vs. true OTC31:15 – Characteristics that qualify devices for OTC status37:55 – Self-diagnosis, self-selection, and patient usability challenges43:00 – “Reasonably foreseeable misuse” and how to interpret guidance49:05 – Do you design for the lowest common denominator?56:10 – Representing diverse user populations in usability testing1:01:45 – Can a device launch OTC first? The case for wellness-to-Rx strategies1:08:15 – FDA's perspective on device safety: OTC vs. RxQuotes“The best regulatory professionals don't just know the rules—they know the exceptions.”Dr. Mike Drues reminds us that exceptional regulatory strategy lies in understanding nuance, especially in OTC classifications where edge cases can redefine categories.“Just because a device is used at home doesn't mean it's over the counter.”This insight challenges a common industry assumption, underscoring the importance of carefully defining intended use and environment early in development.Key TakeawaysOTC ≠ Low Risk by Default – Many Class II and even rare Class III devices can be OTC; it's more about intended user, use environment, and risk mitigation than class alone.Label Expansion Requires Strategy – Transitioning a device from prescription to OTC isn't just about removing a doctor's role—it may involve new usability studies, labeling changes, and potentially a 510(k) or de novo submission.Understand the "Intended Use Environment" – FDA doesn't just care about where the device is used, but how those environmental parameters (like light, humidity, and user training) affect safe operation.Usability Testing Must Reflect Real Users – For OTC devices, human factors validation must account for diverse educational backgrounds, not just ideal users.Don't Rely on Labels Alone – Whether or not users read (or understand) instructions must be tested, not assumed. Intuitive design is critical for OTC success.References & ResourcesEtienne Nichols on LinkedInGreenlight Guru Medical Device Classification Webinar with Mike Drues (for explanation on device classes)FDA Guidance: “Factors to Consider When Making Benefit-Risk Determinations in Medical Device...

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 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 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 episode of the Global Medical Device Podcast, Etienne Nichols and regulatory consultant Mike Drues delve into the often-overlooked yet critical topic of device descriptions in FDA submissions. Discover why this foundational element can determine the success of your regulatory pathway, influence classification, and impact the required testing for your device. With actionable tips and real-world examples, this discussion highlights how to craft effective, clear, and concise device descriptions that resonate with both reviewers and regulators.Key Timestamps[00:01] Introduction: Why device descriptions are foundational for regulatory submissions.[07:15] Common challenges: Why device descriptions are often poorly written.[14:30] Purpose and impact: How descriptions influence classification, testing, and approval pathways.[25:45] Practical advice: Balancing simplicity with technical detail for diverse audiences.[36:10] Pre-sub meetings: Communicating device descriptions effectively with the FDA.[50:30] Final recommendations: Testing the efficacy of your device description.Memorable QuotesMike Drues: "If the FDA doesn't understand your device, it's not their fault—it's the manufacturer's responsibility to communicate effectively."Etienne Nichols: "Uncertainty in your device description leads to questions, delays, and potential rejection."Mike Drues: "A picture's worth a thousand words, but a video is worth a thousand pictures—use it to demonstrate your device clearly."Key TakeawaysMedTech TrendsClear communication is essential in the increasingly complex regulatory environment, especially with AI and software-based devices.Ambiguity in device descriptions can lead to unnecessary testing or inappropriate classification.Visual aids, like images and videos, are becoming standard tools to enhance submissions.Practical TipsTest your description's efficacy by asking someone unfamiliar with the device to explain it back to you.Write layered descriptions—simple overviews for general audiences and detailed appendices for specialists.Incorporate visuals or videos to clarify complex mechanisms or testing processes.Future QuestionsHow might advancements in AI reshape the expectations for device descriptions?Could the FDA eventually require interactive or multimedia submissions as standard?What new tools or technologies can help manufacturers streamline the description-writing process?References & ResourcesGreenlight Guru: Purpose-built quality management systems for MedTech. Learn more.Stephen Covey: Seven Habits of Highly Effective People—inspiration for improving communication practices.Etienne Nichols on LinkedIn: Connect with Etienne for insights on MedTech and regulatory affairs. Connect now.MedTech 101: Device DescriptionsWhat is a device description?A section of your regulatory submission detailing what your device is, how it works, and its intended use. It includes:Anatomy: Components and materials.Physiology: Function and mechanism of action...

In this episode of the Global Medical Device Podcast, Etienne Nichols sits down with regulatory expert Dr. Mike Drues to demystify the pre-market approval (PMA) process for medical devices. They delve into the key differences between PMAs, 510(k)s, and de novos, bust common myths, and explore strategic advantages for companies willing to pursue the rigorous PMA pathway. Mike explains the nuances of the “six-year rule,” alternatives like the humanitarian device exemption (HDE), and the evolving role of clinical data. With insights on using PMAs as a competitive strategy and overcoming internal resistance to high-risk device development, this discussion is essential for MedTech innovators looking to turn regulatory challenges into opportunities.Key Timestamps:00:00 – Intro and Greenlight Guru's Quality Management System software sponsor message03:15 – Introduction to Dr. Mike Drues and his background in PMAs05:45 – Overview of PMAs and when they should be used11:30 – Are PMAs the only pathway for Class 3 devices?16:20 – Types of PMAs: Traditional, Modular, and Streamlined22:40 – Advantages of PMAs compared to 510(k)s and de novos27:50 – The strategic use of predicates in the PMA process33:00 – Clinical data requirements and misconceptions for PMAs41:10 – Post-market requirements and differences for PMA devices47:25 – Innovation and the future of PMAs: Six-year rule and potential EU approvals54:30 – Final thoughts on overcoming industry resistance to PMAsStandout Quotes:"Don't be afraid of the big bad PMA—often, the regulatory burden is justified for complex devices tackling high-risk conditions." – Dr. Mike Drues"Regulatory professionals know the rules; the best ones know the exceptions. When it comes to PMAs, there are more options than many realize." – Dr. Mike Drues3 Key Takeaways:PMA Isn't the Only Path for Class 3 Devices: Companies can consider alternatives like the Humanitarian Device Exemption (HDE) and Product Development Protocol (PDP) to reduce the regulatory burden.Strategic Use of PMAs Can Provide a Competitive Edge: By choosing the PMA route, companies can create barriers for competitors, potentially driving smaller rivals out of the market.Clinical Data Isn't Always Mandatory for PMAs: While most PMAs involve clinical trials, there is flexibility in requirements, offering an opportunity to minimize the scope and cost of clinical studies.References:Previous Greenlight Guru Webinars by Dr. Mike DruesGreenlight Guru's QMS SoftwareEtienne Nichols' LinkedInMedTech 101:PMA Pathway Explained – Pre-market approval (PMA) is the FDA's strictest regulatory pathway, typically reserved for Class 3 medical devices with higher risks. Unlike the 510(k) pathway, PMA requires evidence of safety and efficacy, often through clinical trials, but the scope can vary. There are traditional, modular, and streamlined PMA types, each with unique requirements.Audience Engagement:Poll Question: "Have you considered using a PMA as a strategic advantage for your MedTech device? What challenges do you...

