In this episode, Duane Mancini is joined by Harrison Lands, Director of Translational Sciences at UPMC Enterprises. Harrison brings a unique perspective, shaped by his background as a physician, MBA, consultant, and now investor. We delve into the workings of UPMC Enterprises, exploring their investment thesis – the who, what, how much, when, and h…

In this episode, Duane Mancini sits down with Isaiah Kaiser, Co-Founder and CEO of Auxilium Health, and Elyse Ball, Vice President of Programming at Bounce Innovation Hub. Fresh off Auxilium Health's exciting $1.5M oversubscribed pre-seed round and new office at Cleveland Clinic, Isaiah returns to share their journey since his first appearance in e…

In this episode, Duane Mancini interviews Devon Campbell, Christie Johnson, and Dan Tipaldo to continue the theme from episodes 207, 208, and 209 about how startups can effectively 'do it yourself' when budgets are tight, this episode tackles the next frontier: Artificial Intelligence. We acknowledge that resource-strapped startups need to be resou…

In this episode, Duane Mancini interviews Joao Rezende-Neto on his remarkable journey through the global landscape of medicine and innovation. From medical training in Brazil to a trauma fellowship in the US, exposure to Boston's cutting-edge medical advancements, and experiences in Canada, this episode explores the unique insights gained from navi…

In this episode, Duane Mancini interviews Kelly Collier at LifeX on the dynamic life science startup ecosystem thriving in Pittsburgh. We explore the unique synergy between major academic institutions like the University of Pittsburgh and Carnegie Mellon University, and healthcare giants such as UPMC and Allegheny Health Network. Discover Kelly's e…

In this episode, Duane Mancini explores the critical aspects of medtech regulation and product development with Niki Caporali Spaniel and Chad Gibson of CMD Medtech. Niki shares her expertise in post-market clinical follow-up and navigating the complexities of the Medical Device Regulation (MDR). Chad emphasizes the importance of integrating cybers…

In this episode, Duane Mancini delves into the life science ecosystem in Kentucky with Christin Godale, Executive Director at LifeSciKY, and Nicholas Lyktey, Chief of Laboratory Operations at Gravity Diagnostics. Christin discusses the collaborative, bipartisan efforts driving innovation in the Commonwealth, including the launch of strategic initia…

In this episode, Matt Sokany joins Duane Mancini at Project Medtech to share his extensive experience in the medtech industry, from his time at Ethicon Endosurgery (Johnson & Johnson) to his impactful journey in the startup world. Matt details his strategic approach to building successful companies, including his remarkable exit with New Wave Surgi…

In this episode, Tim Grace, Managing Partner at Techstars Columbus, joins Duane Mancini to unpack the dynamic world of startup acceleration and venture funding. Tim shares his journey from a tech background to leading a pivotal Techstars program, and discusses the creation of the LongJump venture fund. We delve into the origins and growth of Techst…

In this episode, Antony Watson, COO of Xenocor, joins Duane Mancini to share his journey from Medtronic sales rep to startup founder. Antony discusses his experience in the operating room, observing surgical cases firsthand, and how this unique perspective shaped his leadership approach and ultimately prepared him to launch and lead Xenocor. Discov…

In this episode, Yaky Yanay, CEO at Pluri, joins Duane Mancini to explore the captivating world of regenerative medicine and the unwavering resilience required to lead in the life sciences. We delve into the profound power of cells and how Yaky's deep scientific understanding fuels Pluri's entrepreneurial success. Yaky shares invaluable insights on…

In this episode, Tino Chow, CEO and Founder of Giant Shoulders, joins Duane Mancini for a deep dive into the power of branding in the medtech industry. 1 Tino, a "three-headed monster" with experience in the military, industrial design, and business, shares his expertise on building a brand strategy that empowers "on-brand" decisions, even in the a…

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In this episode, Susan Xu, Principal at WyDus, joins Duane Mancini to unravel the complexities of reimbursement in the digital health landscape. Susan explains how Medtech startups can navigate the system to get paid for their innovations, covering everything from Health IT and wearables to telehealth and AI. Learn about the crucial role of diagnos…

In this episode, Devon Campbell, Founder and Managing Director at Prodct, and Tino Chow, Founder, and CEO at Giant Shoulders, join Duane Mancini to discuss building a strong Medtech brand without big budgets. Learn how to develop a compelling brand strategy, create a professional website on a shoestring budget, design impactful pitch decks, and max…

In this episode, Devon Campbell, Founder and Managing Director at Prodct, and Eric O'Dell, Consultant at Project Medtech, join Duane Mancini in a must-listen for bootstrapped Medtech founders! This episode provides a DIY guide to managing your startup's finances without hiring expensive professionals. Learn how to set up bank accounts, choose the r…

In this episode, Devon Campbell, Founder and Managing Director at Prodct, and Tom Morgan, Chief Scientific Officer at myBiometry, join Duane Mancini for a practical discussion on optimizing early development for Medtech startups. Devon and Tom highlight the crucial role of organization, process, and software in driving efficiency and success, even …

