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

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 [email protected]: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 [email protected] 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.

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"Mark DuVal on LinkedInDuVal & Associates Client AlertsFDA guidelines on off-label promotionsEtienne Nichols on LinkedInMedTech 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 [email protected] on iTunes are also greatly appreciated!Sponsors:Today’s episode is brought to you by Greenlight Guru, a quality management software designed specifically for the medical device industry. Here’s what Greenlight Guru offers:Quality Management System (QMS) Software: Streamline your compliance processes with a system built for FDA and ISO standards, enhancing control and visibility over quality-related activities.Design & Development Software: Accelerate your device's journey from concept to market with robust tools that support risk management and ensure design controls.Electronic Data Capture System: Efficiently gather and manage clinical trial data with an easy-to-use system that meets global regulatory standards.Special Offer: Visit www.greenlight.guru to get a free demo. Mention the Global Medical Device Podcast for exclusive offers just for our listeners.Enhance your medical device development with Greenlight Guru—where quality management meets innovation.

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

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 [email protected]: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!

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 [email protected]’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.

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: Listeners are encouraged to leave a review on iTunes and suggest topics for future episodes by emailing [email protected] episode is proudly sponsored by Greenlight Guru, a leading provider of MedTech quality management & electronic data capture software. Greenlight Guru's platform is specifically designed to help medical device companies enhance the efficacy and safety of their products, ensuring they meet the stringent standards of regulatory bodies worldwide. Check out their exclusive offer for podcast listeners to streamline your quality management & data capture process.

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 [email protected] 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 specifically for medical device companies. Streamline your processes and stay compliant with Greenlight Guru. Visit us at www.greenlight.guru to learn more.

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 [email protected] 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!

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 SuccessDesign News ColumnsPractical Monte Carlo AnalysisQuestions for the Audience:Poll: Which MedTech advancement do you believe will have the most significant impact on healthcare in the next decade?Discussion: How do you envision the future of healthcare changing with the continuous integration of MedTech innovations?We're eager to hear your thoughts on this episode and your suggestions for future topics. Please share your feedback and leave us a review on iTunes!For in-depth discussions and questions, email us at [email protected]:This episode is brought to you by Greenlight Guru, the only quality management system (QMS) and electronic data capture (EDC) software designed specifically for the medical device industry. Make your product development process smoother, faster, and compliant with Greenlight Guru. Discover the difference at www.greenlight.guru

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 Voluntary Improvement Program (VIP)Questions for the Audience:Poll: Which area of MedTech do you believe will benefit most from VIP and CMMI in the next five years? Email us your thoughts at [email protected] Question: How do you envision the future of healthcare changing with advancements in MedTech quality and innovation?Feedback and Future Topics:We value your feedback! Please email us at [email protected] with your thoughts on this episode, suggestions for future topics, or any questions you’d like addressed in upcoming episodes.Sponsors:This episode is brought to you by Greenlight Guru, a leader in MedTech solutions. Their eQMS platform aligns perfectly with today's discussion on quality and innovation in the medical device industry. Special offer for our listeners: www.greenlight.guru

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 [email protected] 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

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 today?"Share your thoughts and experiences with us at [email protected]:We value your feedback on this episode! Please leave us a review on iTunes and share your suggestions for future topics at [email protected]:This episode is brought to you by Greenlight Guru, the MedTech industry's leading Quality Management Software, designed to enhance efficiency and compliance in medical device product development.

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 [email protected]: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.

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 [email protected], 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.

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

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 [email protected] 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!

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 ActMaria 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 [email protected]: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 suite not only streamlines your processes but also helps prepare for the complexities of FDA and ISO compliance with ease. Built-in quality management ensures your focus stays on innovation and speed to market, while our real-time dashboards provide clear visibility into every stage of the product lifecycle. It's time to accelerate your path to market, minimize risk, and release products with confidence. And for our Global Medical Device Podcast listeners, Greenlight Guru is offering an exclusive, guided walkthrough of their groundbreaking platform. Transform the way you bring devices to market and stay ahead of the MedTech curve. Visit greenlight.guru today and mention this podcast for your special offer. Embrace progress, with Greenlight Guru

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 [email protected] 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.

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!

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!

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!

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!

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

In this episode, we delve into the multifaceted aspects of advisory roles within medical device startups. These discussions explore the nuanced differences between consulting and advisory work, the intricacies of the advisor-startup relationship, strategies for growth, and the delicate balance of equity and compensation in these roles. Devon Campbell shares invaluable advice and experiences, focusing on mentorship, relationship-building, risk management, and navigating the challenges of the MedTech startup ecosystem.Some of the highlights of this episode include:The distinction between consulting and advisory roles, highlighting the long-term, relationship-focused nature of advisory work.The critical role of experience and mentorship in guiding startups, enhancing their growth and success.Strategies to transform challenges into opportunities, fostering innovation and resilience in the MedTech industry.The importance of understanding and respecting employment contracts and avoiding conflicts of interest in advisory roles.The necessity of due diligence and setting high standards in choosing companies to advise, to protect one's reputation.The power of passive networking and the proactive seeking of advisors to fill knowledge gaps, especially in areas like quality systems.Insights into equity and compensation in advisory roles, emphasizing realistic expectations and adequate self-compensation.The value of accelerator programs like MassChallenge in connecting startups with experienced mentors and advisors.The importance of risk management and the strategic formation of diverse advisory boards to provide multifaceted guidance.Quote:"Having a board of diverse advisors can significantly enhance the quality of advice and direction for a startup." – Devon CampbellReference Links:Devon CampbellProdctGreenlight GuruEtienne Nichols' LinkedIn*Interested in sponsoring an episode? Click here to learn more!