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 episode of the Global Medical Device Podcast, Etienne Nichols and regulatory expert Mike Drues discuss FDA's new framework, the Predetermined Change Control Plan (PCCP), designed to streamline change approvals for medical devices. Originally developed for AI-based devices, the PCCP framework is now available for all types of medical devices, providing a way for manufacturers to get pre-approval for certain future device changes. Etienne and Mike explore the origins of PCCPs, the intricacies of implementing them, and how this regulatory tool may allow for faster device modifications without additional market submissions. They also examine the benefits and limitations of PCCPs for both AI-driven and physical medical devices and provide practical tips for incorporating this into regulatory and quality management strategies.Key Timestamps:[03:15] Introduction to PCCPs and Change Management[08:40] PCCP's origin and application for AI-driven devices[14:20] Expansion of PCCPs to all medical devices[25:10] Practical challenges and best uses for PCCPs[34:55] Submitting PCCPs: Considerations and tips[45:30] Potential of PCCPs for non-software devices: 3D-printed knees case[52:40] FDA guidance and limitations for label changes[1:06:20] Final recommendations and quality system implications for PCCPsMemorable Quotes:“PCCPs could allow us to get anticipated changes approved without a new market submission — but that isn't a blank check. It's a pre-validation of boundaries.” — Mike DruesTop Takeaways:Consider PCCPs for High-Impact Changes: PCCPs are valuable for anticipated changes to AI-driven or complex devices, potentially reducing regulatory delays.Limit Scope for Efficiency: Keep PCCPs specific, with only a few anticipated changes, as this simplifies review and helps secure approvals faster.Integrate PCCPs in QMS: Adding PCCP protocols to quality systems may streamline change implementation and regulatory compliance for future device iterations.References:Mike Drues on LinkedInFDA PCCP Guidance (2023 & 2024) on anticipated changes and market submissionsMedTech 101:Predetermined Change Control Plan (PCCP): A regulatory tool from the FDA allowing manufacturers to gain pre-approval for anticipated changes to a medical device, simplifying future modifications. Initially created for AI-driven devices, PCCPs now apply to all device types.Audience Engagement:Have you considered or implemented a PCCP for your device? What changes would you include if you could pre-approve future modifications?Feedback:We'd love your thoughts on the PCCP framework! Email us at podcast@greenlight.guru with your feedback, questions, or ideas for future topics.Sponsors:Special thanks to Greenlight Guru — the industry's eQMS & EDC platform designed for medical devices. Learn more about how Greenlight Guru can streamline your change management at greenlight.guru.

In this episode of the Global Medical Device Podcast, host Etienne Nichols continues his conversation with regulatory expert Mike Drues in part two of their series on home use medical devices. The discussion centers on critical topics such as labeling, usability challenges, and the future of medical devices in home settings. They explore how these devices, increasingly used by non-healthcare professionals, face unique hurdles such as user training, environmental factors, and technological concerns like cybersecurity and data security. Together, Etienne and Mike also delve into how regulatory frameworks need to adapt for home use, and they highlight potential future issues with devices as AI and robotic assistance grow in prominence.Key Timestamps:[02:20] - Recap of Part 1 & Introduction to Home Use DevicesMike revisits key topics from part 1, focusing on why home use devices matter.[10:45] - Defining the Intended User and EnvironmentDiscussion about how labeling must account for who will use the device and where.[15:30] - Technological and Environmental Challenges for Home Use DevicesExploring temperature, humidity, and power inconsistencies affecting performance.[30:05] - Reprocessing and Cleaning Devices at HomeThe challenges and risks associated with reusing and cleaning devices like CPAPs.[40:15] - Usability Testing & Human FactorsImportance of considering non-healthcare users when designing home devices.[55:12] - Cybersecurity Risks in Home DevicesThe growing significance of data security and strategies for protecting devices in non-clinical settings.[1:05:30] - Post-Market Surveillance and Reporting for Home DevicesThe complexities of tracking device performance and recalls when used in home environments.Memorable Quotes:"When we talk about intended users, we must shift our thinking from healthcare professionals to patients. Designing for non-clinicians is crucial because usability directly impacts safety." – Mike Drues"If your device has to be recalibrated, why not have a mechanism that disables it when calibration is overdue? That's a much stronger safeguard than relying on users to remember." – Mike Drues"Cybersecurity is a growing challenge in home devices. It's not just about protecting personal data—imagine if a critical medical device was hacked." – Etienne NicholsKey Takeaways:Latest MedTech Trends:Increasing Use of Home Medical Devices: Patients are increasingly managing their own health at home, necessitating devices that are user-friendly and adaptable to various home environments.AI & Robotics in Home Devices: With the rise of AI and robotic assistance, the definition of an "intended user" is evolving, requiring future-proof regulatory considerations.Data Security: As more devices become connected, cybersecurity is becoming a top priority, particularly for critical, life-sustaining technologies.Practical Tips for MedTech Professionals:Understand the End-User: When designing devices, consider that patients, not healthcare professionals, will be the primary users. Usability is key.Incorporate Environmental Testing: Take environmental factors like humidity, power outages, and storage conditions into account during the device development phase.Push Updates Automatically: For connected devices, push software updates automatically to mitigate cybersecurity risks, rather than relying on users to pull...

