Global Medical Device Podcast powered by Greenlight Guru

Many MedTech startups and innovators focus heavily on core technology development, often assuming physical product design is simple polishing once a working concept exists. Michael Sprauve explains that this approach frequently creates a gap between brilliant engineering and a market-ready, commercially viable medical device. Succeeding in hardware requires looking past the technology to consider every individual who will interact ...

Medical device cybersecurity is no longer an optional feature or a last-minute checkbox prior to market entry. Hosted by Etienne Nichols, this episode features Chris Gates, founder and CEO of arsMedSecurity, who delivers a practical, engineering-first perspective on embedding security directly into the development lifecycle. Gates highlights that deferring cybersecurity efforts until the end of development leads to severe financial...

The transition from academic research to commercial MedTech entrepreneurship requires a strategic mindset shift, particularly when navigating high-risk vascular innovations. Jordi Martorell, CEO and co-founder of Aortyx, shares his journey from mapping arterial blood flow at the Harvard-MIT Biomedical Engineering Center to developing bioresorbable endovascular patches for aortic dissection. Driven by a desire to solve true unmet me...

In this episode of the Global Medical Device Podcast, host Etienne Nichols sits down with Nikhil Mangale, Vice President of Quality at Kapstone Medical, to discuss the real-world impact of the FDA's Quality Management System Regulation (QMSR). Seven months post-implementation, the industry is seeing actual inspection data that shifts the focus away from superficial documentation updates and directly onto core quality system operati...

Medical device startups frequently fall into the trap of developing complex technology first, only to struggle downstream with clinical adoption, regulatory hurdles, and reimbursement. In this episode, host Etienne Nichols sits down with Shai Policker, Managing Partner at Edge Medical Ventures, to explore why reversing this traditional paradigm leads to sustainable, category-defining products.

Policker details how working backward f...

Most discussions around medical device quality stop at commercial launch. Once a product ships, teams tend to celebrate and move on to the next development cycle. However, the real engineering work often begins the moment a device leaves the manufacturing floor. In this episode of the Global Medical Device Podcast, host Etienne Nichols sits down with Shawnnah Monterrey, founder of Beanstalk Ventures and an FDA-accredited third-part...

Navigating the regulatory landscape for combination products requires understanding how primary modes of action (PMOA) dictate oversight pathways. In this episode, host Etienne Nichols sits down with Jim Fentress, Director of Regulatory Affairs at Galero (a Santa Group company), to unpack the structural differences and hidden pitfalls when medical device and pharmaceutical worlds collide. They discuss how the FDA handles lead agenc...

Many early-stage medical device founders face a major dilemma: how do you prove regulatory maturity to investors and partners before you actually hold a final CE mark or FDA approval? Waiting until the end of a long development cycle creates significant commercial risk. By treating regulatory readiness as a continuous maturity process rather than an all-or-nothing milestone, startups can build trust early and avoid costly late-stag...

In this episode, host Etienne Nichols sits down with Ali Samiian, founder and managing principal of Popular Access Advisors, to demystify the critical and often misunderstood world of MedTech reimbursement. Far too many early-stage medical device companies treat reimbursement as a secondary, post-launch paperwork exercise, only to find that their brilliant, FDA-cleared technology fails because no one has figured out who will pay fo...

Artificial intelligence has officially entered the mainstream cultural zeitgeist, creating a wave of excitement—and a fair share of fatigue—across the medical device industry. In this episode, host Etienne Nichols sits down with Tyler Harmon, biomedical engineer and CEO of Iaso Automated Medical Systems, to cut through the marketing buzzwords. Together, they explore the technical realities behind the technology stack, s...

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 MedTech Leading Voices. Toge...

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 that plague traditional paper and ...

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 background spanning aerospace engineering...

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 executing documentation correctly.

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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, but rather a fundamental failure of ...

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 longer treat AI as a buzzword; it de...

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; it requires an exact blueprint to n...

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 for safety and effectiveness remains...

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, resource-dependent world of a start...