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Project Medtech

Project Medtech

A Life Sciences and Science podcast

#37 in Life Sciences · 🇦🇺 #68 in Life Sciences · 🇩🇰
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About the show

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.

Newest episodes

Episode 287 | MTI Leadership Pod #3: "The L-Chain" | How Six Medtech Founders Create & Bring Value

56 min

What does it take to turn a frustration from the bedside into a device the world will actually buy? In this first special episode of our MedTech Innovator miniseries, Lindsey Dinneen sits down with the "L-Chain," one of MTI's 2026 leadership pods (and the winner of the Most Valuable Pod Award), for a candid roundtable on value, focus, and founder grit. Meet Dori Jones of AcQumen Medical, building the first non-invasive blood flow monitor for babies and children in the ICU after her own son was hospitalized at four months old; Abbey Azar, RN of Lenneuro, a 20-year bedside nurse whose SnapCath makes vascular lines shower-proof so patients can live at home without fear of dislodgement; Dr. Rhodel Dacanay of Nevent, an anesthesiologist on a mission to end retained guide wires for good; Dr. James Stone of Cannulight Technology, whose light-up IV sensor is already in the hands of combat medics in Ukraine; Dr. Kentaro Hayashi of HICKY, developing an implantable, wireless stimulator to treat central sleep apnea in heart failure patients; and Sahar Jalal of Lucentia, a rocket scientist building "the mammogram of the heart" to catch disease in the half of patients whose first cardiac event comes with no warning. They get real about why the hospital paying the bill rarely cares as much as you do, how to say no to five good use cases so you can win with one, why the Radar Forum felt like Shark Tank but turned out to be a school of fish all swimming in the same direction, and the advice they'd give anyone thinking about taking the leap into medtech startup life. If you're building in medtech, or thinking about it, this is the peer group conversation you need to hear. Dori Jones LinkedIn AcQumen Medical Website Abbey Lenore Azar LinkedIn Lenneuro Website Rhodel Dacanay LinkedIn Nevent Website James Stone LinkedIn Cannulight Technology Website Kentaro Hayashi LinkedIn HICKY Website Sahar Jalal LinkedIn Lucentia Website MedTech Innovator Website Lindsey Dinneen LinkedIn  Project...

Episode 286 | Paul Grand, CEO at MedTech Innovator | A Look Inside the World's Largest Healthcare Accelerator

1 hr 4 min

Paul Grand, CEO of MedTech Innovator, and Lindsey Dinneen kick off Project Medtech Podcast's new MTI miniseries, where 2026 cohort companies will share their startup journeys so far, stories, and advice. In this episode, Lindsey and Paul discuss his path from eight-time founder and venture capitalist to building the world's largest healthcare accelerator, what happens inside the accelerator, and how strategics and specialty societies champion startups. Paul also shares his best pitch advice, why FDA clearance is the starting line rather than the finish line, and what to know before applying for the 2027 cohort. Stay tuned for the miniseries, featuring MTI Leadership Pod companies, to go live with bonus episodes starting this Thursday! Paul Grand LinkedIn MedTech Innovator Website Lindsey Dinneen LinkedInProject Medtech LinkedIn Project Medtech Website Thank you to our sponsors: Ward Law, Wheelhouse DMG, and JumpStart Inc.

Episode 285 | Morgan Evans, Co-Founder at Agitated Solutions | Product & Business Model Innovation in Medtech

50 min

In this episode, Morgan Evans shares her unconventional path into medtech, from a Stanford pre-med track to startup roles, business school at Northwestern, and M&A at Medtronic, before returning to entrepreneurship with a focus on both product and business model innovation. She explains how her company, Agitated Solutions, is tackling better detection and characterization of PFO, including the clinical risk and variability of today’s manual contrast process and the evolution toward a drug-led combination product and software. The conversation dives into how she “kills” ideas using clinical diligence, market size, and value economics, why being an operator makes her a stronger investor through Engage Venture Partners, and how she’s built a broader ecosystem through Moonshot Medical, SurgiSmoke, and Avio Medtech Consulting. She also unpacks leadership fundamentals like trust vs. performance, intent and process failures, decision fatigue, saying no, and using time-blocking and AI assistants as a chief-of-staff to scale focus and execution. Morgan Evans LinkedIn Agitated Solutions Website Avio Medtech Consulting Website Engage Venture Partners Website Moonshot Medical Website SurgiSmoke LinkedIn Duane Mancini LinkedInProject Medtech LinkedIn Project Medtech Website Thank you to our sponsors: Ward Law, Wheelhouse DMG, and JumpStart Inc.

