Global Medical Device Podcast powered by Greenlight Guru

Episodi

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  Project Management for Product Development of Medical Devices 27.10.2021 36min

  What is the best way to approach project management (PM) for medical device product development? Don't settle for the trial and error method, turn to the experts with proven best practices for managing your product development project.In this episode of the Global Medical Device Podcast, Jon Speer talks to Devon Campbell with Prodct and Christie Johnson with Kasota Engineering and Prodct partner about Greenlight Guru Academy’s new course offering, Introduction to Project Management for Product Development of Medical Devices.Some of the highlights of this episode include:It’s assumed that engineers good at managing projects, getting things done, and working with different resources/team members make good project managers.The gold standard is Gantt charts and waterfall methodologies. They have their place and have done a lot of good, but developers do not have to follow the waterfall method - it’s simply a project management practice and example.There’s an appropriate time and place for PM practices and tools, including the Gantt chart. However, don’t blindly apply learned principles.The wrong time to use a Gantt chart is managing how people do their work. Be vulnerable, open, and trust the professionals to know what they are doing and get their work done.Project planning and management are not the same. Project planning does not equal project management.Follow the Keep It Simple Stupid (KISS) philosophy. Rather than build complex and sophisticated tools, acknowledge that you won’t do it right the first time and put time in to react to what you learn and optimize.Who’s running the show? There’s a lot of overlap and not enough room to redo, learn, and make a product better. Also, a lot of iteration happens between those steps. Give time and respect to making a product stronger.Good project management is perpetual because there is a flow to it. It’s cyclical. Prototype and conduct testing early and often if the schedule allows to define and refine product details.Memorable quotes from this episode:“Starting as an engineer and then moving into quality and approaching things with a 30,000-foot view, you kind of see the whole project and the impact of all the sub-tasks. It’s hard not to want to get involved and make sure that everything that needs to get done does.” Christie Johnson“It will ultimately deliver something. It might deliver it over budget. It might deliver it over time. It might deliver it with a bunch of disgruntled employees who hate going through product development because of the way that the project is being managed.” Devon Campbell“Potentially, too many bells and whistles that it makes it really easy for you to create something that looks really awesome, but it’s really hot garbage.” Devon Campbell“Critical path calculations and analyses through tools is generally meaningless. I don’t believe it whenever I see it because we build these really complex and sophisticated models.” Devon Campbell“There’s a lot of overlap and not enough...room to go back and redo and learn and make the product better. There’s a lot of iteration that happens between those steps.” Christie JohnsonLinks:Introduction to Project Management for Product Development of Medical DevicesMedical Device HQDevon Campbell with ProdctChristie Johnson with Kasota EngineeringThe Critical ChainTheory of ConstraintsWhat is a Gantt Chart?FDA - Design Control Guidance for Medical Device Manufacturers (Waterfall Diagram)FDA - Quality System Regulation, Part 820Waterfall vs. Agile: Battle of the Product Development MethodologiesX-teams: How to Build Teams That Lead, Innovate, and Succeed by Deborah AnconaDesign Structure Matrix (DSM)Steven D. EppingerGreenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitMedTech True Quality Stories PodcastGreenlight Guru YouTube ChannelGreenlight Guru
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  #367: Interviewing the Interviewer 16.05.2024 39min

  In this special episode of the Global Medical Device Podcast, Etienne Nichols switches roles from host to guest as Devon Campbell turns the tables to explore the invaluable lessons Etienne has learned from over 100 podcast episodes. Delve into key insights on product development, quality management, and the power of vulnerability and networking. Etienne shares practical tips and personal anecdotes that reveal the nuances of the MedTech industry, making this episode a treasure trove of knowledge for both new and seasoned professionals.Key Timestamps:[02:15] - Introduction and Etienne’s journey to becoming a podcast host[12:30] - The importance of vulnerability and honesty in product development[22:45] - Balancing quality for audits versus operational benefits[30:10] - Human factors and usability in MedTech product development[37:55] - Simplifying quality management systems[45:00] - The mantra of learn, lead, and love in networking[54:20] - Encouraging emerging entrepreneurs to own their expertise and impact regulationsQuotes:"The heart of the problem is the seed of the solution.""Quality management documents should benefit your company first and be audit-ready second.""Be genuinely curious. Assume the person in front of you knows something worth listening to."Takeaways:Key Insights on the Latest MedTech Trends:Human factors and usability are often misunderstood but crucial in MedTech product development.Quality management systems should be practical and beneficial for the company, not just for audits.Networking is more than collecting business cards; it's about building meaningful connections.Practical Tips for MedTech Professionals:Be vulnerable and honest about the state of your projects.Focus on solving the right problems and avoid over-engineering.Create quality management documents that are easy to understand and useful for your team.Questions Predicting Future Developments:How will AI and machine learning shape the future of MedTech product development?What emerging trends in usability and human factors will impact regulatory changes?How can MedTech companies better prepare for cybersecurity challenges?References:Greenlight Guru - Quality management software for medical devices.Etienne Nichols - LinkedInDevon Campbell - LinkedInProdct LLC - Devon's advisory firmFred Crosby’s Quality is Free - A book on quality management principles.Beginner's Section: MedTech 101Quality Management System (QMS): The system that outlines the processes and procedures to ensure product quality.Human Factors and Usability: The study of how people interact with products to improve design and user experience.Regulatory Strategy: The plan for complying with regulations to bring a medical device to market.Questions for the Audience:Poll: What do you think will be the most impactful MedTech advancement in the next five years? Email us your thoughts at podcast@greenlight.guruFeedback:We'd love to hear your feedback on this episode! Please leave us a review on iTunes and share your thoughts and suggestions for future topics. Email us at podcast@greenlight.guru with your ideas and comments.Sponsors:This episode is sponsored by Greenlight Guru. Their all-in-one platform is designed specifically for the unique needs of the medical device industry, helping you maintain compliance, reduce risk, and improve quality. Visit www.greenlight.guru today to learn how their platform can transform your medical device development process.