Description:In this episode, we discuss with with regulatory expert Mike Drues to dissect the evolving landscape of FDA medical device regulations. These discussions provide a comprehensive overview of the historical context and current implications of FDA guidances, with a particular focus on 510K predicate selection, clinical data requirements, and the nuances of permanent implants. The conversations address the challenges and complexities inherent in aligning medical device design and development with contemporary FDA expectations and offer invaluable insights for professionals in Product Development, Quality Assurance, and Regulatory Affairs.Some of the highlights of this episode include:How the 510K, originally an exception, has ironically become the predominant pathway in medical device regulation.That, despite efforts to raise regulatory compliance standards, the enforceability of current guidances is limited due to unchanged regulations.Discussion of FDA's non-binding guidances balance between being commendable for clarity and somewhat overreaching, reflecting a nuanced industry challenge.How evolving FDA thinking underscores the importance of aligning with contemporary standards, going beyond mere compliance.That selecting predicates with past design-related recalls for 510K submissions poses legal challenges and necessitates reevaluating older predicates in light of new risks.How clinical data requirements in medical device regulation are dictated by engineering and biological factors, not just regulatory pathways.How demonstrating substantial equivalence can be complex, and small technological differences must not introduce new safety concerns.The definition of 'permanent implant' challenges traditional understanding, emphasizing the importance of biocompatibility and safety in regulation.Quote:"Just because you're meeting the standard, that just means that you're passing... That doesn't necessarily mean that you're making a safe and effective product." – Mike DruesReference Links:Mike DruesFDA Guidance: Best Practices for Selecting a Predicate Device to Support a Pre-Market Notification [510k] SubmissionFDA Guidance : Recommendations for the Use of Clinical Data in Premarket Notification [510(k)] SubmissionsFDA Guidance: Evidentiary Expectations for 510(k) Implant DevicesGreenlight GuruEtienne Nichols' LinkedIn*Interested in sponsoring an episode? Click here to learn more!

Description:In this episode, Ellie Reynolds, Associate Director of Quality Assurance and Regulatory Affairs at Proxima Clinical Research, dives deep into the complexities of FDA submissions for medical devices. She sheds light on the nuances of different submission types, such as 510K, De Novo, and PMA, and underscores the criticality of timelines, strategic planning, and a robust Quality Management System (QMS). Reynolds also guides listeners through effective FDA interactions, the eSTAR system, and the significance of building relationships with review teams. Her expertise illuminates the path to successful FDA submissions, emphasizing preparation, organization, and proactive engagement with regulatory bodies.Some of the highlights of this episode include:Strategic alignment of clinical trials with market launch timelines is crucial for successful FDA submissions.Differentiating between submission types (510K, de novo, PMA) and how they are essential for navigating the regulatory landscape.Early interactions with the FDA through Q submissions and how those interactions streamline the market submission process.The importance of understanding and managing FDA review timelines, including potential pauses and extensions.How utilizing eSTAR helps identify documentation gaps and assess submission readiness.How pre-submission meetings with the FDA are instrumental in addressing potential gaps and receiving regulatory pathway guidance.The importance of comprehensive preparation and organization facilitate expedited FDA review, despite uncontrollable factors.Quote:"Interact with FDA early and often. It's what ultimately will make your submissions as seamless as possible." - Ellie ReynoldsReference Links:Ellie Reynolds LinkedInGreenlight GuruEtienne Nichols LinkedIn*Interested in sponsoring an episode? Use this form and let us know!

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

Description:In this episode, host Etienne Nichols and Shannon Bennett, a regulatory affairs expert in the diagnostic testing space dive into the FDA's proposed rules for Laboratory Developed Tests (LDTs) and In Vitro Diagnostic products (IVDs). Shannon breaks down the past and present regulatory landscapes of LDTs, the differences between IVDs and LDTs, and what the FDA's changes could mean. They discuss the cost implications and the learning curve for labs new to FDA's processes. Shannon explains the FDA's four-year phased plan for labs to comply with the new rules, touching on the challenges at each phase, like the administrative burden and the influx of submissions the FDA might have to review. Focusing on the transition for new or modified tests, Shannon emphasizes the need for more guidance from the FDA and educational efforts to help labs understand the new terms and requirements. We also discuss the potential disruption to healthcare and urge labs to actively comment on the draft regulations to the FDA. Through engaging dialogue, this episode is a deep dive into the regulatory shifts in the lab industry, making it a great listen for those in the regulatory and healthcare fields.Some of the highlights of this episode include:Concerns regarding the handling of new or modified tests during the four-year phase-in period, emphasizing the need for clear guidance alongside historical tests.Discussion on a unique approach from the Valid Act called technology certification, aimed at easing submission and review burdens on both labs and the FDA.The significant educational effort required from the FDA to help labs navigate new terminologies and requirements.The potentially disruptive impact on healthcare, given the critical role laboratory testing plays.Encouragement for labs to actively provide comments on draft regulations to the FDA, advocating for a balanced approach to regulatory developments.Year One: The focus is on adverse event reporting, with Shannon suggesting additional FDA guidance to manage irrelevant adverse event reports.Year Two: registration and listing phase is discussed, pointing out the clerical burden on labs despite having most required information.Year Three: The introduction of Quality System Regulation (QSR) or Good Manufacturing Practice (GMP) requirements in year three is explored, with Shannon mentioning some overlap with existing CLIA compliant quality systems but highlighting FDA's additional documentation expectations.Year 3.5 & 4: Shannon delves into the submission of Premarket Approval Applications (PMAs) for high risk, low, and moderate risk tests in year three and a half and year four, underlining the challenge for labs in categorizing their tests and for the FDA in handling a potential influx of 80,000 to 100,000 new submissions.Quote:"I think the bottom line is this will be potentially very disruptive to the healthcare environment. Lab developed tests. There are studies that have shown that 70% of the information in the medical record is due to laboratory testing. So obviously, they play a really important role in the healthcare environment." - Shannon BennettReference Links:Shannon Bennett on LinkedInIVDs and LDTs: What’s the Difference?FDA Proposes New Rule to Regulate LDTs as IVDs: Here’s What’s at StakeGG Academy - use Promo Code "podcast25" for a 25% discountGreenlight GuruEtienne Nichols LinkedIn*Interested in sponsoring an episode? Use this form and let us know!

