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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.
 
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.
 
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LATAM Medtech Leaders

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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 ...
 
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 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.
 
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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In this episode of Medsider Radio, we sat down with Yoav Kimchy, Founder and CTO of Check-Cap. Yoav has more than 20 years of experience in the development and management of innovative medical device companies. In 2005, he founded Check-Cap, a clinical-stage medical diagnostics company that aims to change the colorectal cancer (CRC) screening lands…
 
On this episode I was joined by Chris Tsai from Boothroyd Dewhurst, Inc. Chris and I discuss: Value Engineering at Eastman Kodak in the 1990's Inventing and Deploying Concurrent Engineering Defining Design Robustness QFD and Design Control in Non-Regulated Industries Verb/Noun Pairs and Product Development Design for Manufacturability and Assembly …
 
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we take a deep dive on the letter to file tool that companies can use for certain situations. But what are those situation and how do you know when it’s appropriate to use this pathway? Also, how do you ensure you are using a letter to file c…
 
Each year, millions of people in the U.S. require some sort of neurosurgery due to injury, disease, or genetic condition. They often undergo multiple procedures and face long, painful recoveries. This inspired Jesse Christopher to start tinkering with his kid’s toys in his garage, which was the beginning of Longeviti Neuro Solutions. Starting from …
 
In this episode, Sanjeev Saxena and Duane Mancini discuss Harae DX, Lawerence Livermore National Labs, women cancer diagnostics, what he has learned as a 6x entrepreneur, his best advice to the first time entrepreneur and so much more. Sanjeev Saxena LinkedIn Harae DX Website Project Medtech Website Duane Mancini LinkedIn Project Medtech LinkedIn…
 
Dr. Josh Makower is one of the few multidisciplinary leaders making a tremendous and broad-reaching impact on the medical device and consumer product industries. As an inventor, professor, CEO, and venture capitalist with experiences in medicine, bioengineering, business, and big pharma, Makower has led the charge in creating some of the most uniqu…
 
In an ideal world, no one would have a catheter, but the reality is that 100M patients worldwide rely on an indwelling urinary catheter. Catheterized patients often experience problems, such as catheter-associated urinary tract infections (CAUTI), catheter blockages, leaking and bladder spasms. FLUME estimates the healthcare burden of Foley cathete…
 
On this special episode of the podcast, I was joined by Larry Mager. As the 52nd episode, I wanted to thank Larry for being my first interview a little more than a year ago! On this episode, Larry and I discuss: - His experiences with Pharma and CRO clients vs. Medical Device - Predictive Quality Management across both medical device and pharma - M…
 
In this episode, Ti Benson and Duane Mancini discuss global regulatory strategy, the current landscape in the EU, MDSAP, hidden expenses, terminology, and so much more. Ti Benson LinkedIn LeanRAQA Website Project Medtech Website Duane Mancini LinkedIn Project Medtech LinkedIn
 
On this episode, I was joined by Bassil Akra, the CEO of AKRA Team. Bassil and I discuss: EU MDR and Implementation Timeframe Notified Bodies, Competent Authorities, MOH's and the EU Commission Article 117 & Drug/Device Combination Products Differences between MDD and MDR for Economic Operators His Favorite Book: EU MDR Dr. Bassil Akra spent the la…
 
Coagusense developed the first point-of-care prothrombin time/Internationalized Normalized Ratio (PT/INR) monitoring system for cardiac patients to help them maintain warfarin dosage within a therapeutic range. In the latest version of their device, they actually removed connectivity features to accommodate the needs of their older, less-tech-savvy…
 
In this episode, Patrick Pfeffer and Duane Mancini discuss the investment group he founded in Frankfurt, Germany, how they named their company, the podcast that he hosts, from sick care to healthcare, the German Medtech scene, and so much more. Patrick Pfeffer LinkedIn Aescuvest Website Project Medtech Website Duane Mancini LinkedIn Project Medtech…
 
In this episode of Medsider Radio, we sat down with Bryce Klontz, President and CEO of New View Surgical. With over 20 years of experience working in the surgical device space from Canada to Singapore, Bryce brings a tactical advantage to his role as the CEO of New View Surgical. Under his leadership, New View Surgical has closed a successful Serie…
 
On this episode, I was joined by Dr. James Somauroo of SomX and The HealthTech Podcast. James and I discuss: HealthTech Communication Growing a Passion The HealthTech Podcast Healthtech Pigeon Delegating vs. Creating Systems James is the founder of SomX: The Healthtech Agency and supports the best healthtech companies in the world. He covers health…
 
In this episode, Rob Packard and Duane Mancini discuss the current landscape of regulatory requirements in the EU, evolution of regulatory in the EU, the MDR, what is a notified body, post market surveillance in the US, global regulatory strategy, and so much more. Rob Packard LinkedIn Medical Device Academy Website Project Medtech Website Duane Ma…
 
