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Medtech Matters

Medical Product Outsourcing

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A podcast focused on the medical device technology industry, from design and development to outsourcing services and relationships to finished medtech products.
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Project Medtech

Project Medtech

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The Project Medtech podcast is interview-style podcast on the Medtech Industry where guests share stories, advice, pitfalls, trends and innovations produced by Project Medtech.
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Medtech Innovation Podcast: Spencer Jones dives deep into winning medtech startup strategies. Each episode unpacks hot takes and insider tactics from the trenches of medtech innovation. Join physician inventors, founders, engineers, and healthcare market makers as they share actionable insights to navigate the FDA, secure medtech funding, and drive medtech breakthroughs. No-nonsense advice to be a change maker in medtech.
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MedTech 101

Rodney Moses

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Discussions about Medical Technology, Pharmaceuticals and popular trends; covering from basic to complex topics in a simplified way to make you understand. Rodney is a Biomedical Engineer and co-inventor working in R&D, ex Johnson & Johnson.
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Speed-to-data determines go-to-market success for medical devices. You need to inform critical decisions with user data, technical demonstration data, and clinical data. We interview med tech leaders about the critical data-driven decisions they make during their product development projects.
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LATAM Medtech Leaders

Julio G. Martinez-Clark

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Latin America is undergoing dramatic demographic and epidemiological changes. Its population is rapidly aging, and there is a worrisome increase in the prevalence of chronic diseases. Despite this, innovative medical technologies sometimes take years to reach these patients. US and European Medical technology ("Medtech") companies struggle to find a cost-effective first-in-human clinical research center or to gain market share in Latin America; this prevents patients in Latin America from ha ...
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MedTech Trailblazers