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The newest 50 of 343 episodes

Episode 287 | MTI Leadership Pod #3: "The L-Chain" | How Six Medtech Founders Create & Bring Value

56 min

What does it take to turn a frustration from the bedside into a device the world will actually buy? In this first special episode of our MedTech Innovator miniseries, Lindsey Dinneen sits down with the "L-Chain," one of MTI's 2026 leadership pods (and the winner of the Most Valuable Pod Award), for a candid roundtable on value, focus, and founder grit. Meet Dori Jones of AcQumen Medical, building the first non-invasive blood flow monitor for babies and children in the ICU after her own son was hospitalized at four months old; Abbey Azar, RN of Lenneuro, a 20-year bedside nurse whose SnapCath makes vascular lines shower-proof so patients can live at home without fear of dislodgement; Dr. Rhodel Dacanay of Nevent, an anesthesiologist on a mission to end retained guide wires for good; Dr. James Stone of Cannulight Technology, whose light-up IV sensor is already in the hands of combat medics in Ukraine; Dr. Kentaro Hayashi of HICKY, developing an implantable, wireless stimulator to treat central sleep apnea in heart failure patients; and Sahar Jalal of Lucentia, a rocket scientist building "the mammogram of the heart" to catch disease in the half of patients whose first cardiac event comes with no warning. They get real about why the hospital paying the bill rarely cares as much as you do, how to say no to five good use cases so you can win with one, why the Radar Forum felt like Shark Tank but turned out to be a school of fish all swimming in the same direction, and the advice they'd give anyone thinking about taking the leap into medtech startup life. If you're building in medtech, or thinking about it, this is the peer group conversation you need to hear. Dori Jones LinkedIn AcQumen Medical Website Abbey Lenore Azar LinkedIn Lenneuro Website Rhodel Dacanay LinkedIn Nevent Website James Stone LinkedIn Cannulight Technology Website Kentaro Hayashi LinkedIn HICKY Website Sahar Jalal LinkedIn Lucentia Website MedTech Innovator Website Lindsey Dinneen LinkedIn  Project...

Episode 286 | Paul Grand, CEO at MedTech Innovator | A Look Inside the World's Largest Healthcare Accelerator

1 hr 4 min

Paul Grand, CEO of MedTech Innovator, and Lindsey Dinneen kick off Project Medtech Podcast's new MTI miniseries, where 2026 cohort companies will share their startup journeys so far, stories, and advice. In this episode, Lindsey and Paul discuss his path from eight-time founder and venture capitalist to building the world's largest healthcare accelerator, what happens inside the accelerator, and how strategics and specialty societies champion startups. Paul also shares his best pitch advice, why FDA clearance is the starting line rather than the finish line, and what to know before applying for the 2027 cohort. Stay tuned for the miniseries, featuring MTI Leadership Pod companies, to go live with bonus episodes starting this Thursday! Paul Grand LinkedIn MedTech Innovator Website Lindsey Dinneen LinkedInProject Medtech LinkedIn Project Medtech Website Thank you to our sponsors: Ward Law, Wheelhouse DMG, and JumpStart Inc.

