Global Medical Device Podcast powered by Greenlight Guru

Odcinki

• 
  #474: Behind the QMSR Audits: The Top 5 FDA Citations & Risk Management Pitfalls 21.09.2026 33min

  In this episode of the Global Medical Device Podcast, host Etienne Nichols sits down with Nikhil Mangale, Vice President of Quality at Kapstone Medical, to discuss the real-world impact of the FDA's Quality Management System Regulation (QMSR). Seven months post-implementation, the industry is seeing actual inspection data that shifts the focus away from superficial documentation updates and directly onto core quality system operations.Nikhil breaks down the top five areas where the FDA is issuing citations under the new regulation: risk management, supplier controls, complaint handling, Unique Device Identification (UDI), and corrective actions. The discussion highlights how the industry spent years worrying about renaming documents like Design History Files (DHFs) to Design and Development Files (DDFs), yet inspectors are bypassing mere translation projects to evaluate how information flows across living quality processes.The conversation offers actionable guidance on conducting thorough, multi-layered gap assessments for both active and legacy products. Nikhil provides strategic advice for small companies and startups on prioritizing risk management, handling supplier audit visibility, navigating ISO 13485 alignment, and weighing the benefits of participating in programs like MDSAP.TakeawaysPrioritize Risk as a Living Process: Risk management must continuously integrate post-market feedback, complaint data, and nonconformances rather than remaining a static file archived after design release.Re-evaluate Supplier Audits for External Scrutiny: Routine supplier audit records are now accessible to FDA inspectors; ensure reports are well-documented, audit schedules are risk-proportionate, and findings are formally resolved.Implement a Three-Layer Mapping Strategy: Move beyond surface-level terminology updates (Layer 1) to establish subclause conformity (Layer 2) and verify operational evidence across interrelated processes (Layer 3).Maintain Open Design and Development Files (DDF): Unlike legacy DHFs that were closed at commercial launch, DDFs must remain active throughout the product lifecycle to evaluate ongoing design changes.Formulate a Defensible Quality Plan: When addressing gaps, document a risk-prioritized, sequential quality plan to show objective evidence of a structured compliance roadmap during an inspection.ReferencesFDA Compliance Program CP 7382.045: The FDA inspection guidance replacing QSIT, organizing surveillance around core QMS areas and specific regulations.ISO 13485:2016: The international standard for medical device quality management systems incorporated by reference into the FDA's QMSR.Etienne Nichols LinkedIn Profile - Connect with the host of the Global Medical Device Podcast.Feedback Call-to-ActionWe want to hear from you! What challenges are you experiencing with your QMSR implementation or risk management files? Send your feedback, reviews, or topic suggestions directly to [email protected]. We personally review and respond to every message from our listeners!SponsorsThis episode is brought to you by Greenlight Guru.
• 
  #473: The MedTech Odyssey: Bridging Academic Science to Series A Success 21.09.2026 42min

  The transition from academic research to commercial MedTech entrepreneurship requires a strategic mindset shift, particularly when navigating high-risk vascular innovations. Jordi Martorell, CEO and co-founder of Aortyx, shares his journey from mapping arterial blood flow at the Harvard-MIT Biomedical Engineering Center to developing bioresorbable endovascular patches for aortic dissection. Driven by a desire to solve true unmet medical needs, Martorell leveraged his background in fluid mechanics and vascular engineering to build a company capable of transforming clinical outcomes.Navigating early-stage funding outside major venture capital hubs presents unique structural challenges. Martorell explains how Aortyx sustained a multi-year development timeline prior to Series A by combining friends-and-family rounds, community equity crowdfunding, and non-dilutive European public grants. Maintaining radical transparency regarding investment risk and establishing clean cap table structures were critical components in maintaining investor trust over extended timelines.Securing a Series A round for a Class III medical device requires managing shifting macroeconomic landscapes, rising clinical costs, and complex regulatory pathways. Martorell reflects on the realities of negotiating with venture capital firms, facing unexpected round restructurings, and adapting to post-pandemic inflation across preclinical and clinical trial execution. The discussion highlights the importance of maintaining core product continuity while remaining flexible in execution strategy.TakeawaysValidate Unmet Needs Over Market Incrementalism: Avoid competing in saturated markets where large strategics only seek non-inferiority; focus R&D on clear, unaddressed clinical gaps.Structure Clean Cap Tables for Retail Capital: When utilizing equity crowdfunding or large groups of early individual investors, leverage syndication and SPVs to preserve a single point of negotiation for future institutional VCs.Prepare for Extended Series A Timelines: Deep-tech Class III devices can face multi-year fundraising cycles, requiring a multi-tiered capital strategy blending non-dilutive grants, bridge rounds, and follow-on commitments.Factor Post-Pandemic Inflation into Preclinical Budgets: Account for significant cost increases in animal studies, raw material procurement, and clinical trial execution compared to historical baseline estimates.ReferencesAortyx: Medical device company developing bioresorbable endovascular patches for aortic dissection repair.EIC Accelerator Program: European Innovation Council grant initiative providing non-dilutive funding to high-impact European startups.Capital Cell: Specialized health-focused equity crowdfunding platform based in Spain.Etienne Nichols: LinkedIn ProfileFeedback Call-to-ActionWe want to hear from you. What were your key takeaways from this episode? Do you have topics or guest suggestions for future discussions? Send your thoughts, feedback, and questions directly to [email protected]. Every email is reviewed by our team to help shape upcoming episodes.SponsorsThis episode is brought to you by Greenlight Guru. Learn how Greenlight Guru's modern QMS and EDC software can support your medical device journey at greenlight.guru.
• 
  #472: Cost Containment: Right-Sizing Medical Device Cybersecurity with Chris Gates 21.09.2026 40min

