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 Adams Key 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 devices Questions for the Audience: Poll: Do you believe that advances in electronic QMS will significantly reduce compliance issues in the next 5 years? Call for Feedback: Enjoy this episode? Leave us a review on iTunes and suggest topics you’d like to hear about in future episodes. Email us your feedback and ideas at podcast@greenlight.guru Connect with Us: Follow Etienne on LinkedIn: Etienne Nichols Follow Sara on LinkedIn: Sara Adams Join 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 focus 00:03:50 - Discussing the challenges of MedTech product development and regulatory hurdles 00:12:20 - Agile methodologies vs. traditional project management in MedTech 00:22:35 - The importance of risk management and Monte Carlo simulation in project planning 00:34:10 - Perry's perspective on innovation, compliance, and balancing project priorities 00:45:55 - Strategies for efficient and effective product development processes Quotes: "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 Parendo Takeaways Insights 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 LinkedIn Etienne Nichols on LinkedIn Behavioral Grooves podcast with Annie Duke - Thinking in Bets Book - Someday is Today, Ron Richard Youtube video - the Heartbeat of New Product Development Quality Culture for Product Design Success

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 participation Notable 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 Kaplan Key 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 LinkedIn Kim Kaplan on LinkedIn FDA’s Final Guidance on the Voluntary Improvement Program ISACA's overview of FDAs Voluntary Improvement Program (VIP) Regulatory opportunities of the...

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 Saner Takeaways: 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 LinkedIn Etienne Nichols on LinkedIn The Ultimate Guide for UDI ReedTech's UDI Compliance Solution Beginner's Section: MedTech 101 For new listeners, UDI (Unique Device Identification) is a system used by regulatory authorities to identify and track medical devices through their distribution and use. It's a crucial component of medical device regulation, ensuring the safety, efficacy, and traceability of devices. Questions for the Audience: Poll: "What do you believe is the biggest challenge in achieving global UDI compliance?" Discussion Question: "How do you foresee the advancements in MedTech impacting healthcare delivery in the next decade?" Feedback and Future Topics: We value your feedback and ideas for future episodes. Please email us at podcast@greenlight.guru with your suggestions and thoughts. Sponsors: This episode is brought to you by Greenlight Guru, the MedTech industry's leading solution for product development and compliance. Discover how Greenlight Guru can accelerate your product's journey to market by visiting www.greenlight.guru

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 professionals Quotes: "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-learned Connect 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...

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 Karow Takeaways: 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 video Medtech Innovator Blythe Karow on LinkedIn Etienne Nichols LinkedIn Springboard Digital Health Innovation Program Feedback and Future Topics: We value your feedback and suggestions for future episodes. Share your thoughts and ideas by leaving a review on iTunes or emailing podcast@greenlight.guru Sponsors: 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 proactive Quotes: "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 Ram Key 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 Profile Etienne Nichols' LinkedIn Profile Greenlight Guru Questions for the Audience: "What advice do you have for budding Regulatory Affairs professionals?" Reach out to us and let us know what you thought of the episode at podcast@greenlight.guru Also, 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 Rasooli 00:00 - Introduction to AI in MedTech 05:15 - Discussing AI's deterministic vs. statistical nature 12:30 - AI in diagnostics: Radiology, Cardiology, and Neurology 20:45 - Wearable health monitors and patient-driven health data 28:10 - The role of AI in medical device operations and manufacturing 35:00 - AI at the point of care: Enhancing patient and clinician experience 42:15 - Regulatory challenges and the future of AI in healthcare Key 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 LinkedIn ashkon@engeniussolutions.com Engenius Solutions AFDO/RAPS Working Group Etienne Nichols on LinkedIn Sponsors: 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.guru Share your thoughts and questions with us at podcast@greenlight.guru

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-Tudor MedTech 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 Consulting Jennifer Mascioli-Tudor on LinkedIn Etienne Nichols on LinkedIn Greenlight Guru’s platform for Quality Management & Clinical Investigations Questions for the Audience: Discussion: "How do you envision MedTech changing the landscape of healthcare in the next decade?" Feedback: Love the episode? Have suggestions or topics you’d like to hear about? Email us at podcast@greenlight.guru and leave a review on iTunes! Sponsors: This episode is brought to you by Greenlight Guru, the only quality management software designed specifically for the medical device industry. Streamline your process and foster innovation with Greenlight Guru’s intuitive platform!

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 MedTech Quotes: "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 Nichols Takeaways: 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 Act US Executive Order on AI Maria Nyakern on LinkedIn Etienne Nichols on LinkedIn Questions for the Audience: Which AI-driven MedTech advancement excites you the most, and why? How do you envision healthcare changing in the next decade with the rise of MedTech innovations?" We value your thoughts - if you enjoyed this episode, would like to give feedback, or have suggestions for future episodes, please email us at podcast@greenlight.guru Sponsors: Greenlight Guru Today'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...

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 Henry Takeaways FTC'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. References Visit www.greenlight.guru for insights on streamlining product development in Medtech. Follow Eric Henry on LinkedIn for updates on AI, quality systems, and regulatory compliance. Explore the AI Global Health Initiative under AFDO and RAPS sponsorship. For questions or consultations, contact Eric Henry at ehenry@kslaw.com Visit 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 Kyria Takeaways Networking 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 LinkedIn Elemed Working Genius Greenlight Guru Etienne Nichols' LinkedIn Remember 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 Brown Reference Links: Carmen Brown Proxima Clinical Research Greenlight Guru Etienne 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 Shearlaw Fearsome Greenlight Guru Etienne 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 CDRH Lisa Pritchard, Vice President of Regulatory, Quality, Clinical and Engineering at DuVal & Associates Kathy Herzog, Senior Regulatory, Quality & Compliance Consultant at DuVal & Associates As 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 Herzog Reference Links: Lisa Pritchard Kathy Herzog Etienne Nichols Greenlight Guru DuVal & Associates Client Alert: "eSTAR & I" FDA eSTAR Program webpage FDA electronic Submission Template guidance for 510(k) Submissions

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 Schroeder Reference Links: Wade Schroeder on LinkedIn AI in MedTech Report 2023 Digital Guru Greenlight Guru Etienne Nichols on LinkedIn Interested 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 Campbell Reference Links: Devon Campbell Prodct Greenlight Guru Etienne 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 Drues Reference Links: Mike Drues FDA Guidance: Best Practices for Selecting a Predicate Device to Support a Pre-Market Notification [510k] Submission FDA Guidance : Recommendations for the Use of Clinical Data in Premarket Notification [510(k)] Submissions FDA Guidance: Evidentiary Expectations for 510(k) Implant Devices Greenlight Guru Etienne 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 Reynolds Reference Links: Ellie Reynolds LinkedIn Greenlight Guru Etienne 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 Drues Reference Links: GG Academy - use Promo Code "podcast25" for a 25% discount Greenlight Guru Vascular Sciences Michael Drues LinkedIn Etienne Nichols LinkedIn *Interested in sponsoring an episode? Use this form and let us know!