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Project Medtech

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.

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29 episodes
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Avg 43 min
English

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S1 · E282
Monday · 52 min
Episode 282 | Don Webber & Mauricio Carvalho of Bridge to Life | Transforming Organ Transplantation Through Innovative Solutions
In this episode, Don Webber, CEO and Mauricio Carvalho, VP of Medical & Scientific Affairs at Bridge to Life unpack the urgent challenge behind transplant medicine: outcomes are strong, but organ availability and perceived risk keep waiting lists high. Expanding the donor pool requires new preservation and assessment tools, and they explain how Bridge to Life is advancing hypothermic and perfusion-based organ preservation to protect cells, improve viability assessment, and help match organs to recipients with more objective biological insights. Mauricio shares hard-earned lessons bringing technology from Europe to the U.S. (where reimbursement, procurement, workflows, and contracting add layers that can make or break adoption) captured in the theme “science can be global, but implementation is local.” Don details Bridge to Life’s evolution, Series C $110M raise, and why adoption is earned through evidence, simplicity, economics, and deep onsite clinical support. Don Webber LinkedIn Mauricio Carvalho LinkedIn Bridge to Life Website Latest Bridge to Life News & Press Releases Duane Mancini LinkedIn Project Medtech Website Project Medtech LinkedIn Thank you to our sponsors: Ward Law, Wheelhouse DMG, and JumpStart Inc.
S1 · E281
October 5 · 50 min
Episode 281 | Tyler Zanon & Milad Behbahaninia of EndoShunt | From Frustration to Innovation: Revolutionizing Trauma Surgery
In this episode, trauma surgeon and EndoShunt's co-founder Milad Behbahaninia and CEO Tyler Zanon share how the company was born from frontline frustration: critically injured patients bleeding out before surgeons can reach hard-to-access injuries. They explain why endovascular innovation is the next horizon in trauma care, how the team engineered a solution that fits existing clinical workflows, and why incremental, surgeon-built improvements can drive outsized impact. They walks through EndoShunt’s rapid maturation since 2023, including multiple preclinical models, meaningful non-dilutive funding, a shrinking catheter profile toward a 7 French design, and plans toward an FDA submission next year. Milad Behbahaninia LinkedIn Tyler Zanon LinkedIn EndoShunt LinkedIn EndoShunt Website “The House of God” by Samuel Shem “ The Power of Full Engagement” by Jim Loehr & Tony Schwartz Duane Mancini LinkedIn Project Medtech Website Project Medtech LinkedIn Thank you to our sponsors: Ward Law, Wheelhouse DMG, and JumpStart Inc.
S1 · E280
September 28 · 50 min
Episode 280 | Stephen Ippolito, Managing Partner & Founder at Human Health Platform | Unlocking Value in Healthcare: Venture Capital's Role in Advancing Medtech
Stephen Ippolito shares his path from $5B+ in investment banking M&A to founding Veritus and launching the Human Health Platform, an ecosystem focused on shaping investable healthcare companies earlier than traditional VC. Stephen breaks down the stark differences between PE-backed and family-owned transactions, why founder psychology and identity can make or break outcomes, and what he looks for in first-time leaders—especially the balance of EQ and IQ, coachability, and healthy co-founder dynamics. The conversation dives into why too much healthcare innovation dies in academia, the need for better IP audits and university commercialization programs, and the case for combining complementary startups to unlock disproportionate value. Stephen also offers a blunt reality check on succeeding in U.S. healthcare: know your true customer, distribution, and incentives—then build accordingly. Stephen Ippolit LinkedIn Human Health Platform LinkedIn Human Health Platform Website “Good to Great” by Jim Collins Duane Mancini LinkedIn Project Medtech Website Project Medtech LinkedIn Thank you to our sponsors: Ward Law, Wheelhouse DMG, and JumpStart Inc.
S1 · E279
September 21 · 25 min
Episode 279 | Melissa Muller, Founder & Principal Consultant at Muller Advisory Company | The First Five Things Medtech Founders Need to Know Before They Scale
Melissa Muller, Founder and Principal Consultant at Muller Advisory Company, joins Duane Mancini for a practical conversation on what medtech founders must know before scaling beyond early adopters. Melissa breaks down why FDA clearance is only the starting line and why true growth depends on adoption readiness across clinical, financial, and commercial stakeholders. They dive into mapping the full clinical workflow end-to-end (including setup, IT, biomed, and reprocessing), identifying who must say yes (and who can still veto) through contracting and value analysis realities, and clarifying exactly how customers pay across hospitals, ASCs, and other sites of care. The conversation closes with how to drive repeat use, build advocates, and avoid “scaling assumptions” as care shifts and teams beyond the founder must carry the story. Melissa Muller LinkedIn Muller Advisory Company LinkedIn Muller Advisory Company Website Duane Mancini LinkedIn Project Medtech Website Project Medtech LinkedIn Thank you to our sponsors: Ward Law, Wheelhouse DMG, and JumpStart Inc.
