Global Medical Device Podcast powered by Greenlight Guru

Greenlight Guru + Medical Device Entrepreneurs

The Global Medical Device Podcast, powered by Greenlight Guru, is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies. read less
Health & FitnessHealth & Fitness
Start Here
#366: Cardiac Arrest: Five Heart-Stopping Years as a CEO on the Feds Hit-List
Today
#366: Cardiac Arrest: Five Heart-Stopping Years as a CEO on the Feds Hit-List
In this episode of the Global Medical Device Podcast, host Etienne Nichols engages with Howard Root, former CEO of Vascular Solutions and author of "Cardiac Arrest: Five Heart-Stopping Years as a CEO on the Fed’s Hit List," and Mark Duval, President and CEO of DuVal & Associates. The episode delves into the harrowing experiences of navigating severe legal battles over off-label promotions, highlighting crucial insights into maintaining innovation while managing legal risks in the MedTech field. Additionally, Mark DuVal, a noted regulatory attorney, provides his expertise on the responsible corporate officer doctrine and its implications for industry executives.Key Timestamps:[00:00:15] - Introduction by Etienne Nichols.[00:01:30] - Howard Root's background and the origins of Vascular Solutions.[00:05:00] - Mark DuVal introduces Howard Root, detailing his legal battles.[00:10:00] - Howard Root discusses the intricacies of his federal indictment and the subsequent trial.[00:30:00] - Discussion on corporate responsibility and regulatory implications in the MedTech industry.[00:50:00] - Audience Q&A session with Howard Root and Mark DuVal.[01:10:00] - Closing remarks and takeaways.Quotes:Howard Root: "We're not imposing rules at the bare legal minimum...we want to have a gray area. It’s why you drive 55 in a 60 zone."Mark DuVal: "Always be truthful, fairly balanced, and not misleading when discussing device applications."Takeaways:Latest MedTech Trends:Increased scrutiny on off-label promotions highlights the need for clear regulatory strategies.Growing legal precedents emphasize the importance of corporate responsibility at all levels of operation.The role of ethical practices in sustaining innovation within the MedTech industry.Practical Tips for MedTech Professionals:Ensure thorough understanding and compliance with FDA guidelines and local regulations.Implement robust training and compliance programs for all staff, particularly in sales and marketing.Engage experienced legal counsel to navigate complex regulatory landscapes.Future Predictions in MedTech:Enhanced regulatory frameworks to better define and manage off-label use.Greater use of AI and data analytics to monitor compliance and ethical practices.Increased advocacy for legislative changes to protect innovators from aggressive legal challenges.References:Howard Root's book, "Cardiac Arrest: Five Heart-Stopping Years as a CEO on the Fed’s Hit List" (Link to book).Mark DuVal on LinkedInDuVal & Associates Client AlertsFDA guidelines on off-label promotions.Etienne Nichols on LinkedInResponsible corporate officer doctrine.MedTech 101:Explaining terms like 'off-label use', which refers to the use of medical devices for indications not specifically approved by the FDA. While legally permissible under certain conditions, it requires careful communication and documentation to ensure compliance and mitigate legal risks.Audience Interaction:Poll Question: "Do you believe current regulations fairly balance innovation with patient safety in MedTech?"Call to Action:We encourage you to leave feedback on the episode and suggestions for future topics via email at podcast@greenlight.guruReviews on iTunes are also greatly appreciated!Sponsors:Today’s episode is brought to you by...

Episodes

#366: Cardiac Arrest: Five Heart-Stopping Years as a CEO on the Feds Hit-List
Today
#366: Cardiac Arrest: Five Heart-Stopping Years as a CEO on the Feds Hit-List
In this episode of the Global Medical Device Podcast, host Etienne Nichols engages with Howard Root, former CEO of Vascular Solutions and author of "Cardiac Arrest: Five Heart-Stopping Years as a CEO on the Fed’s Hit List," and Mark Duval, President and CEO of DuVal & Associates. The episode delves into the harrowing experiences of navigating severe legal battles over off-label promotions, highlighting crucial insights into maintaining innovation while managing legal risks in the MedTech field. Additionally, Mark DuVal, a noted regulatory attorney, provides his expertise on the responsible corporate officer doctrine and its implications for industry executives.Key Timestamps:[00:00:15] - Introduction by Etienne Nichols.[00:01:30] - Howard Root's background and the origins of Vascular Solutions.[00:05:00] - Mark DuVal introduces Howard Root, detailing his legal battles.[00:10:00] - Howard Root discusses the intricacies of his federal indictment and the subsequent trial.[00:30:00] - Discussion on corporate responsibility and regulatory implications in the MedTech industry.[00:50:00] - Audience Q&A session with Howard Root and Mark DuVal.[01:10:00] - Closing remarks and takeaways.Quotes:Howard Root: "We're not imposing rules at the bare legal minimum...we want to have a gray area. It’s why you drive 55 in a 60 zone."Mark DuVal: "Always be truthful, fairly balanced, and not misleading when discussing device applications."Takeaways:Latest MedTech Trends:Increased scrutiny on off-label promotions highlights the need for clear regulatory strategies.Growing legal precedents emphasize the importance of corporate responsibility at all levels of operation.The role of ethical practices in sustaining innovation within the MedTech industry.Practical Tips for MedTech Professionals:Ensure thorough understanding and compliance with FDA guidelines and local regulations.Implement robust training and compliance programs for all staff, particularly in sales and marketing.Engage experienced legal counsel to navigate complex regulatory landscapes.Future Predictions in MedTech:Enhanced regulatory frameworks to better define and manage off-label use.Greater use of AI and data analytics to monitor compliance and ethical practices.Increased advocacy for legislative changes to protect innovators from aggressive legal challenges.References:Howard Root's book, "Cardiac Arrest: Five Heart-Stopping Years as a CEO on the Fed’s Hit List" (Link to book).Mark DuVal on LinkedInDuVal & Associates Client AlertsFDA guidelines on off-label promotions.Etienne Nichols on LinkedInResponsible corporate officer doctrine.MedTech 101:Explaining terms like 'off-label use', which refers to the use of medical devices for indications not specifically approved by the FDA. While legally permissible under certain conditions, it requires careful communication and documentation to ensure compliance and mitigate legal risks.Audience Interaction:Poll Question: "Do you believe current regulations fairly balance innovation with patient safety in MedTech?"Call to Action:We encourage you to leave feedback on the episode and suggestions for future topics via email at podcast@greenlight.guruReviews on iTunes are also greatly appreciated!Sponsors:Today’s episode is brought to you by...