  Medical device cybersecurity is no longer an optional feature or a last-minute checkbox prior to market entry. Hosted by Etienne Nichols, this episode features Chris Gates, founder and CEO of arsMedSecurity, who delivers a practical, engineering-first perspective on embedding security directly into the development lifecycle. Gates highlights that deferring cybersecurity efforts until the end of development leads to severe financial penalties, extended regulatory delays, and potential company failure.The discussion demystifies common misconceptions held by executive teams and "bean counters," such as the myth that off-network devices or small companies are exempt from cyber threats. Under current FDA expectations and the eStar submission process, any medical device containing software is subject to stringent pre-market cybersecurity requirements. Gates illustrates how unexpected 180-day regulatory holds impact a company's daily burn rate, showing that proactive security measures are far cheaper than reactive fixes.Looking ahead, the conversation explores the evolving threat landscape driven by Large Language Models (LLMs) and advanced exploits that reduce vulnerability exploitation windows from years to minutes. Gates provides concrete steps for medical device manufacturers to take control of their product security, emphasizing early threat modeling, continuous risk management, and the alignment of software development SOPs with recognized international standards.TakeawaysCalculate Delay Impact via Burn Rate: Evaluate cybersecurity risk against your organization's daily burn rate multiplied by a potential 180-day FDA submission delay to understand the true financial cost of non-compliance.Software Triggers Cyber Requirements: Do not assume a device is exempt from cybersecurity requirements because it lacks active internet connectivity; any device running software falls under FDA pre-market expectations.Perform Threat Modeling Before Hardware Freeze: Execute system-level threat modeling (e.g., STRIDE methodology) during the initial design phase before finalizing active hardware components and component selections.Adopt Recognized SDLC Standards: Establish standard operating procedures (SOPs) that map secure development activities directly to ISO/IEC 81001-5-1 and ISO 62304 frameworks.ReferencesMedical Device Cybersecurity for Engineers and Manufacturers (2nd Edition): Practical reference handbook authored by Chris Gates detailing implementation techniques for device developers.ISO/IEC 81001-5-1: Health software and health IT systems safety, effectiveness, and security standard for secure development lifecycles.STRIDE Threat Model: A system decomposition methodology developed by Microsoft to identify data-in-motion and data-at-rest security threats per system element.Host LinkedIn Profile: Connect with Etienne Nichols on LinkedIn.Feedback Call-to-ActionWe want to hear from you! What cybersecurity challenges is your team currently navigating during product development? Send your questions, feedback, or topic suggestions directly to us at [email protected]. Every email is reviewed by our team, and we regularly incorporate listener-submitted questions into upcoming episodes and expert Q&A segments.SponsorsThis episode is brought to you by Greenlight Guru.
• 
  #471: From AI Visuals to FDA Approval: Fixing MedTech’s Design-to-Market Gap 21.09.2026 38min

  Many MedTech startups and innovators focus heavily on core technology development, often assuming physical product design is simple polishing once a working concept exists. Michael Sprauve explains that this approach frequently creates a gap between brilliant engineering and a market-ready, commercially viable medical device. Succeeding in hardware requires looking past the technology to consider every individual who will interact with the device throughout its entire lifecycle.A critical challenge in MedTech design is managing the complex web of user personas involved. Unlike consumer electronics, where design caters to one or two primary end users, medical devices must meet the needs of surgeons, operating room staff, post-surgical nurses, maintenance technicians, disposal personnel, and regulatory bodies. Overlooking support staff—such as nurses managing crowded, alarm-fatigued rooms or technicians handling biological waste and lithium-ion batteries—can derail an otherwise promising device.As AI image generation tools become widespread, creators increasingly present AI-rendered concepts as finished designs. While these tools offer creative inspiration, they lack awareness of physical constraints, manufacturing rules, and real-world usability. By establishing a non-physical "North Star" based on emotional attributes and sensory cues, design teams can guide products through concepting, engineering, and manufacturing without losing sight of user needs and regulatory mandates.TakeawaysMap the Entire User Lifecycle: Design for every individual who touches the product, from the operating surgeon to the maintenance nurse, sterilization technician, and waste handler.Mitigate Alarm Fatigue Early: Ensure auditory and visual indicators comply with FDA standards while avoiding chaotic, high-stress clinical environments caused by competing alerts.Establish a Non-Physical North Star: Use emotional and sensory attributes to anchor design, engineering, and CMF (Color, Material, Finish) choices, keeping the project aligned across development stages.Involve Manufacturing Engineers from Day One: Incorporate Design for Manufacturability (DFM) considerations during initial concept phases rather than waiting until design freeze to prevent expensive re-tooling and regulatory delays.ReferencesSpeck Design: Hardware design and engineering firm specializing in taking complex medical and life science concepts to market.Intuitive Surgical (DaVinci & Ion Platforms): Advanced robotic-assisted surgical systems highlighting high-precision hardware requirements discussed in the episode.Microport MedBot (Toumai System): Four-arm laparoscopic surgical robot referenced as a key benchmark for international regulatory clearances.Etienne Nichols' LinkedIn: Etienne Nichols on LinkedInFeedback Call-to-ActionWe want to hear from you! What challenges have you faced when balancing user feedback against clinical and regulatory requirements? Send your thoughts, topic suggestions, or questions to [email protected]. Every email goes directly to our team, and we personally review listener notes for future episodes.SponsorsThis episode is brought to you by Greenlight Guru.Learn more at greenlight.guru.
• 
  #470: The Real Cost of MedTech Innovation: From Idea to Pre-Production with Lisa Voronkova 22.09.2026 39min