Episode 285 | Morgan Evans, Co-Founder at Agitated Solutions | Product & Business Model Innovation in Medtech

50 min

In this episode, Morgan Evans shares her unconventional path into medtech, from a Stanford pre-med track to startup roles, business school at Northwestern, and M&A at Medtronic, before returning to entrepreneurship with a focus on both product and business model innovation. She explains how her company, Agitated Solutions, is tackling better detection and characterization of PFO, including the clinical risk and variability of today’s manual contrast process and the evolution toward a drug-led combination product and software. The conversation dives into how she “kills” ideas using clinical diligence, market size, and value economics, why being an operator makes her a stronger investor through Engage Venture Partners, and how she’s built a broader ecosystem through Moonshot Medical, SurgiSmoke, and Avio Medtech Consulting. She also unpacks leadership fundamentals like trust vs. performance, intent and process failures, decision fatigue, saying no, and using time-blocking and AI assistants as a chief-of-staff to scale focus and execution. Morgan Evans LinkedIn Agitated Solutions Website Avio Medtech Consulting Website Engage Venture Partners Website Moonshot Medical Website SurgiSmoke LinkedIn Duane Mancini LinkedInProject Medtech LinkedIn Project Medtech Website Thank you to our sponsors: Ward Law, Wheelhouse DMG, and JumpStart Inc.

Episode 284 | Oscar Daws, Co-Founder of Tone Product Design | The Art of Medtech Design: Challenges, Usability, and Branding

37 min

In this episode, Oscar Daws, London-based product designer and co-founder of Tone Product Design, joins Duane Mancini to explore what it really takes to turn complex medical technology into products people can use, and want to use. Oscar shares how he moved from broad product design training into medtech through early consultancy work in the UK’s Cambridge–London–Oxford “Golden Triangle,” and why he’s drawn to high-complexity challenges with real patient impact. They break down how regulatory and technical constraints shape medical device timelines, why design must be embedded from concept through design transfer to protect the original vision, and how iteration—from prototypes to limited market releases—reveals issues that studies can’t. The conversation also covers designing for multiple stakeholders (patients, clinicians, procurement), leveraging packaging to reduce risk and build brand, and translating graphic identity into a cohesive 3D visual design language. Oscar Daws LinkedIn Tone Product Design Website “Zero to One” by Peter Thiel “The Hard Thing About Hard Things” by Ben Horowitz Duane Mancini LinkedInProject Medtech LinkedIn Project Medtech Website Thank you to our sponsors: Ward Law, Wheelhouse DMG, and JumpStart Inc.

Episode 283 | Aaron Burnett, CEO at Wheelhouse DMG | Data-Driven Marketing Solutions for Regulated Industries

47 min

In this episode, Aaron Burnett, CEO of Wheelhouse Digital Marketing Group, joins the podcast to unpack how medtech and healthcare companies can drive measurable growth in an era where third-party tracking, long sales cycles, and HIPAA constraints break traditional performance marketing. Aaron shares his path from VP roles at AT&T Wireless and Seattle-area tech to building the agency he couldn’t find—one that pairs technical rigor with strategic sophistication and a values-led approach. The conversation dives deep into Wheelhouse’s privacy-first marketing stack, including HIPAA-compliant measurement built on private client IDs and server-side tracking, a secure AWS-based data warehouse that unifies web, ad, and CRM data, and real-time propensity modeling that sends estimated lifetime value signals back to ad platforms. Aaron Burnett LinkedIn Wheelhouse DMG LinkedIn Wheelhouse DMG Website “The Art of Possibility” by Benjamin Zander & Rosamund Stone Zander “What Got You Here Won’t Get You There” by Marshall Goldsmith Duane Mancini LinkedInProject Medtech LinkedIn Project Medtech Website Thank you to our sponsors: Ward Law, Wheelhouse DMG, and JumpStart Inc.

Episode 282 | Don Webber & Mauricio Carvalho of Bridge to Life | Transforming Organ Transplantation Through Innovative Solutions

52 min

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

Episode 281 | Tyler Zanon & Milad Behbahaninia of EndoShunt | From Frustration to Innovation: Revolutionizing Trauma Surgery

50 min

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.

Episode 280 | Stephen Ippolito, Managing Partner & Founder at Human Health Platform | Unlocking Value in Healthcare: Venture Capital's Role in Advancing Medtech

50 min

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.

Episode 279 | Melissa Muller, Founder & Principal Consultant at Muller Advisory Company | The First Five Things Medtech Founders Need to Know Before They Scale

25 min

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.

