Project Medtech

Project Medtech
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The Project Medtech podcast is interview-style podcast on the Medtech Industry where guests share stories, advice, pitfalls, trends and innovations produced by Project Medtech.

  1. vor 1 Tag

    Episode 265 | Dr. Malcolm Townes, Innovation Fund Manager at Washington University | Strategic Medtech Commercialization: Lessons from the Gap Fund

    In this episode, Dr. Malcolm Townes breaks down how WashU is building a more execution-focused commercialization engine through its Gap Fund, designed to advance non-drug, non-therapeutic technologies by funding the technology (not startups) to avoid conflicts and drive sharper development decisions. He shares why hands-on, milestone-based funding and rigorous customer discovery are essential to uncovering “unknown unknowns,” preventing expert blindness, and aligning products with real clinical workflows. The conversation also explores how WashU leverages EIRs and Venture Fellows to add commercialization horsepower, why “coachability” is the strongest predictor of success, and what innovators most often miss: FDA clearance isn’t enough—market access and reimbursement require different proof, data, and strategy. Dr. Malcolm Townes LinkedIn Washington University in St. Louis Gap Fund Website Duane Mancini LinkedIn Project Medtech Website Project Medtech LinkedIn Thank you to our sponsors: Ward Law and JumpStart Inc.

    46 Min.

  2. 8. Juni

    Episode 264 | Will Kaigler & Megan Shaw | From Innovation to Impact: Crafting Medtech Culture and Success in Pittsburgh

    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 LinkedIn Megan Shaw LinkedIn sovaSage Website Pittsburgh Life Science Alliance Website Duane Mancini LinkedIn Project Medtech Website Project Medtech LinkedIn Thank you to our sponsors: Ward Law and JumpStart Inc.

    48 Min.

  3. 1. Juni

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

    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.

    56 Min.

  4. 25. Mai

    Episode 262 | Huzaifah Salat, MD, Physician Executive | Pioneering Lung Cancer Diagnosis & Driving Clinical Insight in Healthcare Innovation

    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.

    44 Min.

  5. 18. Mai

    Episode 261 | Sean Thompson, Senior Sales Engineer at Packaging Compliance Labs | The First Five Things You Need to Know About Medical Device Packaging

    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.

    24 Min.

  6. 11. Mai

    Episode 260 | Alicia Wagner, Founder & CEO of Sunra Health | Personalized Pediatric Care through Genetic Insights

    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.

    47 Min.

  7. 4. Mai

    Episode 259 | Grant Kruger, CEO/Founder at Veracron Wellness Systems | Bridging Engineering and Medical Needs to Revolutionize Chronic Pain Care

    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.

    50 Min.

  8. 27. Apr.

    Episode 258 | Tony Mango & Evan Gomez, Orlando Health | Inside-Out and Outside-In: Navigating Healthcare Innovation

    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 LinkedIn Evan Gomez LinkedIn Orlando Health Website Duane Mancini LinkedIn Project Medtech Website Project Medtech LinkedIn Thank you to our sponsors: Ward Law and JumpStart Inc.

    55 Min.
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Info

The Project Medtech podcast is interview-style podcast on the Medtech Industry where guests share stories, advice, pitfalls, trends and innovations produced by Project Medtech.

Informationen

  • Erstellt von
    Project Medtech
  • Jahre aktiv
    2020 - 2026
  • Folgen
    321
  • Bewertung
    Unbedenklich
  • Copyright
    © Project Medtech
  • Sendungswebsite
    Project Medtech

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