#365: Medical Device Reporting: The Do's and Don'ts
1w ago
#365: Medical Device Reporting: The Do's and Don'ts
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...
#364: Building a Partnership with your Regulatory Consultant
Apr 30 2024
#364: Building a Partnership with your Regulatory Consultant
In this episode, host Etienne Nichols speaks with Christine Luk, Associate Regulatory Affairs Manager at Proxima, about her journey through the medical device sector. From her academic beginnings in biochemistry and biomedical engineering to founding a startup and navigating FDA regulatory pathways, Christine offers a wealth of knowledge. The discussion delves into the intricacies of working with regulatory consultants, the significance of FDA interactions, and practical tips for medical device startups aiming to maneuver through regulatory challenges successfully.Key Timestamps:[00:02:30] Christine's journey from biochemistry to medical device innovation[00:15:00] Insights on starting a medtech startup and the early failures[00:30:45] Effective collaboration with regulatory consultants[00:45:10] Handling FDA interactions and strategic submissions[01:00:20] Advice for medtech startups on navigating regulatory environmentsNotable Quotes:"You're pitching all these awesome capabilities of your device, meanwhile on the FDA side, we're asking, who are you most like?" – Christine Luk"Every meeting is money. Making sure everybody is aligned and on the same page is crucial when dealing with consultants." – Christine LukKey Takeaways:Engage with local medtech communities and resources, such as accelerators or innovation hubs.Early interactions with the FDA can significantly influence your device’s regulatory pathway.Thorough documentation and clear communication with consultants are essential for effective project management.References and Resources:Texas Medical Center Innovation InstituteProxima Clinical ResearchChristine Luk on LinkedInEtienne Nichols on LinkedInCall to Action:Feedback is crucial! Please email us your thoughts on this episode and suggestions for future topics at podcast@greenlight.guruDon’t forget to leave us a review on iTunes!Sponsor Segment:This episode is proudly sponsored by Greenlight Guru, a global leader in MedTech-specific software solutions. Whether you're in the clinical trial phase or ensuring compliance with quality standards, Greenlight Guru offers tailored solutions to streamline your processes. Their software is designed specifically for the medical device industry, helping companies accelerate their product development with confidence and compliance. Learn more about how Greenlight Guru can illuminate your path to market success by visiting their website at Greenlight Guru. Equip your team with the tools to simplify quality management and keep your focus on innovation and patient safety.
#363: Bringing a Self-Funded Medical Device to Market
Apr 25 2024
#363: Bringing a Self-Funded Medical Device to Market
In this insightful episode of the Global Medical Device Podcast, host Etienne Nichols delves into the journey of Dr. Lee Hunter, an orthopedic surgeon and innovator in elbow surgery devices. Dr. Hunter shares his experience from the conception of a simple yet effective surgical device through its development, struggles with initial licensing, and ultimate success in the market. The discussion highlights the importance of perseverance, the impact of regulatory insights, and the significant role of strategic innovation in enhancing patient outcomes.Key Timestamps:[00:45] - Introduction of Dr. Lee Hunter and his medical device journey.[05:30] - Challenges and breakthroughs in designing elbow surgery devices.[14:20] - The licensing journey and learning from initial failures.[22:50] - Insights into the current medical device market and innovations.[35:40] - Discussion on the importance of simplicity and efficiency in medical devices.[48:15] - Future directions in MedTech and advice for new innovators.Memorable Quotes:"Sometimes the simplest solutions are the hardest to find but the most effective once implemented." - Lee HunterKey Takeaways:Innovation in MedTech: Dr. Hunter's journey emphasizes that true innovation often stems from a deep understanding of specific medical needs rather than broad technological applications.Challenges and Resilience: Early failures are often stepping stones to success, highlighting the importance of resilience and adaptability in the medical device industry.Future of MedTech: The potential for simpler, more effective devices that streamline medical procedures and improve outcomes is vast, urging current and future innovators to focus on practical and impactful innovations.MedTech 101:In today's episode, terms like "elbow arthroscopy" and "lateral decubitus position" were discussed. Elbow arthroscopy involves a minimally invasive surgical procedure on the elbow using an arthroscope, while lateral decubitus position refers to the patient lying on their side, which is common during such surgeries.Call to Action:Did this episode on medical device innovation resonate with you? We would love to hear your thoughts and feedback. Leave us a review on iTunes and share your views on the future of MedTech innovations! For suggestions on future topics, please email us at podcast@greenlight.guruReferences:Hunter Medical DevicesDr. Lee hunter on LinkedInTennessee Orthopedic AllianceEtienne Nichols on LinkedInSponsors:This episode is brought to you by Greenlight Guru, a leading company in medical device consulting. Their expertise and services align seamlessly with the needs of the MedTech community, helping bring revolutionary devices to the market efficiently. Check out their special offers for podcast listeners today!