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  #349: Climbing the MedTech Career Ladder - How to Get to the Top 21.12.2023 1h 10min

  In this episode of the Global Medical Device Podcast, we’re joined by Elena Kyria, a talent acquisition specialist and CEO of Elemed. Elena delves into what it takes to climb the career ladder in the medtech industry, whether you're early or late in your career journey. Our host, Etienne Nichols, engages in a rich discussion on career paths, leveraging personal strengths, and the importance of networking and personal branding.Quotes"If you're not talking about the value that you add, how is anybody going to know what impact you're having?" - Elena Kyria"Everything's uncertain really, isn't it? What you've got to have is a clear sense of forwards and just have a goal." - Elena Kyria"Nobody goes to the gym and looks at the weights and gets fit. You have to do the reps." - Elena KyriaTakeawaysNetworking is Key: It's not just what you know, but who knows you and what they know you're doing.Visibility of Achievements: Share your successes within your company; if you don't, others may not recognize your contributions.Defining Success: Success doesn't always mean reaching the VP level; it's about personal satisfaction and contribution.Strengths and Weaknesses: Focus on your strengths but be aware of your weaknesses and compensate with your team.Career Paths: Understand the different career paths (leadership, expert, generalist) and what they entail for growth.Communication Skills: Strong communication skills are paramount for leadership and for translating technical details to a broader audience.Continuous Learning: Always seek new knowledge and experiences, no matter where you are in your career.Adaptability: Be prepared to pivot and adapt to changes within the industry and your career.Take Action: Don't just reflect on advice; apply it to make actual changes in your career approach.Reference Links:Elena Kyria's LinkedInElemedWorking GeniusGreenlight GuruEtienne Nichols' LinkedInRemember to engage with the hosts and guests on LinkedIn for feedback and further discussions. Don’t forget to leave a review on iTunes!*Interested in sponsoring an episode? Use this form and let us know!