Description:In this episode, we discuss the past, present, and future state of EUDAMED. EUDAMED is the European Database for Medical Devices, and is part of the European Medical Device Regulation. While the EUMDR may have been published in 2017, many companies are still unsure how to handle the submission of their UDI (Unique Device Identification) data.Joining us to discuss this topic is Richard Houlihan, an international speaker and guest university lecturer on EUDAMED. His time running the European Commission IT teams developing EUDAMED has given him unrivalled insights into how EUDAMED affects the MedTech industry. This EUDAMED experience and his 28 years in IT give him a real advantage when helping companies prepare for EUDAMED, FDA GUDID, and other regulatory submissions. His company EirMed with the website eudamed.com provides ongoing EUDAMED and regulatory submission support, training, an EUDAMED mobile search app, and software to help Manufacturers, Importers, European authorised reps, and Distributors meet their EUDAMED obligations. To date, Richard and his team have trained over a thousand people on EUDAMED and helped hundreds of companies with EUDAMED consultancy and their regulatory data submissions to EUDAMED.We hope you enjoy this episode on EUDAMED!Some of the highlights of this episode include:After the European Commission's EUDAMED working group meeting in June 2023 and the publication of the minutes, we know that the legally required audit of EUDAMED will now take up to nine months and is to be completed in Q4 2024.Six months after the OJEU publication, EUDAMED will be deemed fully functional and EUDAMED will be mandatory. EUDAMED vigilance reporting for serious incidents will be mandatory from that point, Q2 2025 - the day after EUDAMED is fully functional.EUDAMED’s fully functional date is now expected to be Q2 2025. Ireland and France have already made EUDAMED mandatory for new products.For most medical device manufacturers, EUDAMED’s Actor, Device, and Certificate modules will be the only modules they'll use. These modules are already up and running. Quote:"...it's a hugely ambitious project. Now, the device module and the certificates module, they're both huge in themselves. The vigilance module, that's a whole ecosystem in itself and the clinical investigations for any poor devil involved in clinical investigations, this thing is an absolute monster, it's huge. But what they've done is they're putting them all together and they're connecting them all - in the real world, we would call that consolidation in a marketplace... I was told it was the second biggest It project ever undertaken by the Commission." - Richard HoulihanReference Links:Richard HoulihanEirMed (eudamed.com)GG Academy - use Promo Code "podcast25" for a 25% discountGreenlight GuruEtienne Nichols LinkedIn*Interested in sponsoring an episode? Use this form and let us know!

Description:In this episode, we discuss how to select a site for a Clinical Trial. Joining us for the conversation is Isabella Schmitt, MBA, RAC, the Vice President of Life Science Solutions at Proxima Clinical Research. Isabella brings a wealth of knowledge and experience in the intricacies of clinical study site selection, shedding light on the critical role it plays in MedTech product development.In addition, we're joined by Samantha Pickett, an Associate Director at Proxima Clinical Research. Samantha dives deep into the key considerations for site selection, emphasizing the significance of patient demographics, regulatory compliance, and technological access.This was a fun conversation as we discussed how to navigate the complexities of regulatory landscapes, explore collaboration strategies, share best practices, and draw insights from real-world case studies.Some of the highlights of this episode include: 1. Why Site Selection Matters:In the realm of MedTech product development, site selection is the linchpin. It can make or break the trajectory of your innovation.Selecting the right geographic location and clinical trial site sets the stage for successful outcomes and paves the way for future success. 2. Key Considerations for Site Selection:Let's dig into the key considerations when selecting a site for your clinical study. Patient demographics, regulatory environment, and investigator expertise are vital factors.Infrastructure, access to cutting-edge technology, and the patient population at the site are equally critical aspects to consider. 3. Navigating Regulatory Landscape:Regulatory challenges can be formidable obstacles in the site selection process. We'll explore the complexities and implications these challenges can have.Tune in to learn about strategies that can help you navigate these hurdles, ensuring compliance and successful site selection. 4. Collaboration and Partnerships:Collaborating with research institutions, hospitals, and academic centers can be a game-changer. We'll discuss the numerous benefits this collaboration can bring to your site selection process.Moreover, we'll provide insights into strategies for establishing fruitful partnerships that enhance your site selection efforts. 5. Best Practices and Case Studies:Let's delve into real-world examples from the MedTech industry. We'll share success stories and case studies that illuminate the art and science of site selection.By extracting actionable insights and best practices from these examples, we aim to empower you in your own site selection endeavors.Quote:"Your aim should be to ensure everything aligns with expectations. The IRB's primary focus is patient protection, ensuring they comprehend the trial's details, risks, and benefits while safeguarding their privacy." ~Samantha PickettReference Links:Samantha PickettIsabella SchmidtGG AcademyGreenlight GuruEtienne Nichols LinkedIn*Interested in sponsoring an episode? Use this form and let us know!

