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.

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.

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.

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.

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.

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.

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.

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.

In this episode, Scott Filer at ProMedix and Duane Mancini discuss his background as a green beret, the problem with diagnosing sepsis, what he has learned in his entrepreneurial journey, and so much more. Scott Filer LinkedIn ProMedix Website Project Medtech Website Duane Mancini LinkedIn

In this episode, Tosan Ugbeye at ScopeMed and Duane Mancini discuss his background as a clinician, the evolution of Scope Med, what he has learned so far, and so much more. Tosan Ugbeye LinkedIn Scope Med Website Project Medtech Website Duane Mancini LinkedIn

In this episode, Karen Zaderej at Axogen and Duane Mancini discuss her background in the medtech space, the story of Axogen, how they are revolutionizing nerve repair and so much more. Karen Zaderej LinkedIn AxoGen Website Project Medtech Website Duane Mancini LinkedIn

In this episode, Shawnnah Monterrey at BeanStock Ventures and Duane Mancini discuss Grassroots Dx, 3rd party review accreditation for FDA, software in Medtech, digital health and so much more. Shawnnah Monterrey LinkedIn BeanStock Ventures Website Project Medtech Website Duane Mancini LinkedIn

In this episode, Howie Chan at Healthy Brand Consulting and Duane Mancini discuss brand development throughout the various stages of a Medtech startup company and so much more. Howie Chan LinkedIn Health Brand Consulting Website Project Medtech Website Duane Mancini LinkedIn

In this episode, Randy Armstrong at Velentium and Duane Mancini discuss innovations, breakthroughs, and challenges in IPG development and so much more. Randy Armstrong LinkedIn Velentium Website Project Medtech Website Duane Mancini LinkedIn

In this episode, Dan Purvis at Velentium and Duane Mancini discuss his background in the Medtech industry, how and why he founded Velentium, the importance of why and who, culture and so much more. Dan Purvis LinkedIn Velentium Website Project Medtech Website Duane Mancini LinkedIn

In this episode, Susan Xu at WyDus and Duane Mancini discuss healthcare in the United States and its reimbursement maze, reimbursement of digital health products, what payers look for, and so much more. Susan Xu LinkedIn Link to Book by Susan Xu Project Medtech Website Duane Mancini LinkedIn

In this episode, Christopher Gates at Velentium and Duane Mancini discuss embedded cybersecurity for medical devices, the importance of addressing cybersecurity early, hackers, and so much more. Christopher Gates LinkedIn Velentium Website Project Medtech Website Duane Mancini LinkedIn

In this episode, Chris Hanna at Pacific Therapy Access, Kathleen O'Neill at Pacific Therapy Access and Duane Mancini discuss the reimbursement process of medical technologies in the United States, the coding system, why reimbursement pathway is so important and so much more. Chris Hanna LinkedIn Kathleen O'Neill LinkedIn Pacific Therapy Access Webs…

In this episode, Brendan Boland at Loci Orthopaedics, Fionn Lahart at LUMA Vision, Gerard Insley at PBCbiomed and Duane Mancini discuss what each one of them are working on, the Medtech ecosystem in Ireland, what makes the ecosystem so strong, their favorite Irish Whiskey and so much more. Brendan Boland LinkedIn Loci Orthopaedics Website Fionn Lah…

In this episode, Rich Mazzola and Duane Mancini discuss Rich's background in the Medtech space, what we can expect from him as host of the Medtech Money podcast series and so much more. Rich Mazzola LinkedIn Project Medtech Website Project Medtech LinkedIn Duane Mancini LinkedIn

In this episode, Giovanni Lauricella and Duane Mancini discuss Giovanni's time as the @medtech money podcast host, what he learned, the connections he made along the way and so much more. Giovanni Lauricella LinkedIn Lifeblood Capital Website Project Medtech Website Project Medtech LinkedIn Duane Mancini LinkedIn…

In this episode, Devon Campbell and Duane Mancini discuss the due diligence process, what you need to be prepared to answer as a startup company, common errors, recommendations, and so much more. Devon Campbell LinkedIn Prodct Website Project Medtech Website Project Medtech LinkedIn Duane Mancini LinkedIn…

In this episode, Edward Steakley, Devon Campbell and Duane Mancini discuss intellectual property, patents, trade secrets, overall strategy around these topics, why they are important, and so much more. Edward Steakley LinkedIn Devon Campbell LinkedIn Cognition IP Website Prodct Website Project Medtech Website Project Medtech LinkedIn Duane Mancini …

In this episode, Nikki Batista, Devon Campbell and Duane Mancini discuss the merger of regulatory and business strategy, allowing business to lead decisions not regulatory, global regulatory strategy, how to communicate with the FDA, and so much more. Nikki Batista LinkedIn Devon Campbell LinkedIn MCRA Website Prodct Website Project Medtech Website…

In this episode, Sean McKibben, Stefan Agamanolis, Rich Mazzola, Aaron TenHuisen and Duane Mancini discuss the problem they saw in the industry, the mission of Project Medtech, the growth and expansion of Project Medtech's consulting and advisory services and so much more. Sean McKibben LinkedIn Stefan Agamanolis LinkedIn Rich Mazzola LinkedIn Aaro…

In this episode, Lissa Tallman and Duane Mancini discuss market research, when you should think about doing market research, the different kinds of market research, AI and Machine Learning in Market Research and so much more. Lissa Tallman LinkedIn Flashfield Website Project Medtech Website Project Medtech LinkedIn Duane Mancini LinkedIn…

In this episode, Salvatore Buscemi and Duane Mancini discuss his new book called “Investing Legacy: How the .001% invests”, family offices and how they evaluate opportunities and so much more. Salvatore Buscemi LinkedIn HRN Website Project Medtech Website Project Medtech LinkedIn Duane Mancini LinkedIn…

In this episode, Isaiah Kaiser and Duane Mancini discuss the technology they spun out of University of Akron, how his PhD helped him with his entrepreneurial skills, finding non-dilutive capital, their experience with the iCorp program, working with the University so that both parties win, what he has learned so far during his early journey of entr…

In this episode, Neal Piper and Duane Mancini discuss his personal tie to the problem they are solving, the importance of culture, the focus on team and problem, advice for raising capital, not delaying hard conversations, and so much more. Neal Piper LinkedIn Luminoah Website Project Medtech Website Project Medtech LinkedIn Duane Mancini LinkedIn…