David Blumenthal spent 35 years practicing primary care before most physicians had electronic health records. He worked on Senator Edward Kennedy's health policy staff in the 1970s, advised three presidential campaigns on health policy, and under Obama ran the Office of the National Coordinator for Health Information Technology, overseeing the $25 billion federal push that digitized American medicine. He is now at the Harvard T.H. Chan School of Public Health, co-authoring re

Andrew Carney started his career in classified offensive cyber operations, writing code to break into systems for a living. After a decade of that, he joined HSBC as a defender and landed during his second week there in the middle of the Log4j crisis, one of the most significant software vulnerabilities ever discovered. He now runs cybersecurity programs at ARPA-H and DARPA, translating national security tools into healthcare. He came on Inside MedTech Innovation with a thesi

This content was created with AI assistance from the full episode transcript. Robert Charette has spent 50 years documenting why large-scale IT systems fail. Not medical device systems specifically — he is the first to say that medical devices are not his specialty area. What he has studied is DOD procurement disasters, national EHR rollouts, government payroll systems, space shuttle software safety, and Fortune 100 enterprise failures. The patterns he has documented across t

Dr. Adam Cifu is a general internist and professor at the University of Chicago, where he has practiced primary care continuously since 1997. He is the co-author of Ending Medical Reversal, the book that introduced the term to the field, and a co-founder of Sensible Medicine, one of the most widely read independent medical publications in the country. He still sees patients in clinic, still rounds on the inpatient service, and still staffs the urgent care half a day a week —

Randy Horton is the Chief Solutions Officer at Orthogonal, a firm that specializes in accelerating software as a medical device, digital therapeutics, and connected medical device systems. He co-chairs the cloud computing standards committee at AAMI with Pat Baird of Philips, where the consensus report he helped produce — and the technical information report now up for final vote — will be the first time the FDA has a recognized consensus standard for evaluating cloud-based m

Mike Monovoukas is the co-founder and CEO of Acuity MD, a platform that helps medical device manufacturers find and convert commercial opportunities by combining publicly available market data with companies' internal commercial data. Mike studied International Affairs and Public Policy at Princeton, holds an MBA from Harvard, started his career in management consulting at Bain, and before Acuity MD co-founded a medical device startup with his brother. That first startup didn

Dr. Robert Califf is one of the most experienced regulatory leaders in American healthcare history. A cardiologist by training, he built the world's largest clinical research coordinating center at Duke, served two separate terms as FDA Commissioner, making him one of the few people to lead the agency twice, spent time at Google's Alphabet, and now publishes widely on Substack and elsewhere on the state of healthcare in the United States and globally. What makes him worth lis

Dr. William Brody has had at least four careers. He earned an MD and a PhD in electrical engineering simultaneously at Stanford — enrolling in both programs without formally applying to the engineering school, simply sitting the qualifying exams. He made foundational contributions to CT and MRI technology, holds more than 300 patents, and co-founded three medical device companies, two of which were acquired by GE and Johnson & Johnson. He served as president of Johns Hopkins

Dr. Josh Makower's career reads like a masterclass in turning clinical frustration into durable, scalable healthcare technology. A physician and mechanical engineer by training, NYU Med, MIT, Columbia MBA, he spent decades not just building companies but building the infrastructure that helps others build companies. As co-founder and director of the Stanford Mussallem Center for Biodesign, he created what's now known as the Biodesign Process: a methodology that has fundamenta

Dr. Bob Gabbay on what's actually standing between people with diabetes and better health — and why the last mile is the hardest mile In 1993, it was not yet proven that better blood glucose control prevented the complications of diabetes. There were researchers on both sides. Some believed complications were inevitable regardless of glucose management. Others believed tighter control made a difference, but the clinical trial data hadn't confirmed it. When the results of the

Michael Edenzon built Fianu to replace weeks of manual compliance work with continuous, objective evidence collection baked into how software gets built In a regulated industry like MedTech, every software release carries an auditable promise. Did the code get tested? Were vulnerability assessments completed? Were residual software risks evaluated? These aren't optional steps — they're commitments embedded in a quality system, and a manufacturer is responsible for proving eve

CMS ACCESS has be more excited than I've ever been about a payment program. Usually I stay in the innovation lane. But this is too juicy. What if Apple, Google, WHOOP, Dexcom, Oura, Insulet, Tandem, ResMed, and Noom all entered a competition to see who could improve the well-being of as many Medicare beneficiaries as possible? What if they were explicitly allowed to advertise their technology to medicare beneficiaries, and anticipated that if they performed well, they’d get t

Joy Duemke spent 15 years at Terumo figuring out how to actually put patients at the center of innovation When Joy Duemke tells you about medical device marketing, she doesn't talk about ad campaigns or jingles. She talks about looking at data, drawing hypotheses, testing them, and ensuring every statement is scientifically relevant. "In med device, marketing's closer to science," Joy explained during our conversation. "You're a translator for science in a lot of ways." Joy i

"Younger engineers don't want to work." I keep hearing this narrative. And then I meet engineers like Sasha Keck. Sasha is a Technical Development Program Engineer at Edwards Lifesciences. She co-owns a patent for a surgical device she helped invent as a college senior. In our conversation on Inside MedTech Innovation, she shared what it's like to be an early career professional navigating the medtech ecosystem—from being the only girl in her high school engineering class to

My mission is to accelerate the innovation of great technology for people who need it. TEMPO is a great opportunity for acceleration. What if a device manufacturer could propose to the FDA that their device is relatively low-risk, and the only way to affordably determine efficacy is to bring it to market and measure real-world outcomes? Well, now it seems they can. The FDA is welcoming applicants to the TEMPO pilot to evaluate the feasibility of doing just that, specifically

A cell-free DNA test during pregnancy. A maxillofacial surgery for a restricted airway. An ovarian cancer treatment. Breast reconstruction after mastectomy. What do these all have in common? Health insurance denials—even when doctors say the treatment is medically necessary. We've all heard the stories. Maybe we've lived them. But what if patients and their doctors had the same tools insurers use to deny care? What if advocacy could be powered by AI instead of exhaustion? Thi