Description:In this riveting episode of the Global Medical Device Podcast, Etienne Nichols brings together the dynamic leaders from Greenlight Guru: David DeRam (internally known as DD) and Pall Johannesson. Together, they embark on a journey through the chronicles of Greenlight Guru and SMART-TRIAL, exploring its growth, trials, and moments that defined its course. The conversation is sprinkled with heartfelt personal anecdotes, emphasizing the brand's commitment to unwavering quality and the pivotal shifts during the COVID-19 pandemic.The trio delves into the intricate dance of nurturing a thriving work culture in the MedTech arena, especially amidst the waves of the changing remote work landscape. They share profound insights into navigating the maze of regulations in the medical device sector, underscoring the critical importance of resilience—captured by the evocative term "alligator blood"—to thrive in such a challenging environment.Drawing the curtain back on the transformative world of medical technology, this episode is a deep dive into the role of mindset coaching, poignant patient stories, and the horizon of MedTech. With glimpses into AI's impending role and technological leaps, interwoven with light-hearted tales of branded socks, Etienne, DD, and Pall craft a narrative that underscores the core values and vision that propel Greenlight Guru forward.Some of the highlights of this episode include:A deep dive into why thriving in MedTech hinges on a fervent love for the mission, an unwavering dedication to the community, and an undying drive to champion quality of life.The compelling origin story of Greenlight Guru, birthed from an unmistakable need to provide robust backing for medical device professionals.The courageous pivot of Smart Trial: How they chose to scrap months of effort and boldly embrace the future with cutting-edge technology.The resilience shown by Greenlight Guru during the COVID-19 storm: A seamless evolution from traditional office environments to adaptive global remote workspaces.How, even in a virtual setting, Greenlight Guru maintained a palpable culture that not only kept the team connected but resonated profoundly with customers.The blueprint for businesses in a post-COVID world: Understanding that adaptability and innovation aren’t just trends, but necessities for survival and growth.An exploration into the challenges and opportunities presented by regulatory shifts: For the forward-thinkers, these aren't mere hurdles, but potential goldmines.Why the term “Alligator blood” embodies the very resilience and fortitude required to chart the tumultuous waters of the MedTech industry.The secret sauce of MedTech success: A strategic focus on investing in individuals defined by their grit, fiery passion, and boundless ambition.A heartening reminder that MedTech’s real impact goes far beyond just technology—it's about making profound, tangible improvements in the quality of life.Quotes:"You have to fall in love with the space and the community and the patients, and the concept that improving the quality of life is everything if you're going to be successful here." - David DeRam"We all have almost unlimited capacity. We can do pretty much anything that we want to do... It comes down to are we going to quit or are we not going to quit? We know what to do... Which is why we invest in Mindset coaching. We talk a lot about energy, we talk a lot about intention, and we built our team on that culture." - David DeRamReference Links:David DeRam LinkedInPall Johannessen LinkedInGG AcademyGreenlight GuruEtienne Nichols LinkedIn*Interested in sponsoring an episode? Use this form and let us know!

Description:In this episode recorded in front of a live audience in Boston, MA, we speak with Christy Sheehy-Bensinger, the CEO & Founder of C-Light Technologies, Inc. about their recently cleared eye movement monitor. Listen as we unpack her journey from academia to startup life, explore the complexities of medtech communication, and delve into the intricate dance of securing FDA clearance. This was a fun conversation, with good Q&A at the end where we discuss the highs and lows of pioneering digital health solutions, the significance of a quality-first mindset in MedTech, and the art of crafting a passionate team.Some of the highlights of this episode include:Transitioning from academia to startup, and the demands of adaptability; navigating the real-world validation while staying solution-driven.Navigating the regulatory landscape, and the marathon that it is and how being FDA-cleared is just one of the many milestones.Building a quality-centric culture from day one to set the tone for long-term success in the MedTech space.How building a startup is akin to fixing a plane mid-flight – it's challenging but passion and clarity make it feasible.Tailoring communication, and how suiting it to the listener's background can be the game-changer in understanding and collaboration.Quote:"Management, speaking their language is super important. If I can compare it to what I already know, then that's easier." - Christy Sheehy-BensingerReference Links:Christy Sheehy-BensingerC-Light TechnologiesGG Academy - use Promo Code podcast25 for a 25% discountGreenlight GuruEtienne Nichols LinkedIn*Interested in sponsoring an episode? Use this form and let us know!