  Building a medical device rarely follows the smooth, predictable trajectory presented in investor pitch decks. While regulatory consultants often default to "it depends," medical device teams require concrete figures regarding engineering hours, calendar timelines, and budget allocations to bring a concept to market safely and effectively.Lisa Voronkova, co-founder of OVA Solutions, draws on a dataset from developing over 200 medical devices to pull back the curtain on hardware engineering realities. She outlines the four structured phases of engineering—Discovery, Proof of Concept, Design, and Development—explaining how disciplined phase-gate management mitigates costly late-stage redesigns and protects capital.The conversation dives into transparent, real-world case studies ranging from short pre-production hardware tracks to complex, multi-year continuous glucose monitor (CGM) developments. Lisa and host Etienne Nichols explore the true financial scope of Design for Manufacturability (DFM), realistic blended hourly rates across global markets, and why shortcuts in early contextual validation often lead to catastrophic manufacturing overhead.TakeawaysPhase-Gate Discipline Controls Financial Risk: Moving into high-cost tooling or manufacturing before proving core function in a low-fidelity mock-up risks turning a $1,500 prototype adjustment into a $150,000 production mold tool rework.Validate in the Real Operating Environment: Conducting customer interviews is insufficient if engineers do not observe the actual clinical setting; lighting conditions, sterile field constraints, and physical workflows dictate foundational hardware requirements.Benchmark Engineering Hours accurately: Standard hardware projects generally fall into three tiers: 2,000–3,000 hours for simple electronics integrations, 5,000–6,000 hours for multi-system electro-mechanical devices, and 10,000–30,000+ hours for high-complexity Class II/III systems (e.g., CGMs, surgical robotics).DFM Accounts for a Massive Secondary Investment: Completing the initial "golden sample" prototype is only half the engineering journey; preparing a device for mass production (assembly sequences, test fixtures, second-sourcing components) can demand an additional 2,500 to 7,000+ engineering hours.ReferencesOVA Solutions: Engineering group specializing in full-cycle medical device design, electronics, and firmware development.The Hardware Bible: Book authored by Lisa Voronkova detailing practical expectations and framework strategies for medical device development.Host LinkedIn: Connect with Etienne Nichols on LinkedIn for ongoing discussions with MedTech industry leaders.Feedback Call-to-ActionWe want to hear from you! What was your biggest takeaway regarding medical device engineering budgets and timelines? Have a guest recommendation or a topic you want us to dissect in an upcoming episode?Send your feedback, reviews, and topic suggestions directly to [email protected]. Etienne reads every message and responds personally to our listeners!SponsorsThis episode is brought to you by Greenlight Guru.Learn more at www.greenlight.guru.
• 
  #469: Why Market Strategy Comes First in MedTech Development 21.09.2026 39min

  Medical device startups frequently fall into the trap of developing complex technology first, only to struggle downstream with clinical adoption, regulatory hurdles, and reimbursement. In this episode, host Etienne Nichols sits down with Shai Policker, Managing Partner at Edge Medical Ventures, to explore why reversing this traditional paradigm leads to sustainable, category-defining products.Policker details how working backward from validated clinical needs—identified directly by multinational corporations, physicians, and health systems—allows developers to map out the regulatory and reimbursement landscapes before building the first prototype. By addressing the commercial critical chain early, ventures avoid costly mid-development pivots and align technical innovation with true market demand.The conversation covers real-world portfolio examples, including non-invasive urodynamics and smart surgical drains, demonstrating how focused differentiation transforms clinical workflows and patient outcomes. Policker also shares key insights into helping international MedTech companies navigate the nuances of the US healthcare system.TakeawaysValidate Reimbursement Before Prototyping: Map existing CPT/HCPCS codes, coverage policies, and economic incentives prior to freezing design specifications.Leverage Strategic Partnerships Early: Engage R&D, sales, and clinical leaders at strategic corporations to identify validated gaps in three-to-five-year commercial pipelines.Target Dramatic Outcome Improvements: Focus engineering efforts on innovations that yield step-function clinical improvements rather than incremental 5% gains.Preserve Familiarity for Pathways: Design physical devices to deliver game-changing outcomes while maintaining predicate-equivalent forms to fit existing 510(k) cleared classes and billing mechanisms.Evaluate the Full Critical Chain: Ensure every element—referral patterns, physician time, hospital economics, regulatory constraints, and patient compliance—is fully solved before committing venture capital.Essential ReferencesEdge Medical Ventures: Venture creation firm focused on category-defining medical device companies built around validated strategic needs.Etienne Nichols LinkedIn: Connect with podcast host and MedTech community leader Etienne Nichols.Feedback & CommunityWe want to hear from you! What was your biggest takeaway from Shai Policker's approach to venture creation? Do you have topic suggestions or guests you would like to see on the show?Send your thoughts, feedback, and questions directly to the team at [email protected]. Every email receives a personalized response from our team!Episode SponsorsThis episode is brought to you by Greenlight Guru, the only MedTech lifecycle management platform purpose-built for medical device companies.Learn how to accelerate your medical device journey at www.greenlight.guru.
• 
  #384: Insights from an Ex-FDA Investigator: Compliance, Quality Systems, and MedTech Trends 26.09.2024 44min

