Global Medical Device Podcast powered by Greenlight Guru

The medical device industry functions as a highly complex ecosystem where diverse niches—including regulatory affairs, quality assurance, marketing, and reimbursement—must seamlessly interconnect to bring life-saving technologies to life. In this episode, host Etienne Nichols sits down with Sean Smith, a 25-year B2B marketing veteran, journalist, and founder of the weekly LinkedIn newsletter MedTe...

In this episode, host Etienne Nichols sits down with Michaela Kivett, a seasoned medical device consultant at Greenlight Guru, to break down the complexities of implementing an electronic Quality Management System (eQMS). Drawing from her background in orthopedic implant contract manufacturing and pharmaceutical process engineering, Michaela shares firsthand accounts of the critical inefficiencies...

The traditional approach to medical device commercialization often treats manufacturing as a distinct, isolated step executed after the design phase is completed. In this episode, Mike Dolphin, CEO of GuideStar Medical Devices, challenges this linear mindset by arguing that manufacturing process development is fundamentally an extension of product development itself. Drawing from his unique backgr...

The FDA is actively shaping the regulatory landscape for Artificial Intelligence (AI) and Machine Learning (ML) in real time. As the agency expands its internal expertise through the Digital Health Center of Excellence, FDA reviewers are becoming highly sophisticated. The era of submitting vague algorithm descriptions is over, paving the way for a more level playing field that rewards companies ex...

The MedTech industry widely misread the FDA's recent warning letter to Purolea Cosmetics Lab as a direct crackdown on Artificial Intelligence (AI). Host Etienne Nichols challenges this narrative, explaining that viewing the event strictly through an AI lens causes medical device manufacturers to miss the actual compliance lesson. At its core, the Purolea situation is not a story of bad software, b...

The medical device industry is undergoing a paradigm shift as Artificial Intelligence (AI) and Machine Learning (ML) transition from novelties into heavily regulated realities. The turning point arrived when the FDA integrated its own internal AI tool, Elsa, into its scientific review and inspection targeting processes. With regulators actively leveraging the technology, MedTech companies can no l...

The transition from a cleared medical device to a commercialized product is one of the most perilous phases for a MedTech startup. While founders frequently anticipate the technical and regulatory hurdles of early-stage development, they often underestimate the "commercial valley of death." Success in the modern healthcare economy requires more than a functional prototype and clinical validation;...

In this episode, host Etienne Nichols sits down with industry veteran Mike Drues to explore a critical theme in modern MedTech: the danger of "not knowing what you don't know." The conversation centers on the growing trend of companies making avoidable, "boneheaded" mistakes despite a robust regulatory framework. Mike Drues emphasizes that while technology evolves, the fundamental responsibility f...

In this episode of the Global Medical Device Podcast, host Etienne Nichols sits down with John Schindler, CEO of Liquet Medical, for a "MedTech Founder 101" masterclass. With over 25 years of experience at industry giants like Atrium and Merit Medical, Schindler shares the "painful reality checks" that come when transitioning from the structured umbrella of a large corporation to the high-stakes,...

In this episode, host Etienne Nichols sits down with Dr. Adam Saltman, Chief Medical Officer at NAMSA, to explore the treacherous "valley of death" that exists between a medical device prototype and the patient. With a unique "triple threat" perspective as a cardiothoracic surgeon, former FDA official, and industry consultant, Dr. Saltman reveals why technical brilliance often fails in the face of...

Sustainability in the medical device industry is far more complex than simple material substitution. It involves a rigorous balancing act between biocompatibility, regulatory requirements, and supply chain logistics. Etienne Nichols sits down with Lucas Pianegonda, founder of Gradical, to explore why the industry is finally moving toward greener solutions and how companies can adapt without sacrif...

In this episode, host Etienne Nichols speaks directly to professionals in industries like automotive, aerospace, and manufacturing who are looking to transition into MedTech. Drawing from his own experience moving from aerospace to medical devices, Etienne demystifies the industry’s high barriers to entry and explains why your existing skills are more valuable than you might think. The conversatio...