Description:In this episode, we explore the impact of software development methodologies in the medical device industry. With industry experts from HTD Health, we dissect the Agile approach to compliance, the intricacies of Quality Management Systems (such as Greenlight Guru), and go-to-market challenges for innovative medical devices.Zach, CEO of HTD Health, is a self-taught software engineer turned serial entrepreneur. His first venture, Fresh Corner Cafe, served fresh food in Detroit's food deserts for eight years. He then founded HTD Health to craft digital health solutions, pioneering the shift to virtual care. The company supports care providers, device makers, and life sciences. Zach also founded Exos, a governance SaaS, and sold it in 2022.Weronika Michaluk, a jack-of-all-trades in biomedical engineering, business, and public health, leads HTD's Software as a Medical Device unit. With degrees from Miami and Warsaw, plus a Doctorate in Public Health, she's worked on everything from wireless ECGs to digital health consulting. At HTD, her laser focus on quality and customer satisfaction drives organizational success.Some of the highlights of this episode include:An introduction to "Compliant Agile," a balanced methodology for MedTech development that prioritizes customer interaction while maintaining regulatory compliance.The importance of choosing the right Quality Management System (QMS), highlighting the flexibility and feature-rich experience of Greenlight Guru.The need for companies to focus on their core competencies while being adaptable and compliant.The importance of a positive mindset and a well-defined success metric for any MedTech project.Quote:"Our mission is to make the industry more accessible, more human centric and more productive" - Zach MarkinReference Links:HTD Health pageHTD SaMD InsightsHTD SaMD ChassisZach Markin LinkedInWeronika Michaluk LinkedIn GG AcademyGreenlight GuruEtienne Nichols LinkedIn*Interested in sponsoring an episode? Use this form and let us know!

Description:Join Devon Campbell in MedTech funding. He unveils startup red flags, from data integrity to product maturity. His message? Know your weaknesses, fill the gaps.Considering cold-calling other Founders? It works. Understand your their investment landscape first. Recognize that VCs and Angels have different risk profiles. Devon says know your funding options and their strings. It’s about terms and expectations, not just money.Think a sleek exterior hides internal flaws? Devon focuses on product readiness and QMS. Be manufacturing-ready and optimize. No shortcuts in MedTech.In a red-tape world, paperwork matters. It's about confidence, not bureaucracy. Devon shifts focus to quality systems as confidence builders. His point? "Unquestionable, indelible data—that’s what I can trust." Get organized, and confidence becomes your MedTech currency.Some of the highlights of this episode include:Knowing your weaknesses. It's important to recognize your gaps and seek the right help.Maintain data integrity. Full disclosure of data builds trust - no sugar-coating..Evaluating product maturity - good looks aren't enough; be manufacturing-ready.The importance of a strong Quality Management Systems (QMS). Document, document, document. No excuses.Risk Management isn’t a checkbox: it's an ongoing pledge to safety.Quote:"Unquestionable, indelible data—that's what I can trust. That's confidence." ~Devon CampbellReference Links:Devon CampbellProdctGG AcademyGreenlight GuruEtienne Nichols LinkedIn*Interested in sponsoring an episode? Use this form and let us know!

Description:In this episode, Etienne Nichols and Ellie Reynolds explore FDA's Breakthrough Device designation. They discuss pursuing breakthrough status, aligning marketing strategies with FDA review, and navigating the medical device industry. This episode provides a roadmap for this complex regulatory terrain.Learn about the benefits and scrutiny of the breakthrough designation, hear examples that emphasize the need for precise data and quality in the application process, and listen as we explain the planning and considerations for success, and how innovation can thrive within regulation.Some of the highlights of this episode include:The changes in CMS reimbursement, and how breakthrough devices no longer guarantee automatic CMS reimbursement.Planning for FDA Submission, and how to align with FDA timelines.Competitive Landscape - how achieving breakthrough is still possible, even if competitors have it.Whether or not it's worth pursuing Breakthrough Designation.The benefits of Breakthrough Designation Benefits (such as FDA priority review and potential marketing buzz).Quote:"Say you are a direct competitor with someone else, and they got breakthrough but they're not on the market yet... You can still get breakthrough for the same indication. FDA does not consider that as a cleared or approved alternative - even if they're miles ahead of you."Reference Links:Ellie Reynolds LinkedInProxima CROEtienne Nichols [email protected] AcademyGreenlight Guru*Interested in sponsoring an episode? Use this form and let us know!

Description:In this episode of the Global Medical Device podcast, we discuss the intricate world of medical device regulations, design, and innovation. Hosted live in San Jose, the podcast features the esteemed Nada Hanafi, SVP - Regulatory Strategy at Veranex, who brings her rich experience of 12 years at the the FDA and Regulatory Strategy to discuss pressing issues and notable developments in the industry.Join us as we delve deep into crucial topics such as biases in medical device testing, the evolving approach of the FDA, and the importance of user-centric design. This episode offers a comprehensive look into the dynamic and ever-evolving realm of medical technology, emphasizing the balance of innovation and regulation.Highlights of the episode include:Skin Tone Bias in Medical Devices: Nada Hanafi spotlighted the biases in pulse oximeters, shedding light on how these devices often fail to perform efficiently across varied skin tones. A lack of diversity in validation tests, mostly relying on Caucasian young men, resulted in compromised health outcomes for others.Evolution and Transparency of the FDA: Nada traced the journey of the FDA, illustrating its transformation towards greater transparency and predictability. Emphasizing the human touch behind FDA's decisions, she dispelled the myth of the FDA being an impersonal "black box".Global Regulatory Movements: Highlighting a shift in the MedTech landscape, Nada pointed to the trend of global regulatory harmonization, particularly noticeable in the realm of software-based medical devices.Importance of User-Centered Design: Nada and the panel emphasized the significance of involving patients early in the design phase. Using tools like personas and human factor tables can lead to products that truly cater to users' needs, ensuring both usability and safety.Embracing Learning in MedTech: Nada's hope for companies to learn from past oversights and adapt to changing regulations stressed the crucial role of iteration and learning in medical device innovation.Navigating Modern MedTech Challenges: From addressing the significance of thorough documentation practices to discussing the challenges of regulating AI-driven medical devices, the discussion underscored the ever-evolving MedTech arena and the imperative need for regulators to stay updated.This episode paints a comprehensive picture of the medical device industry, addressing both its challenges and its advancements.Quote:"Medical devices shouldn't be designed with a one-size-fits-all approach. We've seen firsthand the impact of biases, like with pulse oximeters. It's crucial that we validate devices across diverse populations to ensure safety and efficacy for all."Reference Links:Nada HanafiMedTech ColorMedTech InnovatorVeranexEtienne NicholsTrue Quality RoadshowGreenlight Guru AcademyGreenlight Guru Software