#362: Managing Risk in Clinical Investigations
Apr 23 2024
#362: Managing Risk in Clinical Investigations
In this episode of the Global Medical Device Podcast, host Etienne Nichols engages with Helene Quie, an expert in medical device regulations and clinical investigations. They delve into the dual aspects of risk management: ensuring product safety and the procedural risks associated with clinical protocols. Helene emphasizes the importance of a measurable, data-driven approach to balancing risks and benefits and discusses the challenges companies face in aligning their clinical investigations with stringent regulatory standards.Key Timestamps00:00:45 - Introduction to Helene Quie and the topic of risk management in clinical investigations.00:05:22 - Discussing the first leg of risk management: managing residual risks in product safety.00:17:50 - Exploring the second leg: the procedural risks in clinical protocols.00:28:30 - Challenges of enrollment and protocol design.00:35:45 - The impact of regulatory changes on clinical investigations.00:49:10 - Addressing the integration of artificial intelligence in medical devices.01:03:15 - Closing thoughts and call to action from Helene Quie.Provocative Quotes"It's not just about managing risks; it's about ensuring that the benefits are powerful enough to justify those risks." - Helene Quie"Every clinical investigation introduces its own set of risks, not just from the product but from the study protocol itself." - Helene Quie"We must not only wear different glasses to see through the regulatory and practical aspects but also validate our views with the actual stakeholders involved." - Helene QuieKey Takeaways1. Insights on MedTech Trends:The increasing importance of data in justifying product safety and efficacy.The shift from intuition-based to evidence-based risk assessment.Regulatory bodies are placing greater emphasis on comprehensive clinical evaluations.2. Practical Tips for MedTech Professionals:Ensure that risk assessments are detailed and backed by solid data.Consider the practical aspects of clinical trial protocols from multiple perspectives.Stay updated on regulatory changes to adapt protocols and product development effectively.3. Future Predictions in MedTech:Enhanced scrutiny and requirements for clinical investigations.Greater integration of AI and digital tools in medical devices.Potential regulatory adaptations to accommodate innovations.ReferencesHelene Quie on LinkedInEtienne Nichols on LinkedInQMED ConsultingQuestions to ask for Clinical PreparationEUMDR and MDD Comparisons: Insights into how regulatory frameworks have evolved and their impact on medical device development.MedTech 101For new listeners, this episode touches upon fundamental concepts like residual risk, clinical protocol, and risk-benefit assessment in the context of medical device clinical investigations. Understanding these terms is crucial for grasping the detailed discussions of the episode.Audience EngagementDiscussion Question: "What are your expectations for the future of healthcare with advancements in MedTech?"Feedback Request:...
#361: Speaking the Language of IVD
Apr 19 2024
#361: Speaking the Language of IVD
In this episode of the Global Medical Device Podcast, host Etienne Nichols delves into the intricate world of in vitro diagnostics (IVDs) with Christie Hughes, a principal consultant and IVD expert at Qserve Group. With over 25 years of experience, Christie shares her extensive knowledge, discussing the nuances of IVDs, regulatory landscapes, and practical insights for professionals transitioning into or within the IVD sector.Key Timestamps:[00:00:45] - Christie Hughes's introduction and background in IVDs[00:03:30] - Discussion on the regulatory challenges and trends in 2023[00:15:22] - Differences between IVDs and other medical devices in terms of regulatory and operational frameworks[00:25:50] - Impact of regulatory changes on labs and manufacturers[00:40:10] - Detailed exploration of user needs and design controls in IVD development[00:52:00] - Advice for medical device professionals entering the IVD spaceNotable Quotes:"Understanding the user—whether a lab technician or a layperson—is critical in IVD development to ensure safety and effectiveness." - Christie HughesKey Takeaways:Trends in MedTech: The regulatory environment for IVDs is rapidly evolving, with increased scrutiny and changes in compliance requirements globally.Practical Tips: For those entering the IVD field, familiarize yourself with FDA decision summaries and EUA documentation to understand current regulatory expectations.Future Predictions: Expect continued integration of IVDs with digital health technologies, raising both opportunities and regulatory complexities.References and Resources:FDA decision summaries for recent IVD clearancesEuropean In Vitro Diagnostic Regulation (IVDR) updatesCDRH LearnFDA Proposed Rule for LDTsEpisode on LDTs with Shannon BennettChristie Hughes on LinkedInEtienne Nichols on LinkedInMedTech 101:In Vitro Diagnostic (IVD) Devices: Tools that analyze human samples (like blood or tissue) outside the body, used to diagnose diseases, conditions, or to monitor a person’s overall health.Audience Interaction:Discussion Question: "How do you envision IVDs changing everyday healthcare practices in the future?"Call for Feedback:Love this episode? Leave us a review on iTunes and share your thoughts. Feedback drives our growth and allows us to improve. Reach out directly via email at podcast@greenlight.guru with your suggestions for future topics.Special Thanks to Our Sponsor:This episode is brought to you by Greenlight Guru, a quality management system and electronic data capture software designed...
#360: Is It Possible to "Buy" a QMS?
Apr 13 2024
#360: Is It Possible to "Buy" a QMS?
