Project Medtech

In this episode, Jimmy Jin, Ronnie Wang and Duane Mancini discuss CIIE, Mednovation, why one would want to take their product to market in China, the process for entering the Chinese market, common mistakes companies make, the importance of commercial and IP, and so much more. Jimmy Jin LinkedIn Ronnie Wang LinkedIn Project Medtech Website Duane Mancini LinkedIn Project Medtech LinkedIn

In this episode, Greg Tuers and Duane Mancini discuss IEC 60601, power supply for medical devices, normal use vs. intended use, shelf life of various components, manufacturing tips, other standards and so much more. Greg Tuers LinkedIn Ram Technologies Website Project Medtech Website Duane Mancini LinkedIn Project Medtech LinkedIn

In this episode, Chris Lah and Duane Mancini discuss middlemen in the US healthcare system, a look into the revenue cycle at a hospital, how various players in the healthcare system evaluate technology, payment reimbursement strategies, his participation in TedX, and so much more. Chris Lah LinkedIn Mayfield Brain & Spine Website Project Medtech Website Duane Mancini LinkedIn Project Medtech L...

In this episode, Dave Albert and Duane Mancini discuss his history in the Medtech space, his various patents, his current company AliveCOR, his video that went viral, what it was like selling a company on 9/11, what it is like fighting the behemoth companies, the power of data, prediction becomes prevention, finding that complimentary team, there is no such thing as a solo entrepreneur, and so muc...

In this episode, Joseph Mocanu and Duane Mancini discuss his current fund called Verge HealthTech Fund, what sucks in healthcare right now that could be fixed with technology, sick care vs. healthcare, global healthcare access, what it truly means to be an impact investor, how an impact fund looks at opportunities vs. a typical venture group, entrepreneurship and how it is viewed around the world,...

In this episode, Keith Matheny and Duane Mancini discuss the complexities of spending time as an entrepreneur but also still a practicing a clinician, the benefit to continuing to practice, the multiple companies he is running, building your clinical advisor board and key opinion leaders, the US healthcare system, the need for healthcare reform and who should own that, and so much more. Keith Math...

In this episode, Richard Hanbury and Duane Mancini discuss what he is working on at Sana Health, how he started this journey of solving pain, how he looked at the De Novo process as a startup company, why breakthrough status was powerful for them, how he built his team, what to fractionalize and what to bring in-house, building a team to balance your gaps, his best advice for fundraising, paying a...

In this episode, David Sylvan, Brian Rothstein and Duane Mancini discuss why Brian wanted to get into innovation, how UH Ventures got it start, the SPICE filter they apply, who uses, who benefits, who buys, who measures, and why selling into healthcare is so hard, what are the non-starters before they will work with a company, why journey mapping for a device is so important, and so much more. Dav...

In this episode, Etienne Nichols and Duane Mancini discuss how he supports Medtech companies in implementing electronic quality management systems, the 2022 benchmark study they did this year on 519 Medtech professionals, what headwinds Medtech companies are facing, what the survey said about time to market, common errors on supplier management, opportunities that a lot of the professionals saw, t...

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 whe...

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 m...

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 make...

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 Medte...

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 a...

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,...

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...

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 a...

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...

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 RS...

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...

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 Ac...

Niall Casey LinkedIn Carlsmed Website Neil Thompson LinkedIn Kevin Buckley LinkedIn Torrey Pines Law Website Duane Mancini LinkedIn Project Medtech LinkedIn Project Medtech Website

In this episode, Kevin Kallmes, Keith Kallmes and Duane Mancini discuss how they took the problems they encountered from their first company and spun it into another company, how they are tackling systematic literature review and meta analysis as a process, the issue with clinical data storage, lessons they learned along the way in their first startup company, how to realize when you are not the b...

In this episode, Tamir Meiri and Duane Mancini discuss his background and how he became a “geek” of healthcare, the sense of pride in Israel about their healthcare innovation, we do a deep dive into Johnson & Johnson and the different branches, how they evaluate investments, the importance of partnerships to bring innovation to patients, do venture arms of strategics work together, what trends...

In this episode, Matt McBride and Duane Mancini discuss his background at Cleveland Clinic Innovation and Bioenterprise, the main buckets of clients that Wave Strategy supports, the importance of determining not just your clinical unmet need but determining if you are truly different enough than the current solution, what is their process to identifying their clinical problem, pinning down what su...