In this deep-dive episode, host Etienne Nichols shifts away from the "inspiring" fluff of entrepreneurship to deliver a gritty, practical masterclass for medical device founders. Drawing from his experience judging at MedTech Innovator and speaking with hundreds of founders, Etienne highlights a sobering reality: success in this industry isn't just about having the best technology. It is about get...

In this episode, Etienne Nichols sits down with Staci Miller , a Human Factors and UX Strategist at GenUX , to demystify the role of human factors (HF) in the medical device regulatory pathway. Staci explains that many companies mistakenly treat HF as a "box-checking" exercise late in development, leading to costly submission delays or rejections when the FDA finds the documentation fails to tell...

In this episode, Etienne Nichols sits down with regulatory expert Mike Drues, President of Vascular Sciences, to discuss the "culture shock" international medical device companies face when entering the U.S. market. They challenge the traditional assumption that a device should always launch outside the U.S. first, noting that shifting regulatory landscapes—especially in Europe—have made the U.S....

This episode features Ivanny Franklin , Managing Partner at MedSight Capital, who brings a wealth of experience from her background in molecular biology and her decade-long tenure at NAMSA. The conversation centers on the shifting paradigms of medical device investment, specifically how the industry is moving away from service-based models toward a focus on clinical outcomes . Etienne and Ivanny e...

In this episode, Etienne Nichols sits down with Edwin Lindsay, a seasoned MedTech operator and QARA leader, to discuss the systemic challenges facing the pediatric medical device market. Following a personal experience in a neonatal ward, Edwin highlights the stark reality that many pediatric treatments rely on adult devices adapted off-label, often leading to safety risks and clinical inefficienc...

In this episode, Etienne Nichols sits down with Dr. Kristy Katzenmeyer-Pleuss, President and Founder of KP Medical Device Consulting, to unpack the complexities of the medical device life cycle. The conversation centers on how manufacturers often overlook critical phases of a product’s journey, such as transportation, shelf life, and the decommissioning phase, focusing instead solely on the point...

In this episode, Etienne Nichols sits down with Thor Rollins , a leader at Nelson Labs and the convener of the committee revising ISO 10993-1 . The conversation centers on the newest 2025 version of the standard, which represents a massive philosophical shift from a "checkbox" testing mentality to a rigorous, risk-based approach aligned with ISO 14971. Rollins explains that modern medical devices...

This episode explores the transition from the Quality System Regulation (QSR) to the Quality Management System Regulation (QMSR) and the foundational elements required for medical device compliance. Host Etienne Nichols and guest Mike Drues discuss the philosophy of building a usable system rather than a "museum of SOPs," emphasizing that the standard list of QMS sections should be viewed as a sta...

In this episode, host Etienne Nichols sits down with Ashkon Rasooli, founder of Ingenious Solutions and a specialist in Software as a Medical Device (SaMD). The conversation previews their upcoming session at MD&M West, focusing on the critical intersection of generative AI (GenAI) and quality assurance. While many AI applications exist in MedTech, GenAI presents unique challenges because it c...

Dr. Jenny Hoffmann, MedTech executive and author of Open Up: Step Into the Leader You Are Meant to Be, joins host Etienne Nichols to discuss the evolution of leadership in the medical device industry. Drawing from her experience as a bioengineer and CEO, Dr. Hoffmann explains why the traditional model of the "rigid, perfect leader" is no longer sustainable. She shares her personal journey—from bei...

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, hig...

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 c...

In this episode, Etienne Nichols sits down with Michelle Wu, Founder and CEO of Nyquist AI and one of the top 100 women in AI, to discuss the transformative state of artificial intelligence within the MedTech regulatory and quality space. Reflecting on her recent personal experience as a surgical patient, Michelle shares a unique perspective on the critical importance of the devices and quality sy...