Global Medical Device Podcast powered by Greenlight Guru

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: Insightful Quotes: Key Takeaways: References and Resources: Medical Device Reporting (MDR): How to Take Advantage of Your Electronic RecordsLisa Van Ryn on LinkedInEtienne Nichols on LinkedIn Beginner’s Section: MedTech 101 Questions for the Audience: Feedback Request: We value your thoughts! Please leave us a review on iTunes and share your feedback. Your suggestions help us improve and guide our future topics. Email your thoughts and topic suggestions to podcast@greenlight.guru. Sponsors: This episode is brought to you by Greenlight Guru, a leading platform that offers MedTech companies a...

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: Notable Quotes: Key Takeaways: References and Resources: Texas Medical Center Innovation InstituteProxima Clinical ResearchChristine Luk on LinkedInEtienne Nichols on LinkedIn Call to Action: Feedback is crucial! Please email us your thoughts on this episode and suggestions for future topics at podcast@greenlight.guru Don’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 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: Memorable Quotes: Key Takeaways: Innovation in MedTech:Challenges and Resilience:Future of MedTech: MedTech 101: In today's episode, terms like "elbow arthroscopy" and "lateral decubitus position" were discussed. Elbow arthroscopy involves a minimally invasive surgical procedure on the elbow using an arthroscope, while lateral decubitus position refers to the patient lying on their side, which is common during such surgeries. Call to Action: Did this episode on medical device innovation resonate with you? We would love to hear your thoughts and feedback. Leave us a review on iTunes and share your views on the future of MedTech innovations! For suggestions on future topics, please email us at podcast@greenlight.guru References: Hunter Medical DevicesDr. Lee hunter on LinkedInTennessee Orthopedic AllianceEtienne Nichols on LinkedIn Sponsors: 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 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 Timestamps Provocative Quotes Key Takeaways 1. Insights on MedTech Trends: 2. Practical Tips for MedTech Professionals: 3. Future Predictions in MedTech: References Helene 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 101 For 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 Engagement

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: Notable Quotes: Key Takeaways: 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 LinkedIn MedTech 101: Audience Interaction: Call for Feedback: Love this episode? Leave us a review on iTunes and share your thoughts. Feedback drives our growth and allows us to improve. Reach out directly via email at podcast@greenlight.guru with your suggestions for future topics. Special Thanks to Our Sponsor: This episode is brought to you by Greenlight Guru, a quality management system and electronic data capture software designed...

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: Notable Quotes: Key Takeaways: Latest MedTech Trends: Practical Tips for MedTech Listeners: Future Questions: References: Questions for the Audience: 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: Etienne NicholsSara 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: Quotes: Takeaways Insights on MedTech Trends: Practical Tips for Listeners: Questions for Future Developments: References: Perry Parendo on LinkedInEtienne Nichols on LinkedInBehavioral Grooves podcast with Annie Duke - Thinking in BetsBook - Someday is Today, Ron RichardYoutube video - the Heartbeat of New Product DevelopmentQuality Culture for Product Design Success

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: Notable Quotes: Key Takeaways: Practical Tips for Listeners: Future Questions: 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...

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: Notable Quotes: Key Takeaways: Practical Tips for Listeners: Future Questions: References and Resources: Etienne Nichols on LinkedInKim Kaplan on LinkedInFDA’s Final Guidance on the Voluntary Improvement Program Questions for the Audience:

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: Takeaways: Latest MedTech Trends: Practical Tips for Listeners: Predicting Future Developments: References: Gary Saner on LinkedInEtienne Nichols on LinkedInThe Ultimate Guide for UDIReedTech'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: 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: Quotes: Takeaways: References: https://www.greenlight.guru/blog/quality-myths-and-lessons-learnedhttps://www.linkedin.com/in/kevin-becker-48627014/"Quality Myths and Lessons Learned" (Second Edition) https://www.linkedin.com/in/etiennenichols/ Questions for the Audience:

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: Quotes: Takeaways: Latest MedTech Trends: Practical Tips for Listeners: References: NeurogenecesEvren 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.

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: Quotes: Key Takeaways: Insights into MedTech Trends: Practical Tips for MedTech Enthusiasts: References: Kavetha Ram's LinkedIn ProfileEtienne Nichols' LinkedIn ProfileGreenlight Guru Questions for the Audience: 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 Key Takeaways: 1. Latest MedTech Trends: 2. Practical Tips for MedTech Enthusiasts: 3. Predictions for the Future: 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

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: Quotes: MedTech Trends: Practical Tips: References: JMT Compliance ConsultingJennifer Mascioli-Tudor on LinkedInEtienne Nichols on LinkedInGreenlight Guru’s platform for Quality Management & Clinical Investigations Questions for the Audience: Feedback: podcast@greenlight.guru 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: Quotes: Takeaways: Latest MedTech Trends: Practical Tips: Future Predictions: References: European AI ActUS Executive Order on AIMaria Nyakern on LinkedInEtienne Nichols on LinkedIn Questions for the Audience: 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 Takeaways References www.greenlight.guruEric Henry on LinkedIn AI Global Health Initiativeehenry@kslaw.comGreenlight Guru 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 Takeaways Reference Links: Elena Kyria's LinkedInElemedWorking GeniusGreenlight GuruEtienne 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: 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 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: 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!