Episode 278 | Staci Miller, Founder of Gen UX Consulting | The First Five Things You Need to Know About Human Factors Validation Testing

24 min

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.

Episode 277 | Merom Klein, Principal at Courage Growth Partners | Building Courage in Medtech: Turning Fear Into Adoption, Investment & Innovation

55 min

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.

Episode 276 | Ashkon Rasooli, Founder & CEO of EnGenius Solutions LLC | Beyond Compliance: Building Quality Systems That Give Medtech Companies an Edge

34 min

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.

Episode 275 | Shannon Clark, Founder & President of HavenSafe | From Human Factors to Ending Homelessness

36 min

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.

Episode 274 | Joe Tumolo, Founder & President at JTSC | Why Relationships Win in MedTech Commercialization

52 min

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.

Episode 273 | Caron Trumbo, Vice President of Operations at VirginiaBio | Building a Biotech Ecosystem That Actually Works

36 min

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.

Episode 272 | Mike Monovoukas, CEO & Co-founder at AcuityMD | The Future of Medtech Commercialization: AI, Data, and Smarter Growth

50 min

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.

Episode 271 | Christopher Gates, Founder & CEO of arsMedSecurity | The First Five Things You Need to Know About Medical Device Cybersecurity

22 min

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.

Episode 270 | Franco Kraiselburd, Founder & CEO, Asclepii | Reimagining Wound Care Through Accessible Innovation

36 min

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.

Episode 269 | Edwin Lindsay, Principal Consultant at CS Life Sciences | Unlocking Innovation with Strategic Roadmaps

43 min

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.

Episode 268 | Ethan Drower, Co-Founder & CEO of CiteMed | Breaking Down Barriers with Clinical Evidence

38 min

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.

Episode 267 | Michelle Ottey, President of CIC Campuses & Labs | Strategic Growth & Community Building in Innovation Spaces

49 min

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.

Episode 266 | Laura Corcoran, CEO & Founder of Dignity Care | Innovating Compassionate Solutions for Pregnancy Loss

48 min

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.

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

45 min

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.

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

48 min

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.

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

55 min

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.

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

44 min

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.

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

23 min

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.

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

46 min

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.

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

49 min

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.

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

54 min

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.

Episode 257 | Ankit Shah & Brent Pekarski of UGen | Transforming Rehabilitation Through Cutting-Edge Sensor Technology

55 min

In this episode, Ankit (founder of UGen) and Brent (a physical therapist at University Hospitals) about why rehab is primed for innovation, and how UGen is tackling the biggest breakdowns in physical therapy. Ankit shares how his grandfather’s Parkinson’s journey inspired him to apply his electrical engineering and sensor research background to build wearable motion sensors that deliver real-time, multi-sensory feedback at home, while capturing clinician-ready data to improve care decisions. Brent explains the clinical pain points UGen can solve: limited face-to-face time, poor home-exercise compliance, and the “honor system” that leaves therapists guessing, plus how UH’s sports medicine growth and the Haslam Sports Innovation Center create a pathway for tech adoption. They also discuss UGen's presence at the NFL Combine, expansion into neuro and assessment, and founder lessons on hardware difficulty, workflow fit, and building with patient safety in mind. Ankit Shah LinkedIn Brent Pekarski LinkedIn UGen Website Haslam Sports Innovation Center Website SportsLand Website Duane Mancini LinkedIn Project Medtech Website Project Medtech LinkedIn Thank you to our sponsors: Ward Law and JumpStart Inc.

Episode 256 | Cory Criss, Pediatric Surgeon, Nationwide Children's | Leading Pediatric Innovation & Industry Collaboration

