Project Medtech

In this episode, Jeremy Stackawitz and Duane Mancini discuss his current pre-commercial diagnostic company he is leading, how to choose your first indication for use when you are a platform technology, what about the second and third indication, what led him to Senzo, his experience with raising capital, the importance of naming of the rounds, what it is like being brought in to lead a company when you are not a co-founder, and so much more. Jeremy Stackawitz LinkedIn Senzo Website Project Medtech Website Duane Mancini LinkedIn Project Medtech LinkedIn

In this episode, Jasmin Hounsell and Duane Mancini discuss her company Evolene, how they support Medtech startups, how commercialization strategy differs between UK vs. US and why the differences are underestimated, commercialization strategy, reimbursement, having a commercialization plan and which countries you go to go first, dos and don’ts in Medtech companies trying to commercialize, and so much more. Jasmin Hounsell LinkedIn Evolene Website Project Medtech Website Duane Mancini LinkedIn Project Medtech LinkedIn

In this episode, Shai Policker and Duane Mancini discuss the incubator he is running in Israel, his past experience as an entrepreneur, the partners they work with, helping companies get to a fundable milestone, what kind of companies this is open to from a geographical perspective, what type of Medtech companies they look for, your window of opportunity, the importance of communication, what makes the Israel ecosystem so great, and so much more. Shai Policker LinkedIn MEDX Xelerator Website Project Medtech Website Duane Mancini LinkedIn Project Medtech LinkedIn

In this episode, Yin He and Duane Mancini discuss her background as scientist and what lead her to Amazon Web Services, how her team at AWS works with early-stage innovation, the 16 leadership principles at Amazon and how startups can use these elements at their own company, the healthy tension between scientists, engineers, and the commercial team, diversity, equity, and inclusion, women in Medtech, how do you get an investors attention, and so much more. Yin He LinkedIn AWS Website Project Medtech Website Duane Mancini LinkedIn Project Medtech LinkedIn

In this episode, Mary Yost and Duane Mancini discuss why she founded the Sage Group, her background and why she got into this role, Peripheral arterial disease (PAD), the financial cost to the healthcare system, why it is undiagnosed and under-treated, who is most affected by this disease, current treatments and diagnostic tools, new devices and diagnostics on the horizon, what is next to spread awareness about this issue, and so much more. Mary Yost LinkedIn The Sage Group Website Project Medtech Website Duane Mancini LinkedIn Project Medtech LinkedIn

In this episode, Danielle Bodicoat and Duane Mancini discuss being a biostatistician (medical statistics), why she started her own consulting practice, the importance of clinical evidence beyond regulatory requirements, the cost drivers of a clinical trial, factors that go into clinical trial design, the basics of sample size calculation, clinical evaluation plans and clinical evaluation reports, the MDR and how it is affecting clinical in the EU and UK, and so much more. Danielle Bodicoat LinkedIn Danielle Bodicoat Website Project Medtech Website Duane Mancini LinkedIn Project Medtech LinkedIn

In this episode, Nick Accordino and Will Braeutigam from Deloitte and Duane Mancini discuss discuss SPACs, what are SPACs, why would a company want to go public, the differences in going public through an IPO vs. SPAC, strategic acquisition vs. going public, the myths of going public via a SPAC, preparing your company to go public, and so much more. Nick Accordino LinkedIn Will Braeutigam LinkedIn Deloitte Website Project Medtech Website Duane Mancini LinkedIn Project Medtech LinkedIn

In this episode, Ashley Mooneyham from Superior Medical Experts and Duane Mancini discuss the world of grants in the United States, the SBIR and STTR grant mechanisms, America’s seed fund, the mechanics of where the money can go if you get grant funding, the NIH vs. NSF grant opportunities, phase I vs. Phase II, the application process for both, what you can do with the money in each stage, tips and pitfalls when putting together your application, success rates, budget exceptions, and so much more. Ashley Mooneyham LinkedIn Superior Medical Experts Website Project Medtech Website Duane Mancini LinkedIn Project Medtech LinkedIn

In this episode, Kyle Rose from Rook Quality Systems and Duane Mancini discussthe FDA’s ISO-13485 transition plan, when it was announced, what it looks like, the differences 21 CFR Part 820 vs. ISO 13485, the importance of a risk based approach in quality, updates on the MDR and current trends, could the FDA move towards requiring more clinical data from medical device manufacturers, if regulatory and quality were the only factors in determining your global get-to-market strategy…where would you go, and so much more. Kyle Rose LinkedIn Rook Quality System Website Project Medtech Website Duane Mancini LinkedIn Project Medtech LinkedIn

In this episode, Moshe Safran and Duane Mancini discuss his journey from physicist to c-suite, the importance of communication, the history of algorithms and software in Medtech imaging, tips on getting your technology adopted by the industry, common errors he sees with startups in this space, what makes Israel’s Startup landscape for innovation so great, and so much more. Moshe Safran LinkedIn RSIP Vision USA Website Project Medtech Website Duane Mancini LinkedIn Project Medtech LinkedIn