Fogarty Innovation

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Welcome to MedTech Trailblazers where Andrew Cleeland, CEO of Fogarty Innovation, hosts in-depth conversations with the disruptors and innovators in the field of medical technology. Join him as he shares their insightful stories, effective leadership styles and what they're doing to transform patient outcomes and shape the future of human health.
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We believe in enabling innovation within the MedTech industry. We are an educational platform that supports early-stage entrepreneurs interested in being successful in the medical device space. We provide free education and a support system to better prepare startups. While there is value to startup accelerators or competitions, we want to ensure the startups reach the next milestone consistently. Follow us and learn from the best in class.
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Join us on DeviceAlliance's Podcast: MedTech Radio where we interview today's brightest minds in Southern California's medical device industry. Each episode deconstructs complex topics and provides the tactics, tools, and strategies to overcome tomorrow's challenges. DeviceAlliance strives to be the one-stop-shop at the center of the medical device ecosystem helping drive collaboration, innovation, and career development for all device professionals in Southern California.
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Nectar is an award-winning product development company based in southern California. Our product design and development process is an interdisciplinary approach combining industrial design, user experience design, mechanical engineering, and electrical engineering that ensures product designs are successfully executed into production. We’ve been helping clients design products that connect to their users and expand their markets for over 30 years. We are firm believers in the team approach t ...
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Welcome to the MassDevice Fast Five medtech news podcast, the show that keeps you up to date on the latest breakthroughs in medical technology with the top five news stories to get your day started. Subscribe and join us every weekday for your daily medtech news roundup.
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Have you ever wondered how the machines in the hospital work? The doctors don't have time to explain them to you? Then you've come to the right place! The MedTech Hub is a podcast that explains medical technologies and new innovations in healthcare. I am a medical physicist and your host - Daniela Prinz. (Disclaimer: This podcast does not give medical advice, I am not a doctor, please always consult with your physician!) Uploads every Monday!
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The many stages of market entry into the health and care industry can feel like a never-ending process. Join Kate Pym, healthcare consultant veteran with decades of experience, as she interviews some of the industry’s key players from product developers to startup managers. Unlock the key to transforming your ideas into impactful realities within the health and care industry with MedTech for Beginners. Kate Pym runs Pym's Consultancy, a multi-award-winning consultancy offering support and tr ...
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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re drawing inspiration from an item I wrote about recently in one of my MPO editor’s letters. Specifically, I’m referring to the news of an assisted suicide machine that was being considered for introduction in Switzerland, where assisted …
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In this episode of Medsider Radio, we sat down with Steffen Hovard, CEO of Neuspera Medical, where his team is developing a novel, less invasive device that uses neuromodulation to treat conditions like overactive bladder. Previously, Steffen spent two decades at Coloplast, where he held various senior leadership roles that contributed to the compa…
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Cell therapy research and manufacturing are driving demand for automated high-throughput equipment to improve quality, reduce costs, and shorten the development cycles of innovative treatments that save lives. But what factors shape a startup’s journey from the lab to commercialization? In Episode #35 of the Speed to Data podcast, Key Tech Business…
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⁠⁠In this episode, Aaron TenHuisen, Jamie Easterling, and Rich Mazzola at Project Medtech and Duane Mancini discuss the growth at Project Medtech, the growth of the commercial consulting group, our expansion into talent and quality support, and so much ⁠Duane Mancini LinkedIn⁠⁠⁠⁠⁠⁠⁠⁠ ⁠Aaron TenHuisen LinkedIn⁠ ⁠Rich Mazzola LinkedIn⁠ ⁠Jamie Easterl…
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In this episode, I'm joined by Kat Weaver, founder of Power To Pitch and a successful entrepreneur who scaled and sold her first company she started in her college dorm room. With an impressive track record of winning 22 out of 23 pitches, Kat now helps founders craft winning pitch decks and fundraising strategies. In this episode, we breakdown: Th…
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Send us a Message Start-ups in MedTech have a failure rate of over 75%. Therefore navigating this minefield needs extensive strategic planning to reach a successful point. Thus, in this episode, I sat down with Steve Bell, an expert in MedTech startups. With a career spanning from Johnson and Johnson to being Chief Comercial Officer at CMR Surgical…
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Paulo Fernandes is a distinguished clinical research executive with extensive experience in international clinical trials across various phases and therapeutic areas. With a solid foundation in the CRO industry, he has successfully held roles in project management, start-up, operations management, and business development. Paulo has worked at renow…
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In this episode of Medsider Radio, we sat down with returning guest, Don Crawford, CEO of CorVista Health. CorVista is developing a non-invasive medical device that uses advanced machine-learned algorithms to detect heart conditions, right in a doctor’s office. Don's career began at Medtronic, followed by progressively senior sales and marketing ro…
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In this episode of Medsider Radio, we sat down with, Tim Rosa, CEO of Somnee, a company developing wearables based on personalized neuroscience to improve sleep quality. Previously, Tim was the CMO at Fitbit, where he played a key role in establishing the health and fitness wearables category. He built the organization’s global marketing function, …
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In this episode, Rebecca McManus at Amethyst Care and Duane Mancini discusses the technology she is working on out of Trinity College of Dublin, their next 18 months, the innovation scene in Dublin, Ireland, her interest in Northeast Ohio, Adapt Research Center, lessons learned so far, how she overcame the anxiety of how long everything takes in Me…