  In this episode of the Global Medical Device Podcast, host Etienne Nichols sits down with Vincent Cafiso, Director of Quality and Regulatory Services at Creo Consulting and former FDA investigator. Vincent brings 30 years of life sciences and regulatory expertise, offering a unique perspective on navigating FDA inspections, building robust quality systems, and managing innovation within the MedTech industry. They dive deep into the challenges faced by MedTech companies, particularly small startups, and how to balance regulatory requirements with creativity and innovation. Vincent also highlights the common pitfalls companies encounter with design controls and shares strategies to ensure R&D and production teams work in harmony.Key Timestamps:[00:01] – Introduction: Vincent Cafiso’s background as an FDA investigator and transition into industry.[04:15] – Crayo Consulting’s Scope: How Creo Consulting supports MedTech companies from launch strategy to compliance.[12:40] – Bridging R&D and Production: Overcoming challenges when R&D environments don’t align with production standards.[19:50] – Top Trends in Quality Systems: Addressing documentation gaps and missing standards in design history files.[27:10] – Management’s Role in Supporting Quality: The importance of management’s involvement in enforcing quality controls and processes.[38:30] – From FDA to Industry: How Vincent’s FDA background influences his approach to quality and compliance.[54:25] – Skip-Level Meetings and Breaking Silos: Enhancing collaboration and communication within large organizations.[1:06:00] – Final Takeaways and Advice: Building a culture of quality and fostering innovation while staying compliant.Key Quotes:“The regulations are written for tongue depressors and pacemakers—two very different devices. It’s up to the companies to interpret how to apply those rules to their specific products.” – Vincent Cafiso“Documentation shouldn’t just be a checkbox for submission. There’s a lot more innovation happening that doesn’t make it onto paper because companies don’t realize its value.” – Vincent CafisoKey Takeaways:1. MedTech Trends:Alignment of R&D and Production: Ensure that testing environments and protocols in R&D align with the standards of production to avoid costly discrepancies and rework.Regulatory Understanding Across Teams: Companies need to educate teams on the specific regulatory standards that apply to their product types to avoid misinterpretation and gaps in compliance.Cross-Departmental Collaboration: Maintaining a startup-like collaborative culture, even as the company scales, is crucial for innovation and quality.2. Practical Tips for MedTech Professionals:Integrate Quality Early: Implement quality controls and validation processes at the R&D stage to avoid repeating tests or redesigns during production.Leverage Skip-Level Meetings: Encourage direct communication between upper management and employees for better understanding and faster issue resolution.Document Everything: Don’t treat documentation as a formality. Capture all the engineering studies and real data to support design decisions and regulatory submissions.3. Questions for Future Consideration:How can large organizations maintain the flexibility and collaborative spirit of a startup?What creative approaches can be used to align R&D and production standards in smaller companies?What role will emerging technologies like AI and IoT play in shaping future regulatory landscapes?References:Vincent Cafiso on LinkedInEtienne Nichols on LinkedInCreo Consulting: Vincent Cafiso’s current company offering regulatory and quality services to MedTech organizations.FDA Guidance on Design Controls: Essential reading for understanding how to document and verify design history files.Greenlight Guru's EQMS Software: A quality management system built specifically for the MedTech industry, aiding in compliance and product development.Connect with Etienne Nichols on LinkedIn.MedTech 101:What is FDA Inspection Readiness?FDA inspection readiness refers to the ongoing state of compliance and preparedness for an FDA audit or inspection. It involves having robust quality systems, complete documentation, and trained personnel to demonstrate adherence to applicable regulations and standards. This ensures that a company can efficiently respond to any FDA inquiries and avoid costly delays or compliance issues.What are Design Controls?Design controls are a set of quality practices and procedures integrated into the product development process to ensure that medical devices meet user needs, intended uses, and specified requirements. They include stages like design planning, design inputs and outputs, verification, validation, and design transfer.Poll for the Audience:What is the biggest challenge your MedTech company faces when preparing for FDA inspections?a) Documentation and record-keepingb) Cross-departmental communicationc) R&D and production alignmentd) Understanding complex regulationsShare your answer and thoughts by emailing us at [email protected]!Feedback:Did you enjoy this episode? Leave us a review on iTunes and share your thoughts! Your feedback helps us improve and curate content that matters most to you. Feel free to email us at [email protected] with any suggestions for future topics or guest recommendations.Sponsor Segment:This episode is brought to you by Greenlight Guru, the only quality management software designed by MedTech professionals for MedTech companies. With a robust EQMS platform, Greenlight Guru helps streamline compliance and innovation processes, ensuring faster market access and safer medical devices. Visit greenlight.guru to learn more and schedule a demo today!
• 
  #466: Leaving the Ivory Tower - How Notified Body Engagement Unlocks Startup Growth 27.07.2026 31min