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  #439: MedTech AI Trends 2025: Scaling Regulatory Intelligence with Michelle Wu 29.12.2025 42min

  In this episode, Etienne Nichols sits down with Michelle Wu, Founder and CEO of Nyquist AI and one of the top 100 women in AI, to discuss the transformative state of artificial intelligence within the MedTech regulatory and quality space. Reflecting on her recent personal experience as a surgical patient, Michelle shares a unique perspective on the critical importance of the devices and quality systems that keep the industry running.The conversation dives deep into the "Great Rewiring" of the medical device industry. Michelle outlines how we have moved past the initial phase of AI skepticism and "AI fatigue" into a period of hyper-acceleration. With the introduction of the FDA’s ELSA and the implementation of the EU AI Act, the industry has reached a point where AI is no longer a side project but a fundamental requirement for operational longevity.Finally, the episode provides a roadmap for both organizations and individual contributors. Michelle introduces her "Holy Trinity" framework for AI implementation—Data, Workflow, and Agents—and explains why the next two years will be defined by the "Invisible Colleague" or AI copilot. For junior professionals, the message is clear: knowledge is now a commodity, and the real value lies in the ability to ask high-quality, strategic questions.Key Timestamps00:00 – Introduction and Michelle Wu’s background in MedTech and AI.03:45 – A founder’s perspective: Michelle’s personal experience in the OR seeing her clients' devices.08:12 – The 2025 Inflection Point: FDA ELSA, EU AI Act, and global AI expectations.11:50 – From billable hours to value-based output: How AI is disrupting the consulting business model.15:35 – Micro-timestamp: 2026 Predictions. The shift toward universal AI Copilots and Agents for every MedTech role.18:22 – The Holy Trinity of AI: Breaking down Data Layers, Workflow Automation, and AI Agents.22:10 – Case Study: How a top-tier MedTech company automated 17,000 quality and regulatory tasks.27:45 – The 56.8% Salary Premium: Why AI literacy is the most important skill for young RAQA professionals.31:15 – Shifting from memorization to "Clarity of Mind" and high-quality inquiry.Quotes"Knowledge is a commodity now. Previously, regulatory consultants or professionals stood out by their knowledge. Now, with AI leveling the field, the capability lies in those who can ask high-quality questions." - Michelle Wu, Nyquist AITakeawaysAI Literacy is a Financial Multiplier: LinkedIn data shows that non-engineering knowledge workers with AI literacy can command a salary premium of up to 56.8%.The 80/20 Rule of Automation: Approximately 80% of current RAQA tasks are tedious, manual, or administrative. Successful teams are using AI to automate that 80%, allowing humans to focus on the 20% that is strategic and high-value.The Three-Layer AI Strategy: To effectively implement AI, companies should look at the Data Layer (intelligence), the Workflow Layer (automation of specific tasks), and the Agent Layer (autonomous "employees").Value-Based Billing: As AI reduces the time required for regulatory submissions and gap analyses, the industry is moving away from the "billable hour" toward pricing based on the value and quality of the output.ReferencesNyquist AI: Michelle Wu’s platform specializing in global regulatory intelligence and AI-driven workflow automation for MedTech.FDA ELSA: The FDA’s internal AI tool that marked a significant shift in the agency's embrace of the technology.IMDRF GMLP: Good Machine Learning Practice guidelines for AI-enabled medical devices.EU AI Act: The first comprehensive legal framework for AI, affecting MedTech compliance timelines.Etienne Nichols: Connect with Etienne on LinkedIn.MedTech 101: AI Agents vs. AI ChatbotsWhile many people are familiar with AI Chatbots (like the early versions of ChatGPT), the industry is moving toward AI Agents.Think of a Chatbot like a very smart encyclopedia. You ask it a question about a 510(k) submission, and it gives you information.An AI Agent, however, is like an AI Intern. It doesn't just give you information; it performs a multi-step task. For example, you can tell an Agent to "find the three most relevant predicates for this new device, summarize their 510(k) summaries, and draft a gap analysis table." The Agent "thinks" through the steps and delivers a finished product, not just a response.SponsorsThis episode is brought to you by Greenlight Guru. As Michelle and Etienne discussed, the future of MedTech is driven by data and efficiency. Whether you are navigating the complexities of the EU AI Act or scaling your R&D, Greenlight Guru’s QMS (Quality Management System) and EDC (Electronic Data Capture) solutions provide the structured data foundation necessary to leverage AI effectively. By integrating quality and clinical data, Greenlight Guru helps you move from "reactive" compliance to "proactive" innovation.Feedback Call-to-ActionWe want to hear from you! How is your team currently leveraging AI in your regulatory or quality workflows? Are you feeling the "AI fatigue," or are you seeing the "salary premium" Michelle mentioned?Send your thoughts, guest suggestions, or specific questions to podcast@greenlight.guru. Etienne personally reads and responds to listener feedback, and we would love to feature your insights in a future episode.
