Project Medtech

00:50:52

Episode 280 | Stephen Ippolito, Managing Partner &...

Project Medtech ·

2026/09/28

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

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00:25:08

Episode 279 | Melissa Muller, Founder & Principal...

Project Medtech ·

2026/09/21

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

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00:24:13

Episode 278 | Staci Miller, Founder of Gen UX...

Project Medtech ·

2026/09/14

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

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00:55:25

Episode 277 | Merom Klein, Principal at Courage...

Project Medtech ·

2026/09/07

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

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00:34:46

Episode 276 | Ashkon Rasooli, Founder & CEO of...

Project Medtech ·

2026/08/31

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

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00:36:35

Episode 275 | Shannon Clark, Founder & President of...

Project Medtech ·

2026/08/24

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

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00:52:31

Episode 274 | Joe Tumolo, Founder & President at JTSC...

Project Medtech ·

2026/08/17

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

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00:36:39

Episode 273 | Caron Trumbo, Vice President of...

Project Medtech ·

2026/08/10

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 LinkedInVirginiaBio WebsiteVirginiaBio LinkedInDuane Mancini

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00:50:30

Episode 272 | Mike Monovoukas, CEO & Co-founder at...

Project Medtech ·

2026/08/03

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,

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00:22:48

Episode 271 | Christopher Gates, Founder & CEO of...

Project Medtech ·

2026/07/27

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

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00:36:51

Episode 270 | Franco Kraiselburd, Founder & CEO,...

Project Medtech ·

2026/07/20

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

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00:43:30

Episode 269 | Edwin Lindsay, Principal Consultant at...

Project Medtech ·

2026/07/13

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

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00:38:57

Episode 268 | Ethan Drower, Co-Founder & CEO of...

Project Medtech ·

2026/07/06

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

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00:49:43

Episode 267 | Michelle Ottey, President of CIC...

Project Medtech ·

2026/06/29

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

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00:48:46

Episode 266 | Laura Corcoran, CEO & Founder of...

Project Medtech ·

2026/06/22

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

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00:45:42

Episode 265 | Dr. Malcolm Townes, Innovation Fund...

Project Medtech ·

2026/06/15

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

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00:48:27

Episode 264 | Will Kaigler & Megan Shaw | From...

Project Medtech ·

2026/06/08

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

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00:55:55

Episode 263 | Mark Domyahn, Partner at JD Lymon Group...

Project Medtech ·

2026/06/01

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

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00:44:07

Episode 262 | Huzaifah Salat, MD, Physician Executive...

Project Medtech ·

2026/05/25

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

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00:23:42

Episode 261 | Sean Thompson, Senior Sales Engineer at...

Project Medtech ·

2026/05/18

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

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