44 min

In this episode, Cory Criss joins Duane Mancini to share his path from pediatric surgeon to building innovation infrastructure at Nationwide Children’s and helping launch the Midwest Pediatric Device Consortium (MPDC), an FDA-funded Pediatric Device Consortium created to accelerate pediatric device development. The conversation breaks down why pediatrics is uniquely hard—small, fragmented markets and the need for multi-institutional clinical evidence—alongside the stark funding gap, with less than 1% of VC dollars going to pediatric-only companies despite children representing 25% of the population. Corey explains how Nationwide’s Innovation Center de-risks and educates through an innovation fellowship, and how MPDC unites Nationwide, Cincinnati Children’s, Ohio State, Cleveland Clinic Children’s, and others to support pediatric startups nationwide with expert evaluation, hospital access, and non-dilutive funding. They also discuss lessons learned managing multi-institution partnerships, sustainability beyond grant funding, and why clinician and hospital buy-in is critical for international startups entering the U.S. market. Cory Criss LinkedInNationwide Children’s Hospital WebsiteMPDC Website MPDC YouTube Channel Pediatric Device Consortium: Cardiovascular Focus Event Registration  Duane Mancini LinkedIn Project Medtech Website Project Medtech LinkedIn Thank you to our sponsors: Ward Law and JumpStart Inc.

Episode 255 | Brent Lavin, Founder at Ironwood Medtech Partners | Innovation Dynamics: Engineering Meets Marketing & Customer Discovery

42 min

In this episode, Brent Lavin shares how two decades in product and portfolio management at GE Healthcare, C.R. Bard, and BD shaped his mission to help Series A and B medtech startups build commercial logic into every stage of innovation. Brent breaks down what surprised him most moving from strategics to early-stage teams and why large companies often operate like startups when resources must be earned through influence, not authority. The conversation dives into how his engineering training powers a structured, “marketing-as-a-science” approach to product management, the most-missed elements of customer discovery, and a concrete example of winning by simplifying a “Cadillac” product into a segmented solution. Brent also unpacks what strategics look for in acquisitions plus lessons from LSI, leadership, and the discipline of endurance running. Brent Lavin LinkedIn Ironwood Medtech Partners LinkedIn Duane Mancini LinkedIn Project Medtech Website Project Medtech LinkedIn Thank you to our sponsors: Ward Law and JumpStart Inc.

Episode 254 | Dr. Anit Behera, Vascular Neurologist & Medical Consultant | Advancing Stroke Care and Innovation in Medtech

45 min

In this episode, Duane Mancini speaks with vascular neurologist Anit Behera about what it takes to improve stroke care from the ER through long-term recovery. Anit shares his path through an MD-PhD in outcomes research, how consulting and clinical trials shaped his innovation mindset, and why stroke care advancement spans four phases: prevention, acute treatment, post-acute care, and rehabilitation. He explains where he sees major opportunity next, pointing to emerging devices and research in post-stroke rehab alongside stronger prevention strategies and better health literacy. The conversation also breaks down how clinicians evaluate new technologies, emphasizing rigorous data, patient safety, and real-world workflow fit, plus the role of key opinion leaders and conferences in driving adoption. Anit Behera LinkedIn Duane Mancini LinkedIn Project Medtech Website Project Medtech LinkedIn Thank you to our sponsors: Ward Law and JumpStart Inc.

Episode 253 | Jake Ward, Founding Member of Ward Law Office | Legal Insights on Patents, Trademarks, and Responsible Use of AI

40 min

In this episode, Jake Ward joins Duane Mancini to break down how startups should think about intellectual property from day one and why smart IP decisions directly impact fundability. Jake shares how Ward Law grew from a three-person boutique to a 35-person, multi-state virtual firm, and why their Midwest roots help deliver high-quality IP services at accessible rates for entrepreneurs. The conversation dives into where to start with patents, then shifts to trademarks and brand strategy and why selecting the right mark early, staying consistent, and timing registration can prevent costly rebrands later. They also tackle AI in legal work, exploring confidentiality concerns, “don’t trust the robot” pitfalls, and how to use AI as a tool without letting it undermine strategy or enforceability. Jake Ward LinkedIn Ward Law Website  Duane Mancini LinkedIn Project Medtech Website Project Medtech LinkedIn Thank you to our sponsors: Ward Law and JumpStart Inc.

