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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 LinkedInProject Medtech Website Project Medtech LinkedIn Thank you to our sponsors: Ward Law, Wheelhouse DMG, and JumpStart Inc.

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 LinkedInProject Medtech Website Project Medtech LinkedIn Thank you to our sponsors: Ward Law, Wheelhouse DMG, and JumpStart Inc.

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 LinkedInProject Medtech Website Project Medtech LinkedIn Thank you to our sponsors: Ward Law, Wheelhouse DMG, and JumpStart Inc.

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 LinkedInProject Medtech Website Project Medtech LinkedIn Thank you to our sponsors: Ward Law, Wheelhouse DMG, and JumpStart Inc.

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 LinkedInProject Medtech Website Project Medtech LinkedIn Thank you to our sponsors: Ward Law, Wheelhouse DMG, and JumpStart Inc.

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 LinkedInProject Medtech Website Project Medtech LinkedIn Thank you to our sponsors: Ward Law, Wheelhouse DMG, and JumpStart Inc.

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 LinkedInProject Medtech Website Project Medtech LinkedIn Thank you to our sponsors: Ward Law, Wheelhouse DMG, and JumpStart Inc.

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 LinkedInProject Medtech Website Project Medtech LinkedIn Thank you to our sponsors: Ward Law, Wheelhouse DMG, and JumpStart Inc.

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 LinkedInProject Medtech Website Project Medtech LinkedIn Thank you to our sponsors: Ward Law, Wheelhouse DMG, and JumpStart Inc.

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 LinkedInProject Medtech Website Project Medtech LinkedIn Thank you to our sponsors: Ward Law, Wheelhouse DMG, and JumpStart Inc.

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 LinkedInProject Medtech Website Project Medtech LinkedIn Thank you to our sponsors: Ward Law, Wheelhouse DMG, and JumpStart Inc.

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 LinkedInInnovators Dilemma by Clay Christensen The Hard Thing About Hard Things by Ben Horowitz Duane Mancini LinkedInProject Medtech Website Project Medtech LinkedIn Thank you to our sponsors: Ward Law, Wheelhouse DMG, and JumpStart Inc.

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.

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.

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.