In this episode, Etienne Nichols hosts regulatory expert Mike Drues to discuss the evolving landscape of home use medical devices. The conversation covers critical topics such as regulatory definitions, safety challenges, and compliance hurdles for devices intended for use outside traditional clinical settings. They explore how home use devices, such as CPAP machines and infusion pumps, can differ significantly from hospital-based devices in terms of design, post-market surveillance, and user interaction. The discussion is grounded in real-world examples, most notably the Philips Respironics recall, which became the largest medical device recall in history due to design oversights and failure in post-market surveillance. This episode sets the stage for a deeper dive into technical, regulatory, and user-related challenges in the next installment.Key Timestamps:[00:01] – Introduction: Etienne introduces the episode and topic of home use medical devices, along with a quick sponsor message.[02:30] – Defining Home Use Devices: Mike Drues explains what qualifies as a home use medical device from a regulatory standpoint.[07:50] – Why Home Use Devices Matter: Discussion on why home use medical devices are a strategic priority for CDRH in 2025 and the safety issues identified by the Emergency Care Research Institute (ECRI).[12:15] – Case Study: Philips Respironics Recall: Mike discusses the technical and regulatory issues behind the Philips Respironics recall and its implications for manufacturers.[25:45] – Post-Market Surveillance and Complaint Handling: The challenges of post-market surveillance and complaint handling for home use devices, and the role of regulatory compliance.[35:30] – The Importance of Intended Use Environment: Exploring how intended use environment should influence design and usability considerations.[45:20] – Teaser for Part 2: Mike and Etienne preview topics for the next episode, including labeling challenges, human factors, and usability testing for home use medical devices.Key Quotes:“A home use device isn't just a device that could be used at home; it's one that's intended and labeled for use outside traditional clinical settings.” — Mike Drues“When post-market surveillance fails, it's not just a compliance issue—it's a safety issue that can put lives at risk.” — Mike Drues“Regulatory logic goes beyond the written rules—it's about understanding the intent behind them to ensure devices are safe wherever they're used.” — Mike DruesKey Takeaways:Latest MedTech Trends:Home Use Device Surge: There is a growing trend toward designing devices for non-clinical environments, driven by technological advancements and patient demand for convenience.Regulatory Focus on Safety: Regulatory bodies like the FDA are increasingly prioritizing the safety of home use devices, as seen in CDRH's 2025 strategic priorities.Impact of High-Profile Recalls: Large-scale recalls, like the Philips Respironics case, highlight the need for robust design controls and post-market surveillance practices for home use devices.Practical Tips:Design for Real-World Use: When designing home use devices, consider environmental factors like temperature, humidity, and patient handling to prevent unintended failures.Emphasize Post-Market...

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 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'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 episode of the Global Medical Device Podcast, host Etienne Nichols welcomes back Dr. Mike Drues to discuss the critical aspects of obtaining Institutional Review Board (IRB) approval and interacting with the FDA for medical device clinical trials. They explore the roles of IRBs, the difference between significant and non-significant risk devices, and share invaluable advice on mitigating risks associated with clinical trials. Whether you're a newcomer or a seasoned professional in the MedTech industry, this episode offers essential insights to ensure your clinical studies are compliant and efficient.Key Timestamps:00:01:20 – Introduction to Dr. Mike Drues and his accolades.00:05:30 – Explanation of IRBs and their role in clinical trials.00:15:10 – Differences between traditional and commercial IRBs.00:22:40 – Discussion on significant vs. non-significant risk devices.00:32:00 – Importance of pre-submission meetings with the FDA.00:44:15 – Steps to take when an IRB disapproves your clinical trial.01:00:30 – Practical tips for choosing the right IRB for your study.Quotes:"Most 510 devices do not need clinical data. But if you do, even for a non-significant risk device, vetting that with the FDA in advance is wise." – Dr. Mike Drues"You don't want to create a problem where none exists, but avoiding FDA consultation can lead to costly surprises later." – Dr. Mike Drues"The primary mission of an IRB is to ensure the safety of the patients at that institution." – Dr. Mike DruesTakeaways:Key Insights:Understanding IRBs: IRBs are local entities responsible for the ethical oversight of clinical trials, ensuring patient safety and compliance.Risk Classification: The classification of your device as significant or non-significant risk dictates whether FDA approval is needed for your clinical trial.Strategic Pre-Submission: Engaging in a pre-submission meeting with the FDA can prevent costly delays and ensure your clinical trial meets all necessary endpoints.Practical Tips:IRB Shopping: If faced with an IRB denial, consider alternative institutions or commercial IRBs to avoid delays.Comprehensive Submissions: Prepare thorough submissions for IRBs, including device descriptions, clinical trial protocols, and informed consent forms.Physician Champions: Having a physician advocate at the institution can streamline the approval process and facilitate patient enrollment.Future Questions:How will the evolving landscape of MedTech regulations impact the approval process for new devices?What role will real-world evidence play in future clinical trials for medical devices?How can smaller companies navigate the complexities of FDA and IRB requirements effectively?References:Etienne Nichols on LinkedInMike Drues on LinkedInFDA Guidance on Artificial Intelligence and Medical DevicesFDA Guidance on Avoiding Potential Issues with Your 510(k) SubmissionGood Clinical Practices (GCP) regulations for IRBsMedTech 101:What is an IRB?An Institutional Review Board (IRB) is a committee established to review and approve research involving human subjects. The primary purpose of an IRB is to ensure the ethical and safe treatment of participants in clinical trials.What is an IDE?An Investigational Device Exemption (IDE) allows a medical device to be used in a clinical study to collect safety and effectiveness data. An IDE must be approved by the FDA for significant risk devices before a clinical study can begin.Questions for the...

