350 episodes

The Global Medical Device Podcast, powered by Greenlight Guru, is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.

Global Medical Device Podcast powered by Greenlight Guru Greenlight Guru + Medical Device Entrepreneurs

    • Health & Fitness
    • 4.8 • 78 Ratings

The Global Medical Device Podcast, powered by Greenlight Guru, is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.

    #358: FDAs Voluntary Improvement Program

    #358: FDAs Voluntary Improvement Program

    In this episode of the Global Medical Device Podcast, host Etienne Nichols sits down with Kim Kaplan from ISACA at the MD&M West trade show in Anaheim, California, to discuss the pivotal Voluntary Improvement Program (VIP). This conversation sheds light on how the program, stemming from FDA’s Case for Quality initiative, utilizes the Capability Maturity Model Integration (CMMI) to push medical device companies beyond compliance, towards excellence. Kaplan elucidates the history of VIP, its benefits, and how it aligns with the FDA’s vision for a more innovative and quality-focused MedTech industry.
    Key Timestamps:[00:00:30] Introduction of Kim Kaplan and the Voluntary Improvement Program[00:05:00] Explanation of CMMI and its adoption in the medical device industry[00:15:45] Distinctions between CMMI and other quality methodologies[00:25:30] In-depth discussion on the specifics and benefits of the Voluntary Improvement Program[00:40:00] How companies can implement change based on VIP insights[00:50:00] FDA’s perspective and regulatory opportunities tied to VIP 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 LinkedInKim Kaplan on LinkedInFDA’s Final Guidance on the Voluntary Improvement ProgramISACA's overview of FDAs Voluntary Improvement Program (VIP)Regulatory opportunities of the...

    • 28 min
    #357: The State of UDI Across the World

    #357: The State of UDI Across the World

    In this episode of the Global Medical Device Podcast, host Etienne Nichols is joined by Gary Saner, a seasoned expert in medical device Unique Device Identification (UDI) and regulatory compliance. They embark on a comprehensive exploration of the ever-evolving landscape of UDI requirements, shedding light on crucial deadlines, common pitfalls, and strategic insights for achieving global compliance. From the intricacies of European UDI requirements to the specifics of implementing UDI systems in markets like Australia and beyond, this episode is a treasure trove of actionable insider knowledge for medical device professionals navigating the complexities of UDI compliance.
    Quotes:"UDI has this ongoing life connected to it...it just doesn't seem to end. Once you do it, you're not done; you have to keep opening those books and making changes." - Gary 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 LinkedInEtienne Nichols on LinkedInThe Ultimate Guide for UDIReedTech's UDI Compliance Solution
    Beginner's Section: MedTech 101For new listeners, UDI (Unique Device Identification) is a system used by regulatory authorities to identify and track medical devices through their distribution and use. It's a crucial component of medical device regulation, ensuring the safety, efficacy, and traceability of devices.
    Questions for the Audience:Poll: "What do you believe is the biggest challenge in achieving global UDI compliance?"Discussion Question: "How do you foresee the advancements in MedTech impacting healthcare delivery in the next decade?"
    Feedback and Future Topics:We value your feedback and ideas for future episodes. Please email us at podcast@greenlight.guru with your suggestions and thoughts.
    Sponsors:This episode is brought to you by Greenlight Guru, the MedTech industry's leading solution for product development and compliance. Discover how Greenlight Guru can accelerate your product's journey to market by visiting www.greenlight.guru

    • 52 min
    #356: Quality Myths & Lessons Learned Part II

    #356: Quality Myths & Lessons Learned Part II

    In this episode of the Global Medical Device Podcast, host Etienne Nichols delves into the world of medical device quality and reliability with expert guest Kevin Becker. They explore the nuanced challenges of ethical decision-making in the MedTech industry, the complexities of accelerated testing, and the continuous quest for quality improvement. Becker, author of "Quality Myths and Lessons Learned," shares his insights from the second edition of his book, emphasizing the importance of ethics, the intricacies of statistical models, and the practical aspects of quality management in medical devices.
    Key Timestamps:
    [00:00:00] Introduction to Kevin Becker and the topic of the episode[00:05:20] Discussion on the new chapter about ethics in Becker's book[00:10:35] Insights into accelerated testing and its application in medical devices[00:15:50] Kevin Becker's five levels of knowledge and its relevance to MedTech professionals[00:20:45] The significance of standing up for what's right in quality and regulatory matters[00:25:30] Real-life examples of complex problem-solving in medical device engineering[00:30:55] Final thoughts and advice from Kevin Becker for MedTech 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-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...