Episode 252 | Jenny Lynn Walding, CEO at milkmade | Solving Breastfeeding Challenges with Medtech

48 min

In this episode, Jenny Lynn—founder of milkmade and a mom-turned-entrepreneur—shares how a frightening breastfeeding experience, including an undiagnosed tongue tie and the exhausting “weighted feed” routine, sparked the idea for a Smart Nipple Shield that can deliver continuous, actionable insight into infant milk intake. The conversation explores why breastfeeding—despite being the clinical “gold standard”—so often breaks down early, driven by perceived and actual low milk supply, fragmented care, and limited access to lactation support, especially in rural communities. Jenny Lynn also unpacks her path from marketing and health tech into regulated medtech, including patents, pursuing clinical validation, and navigating a Class II De Novo pathway with no predicate. Jenny Lynn Walding LinkedIn milkmade Website “Invisible Women” by Caroline Criado Perez “She Persisted” by Chelsea Clinton & Alexandra Boiger  Duane Mancini LinkedIn Project Medtech Website Project Medtech LinkedIn Thank you to our sponsors: Ward Law and JumpStart Inc.

Episode 251 | Sarah Fox, Investor at Angelini Ventures | Navigating Venture Capital in MedTech

42 min

In this episode, Duane Mancini sits down with Sarah to unpack her path from healthcare operator to investor and what founders should know when raising capital today. Sarah shares how her experience as the 10th employee at a digital health startup shaped her empathy for founders and the practical lens she brings to diligence, from ICP and pricing to building durable foundations early. The conversation pulls back the curtain on venture mechanics—how syndication and relationships really work, why fundraising is difficult when LPs demand DPI, and how fund structure, lifecycle, and co-investments can shape outcomes for startups. Sarah also explains Angelini Ventures’ global strategy and thesis-driven focus in areas like cardiology and neurology, and why “exitability” requires forward-looking insight into strategic buyers, technology shifts, and long-term fit. Sarah Fox LinkedIn Angelini Ventures Website Duane Mancini LinkedIn Project Medtech Website Project Medtech LinkedIn Thank you to our sponsors: Ward Law and JumpStart Inc.

Episode 250 | Duane Mancini with Lindsey Dinneen | The Journey of Project Medtech: Creating Impact & Bringing Value

42 min

Join us for a special 250th episode of The Project Medtech Podcast as host Duane Mancini and Director of Marketing and Engagement, Lindsey Dinneen, flip the script. Duane shares the journey from the podcast's inception during the height of COVID-19 to becoming a consulting, networking, and education resource for medtech startups. They delve into the core philosophy of creating value, the realities of team-building, and the exhilarating moments of client success. This episode is a candid reflection on the impact of the Project Medtech mission, the importance of a value-driven approach, and exciting future prospects. Lindsey Dinneen LinkedIn Duane Mancini LinkedIn Project Medtech Website Project Medtech LinkedIn Thank you to our sponsors: Ward Law and JumpStart Inc.

Episode 249 | Louise Yochee Klein, Principal at Courage Growth Partners | Innovation Leadership & Risk-Readiness in Medtech

50 min

In this episode, Duane Mancini sits down with Louise Yochee Klein to explore the fundamentals of fostering courage and innovation in the MedTech industry. Louise shares her journey from Canada to Philly, co-founding Courage Growth Partners, and emphasizes the importance of understanding and overcoming fear in business. The conversation highlights the critical need for aligning team objectives, adhering to detailed plans, and maintaining positive energy for personal and business success. Louise Yochee Klein LinkedIn Courage Growth Partners Website “Courage to Champion” Book Duane Mancini LinkedIn Project Medtech Website Project Medtech LinkedIn Thank you to our sponsors: Ward Law and JumpStart Inc.

Episode 248 | Aileen Helsel, Director of Innovation at Carilion Clinic | Cultivating a Thriving MedTech Ecosystem in Roanoke, Virginia

47 min

In this episode, Duane Mancini welcomes Aileen Helsel, Director of Innovation at Carilion Clinic, to discuss the exciting advancements in healthcare innovation in Roanoke, Virginia. Aileen shares her journey from academia to technology transfer and ultimately to her current role, emphasizing the transition from research to real-world application. They explore Carilion Clinic's unique position serving a diverse population, including rural communities, and how this drives impactful healthcare solutions. Aileen Helsel LinkedIn Carilion Clinic Innovation Duane Mancini LinkedIn Project Medtech Website Project Medtech LinkedIn Thank you to our sponsors: Ward Law and JumpStart Inc.