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Send us a Message Start-ups in MedTech have a failure rate of over 75%. Therefore navigating this minefield needs extensive strategic planning to reach a successful point. Thus, in this episode, I sat down with Steve Bell, an expert in MedTech startups. With a career spanning from Johnson and Johnson to being Chief Comercial Officer at CMR Surgical…
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In this episode, Crystal Weber at Group 31 and Duane Mancini discuss her second career as a marketing expert, how her first career as a nurse prepared her for this role, the importance of tailoring messaging to investors, how to position your product in the healthcare system, and so much more. Crystal Weber LinkedIn Group 31 Communications LinkedIn…
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In this episode of Medsider Radio, we sat down with medtech veteran, Eric Goslau, the co-founder and CEO of Transverse Medical. His startup is developing the Point Guard Cerebral Embolic Protection device that shields the brain from debris during cardiovascular procedures, reducing the risk of strokes. Co-inventor of Point Guard, Eric has 29 years …
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In this episode of Medtech Talk, host Geoff Pardo and Per Langoe, CEO of GT Medical, discuss Langoe’s extensive career, from his start in sales to eventually making his way to medtech. Langoe gives tips on how to keep investors on board during times of crisis (such as the Covid-19 pandemic) and how he hires the right people for the job, as well as …
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Send us a Message Pneumonia is a deadly illness that claims countless lives each year. Early detection could significantly improve survival rates, and that’s exactly what Prithvi Krishnan, a 17-year-old high school student, aims to achieve with the AI algorithm he developed. This algorithm can detect pneumonia in chest X-rays, offering a promising …
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In this episode, Todd Ponsky at Cincinnati Children's and Duane Mancini discuss his background as a pediatric surgeon, his startup company that he launched around education, the changes to the innovation and venture arm of Cincinnati Children's, the importance of having a supportive hospital leadership team for the innovation department, and so muc…
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The Quality Mindset: Unlocking Medtech Success with Kyle Rose In this episode, Spencer is joined by Kyle Rose, CEO of Rook Quality Systems and expert quality and regulatory consultant, to explore the critical role that quality management plays in medtech innovation and startup success. Key topics covered: The Importance of Early Quality Integration…
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Send us a Message Blood clots cause many health problems so solving this issue with minimally invasive ways of entering the body's blood vessels is revolutionary. Faster recovery for patients. Innova Vascular is developing innovative medical devices for treating vascular disease using a minimally invasive approach. Timestamp: 00:00 Intro 02:01 Sanj…
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In this episode, Dylan Horvath at Cortex Design and Duane Mancini discusses how he founded his company, features vs. innovations, lessons learned, common mistakes, and so much more. Dylan Horvath LinkedIn Cortex Design LinkedIn Cortex Design Website Duane Mancini LinkedIn⁠⁠⁠⁠ ⁠⁠⁠⁠Project Medtech LinkedIn⁠⁠⁠⁠ ⁠⁠⁠⁠Project Medtech Website ⁠ ⁠Mittal Co…
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In this episode of Medsider Radio, we sat down with the exuberant Aakash Shah, co-founder and CEO of Wyndly, a telehealth startup that helps people overcome their allergies with personalized, at-home treatment plans. Aakash was part of the Y Combinator W21 batch. As the CEO of Wyndly, he’s led the company from early inception through product develo…
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In this episode, Don Pohl and Sheri Krajewski at NAMSA and Duane Mancini discuss ISO 10993 and biocompatibility testing for medical devices, the history of the standard and how it has evolved, why following the risk-based approach is becoming more important, tips to avoid having your submission delayed with various regulatory bodies across the glob…
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In this episode of Medsider Radio, we sat down with Ajay Shah, co-founder and CEO of Cytovale. The company is helping solve the sepsis problem with IntelliSep, a simple, cost-effective, and quick sepsis test. Ajay is a serial entrepreneur and engineer with expertise in cell-based diagnostic technologies. Before Cytovale, Ajay co-founded two other l…
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I'm joined by Mark Norton, former Apple Manufacturing Manager and now Founder and CEO of Adele Health, as we explore the journey from tech giant to medtech startup and the challenges of building an innovative diabetes management solution. In this episode, we breakdown: The Apple Manufacturing Experience → Transitioning from oil rigs to the cutting …
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Interested in designing medical device products? Want to know the do's and dont's of medtech design? Then you must listen to this all-new episode of Let's Talk Medtech featuring BlackHägen Design's Philip Remedios and Renee Bailey. Both will talk about what you need to have in mind when building device and breakdown how Contextual Inquiry is changi…
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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we continue speaking on the topic of predetermined change control plans. Potential scenarios for their use are discussed, examples are provided, and role of PCCPs for manufacturing processes are explored. If you haven’t yet listened to Part 1…
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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we examine the FDA’s recent guidance documents regarding predetermined change control plans (PCCP). The first guidance addresses PCCPs for artificial intelligence (AI) and/or machine learning (ML) based devices (click here to hear an earlier …
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Send us a Message Improving eyesight via a computer program from the comfort of our homes is something that most people would not imagine. At Revital Vision, their vision training software program, clinically and scientifically proven to improve vision in amblyopia, eye diseases, and vision impairments. Although this is not intended to replace eye …
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Send us a Message Improving eyesight via a computer program from the comfort of our homes is something that most people would not imagine. At Revital Vision, their vision training software program is clinically and scientifically proven to improve vision in amblyopia, eye diseases, and vision impairments. Although this is not intended to replace ey…
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In this episode of Medtech Talk, host Geoff Pardo speaks with Punit Soni, CEO of Suki, about using AI to build better technology in healthcare, the origins of Suki, and how Soni shifted from Google to healthcare. Soni also delves into the difficulties and challenges of healthcare, including handling the regulatory aspects and encouraging doctors to…