In this episode, Simon Malpas, CEO of Kitea Health, joins Duane Mancini to share his incredible journey from blood pressure researcher to Medtech CEO. Simon details Kitea Health's innovative brain pressure implant, revealing the challenges and triumphs of navigating clinical trials and the FDA's PMA process as a startup. Hear firsthand accounts of …

In this episode, Kirk Petyo at Talent Factory Recruiting and Duane Mancini discusses his background in recruiting, how startups attract talent, the biggest mistakes companies make in hiring, managing company culture, implementing a successful onboarding process, and so much more. Kirk Petyo LinkedIn Talent Factory Recruiting LinkedIn Talent Factory…

In this episode, Shalabh Gupta at Unicycive Therapeutics and Duane Mancini discuss going from a practicing physician to a biotech entrepreneur, why he made the switch, lessons learned in his career, how to think about your career long term and not short term, how he took his company public, measuring success, his best advice and so much more. Shala…

In this episode, Eric Eskey at Dark Horse Works and Duane Mancini discuss his background as an engineer, understanding what your customer wants, recommended books about innovation, behavioral economics, early adopters vs. laggers, common mistakes, his best advice to entrepreneurs, and so much more. Eric Eskey LinkedIn Dark Horse Works LinkedIn Dark…

In this episode, Staci Miller at Gen UX Consulting and Duane Mancini discusses her background as a fashion designer, cognitive psychology, how she got into human factors testing, what she learned from her time with Medtronic and Abbott, and so much more. Staci Miller LinkedIn Gen UX Consulting LinkedIn Gen UX Consulting Website Duane Mancini Linked…

In this episode, Emma Scharfenberger Off at CincyTech and Duane Mancini discuss her background as an M&A lawyer, who is CincyTech and what they are focused on, how to leverage your board, decision-making within startup companies, bridge rounds, how to create value and so much more.⁠⁠⁠⁠⁠ ⁠Emma Scharfenberger Off LinkedIn⁠ ⁠CincyTech LinkedIn⁠ ⁠Cincy…

⁠⁠In this episode, Aaron TenHuisen, Jamie Easterling, and Rich Mazzola at Project Medtech and Duane Mancini discuss the growth at Project Medtech, the growth of the commercial consulting group, our expansion into talent and quality support, and so much ⁠Duane Mancini LinkedIn⁠⁠⁠⁠⁠⁠⁠⁠ ⁠Aaron TenHuisen LinkedIn⁠ ⁠Rich Mazzola LinkedIn⁠ ⁠Jamie Easterl…

In this episode, Rebecca McManus at Amethyst Care and Duane Mancini discusses the technology she is working on out of Trinity College of Dublin, their next 18 months, the innovation scene in Dublin, Ireland, her interest in Northeast Ohio, Adapt Research Center, lessons learned so far, how she overcame the anxiety of how long everything takes in Me…

In this episode, Crystal Weber at Group 31 and Duane Mancini discuss her second career as a marketing expert, how her first career as a nurse prepared her for this role, the importance of tailoring messaging to investors, how to position your product in the healthcare system, and so much more. Crystal Weber LinkedIn Group 31 Communications LinkedIn…

In this episode, Todd Ponsky at Cincinnati Children's and Duane Mancini discuss his background as a pediatric surgeon, his startup company that he launched around education, the changes to the innovation and venture arm of Cincinnati Children's, the importance of having a supportive hospital leadership team for the innovation department, and so muc…

In this episode, Dylan Horvath at Cortex Design and Duane Mancini discusses how he founded his company, features vs. innovations, lessons learned, common mistakes, and so much more. Dylan Horvath LinkedIn Cortex Design LinkedIn Cortex Design Website Duane Mancini LinkedIn⁠⁠⁠⁠ ⁠⁠⁠⁠Project Medtech LinkedIn⁠⁠⁠⁠ ⁠⁠⁠⁠Project Medtech Website ⁠ ⁠Mittal Co…

In this episode, Don Pohl and Sheri Krajewski at NAMSA and Duane Mancini discuss ISO 10993 and biocompatibility testing for medical devices, the history of the standard and how it has evolved, why following the risk-based approach is becoming more important, tips to avoid having your submission delayed with various regulatory bodies across the glob…

In this episode, Omar Khateeb at Khateeb & Co. and Duane Mancini discuss carrying the bag, growth marketing, talking to investors, meeting with early adopters, his podcast The State of Medtech, speed learning, building loyal customers and so much more. Omar Khateeb LinkedIn Khateeb & Co. Website State of Medtech Podcast ⁠Duane Mancini LinkedIn⁠⁠ ⁠⁠…

In this episode, Kristen Mittal and Mridul Mittal at Mittal Consulting and Duane Mancini discuss their unique backgrounds in medtech, why they started Mittal Consulting, what medtech companies should expect from a regulatory strategy report, breakthrough designation, 513(g) vs. pre-submission meetings, common pitfalls, their advice for entrepreneur…