S1 · E278
September 14 · 24 min
Episode 278 | Staci Miller, Founder of Gen UX Consulting | The First Five Things You Need to Know About Human Factors Validation Testing
Staci Miller, founder of Gen UX Consulting, joins Duane Mancini for a rapid-fire rundown of the first five things you need to know about human factors validation testing, from the risk documents nobody prioritizes but everyone needs, to the razor-thin line between a task sheet and a leading question that could invalidate your study, to why a 300-page report might be doing you more harm than good. Packed with hard-won insight from nearly 15 years in the field, this episode gives you a practical playbook for getting your validation study and your FDA submission right. Staci Miller LinkedIn Gen UX LinkedIn Gen UX Website Duane Mancini LinkedIn Project Medtech Website Project Medtech LinkedIn Thank you to our sponsors: Ward Law, Wheelhouse DMG, and JumpStart Inc.
S1 · E277
September 7 · 55 min
Episode 277 | Merom Klein, Principal at Courage Growth Partners | Building Courage in Medtech: Turning Fear Into Adoption, Investment & Innovation
What if the biggest barrier to medtech innovation isn’t the technology, buti fear? In this episode, Merom Klein explores how entrepreneurs can recognize hesitation, build trust, and move investors, customers, and teams from “wait and see” to active champions of innovation. From raising capital to changing the standard of care, Merom shares practical insights on building courage, understanding incentives, and creating the conditions for meaningful adoption. Tune in for a conversation about the human side of medtech innovation and what it really takes to change the game. Merom Klein LinkedIn Courage Growth Partners LinkedIn Project Medtech Podcast Episode 249 "Biotech in the Balance: Saving a Strategic Industry in an Age of Distrust" by Jeremy M. Levin "Leadership the Hard Way" by Dov Frohman and Robert Howard "Start-Up Nation: The Story of Israel’s Economic Miracle" by Daniel Senor and Saul Singer Duane Mancini LinkedIn Project Medtech Website Project Medtech LinkedIn Thank you to our sponsors: Ward Law, Wheelhouse DMG, and JumpStart Inc.
S1 · E276
August 31 · 34 min
Episode 276 | Ashkon Rasooli, Founder & CEO of EnGenius Solutions LLC | Beyond Compliance: Building Quality Systems That Give Medtech Companies an Edge
What if quality management could be the key to driving medtech innovation, not holding it back? In this episode, Ashkon Rasooli, Founder and Principal of EnGenius Solutions Consulting, breaks down how medtech companies can build quality systems that go beyond compliance to support innovation, efficiency, and long-term growth. The conversation dives into the challenges of keeping quality and regulatory strategies ahead of rapidly evolving technologies like software, cloud platforms, and AI, while exploring how companies can avoid costly mistakes, scale effectively, and prepare for the complexities of entering the U.S. market. Ashkon Rasooli LinkedIn EnGenius Solutions LLC LinkedIn ⁠EnGenius Solutions Website "Never Split The Difference" by Chris Voss "Million Dollar Consulting Toolkit" by Alan Weiss Duane Mancini LinkedIn Project Medtech Website Project Medtech LinkedIn Thank you to our sponsors: Ward Law, Wheelhouse DMG, and JumpStart Inc.
S1 · E275
August 24 · 36 min
Episode 275 | Shannon Clark, Founder & President of HavenSafe | From Human Factors to Ending Homelessness
What happens when a medical device innovator applies human factors thinking to one of society’s biggest challenges? Shannon Clark, founder and president of HavenSafe, shares her journey from pioneering human factors engineering in medical technology to tackling homelessness through data and systems-level solutions. She discusses why human factors goes far beyond FDA compliance, what startups often get wrong, and how the same principles used to improve patient safety can help create better outcomes in social services. Shannon Clark LinkedIn HavenSafe LinkedIn Project Medtech Podcast Episode 121 "Homelessness is a Housing Problem" by Greg Colburn and Clayton Page Aldern "Positive Intelligence" by Shirzad Chamine Duane Mancini LinkedIn Project Medtech Website Project Medtech LinkedIn Thank you to our sponsors: Ward Law, Wheelhouse DMG, and JumpStart Inc.