In this episode of the Global Medical Device Podcast, Etienne Nichols engages with Sara Adams to discuss Quality Management Systems (QMS) in the medical device industry. The discussion unveils the complexities and common misconceptions surrounding QMS, drawing an intriguing analogy between building a QMS and crafting sourdough bread. Sara shares her extensive experience with FDA inspections and audits, emphasizing the essential, tailored approach needed for effective quality management.Sponsor:This episode is brought to you by Cleio Medical Device Design. Discover how Cleio can transform your medical device concepts into market-ready products at cleio.com.Key Timestamps:[02:15] - Sara recounts her experiences with FDA inspections.[05:30] - Etienne introduces the sponsor and the episode’s focus on QMS.[12:00] - Sara explains what a QMS is and is not, breaking down the layers of quality control.[19:45] - Discussion on the practical steps to build and customize a QMS.[34:10] - Sara’s sourdough analogy to illustrate the process of developing a robust QMS.[48:55] - Examples of how different QMS systems can meet specific regulatory requirements.[1:02:30] - Closing thoughts on keeping the patient in mind when building a QMS.Notable Quotes:"You can't buy a QMS off the shelf; it's like trying to bake sourdough bread without understanding the process or the ingredients." – Sara Adams"The patient should be the focus of everything we do in the medical device industry." – Sara AdamsKey Takeaways:Latest MedTech Trends:Increasing regulatory scrutiny on how QMS are implemented.More companies are moving from paper-based to electronic QMS for better compliance and efficiency.Growing emphasis on customizing QMS components to fit specific medical device regulatory needs.Practical Tips for MedTech Listeners:Understand the components of your QMS and ensure they align with regulatory requirements.Regularly review and update your QMS to adapt to new regulations and technologies.Consider electronic solutions for better traceability and compliance.Future Questions:What are the potential impacts of global regulatory harmonization on QMS?How can startups efficiently implement a compliant QMS with limited resources?References:FDA Quality System Regulation (21 CFR Part 820)ISO 13485 standards for medical devicesQuestions for the Audience:Poll: Do you believe that advances in electronic QMS will significantly reduce compliance issues in the next 5 years?Call for Feedback:Enjoy this episode? Leave us a review on iTunes and suggest topics you’d like to hear about in future episodes. Email us your feedback and ideas at podcast@greenlight.guruConnect with Us:Follow Etienne on LinkedIn: Etienne NicholsFollow Sara on LinkedIn: Sara AdamsJoin us next time for more insights and expert advice in the medical device industry!
#359: Project Management in MedTech
Apr 4 2024
#359: Project Management in MedTech
This episode of the Global Medical Device Podcast features a compelling conversation with Perry Parendo, a seasoned expert in product development and project management within the MedTech sector. Host Etienne Nichols and Perry delve into the challenges and opportunities facing medical device development, emphasizing the critical role of agile practices, risk management, and the necessity for a patient-focused approach. The discussion sheds light on how companies can navigate regulatory landscapes, manage project risks, and drive innovation to enhance patient care.Key Timestamps:00:00:15 - Introduction of Perry Parendo and the episode's focus00:03:50 - Discussing the challenges of MedTech product development and regulatory hurdles00:12:20 - Agile methodologies vs. traditional project management in MedTech00:22:35 - The importance of risk management and Monte Carlo simulation in project planning00:34:10 - Perry's perspective on innovation, compliance, and balancing project priorities00:45:55 - Strategies for efficient and effective product development processesQuotes:"We're so focused from a compliance point of view on patient and health risk, we're not focused on project risk. And when I worked in the defense industry, we were hugely focused on project risk," Perry Parendo"There's waterfall, there's agile, there's Toyota, there's set based design, and there's APQP in the automotive industry. They're all a blend. There's no organization that's doing purely the theoretical of any one of those processes," Perry ParendoTakeawaysInsights on MedTech Trends:The convergence of agile and traditional methodologies tailored to MedTech's unique demands.The rising importance of advanced risk management techniques, like Monte Carlo simulations, in navigating project uncertainties.A call for innovation that transcends regulatory compliance to genuinely benefit patient care.Practical Tips for Listeners:Adopt a flexible approach to project management by integrating various methodologies based on project needs.Prioritize risk management early in the development process to foresee and mitigate potential challenges.Always align product development objectives with the ultimate goal of improving patient outcomes.Questions for Future Developments:How will evolving regulatory standards shape the next generation of medical devices?What role will patient feedback play in the design and development of future MedTech innovations?Can MedTech sustain its pace of innovation while ensuring safety and compliance?References:Perry Parendo on LinkedInEtienne Nichols on LinkedInBehavioral Grooves podcast with Annie Duke - Thinking in BetsBook - Someday is Today, Ron RichardYoutube video - the Heartbeat of New Product DevelopmentQuality Culture for Product Design Success
#358: FDAs Voluntary Improvement Program
Mar 21 2024
#358: FDAs Voluntary Improvement Program
In this episode of the Global Medical Device Podcast, host Etienne Nichols sits down with Kim Kaplan from ISACA at the MD&M West trade show in Anaheim, California, to discuss the pivotal Voluntary Improvement Program (VIP). This conversation sheds light on how the program, stemming from FDA’s Case for Quality initiative, utilizes the Capability Maturity Model Integration (CMMI) to push medical device companies beyond compliance, towards excellence. Kaplan elucidates the history of VIP, its benefits, and how it aligns with the FDA’s vision for a more innovative and quality-focused MedTech industry.Key Timestamps:[00:00:30] Introduction of Kim Kaplan and the Voluntary Improvement Program[00:05:00] Explanation of CMMI and its adoption in the medical device industry[00:15:45] Distinctions between CMMI and other quality methodologies[00:25:30] In-depth discussion on the specifics and benefits of the Voluntary Improvement Program[00:40:00] How companies can implement change based on VIP insights[00:50:00] FDA’s perspective and regulatory opportunities tied to VIP participationNotable Quotes:“Organizations that are compliant aren't necessarily avoiding the types and numbers of issues faced by non-compliant ones.” - Kim Kaplan“CMMI focuses on the 'what' to do rather than the 'how,' allowing for a framework that compliments existing processes.” - Kim Kaplan“The Voluntary Improvement Program isn't just about compliance; it's about embracing continuous improvement as a culture.” - Kim KaplanKey Takeaways:Understanding VIP: The program aims to elevate quality and operational efficiency through a collaboration involving FDA, MDIC, industry stakeholders, and ISACA.CMMI’s Role: CMMI’s flexible, globally adopted framework helps MedTech companies identify and implement best practices in product development and project management.Benefits of Participation: Beyond improving quality, VIP participation can streamline regulatory processes, fostering quicker innovation and market access.Practical Tips for Listeners:Engage with CMMI: Consider how CMMI’s framework could complement your company’s existing quality and project management processes.Explore VIP: Assess your organization's readiness and potential benefits from enrolling in the Voluntary Improvement Program.Continuous Improvement: Embrace continuous improvement, not just for compliance, but as a cornerstone of your company culture.Future Questions:How will the integration of AI and digital health technologies impact the criteria for CMMI and VIP?In what ways might the Voluntary Improvement Program evolve to further incentivize innovation in MedTech?How will FDA’s regulatory framework adapt to the rapid advancements in medical device technologies?References and Resources:Etienne Nichols on LinkedInKim Kaplan on LinkedInFDA’s Final Guidance on the Voluntary Improvement ProgramISACA's overview of FDAs Voluntary Improvement Program (VIP)Regulatory opportunities of the...