In this episode, Monica Vajani at mHUB and Duane Mancini discuss her background at Abbott and Medtronic, carrying the bag, early adopters vs. laggers, mHUB, the next cohort of companies for their medtech accelerator, and so much more. Monica Vajani LinkedIn mHub Medtech Accelerator Application mHub LinkedIn mHub Website Duane Mancini LinkedIn Proje…

In this episode, Craig Misrach at UpLyft and Duane Mancini discuss what has changed since his last appearance on the podcast, choosing and changing your contract manufacturer based on the commercialization stage, the importance of quality, creative ways to finance your startup, and so much more. Craig Misrach LinkedIn UpLyft LinkedIn UpLyft Website…

In this episode, Hilary Swan at Rebel Scout Consulting and Duane Mancini discuss her background in the medtech space, inside sales vs. outside sales, tips for selling into a hospital, the user journey, the importance of implementation and so much more. Hilary Swan LinkedIn Rebel Scout LinkedIn Rebel Scout Website Duane Mancini LinkedIn Project Medt…

In this episode, Megan Doberstein at Ignite Medtech and Duane Mancini discuss her background in the medical device space, marketing for a direct to consumer medical device, understanding all your customer profiles, strategically marketing to all of those customers and so much more. Megan Doberstein LinkedIn Ignite Medtech LinkedIn Ignite Medtech We…

In this episode, Tim Lucas at The NeuroTech Institute and Duane Mancini discuss why Universities have historically struggled to commercialize innovation, the Broad Institute, how he modeled the NeuroTech Institute after it, achieving clinical adoption, and so much more. Tim Lucas LinkedIn The NeuroTech Institute Website Duane Mancini LinkedIn Proje…

In this episode, Kathryn Dougherty at KCD and Duane Mancini discuss her background in the medtech space, the intersection of finance and marketing, upstream and downstream marketing, the difficulties of being an entrepreneur, her best advice for medtech startup companies and so much more. Kathryn Dougherty LinkedIn Project Medtech Podcast Duane Man…

In this episode, Matthew Schonauer and Anthony Tomusko at UB Greensfelder and Duane Mancini discuss what led them into being life science-focused IP attornies, the process of engaging an IP attorney, the intangibles an IP attorney can bring to the team, freedom to operate and so much more.

In this episode, Simon Mason at NEST and Duane Mancini discuss the NEST program with the FDA, real-world evidence and so much more.

In this episode, Matt Iorio at Neuros Medical and Duane Mancini discuss his background in the Medtech space, the collection of clinical data, the importance of clinical data for regulatory and commercial purposes, and so much more.

In this episode, Rick Geoffrion at Cyrano Therapeutics and Chip Hance at Regatta Medical and Duane Mancini discuss history of the Early Feasibility Studies (EFS) Program at the @FDA, the importance of it, how @MDIC supported mission and so much more.

In this episode, Andrew Fish and Joseph Sapiente at Medical Device Innovation Consortium (MDIC) and Duane Mancini discuss the mission of MDIC, the various initiatives and programs, how to engage MDIC and so much more.

In this episode, Brittani Ritchie at Project Medtech and Duane Mancini discuss her background in the Medtech industry, making quality a part of your culture, what to expect in an FDA audit and so much more.

In this episode, Charles Allan at MY01 and Duane Mancini discuss his background in the Medtech industry, what MY01 is working on, the Medtech Innovator program, focus on collecting clinical data for commercialization support, fundraising strategies as you advance rounds, the Canadian Medtech ecosystem and so much more.…

In this episode, Michelle Lott at LeanRAQA and Duane Mancini discuss the QMSR, FDA e-start program, 513g vs. presubmission meeting, MDR update and so much more.

In this episode, Kevin Saem at Zapyrus and Duane Mancini discuss what Zapyrus does, their 2023 Medtech report on the industry and so much more.

In this episode, Katrina Holland at MedTech Color and Duane Mancini discuss her new role at MedTech Color, closing the diversity gap in Medtech, her short, medium and long term vision of Medtech Color, and so much more.

In this episode, Ken Callahan at The Hargan Group and Duane Mancini discuss his background with HHS, what startups need to know about the department, what are the biggest policy decisions being discussed right now, how the upcoming election could affect those policies, big issues coming up in 2025 and beyond, and so much more.…

In this episode, Tim Boire and Geoff Lucks at VenoStent and Duane Mancini discuss their background in the Medtech space, how they founded VenoStent, their clinical trial, fundraising strategy, and its correlation to achieving milestones and so much more.

In this episode, Ronan O'Hagan at Bectas Therapeutics and Duane Mancini discuss the overlap between pharma and medtech, what can a medtech company learn from a pharma startup, the importance of communicating science in a digestable manner, building your team, fundraising strategy and so much more.