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.

Description:Dive into the enlightening world of FDA inspections with Etienne Nichols and Mike Drues. In this comprehensive episode, the duo decodes the essence of effective communication, the importance of managing expectations, and the art of proactive dialogue with the FDA. They reveal insights that every MedTech professional must know, breaking down the philosophy, challenges, and expectations surrounding inspections, all while blending unique "Mike Drues isms" and Etienne's candid takes.Some of the highlights of this episode include:Grasping the art of proactive communication with the FDA, laying the foundation for regulatory success.Delving into the essence of managing FDA's expectations during pivotal conversations.Exploring the unpredictability of FDA inspections and the mantra of always being prepared.Differentiating between inspections for class two/lower medical devices and class three devices.Unpacking the role of FDA registration in attracting the FDA's attention for inspections.Achieving the perfect equilibrium when providing information during inspections.Navigating through concerns raised by FDA reviewers and appreciating the value of swift responses.Navigating the nuanced gray areas, ranging from "sufficient investigation" to acknowledging and rectifying errors.Unveiling real-world scenarios where complaints in medical device manufacturing are addressed effectively.Quote:""The solution to most problems is more communication, not less." - Mike DruesReference Links:GG Academy - use Promo Code "podcast25" for a 25% discountGreenlight GuruVascular SciencesMichael Drues LinkedInEtienne Nichols LinkedIn*Interested in sponsoring an episode? Use this form and let us know!

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.

DescriptionIn April of 2023, FDA released a draft guidance entitled, "Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence / Machine Learning (AI/ML) - Enabled Device Software Functions." In today's episode, we speak with Mike Drues, PhD, President of Vascular Sciences, about artificial intelligence in medical devices, the history of this type of technology in the medical device field, and what this guidance means and doesn't mean. We hope you enjoy this episode of the Global Medical Device Podcast!Questions AskedWhat does artificial intelligence mean in software as a medical deviceWhy is this new draft guidance needed?What recommendation for medical device companies does the draft guidance provide?What are the challenges with validating the modifications for an ML-DSF? (Or are there other, greater challenges?)What are some of the specific items a PCCP should include?Does a PCCP negate a future need of a Letter to File or new 510k? What would necessitate an additional market submission?Quotes"I really try to stress what I call 'regulatory logic,' because if you understand the regulatory logic, really, all of this should be common sense." - Mike DruesReference LinksDraft FDA GuidanceEtienne NicholsGreenlight Guru

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.

When bringing a medical device to the market, it's important to be aware of the fatal 510(k) flaw. In today's episode, Mike Drues joins the podcast to discuss the potential issues the 510(k) program presents and how companies are dealing with it.Mike holds a Ph.D. in biomedical engineering, has served as an expert witness, and is one of the foremost regulatory minds, currently serving as the president of Vascular Sciences. Listen to today's conversation to learn how to approach a 510(k) submission if your predicate had a recall, how to develop products that are safer and more effective, and the importance of tracing the genealogy of your predicate. Some of the highlights of this episode include:What happens when the predicate that you'd like to use for your 510(k) has undergone a Class 1 recallThe risk management element of using a predicate that's undergone a Class 1 recallThe statistics about recall predicates used in 510(k)sHow the way the 510(k) is used has changed since it was first createdWhy the descendants of a predicate with a Class 1 recall are so much more likely to also undergo a recallSolving the problem of a predicate that's been through multiple recallsConsidering competitor's products or other products similar to the one yours is based onWhat post-market surveillance should entailThe direct and indirect economic impact of a Class 1 recallChanges that may happen with the FDA in the futureMemorable quotes from Mike Drues:“I can tell you that of the total number of devices that come onto the market, less than 5% are Class 3s.”“When the 510(k) was created half a century ago, it was intended to be an exception, not the rule.”“I do not advocate these simple-minded solutions like no 510(k) should allow to use a predicate that's undergone a recall.”“Unfortunately, good news does not sell. Bad news sells.”Links:Mike DruesVascular Sciences510(k) GuidanceJAMA Study 1JAMA Study 2FDA 510(k) Submission: A Step-By-Step Guide On How To Prepare YoursUltimate Guide to Postmarket Surveillance of Medical DevicesEtienne Nichols LinkedInGreenlight Guru AcademyGreenlight Guru

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.

Why do the same types of problems show up again and again in FDA medical device inspections? In today's episode, Mike Drues joins the podcast to talk about the FDA's Fiscal Year Report for 2022 Inspections and discusses the most common problems found during these inspections.Recurring guest Mike Drues is the President of Vascular Sciences where he works to educate the industry and offers help to bring medical devices to market in the most effective way possible. Mike is a medical device professional possessing regulatory expertise who understands the ins and outs of the regulation systems in the medical device industry and is passionate about helping others better understand it as well.Listen to the episode to learn more about the most common mistakes companies make that result in Form 483s, what companies can do to avoid these mistakes, and how you should be thinking about root cause analysis.Some of the highlights of this episode include:Common reasons why companies get in trouble during FDA inspectionsWhy CAPA is specifically at the top of reasons for 483s and how to prevent thatExamples of design control problems and how to avoid themThe root causes of these issues and root cause analysisWhat complaint handling problems look likeWhat causes people not to handle complaints correctlyWhether anything about these problems is new or trendingWhat the FDA does when they find these problemsMemorable quotes from Mike Drues:“The emphasis should be on prevention, not correction.”“I consider myself to be a medical device professional, and I do not use the word “professional” lightly. Along with it comes the responsibility, including knowing what the heck you're doing.” “What is the point of getting complaints or post-market surveillance or anything else if you're not going to act on it?”“I hate to say it, but we are the poster children for Einstein's definition of insanity.”Links:Mike Drues LinkedInVascular SciencesEtienne Nichols LinkedInGreenlight Guru AcademyMedTech Excellence CommunityGreenlight Guru

