Inside MedTech Innovation

The technology to secure healthcare already exists. Getting it adopted by the people building medical devices is a different problem entirely. Andrew Carney spent a decade in classified offensive cyber operations, defended one of the world's largest banks through the Log4j crisis, and now runs cybersecurity programs at ARPA-H and DARPA. Shannon and Andrew get into what it actually means to run...

Software problems cause 20 medical device recalls a month. 82% of those are classified as software design failures. Dr. Robert Charette has spent five decades documenting why large-scale technology systems fail and why organizations keep repeating the same mistakes. In this conversation with Shannon Lantzy, Bob brings a perspective rarely heard in medtech: one shaped not by the device industry, bu...

Randy Horton is Chief Solutions Officer at Orthogonal, a firm that specializes in accelerating software as a medical device, digital therapeutics, and connected device ecosystems. He has spent his career at the intersection of product management, digital transformation, and regulatory compliance, and co-chairs the cloud computing standards committee at AAMI with Pat Baird from Philips. In this con...

Dr. Adam Cifu is a general internist and professor at the University of Chicago, co-author of Medical Reversal , and co-founder of Sensible Medicine, one of the most widely read independent medical publications in the country. He sees patients daily, teaches the next generation of physicians, and writes about the gap between medical consensus and medical evidence. In this conversation with Shannon...

Mike Monovoukas is the co-founder and CEO of AcuityMD, a platform that helps medical device manufacturers accelerate commercial adoption. Before founding AcuityMD, Mike started his career as a management consultant, then co-founded a medical device startup with his brother, where he first experienced firsthand how much time and effort it took just to prepare for a single sales call. That experienc...

Dr. William Brody has had at least four careers: foundational researcher in CT and MRI, co-founder of three medical device companies, 13-year president of Johns Hopkins University, and leader of the Salk Institute. Now he's codified a lifetime of lessons in his new book, Uncommon Sense , released April 28, 2026. In this conversation with Shannon Lantzy, Dr. Brody shares the decision-making framewo...

FDA commissioners come and go, but career civil servants are always there, applying the rules without financial conflicts of interest. Dr. Robert Califf served as FDA Commissioner twice, making him one of the most experienced regulatory leaders in healthcare history. Before FDA, he built the world's largest clinical research institute at Duke and spent time in Silicon Valley with Google's...

The Stanford Mussallem Center for Biodesign has trained innovators whose inventions have touched over 18 million lives while they were still in training. Most people think breakthrough innovation is magic or unpredictable. Dr. Josh Makower proved otherwise. As co-founder of the Stanford Mussallem Center for Biodesign, he created a systematic methodology that breaks innovation into learnable steps:...

Dr. Bob Gabbay has spent decades at the intersection of diabetes research, clinical care, and technology innovation. From leading the Joslin Diabetes Center to serving as Chief Scientific and Medical Officer at the American Diabetes Association, he witnessed the field transform from sharpening needles on stones to closed-loop insulin systems. Yet despite incredible technological advances, a critic...

One medical device company cut their software recall response time from 180 days to under 30 by automating compliance evidence collection. In regulated industries like MedTech, shipping software takes weeks not because the code isn't ready, but because proving compliance requires manual evidence gathering. Automated governance captures proof continuously as developers work. When it's time...

Only 2% of sickle cell patients who could benefit from blood therapy actually receive it, despite it being first-line treatment. Marketing in medical devices isn't about jingles or promotions. It's about looking at data, drawing hypotheses, testing them, and ensuring every claim you make is scientifically relevant. It's closer to research than advertising, requiring the ability to tran...

What if you could see inside a patient's body instantly, without moving them from their bed in the emergency department? Dr. Resa Lewiss spent 25 years in emergency medicine, pioneering the integration of point-of-care ultrasound into clinical practice. As the founding head of ultrasound at Mount Sinai St. Luke's Roosevelt, she built education curricula, established quality improvement processes,...

Sasha Keck was the only girl in her high school engineering class of 26 students. By her senior year of college, she and her team had patented a surgical device that could cut spinal surgery exposure time in half. As a Technical Development Program Engineer at Edwards Lifesciences, Sasha bridges the gap between R&D innovation and manufacturing reality. She's part of a generation that grew...