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  #429: MedTech Regulatory Risk: Navigating the FDA During a Government Shutdown 20.10.2025 22min

  This episode, hosted by Etienne Nichols, delves into the critical impact of a U.S. government shutdown on the medical device industry, specifically focusing on the Food and Drug Administration (FDA). Guest Michael Nilo, President and Principal Consultant of Nilo Medical Consulting Group and a former FDA Scientific Reviewer, offers an insider's perspective on which FDA functions halt and which remain active during a funding lapse. He clarifies that while the processing of new, user-fee-supported marketing applications like PMAs and 510(k)s typically stops, essential activities like active review of already-filed submissions, post-market safety surveillance, enforcement of recalls, and Investigational Device Exemption (IDE) reviews continue, drawing on existing user fee reserves.The discussion pivots to the significant slowdowns that occur, notably the suspension of non-MDUFA-goal-tied interactions, such as Q-submissions (Pre-Submissions) and most interactive reviews. For startups and small manufacturers, the halting of the crucial small business designation processing can be particularly detrimental, leading to astronomically higher user fees once the government reopens. Michael emphasizes that the industry should anticipate this political risk and plan submission timelines strategically, positioning a government shutdown as an "uncontrollable natural disaster" that requires proactive risk mitigation.Michael provides actionable advice for MedTech leaders to pivot during a shutdown. He recommends using the enforced delay to significantly improve the quality of submissions—making them easier to navigate and review once the FDA is fully operational—to gain a crucial advantage over the backlog of queued submissions. Furthermore, companies should utilize the time to focus on parallel activities such as process validation, refining quality systems, and strengthening commercial and reimbursement strategies. Michael stresses the importance of remembering the core mission: getting life-improving technologies to patients, and using any delay as an opportunity to emerge stronger and more prepared for commercial launch.Key Timestamps1:45 - The initial effects of a shutdown: What truly stops at the FDA (new submissions) versus what keeps running (existing reviews, IDEs, post-market surveillance).3:50 - Why active review of filed submissions continues—the role of the user fee "reserve."5:58 - Critical functions that stop or slow down: Pre-submissions (Q-subs), interactive reviews, new policy guidance, and routine inspections.7:25 - The major impact of halting the small business designation process on user fees for new manufacturers.8:36 - MDUFA (Medical Device User Fee Amendments) explained: How user fees fund the FDA and maintain operations during a lapse.11:51 - Direct effects on a MedTech company's runway and the loss of interactive review.13:17 - Actionable advice: Improving submission quality for easier review to mitigate the post-shutdown backlog.15:00 - Strategic pivot: Focusing on parallel work like process validation and quality system refinement.16:03 - Communicating with investors and partners: Positioning the shutdown as an uncontrollable event and shortening the commercial launch gap.18:50 - Looking ahead: Planning submissions around budget resolution deadlines to anticipate shutdown risk.20:53 - Final advice: Keeping the patient-focused mission in mind and maximizing internal efforts.Quotes"Active review of device submissions, if you already had something in or you were smart enough, you saw the writing on the wall, you got it in on September 30, you’re good to go. Those will still keep going on schedule with and the FDA is going to try to meet their MDUFA goals..." - Michael Nilo"If yours stands out as being something that is easier to handle, makes it easier to process, they can navigate through it better, you have a better chance of getting a quicker, faster, better review process once it’s opened up."TakeawaysRegulatory Strategy & Submission Quality: Use any government shutdown delay to drastically improve the navigability and clarity of your marketing submission (PMA, 510(k)). A well-organized, hyperlinked, and clear application will likely be processed faster by reviewers facing a post-shutdown submission backlog.Financial Risk & Small Business Designation: Small medical device manufacturers should anticipate potential government shutdowns and file their small business designation application well in advance. Failure to process this designation during a lapse can result in paying the full, significantly higher user fee, which dramatically impacts startup runway.Operations & Quality Focus: While regulatory submissions are stalled, pivot R&D and Quality teams to focus on parallel work streams. This includes advancing process validation, completing outstanding quality system activities (e.g., risk management file updates), and solidifying commercialization and reimbursement strategies.IDE Reviews Continue: Companies initiating clinical trials should note that Investigational Device Exemption (IDE) submissions are generally considered essential and will still be reviewed within the MDUFA 30-day timeline. This is one of the few submission types that allows for continued progress during a shutdown.Leverage User Fee Systems: Understand that the FDA's user fee structure (MDUFA) ensures that key pre- and post-market safety functions, as well as active review of existing applications, can be maintained for a period, acting as a crucial shock absorber for the industry.ReferencesMichael Nilo's LinkedInEtienne Nichols' LinkedIn: Connect with EtienneMDUFA (Medical Device User Fee Amendments): The legislation that authorizes the FDA to collect fees from companies that submit certain marketing applications for medical devices, which funds a significant portion of the agency's device-related activities and performance goals.IDE (Investigational Device Exemption): An FDA process that allows a device that is not yet legally marketed to be used in a clinical study to collect safety and effectiveness data. IDE reviews are generally protected during a shutdown.MedTech 101 Section: User Fees and the MDUFA BufferWhen the U.S. government shuts down, it means Congress hasn't passed a budget, and non-essential federal agencies must pause most operations because their taxpayer funding stops. However, the FDA has a financial safety net for its medical device work: User Fees, authorized by the Medical Device User Fee Amendments (MDUFA).Think of MDUFA as a dedicated savings account funded by MedTech companies. When a company submits a major application like a 510(k) or PMA, they pay a fee. This money goes into a separate reserve. When a government shutdown happens, the FDA can tap into this reserve to keep essential, MDUFA-related work going. This includes the salaries of reviewers who are already working on your application, ongoing post-market surveillance, and crucial safety functions. The money acts as a buffer, allowing the FDA to continue its core mission for a limited time, which is why existing reviews aren't immediately halted. New submissions, however, often can't be processed because that intake and processing function is deemed non-essential and is not typically covered by the emergency user fee funding.Feedback Call-to-ActionWe thrive on your input! If this discussion about government shutdowns and MedTech strategy sparked any thoughts, or if you have a topic you'd like us to cover, we want to hear from you. Email us directly at podcast@greenlight.guru. We personally read every email and are committed to providing you with the most relevant and actionable MedTech insights.SponsorsThis episode is brought to you by Greenlight Guru, the only MedTech-specific platform providing end-to-end solutions. Don't let a government shutdown pause your internal quality momentum. Leverage Greenlight Guru's eQMS and EDC solutions to keep your product development, design controls, and clinical data management moving forward, ensuring your systems are inspection-ready and helping you build a submission so flawless it cuts through the FDA's post-shutdown backlog. Visit www.greenlight.guru to learn more.