  Many early-stage medical device founders face a major dilemma: how do you prove regulatory maturity to investors and partners before you actually hold a final CE mark or FDA approval? Waiting until the end of a long development cycle creates significant commercial risk. By treating regulatory readiness as a continuous maturity process rather than an all-or-nothing milestone, startups can build trust early and avoid costly late-stage surprises.In this episode, host Etienne Nichols sits down with Malte Knowles Schmidt, Global Portfolio Lead for Medical Device Software, AI, and Cybersecurity at TÜV SÜD. Drawing from his background as an ICU nurse, an R&D product leader for Class III cardiac implantables at Biotronik, and now a notified body leader, Malte breaks down how startups can step out of their silos. He emphasizes that notified bodies and medical device companies must both "leave the ivory tower" to establish practical, real-world communication long before a formal audit occurs.The conversation explores concrete strategies for demonstrating regulatory maturity during development, including standing up an enterprise Quality Management System (eQMS), securing partial ISO 13485 certification for core design processes, and leveraging external testing as strategic "breadcrumbs." Malte also cautions founders against chasing "Pyrrhic certifications"—winning regulatory approval at the cost of commercial viability—and shares practical guidance on when and how to initiate early structured dialogues with notified bodies.Key Timestamps00:00 - 02:15 | Introduction to the "Regulatory Ivory Tower"Etienne introduces guest Malte Knowles Schmidt and sets up the challenge of proving regulatory maturity early in the startup lifecycle.02:16 - 05:04 | Why Communication Gap Exists Between Startups & Notified BodiesMalte discusses why structured dialogues often feel too abstract for founders and why concrete examples are needed to make early engagement approachable.05:05 - 08:30 | Defining Regulatory Maturity & The Agile QMSExploring how investors view regulatory progress, why build-measure-learn mindsets belong inside a QMS, and how an eQMS acts as a foundational framework.08:31 - 12:10 | Unlocking Value Through Partial ISO 13485 CertificationA breakdown of how certifying core design and development processes early builds commercial credibility and attracts investor funding before full scope audits.12:11 - 16:45 | Leveraging External Testing & Avoiding "Pyrrhic Certifications"How penetration testing and biocompatibility act as evidence breadcrumbs, plus the trap of sacrificing commercial viability just to get a certificate.16:46 - 20:30 | When and How to Initiate Contact with a Notified BodyPractical advice for founders on overcoming the fear of reaching out, preparing essential homework (intended purpose, risk classification), and taking the first step.Quotes"A Pyrrhic certification comes from a Pyrrhic victory, where you win the battle, but the losses are so great that the victory is basically meaningless... startups make the certification their core goal and not the commercial success." - Malte Knowles Schmidt"If you're asking yourself the question, 'Should I be talking to a notified body?'—then stop right there, because the answer is yes." - Malte Knowles SchmidtKey TakeawaysEstablish Early Regulatory Breadcrumbs: Investors want to see continuous progression. Utilizing an eQMS, conducting third-party testing (e.g., penetration or biocompatibility testing), and mapping regulatory roadmaps provide tangible proof of maturity long before final approval.Consider Partial ISO 13485 Certification: Startups do not need to wait for full scope certification. Certifying core design and development processes first demonstrates organizational discipline and can unlock major funding rounds.Avoid the Pyrrhic Certification Trap: Do not sacrifice your core business model or reduce critical product capabilities solely to make certification easier. Always align regulatory strategy with ultimate commercial viability.Treat Your QMS as an Agile System: Quality management is not a static set of restrictive rules; it is an iterative framework that should evolve alongside your product and team processes.Initiate Dialogue Early: Notified bodies are accessible for preliminary discussions. Reaching out early helps validate your intended purpose, risk classification, and submission assumptions before sinking capital into the wrong pathway.ReferencesWhite Paper: Leaving the Regulatory Ivory Tower: How Early Notified Body Dialogues Reduce Business Risk by Malte Knowles Schmidt (TÜV SÜD).ISO 13485 Standard: Quality management systems requirements for regulatory purposes in the medical device sector.Host LinkedIn: Etienne Nichols on LinkedInMedTech 101 SectionPyrrhic Certification: Named after King Pyrrhus of Epirus, whose army won a battle against the Romans but suffered devastating losses in the process. In MedTech, a Pyrrhic certification occurs when a company successfully gets a medical device certified, but had to compromise so many features, intended uses, or commercial claims during the process that the resulting product has no real value in the market.Notified Body: An independent organization designated by an EU member state to assess whether a medical device complies with applicable regulatory standards (such as EU MDR) before it can be placed on the European market. Think of them as accredited referee agencies that verify safety and performance.Partial ISO 13485 Certification: Instead of waiting until an entire company, manufacturing line, and distribution network are fully operational to get audited, a company can undergo a certified audit specifically for a limited scope—such as its initial design and development processes.Feedback Call-to-ActionWe love hearing from our listeners! Did this episode change how you view early engagement with notified bodies? Do you have questions about implementing an eQMS or navigating partial ISO certification?Send your thoughts, topic requests, or guest recommendations directly to [email protected]. We read every message and respond personally to our community!SponsorsThis episode of the Global Medical Device Podcast is brought to you by Greenlight Guru.Navigating the regulatory landscape requires a solid foundation built on quality and clear clinical evidence. Greenlight Guru provides the only dedicated eQMS (Quality Management System) and EDC (Electronic Data Capture) platform purpose-built for medical device and software-as-a-medical-device (SaMD) companies. Whether you are aiming for partial ISO 13485 certification, setting up your first design controls, or running clinical trials to collect vital regulatory breadcrumbs, Greenlight Guru helps you scale efficiently while keeping you audit-ready. Learn more about how Greenlight Guru's modern QMS and EDC solutions can accelerate your path to market at www.greenlight.guru.
• 
  A Special Glimpse into Medtronic's Recent Developments in Spine & Biologics Technology 17.11.2021 17min

  Do you want to alleviate pain, restore health, and extend patients’ lifespan? Accelerate the transformation of the spine industry by making outcomes and technologies standardized and reproducible.In this episode of the Global Medical Device Podcast Jon Speer talks to Carlton Weatherby, Vice President and General Manager of Spine and Biologics at Medtronic. Listen to Carlton discuss recent developments in spine and biologics technology at Medtronic, a global healthcare technology leader tackling the most challenging health problems with innovative medical devices that transform patient lives.Some of the highlights of this episode include:The spine business is an untapped opportunity that can impact patients across the globe with technology solutions being developed by Medtronic.Would you rather live with back pain or have surgery? Basic spine surgery has advanced and improved, but there’s still a wide variability in the outcomes based on where patients live, training of the surgeons, and technologies used.Surgeons have more confidence and patients have more confidence in the surgeons as they identify a path to improve the patient’s condition, alleviate their pain, and perform a procedure to achieve greater outcomes.The golden age of medical devices due to innovation has made the regulatory environment more willing to collaborate. Regulators and the medical device industry try to help patients, but agree that there’s still room for improvement.Through partnership, acquisition, and organic development, Medtronic already has the assets and pieces to determine if surgery makes sense for patients.Medtronic has brought new products to the market to replace invasive spine surgery. An open procedure versus a minimally invasive surgery (MIS) takes more time and has more complications.Medtronic is bigger than most, and 80% of medical device companies have 50 or fewer employees. Startups dream about an acquisition. Carlton advises them to start with a clinical value proposition connected to a clinical need for customers.Memorable quotes from Carlton Weatherby:“Spine is very much an untapped opportunity in terms of the impact it can have on patients across the globe with technology solutions like the ones we’re developing.” “It’s still more of an art than a science and that’s where the opportunity lies.” “Areas of technology advancements that we’re making allow us to support our surgeons to instill the confidence that they have going into it and especially their patients.” “When you integrate new technologies, it’s not easy, especially if those technologies don’t talk together. That’s where an ecosystem truly becomes valuable.” Links:Carlton Weatherby on LinkedInMedtronicMedtronic Spine SurgeryMedtronic Minimally Invasive Spine Surgery (MIS+)Greenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitMedTech True Quality Stories PodcastGreenlight Guru YouTube ChannelGreenlight Guru
• 
  Developing a Regulatory Strategy 23.11.2022 43min