#357: The State of UDI Across the World
Mar 7 2024
#357: The State of UDI Across the World
In this episode of the Global Medical Device Podcast, host Etienne Nichols is joined by Gary Saner, a seasoned expert in medical device Unique Device Identification (UDI) and regulatory compliance. They embark on a comprehensive exploration of the ever-evolving landscape of UDI requirements, shedding light on crucial deadlines, common pitfalls, and strategic insights for achieving global compliance. From the intricacies of European UDI requirements to the specifics of implementing UDI systems in markets like Australia and beyond, this episode is a treasure trove of actionable insider knowledge for medical device professionals navigating the complexities of UDI compliance.Quotes:"UDI has this ongoing life connected to it...it just doesn't seem to end. Once you do it, you're not done; you have to keep opening those books and making changes." - Gary SanerTakeaways:Latest MedTech Trends:Increasing global adoption of UDI requirements signifies a move towards standardized device identification for enhanced patient safety.The push towards digital transformation in regulatory compliance highlights the industry's shift towards efficiency and data accuracy.The growing complexity of global UDI regulations challenges manufacturers to adopt flexible and scalable solutions for compliance.Practical Tips for Listeners:Start early with your UDI compliance strategy to accommodate the evolving nature of global regulations.Engage with experts and consider leveraging technology solutions like ReTech for streamlined compliance processes.Stay informed about regulatory changes in key markets to ensure continuous compliance and market access.Predicting Future Developments:Will AI and machine learning play a more significant role in automating UDI compliance processes?How will the expansion of UDI requirements into emerging markets affect global medical device distribution?Can we expect a universal standard for UDI compliance to emerge, simplifying global regulatory landscapes?References:Gary Saner on LinkedInEtienne Nichols on LinkedInThe Ultimate Guide for UDIReedTech's UDI Compliance SolutionBeginner's Section: MedTech 101For new listeners, UDI (Unique Device Identification) is a system used by regulatory authorities to identify and track medical devices through their distribution and use. It's a crucial component of medical device regulation, ensuring the safety, efficacy, and traceability of devices.Questions for the Audience:Poll: "What do you believe is the biggest challenge in achieving global UDI compliance?"Discussion Question: "How do you foresee the advancements in MedTech impacting healthcare delivery in the next decade?"Feedback and Future Topics:We value your feedback and ideas for future episodes. Please email us at podcast@greenlight.guru with your suggestions and thoughts.Sponsors:This episode is brought to you by Greenlight Guru, the MedTech industry's leading solution for product development and compliance. Discover how Greenlight Guru can accelerate your product's journey to market by visiting www.greenlight.guru
#356: Quality Myths & Lessons Learned Part II
Feb 22 2024
#356: Quality Myths & Lessons Learned Part II
In this episode of the Global Medical Device Podcast, host Etienne Nichols delves into the world of medical device quality and reliability with expert guest Kevin Becker. They explore the nuanced challenges of ethical decision-making in the MedTech industry, the complexities of accelerated testing, and the continuous quest for quality improvement. Becker, author of "Quality Myths and Lessons Learned," shares his insights from the second edition of his book, emphasizing the importance of ethics, the intricacies of statistical models, and the practical aspects of quality management in medical devices.Key Timestamps:[00:00:00] Introduction to Kevin Becker and the topic of the episode[00:05:20] Discussion on the new chapter about ethics in Becker's book[00:10:35] Insights into accelerated testing and its application in medical devices[00:15:50] Kevin Becker's five levels of knowledge and its relevance to MedTech professionals[00:20:45] The significance of standing up for what's right in quality and regulatory matters[00:25:30] Real-life examples of complex problem-solving in medical device engineering[00:30:55] Final thoughts and advice from Kevin Becker for MedTech professionalsQuotes:"The first level of knowledge is you don't have a clue... The third level is you know enough to be effective, which is where we all want to be." - Kevin Becker"All models are wrong; some models are useful." - Quoted by Kevin Becker, highlighting the pragmatic approach in engineering and quality assurance."Do something, do anything. If it's wrong, we'll learn from it. Just do something." - Kevin Becker's advice to overcome analysis paralysis in product development.Takeaways:Latest MedTech Trends: The episode underscores the critical role of ethics in the rapidly evolving MedTech industry, where technological advancements and moral responsibilities intersect.Practical Tips: Listeners gain practical insights into the importance of rigorous testing, continuous learning, and ethical decision-making in ensuring the quality and reliability of medical devices.Future Predictions: The discussion hints at the increasing significance of statistical models and accelerated testing in predicting and enhancing the longevity and efficacy of medical devices.References:Quality Myths and Lessons Learned Part I: https://www.greenlight.guru/blog/quality-myths-and-lessons-learnedConnect with Kevin Becker on LinkedIn: https://www.linkedin.com/in/kevin-becker-48627014/Kevin Becker's book "Quality Myths and Lessons Learned" (Second Edition) offers a deeper dive into the topics discussed, with a focus on ethics, quality management, and statistical methods in the medical device industry. Connect with Etienne Nichols on LinkedIn: https://www.linkedin.com/in/etiennenichols/Questions for the Audience:Poll: "What do you believe is the most significant ethical challenge facing the MedTech industry...