Episode 247 | Stan Glezer, Managing Director at Outcome Capital | Strategic Transactions in MedTech: Insights & Advice

39 min

In this episode, Duane Mancini sits down with Stan Glezer, Managing Director at Outcome Capital, to dive deep into the roles of strategic advisory and investment banking in driving innovation within the life sciences sector. Stan elaborates on his multifaceted career, from his beginnings as a physician to leading roles in biopharma and MedTech companies. He discusses the importance of aligning a company's value proposition with market dynamics, the art and science behind M&A deals, and why realistic, transparent goals can unlock transactional success. Stan Glezer LinkedIn Outcome Capital Website Duane Mancini LinkedIn Project Medtech Website Project Medtech LinkedIn Thank you to our sponsors: Ward Law and JumpStart Inc.

Episode 246 | Katie Brinkman, Biocompatibility Program Manager at Hohenstein | Navigating Biocompatibility in MedTech

36 min

In this episode, Duane Mancini sits down with Katie Brinkman to discuss the nuances of biocompatibility, the critical role of biological evaluation plans, and the evolving regulatory landscape, including the importance of risk assessment. Katie also shares her experience with biocompatibility evaluation during significant regulatory changes such as EU MDR remediation and the 10993 standard updates. Katie Brinkman LinkedIn Hohenstein Website Hohenstein Group LinkedIn Duane Mancini LinkedIn Project Medtech Website Project Medtech LinkedIn Thank you to our sponsors: Ward Law and JumpStart Inc.

Episode 245 | Matt Wunzin, Founder at Five Design and Development | Embracing Quality, Innovation, and Family in Medtech

44 min

In this episode, Duane Mancini speaks with Matt Wunzin, a biomedical engineer from Ohio with nearly 20 years of experience in the medtech industry. Matt shares his career journey from earning his degree at the University of Akron to working at various medical device companies, both large and small, and also discusses his transition to consulting with his firm, Five Design and Development. He shares the importance of quality management and documentation in the medtech field, and highlights the opportunities available in Ohio's medtech ecosystem. Matt Wunzin LinkedIn Five Design & Development Website Duane Mancini LinkedIn Project Medtech Website Project Medtech LinkedIn

Episode 244 | Michael Challenor, Director of Innovate Medtech | Navigating MedTech Startups and Australia's Ecosystem

51 min

Duane Mancini chats with Michael Challenor to discuss his entrepreneurial journey in the medtech industry, starting from his early passion for invention through his pivotal experiences in the Stanford Biodesign program in Perth, to co-founding Vital Trace. He highlights his current venture, Innovate Medtech, which supports medtech startups with grants, fundraising, and product development. Michael shares valuable insights into the Australian medtech ecosystem, the significance of team and culture, and offers crucial advice for aspiring medtech entrepreneurs. Michael Challenor LinkedIn Innovate Medtech AusMedtech 2026 Duane Mancini LinkedIn Project Medtech Website Project Medtech LinkedIn

Episode 243 | Spencer Jones, Founder of XO Medtech | Building Community and Accelerating Innovation in Medtech

51 min

Duane Mancini interviews Spencer Jones, a registered nurse turned medtech entrepreneur. Spencer recounts his journey from bedside nursing to founding two medtech companies, sharing valuable advice on navigating the often complex medtech landscape, including the critical role of thorough customer discovery and strategic vendor relationships in mitigating commercial risks. He also introduces XO MedTech, a training and community platform for medtech innovators, and MedTech Vendors, an AI-driven platform designed to connect medtech teams with ideal service providers. Spencer Jones LinkedIn XO Medtech Medtech Vendors Duane Mancini LinkedIn Project Medtech Website Project Medtech LinkedIn

Episode 242 | Emily Adams, Co-Founder at Leading with Human Design | Empowering Teams with Human Design Principles