Description:During the Houston leg of our True Quality Roadshow series, we had the opportunity to sit down with Dan Purvis, CEO of Velentium and author of "28 Days to Save The World." Dan tells the story of how his company weathered the early days of startup life, and how the pandemic - which took so many companies down - turned out to be the springboard that tested the culture that Dan and his co-founder had molded from the very beginning.If you're not familiar with our True Quality Roadshow - you should definitely check it out! It's a free half-day event at one of 6 cities across the world. Links below!Some of the highlights include:The role Velentium played in upscaling the production of ventilators during the pandemic - this was a significant achievement and showcases Velentiums leadership, collaboration, and company responsiveness during this worldwide crisis.Real-life challenges faced by companies, especially dramatic stories like the purchase of parts without a PO and the personal involvement of the leadership, and paint a vivid picture of commitment and dedication.The central theme of a company's mission ("We exist to change lives for a better world") and how it guides its decisions is foundational and deeply impactful.The pivotal role that company culture plays, even when compared to strategic planning.The long-term vision of a company, and we emphasize that while actions and technologies change, the core mission remains constant.The decisions Dan was faced with, such as how (or if!) to pay employees during a crisis, and we highlight the ethical considerations a company has to make, and how to stay aligned with a company's core values.The emphasis on finding clients to fund growth rather than relying on investors - this is not only pragmatic advice for startups but also provides a unique perspective on business growth.Quote:"Because as a leader, if you don't clearly know where you're headed, it's really hard to get a bunch of people to follow you. And I don't want people to follow me. I want them to race me up the mountain, which is the one that we've all decided to ascend together."Reference Links:Dan Purvis LinkedIn28 Days to Save The World bookEtienne Nichols LinkedInTrue Quality RoadshowVelentiumTexas Medical Center for Innovation

DescriptionIn today’s episode, Shawnnah Monterrey discusses the 3P510k - which is short for the 510k 3rd Party Review Program. This is a lesser known program, but there can be significant benefits from using it, which we talk about during the episode. Some of the issues we discussed include:How utilizing this program can accelerate the submission process, or at least remove some uncertainty around the timelineWho this program is for - not just for small startups, but rather how even experienced Regulatory Affairs specialists working at large corporations can benefit from this program.Lastly, we don’t usually get into the specifics of cost and expenses, but we even discuss some of the differences in how much you’ll pay using the 3P510k route vs. the traditional submission route.Shawnnah Monterrey is the founder of BeanStock Ventures after nearly a 20-year career as a technical leader. Shawnnah was responsible for developing strategies and leading complex global product development programs and functional management of software and software quality assurance departments for both startup and mature organization with emphasis on the development of medical instruments, life science, diagnostics, clinical applications.Reference Links:Shawnnah Monterrey on LinkedInBeanStock Ventures – 3P510kEtienne Nichols on LinkedInGreenlight Guru softwareFDAs 3P510k page

DescriptionMost people in the world of Medical Devices know that they need a Quality Management System, but what is the best way to go about building that QMS, when should you start, and how do you know when you've built it to the point it can stand on this own?In this episode, Rob MacCuspie, PhD, Manager of Regulatory and Quality Affairs at Proxima Clinical Research, Inc., discusses the best practices of companies he has worked with to help implement their Quality Management System in a manageable way.Takeaways:What is the difference in your QMS and a Document Management System?What is the most important aspect of a QMS?Who really needs a QMS, and when?What are the phases of a QMS?How to start building a QMS.Quote:""If my SOPs and training process can bring in somebody that has no experience and they can hit the ground running, I'm not worried if the auditor has any experience now in my space, right. Because I now have everything in place to show somebody how they can teach themselves and learn and get up to speed and walk through the process."Reference Links:Rob MacCuspie on LinkedInEtienne Nichols on LinkedInProxima Clinical ResearchGreenlight Guru software