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  Crash Course on Greenlight Guru Academy: How Medical Device Professionals Stay Ahead 02.06.2021 31min

  If you love learning and want to level up your medical device industry knowledge on topics such as audits, document management, design controls, risk management, and more, Greenlight Guru Academy is your education destination.In this episode of the Global Medical Device Podcast, Jon Speer invites colleagues Aaron Lucas, Training and Education Manager, and Jesseca Lyons, Operations and Enablement Guru, to join the show and explain to listeners what Greenlight Guru Academy is and how the eLearning platform is helping users around the world advance their medical device careers.Some highlights of this episode include:Greenlight Guru Academy is a learning management system (LMS) path that allows medical device gurus, customers, and others to share knowledge and educational content and courses to encourage retention and effectiveness.About six years ago, whenever a new customer would come on board with Greenlight Guru, it was a manual process. Fast forward to a few years later, Greenlight Guru Academy has made that process automatic and evergreen.Feedback from some of the thousands of Greenlight Guru Academy users who have completed the various courses help gauge success and types of content.Learner’s Mindset: I want to do the right thing. I want to make it better. I want to help someone, but it’s next to impossible to do. Demystify the medical device space, especially as the industry changes.Greenlight Guru Academy is for anyone getting started to veterans wanting to hone their skills in the medical device industry. Expect to see a lot more audit and inspection courses and content. Also, expect basic regulatory learning.Memorable quotes from this episode:“In the academy, we have all sorts of awesome courses - go at your own pace courses - on topics like document management, design controls, risk management, training, audits, and the list is going to continue to grow and evolve.” Jon Speer“Ultimately, the academy looks to really be this educational kind of beacon in the medical device industry for anything anyone could ever need to know from just getting started to a veteran looking to hone their skills.” Aaron Lucas“There’s something about the medical device industry that breeds these folks who don’t just recognize that they have to learn this stuff but they actually kind of like it.” Aaron Lucas“Why am I making a medical device in the first place? I want to help someone.” Jesseca Lyons“This is an opportunity to get a chance to really impact more and more people.” Jesseca LyonsLinks:Aaron Lucas on LinkedInJesseca Lyons on LinkedInGreenlight Guru Academy - Enroll NowAbout Greenlight Guru AcademyFDA - Medical DevicesInternational Organization for Standardization (ISO)510(k) Premarket NotificationEuropean Union’s Medical Device Regulation (EU MDR)Risk Management True Quality Summit SeriesGreenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru
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  What is a Multiple Function Device? 30.09.2020 41min

  What is a multiple function device? From a high level, it’s a product with at least one portion that meets FDA’s Code of Regulations’ (CFR) definition of a medical device and at least one other portion that does not. In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues from Vascular Sciences about multiple function devices to help listeners gain a clear understanding of this increasingly popular device type.