36 min

Duane Mancini welcomes Emily Adams, Co-Founder of Leading with Human Design, who shares her remarkable journey from growing up in the Amish culture to becoming a leader in the tech and consulting world. Emily details her escape at 17, her transition into the corporate world, her rapid rise in the automotive manufacturing industry, and her healing journey through therapy and powerlifting, which led her to discover human design. Now, with her tech platform, she helps teams understand their unique working and decision-making styles to improve leadership and team dynamics. Emily Adams LinkedIn Leading with Human Design Website “From Choice to Change” Book Duane Mancini LinkedIn Project Medtech Website Project Medtech LinkedIn

Episode 241 | Ben Fogarty, Chief Design Officer at Council | Bridging Art & Strategy for Medtech Success

40 min

Duane Mancini welcomes Ben Fogarty, a design generalist and strategist and founder partner at Council. Ben shares his journey from an art student to leading an independent design practice working with startups and Fortune 500 companies. The conversation delves into the vital role of design thinking in problem-solving, the importance of internal and external brand alignment, and crafting clear, compelling narratives crucial for success in the MedTech industry. Ben Fogarty LinkedIn Council Website Duane Mancini LinkedIn Project Medtech Website Project Medtech LinkedIn

Episode 240 | Panel Discussion at Ohio VC Fest | AI-Driven Healthcare: The Heartland Advantage

48 min

This special episode of the podcast is a recording of a panel discussion that took place at the 2025 Ohio VC Fest powered by @JumpStart Inc. entitled "AI-Driven Healthcare: The Heartland Advantage." Panelists include Michael Dalton (CEO & Founder at @Ovatient), Kaleigh Gallagher (VP of Tech Services & Network Management at @JumpStart), Matthew Zenker (Director of Tech Partnerships & Investments at @University Hospitals Ventures), Jennifer Owens (Senior AI Program Administrator at @Cleveland Clinic), and moderated by Duane Mancini. The conversation dives into the rapidly-growing AI-driven healthcare innovation in the Midwest, exploring the unique advantages the region faces. The discussion covers various topics including talent acquisition, clinical validation, partnerships with healthcare systems, and the role of data in accelerating growth. Michael Dalton LinkedIn Kaleigh Gallagher LinkedIn Matthew Zenker LinkedIn Jennifer Owens LinkedIn JumpStart Inc. Website Duane Mancini LinkedIn Project Medtech Website Project Medtech LinkedIn

Episode 239 | Holly Cotter, Co-Founder of indieMedTech | Building Community & Innovation in Medtech

29 min

In this episode, Duane Mancini chats with Holly Cotter, a seasoned regulatory quality and clinical consulting expert in MedTech and co-founder of indieMedTech. Holly discusses the inception of indieMedTech, a platform designed to support MedTech professionals, especially independent consultants and startups, with a robust community and marketplace. The conversation delves into Holly's background in biomedical engineering, her hands-on experiences with regulatory submissions, quality management, and clinical trials, and the significance of community and networking within the MedTech space. Holly Cotter LinkedIn indieMedTech Website Duane Mancini LinkedIn Project Medtech Website Project Medtech LinkedIn

Episode 238 | Allison Komiyama, Founder of Bluestocking Health | From the FDA to Regulatory Consultant to Medtech Entrepreneur

42 min

In this episode, Duane Mancini interviews Allison Komiyama, a former FDA reviewer turned successful entrepreneur, who shares her journey from her early passion for biology, through her academic achievements in molecular cell biology and neuroscience, to landing a role at the FDA. She recounts the challenges and lessons learned starting her own regulatory consulting business and scaling it to a successful acquisition. The conversation delves into her latest venture, Bluestocking Health, a medtech hype company aimed at educating the public and professionals about medical technology. They discuss the importance of understanding the FDA’s role, navigating the complexities of bringing new tech to market, and the significance of promoting and celebrating medtech innovations. Allison Komiyama LinkedIn Bluestocking Health LinkedIn Bluestocking Health Website “Your Life Depends on It” Book by Talya Miron-Shatz, PhD Duane Mancini LinkedIn Project Medtech Website Project Medtech LinkedIn

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