Episode 263 | Mark Domyahn, Partner at JD Lymon Group | Strategic Reimbursement Planning for Medtech Innovators

In this episode, Megan Shaw, CEO of the Pittsburgh Life Sciences Alliance, and Will Kaigler, co-founder and CEO of SovaSage, join the Project Medtech podcast to unpack what it really takes to build, scale, and ultimately create optionality in health tech startups. Megan shares her journey from being the first employee at HemoSonics to launching PLSA in 2024 to accelerate Pittsburgh’s life sciences ecosystem. Will reflects on his experience with multiple startups, and explains how sovaSage is reimagining sleep apnea management to improve outcomes and lower costs. Together, they discuss why customer value—not fixation on an exit—drives success, how to hire the right early team without over-hiring, and why systems and rigorous user discovery can make or break a company. They close with a deep dive into Pittsburgh’s unique strengths and upcoming opportunities to plug into the region’s innovation community.Will Kaigler LinkedInMegan Shaw LinkedInsovaSage WebsitePittsburgh Life Science Alliance WebsiteDuane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedInThank you to our sponsors: Ward Law and JumpStart Inc.

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 LinkedInJD Lymon Group WebsiteRAPID Coverage Pathway InformationDuane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedInThank 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 LinkedInDuane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedInThank 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 LinkedInPackaging Compliance Labs WebsiteDuane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedInThank 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 LinkedInSunra Health WebsiteDuane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedInThank 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 LinkedInVeracron Wellness Systems WebsiteDuane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedInThank you to our sponsors: Ward Law and JumpStart Inc.

In this episode, Tony Mango and Evan Gomez from Orlando Health’s Strategic Innovations team break down how a major nonprofit health system accelerates ideas from its 40,000+ team members into real solutions. They explain Orlando Health’s unique capability to develop medical devices in-house under FDA registration, how they triage innovation disclosures, and when they choose outside-in partnerships versus building internally based on speed, workflow fit, and adoption. The conversation explores the realities of commercialization—reimbursement, CFO-driven purchasing, long U.S. sales cycles, and why great technology can still fail without economic alignment. They also share how Orlando Health uses innovation as a recruitment and retention engine, expands regionally, and builds industry connections through curated clinical immersion sessions. Tony Mango LinkedInEvan Gomez LinkedInOrlando Health WebsiteDuane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedInThank you to our sponsors: Ward Law and JumpStart Inc.

In this episode, Ankit (founder of UGen) and Brent (a physical therapist at University Hospitals) about why rehab is primed for innovation, and how UGen is tackling the biggest breakdowns in physical therapy. Ankit shares how his grandfather’s Parkinson’s journey inspired him to apply his electrical engineering and sensor research background to build wearable motion sensors that deliver real-time, multi-sensory feedback at home, while capturing clinician-ready data to improve care decisions. Brent explains the clinical pain points UGen can solve: limited face-to-face time, poor home-exercise compliance, and the “honor system” that leaves therapists guessing, plus how UH’s sports medicine growth and the Haslam Sports Innovation Center create a pathway for tech adoption. They also discuss UGen's presence at the NFL Combine, expansion into neuro and assessment, and founder lessons on hardware difficulty, workflow fit, and building with patient safety in mind.Ankit Shah LinkedInBrent Pekarski LinkedInUGen WebsiteHaslam Sports Innovation Center WebsiteSportsLand WebsiteDuane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedInThank you to our sponsors: Ward Law and JumpStart Inc.

In this episode, Cory Criss joins Duane Mancini to share his path from pediatric surgeon to building innovation infrastructure at Nationwide Children’s and helping launch the Midwest Pediatric Device Consortium (MPDC), an FDA-funded Pediatric Device Consortium created to accelerate pediatric device development. The conversation breaks down why pediatrics is uniquely hard—small, fragmented markets and the need for multi-institutional clinical evidence—alongside the stark funding gap, with less than 1% of VC dollars going to pediatric-only companies despite children representing 25% of the population. Corey explains how Nationwide’s Innovation Center de-risks and educates through an innovation fellowship, and how MPDC unites Nationwide, Cincinnati Children’s, Ohio State, Cleveland Clinic Children’s, and others to support pediatric startups nationwide with expert evaluation, hospital access, and non-dilutive funding. They also discuss lessons learned managing multi-institution partnerships, sustainability beyond grant funding, and why clinician and hospital buy-in is critical for international startups entering the U.S. market.Cory Criss LinkedInNationwide Children’s Hospital WebsiteMPDC WebsiteMPDC YouTube ChannelPediatric Device Consortium: Cardiovascular Focus Event Registration Duane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedInThank you to our sponsors: Ward Law and JumpStart Inc.

In this episode, Brent Lavin shares how two decades in product and portfolio management at GE Healthcare, C.R. Bard, and BD shaped his mission to help Series A and B medtech startups build commercial logic into every stage of innovation. Brent breaks down what surprised him most moving from strategics to early-stage teams and why large companies often operate like startups when resources must be earned through influence, not authority. The conversation dives into how his engineering training powers a structured, “marketing-as-a-science” approach to product management, the most-missed elements of customer discovery, and a concrete example of winning by simplifying a “Cadillac” product into a segmented solution. Brent also unpacks what strategics look for in acquisitions plus lessons from LSI, leadership, and the discipline of endurance running.Brent Lavin LinkedInIronwood Medtech Partners LinkedInDuane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedInThank you to our sponsors: Ward Law and JumpStart Inc.