Global Medical Device Podcast powered by Greenlight Guru
Health & Fitness:Medicine
In this episode of the Global Medical Device Podcast, host Etienne Nichols engages with Howard Root, former CEO of Vascular Solutions and author of "Cardiac Arrest: Five Heart-Stopping Years as a CEO on the Fed’s Hit List," and Mark Duval, President and CEO of DuVal & Associates.
The episode delves into the harrowing experiences of navigating severe legal battles over off-label promotions, highlighting crucial insights into maintaining innovation while managing legal risks in the MedTech field. Additionally, Mark DuVal, a noted regulatory attorney, provides his expertise on the responsible corporate officer doctrine and its implications for industry executives.
Key Timestamps:Latest MedTech Trends:
Practical Tips for MedTech Professionals:
Future Predictions in MedTech:
Explaining terms like 'off-label use', which refers to the use of medical devices for indications not specifically approved by the FDA. While legally permissible under certain conditions, it requires careful communication and documentation to ensure compliance and mitigate legal risks.
Audience Interaction:Poll Question: "Do you believe current regulations fairly balance innovation with patient safety in MedTech?"
Call to Action:We encourage you to leave feedback on the episode and suggestions for future topics via email at podcast@greenlight.guru
Reviews on iTunes are also greatly appreciated!
Sponsors:Today’s episode is brought to you by Greenlight Guru, a quality management software designed specifically for the medical device industry. Here’s what Greenlight Guru offers:
Quality Management System (QMS) Software: Streamline your compliance processes with a system built for FDA and ISO standards, enhancing control and visibility over quality-related activities.
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Special Offer: Visit www.greenlight.guru to get a free demo. Mention the Global Medical Device Podcast for exclusive offers just for our listeners.
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#369: Advice to Medical Device Inventors
#368: Institutional Review Boards (IRBs)
#367: Interviewing the Interviewer
#365: Medical Device Reporting: The Do's and Don'ts
#364: Building a Partnership with your Regulatory Consultant
#363: Bringing a Self-Funded Medical Device to Market
#362: Managing Risk in Clinical Investigations
#361: Speaking the Language of IVD
#360: Is It Possible to "Buy" a QMS?
#359: Project Management in MedTech
#358: FDAs Voluntary Improvement Program
#357: The State of UDI Across the World
#356: Quality Myths & Lessons Learned Part II
#355: Mastering the Pitch: MedTech Innovations from Concept to Market
#354: Advice for MedTech Regulatory Affairs Professionals
#353: How Artificial Intelligence is Impacting the MedTech Industry
#352: Fundamentals of Quality & Regulatory
#351: The State of AI & Clinical Investigations
#350: The Evolving Landscape of AI in MedTech
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