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

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

In this episode, Sandra Rodriguez, an analyst at Axendia, dives deep into the complexities of Computer Systems Validation (CSV) versus Computer Software Assurance (CSA) in the MedTech sector. She discusses the FDA's draft guidance from September 2022, the industry's response, and the practical applications of it all. The conversation also covers the evolution of software validation processes, the cost of system implementation, and the importance of critical thinking in Quality System Regulations. The impact of AI on Quality Assurance, the changing dynamics of the CSA Modern Validation, and the role of Software Assurance in the life sciences industry are also discussed.Some of the highlights of today’s show include:The evolution of software validation processes, the cost of implementing a system in the life sciences industry, and the role of critical thinking in Quality System Regulations.FDA's draft guidance from September 2022, the industry's response, and its practical implementationsThe cultural shift and challenges that accompany the transition to CSA Modern Validation.The evolving relationship between life science companies and their technology vendors and how it can bring value to the organizationThe pivotal role of Computer Software Assurance (CSA) in the life sciences industry, including the unintended consequences Cybersecurity and how the FDA is looking to adopt this approach across multiple agenciesHow companies can stop spending resources on testing every feature and functionThe industry's shift towards automation and data-driven processesThe use of the word “validation” vs. “assurance”Links:Medical Device International ConsortiumCase for Quality Working GroupsFDA CSA Draft GuidanceEtienne Nichols LinkedInGG AcademyOmnibus BillGreenlight GuruQuotes: “Keep in mind if you talk software validation to anyone outside of life sciences, they're going to glaze over. Validation is not used. Software validation is not used outside of this industry.”“You could tell a lot about potential changes to a draft guidance based on the number of times you see certain things show up as a comment.”“Now look, if everything is high risk, then you didn't do a risk assessment, just like if everything's a high priority, you haven't prioritized anything.”

How can dFMEA and ISO14971 work together? This topic is controversial but essential, and today’s guest is more than capable of tackling it. Risk management is one of the top 3 reasons why the FDA issues 483s, so it’s important to understand.In today’s episode, Wade Schroeder, a medical device guru with a master's degree from the University of Dayton, shares his insights on risk management in medical device design. Wade discusses the importance of a top-down approach, the collaboration between dFMEA and ISO4971, and how Greenlight Guru software aligns with ISO14971. The conversation covers the value of considering the patient perspective, the complexities of regulatory, ethical, and business obligations, and the benefits of tools like dFMEA and fault tree analysis.Some of the highlights of today’s show include:Understanding risk management in medical device designImportance of collaboration between dFMEA and ISO4971Exploring ISO14971 and FDA consensus standardsA top-down approach to risk management in medical device designConsidering the patient perspective in the risk management processThe complexity of regulatory, ethical, and business obligationsISO14971 as a regulatory burden ensuring patient safetyHow Greenlight Guru is designed to align with ISO14971Benefits of tools like dFMEA and fault tree analysisMapping dFMEA and ISO14971 for FDA reviewLinks:Wade SchroederEtienne Nichols [email protected] NationGG AcademyGreenlight GuruQuotes: “Put simply, it's all about telling the story of what could go wrong with your device and what harms could that lead to." -- Wade Schroeder "Before you even start your design, you’ve identified, ok, here’s the serious harms we need to avoid." -- Wade Schroeder

Management responsibility is crucial to the success of a QMS… but what is it? What’s covered by the topic of management responsibility and who’s the responsible party? In today’s episode, you’ll hear from Sara Adams, Lead Auditor, Quality Engineer, and now Medical Device guru, on the subject of management responsibility and all that entails. Listen to the episode to learn what Sara is thinking about when she thinks about the topic of management responsibility. She shares her thoughts on quality policy, organizational structure, management review, and quality systems procedures. Some of the highlights of today’s show include:Whether a summary statement is enough, or whether the policy needs to be a paragraphWho the management representative is and what they are supposed to doWhy you need management review even if you’re not selling productsGetting executive management on board with a culture of qualityMaking management review meaningfulLinks:Sara AdamsEtienne Nichols LinkedInGG AcademyGreenlight GuruQuotes: “The quality policy should be the battle cry, the rally cry, the thing that pumps us up that we remember, not just words on a page.”“It is really important to have enough resources in the right roles to be able to meet the requirements of this regulation.”“Don’t just gloss over it. It is something that you have to do, but make it meaningful.”

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

What is lean documentation and how can you achieve it? Our guest on today’s live podcast is an expert on quality management systems, audits, and most importantly for today’s conversation, documentation. Steve Gompertz is a partner at QRX Partners and has led initiatives in project management, engineering automation, configuration management, audit, and software development.During today’s episode, we’ll talk about the most important parts of a QMS, what differentiates a good QMS from a bad one, and how to prove ROI on a QMS. Steve will also discuss what he would do if he were starting a medical device company today. Listen to the episode to learn more about lean documentation and how you can learn to write for your actual audience – the workers – while still pleasing the auditors.Some of the highlights of this episode include:What it means to have lean documentation, and what the norm is in the MedTech communityHow to write for employees while meeting auditor requirementsBuilding a template for a standard operating procedureCollaboration between the production of a document and ownership of that documentMaking repairs on documentation vs. starting overProving the ROI on a good or bad QMSTaking care not to be overly prescriptiveThe importance of root cause analysis over treating symptomsMapping instead of including every SOP and repeating yourselfWhat management responsibility looks likeMaking documentation work better in terms of root causesMemorable quotes from Steve Gompertz:“I’m fond of telling people, ‘The auditors don’t work here. That’s not who these documents are for.’”“Done correctly, efficiency and effectiveness are not enemies.” “Everybody has a customer internally; everyone produces a product.”“On the quality systems pyramid, the smallest piece is the quality manual. So why is it the biggest document.”Links:Steve Gompertz LinkedInQRX PartnersEtienne Nichols LinkedInGreenlight Guru

