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 Consulting Rook Quality Systems Beginski Wegner & CO...
Oct 07, 2024•50 min
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 globe, common mistakes and so much more. Don Pohl LinkedIn Sheri Krajewski LinkedIn NAMSA LinkedIn NAMSA Website Duane Mancini LinkedIn Project Medt...
Oct 01, 2024•48 min
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 Project Medtech LinkedIn Project Medtech Website...
Sep 16, 2024•1 hr 3 min
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 entrepreneurs, and so much more. Kristen Mittal LinkedIn Mridul Mittal LinkedIn Mittal Consulting LinkedIn Mittal Consulting Website Duane Mancini Linke...
Sep 09, 2024•46 min
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 Project Medtech LinkedIn Project Medtech Website...
Aug 26, 2024•46 min
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 Duane Mancini LinkedIn Project Medtech LinkedIn Project Medtech Website...
Aug 19, 2024•50 min
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 Medtech LinkedIn Project Medtech Website...
Aug 04, 2024•30 min
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 Website Duane Mancini LinkedIn Project Medtech LinkedIn Project Medtech Website...
Jul 29, 2024•42 min
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 Project Medtech LinkedIn Project Medtech Website...
Jul 22, 2024•43 min
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 Mancini LinkedIn Project Medtech LinkedIn...
Jul 15, 2024•48 min
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.
Jul 01, 2024•46 min
In this episode, Simon Mason at NEST and Duane Mancini discuss the NEST program with the FDA, real-world evidence and so much more.
Jun 24, 2024•35 min
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.
Jun 17, 2024•39 min
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.
Jun 10, 2024•38 min
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.
Jun 03, 2024•43 min
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.
May 27, 2024•34 min
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.
Apr 29, 2024•37 min
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.
Apr 22, 2024•35 min
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.
Apr 15, 2024•43 min
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.
Apr 08, 2024•34 min
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.
Apr 01, 2024•51 min
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.
Mar 25, 2024•55 min
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.
Mar 11, 2024•45 min
In this episode, Matt Eisendrath at Full Spectrum Software and Duane Mancini discusses his background in the medtech space, software as a medical device vs. digital therapeutics, what excites him about the future of Medtech and so much more.
Mar 04, 2024•55 min
In this episode, Angelica Maestas at Healthtech Rx and Duane Mancini discuss her time in the Medtech space, health economics and reimbursement, her obsession with data analytics, taking a company through an exit, her passion for ending health inequities and so much more.
Feb 19, 2024•38 min
In this episode, Eric Horesnyi at Matrix Requirements and Duane Mancini discuss his background as an entrepreneur, quality management systems and the importance of quality as a key pillar for culture, and so much more.
Feb 12, 2024•37 min
In this episode, Ryan Confer at Genprex and Duane Mancini discuss his background in startup companies, the importance of understanding finances in an early-stage company, why they took Genprex public, and so much more.
Feb 04, 2024•47 min
In this episode, Mark Dybul at Renovaro Biosciences and Duane Mancini discusses his background in the US government, what they are working on at Renovaro Biosciences, the importance of being able to communicate complex problems in an easy-to-understand way, and so much more.
Jan 29, 2024•54 min
In this episode, Anish Kaushal at Amplitude Ventures and Duane Mancini discuss his background in the medtech space, his transition from being a medical doctor to venture capitalist, his new book and so much more.
Jan 21, 2024•49 min
In this episode, Jeffrey Sirek at PRIA Healthcare and Duane Mancini discuss the importance of health economics and reimbursement, scaling a medtech service company, the culture of a growing company, and so much more.
Jan 08, 2024•38 min