  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
• 
  #365: Medical Device Reporting: The Do's and Don'ts 07.05.2024 40min

  In this episode, Lisa Van Ryn, a seasoned expert from Greenlight Guru, shares her extensive knowledge on the FDA’s Medical Device Reporting (MDR). We unpack the nuances of when and how to report incidents, the definition of serious injuries, and the importance of effective complaint management systems. Lisa provides practical advice on setting up robust reporting processes and explains how manufacturers can avoid common pitfalls.Key Timestamps:[01:20] Introduction of Lisa Van Ryn and discussion on FDA's Medical Device Reporting[05:45] Lisa's transition from the restaurant industry to medical devices[10:30] What triggers a medical device report to the FDA?[15:25] Role-play on handling complaints and determining reportability[25:00] Detailed explanation of the decision tree for reporting[35:15] Differentiating between device malfunctions and serious injuries[40:10] Real-life examples and clarifying complex reporting scenarios[50:30] The repercussions of late reporting and the importance of timing[55:20] Wrapping up and resources for deeper understandingInsightful Quotes:"Every complaint needs to be evaluated to determine if it is reportable under 21 CFRR Part 803." - Lisa Van Ryn"Having a beginner’s mindset but the heart of a teacher is essential in the medical device industry." - Etienne Nichols"If you’re not considering the feedback as important, whether it’s reportable or not, you are missing valuable data." - Lisa Van RynKey Takeaways:Understanding MDR: The importance of being thoroughly familiar with Medical Device Reporting guidelines to ensure proper reporting and compliance.Setting Up Processes: Tips on setting up an effective complaint handling system to manage and report incidents correctly.Common Pitfalls: Common issues manufacturers face and how to avoid them by implementing efficient and compliant processes.References and Resources:Medical Device Reporting (MDR): How to Take Advantage of Your Electronic RecordsLisa Van Ryn on LinkedInEtienne Nichols on LinkedInBeginner’s Section: MedTech 101Medical Device Reporting (MDR): This refers to the regulatory process in which manufacturers are required to report certain types of incidents and malfunctions related to medical devices to the FDA.Serious Injury: A serious injury in the context of MDR is defined as an injury that is life-threatening, results in permanent impairment, or necessitates medical or surgical intervention to prevent permanent damage.Complaint Handling: The process by which manufacturers receive, review, and respond to customer complaints about the safety and quality of their medical devices.Questions for the Audience:Poll: Do you believe current regulations on medical device reporting are sufficient for ensuring patient safety?Feedback Request:We value your thoughts! Please leave us a review on iTunes and share your feedback. Your suggestions help us improve and guide our future topics. Email your thoughts and topic suggestions to [email protected]:This episode is brought to you by Greenlight Guru, a leading platform that offers MedTech companies a comprehensive quality management software, designed to help navigate the complex landscape of medical device regulations.Connect with Etienne Nichols:Enhance your professional network by connecting with our host, Etienne Nichols, on LinkedIn!For more resources and information, visit the Global Medical Device Podcast page.
• 
  #445: ISO 10993-1:2025: What Risk-Based Biocompatibility Means for MedTech 02.02.2026 37min

  In this episode, Etienne Nichols sits down with Thor Rollins, a leader at Nelson Labs and the convener of the committee revising ISO 10993-1. The conversation centers on the newest 2025 version of the standard, which represents a massive philosophical shift from a "checkbox" testing mentality to a rigorous, risk-based approach aligned with ISO 14971.Rollins explains that modern medical devices are far more complex than the metal and hard plastics of the past. With the rise of degradable materials, coatings, and nanomaterials, traditional animal testing often fails to provide the best science. The new standard introduces critical concepts such as biological risk estimation, foreseeable misuse, and a comprehensive lifecycle evaluation that looks beyond "time zero" safety.The duo also discusses the practical implications for manufacturers, including the controversial requirement to evaluate biocompatibility at the end of a product's lifecycle—a particular challenge for reprocessed devices. Rollins provides insider knowledge on the US’s stance on the revision, the timeline for FDA recognition, and how companies can leverage biological equivalence to potentially reduce their testing burden.Key Timestamps01:45 – The shift from "checkboxing" to a risk-based approach.03:10 – The rapid timeline of the 2025 revision and the influence of ISO 14971.04:22 – Lifecycle Evaluation: Assessing safety beyond the "brand new" state.06:50 – Chronic toxicity vs. acute reactions: Why front-end evaluation matters.08:15 – Foreseeable Misuse: When doctors use scopes outside their intended anatomy.12:10 – The concept of Bioequivalence: Using existing data to justify reduced testing.13:45 – Breakthrough: The removal of material-mediated pyrogenicity testing for known materials.15:30 – Why the US voted "No" on the current draft: A call for better guidance.18:50 – Notified Bodies and MDR: The 2025 version as "State of the Art."21:15 – Practical chemistry tests for aging polymers (DSC, GPC, FTIR).25:40 – Advice for small vs. large companies on building material databases.Quotes"The testing that we developed back in the 50s and 60s actually doesn't really work the best with some of these complex devices... we've been moving the standard away from what we call checkboxing." - Thor Rollins"I only say that expensive tests always impact innovation. We don't want to over-test, but we want to do the right tests." - Thor RollinsTakeawaysLifecycle is the New Frontier: You must now evaluate biocompatibility throughout the product's life, especially for reprocessed devices that may degrade after hundreds of cleaning cycles.Foreseeable Misuse is a Regulatory Reality: If it is likely a clinician will use your device off-label (e.g., a pulmonary scope used in vascular applications), you must account for that biological risk in your assessment.Leverage Bioequivalence: Stop testing the same stainless steel or titanium repeatedly. Use existing data and internal databases to justify "no testing" for known materials and processes.Partner with Expertise: Because the standard is less prescriptive and more risk-based, the quality of your Biological Evaluation Plan (BEP) depends entirely on the expertise of the person writing it.Chemistry over Animals: Whenever possible, use chemistry (Extractables & Leachables) and in vitro methods to replace legacy animal tests, as the 2025 revision officially begins to phase out certain animal-based requirements.ReferencesISO 10993-1:2025: The primary global standard for the biological evaluation of medical devices.ISO 14971: The standard for the application of risk management to medical devices, now heavily integrated into 10993-1.Nelson Labs: The laboratory where Thor Rollins leads biocompatibility strategy.Etienne Nichols: Connect with Etienne on LinkedIn.MedTech 101: BioequivalenceThink of bioequivalence like buying a generic medication versus a brand-name one. If you know the ingredients (materials) and the way they are manufactured (processes) are identical to a device that has already been proven safe on the market, you shouldn't have to re-run expensive, time-consuming tests. In MedTech, this means showing that your "New Device B" is biologically the same as your "Proven Device A" because they use the same grade of titanium and the same sterilization method.SponsorsThis episode is brought to you by Greenlight Guru. As the industry shifts toward a risk-based approach as seen in ISO 10993-1:2025, having a centralized source of truth is vital. Greenlight Guru's QMS (Quality Management System) allows you to integrate risk management directly into your design process, while their EDC (Electronic Data Capture) solution helps you gather the clinical evidence needed to prove long-term safety. When your risk assessments and clinical data live in the same ecosystem, "state of the art" compliance becomes a standard, not a struggle.Feedback Call-to-ActionWe want to hear from you! How is your team preparing for the 2025 revision of ISO 10993-1? Are you concerned about the lifecycle evaluation requirements? Send your thoughts, questions, or topic suggestions to [email protected]. We read every email and love providing personalized responses to our community.
• 
  #441: ICYMI (In Case You Missed It!) How Artificial Intelligence is Impacting the MedTech Industry 12.01.2026 45min