In this episode of Medsider Radio, we sat down with Eugene Malinskiy, CEO and Co-founder of Lazurite. Eugene is a serial entrepreneur with expertise in the IT and medical fields. He also has hands-on experience as a medic and has worked in operating rooms throughout the country. He founded Lazurite, an innovative healthcare company focused on cutti…
 
On this episode of the podcast, I was joined by Shannon Hoste, President of Agilis Consulting. Shannon and I discuss: - FDA Human Factors Review for Combination Products (CDRH, CDER/DMEPA, OCP) - Human Factors vs. Usability Engineering vs. Design Validation - Risk Management and User Risk - Summative HF Evaluation and Sampling Shannon is the Presid…
 
Jim Ohneck is the Founder and Chief Executive Officer (CEO) of Epoch Lasers and holds a US patent for his unique Laser Therapy device for treating chronic pain. Jim holds degrees in Business Administration and Electronic Engineering and has thirty-five years of medical device development experience. He is a Fellow of the American Society of Laser M…
 
There’s nothing like finding a partner with a map when you're exploring new territory. CoaguSense developed the first point-of-care prothrombin time/Internationalized Normalized Ratio (PT/INR) monitoring system for cardiac patients who have been prescribed warfarin. Their Coag-Sense® device monitors blood clotting rates and helps patients maintain …
 
Luís Meireles is currently CEO and co-owner of MDI Industrial a Medical Device Industry in Brazil and a senior consultant for European companies. Luís is Portuguese, Ph.D. in Biotechnology but moved to Brazil, spending the last decade helping to introduce medical devices into Latin America he was responsible for the introduction of Mortara Instrume…
 
On this episode of the podcast, I was joined by Hsinjin Yang of Pioneer Scientific Solutions. Hsinjin and I discuss: - Materials for Biomedical Applications - Mechanical Properties, Physical Properties, Biocompatibility, E&L and Sterilization - Commercialization Considerations - 4 Major Factors for the appropriate selection of materials Dr. Hsinjin…
 
In this episode, Jimmy Jin, Ronnie Wang and Duane Mancini discuss CIIE, Mednovation, why one would want to take their product to market in China, the process for entering the Chinese market, common mistakes companies make, the importance of commercial and IP, and so much more. Jimmy Jin LinkedIn Ronnie Wang LinkedIn Project Medtech Website Duane Ma…
 
On this episode, I was joined by Darshan Kulkarni, of - Free Speech and Promotional Compliance - Misbranding - Regulatory vs. Legal Compliance - From Congress to the FDA - the flow from legislation to regulations - Sunshine Act Darshan Kulkarni is an FDA regulatory lawyer, author, professor, and speaker, who takes a holistic approach to the healthc…
 
Before he began his Ph.D. program in biomedical engineering, Andy Doraiswamy bought a one-way ticket to Southeast Asia to explore and “find himself.” He was successful: discovering a love for mountain climbing’s physical and mental challenges and developing a practice of meditation that has proven helpful in both climbing and commerce. Since leavin…
 
In this episode of Medsider Radio, we sat down with Cody Simmons, CEO of DermaSensor. Cody spent four years learning about business strategy and analytics at biotechnology giant Genentech before becoming CEO of DermaSensor in 2016, where he leads development and commercialization efforts for the company’s novel skin cancer detection tool. In 2018, …
 
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…
 
Christian is an entrepreneur and advisor in the bio, pharma, healthcare, and technology sectors with 20 years of strategic advisory, business creation, development, and operational experience. He works with biotech companies and VCs on business development and strategy, with industry on innovation, pipeline, and business development, with instituti…
 
The Massachusetts Medical Device Industry Council (MassMEDIC) has launched the Why Medtech campaign to build awareness of the medical device industry. MassMEDIC's Brian Johnson and Rachel Robinson joins us for this episode to discuss how people can take part in this campaign and why everyone has medtech story.…
 
On this episode of the podcast, I was joined by Sarfaraz Niazi. Dr. Niazi and I disucss: - The Inflation Reduction Act - Out of Pocket Costs - Part B and Part D Drugs - Price Negotiation vs. Price Control Prof. Sarfaraz K. Niazi, Ph.D., SI, FRSB, FPAMS, FACB, founder of Pharmaceutical Scientist Inc. and Adello Biologics (acquired by Kashiv Bioscien…
 
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:- CPC Summit and Updates from FDA- Essential Performance Requirements(EPR's)- ASTM Harmonization for an International Combination Products Terminology Standard-Different Approaches to Combination…
 
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…
 
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…
 
Mona Oliveira is one of the creators and founders of the startup BIOLINKER, which in 2019 was awarded as one of the TOP 500 best startups in the world in the area of biotechnology for the project she coordinates. Double Ph.D. in Biochemistry and Nanotechnology from USP (Brazil) and IJS (Slovenia). During her academic career, she has accumulated awa…
 
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…
 
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…
 
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…
 
On this episode of the podcast, I walk through some of the takeaways I got from reading "Statistical Method from the Viewpoint of Quality Control" by Walter A. Shewhart. ---------------------------------------------------------- Who Was Walter Shewhart? Link
 
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…
 
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…
 
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…
 
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