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 podcast@greenlight.guruFeedback:We value your feedback on this episode! Please leave us a review on iTunes and share your suggestions for future topics at podcast@greenlight.guruSponsors: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 podcast@greenlight.guruSponsors:This episode is brought to you by Greenlight Guru, a MedTech Suite designed to accelerate product development while ensuring regulatory compliance. Learn more at Greenlight Guru.

In this episode of the Global Medical Device Podcast, Etienne Nichols is joined by Kavetha Ram, a seasoned expert in health and pharmaceutical sciences and the regulatory department leader at Spectra Medical Devices. Together, they delve into how new regulatory affairs professionals can get started in a career of medical device regulations and the shifting field of MedTech. The discussion offers a roadmap for professionals to navigate and thrive amidst these shifts. The episode is a treasure trove of knowledge for anyone looking to stay ahead in the MedTech realm.Key Timestamps:[00:00:30] Introduction to Kavetha Ram and the episode's focus[00:05:15] Discussion on the challenges and opportunities of new regulations[00:10:40] Insights into the importance of confidence and adaptability in the regulatory field[00:15:20] Kavetha's journey and advice for emerging professionals[00:25:00] The role of innovation and collaboration in MedTech advancements[00:35:10] Strategies for professionals to stay relevant and proactiveQuotes:"Regulations are not just hurdles; they are stepping stones to innovation and safety in MedTech." - Kavetha Ram"Embracing change in regulations is not an option but a necessity for MedTech's future." - Etienne Nichols"Diversity in teams isn't just about varied backgrounds; it's about unlocking unique perspectives that drive innovation." - Kavetha RamKey Takeaways:Insights into MedTech Trends:Regulatory changes are both a challenge and an opportunity for innovation.Practical Tips for MedTech Enthusiasts:Stay updated with regulatory changes and understand their implications.Engage in continuous learning and skill development.Foster collaboration across disciplines to enhance innovation.References:Kavetha Ram's LinkedIn ProfileEtienne Nichols' LinkedIn ProfileGreenlight GuruQuestions for the Audience:"What advice do you have for budding Regulatory Affairs professionals?"Reach out to us and let us know what you thought of the episode at podcast@greenlight.guruAlso, if you enjoyed this episode, please leave us a review on iTunes!Sponsors:This episode is brought to you by Greenlight Guru, the only quality management software designed specifically for the medical device industry. Greenlight Guru's platform streamlines product development and compliance, making the process more efficient and less risky. Discover how Greenlight Guru can accelerate your product development at www.greenlight.guru.

AI in MedTech expert Ashkon Rasooli explores the transformative impact of AI in the medical device industry. Topics discussed include AI-driven diagnostics, wearable health monitors, future of surgical robots, challenges in validating and regulating AI in MedTech, real-world applications, and future trends.

In this podcast, they discuss the importance of project management skills in quality and regulatory work in the medical device industry. They also cover topics such as influencing business leaders with quality, understanding changing regulations, designing products with the end user in mind, and the concept of design freeze in the medical device industry.

In a today's conversation on the Global Medical Device Podcast, host Etienne Nichols engages with Dr. Maria Nyakern on the burgeoning integration of AI in medical devices. They delve into the European AI Act, discussing its impact on innovation and the critical role of trustworthy systems in clinical research. The episode also touches upon the challenges and opportunities AI presents in MedTech, from data integrity to job displacement, and the human-centric approach to technology.Key Timestamps:[00:00:00] Introduction to the podcast and topic of AI in medical devices[00:03:25] Greenlight Guru's streamlined product development for MedTech[00:05:15] Dr. Maria Nyakern's background and entrance into AI[00:07:30] Discussion on the European AI Act and its significance[00:13:45] Comparison of US and European approaches to AI regulation[00:18:55] The intersection of MedTech experience and AI governance[00:23:10] The importance of data quality and integrity in AI-driven clinical research[00:29:00] The human aspect in AI development and clinical trials[00:35:10] Ethical considerations and the future of AI in MedTechQuotes:"AI systems...will be more cost-effective and less of a hurdle for companies to generate data sets for subsets of patients." - Maria Nyakern"Trustworthy AI systems must be worthy of humans." - Maria Nyakern"Embrace innovation with Greenlight Guru." - Etienne NicholsTakeaways:Latest MedTech Trends:Increased integration of AI in clinical research.The rise of wearable health monitors.Advancements in surgical robotics technology.Practical Tips:Stay updated on AI regulations.Invest in trustworthy AI systems.Leverage AI for cost-effective data generation.Future Predictions:AI will play a larger role in personalized medicine.There will be a push for global AI data sharing.Expect AI to drive faster, more accurate diagnostics.References:European AI ActUS Executive Order on AIMaria Nyakern on LinkedInEtienne Nichols on LinkedInQuestions for the Audience:Which AI-driven MedTech advancement excites you the most, and why?How do you envision healthcare changing in the next decade with the rise of MedTech innovations?"We value your thoughts - if you enjoyed this episode, would like to give feedback, or have suggestions for future episodes, please email us at podcast@greenlight.guruSponsors:Greenlight GuruToday's episode is brought to you by Greenlight Guru, the only MedTech-exclusive Quality Management Software designed with the direct input of industry insiders. Dealing with cumbersome product development cycles? Facing the maze of regulatory compliance? Greenlight Guru is your guiding light. Our comprehensive software 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

Eric Henry, AI in MedTech expert, and Etienne Nichols discuss the evolving landscape of AI in MedTech, focusing on regulatory compliance and the future of AI in medical devices. They explore the role of FDA and FTC, the implications of generative AI, and the potential revolution in quality management systems. The FTC's growing role and algorithmic disgorgement are highlighted, along with the importance of pre-market and post-market oversight.

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!