Global Medical Device Podcast powered by Greenlight Guru

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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 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...

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...

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...