S1 · E274
August 17 · 52 min
Episode 274 | Joe Tumolo, Founder & President at JTSC | Why Relationships Win in MedTech Commercialization
In this episode, Joe Tumolo shares why the best medtech companies don't just build innovative products; they build relationships that drive commercialization. Drawing on more than 25 years in healthcare and life sciences, Joe reveals how founders can strengthen fundraising, hire the right sales team, navigate healthcare adoption, and create commercialization strategies that lead to lasting success. Discover why aligning with customers, investors, and partners may be the most valuable competitive advantage a startup can have. Joe Tumolo LinkedIn JTSC, LLC LinkedIn JTSC, LLC Website “Thinking Fast and Slow” by Daniel Kahneman Revisionist History Podcast with Malcolm Gladwell “The Undoing Project” by Michael Lewis Duane Mancini LinkedIn Project Medtech Website Project Medtech LinkedIn Thank you to our sponsors: Ward Law, Wheelhouse DMG, and JumpStart Inc.
S1 · E273
August 10 · 36 min
Episode 273 | Caron Trumbo, Vice President of Operations at VirginiaBio | Building a Biotech Ecosystem That Actually Works
How do you build a thriving biotech ecosystem? In this episode, Caron Trumbo, VP of Operations at VirginiaBio, shares how collaboration, workforce development, commercialization support, and statewide partnerships are helping Virginia become a growing hub for life science innovation. Learn why connecting startups, universities, investors, and healthcare systems is key to turning breakthrough ideas into real-world impact. Caron Trumbo LinkedIn VirginiaBio Website VirginiaBio LinkedIn Duane Mancini LinkedIn Project Medtech Website Project Medtech LinkedIn Thank you to our sponsors: Ward Law, Wheelhouse DMG, and JumpStart Inc.
S1 · E272
August 3 · 50 min
Episode 272 | Mike Monovoukas, CEO & Co-founder at AcuityMD | The Future of Medtech Commercialization: AI, Data, and Smarter Growth
What does it take to successfully commercialize medical technology in today's rapidly evolving healthcare landscape? In this episode, Mike Monovoukas, CEO and Co-Founder of AcuityMD, shares how a failed startup inspired him to build one of medtech's leading commercialization platforms. From leveraging AI and data to helping companies launch products more effectively, to raising an $80M Series C and building a mission-driven business, Mike offers valuable insights for medtech founders, innovators, and commercial leaders. Tune in to learn why commercialization starts long before product launch and how AI is changing the future of medtech. Mike Monovoukas LinkedIn AcuityMD LinkedIn AcuityMD Website AcuityMD Press Release Biodesign Book Link Duane Mancini LinkedIn Project Medtech Website Project Medtech LinkedIn Thank you to our sponsors: Ward Law, Wheelhouse DMG, and JumpStart Inc.
S1 · E271
July 27 · 22 min
Episode 271 | Christopher Gates, Founder & CEO of arsMedSecurity | The First Five Things You Need to Know About Medical Device Cybersecurity
Cybersecurity has become one of the biggest challenges facing medical device innovators, and it's about much more than protecting data. In this episode of Project Medtech's mini series, cybersecurity expert Christopher Gates breaks down the first five essential principles every medtech company should understand, from designing secure devices from day one to navigating FDA expectations and staying ahead of evolving threats powered by AI and quantum computing. Whether you're building your first device or scaling an established company, this conversation is packed with practical insights to help you strengthen your cybersecurity strategy and bring safer technologies to market. Christopher Gates LinkedIn arsMedSecurity Website Duane Mancini LinkedIn Project Medtech Website Project Medtech LinkedIn Thank you to our sponsors: Ward Law, Wheelhouse DMG, and JumpStart Inc.
S1 · E270
July 20 · 36 min
Episode 270 | Franco Kraiselburd, Founder & CEO, Asclepii | Reimagining Wound Care Through Accessible Innovation
What if the biggest breakthrough in wound care is making advanced treatments simpler? In this episode, Franco Kraiselburd, founder of Asclepii, shares how mentorship from stem cell pioneer Arnold Kaplan inspired a mission to transform wound care through accessible innovation. He discusses the launch of Poseidon, an innovative silver nanoparticle hydrogel designed to improve healing while simplifying treatment, previews the future of Artemis, a next-generation collagen dressing, and reflects on the lessons he's learned building a medtech startup. From raising capital to bringing new technologies to market, Franco offers an inside look at what it takes to challenge the standard of care and deliver innovations that have the potential to improve outcomes for patients and providers alike. Franco Kraiselburd LinkedIn Asclepii LinkedIn Innovators Dilemma by Clay Christensen The Hard Thing About Hard Things by Ben Horowitz Duane Mancini LinkedIn Project Medtech Website Project Medtech LinkedIn Thank you to our sponsors: Ward Law, Wheelhouse DMG, and JumpStart Inc.