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In this episode, Omar Khateeb at Khateeb & Co. and Duane Mancini discuss carrying the bag, growth marketing, talking to investors, meeting with early adopters, his podcast The State of Medtech, speed learning, building loyal customers and so much more. Omar Khateeb LinkedIn Khateeb & Co. Website State of Medtech Podcast ⁠Duane Mancini LinkedIn⁠⁠ ⁠⁠…
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In this episode of Medsider Radio, we had an insightful chat with Brian Fahey, CEO of Adona Medical, which is a Shifamed-portfolio company. The Adona Interatrial Shunt is a smart implant designed to enable individualized management of heart failure. Before Adona, Brian founded a critical care company, Niveus Medical. He also spent time at J&J Innov…
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I'm joined by Samantha Wagner, Business Development Manager at Medical Murray, as we explore the journey from R&D engineer to medtech business strategist and the challenges of bringing novel devices to market. In this episode, we breakdown: Navigating the RFQ Process → Essential preparation steps for founders → Balancing technical details with busi…
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In this episode, Kristen Mittal and Mridul Mittal at Mittal Consulting and Duane Mancini discuss their unique backgrounds in medtech, why they started Mittal Consulting, what medtech companies should expect from a regulatory strategy report, breakthrough designation, 513(g) vs. pre-submission meetings, common pitfalls, their advice for entrepreneur…
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Miriam is a seasoned professional in Health and Law, specializing in Sanitary Regulation and Clinical Research. With over 20 years of experience, she has a track record in planning and executing global, regional, and local clinical development programs, including Bioequivalence studies and Phase I-IV clinical trials. Her expertise spans Clinical Mo…
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Send us a Message With the potential to diagnose some brain illnesses 7 years before their onset, Optical Coherence Tomography can do a lot more than checking eye health. JuneBrain was founded to improve remote assessments and monitoring of neurological and retinal diseases. They provide telehealth devices and AI software solutions. Their products …
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In this episode of Medsider Radio, we sat down with Konrad Morzkowski, co-founder and CEO of WearLinq. The startup is commercializing eWave, an FDA-cleared EKG monitor for continuous cardiac monitoring. Konrad is an engineer from Sweden and a member of Forbes’ 30 under 30 list. After obtaining an MS at Stanford – where he met his co-founders and ra…
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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re focusing in on a regulatory piece that’s been mentioned numerous times with regard to other topics we’ve discussed. This episode is focused on CAPA or corrective and preventive action. We’re digging into the CAPA, what it is, its purpos…
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In this episode of Medsider Radio, we had a fun chat with Bryan Lord, President and CEO of Pristine Surgical. Pristine's flagship product, Summit, is a 4K, single-use digital arthroscope that streamlines arthroscopic procedures. Bryan started his career as a “deal guy” – originally a tech lawyer in Boston, and always involved in startups. He has a …
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In this episode, Monica Vajani at mHUB and Duane Mancini discuss her background at Abbott and Medtronic, carrying the bag, early adopters vs. laggers, mHUB, the next cohort of companies for their medtech accelerator, and so much more. Monica Vajani LinkedIn mHub Medtech Accelerator Application mHub LinkedIn mHub Website Duane Mancini LinkedIn Proje…
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I'm joined by Dr. Josh Ammerman, Founder and CEO of ComboSpine, as we explore the journey from practicing neurosurgeon to medtech entrepreneur and the challenges of building a successful startup in the spine surgery space. In this episode, we breakdown: 1. The Physician Entrepreneur's Journey →Transition from clinical practice to medtech innovation…
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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re discussing what the process should be for a company once they receive a 483 or warning letter from the FDA. Best practices, first steps to take, who is responsible, and potential strategies for avoiding them are shared. Specifically, th…
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In this episode, Craig Misrach at UpLyft and Duane Mancini discuss what has changed since his last appearance on the podcast, choosing and changing your contract manufacturer based on the commercialization stage, the importance of quality, creative ways to finance your startup, and so much more. Craig Misrach LinkedIn UpLyft LinkedIn UpLyft Website…
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In this episode of Medsider Radio, we had an insightful chat with Amarpreet Sawhney, inventor, serial entrepreneur, and CEO of a few startups, including Instylla, which is developing polymerizing liquid embolics that can be used to shut down blood supply to hypervascular tumors and control bleeding. Amar is also the CEO of Rejoni, Sealonix, and Pra…
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In this in-depth interview with Kelly Prchal, the founder and managing director of Engage Venture Partners, we discuss her unique investment approach in the MedTech industry. Prchal shares details about Engage's Special Purpose Vehicle (SPV) based model, where they invest in individual companies and rounds by assessing opportunities through their c…
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In this episode of Medsider Radio, we had an engaging chat with Reinhard Krickl, CEO of Phagenesis, a startup commercializing a neurostimulation system designed to treat dysphagia, a condition that impairs a patient's ability to swallow. An Austrian engineer with over 25 years of experience in medtech, Reinhard specializes in neurology-based medica…
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Scott Nelson, one of the medical device's top insiders, stops by to discuss the trends in the industry and to give tips to entrepreneurs looking to jump into the world of medtech. Nelson is the co-founder and CEO of FastWave Medical, a medical device startup developing intravascular lithotripsy systems for cardiovascular disease. Additionally, he’s…
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In this episode, Hilary Swan at Rebel Scout Consulting and Duane Mancini discuss her background in the medtech space, inside sales vs. outside sales, tips for selling into a hospital, the user journey, the importance of implementation and so much more. Hilary Swan LinkedIn Rebel Scout LinkedIn Rebel Scout Website Duane Mancini LinkedIn Project Medt…
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