#355: Mastering the Pitch: MedTech Innovations from Concept to Market
Feb 15 2024
#355: Mastering the Pitch: MedTech Innovations from Concept to Market
In this episode of the Global Medical Device Podcast, host Etienne Nichols dives into the art of pitching to medical device investors with Blythe Karow, COO at Neurogeneces. Blythe shares her wealth of experience, from her early days as a marketer to leading significant product launches and achieving FDA breakthrough designations. The conversation revolves around crafting compelling pitches, understanding investor expectations, and navigating the challenges of presenting complex medical technologies to diverse audiences.Key Timestamps:[00:00:45] - Introduction to Blythe Karow and her background in MedTech.[00:03:22] - Insights into the dynamics of pitching to investors and adapting to different audiences.[00:10:15] - Discussion on the evolution of Blythe's pitching strategies over her career.[00:15:30] - Blythe's experience with gender dynamics in pitching and advice for female entrepreneurs.[00:20:45] - The importance of team presentation and handling expert critiques during pitches.[00:25:30] - Blythe's memorable pitch experiences and the impact of audience engagement.[00:30:00] - Tips for early-stage startups and resources for pitch preparation.[00:35:25] - Closing thoughts and where to connect with Blythe Karow.Quotes:"You want to start with a problem, you want that problem to be in the voice of who would pay for it." - Blythe Karow"It's like dating, and you're going to find people you click with and people you don't click with." - Blythe Karow on finding the right investors."Anyone can pitch. You just have to practice." - Blythe KarowTakeaways:Latest MedTech Trends:The convergence of digital health and traditional medical devices.The rising importance of FDA breakthrough designations for startups.The shift towards patient-centered design in medical devices.Practical Tips for Listeners:Understand your audience before crafting your pitch.Practice your pitch extensively to refine your message and delivery.Build a cohesive team presentation to demonstrate unity and competence.References:Neurogeneces, Blythe's current venture in brain health wellness.Evren Technologies pitch videoMedtech InnovatorBlythe Karow on LinkedInEtienne Nichols LinkedInSpringboard Digital Health Innovation ProgramFeedback and Future Topics:We value your feedback and suggestions for future episodes. Share your thoughts and ideas by leaving a review on iTunes or emailing podcast@greenlight.guruSponsors:This episode is brought to you by Greenlight Guru, a MedTech Suite designed to accelerate product development while ensuring regulatory compliance. Learn more at Greenlight Guru.
#354: Advice for MedTech Regulatory Affairs Professionals
Feb 7 2024
#354: Advice for MedTech Regulatory Affairs Professionals
In this episode of the Global Medical Device Podcast, Etienne Nichols is joined by Kavetha Ram, a seasoned expert in health and pharmaceutical sciences and the regulatory department leader at Spectra Medical Devices. Together, they delve into how new regulatory affairs professionals can get started in a career of medical device regulations and the shifting field of MedTech. The discussion offers a roadmap for professionals to navigate and thrive amidst these shifts. The episode is a treasure trove of knowledge for anyone looking to stay ahead in the MedTech realm.Key Timestamps:[00:00:30] Introduction to Kavetha Ram and the episode's focus[00:05:15] Discussion on the challenges and opportunities of new regulations[00:10:40] Insights into the importance of confidence and adaptability in the regulatory field[00:15:20] Kavetha's journey and advice for emerging professionals[00:25:00] The role of innovation and collaboration in MedTech advancements[00:35:10] Strategies for professionals to stay relevant and proactiveQuotes:"Regulations are not just hurdles; they are stepping stones to innovation and safety in MedTech." - Kavetha Ram"Embracing change in regulations is not an option but a necessity for MedTech's future." - Etienne Nichols"Diversity in teams isn't just about varied backgrounds; it's about unlocking unique perspectives that drive innovation." - Kavetha RamKey Takeaways:Insights into MedTech Trends:Regulatory changes are both a challenge and an opportunity for innovation.Practical Tips for MedTech Enthusiasts:Stay updated with regulatory changes and understand their implications.Engage in continuous learning and skill development.Foster collaboration across disciplines to enhance innovation.References:Kavetha Ram's LinkedIn ProfileEtienne Nichols' LinkedIn ProfileGreenlight GuruQuestions for the Audience:"What advice do you have for budding Regulatory Affairs professionals?"Reach out to us and let us know what you thought of the episode at podcast@greenlight.guruAlso, if you enjoyed this episode, please leave us a review on iTunes!Sponsors:This episode is brought to you by Greenlight Guru, the only quality management software designed specifically for the medical device industry. Greenlight Guru's platform streamlines product development and compliance, making the process more efficient and less risky. Discover how Greenlight Guru can accelerate your product development at www.greenlight.guru.