In a continuation of the previous episode, Mike Drues joins the podcast to further discuss LDTs, IVDs, and how those related to the ongoing Theranos situation.Mike is the president of Vascular Sciences, has a Ph.D. in biomedical engineering, and has extensive experience with Regulatory Strategy. In today's episode, he begins by reviewing some of the information in Part 1 of this discussion. He discusses how the current regulations and language around LDTs relate to the Theranos situation and what companies should be doing to ensure they're ready when the VALID act goes through. Listen to this episode to hear what Mike has to say about the risks of LDTs, the engineering work that should go into LDTs, and how the regulations could be changed to close the Theranos loophole. Some of the highlights of this episode include:The risk behind LDTs vs IVDsWhether LDTs belong in the IVD categoryThe relationship between the LDT situation and TheranosPrinciples to use with LDTsWhat companies should be doing now in anticipation of the VALID actThe importance of a contingency planThe criteria for a legitimate LDTSpecific parameters to define an LDTLabelingTechnologyRiskRequiring hospitals to put LDTs through institutional review boardsBetter oversightCreating a EUA-like pathwayMemorable quotes from Mike Drues:“Even from a technology perspective, the technology of these LDTs is becoming much much more complicated.”“Long story short, I think Theranos took a fairly liberal interpretation of the words surrounding the LDT.”“I'm a biomedical engineer first and a regulatory consultant second. And that's the order we should think about these things.”“Even though I'm a regulatory consultant, I'm not a fan of creating new regulation.”Links:Mike Drues LinkedInVascular Sciences webpageVALID ActEtienne Nichols LinkedInGreenlight Guru AcademyMedTech Excellence CommunityGreenlight Guru

What's the difference between an LDT and an IVD and what does that have to do with the Theranos case? In this episode, we dig deep into this topic.Mike Drues, a frequent returning guest to the Global Medical Device podcast is the president of Vascular Sciences. He has a Ph.D. in biomedical engineering and extensive experience with Regulatory Strategy, the FDA, and the history behind most of the regulations. In today's episode, Mike Drues and I spoke about the topic of Lab Developed Tests (LDTs), the ongoing Theranos case, and the state of LDTs & IVDs.Listen to the episode to learn more about Lab Developed Tests and what some examples of them are, what testing and regulations are required for LDTs, and how Theranos was able to market a test without the typical testing rigor. Some of the highlights of this episode include:Why Lab Developed Tests fit in with medical devicesWhat the difference is in LDTs and IVDsHow LDTs are regulatedExamples of LDTsWhy labs develop their own testsThe risk when it comes to LDTsWhy non-invasive LDTs can be listed as class 3Memorable quotes from Mike Drues:“A lot of people like to talk about what FDA regulates. I like to talk about what FDA doesn't regulate.”“Remember, regulation is about the interpretation of words.”“There is no difference in terms of the technology between an IVD and an LVT. The difference primarily is who uses it and where it's developed.”“If the hospital does one thing, they're treated one way; if a company does exactly the same thing, they're treated another way. Something's not quite kosher about that logic.”Links:Mike Drues LinkedInVascular Sciences webpageVALID ActEtienne Nichols LinkedInGreenlight Guru AcademyMedTech Excellence CommunityGreenlight Guru

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.

Today's episode is a little different than usual. This will be Jon Speer's last podcast for Greenlight Guru, as he'll be moving on to future ventures as of December 31st.In honor of many podcast episodes featuring Jon and Mike Drues, this episode is a tribute to some of the best episode topics that the two of them have tackled. They review some of their favorite episodes and throughlines of their discussions throughout the time they've been podcasting together. Listen to Jon and Mike discuss how they met, which episodes stuck out for them, and what thoughts they want to leave the audience with. Some of the highlights of this episode include:How Mike and Jon metInterpreting regulationsCommunicating with the FDAFDA plans to modernize 510KDeveloping a regulatory strategyThe most important thing to rememberUnderstanding all your pathways to marketUsability testing and how it applies in the real worldThe Emergency Use Authorization for medical devicesMemorable quotes from Mike Drues:“When the rules make sense, follow them, but when they don't make sense should we follow them?” “Regulation is about two things: it's about the interpretation of words and our ability to defend our interpretation.”“You need to know what all of your options are.”“Tell don't ask, lead don't follow.” Links: Jon Speer LinkedInMike Drues LinkedInGreenlight Guru AcademyMedTech Excellence CommunityGreenlight Guru

