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Brought to you by the Advanced Medical Technology Association (AdvaMed), MedTech POV with Scott Whitaker is a podcast that covers the intersection of medtech and policy from every perspective. Tune in to each episode for interesting discussions with medtech and health care policy leaders on issues that are driving the day—from business, to policy, and current events, all viewed through the lens of the medtech industry.
 
Welcome to the Combinate Podcast, a show that is bridging the gap between MedTech and BioTech. My name is Subhi Saadeh, I'm an engineer and for the last decade I've sought to broaden my understanding in these industries, and have been amazed at the wonderful people I've met and the insights they've given me. Each week I sit down with leaders to discuss their expertise, the lessons they learned and continue that mission.
 
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.
 
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.
 
Encode Ideas authors research on publicly traded micro / small cap healthcare (biotech & medtech) companies. The Plainspoken podcast is an extension of our research, where we will interview executives from micro / small cap health care companies, portfolio managers who invest in micro / small cap healthcare, and key opinion leaders who can offer insights into therapeutics areas of interest to investors. The podcast is for entertainment purposes only and should not be considered financial adv ...
 
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show series
 
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 We…
 
On this episode, we were joined again by Susan Neadle! This episode was focused on the current state of Combination Products globally. Susan and I discuss: Topics: - CPC Summit and Updates from FDA - Essential Performance Requirements(EPR's) - ASTM Harmonization for an International Combination Products Terminology Standard -Different Approaches to…
 
One of the current trends in the medtech industry involves companies expanding digital solutions. While digital innovation can be slow to progress in regulated industries like healthcare, GE Healthcare is changing the game with Edison Digital Health Platform, a vendor-agnostic hosting and data aggregation platform with an integrated artificial inte…
 
In this episode of Medsider Radio, we sat down with Sina Habibi, CEO of Cognetivity. Sina has a Ph.D. in engineering from the University of Cambridge, where he met his business partner Seyed-Mahdi Khaligh-Razavi. The two co-founded Cognetivity Neurosciences, which develops cognitive assessment tests for clinicians and patients to detect cognitive i…
 
As medical devices keep advancing, the consumables used in testing and therapeutics are moving forward as well, far beyond grandpa’s diabetes test strips. New semiconductors, circuitry, and sensors, along with automated production, bring a whole new spectrum of functionality within reach for consumables. The burgeoning at-home market is driving dem…
 
Mick Farrell, ResMed CEO and member of the AdvaMed board of directors, joined AdvaMed’s Scott Whitaker on the MedTech POV podcast to discuss how an agile company with skilled staff and a clear mission can pivot sharply as the market demands, from scaling up ventilator production at the outset of the COVID-19 pandemic to informing semiconductor chip…
 
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 i…
 
On this episode, I was joined by Dr. Kasem Akhras, Senior Director, Translational Access, Geneconomics & Outcomes Research - New Products at Novartis. Dr. Akhras and I discuss:-His Book "Frontiers in Market Access"-History of Market Access from the 1980's to now-Where the Market Access function fits in within Product Development-Market Access and C…
 
In this episode of Medsider Radio, we sat down with Olivier Delporte, CEO of Miracor Medical. Olivier has more than 20 years of sales, marketing, and general management experience, mostly in the medical device industry. In 2016, he became the CEO of Miracor Medical, a medical device company based in Belgium. Under Olivier’s guidance, the company is…
 
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, entre…
 
On this episode of the podcast, I was joined by Shadeed Salem, the Founder and President of Synergy Bioscience. Shadeed and I discuss:-War Stories in method validation and NCR/OOS's-What is it that you're going to test and what are you testing for?-Differences between drug and device methods including Analytical, Physical, Mechanical and Visual met…
 
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…
 
In this episode of Medsider Radio, we sat down with Laura Yecies, CEO of Bone Health Technologies. Laura is a Silicon Valley veteran with more than three decades of experience at major tech companies and startups. She’s always had an interest in improving people’s health and wellness and was drawn to medtech startup Bone Health Technologies, which …
 