S1 · E269
July 13 · 43 min
Episode 269 | Edwin Lindsay, Principal Consultant at CS Life Sciences | Unlocking Innovation with Strategic Roadmaps
What does it take to move a medical device from an idea to a solution that reaches patients? In this episode, Edwin Lindsay (Medtech's Guinness Guy) shares how 20+ years in medical devices shaped his hands-on approach to helping startups overcome regulatory, quality, and clinical challenges. He discusses why innovators need more than advice—they need experienced partners who help make decisions, execute strategies, and accelerate progress. Edwin also explores the hurdles facing pediatric device innovation and how his personal connection to the field inspired his mission to support founders and build stronger networks for life-changing technologies. Edwin Lindsay LinkedIn CS Life Sciences Website Duane Mancini LinkedIn Project Medtech Website Project Medtech LinkedIn Thank you to our sponsors: Ward Law, Wheelhouse DMG, and JumpStart Inc.
S1 · E268
July 6 · 38 min
Episode 268 | Ethan Drower, Co-Founder & CEO of CiteMed | Breaking Down Barriers with Clinical Evidence
In this episode, Ethan Drower, co-founder and CEO of CiteMed, shares the story behind Evidence Cloud, an AI-enabled platform transforming how medtech teams approach clinical evidence. Built to simplify complex literature reviews, strengthen regulatory submissions, and create a clear, traceable foundation for clinical claims, Evidence Cloud helps companies navigate one of the most critical steps in bringing innovation to patients. What began as a kitchen-table conversation evolved into a mission to reshape evidence generation and regulatory strategy. In this conversation, Ethan discusses how smarter evidence workflows can improve transparency, accelerate decision-making, and turn clinical evidence from a compliance requirement into a powerful strategic advantage. Ethan Drower LinkedIn CiteMed Website Duane Mancini LinkedIn Project Medtech Website Project Medtech LinkedIn Thank you to our sponsors: Ward Law, Wheelhouse DMG, and JumpStart Inc.
S1 · E267
June 29 · 49 min
Episode 267 | Michelle Ottey, President of CIC Campuses & Labs | Strategic Growth & Community Building in Innovation Spaces
In this episode, Michelle Ottey, President of CIC Campuses and Labs, unpacks what it really takes to build thriving innovation ecosystems and why flexible lab space is only the beginning. Michelle shares her personal journey from genetics and cell biology research into enabling entrepreneurship, and explains how CIC’s “invisible infrastructure” helps life science and medtech founders move faster by reducing operational, regulatory, and capital burdens through plug-and-play wet labs, shared equipment, safety and compliance support, and a deeply staffed community model. The conversation highlights how CIC strategically launches campuses through years of local ecosystem buy-in, why programming and connection points matter as much as square footage, and how CIC’s global footprint helps companies navigate international expansion and business culture. Michelle Ottey LinkedIn CIC Philadelphia Website Duane Mancini LinkedIn Project Medtech Website Project Medtech LinkedIn Thank you to our sponsors: Ward Law and JumpStart Inc.
S1 · E266
June 22 · 48 min
Episode 266 | Laura Corcoran, CEO & Founder of Dignity Care | Innovating Compassionate Solutions for Pregnancy Loss
In this powerful episode, Laura Corcoran, CEO and Founder of Dignity Care, shares the deeply personal experience that drove her to invent the Miscarriage Collection Cradle, a patented Class I medical device designed to bring practical support and dignity to women managing miscarriage or pregnancy loss. Laura walks through the realities of home miscarriage management, the need for reliable collection for cytogenetic testing, and how gaps in standard care can compound trauma. The conversation explores how she translated an unmet need into a scalable product—rapid NHS adoption, health-economic evidence showing major system savings, and the stakeholder strategy required to drive change from hospitals to Parliament. Laura also discusses FDA clearance and plans for U.S. launch, and closes with advice for innovators: obsess over understanding the problem, and the right solution will follow. Laura Corcoran LinkedIn Dignity Care Network Website Duane Mancini LinkedIn Project Medtech Website Project Medtech LinkedIn Thank you to our sponsors: Ward Law and JumpStart Inc.
S1 · E265
June 15 · 45 min
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.
S1 · E264
June 8 · 48 min
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.
S1 · E263
June 1 · 55 min
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.

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