What are the proposed CRDH guidelines for the 2023 fiscal year, and why do they matter? How should you be thinking about them? Today's episode covers the newly-released guidelines and addresses important questions about these guidelines specifically and about the practice of releasing these guidelines in general.Today's conversation is with regular guest Mike Drues. Mike is President of Vascular Sciences, an education, training, and consulting company that offers many services to medical device, pharmaceutical, and biotechnology companies. In this episode, you'll hear what Mike has to say about what's on the FDA's A-list and B-list for the fiscal year 2023, what isn't on the list but perhaps should be, and what differences exist between draft guidelines and final guidelines. Some of the highlights of this episode include:What the CDRH proposed guidelines for fiscal year 2023 are about and why it's important to think about themThings that stick out on the FDA's A-list of guidelinesItems that are surprising or exciting on the A-listWhat is on the FDA's B-list of guidelinesWhat's missing from the A-list or the B-listHow collective wisdom is shared across various organizationsWhether the FDA should be giving guidance to help companies get products to marketThe difference between draft guidance and final guidanceIdentifying changes between versions of guidelinesWhether you have to do something if it's in the guidelinesMemorable quotes from Mike Drues:“Not to be too arrogant here, but I'm very proud of the fact many of the things that I've done in submissions over the years, whether it's with AI or BioComp or other kinds of testing has actually gone into guidance for the future.”“That's why there's a guidance document database, so you and I don't have to memorize such esoteric trivia.”“It's really not FDA's job to help a company bring a product on the market.”“All guidance, indeed all regulation, is very evolutionary. It's a work in progress.”Links:Mike Drues LinkedInFDA Website: CDRH Proposed Guidance's for Fiscal Year 2023RAPS Article: FDA device center guidance priority lists targets COVID, digital health (RAPS, 18 October 2022)Greenlight Guru AcademyMedTech Excellence CommunityGreenlight Guru

EUAs were less known before COVID than they are now. Between COVID and now Monkeypox, what has been learned about EUA, and where is it going as we move forward? Those are important aspects of today's discussion with guest, Mike Drues.Mike Drues is President of Vascular Sciences, an education, training, and consulting company that offers many services to medical device, pharmaceutical, and biotechnology companies. Listen to the episode to learn what Mike has to say about what EUAs are, what COVID has taught the market about EUAs, and what path FDA reviews are on now. Some of the highlights of this episode include:What an EUA is, and when it's usedAn EUA as a pathway to marketWhat the COVID experience has taught us about EUAWhether FDA reviews are back to normalThe poor quality of some EUA submissionsQuality requirements for EUA vs. non-EUA devicesWhat's new in EUAs beyond COVIDMonkeypox EUA developmentsImprovements in EUA qualities as submissions continueTop takeaways from today's discussionMemorable quotes from Mike Drues:“One of the things I've learned in playing this game now for about 30 years is most problems that companies get into, not only are they preventable, they're predictable.”“As a matter of fact, FDA estimates that 80% of submissions, 80% of EUA submissions, needed revisions, needed additional information.” “If you have experience doing these things, you're going to be more successful. If you don't have experience doing these things, that's not a problem; you can't be an expert at everything, but get somebody to help you.” “Don't treat FDA as our elementary school teacher.” Links:Mike Drues LinkedInArticle: FDA wants COVID test developers to shift from EUAs to traditional premarket pathways (RAPS, Sept 27, 2022)Article: FDA Repeatedly Adapted Emergency Use Authorization Policies To Address the Need for COVID-19 Testing (HHS, Office of Inspector General, Sept 2022) ReportCDRH Website: Monkeypox Emergency Use Authorizations for Medical DevicesArticle: FDA issues draft guidance for transitioning medical devices granted EUAs during pandemicFDA Guidance: Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health EmergencyFDA Guidance: Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) During the Coronavirus Disease 2019 (COVID-19) Public Health EmergencyWebinar: How Can Medical Device Companies Use The Emergency Use Authorization (EUA) To Address The Covid-19 Pandemic? Mike on Medtech: COVID-19 (Medical Product Outsourcing Magazine, April, 2020), Part 1 hereMike on Medtech: COVID-19 (Medical Product Outsourcing Magazine, April, 2020), Part 2 hereEmergency Use Authorization (EUA) 101: What Medical Device Companies Need to Know (GreenLight.Guru, April, 2020)Podcast: Tips For Being Prepared Post-EUA (January, 2022)Greenlight Guru AcademyMedTech Excellence CommunityGreenlight Guru

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.

How should you be thinking about 510(k) exemptions for medical devices? Do you know when things do and don't qualify for exemption and how that intersects with how a device is classed?This is the focus of today's episode with recurring guest Mike Drues, in a conversation with host Jon Speer, founder of Greenlight Guru. Mike is President of Vascular Sciences, an education, training, and consulting company that offers many services to medical device, pharmaceutical, and biotechnology companies.Listen to the episode to learn how Mike is thinking about the meaning of 510(k) exemptions, how classifications do and don't intersect with exemptions, and why some items are exempt.Some of the highlights of this episode include:The meaning of 510(k) exemptWhy “exempt” may not be the best wordWhat unregulated medical devices are calledClassifications don't necessarily mean that a device is exemptComparing and contrasting Class I and Class IIThe difference between general controls and special controlsExamples of exemptions and why they're exemptThe shades of gray in regulationThe regulatory logicMemorable quotes from Mike Drues:“An exempt device, whether it's a Class I exempt or a Class II exempt device, it doesn't matter, is still a regulated medical device.”“Instead of calling these special controls, we should call them specific controls.”“One of my frustrations with a lot of folks in this business is they just follow the regulations like a recipe, like a computer executing lines of code one by one without asking does this make sense?”“What is much much more important than the answer is the logic you use to get the answer.”Links:Mike Drues LinkedInCDRH Website: Class I and Class II Device ExemptionsList of Exempt Devices by regulation number (CDRH Website): Medical Device Exemptions 510(k) and GMP RequirementsWebinar: When do we need FDA's permission to market our device and when do we not? (Nov 2020)Webinar: Special Controls: What are they, and how can we use them to our advantage? (May 2022)Webinar: Understanding the Medical Device Classification System (July 2020)Webinar: General Wellness Devices and Wearables (May, 2018)Jon Speer LinkedInGreenlight Guru AcademyMedTech Excellence CommunityGreenlight Guru