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  #379: Meet the Guru - Building Quality Management in Early-Stage Medical Device Companies and other Insights from a Veteran Engineer 15.08.2024 36min

  In this episode of the Global Medical Device Podcast, host Etienne Nichols speaks with Vernon Baker, a medical device guru, about key strategies for early-stage MedTech companies, particularly around implementing Quality Management Systems (QMS), supplier management, and compliance. Vernon shares his experience of transitioning from engineering to quality and regulatory roles, emphasizing the importance of being a "jack of all trades" when hiring early quality managers. They discuss how small companies can navigate the complexities of ISO 13485, supplier audits, and regulatory intelligence. This episode is a must-listen for startup founders and quality professionals seeking to establish a strong foundation in MedTech.Key Timestamps:[00:02] – Introduction: Etienne Nichols introduces the topic of early-stage MedTech QMS implementation and guest Vernon Baker.[04:30] – Vernon’s Background: From mechanical engineer to quality expert in MedTech.[13:00] – Wearing Many Hats: How early hires in quality roles manage multiple responsibilities in small companies.[22:10] – Supplier Management: The importance of supplier audits and choosing the right partners.[35:45] – Management Reviews & Communication: Aligning quality efforts with company goals.[47:00] – Regulatory Intelligence: Staying updated with regulatory changes and standards.[59:20] – Final Advice: Qualities to look for in an early-stage quality manager.Notable Quotes:“You don’t have to be an expert in everything, but you do need to know where to find the answers.” – Vernon Baker on managing quality systems.“A good management review should feel like a real conversation about the direction of the company, not just a checkbox exercise.” – Vernon Baker on management reviews.“Supplier management is critical in small organizations. You’re outsourcing a lot, and you need to vet and audit your suppliers well.” – Vernon Baker on supplier controls.Key Takeaways:MedTech Trends:Focus on Flexibility: Early hires in MedTech quality roles need to be adaptable, covering everything from product development to regulatory compliance.Supplier Audits Are Essential: Strong supplier management, including on-site audits, is vital to mitigate risks and ensure high-quality materials and components.Regulatory Intelligence: Regularly updating your team on changing regulations and standards is crucial for maintaining compliance and avoiding costly mistakes.Practical Tips:Leverage Consultants: For niche areas like biocompatibility and regulatory changes, hiring external consultants can provide critical insights.Invest in Training: Encourage your team to undergo formal training in ISO 13485, risk management, and process validation to build internal competency.Use Document Templates: Start with pre-existing QMS templates and refine them according to your company’s specific needs.References:ISO 13485: The international standard for medical device quality management systems, which is essential for compliance in various jurisdictions.FDA Recognized Standards: Lists that guide device manufacturing and safety, critical for ensuring that products meet U.S. regulatory requirements.EU MDR: A sweeping update to European medical device regulations, requiring stricter quality and reporting standards.Connect with Etienne Nichols on LinkedIn for more insights into quality management in the MedTech industry: Etienne Nichols on LinkedInMedTech 101:QMS (Quality Management System): A structured system that documents processes, procedures, and responsibilities for achieving quality policies and objectives. For MedTech, this typically involves compliance with ISO 13485.Supplier Management: The process of vetting, auditing, and maintaining relationships with external suppliers to ensure they meet your quality and regulatory standards.Management Review: A formal meeting where top management reviews the performance of the QMS to ensure its effectiveness and alignment with business objectives.Questions for the Audience:How do you manage regulatory changes in your MedTech company? What tools or resources do you rely on most?What are your predictions for how supplier management will evolve with advancing technologies in MedTech?Let us know by emailing your thoughts to podcast@greenlight.guru!Feedback:We’d love your feedback on this episode! Please leave us a review on iTunes, or send your thoughts and suggestions for future topics to podcast@greenlight.guru.Sponsor Message:This episode is brought to you by Rook Quality Systems, specializing in custom QMS solutions for MedTech startups. Rook helps streamline processes and ensure regulatory compliance. Visit rookqs.com to learn more and start building your ideal QMS today!
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  Meet a Guru: Maryann Mitchell 02.09.2021 15min

  What makes Greenlight Guru unique and sets it apart from other medical device solutions? It’s Guru edge⁠—a team of medical device professionals with a ton of industry experience.In this episode of the Global Medical Device Podcast Jon Speer talks to Maryann Mitchell, a Medical Device Guru and Solutions Engineer who has recently joined the Greenlight Guru team.Listen as Maryann shares fascinating details about her day-to-day working with device companies who are evaluating the Greenlight Guru Medical Device Success Platform (MDSP) to better understand their product and business needs and how Greenlight Guru's MDSP solution can help them achieve ultimate success.Some of the highlights of this episode include:Maryann’s background is in quality systems initiatives, and she has extensive experience with ISO 13485. She loves being a part of audits and truly enjoys defending quality systems.While Maryann has been through numerous ISO 13485 audits, she has experienced only a few FDA inspections. She explains that there’s a whole different level of terror when it comes to the FDA.Maryann was attracted to joining the Greenlight Guru team because of her interest in quality system software. She wanted to help the company sell its software and connect with customers and medical device companies.Maryann shares some of her favorite stories working with companies trying to evaluate their options for quality systems. The best part is customers’ positive reactions during design control matrix and risk matrix demonstrations.The benefits of Greenlight’s QMS include the ability to quickly and easily find and access visually appealing information and data. Ultimately, it helps people get through audits faster and be in compliance.However, Maryann explains how and why EU MDR continues to be a challenge for medical device companies. Compiling records and evidence for submission as well as interconnectivity are just some of the bigger quality issues.If the FDA transitions to the 13485 standard, Maryann believes the medical device industry shouldn’t panic but anticipate it. It would be better to have a harmonized way of auditing and inspecting companies.Memorable quotes from Maryann Mitchell:“I’ve lived and breathed the 13485, 820, all those fun standards, which I love. It’s really exciting and I love being in audits.”