Podcast
Project Medtech
Hosted by Project Medtech · EN
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.
63episodes
Episodes
Newest firstAll episodes
Episode 272 | Mike Monovoukas, CEO & Co-founder at AcuityMD | The Future of Medtech Commercialization: AI, Data, and Smarter Growth
6d ago00:50:30Tap to summarizeWhat 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 LinkedInAcuityMD LinkedInAcuityMD WebsiteAcuityMD Press Release Biodesign Book Link Duane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedInThank you to our sponsors: Ward Law, Wheelhouse DMG, and JumpStart Inc.
Transcribe →Episode 271 | Christopher Gates, Founder & CEO of arsMedSecurity | The First Five Things You Need to Know About Medical Device Cybersecurity
2w ago00:22:48Tap to summarizeCybersecurity 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 LinkedInarsMedSecurity WebsiteDuane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedInThank you to our sponsors: Ward Law, Wheelhouse DMG, and JumpStart Inc.
Transcribe →Episode 270 | Franco Kraiselburd, Founder & CEO, Asclepii | Reimagining Wound Care Through Accessible Innovation
3w ago00:36:51Tap to summarizeWhat 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 LinkedInAsclepii LinkedInInnovators Dilemma by Clay ChristensenThe Hard Thing About Hard Things by Ben HorowitzDuane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedInThank you to our sponsors: Ward Law, Wheelhouse DMG, and JumpStart Inc.
Transcribe →Episode 269 | Edwin Lindsay, Principal Consultant at CS Life Sciences | Unlocking Innovation with Strategic Roadmaps
4w ago00:43:30Tap to summarizeWhat 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 LinkedInCS Life Sciences WebsiteDuane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedInThank you to our sponsors: Ward Law, Wheelhouse DMG, and JumpStart Inc.
Transcribe →Episode 268 | Ethan Drower, Co-Founder & CEO of CiteMed | Breaking Down Barriers with Clinical Evidence
Jul 600:38:57Tap to summarizeIn 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 LinkedInCiteMed WebsiteDuane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedInThank you to our sponsors: Ward Law, Wheelhouse DMG, and JumpStart Inc.
Transcribe →Episode 267 | Michelle Ottey, President of CIC Campuses & Labs | Strategic Growth & Community Building in Innovation Spaces
Jun 2900:49:43Tap to summarizeIn 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 LinkedInCIC Philadelphia WebsiteDuane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedInThank you to our sponsors: Ward Law and JumpStart Inc.
Transcribe →Episode 266 | Laura Corcoran, CEO & Founder of Dignity Care | Innovating Compassionate Solutions for Pregnancy Loss
Jun 2200:48:46Tap to summarizeIn 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 LinkedInDignity Care Network WebsiteDuane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedInThank you to our sponsors: Ward Law and JumpStart Inc.
Transcribe →Episode 265 | Dr. Malcolm Townes, Innovation Fund Manager at Washington University | Strategic Medtech Commercialization: Lessons from the Gap Fund
Jun 1500:45:42Tap to summarizeIn 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 LinkedInWashington University in St. Louis Gap Fund WebsiteDuane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedInThank you to our sponsors: Ward Law and JumpStart Inc.
Transcribe →Episode 264 | Will Kaigler & Megan Shaw | From Innovation to Impact: Crafting Medtech Culture and Success in Pittsburgh
Jun 800:48:27Tap to summarizeIn 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.
Transcribe →Episode 263 | Mark Domyahn, Partner at JD Lymon Group | Strategic Reimbursement Planning for Medtech Innovators
Jun 100:55:55Tap to summarizeIn 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.
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