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 LinkedIn...
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 much more. Dave Albert LinkedIn AliveCor Website Project Medtech Website Duane Mancini LinkedIn Project...
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, picking the right partners for a startup, and so much more. Joseph Mocanu LinkedIn Verge HealthTech...
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 Matheny LinkedIn Project Medtech Website Duane Mancini LinkedIn Project Medtech LinkedIn...
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 attention to what motivates the type of investor you are pitching, what it is like taking on the big ...
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. David Sylvan LinkedIn Brian Rothstein LinkedIn University Hospitals Ventures Website Project Medtech We...
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, the risk of cybersecurity, the importance of companies spending time and resources on employee growth...
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 Medte...
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 Pr...
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 Pro...
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 Med...
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 Medte...
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 Linke...
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 mo...
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...
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...
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 Link...
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...
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 best person for the job anymore, various failure modes that they have seen through interacting with o...
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 he sees in the industry, the importance of diversity on your board, and so much more. Tamir Meiri L...
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 success looks like at an innovation group, what it is like to help set-up a family office thesis, does...
In this episode, Joe Runge and Duane Mancini discuss what it going on at UNeTech, his background on what lead him to UNeTech, the importance of intellectual property and the reason companies struggle with this topic, the difficulty of when a company might have to expand out of a local ecosystem in order to continue the success of their company, the challenge with capital for midwestern companies, technology that is coming out of UNeTech, non-dilutive funding in the Medtech space and its importan...
In this episode, Adam Steadman and Duane Mancini discuss when to engage a CRO, defining what a CRO really is, understanding how CROs and clinical trials work from a cost perspective, why the switch out of the CRO space, what Smart-Trial is working on and how it differs, hybrid and decentralized clinical trials, the types of data you want to generate and collect during a clinical trial, and so much more. Adam Steadman LinkedIn Smart-Trial Website Duane Mancini LinkedIn Project Medtech LinkedIn Pr...
In this episode, Karandeep Singh Badwal and Duane Mancini discuss comparing regulatory at a startup vs. large organization, the growth of strategics regulatory department, software and AI as a medical device, how companies straddle the line of being a medical device vs. not, how various regulatory bodies are dealing with the rise in software as a medical device, why the FDA is doing such a great job in this space, a common error he sees with companies with software as a medical device, his backg...
In this episode, Ladan Jiracek and Duane Mancini discuss his podcast the Neural Implant podcast, where the neurospace is headed, peripheral nerve stimulation, bioelectronic medicine, the vagus nerve, the power of networking, his mastermind group, and so much more. Ladan Jiracek LinkedIn Neural Implant Podcast Duane Mancini LinkedIn Project Medtech LinkedIn Project Medtech Website...
In this episode, Andrew Elder, Christoph Ruedig and Duane Mancini discuss the background of Albion VC, their focus on late-seed and series A stage investments, their focus on health tech, geographical focus, why they made the switch from practicing physicians to investors, what sparked their interest in digital health, what areas of digital health they focus on, where they see the digital health industry going, the importance of messaging to achieve technology adoption, some of the various compa...
In this episode, our guest Isabella Schmitt and Duane Mancini discuss the rapid growth Proxima has seen in the last 5 years, the new accelerator she founded called M1 Accelerator, the importance of regulatory strategy, why one might choose a de novo vs. 510k, why startups shouldn’t be afraid of a PMA, implementing regulatory strategy into your business strategy, the common mistakes Isabella sees with startups, her best advice for startups and so much more. Isabella Schmitt LinkedIn Proxima CRO W...