Sometimes as a company grows and matures, the corporate identity it started out needs to change. Memic Innovative Surgery is the perfect example as the company has changed its name to Momentis Surgical. In addition the company has also changed the name of its technology from the Hominis Surgical System to Anovo Surgical. DVir Cohen, CEO of Momentis…
 
When you’re trying to add new functionality to existing technology, the data you need won’t be presented on a silver platter. Sometimes, you don’t even know what the right data is until you find it. This was the case with RevMedica, a start-up that’s developing a new hybrid robotic laparoscopic stapler technology. Following Andy Rogers’ talk with R…
 
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 yo…
 
On this episode of the podcast, I was joined by Jane Sarasohn Kahn of Health Populi and THINK-Health. Jane and I discuss:- US Healthcare System - Healthcare economics before Healthcare economics - Her Book: Health Consuming - Health Consuming vs. Health Citizenship- US vs. European Healthcare systemsJane is a health economist, advisor and trend-wea…
 
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 f…
 
Juliana Elstad, President and CEO of Vibrato Medical, recently joined AdvaMed’s Scott Whitaker for a conversation on several policy initiatives that are important for patient care and innovation, including the Transitional Coverage of Emerging Technologies (TCET) proposal before CMS and the Small Business Investment Research (SBIR) program, which i…
 
In this episode of Medsider Radio, we sat down with Justin Zenanko and Greg Molnar, co-founders of SynerFuse. Justin is a Certified Public Accountant who previously led fundraising efforts at Recombinetics and Greg is the former Director of Neuromodulation Research at Medtronic. In 2018, they joined forces to build SynerFuse, a clinical-stage start…
 
On this episode of the podcast, I was joined by Ben Locwin, Executive SME at Black Diamond Networks. Ben and I discuss:- Behavioral Neuroscience and the soft skills of Quality- Quality, Compliance and Risk Management- Pharmacogenomics and Orwell- Combination Products Ben Locwin is a Healthcare Executive, MMA fighter, Jiu Jtisu pro and Quality and R…
 
Following the data leads to a breakthrough idea in laparoscopic surgery. Sometimes a technology starts off in one direction, but the data leads developers somewhere else entirely. This is the case for RevMedica, an early-phase medical device company, and manufacturer. The first product in development at RevMedica is a cybernetic laparoscopic surgic…
 
On this episode of the podcast, I was joined by John Nosta of NostaLab. John and I discuss: -Pharmaceutical Innovation in the last several decades -Patient-Centricity in Pharma -Innovation vs. Implementing Existing Technologies -Genius Being a Birthright & Mediocrity Being Self imposed -Telemedicine & Digital Health -Decentralized Clinical Trials -…
 
In this episode of Medsider Radio, we sat down with David Neale, CEO and co-founder of Argá Medtech. David has three decades of experience bringing medical goods, services, and devices to bear across a range of sectors and in multiple countries. In 2020, he launched Argá Medtech, a multinational company focused on developing new, more efficient way…
 
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, op…
 
On this episode, I was joined by Dan Sfera, aka "The Clinical Trials Guru". Dan and I discuss: Clinical Trials from the View of the Patient and the link to Primary Care Institutional Review Boards Informed Consent Patient Accrual, Inclusion/Exclusion and Screen Failure Role of the Sponsor Sponsor/CRO/Study Site Dynamics Roadblocks in Clinical Resea…
 
Host Geoff Pardo talks with Adam Berman, CEO of Alleviant Medical, about the groundbreaking device treating heart failure without hardware or permanent implants. The Alleviant device mitigates shortness of breath in patients with diastolic heart failure by leaving behind a shunt cut from interatrial septum tissue. The shunt moves blood from the lef…
 
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's no secret that Dexcom is on the rise. From commercials during the Super Bowl, to blockbuster products on the horizon, the company is reaching a new height of popularity in the continuous glucose monitoring space. Kevin Sayer, Dexcom CEO, talks about the company's new position the space and all the hype surrounding the upcoming G7 CGM sensor. H…
 