“There’s a whole different level of terror when it comes to the FDA, but it was really exciting to be there. Thankfully, I wasn’t in the hot seat for those, but I was in the front room to participate.”“Not just during an audit, but for your own internal quality, it’s just so much easier when your systems are connected, and that’s exactly what Greenlight offers to our customers.”“You should always be audit ready.”Links:Maryann Mitchell on LinkedInISO 13485 - Medical DevicesFDA InspectionsEuropean Union’s Medical Device Regulation (EU MDR)Meet a Guru - Sara AdamsMeet a Guru - Taylor BrownGreenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitGreenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru
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  How Mindset Training Can Help Your Team Operate at Peak Performance 09.06.2021 28min

  Close your eyes, take a deep breath in, and imagine your team operating at peak performance, exceeding goals and each member feeling and working at their best. Now, breathe out, letting out a sigh of relief knowing that's fully within the realm of possibility — through mindset training.In this episode of the Global Medical Device Podcast, Jon Speer talks to Kevin Bailey, mindset coach and founder of Dreamfuel, a mindset coaching solution for high growth companies.Kevin is the mindset coach for Greenlight Guru and has worked with Jon and Greenlight Guru employees over the years by providing mindfulness tools and techniques that teams can use to improve overall mindset. Listen to what Jon has learned from this mindset training and how the medical device community, too, can benefit from engaging in mindset practices at work.Some highlights of this episode include:Being the CEO of a high-growth startup proved to take a whole other level of work that required mental strength and resilience. Kevin used mental models to reframe experiences and have a more positive attitude while leading people.CEO Cues: Feeling motivated or burnt out? How is the business doing? People follow their leaders and want to boost productivity and camaraderie.Working with Kevin from Dreamfuel has changed the world for Jon and his colleagues, as well as other companies trying to do great things, make a difference, and feel better.Mindset is an important practice for success in a company. About 95% of thoughts are subconscious and automatic, like a heartbeat. Also, 70-80% of those thoughts and actions are negative, disempowering, limiting beliefs.A measurable difference, consistency, and alignment of peak performance can be achieved by companies, executives, and staff via neuroscience principles.The stigma around meditation is stopping people who need it from doing it. What’s the goal? There’s no outcome you are going for in meditation.Acknowledge and let go of thoughts spinning in your mind because dopamine (pleasure) and serotonin (joy, happiness, and presence) create a balanced mind.Your breath controls your physiology, and your physiology heavily influences how you feel, how you think, and what you do. If you can control your physiology, it’s easier to control your thinking and behaviors. Breathe rhythmically and smoothly.Memorable quotes by Kevin Bailey:“Mindset is such an important practice for success in a company.”“We’re trying to kind of take these practices that have been utilized for ions to help people be happier and perform better, wrap them with some neuroscience, so that people can accept and understand them, but there’s still that stigma.”“There’s no outcome you’re going for in meditation. You purely do meditation to do meditation.”“Your breath controls your physiology, and your physiology heavily influences how you feel, how you think, what you do.”Links:Kevin Bailey on LinkedInDreamfuel CoachingDr. Diane PowellWhy Greenlight Guru Rewards Employees Who Get the Best SleepThe Beatles’ Meditation Coach - Maharishi Mahesh YogiBreath by James NestorGreenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitGreenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru
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  Pros & Cons of Being a Physician turned MedTech Inventor 13.04.2021 49min

  Do you fear needles and the associated pain? No one understands this fear more than physicians who see it firsthand with their patients day in and day out. And one physician in particular set out to do something about it.In this episode of the Global Medical Device Podcast, Jon Speer talks to Dr. Amy Baxter, CEO and founder at Pain Care Labs. Amy discusses the pros and cons of being a physician, entrepreneur, and inventor of reusable, physiologic medical products to eliminate unnecessary pain.Some highlights of this episode include:The medical world works on 2-D pharmaceutical schematics, but doctors’ minds work on three dimensions. Physician inventors see the whole body, person, and need to develop effective medical products.Physician inventors think they know everything, so it’s difficult for them to follow ISO 13485 and painstaking medical device development and not get frustrated. The time duration for Amy’s innovation and invention journey took years to get patents, meet regulatory requirements, and address the opioid crisis. Pain management is esoteric and subjective. Amy encourages physician inventors to fall in love with their problem, not their solution. Pain, chronic or not, is a real problem. Amy shares life lessons for physician colleagues with innovative ideas. Find a group like