Project Medtech

Project Medtech
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Jun 6, 2022 • 40min

Episode 96 | Shai Policker, CEO at MEDX Xelerator | How this Israel Accelerator Helps Medtech Startups Get to a Fundable Milestone

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
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May 30, 2022 • 47min

Episode 95 | Yin He, Principal Business Development, Healthcare and Life Sciences Startups at Amazon Web Services | How One of the Largest Tech Companies in the World Engages Healthtech Startups

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
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May 23, 2022 • 52min

Episode 94 | Mary Yost, Co-Founder at the Sage Group | Peripheral Arterial Disease (PAD): Undiagnosed and Under-treated --- A Dive into the Financial Burden on the Healthcare System

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
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May 16, 2022 • 36min

Episode 93 | Danielle Bodicoat | The Scientific Art of Biostats: Clinical Strategy, Sample Size Calculation, Clinical Trial Design, and CEP/CERs

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
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May 9, 2022 • 1h 9min

Episode 92 | Nick Accordino and Will Braeutigam: Deloitte | Taking your Medtech Company Public: SPACs vs. IPOs

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
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May 2, 2022 • 48min

Episode 91 | Ashley Mooneyham: President and Director of Grants at Superior Medical Experts | The Wonderful Thing about Grants Is Grants are Wonderful Things

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
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Apr 25, 2022 • 42min

Episode 90 | Kyle Rose: President at Rook Quality Systems | FDA's ISO 13485 Transition Plan...What Does it Mean for Your Medtech's Quality Plan?

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
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Apr 18, 2022 • 42min

Episode 89 | Moshe Safran: CEO at RSIP Vision USA | Medical Imaging and the use of Algorithms and Software: Tips to Achieve Successful Development and Commercialization

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
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Apr 11, 2022 • 57min

Episode 88 | Josh Rabinowitz: Co-Founder & CEO at Articulate Labs | An Entrepreneur's Perspective: Remote Patient Monitoring Reimbursement Codes and How to get the Most out of an Accelerator/Incubator

In this episode, Josh Rabinowitz and Duane Mancini discuss how they founded the company, what problem they are trying to solve, remote patient monitoring reimbursement codes, how to get the most out of an accelerator, learning to think as a startup company and not as an individual, thinking of the CEO at the bottom of the organization chart rather than the top, product development tips,  and so much more. Josh Rabinowitz LinkedIn Articulate Labs Website Duane Mancini LinkedIn Project Medtech LinkedIn Project Medtech Website
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Apr 4, 2022 • 38min

Episode 87 | Sean Bittner: Director of Programs at M1 Medtech Accelerator | Houston, Texas: The Next Medtech Hub for Startups?

In this episode, Sean Bittner and Duane Mancini discuss the new M1 accelerator in Houston, Texas, their focus in Medtech, importance of partnerships, how fatal choosing the wrong team can be for an early-stage startup, importance of warm introductions, the Houston ecosystem in Medtech, the importance of great leadership, raising too much money, and so much more. Sean Bittner LinkedIn M1 Medtech Accelerator Website Duane Mancini LinkedIn Project Medtech LinkedIn Project Medtech Website

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