Get feedback early to fast-track your robotics design. Start-ups that inherit robotic prototypes from universities or research labs often get caught up trying to get a product out the door. Instead, they should focus on designing a product that will be competitive in the market. Following a chat with Dave Saunders, CTO at Galen Robotic, Andy Rogers…
 
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 M…
 
In this episode of Medsider Radio, we sat down with Justin Barad, Co-Founder and CEO of Osso VR. Justin is an orthopedic surgeon with a passion for technology and a history of working in the video game industry. Using his experience and knowledge, he developed a virtual reality platform that can reform the way surgeons are trained and assessed. In …
 
On this episode of the podcast, I was joined by Yousef Arman, Founder of The Vial Store. Yousef and I discuss: His background growing up around Pharmacists and Pharmacies What starting a Pharmacy Requires and Day to Day Operations Pharmacy Pricing/Costs and how they make money Demand Planning, Formularies and how pharmacies always seem to have medi…
 
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 oppor…
 
The data you need to design a multi-use surgical robot Surgical robots can do all sorts of things better than humans. But human doctors have a breadth of experiential knowledge and instinct robots cannot replicate anytime soon. Understanding that difference is the key to designing a successful robotic platform. Galen Robotics is expanding the benef…
 
On this episode, I was joined by Dr. Khaudeja Bano, Vice President of Combination Product Quality at Amgen. On this episode Khaudeja and I discuss: - Safety function (Drug vs. Device) - 21 CFR Part 4 Subpart B - Specific Post-Market Safety Reporting Expectations - Industry Challenges with implementing PMSR Requirements - Working in Quality with a b…
 
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…
 
In this episode of Medsider Radio, we sat down with John Mastrototaro, CEO of Movano. John has more than 30 years’ worth of experience in the medical device industry and was part of the MiniMed team that helped develop the world’s first ambulatory continuous glucose monitoring system and sensor-augmented insulin pump. John is now CEO and Director o…
 
On this episode, I was joined by Mitch Robbins, founder of the Anthony Michael Group based in Denver, Co. Mitch and I discuss: - How he got into recruiting - The business model for recruiting (contract, retained, engaged) - Interview Matrix - interview strategies for objective unbiased candidate selection - The overall recruiting/hiring process and…
 
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 di…
 
In this episode of Medsider Radio, we sat down with Jim Biggins, Founder and CEO of Access Vascular. Before starting the company, Jim developed innovative products for companies like Boston Scientific, Ocular Therapeutix, and Medtronic. He then spent 18 months shadowing clinicians in real-life medical settings, which led to the creation of Access V…
 
On this episode of the podcast, we go off our normal topics within BioTech and MedTech and discuss a topic that is near and dear to me; Coffee! I was joined by my friend Erik Barkley, Founder and Owner of Tugboat Coffee Roasters. Erik and I discuss: - How Erik and I met a few years ago - How he works with coffee farms around the globe - The life of…
 
It's hard to believe it's been more than 10 years ago since FitBit pioneered the fitness wearables market. As the technology has advanced, the lines between what is a consumer wellness device and what is a medical-grade wearable have begun to blur, with a number of companies sitting at the intersection of consumer wellness and medical-grade wearabl…
 
Clinical and in-home trials are different, but the essentials are the same –solid data, foresight, and flexibility. Clinical trials are understandably rigorous, but in-home trials add a few wild cards into the mix. Andy and Jake spoke with Steve Schaefer, CEO of CoolTech, about this exact topic in the previous episode. Here, Andy and Jake dig into …
 
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 …
 
In this episode I walk through some of the concepts of the book "Quality is Free" by Phillip Crosby. ------------------------------------------------------------ Amazon Link to the Book: Link ----------------------------------------------------------- Who Was Phillip Crosby(From ASQ): Philip B. Crosby was a legend in the discipline of quality. A no…
 
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…
 
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