What is a regulatory strategy? And for that matter, what do people sometimes think is a regulatory strategy but isn't? Those are the questions that today's guest, Mike Drues, discusses as he begins his conversation with host John Speer, founder of Greenlight Guru.Mike is President of Vascular Sciences, an education, training, and consulting company that offers many services to medical device, pharmaceutical, and biotechnology companies. Listen to the episode to learn how Mike thinks about competitive regulatory strategy, delays in complying with regulation, and reimbursement and regulatory strategy.Some of the highlights of this episode include:What regulatory strategy is and what it isn'tWhy a good regulatory strategy is so importantWhat competitive regulatory strategy isThe mistake of focusing on only one companyHow the EU MDR is affecting regulatory strategyWhat causes delays in complying with regulationsThe industry record on post-market surveillanceReimbursement and regulatory strategyMemorable quotes from Mike Drues:“Let's not forget my old friend, competitive regulatory strategy.”“It's never too soon, in my opinion, to start thinking about regulatory strategy.”“As a general rule, we have done an abysmal job on post-market surveillance across the board.”“I consider this whole thing to be a poker game, in every sense of the word.”Links:Mike Drues LinkedInHow to Construct an Effective Regulatory Strategy Jon Speer LinkedInGreenlight Guru AcademyMedTech Excellence CommunityGreenlight Guru

The 510(k) is the workhorse of regulatory submissions to the FDA from the medical device industry in the United States. However, 510(k)s continue to be the source of problems, delays, and rejections. It only takes common sense and simple solutions to overcome these issues.In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues of Vascular Sciences about common 510(k) mistakes and how to avoid them. They also cover what has changed (if anything) in the past five years since Jon wrote the article, 7 Common Mistakes That Sink FDA 510(k) Clearance.Some of the highlights of this episode include:Mistake #1 - Inconsistency with Documentation: The intended use statement often is inconsistently put into other sections of the 510(k). It's important to understand the difference between indications for and intended use.Mistake #2 - Not Using Checklist: The FDA's 510(k) submission guidance provides a Refuse to Accept (RTA) checklist. Help yourself and reviewers out. The FDA states what it is going to do and what it wants, so there should be no surprises.Mistake #3 - Not Providing All Expected Testing: The FDA rarely accepts promissory commitments to do sterilization, validation, or biocompatibility testing later. Also, you should include protocols, results, and reports to verify rigorousness of testing.Mistake #4 - Not Doing Real-time Shelf-life Studies: FDA wants evidence to back up claims of stated shelf life and wants a correlation between real-time and accelerated aging data. Shelf life is what happens to your product in the future.Mistake #5 - Underestimating Risk Management Requirements: Show list of requirements and provide the paper trail for your traceability. The FDA needs to conclude that your product is safe and substantially equivalent to a predicate.Mistake #6 - Not Demonstrating Equivalence with Predicates: You need to depict your device as novel and unique, but not so different that the FDA thinks your predicate is not a good example.Mistake #7 - Formatting Submission Incorrectly: Include page numbers and an eCopy. Also, the size of the file matters and needs to be named according to conventions.Memorable quotes from this episode:“The intended use statement is a pretty important premise for any 510(k) submission because for all intents and purposes, that statement helps regulators and helps you determine how your product is ultimately going to be classified.” Jon Speer“One of the most common reasons why they are rejected is because the high-level labeling when it is repeated is not repeated exactly the same way.” Mike Drues“Intended use focuses on the device. Whereas, indications for use focuses on the patient.” Mike Drues“The RTA checklist was intended to be a tool for the FDA reviewer, when submission received, for them to go through and make sure all the constituent parts and components and what is expected to be in that submission is included.” Jon Speer“FDA reviewers see probably dozens, maybe hundreds of submissions in a finite period of time. Some are better than others. Well, make yours standout. Make yours easier to read.” Jon SpeerLinks:7 Common Mistakes That Sink FDA 510(k) ClearanceFDA - 510(k) Submission Process7 FDA Pathways to Bring Your Medical Device to MarketCenter for Devices and Radiological Health (CDRH)ISO 14971Mike Drues on LinkedInVascular SciencesGreenlight Guru AcademyMedTech Excellence CommunityGreenlight Guru

Have you done Corrective and Preventive Actions (CAPA) on your CAPA process? If not, you need to seriously consider doing so because CAPA is the #1 reason why companies get 483 observations year after year.In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues of Vascular Sciences about whether your medical device company's CAPA process needs a CAPA. Why are medical devices companies continuing to struggle with CAPAs?Some of the highlights of this episode include:Only 3-5% of adverse events of medical devices are actually reported to the manufacturer or FDA. People tend to report every little event as a CAPA or report nothing at all. The five most common reasons why the FDA issued 483 observations and warning letters over the last 5 years were CAPAs, customer complaints, purchasing controls, medical device reporting, and process validation.If CAPA is the #1 reason why companies are getting 483 observations and warning letters, it may be due to an ineffective quality management system (QMS).Things happen every day during the course of running a business. Processes and routines may not go routinely. When something happens unexpectedly, will it happen again? What are you changing to ensure it does not happen again?CAPAs continue be the #1 reason because people do not have a common sense understanding of the quality system regulation. They focus on the words, but do not try to understand the meaning.CAPAs often generate negative connotations—the process requires extra work and more resources, not in the budget, and time pressure. However, people should view CAPA's as an opportunity to improve a product and prevent problems in the future. People do not follow procedures because sometimes they don't even know that procedures exist, or those procedures are not updated/revised after events.Memorable quotes from this episode:“A CAPA is an opportunity to really do a deep dive investigation to determine, is there a systemic issue that is influencing that process that you are following?” Jon Speer “People don't focus on the common sensical understanding.” Mike Drues “Unless regulation makes sense, I don't care what the regulation is, unless it makes sense, it is not good regulation.” Mike Drues “Part of going through the CAPA procedure is to identify the root cause of the problem.” Mike Drues “Only 3-5% of adverse events of medical devices are actually reported to the manufacturer or to the FDA.” Mike DruesLinks:FDA - Corrective and Preventive Actions (CAPA)FDA - Form 483 Observations and Warning LettersFDA - Medical Device OverviewInternational Medical Device Regulators Forum (IMDRF)ISO 13485 CAPA21 CFR Part 820Mike Drues on LinkedInGreenlight Guru AcademyGreenlight Guru CommunityMedTech NationGreenlight Guru MedTech Lifecycle Excellence