In this episode of Inside MedTech Innovation, Haley King, co-founder and CEO of Paxos Health, joins host Shannon Lantzy to explore how technology can level the playing field when patients face insurance denials. Haley shares her journey from designing cardiovascular implants at Medtronic to founding a company that helps patients overturn insurance denials with a 90% success rate. The conversation...

What happens when a digital health pioneer becomes a cancer patient and discovers his own doctors missed a life-threatening diagnosis? Steve Brown, founder and CEO of CureWise, shares his remarkable journey from building one of the first remote patient monitoring companies to nearly losing his life to a rare blood cancer that went undetected until the Palisades Fire displaced him to new doctors wi...

When your insulin pump connects to your phone or your glucose monitor shares data with the cloud, is it secure? And what does "secure" even mean? In this episode of Inside MedTech Innovation , Shannon Lantzy sits down with Jacob Combs, Chief Information Security Officer and VP of Cybersecurity at Tandem Diabetes Care. Jacob brings deep expertise from across telecom, defense, financial se...

When Justin Eastzer was misdiagnosed with type 2 diabetes at 30, he turned to TikTok to share his experience with a new glucose meter. The community's response changed everything: he actually had type 1 diabetes, and his doctor had missed it. That moment launched Diabetic Tech, now one of the most trusted patient education platforms in the diabetes space with over a million downloads.  In this...

Most medical device companies think quality systems slow them down. Kyle Rose proves the opposite is true. Kyle Rose is the founder and president of Rook Quality Systems, a consulting firm that helps early-stage medical device companies build efficient, compliant quality management systems. With 13 years of experience and nearly 40 employees, Rook has guided companies through FDA submissions, acqu...

When Oleg Yusim joined Baxter in 2016 as one of the first dedicated medical device security architects, the industry was just beginning to understand that shared PINs like "4444" across entire product fleets weren't acceptable security. Ten years later, as Chief Product Security Officer at Illumina, he's mastered something far more difficult than technical security: translating c...

Remote surgery across continents exists today, so why isn't it widespread in the United States? Dr. Omar Al-Kalaa spent 15 years at FDA's Office of Science, Engineering and Laboratories, where he became the bridge between telecom operators, medical device manufacturers, and regulators. His work on wireless coexistence and 5G connectivity shaped how next-generation networks intersect with m...

What does it take to transform cybersecurity from reactive patch management to proactive secure design? Adam Shostack, the world's leading expert on threat modeling, takes us inside Microsoft during its pivotal security transformation in the early 2000s and reveals how those lessons shaped FDA's approach to medical device cybersecurity today. From the auto-run vulnerability that infected m...

What if the LED lights and screens we rely on daily are causing neurological injuries we can't see? Dr. Jennifer Hackett, a molecular biologist who discovered her own sensitivity to LED flicker in 2018, takes us deep into the science and silence surrounding this invisible health threat. From her research background at Johns Hopkins and Harvard to becoming a patient advocate, Jenny shares how she u...

When Lane Desborough's 10-year-old son was diagnosed with type 1 diabetes in 2010, this chemical engineer did what came naturally: he applied industrial-scale automation principles to save his child's life. What followed sparked a movement that continues reshaping medical device innovation today. Lane's journey from creating Nightscout (one of GitHub's most-forked repositories) to...

Obesity is one of the most complex and misunderstood chronic conditions in the world, affecting more than 60% of adults globally and 75% in the U.S. Yet, despite its prevalence, care systems continue to underdeliver, relying on one-size-fits-all advice, outdated stigma, and underutilized data. In this episode of Inside MedTech Innovation , Elina Onitskansky, founder and CEO of Ilant Health, joins...

Shannon Lantzy sits down with Dr. Richard O'Neill, a regulatory innovator who spent 40 years working in energy markets at FERC and ARPA-E. Dr. O'Neill shares the development and implementation of market optimization software that now generates billions in annual cost savings for American consumers through more efficient electricity markets. The conversation covers the 18-year timeline from algorit...