HeyJaredMedTech True Quality Stories
This is MedTech True Quality Stories, hosted by Jon Speer, founder and VP of QA/RA at Greenlight Guru.Each week, we embark on a new storytelling journey with different MedTech executives as they share real-world, actionable best practices for medical device leaders.
- Indexed episodes, last 90 days
- 6
- Latest publication
- Aug 10, 2026
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- Earliest in this view
- Jul 6, 2026
Latest episodes
#468: SaMD Issues, Defects & Detection | Shawnnah Monterrey (opens the original)
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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-party reviewer with 25 years of medical device software experience, t
#467: Combination Product Compliance: PMOA, 21 CFR Part 4 & QMS Alignment (opens the original)
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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 agency designation across CDRH and CDER using interagency agreements a
#466: Leaving the Ivory Tower - How Notified Body Engagement Unlocks Startup Growth (opens the original)
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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-stage surprises. In this episode, host Etienne Nichols sits down with
#465: Why Good Medical Devices Fail: Reimbursement Strategy with Ali Samiian (opens the original)
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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 for it. Ali draws on his 20-plus years of experience in market acce
#464: Why LLM Unpredictability is a Liability in MedTech (opens the original)
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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, shifting the conversation away from generic AI toward specific, actionable eng
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