Project Medtech

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...

In this episode, David and I discuss what he is currently working on, how he builds his teams and the pillars of his companies, his book Innovation In Translation, good money vs. bad money, the strategies he has deployed to raise capital in different companies, evolution of the importance of reimbursement, the importance of IP and why you need to have a strategy, and more. David Ferrera LinkedIn I...

In this episode, Krista and Duane discuss the return on your investment if you focus on building your digital footprint and when to do it. Krista Moon LinkedIn Ascend Business Growth Website Duane Mancini LinkedIn Project Medtech LinkedIn Project Medtech Website

In this episode, Patty and Duane discuss her new company, why she chose North Dakota as the headquarters of her company, how she captured non-dilutive capital, clinical usability studies, developing your pitch, how your pitch should evolve, and more. Patty Post LinkedIn Checkable Medical Website Duane Mancini LinkedIn Project Medtech LinkedIn Project Medtech Website

In this episode, Krista and I discuss SEO basics, website basics, content marketing, social media presence, CRM basics and more. Krista Moon LinkedIn Ascend Business Growth Website Duane Mancini LinkedIn Project Medtech LinkedIn Project Medtech Website

In this episode, Krista and I discuss marketing challenges that will hinder growth, why it is important to do an audit of your marketing strategy, 5 common challenges and more. Krista Moon LinkedIn Ascend Business Growth Website Duane Mancini LinkedIn Project Medtech LinkedIn Project Medtech Website

In this episode, Jeff and I discuss what Advanced Scanners is working on, comparing his experience as an entrepreneur in other industries vs. Medtech, who else to talk to besides just the end-users, how to deal with investors when you have a platform technology, how to choose which indication of use to go after based on market feedback, investors, etc., lessons learned in raising capital as a firs...

In this episode, Abbas and I discuss cybersecurity in the Medtech space, tips of protecting patient data, if the positives outweigh the risks, standards to follow and more.  Abbas Dhilawala LinkedIn Galen Data Website Duane Mancini LinkedIn Project Medtech LinkedIn Project Medtech Website

In this episode, Talya and I discuss her book, her research with Daniel Kahneman, interoperability, multi-disciplinary teams, relationships with clients/patients, the psychology of how patients make decisions and how physicians/other primary care providers make decisions and more. Talya Miron-Shatz LinkedIn "Your Life Depends on It" Book Link Duane Mancini LinkedIn Project Medtech LinkedIn Project...

In this episode, Abass and I discuss connecting medical devices to the cloud, the debate of building your own vs. using an already established one, maintenance of each, safety and security concerns, and more. Abbas Dhilawala LinkedIn Galen Data Website Giovanni Lauricella LinkedIn Project Medtech LinkedIn Project Medtech Website

In this episode, Kyle and I discuss what is Rook Quality System and how they can help, quality system basics, where to start when building one, importance of a quality system as a start-up, how to build a system that can scale with you, and more. Kyle Rose LinkedIn Rook Quality System Website Duane Mancini LinkedIn Project Medtech LinkedIn Project Medtech Website

In this episode, Karen and I discuss their wearable Parkinson product, how they took advantage of the new RPM codes, partnering with Pharma and Medtech companies as a remote monitor for their clinical trials and more. Karen Krygier LinkedIn Global Kinetics Website Duane Mancini LinkedIn Project Medtech LinkedIn Project Medtech Website