Project Medtech

In this episode, Mark Domayhn, Partner at JD Lymon Group, joins Duane Mancini to unpack what medtech innovators often miss most: reimbursement isn’t a box to check after FDA—it’s the commercial foundation that determines whether hospitals and physicians can adopt your technology. Drawing on experience across Medtronic, Zimmer, and St. Jude/Abbott, Mark breaks down the “three-legged stool” of coverage, coding, and payment, why clinical evidence must satisfy payer standards (not just FDA), and how to “follow the money” across fragmented U.S. systems. The conversation then dives into the New Technology Add-On Payment (NTAP) program, why it matters for inpatient launches, how breakthrough designation has increased NTAP success, and the major implications of CMS proposing to repeal the alternative pathway—plus what companies can do before the June 9 comment deadline.

Mark Domyahn LinkedIn

JD Lymon Group Website

RAPID Coverage Pathway Information

Duane Mancini LinkedIn

Project Medtech Website

Project Medtech LinkedIn

Thank you to our sponsors: Ward Law and JumpStart Inc.

In this episode, pulmonologist, intensivist, and advanced bronchoscopist Huzaifah Salat joins Duane Manicini to unpack what’s changing in lung cancer care, and why the biggest constraint in MedTech isn’t the FDA, funding, or clinician adoption, but founders building for clinicians instead of with them. Huzaifah shares how robotic bronchoscopy, advanced imaging, and better CT quality are enabling diagnosis of tiny, moving lung nodules, and why the next wave may be non-invasive diagnostics like blood-based, saliva, or bronchial secretion testing. He offers an inside look at serving as a regional medical director and physician voice to the C-suite, where “no margin, no mission” meets patient-first priorities, and explains how diverse frontline perspectives, beyond physicians alone, shape products that truly fit real clinical workflows.

Huzaifah Salat LinkedIn

Duane Mancini LinkedIn

Project Medtech Website

Project Medtech LinkedIn

Thank you to our sponsors: Ward Law and JumpStart Inc.

In this kickoff episode of Project Medtech’s “Five Things You Need To Know” miniseries, Duane Mancini is joined by Sean Thompson to break down the essentials of sterile medical device packaging compliance. Sean shares a practical, startup-friendly roadmap anchored in ISO 11607, starting with defining device inputs that drive packaging design decisions (sensitivities, geometry, sterilization method, scalability). He then walks through the four pillars—Make, Ship, Store, and Usability—covering sealing process validation, distribution simulation testing and feasibility testing, shelf-life strategy via accelerated and real-time aging, and the newer focus on usability and aseptic presentation. The episode highlights how missed packaging steps can create costly timeline and commercialization setbacks.

Sean Thompson LinkedIn

Packaging Compliance Labs Website

Duane Mancini LinkedIn

Project Medtech Website

Project Medtech LinkedIn

Thank you to our sponsors: Ward Law and JumpStart Inc.

In this episode, Alicia Wagner shares the deeply personal journey that led her to build Sunra Health after her daughter’s long and traumatic health challenges exposed major gaps in how pediatrics handles chronic conditions. She breaks down Sunra Health as an AI-powered pediatric health platform paired with an at-home cheek-swab genetic test, designed to help families and clinicians move from “guessing” to more personalized, data-informed early childhood wellness decisions. The conversation explores how Sunra aims to function as an FDA-aligned clinical decision support tool, why direct-to-consumer access is a key early strategy, and how AI can responsibly translate complex genetic insights into practical guidance, education, and care planning. Alicia also shares hard-earned founder lessons on resilience, pitching, and educating in a controversial space.

Alicia Wagner LinkedIn

Sunra Health Website

Duane Mancini LinkedIn

Project Medtech Website

Project Medtech LinkedIn

Thank you to our sponsors: Ward Law and JumpStart Inc.

In this episode, Grant Kruger joins Duane Mancini to share his journey from growing up in South Africa to becoming a University of Michigan researcher and medtech entrepreneur. He discusses his roots in electrical engineering and AI-driven manufacturing, the leap to Michigan for a postdoc, and the pivotal shift from automotive-focused research into collaborating with physicians to solve real clinical problems. Grant explains how early pain-research tooling evolved into Veracron Wellness Systems, and how an NIH I-Corps-style customer discovery process reshaped their thesis, revealing clinicians didn’t need better pain intensity scores, but objective, workflow-friendly functional data. He outlines their single-use wearable “functional assessment test kit,” designed to remove clinic burden and support better chronic pain decisions, approvals, and patient satisfaction, plus lessons on team, ecosystem support, and why usability beats perfection.

Grant Kruger LinkedIn

Veracron Wellness Systems Website

Duane Mancini LinkedIn

Project Medtech Website

Project Medtech LinkedIn

Thank you to our sponsors: Ward Law and JumpStart Inc.