  In this episode, Etienne Nichols and guest Ashkon Rasooli explore the transformative impact of AI in the medical device industry. From AI-driven diagnostics and wearable health monitors to the future of surgical robots, they delve into how these technologies are reshaping healthcare. The discussion also touches on the challenges and opportunities in validating and regulating AI within MedTech, highlighting real-world applications and predicting future trends."Validation of AI tools in MedTech requires a staged adoption to build confidence due to the inherent uncertainty in AI outcomes." - Ashkon Rasooli00:00 - Introduction to AI in MedTech05:15 - Discussing AI's deterministic vs. statistical nature12:30 - AI in diagnostics: Radiology, Cardiology, and Neurology20:45 - Wearable health monitors and patient-driven health data28:10 - The role of AI in medical device operations and manufacturing35:00 - AI at the point of care: Enhancing patient and clinician experience42:15 - Regulatory challenges and the future of AI in healthcareKey Takeaways:1. Latest MedTech Trends:The integration of AI in diagnostics is growing, particularly in radiology, cardiology, and neurology, aiding in more accurate and quicker diagnoses.Wearable health monitors are empowering patients to take control of their health data, leading to personalized healthcare solutions.2. Practical Tips for MedTech Enthusiasts:Stay informed about the latest AI advancements and regulatory guidelines to leverage AI effectively in MedTech.Consider the ethical implications and ensure bias mitigation in AI model training and deployment.3. Predictions for the Future:Increased adoption of AI across various healthcare sectors, including surgery and patient care management.Evolution of regulatory frameworks to better accommodate and oversee AI-driven medical devices.References:Ashkon Rasooli on [email protected] SolutionsAFDO/RAPS Working GroupEtienne Nichols on LinkedInSponsors:This episode is brought to you by Greenlight Guru, a comprehensive solution designed to streamline MedTech product development and ensure regulatory compliance. Discover how Greenlight Guru can accelerate your projects at www.greenlight.guruShare your thoughts and questions with us at [email protected]
• 
  #346: FDAs eSTAR Program 30.11.2023 47min

  This episode of the Global Medical Device Podcast delves into the world of FDA submissions, specifically focusing on the eSTAR program. Host Etienne Nichols leads an insightful discussion exploring the intricacies, benefits, and strategies for using eSTAR effectively in medical device regulatory submissions.To discuss this topic, we brought in the following experts:Patrick Axtell, Ph.D., the Senior Tools & Templates Engineer for the Office of Regulatory Products at CDRHLisa Pritchard, Vice President of Regulatory, Quality, Clinical and Engineering at DuVal & AssociatesKathy Herzog, Senior Regulatory, Quality & Compliance Consultant at DuVal & AssociatesAs of now, all 510K submissions must use the eSTAR program. eSTAR is designed to streamline the FDA submission process, making it more efficient and standardized. This episode is a must-listen for anyone in the medical device industry looking to navigate the complexities of FDA submissions with a focus on the evolving eSTAR program.Expert Insights:Patrick Axtell: Discusses the development of the eSTAR program, its purpose, and benefits, including standardization and automation in the submission process.Lisa Pritchard: Shares her 30-year experience in regulatory space and her initial skepticism about eSTAR, which later transformed into advocacy for the program.Kathy Herzog: Provides practical advice on using eSTAR, emphasizing the importance of understanding and navigating the program effectively.Key Strategies:Use the help features within eSTAR as a quality control check.Start at the beginning of the template to avoid missing critical sections.Prepare your submission content outside eSTAR before populating the template.Consider the executive summary as a mandatory, not optional, part of your submission for effective advocacy.Future of eSTAR: eSTAR is evolving to include more types of submissions (e.g., PMAs, presubs) and may soon incorporate AI and other technological advances for enhanced efficiency.Quotes:"Standardized submission means that the reviewer can quickly find information...a huge benefit for both applicants and reviewers." - Patrick Axtell"Even after 30 years, I always open those help boxes in eSTAR...each submission is unique." - Lisa Pritchard"The key with eSTAR is eSTAR(t). You just have to get started...no substitute for just getting familiar with the template." - Kathy HerzogReference Links:Lisa PritchardKathy HerzogEtienne NicholsGreenlight GuruDuVal & AssociatesClient Alert: "eSTAR & I"FDA eSTAR Program webpageFDA electronic Submission Template guidance for 510(k) SubmissionsFDA electronic Submission Template guidance for De Novo SubmissionsYouTube video of FDA REdI Conference presentation on eSTAR by Lili Duan*Interested in sponsoring an episode? Use this form and let us know!
• 
  #345: Using AI In MedTech 22.11.2023 24min

