Project Medtech

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...

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,...

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...

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 j...

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 i...

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 w...

In this episode, our guest Mitch Robbins and Duane Mancini discuss his background in recruiting, the current demand for Medtech talent, the future of remote work, progression of going from fractionalized to full time team members, passive vs. active recruitment, how do you attract top talent as a Medtech startup, how many applicants can companies expect for certain positions, how to de-risk your h...

In this episode, Bradley and Duane Mancini discuss his background in the Medtech space, the timeline of exiting to a Medtech strategic, his new Project at Covellus and the unique path to market he has taken, his thoughts on who is his core team members, the importance of augmenting your weaknesses when building your core team, intellectual property strategy, the importance of storytelling as a Med...

In this episode, Craig and Duane Mancini discuss what his team is currently working on at UpLyft, his first company that he started, his experience with non-dilutive capital in Ohio, his advice on raising capital, how he raised money in his first company, why his company focused on digital marketing and the benefit, and so much more. Craig Misrach LinkedIn UpLyft Website Duane Mancini LinkedIn Pro...

In this episode, Alejandro and Duane Mancini discuss why it is so difficult to get to a specialist in the US healthcare system, his new book “healthcare from the trenches” and why he wrote it, the barriers to use for your product and why a startup needs to be concerned with this issue, the adoption of technology and why “too many hands in the cookie jar” will stunt good products from getting to ma...

In this episode, Jon and Duane discuss the issue of clinical data collection in medical device development, the lack of clinical data for products on the market, the need for balance between innovation and safety, why you need to think about clinical data early, why sales and marketing need to have a heavy influence in your clinical data collection, how the MDR is affecting innovation in Europe an...

In this episode, Michelle and Duane discuss discuss her focus on startups, when to get a regulatory strategy done, why regulatory strategy is crucial and should be a part of your business plan, why you need to be careful when building your website, when it makes sense to use a stepwise regulatory approach, benefits to a De Novo pathway, could the US move towards MDRish regulations, and more. Miche...

In this episode, Neil and Duane discuss his new company and what they are working on, his background as a practicing physician, why they are a class III medical device, the lack of innovation and funding in women’s healthcare, why they weren’t afraid of a PMA process with the FDA, first time fundraising as a CEO, and more. Neil Ray LinkedIn Raydiant Oximetry Website Duane Mancini LinkedIn Project...

In this episode, Andy and Duane discuss how his journey has prepared him for being a CEO in the Medtech space, what they are working on at Koya Medical, where are they going next, what he has learned in each phase of his career so far, the importance of trust of team, the importance of who you raise capital from and why you should value that over how much you raise, and more. Andy Doraiswamy Linke...