The "Consolidated Appropriations Act of 2023" (more commonly referred to as the Omnibus Act) was passed and signed into law on December 29th, 2022. This amendment to the Food and Drug Cosmetic Act has expanded the scope of the FDA beyond just "safety and efficacy" to include the cybersecurity of medical devices. This amendment resembles a watered-down version of the PATCH Act, which failed to pass in late 2022.As a result, on March 29, 2023, the FDA gained the legal authority to define and enforce medical device cybersecurity. So for today’s episode, we got THE leading minds in MedTech cybersecurity together to discuss what we need to do next. Chris Gates, Director of Product Security at Velentium, Chris Reed, Vice President of Product Security at Medtronic, and Ken Hoyme, CEO of Dark Star Consulting, join the podcast today to discuss the new guidelines, what the FDA can and can’t say about it, and what kinds of deficiencies you’ll be seeing in the future because of the new legislation.Some of the highlights of this episode include:How the FDA tried to clear a path for routine patches and updatesThe minimum that the omnibus bill is talking aboutNo longer needing to make the link between cybersecurity and safety and effectivenessWhen they have the legal authority to enforce cybersecurityWhy the document took so long to go throughSecurity architecture analysisWhy you should be referencing the April 2022 draftUnpatched vulnerabilities at the time of submissionThe effort needed to understand the FDA’s intentionsMemorable quotes from this episode:“Literally, if you’re not aware of this already, you’re already behind the 8-ball right now and there’s things you’ve got to do.”“Basically, if you think it might be a cyber device, it is a cyber device.”“Don’t sit there and try to be pedantic about this and say “I don’t need to do this because there’s a comma here.” It ain’t gonna work for you.”“A synonym for threat modeling really is security architecture analysis.”Links:Christopher GatesChris ReedKen HoymeVelentiumMedtronicDarkStar ConsultingMedical Device Cybersecurity in 2023 and Beyond SlidesEtienne Nichols LinkedInGreenlight Guru

With the advent of new Artificial Intelligence (AI) tools, where is risk management headed? How are they affected by the changes? Risk management is essential and becoming more so due to increased risk measures, and it’s important to understand what’s happening in the industry. To that end, today’s guest, Tyler Foxworthy, will share his expertise on the subject. Tyler Foxworthy was the Chief Data Scientist at Resultant, then the Chief Scientist at Demand Jump. Before founding his own company, he applied statistics and machine learning to help the medical device industry make informed decisions about changes to their devices. The company that he founded, Vertex was acquired by Greenlight Guru, where Tyler is now the Chief Scientist.Listen to the episode to hear Tyler explain more about data quality, the future of risk assessment, and how Bayesian statistics and analysis come into play.Some of the highlights of this episode include:When can we reach a point where we know the data is accurateThe future of risk assessment for MedTechWhy use a model for predicting riskHow this model impacts a companyThe change in trajectory for the medical device industryMemorable quotes from Tyler Foxworthy:“There is no such thing as absolutely perfect data, there’s only degrees of quality.”“I would like to see it as more rigor, in general, brought to the industry.”“This whole field of probabilistic risk assessment is firmly rooted in Bayesian analysis.”“This idea of using, bringing out tools and techniques and knowledge from other domains and fork lifting it into our industry, and making it valuable, to me there’s just something really intellectually appealing about that.”Links:Tyler Foxworthy LinkedInEtienne Nichols LinkedInGreenlight Guru AcademyGreenlight Guru

What are the 4 buckets of information that MedTech professionals should consider when commercializing their device? Where is the line between perspectives when it comes to regulatory affairs professionals and regulatory affairs attorneys? Those are just a few of the items covered in today’s live discussion with Mark DuVal.Mark is the founder and president of Duval & Associates. He’s been in healthcare marketing and advertising for over 20 years and is a leading expert in medical device promotion. In today’s episode, you’ll learn his tips for creating “appropriately aggressive, yet compliant” ad campaigns. Learn from Mark’s expertise as he discusses the four buckets of knowledge for information sharing, the different perspectives between regulatory and legal, and how to think about the information provided with a medical device.Some of the highlights of this episode include:The difference in perspectives between a regulatory affairs professional and a regulatory affairs attorneyBest recommendations for regulatory affairs professionals when approaching off-labelExamples of when the dissemination or communication of on and off-label information comes into playGeneral and specific use, and being specific with your indication for useWhether a case study could be built around a physician’s off-label useHow compliance monitors sales for off-label promotionAd promo enforcement actionMemorable quotes from Mark DuVal:“The regulatory affairs professionals are, a lot of times, they’re biomedical engineers and scientists, and they are much more steeped in the medicine and the science as we would be as lawyers.”“It’s kind of a mantra I make everyone repeat when I do a training exercise – I make them repeat after me, truthful, not misleading, fairly balanced.”“You have every right to participate in social media. But again, you’re still regulated.”“We don’t feel people should unnecessarily leave money on the table, nor should they foolishly aggravate FDA and receive a warning letter and get told to cease and desist.”“When you’re in the trenches day-to-day, trying to convince them to use something that’s real-world data is work. It can be done, though!”Links:Mark DuValDuVal & AssociatesCardiac Arrest: 5 Years as a CEO on the Feds Hit List (book)Guidance for Industry Distributing Scientific and Medical Publications on Unapproved New Uses — Recommended PracticesMedical Product Communications That Are Consistent With the FDA-Required Labeling — Questions and AnswersWashington legal foundation caseGeneral/Specific Intended Use - Guidance for IndustryEtienne Nichols LinkedInGreenlight Guru