  In this episode, we delve into the burgeoning world of artificial intelligence in MedTech. Listen as we discuss the skepticism and opportunities associated with AI, the revolutionary impact on product development, and provide practical advice for professionals looking to harness AI's potential. Wade Schroeder, Medical Device Guru for Greenlight Guru, shares his expertise on MedTechs AI-powered tools that are redefining risk management and compliance. With a keen focus on the AI in MedTech Trend report, this conversation is a must-listen for those ready to lead at the forefront of medical device innovation. Check out the full report and explore the resources mentioned in this episode by visiting the Reference Links below.Episode Highlights:AI is still in its early stages within the MedTech industry, with potential to save time and improve efficiency.There is a noticeable skepticism about AI, with 65% of respondents doubting the accuracy of AI data.Corporate executives are the highest users of AI at 60%, with manufacturing operations at 50%.Product development and engineering, as well as clinical sectors, are also incorporating AI significantly.Quality and regulatory sectors are the least to adopt AI, possibly due to trust issues in AI's data accuracy.Early adopters of AI in MedTech, akin to early CAD users, may gain a competitive edge in the industry.The development of AI tools like Greenlight Guru's risk intelligence can specifically aid MedTech professionals by streamlining processes like risk assessment.Quote:"It's kind of like an iceberg we're seeing the tip of the iceberg with the use of ChatGPT for manipulating your email, when in reality there's this whole other world under the water." - Wade SchroederReference Links:Wade Schroeder on LinkedInAI in MedTech Report 2023Digital GuruGreenlight GuruEtienne Nichols on LinkedInInterested in sponsoring an episode? Click here to learn more!
• 
  #327 Understanding the ROI of an eQMS 11.07.2023 51min

  In this episode with Fran Cruz, Chief Customer Officer at Greenlight Guru, we explore the investment of a purpose-built electronic Quality Management System (eQMS). Some of the topics we explore are:3rd- party study by Hobson & CO that reveals significant reductions in setup time, full-time employee requirements, time spent on development and documentation, training time, and audit preparation time.The recent ROI Calculator developed by Greenlight Guru to help customers customize the study's findings to their specific inputs and demonstrate the value of the software for their business.The current economic climate, with budget cuts and limited investments, and the importance of efficiency and cost savings provided by a quality management system.Prioritizing success metrics, measuring outcomes, and holding ourselves accountable lead to better decision-making and improved effectiveness in the long run.Success criteria for customers implementing a quality management system include time to implement (time to value) and achieving specific outcomes.How Greenlight Guru aims to balance efficient setup and time to value for customers, focusing on milestones like entering documents and processing changes.The way different customer profiles require different approaches, such as providing guidance and templates for early-stage companies or assisting with migration for existing quality systems.The different functions Greenlight Guru offers, such as services like Guru Assist and GG Academy to support customers in their implementation and learning process."I think ultimately this whole study was really illuminating because it was able to give executive teams, buying teams the numbers that they needed to make a smart decision." ~Fran CruzReference Links:Etienne Nichols LinkedInIndependent Study on ROI of eQMSROI CalculatorGreenlight GurupKtQjeyoDImuAoc2OjH5
• 
  #323 The Combination Products Handbook 16.06.2023 42min

  Combination products are a difficult niche because they combine so many different elements. However, today’s guest literally wrote the book on the topic, and she’s joining the podcast to share her insights. In today’s episode, Susan Neadle and I spoke on the topic of Combination Products, and specifically how she recently wrote the Handbook on this topic, with many co-authors from FDA.Susan is a recognized international Combination Products and Medical Device expert with over 30 years of industry experience. Her FDA peer-reviewed book, “The Combination Products Handbook: A Practical Guide” is available for purchase through CRC Press. Listen to the episode to hear about her past experience and how she ended up in products, how the different chapters of her book came to be, and how her collaborators were involved.Some of the highlights of this episode include:Susan’s past experiences in the industryHow Susan got into the combination products spaceSpecific examples of the multilingual approach Susan had to takeHow the different chapters in Susan’s books evolved and who collaborated with herWhat it was like to work with so many different professionals on the bookThoughts about challenges that may be addressed in the futureHow to harmonize language differences in the glossaryOvercoming the challenge of being a niche within a niche and juggling multiple fieldsHow industry knowledge interacted with FDA knowledgeMemorable quotes from Susan Neadle:“It was really a great adventure, being there right at the ground level when it all started.”“If people aren’t able to use the product effectively, they’re not going to take their drug, which means all sorts of other ramifications.”“It’s important to understand what are the combination inspection product criteria.”“It was great, although it would have been much easier if I was trying to write the book by myself, because I have control of my own timelines.”Links:Susan Neadle on LinkedIn20% Discount for The Combination Products HandbookCombination Products ConsultingEtienne Nichols LinkedInGreenlight Guru
• 
  Avoiding Potential Issues with your 510(k) Submission 27.04.2023 45min

  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
• 
  Most Common Problems Found During FDA Inspections in 2022 23.03.2023 44min

  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
• 
  Part 2: The Theranos Loophole & Lab Developed Tests 16.02.2023 43min

  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