    • 46 min
    #355: Mastering the Pitch: MedTech Innovations from Concept to Market

    #355: Mastering the Pitch: MedTech Innovations from Concept to Market

    In this episode of the Global Medical Device Podcast, host Etienne Nichols dives into the art of pitching to medical device investors with Blythe Karow, COO at Neurogeneces. Blythe shares her wealth of experience, from her early days as a marketer to leading significant product launches and achieving FDA breakthrough designations. The conversation revolves around crafting compelling pitches, understanding investor expectations, and navigating the challenges of presenting complex medical technologies to diverse audiences.
    Key Timestamps:[00:00:45] - Introduction to Blythe Karow and her background in MedTech.[00:03:22] - Insights into the dynamics of pitching to investors and adapting to different audiences.[00:10:15] - Discussion on the evolution of Blythe's pitching strategies over her career.[00:15:30] - Blythe's experience with gender dynamics in pitching and advice for female entrepreneurs.[00:20:45] - The importance of team presentation and handling expert critiques during pitches.[00:25:30] - Blythe's memorable pitch experiences and the impact of audience engagement.[00:30:00] - Tips for early-stage startups and resources for pitch preparation.[00:35:25] - Closing thoughts and where to connect with Blythe Karow.
    Quotes:"You want to start with a problem, you want that problem to be in the voice of who would pay for it." - Blythe Karow"It's like dating, and you're going to find people you click with and people you don't click with." - Blythe Karow on finding the right investors."Anyone can pitch. You just have to practice." - Blythe 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 videoMedtech InnovatorBlythe Karow on LinkedInEtienne Nichols LinkedInSpringboard 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.

    • 40 min
    #354: Becoming a MedTech Regulatory Affairs Professional

    #354: Becoming a MedTech Regulatory Affairs Professional

    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 ProfileEtienne Nichols' LinkedIn ProfileGreenlight 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.

    • 44 min
    #353: How Artificial Intelligence is Impacting the MedTech Industry

    #353: How Artificial Intelligence is Impacting the MedTech Industry

    In this episode, Etienne Nichols and guest Ashkon Rasooli explore the transformative impact of AI in the medical device industry. From AI-driven diagnostics and wearable health monitors to the future of surgical robots, they delve into how these technologies are reshaping healthcare.
    The discussion also touches on the challenges and opportunities in validating and regulating AI within MedTech, highlighting real-world applications and predicting future trends.
    "Validation of AI tools in MedTech requires a staged adoption to build confidence due to the inherent uncertainty in AI outcomes." - Ashkon Rasooli
    00:00 - 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 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 LinkedInashkon@engeniussolutions.comEngenius SolutionsAFDO/RAPS Working GroupEtienne 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

    • 45 min

Customer Reviews

4.8 out of 5
78 Ratings

78 Ratings

New.Shoes ,

Essential Med Device Podcast

Informative and engaging. Everyone working in the medical device industry needs to subscribe to this podcast!

Ttraveller ,

Medical Device podcast is a Fav

Always full of great resources, ideas, people. So helpful & motivating. Also, helps in keeping up with ever changing MedTech landscape.

dltrinkle ,

Helpful, Informative, Entertaining

It would be challenging to produce a podcast that is as well-informed and covering a broad set of topics on medical devices with as much depth, but what’s truly impressive is the balance of that with keeping the conversations lively and entertaining with a personal touch. The show doesn’t just feature experts but lets them come across as real humans too.

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