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

I recently had the privilege of speaking at the H-ISAC Medical Device Security Council meetings for both the European and Americas chapters. The discussions were lively, touching on everything from regulatory innovation to the practical challenges of explaining cybersecurity value to a board of directors. If you missed the sessions, the core message was urgent: We have entered a new era of medical device security.  We are moving past the days of simple awareness and complianc

This episode of Inside MedTech Innovation explores the evolution of point-of-care ultrasound in emergency medicine, the challenges of healthcare technology integration, and what it takes to transform medical training from the inside. Topics include how ultrasound replaced invasive diagnostic procedures, the middleware gap in health IT, why free open access medical education is democratizing clinical knowledge, and the importance of involving clinicians in medical device devel

What happens when a healthcare pioneer becomes the patient? When someone who spent decades building remote patient monitoring systems suddenly needs those very systems to save his own life? This is the story of Steve Brown—founder and CEO of CureWise, digital health pioneer, and cancer patient who nearly missed his own diagnosis. Until the Palisades Fire saved his life. Steve's journey from creating video games for kids with diabetes in the 1990s to building AI-powered cancer

Oleg Yusim has built cybersecurity teams at Baxter, Edwards Lifesciences, and Illumina. At each company, he faced the same challenge: products shipping with shared passwords, executives questioning the business case, and security budgets under constant scrutiny. The pattern repeated. Leadership would say cybersecurity mattered. Then came questions about cost, timeline impact, and whether partial security was acceptable. Most security leaders struggle with these conversations.

When your insulin pump connects to your phone, or your glucose monitor shares data with the cloud, is it secure? More importantly—what does "secure" even mean? These are the questions at the heart of my recent conversation with Jacob Combs, Chief Information Security Officer and VP of Cybersecurity at Tandem Diabetes Care. Jacob brings deep expertise from across telecom, defense, financial services, and healthcare—and now protects connected devices that deliver life-sustainin

A 30-year-old producer at CNET was losing weight fast, constantly thirsty, experiencing blurry vision. Two different doctors gave him metformin, a Type 2 diabetes drug, and sent him on his way. For six months, Justin Eastzer felt isolated, scared, and progressively worse. The doctors never ran the autoantibody test that would've revealed Type 1 diabetes. Then Justin made a TikTok video about a blood glucose meter that sent data to his phone via Bluetooth. He thought the tech

A software company was using Zendesk to track customer feedback. Every issue, from "can't log in" to actual product defects, was automatically categorized as a "complaint." Thousands of them. When Kyle Rose, president of Rook Quality Systems, showed up for their first internal audit, he found exactly what FDA reviewers would've found: a massive compliance gap that could've killed their regulatory submission. This wasn't a careless startup. This was a functioning medical devic

From 5G networks to space station surgery, exploring the invisible infrastructure that makes modern healthcare possible Remote surgery between continents. Glucose monitors competing with Netflix streams for wireless bandwidth. Surgical robots on the International Space Station. None of this is science fiction, it's the cutting edge of medical technology that Dr. Omar Al-Kalaa has been working to make safe, effective, and accessible. In this episode of Inside MedTech Innovati

The pain hit instantly. Dr. Jennifer Hackett had walked into hundreds of classrooms over her teaching career, but this newly renovated...

The year 2002 marked a turning point in cybersecurity history, though few realized it at the time. Microsoft was hemorrhaging customers...