Greenlight Guru or GCMI to understand navigation early on. Branding matters, so choose wisely.Also, Amy advises physician investors to not get hung up on non-disclosure agreements (NDAs). Nobody steals an idea, they steal a medical product.Amy expects the future of pain management to include multiple specific energy devices in people’s medicine cabinets to use before and after surgery. Mechanical stimulation will be the primary one because it’s easy and safe to use.Buzzy® is a palm-sized device that combines cold and mechanical stimulation to block pain and improve muscle soreness, blood flow, and recovery. The VibraCool® Cryo-vibration product, VibraCool’s M-Stim, is 2-3.4 times superior to electrical stimulation (TENS) for physical therapy. It has demonstrated 35% fewer opioid tablets. Also, a lower back pain device is in clinical trials and expected to be released this year.Memorable quotes by Amy Baxter:“We see the whole body, we see the whole person, and we see the need.”“The downside of being a physician inventor is that we both feel like we know everything.” “Wanting to be able to do something is really the push that puts a lot of physicians into the entrepreneurial space.”“Fall in love with your problem, don’t fall in love with your solution.”“Try your idea out on someone who does not love you.”Links:Pain Care LabsISO 13485 - Medical DevicesISO 14971 - Application of Risk ManagementFDA - Part 11EU MDRNIH Small Business Innovation Research (SBIR))/Small Business Technology Transfer (STTR) Mayday FoundationGlobal Center for Medical Innovation (GCMI)Dr. Richard MelkerMedical Device Podcast, Ep 186: Building a Startup in the MedTech Industry Greenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitGreenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru
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  Addressing the 'Who, What, When' of Quality in the Medical Device Industry 08.09.2021 28min

  There are many schools of thought when it comes to the 'who, what, and when' of quality management for medical devices.In this episode of the Global Medical Device Podcast Jon Speer talks to Christie Johnson with Kasota Engineering, a consulting firm focused on quality in the medical device industry. Listen to this episode as Jon and Christie offer their insights and guidance on medical device quality management best practices.Some of the highlights of this episode include:Who manages quality? Most startups first hire someone with years of experience, but Christie encourages early firms to embrace the teach mentality. Christie enjoys training teams to build an understanding of quality from scratch.What is quality? Those with a willingness and capability to learn can be coached to know what a quality management system is and needs to include initially.Two Schools of Thought: Companies either view quality as, do it later when the time is right or that’s not my job. Quality is a way for companies to ensure safety and efficacy. Put your products and services at the center of your universe.Christie’s philosophy is to never do what traditional consultants in the industry do. She never just shows up, throws some documents down, and walks away.Which QMS to implement? The system that you should implement is the one that your team will use. Make it simple and fast. If your team cannot understand and readily use the tool, they’re not going to do it or follow the procedure/process.Delivering a QMS without providing step-by-step training can lose functionality. Start with baby steps into processes, especially for those without experience.What to include? You don’t need to comply with regulations right away. Put things in place - early data, suppliers - document/record what you’re doing during the research and discovery phase. Tell your story and take credit for your hard work.Why are you struggling? The reality is it takes longer than six months to one year to get your idea or product on the market. Trial knowledge can reduce risk.Memorable quotes from Christie Johnson:“If you can read and understand the regulation and if you can sit and work with me and help me understand your background and I can coach you, we can start putting in place your early quality system.”“Our philosophy is very much to never do what traditional consultants in the industry do, which is show up, throw some documents down, and walk away.”“The system that you should implement is the one that your team will use and make it easy.”“It’s really easy to get lost or just ignore the quality system that’s in place, especially if you come into an organization that already has way more than they need.”Links:Christie Johnson on LinkedInKasota EngineeringNational Institutes of Health (NIH) - Rapid Acceleration of Diagnostics (RADx)Devon Campbell with ProdctFDA - Medical DevicesISO 13485Meet a Guru - Taylor BrownGreenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitMedTech True Quality Stories PodcastGreenlight Guru YouTube ChannelGreenlight Guru
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  #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 podcast@greenlight.guru!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 podcast@greenlight.guru 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!
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  #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 podcast@greenlight.guru. 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.
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  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
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  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
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  #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 podcast@greenlight.guru.Sponsors: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.
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  #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 podcast@greenlight.guru. We read every email and love providing personalized responses to our community.
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  #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 LinkedInashkon@engeniussolutions.comEngenius 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 podcast@greenlight.guru
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  #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!