#353: How Artificial Intelligence is Impacting the MedTech Industry
Jan 30 2024
#353: How Artificial Intelligence is Impacting the MedTech Industry
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
#352: Fundamentals of Quality & Regulatory
Jan 18 2024
#352: Fundamentals of Quality & Regulatory
In this episode, we delve into the complexities and essentials of quality and regulatory roles in the medical device industry. Our esteemed guest, Jennifer Mascioli-Tudor, CEO and founder of JMT Compliance Consulting, shares her wealth of experience from top MedTech companies, underscoring the importance of proactive quality management, project management skills, and the ability to influence and communicate within organizations.Key Timestamps:[00:00:50] Introduction to Jennifer Mascioli-Tudor and her extensive background in the MedTech industry.[00:03:30] Jennifer's origin story in quality and regulatory roles.[00:07:15] The pivotal learning moments in quality management and regulatory affairs.[00:10:45] Strategies for influencing business leaders and the importance of storytelling in quality and regulatory roles.[00:16:30] The significance of human factors in product design and learning from end-user feedback.[00:21:50] Project management skills for quality and regulatory professionals.[00:25:20] The concept of 'design freeze' in the MedTech space and its impact on product development.[00:29:55] Jennifer's insights on agility and adaptability in building a quality management system.Quotes:"A really good quality and regulatory professional needs to have really good project management skills." - Jennifer Mascioli-Tudor"It's not just about the design and about the product. It's about everything ancillary that feeds into that finished medical device." - Jennifer Mascioli-TudorMedTech Trends:An emphasis on proactive quality management to ensure patient safety and product efficacy.The rising importance of human factors and user-centered design in medical device development.The shift towards integrating software and digital solutions in medical devices.Practical Tips:Quality and regulatory professionals should hone their project management skills.Communication and storytelling are key in influencing business decisions and leadership.Always present solutions and alternatives when addressing compliance challenges.References:JMT Compliance ConsultingJennifer Mascioli-Tudor on LinkedInEtienne Nichols on LinkedInGreenlight Guru’s platform for Quality Management & Clinical InvestigationsQuestions for the Audience:Discussion: "How do you envision MedTech changing the landscape of healthcare in the next decade?"Feedback:Love the episode? Have suggestions or topics you’d like to hear about? Email us at podcast@greenlight.guru and leave a review on iTunes!Sponsors:This episode is brought to you by Greenlight Guru, the only quality management software designed specifically for the medical device industry. Streamline your process and foster innovation with Greenlight Guru’s intuitive platform!
#351: The State of AI & Clinical Investigations
Jan 11 2024
#351: The State of AI & Clinical Investigations
In a today's conversation on the Global Medical Device Podcast, host Etienne Nichols engages with Dr. Maria Nyakern on the burgeoning integration of AI in medical devices. They delve into the European AI Act, discussing its impact on innovation and the critical role of trustworthy systems in clinical research. The episode also touches upon the challenges and opportunities AI presents in MedTech, from data integrity to job displacement, and the human-centric approach to technology.Key Timestamps:[00:00:00] Introduction to the podcast and topic of AI in medical devices[00:03:25] Greenlight Guru's streamlined product development for MedTech[00:05:15] Dr. Maria Nyakern's background and entrance into AI[00:07:30] Discussion on the European AI Act and its significance[00:13:45] Comparison of US and European approaches to AI regulation[00:18:55] The intersection of MedTech experience and AI governance[00:23:10] The importance of data quality and integrity in AI-driven clinical research[00:29:00] The human aspect in AI development and clinical trials[00:35:10] Ethical considerations and the future of AI in MedTechQuotes:"AI systems...will be more cost-effective and less of a hurdle for companies to generate data sets for subsets of patients." - Maria Nyakern"Trustworthy AI systems must be worthy of humans." - Maria Nyakern"Embrace innovation with Greenlight Guru." - Etienne NicholsTakeaways:Latest MedTech Trends:Increased integration of AI in clinical research.The rise of wearable health monitors.Advancements in surgical robotics technology.Practical Tips:Stay updated on AI regulations.Invest in trustworthy AI systems.Leverage AI for cost-effective data generation.Future Predictions:AI will play a larger role in personalized medicine.There will be a push for global AI data sharing.Expect AI to drive faster, more accurate diagnostics.References:European AI ActUS Executive Order on AIMaria Nyakern on LinkedInEtienne Nichols on LinkedInQuestions for the Audience:Which AI-driven MedTech advancement excites you the most, and why?How do you envision healthcare changing in the next decade with the rise of MedTech innovations?"We value your thoughts - if you enjoyed this episode, would like to give feedback, or have suggestions for future episodes, please email us at podcast@greenlight.guruSponsors:Greenlight GuruToday's episode is brought to you by Greenlight Guru, the only MedTech-exclusive Quality Management Software designed with the direct input of industry insiders. Dealing with cumbersome product development cycles? Facing the maze of regulatory compliance? Greenlight Guru is your guiding light. Our comprehensive software...