After three “Refusals To Accept” Guidance Documents from the FDA, why are there still so many submission issues? Who's to blame? Learn from other people's mistakes. In this episode of the Global Medical Device Podcast, Jon Speer and Etienne Nichols talk to Mike Drues of Vascular Sciences about the FDA's Refusal to Accept (RTA) policy and guidance. Some of the highlights of this episode include:After the FDA receives a 510(k), De Novo, Pre-Market Approval (PMA), or any other submission, the 2-step process is to conduct an administrative and then a substantive/scientific review.If a submission is rejected on the administrative review, it is completely the company's fault, not the FDA's. If the substantive review is rejected, however, there's room for negotiation with the FDA.Most of the FDA's acceptance checklists have been available for more than a decade, but companies submissions are still commonly rejected on administrative review.Electronic tools and software platforms, such as eSTAR, are supposed to help and facilitate the preparation process of submissions. The problem is, this is contingent on what information is entered.Potential hangups for companies using tools like eSTAR for the submission process are that they do not evaluate the quality of the content entered. That said, they do require a Table of Contents and the use of most current forms.Never leave any sections of your submission blank. At the very least, enter Not Applicable (N/A) and explain why - or risk the FDA rejecting the submission. It's a company's responsibility to make sure the FDA understands their device.The draft guidance documents have been published for a reason - don't ignore them and risk a rejection for what could easily have been avoided. Memorable quotes from this episode:“If a submission gets rejected on an administrative review, that is 100% the company's fault, it is not FDA's fault.” Mike Drues“Approximately 60% of 510(k)s are rejected on RTA part of the administrative review.” Mike Drues“An eTool should help facilitate the process. However, caveat—it still is contingent on humans entering information.” Jon Speer“I would like the FDA to be just as careful with the claims that they put on their own website as they are when they are evaluating claims on a device coming in for a submission.” Mike Drues“One of the most common reasons why submissions are rejected is because a particular section is left out. Put yourself in the shoes of the reviewer. They have no idea why you are leaving out that section.” Mike DruesLinks:How To Avoid Having Your FDA Submission Rejected (And What To Do If It Is)Guidance: Refuse to Accept (RTA) Policy for 510(k)sGuidance: Acceptance Review for De Novo Classification RequestsGuidance: Acceptance and Filing Reviews for Premarket Approval Applications (PMAs)Acceptance Checklists for 510(k)sMedical Device User Fee Amendments (MDUFA)FDA - Voluntary eSTAR ProgramWhat is the eSTAR Pilot Program and How Will it Improve FDA's 510(k) Review Process?Mike Drues on LinkedInGreenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru AcademyGreenlight Guru CommunityGreenlight Guru

What are the differences between 3D printing and additive manufacturing? What are the quality and regulatory considerations around 3D printing? What is FDA's approach to whether or not this technology should be regulated?In this episode of the Global Medical Device Podcast, Jon Speer and Etienne Nichols talk to Mike Drues of Vascular Sciences about the pros and cons of 3D printing in the medical device industry and key considerations manufacturers should make with regard to this technology. Some of the highlights of this episode include:Although additive manufacturing and 3D printing are often used interchangeably, Mike explains that 3D printing is a very broad category with at least a dozen different technologies under that category, including additive manufacturing.FDA describes 3D printing as, “a process that creates a three-dimensional object by building successive layers of raw material. Each new layer is attached to the previous one until the object is complete.”Classic or traditional manufacturing is more subtractive than additive. What if the intended patient population is for one person, can a clinical trial be performed for validation? Additive manufacturing poses regulatory and quality challenges.FDA has sought input from the medical device industry, manufacturers, healthcare providers and facilities to explore appropriate regulatory approaches for Point-of-Care (PoC) 3D printing of medical devices.For example, Mike discusses that the regulation of today was not intended for 3D printing face masks and other protective gear. The lack of regulation should not hold back manufacturers from getting products on the market and through FDA.FDA, as well as Mike, recommends software certification for people using 3D printing in a controlled environment to make safe and effective products.Memorable quotes from this episode:“There's been now about 100, a little more, medical devices that have come through the FDA onto the market that have been 3D printed.” Mike Drues“The phrase, ‘additive manufacturing,' comes from the fact that many of these technologies, certainly not all, but many of them are based on layer-by-layer-by-layer technology.” Mike Drues“Additive manufacturing is 3D printing, but not all 3D printing is additive manufacturing.” Jon Speer“There's two ways you can do a validation. One way is to validate the product. The way we do clinical trials today is we essentially validate the product, but the other way we can do a validation is to validate the process.” Mike Drues“The blending of tech and med device, it's scary on one hand, but it can be exciting, as well. I'm looking forward to seeing how this impacts and hopefully improves our health care in the world.” Jon SpeerLinks:FDA - 3D Printing of Medical DevicesFDA - Technical Considerations for Additive Manufactured Medical Devices GuidanceFDA's Role in 3D PrintingFDA - Process of 3D Printing Medical DevicesFDA - 3D Printing Medical Devices at the Point of Care: Discussion PaperFDA - Classify Your Medical DeviceFDA - The 3Rs of 3D Printing: FDA's RolePART 820 - Quality System Regulation (QSR)Mike Drues on LinkedInGreenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru AcademyGreenlight Guru