#350: The Evolving Landscape of AI in MedTech
Jan 4 2024
#350: The Evolving Landscape of AI in MedTech
In this insightful episode, Eric Henry and Etienne Nichols delve into the evolving landscape of AI in MedTech, focusing on regulatory compliance and the future of AI in medical devices. They discuss the role of the FDA, FTC, and other regulatory bodies, and explore the implications of AI in product development and quality assurance.Quotes"We're seeing pushes into adaptive algorithms... algorithms that modify themselves in the field without human oversight." - Eric Henry"The FDA and other regulators are no stranger to the issues in generative AI as well." - Eric Henry"Keep an eye on the FTC... they have a tool called algorithmic disgorgement, which can have significant implications for AI in life sciences." - Eric HenryTakeawaysFTC's Growing Role: The FTC may soon have broader enforcement authority over AI across various industries in the U.S.Algorithmic Disgorgement: A tool that allows the FTC to force companies to delete an algorithm and all its associated training data.Evolving Regulatory Landscape: The FDA is adapting its regulatory framework to accommodate AI, focusing on adaptive and generative AI.Challenges with Locked Algorithms: Current regulatory frameworks primarily support locked algorithms, but there's a movement towards adaptive algorithms.Impact of AI on Quality Systems: AI is set to revolutionize quality management systems and manufacturing processes in the life sciences.Importance of Pre-Market and Post-Market Oversight: Both are crucial for ensuring the safety and efficacy of AI-driven medical devices.The Role of CSA in AI Integration: The transition from CSV to CSA could influence how AI is integrated into software systems.Harmonization of Standards: A significant challenge in AI regulation is the harmonization of numerous standards being developed globally.Public-Private Partnerships: Collaborations like the AI Global Health Initiative are vital for advancing regulatory frameworks in AI.The Need for Industry Engagement: Active involvement in AI-focused organizations can help businesses navigate the evolving regulatory landscape.ReferencesVisit www.greenlight.guru for insights on streamlining product development in Medtech.Follow Eric Henry on LinkedIn for updates on AI, quality systems, and regulatory compliance.Explore the AI Global Health Initiative under AFDO and RAPS sponsorship.For questions or consultations, contact Eric Henry at ehenry@kslaw.comVisit Greenlight Guru to learn more how to prepare your QMS for the future of MedTech.Listeners are encouraged to leave a review on iTunes and reach out to Etienne Nichols on LinkedIn for feedback.
#349: Climbing the MedTech Career Ladder - How to Get to the Top
Dec 21 2023
#349: Climbing the MedTech Career Ladder - How to Get to the Top
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!
#348: Considerations for IVD
Dec 14 2023
#348: Considerations for IVD
In this insightful episode of the Global Medical Device Podcast, host Etienne Nichols engages with Carmen Brown, the regulatory and quality affairs manager at Proxima Clinical Research. They delve into the specifics of In Vitro Diagnostics (IVDs) and explore the challenges and considerations faced by medical device manufacturers in the IVD pathway. Whether you're an industry veteran or new to the field of medical diagnostics, this conversation will enlighten you about the nuances of IVD regulatory compliance, risk assessment, and FDA interactions.Episode Highlights:IVDs are a Specialized Medical Device: Learn how IVDs, which include reagents, instruments, or systems for diagnosis, differ from other medical devices and what specific regulatory pathways they follow.Risk Levels in IVDs: Understand the significance of classifying IVDs into class one, two, or three based on the risk of false or inaccurate results, and how this impacts regulatory strategy.Pitfalls in Performance Characteristic Evaluation: Discover the complexities involved in evaluating the performance of multiband diagnostics and why traditional measures like sensitivity and specificity may not suffice.Likelihood Ratios Over Sensitivity and Specificity: Grasp why likelihood ratios are a more appropriate statistical measure for multiband diagnostics and how they relate to pretest and posttest probabilities.Clinical Relevance is Key: Recognize the importance of ensuring that the markers detected by IVDs are clinically meaningful and relevant to the condition being diagnosed.FDA's Expectations for IVDs: Gain insights into the specific data and performance characteristics the FDA looks for in IVDs and the necessity of clinical data in regulatory submissions.Quote:"With IVDs, you're looking at it from the perspective of what's the risk of a false result or an inaccurate result. So you're looking at who's interpreting the results and the type of condition." ~Carmen BrownReference Links:Carmen BrownProxima Clinical ResearchGreenlight GuruEtienne Nichols' LinkedIn*Interested in sponsoring an episode? Use this form and let us know!
#347: Human-Centered Design in Medical Devices
Dec 7 2023
#347: Human-Centered Design in Medical Devices
In this insightful episode of the Global Medical Device Podcast, host Etienne Nichols engages with Morven Shearlaw, co-founder of Fearsome, in a thought-provoking discussion on the essence of human-centered design in medical devices.Delve into the importance of understanding user needs beyond surface-level assumptions and learn how Fearsome's approach to product development is setting new standards in MedTech. From Glasgow's design desks to global market impacts, this episode is a deep dive into making MedTech better by truly connecting with the end-user experience.Noteworthy Points:The Pitfalls of Premature Solutions: Morven emphasizes the need for extensive user understanding before jumping to design conclusions, challenging the common industry haste to offer solutions.The Evolution of Fearsome: Morven shares the growth story of Fearsome from a broad design firm to a specialized MedTech developer, emphasizing the value of a diverse industry background.The Nuances of Usability: The conversation reveals the stark differences between consumer product design and medical devices, particularly the rigorous safety and risk management requirements in MedTech.Defining the User: A deep dive into identifying the 'user' in medical device design, considering all stakeholders, from clinicians to patients and even those involved in device maintenance.Real-world Feedback and Its Impact: Morven recounts a powerful anecdote where candid feedback from clinicians significantly redirected a product's development path.The Risk and Reward of Human Factors: An exploration of how human factors, beyond safety, can become a competitive edge and a catalyst for enjoyable product experiences.Regulatory Hurdles and Human-Centered Design: A critical look at the intersection of regulatory standards and human-centered design, advocating for earlier and more integrated human factors consideration.Quote:"Quality management is about quality, it's not just about proving that you can sell in the market because you've got a certain certification." - Morven Shearlaw Reference Links:Morven ShearlawFearsomeGreenlight GuruEtienne Nichols' LinkedIn*Interested in sponsoring an episode? Use this form and let us know!