Product architects are challenged to address security throughout the device lifecycle.
During a conference earlier this year, Suzanne Schwartz, M.D., MBA, director of emergency preparedness/operations and medical countermeasures at CDRH framed the problem of device security well: “Cybersecurity isn’t just a design issue. It’s not just at the product launch. It’s a life cycle issue. It requires a change in mindset.”
Why the investment that never fits a budget category keeps losing, and what to put in front of finance instead Budgets run annually. Architecture consequences run five to seven years. Every R&D leader in medtech understands this, and almost no planning process accounts for it. A platform decision made this quarter will shape what your […]
Three numbers from the latest Medtech Big 100 and what they should change about your FY27 planning Three numbers from Medical Design & Outsourcing’s most recent Medtech Big 100 analysis are worth putting side by side. Aggregate revenue across the world’s largest device companies hit a record $486.7 billion, up nearly 3 percent. R&D spending […]
Where the Money Actually Goes Why your R&D spend, not your strategy deck, tells the truth about your portfolio The decisions you make in R&D today will not be visible for two years. That is the uncomfortable math of this job. What you choose to work on right now is what you and your team […]
Every year, a handful of genuinely promising early-detection devices in medtech quietly disappear. Not because the science didn’t work. Because the program didn’t survive long enough to prove that it did. That distinction matters, because it is not how these stories usually get told. When an early-detection platform stalls, the assumption is almost always technical: […]
The Only Metric That Actually Predicts Team Performance You Can’t Mandate High Performance. You Have to Build It. Early in my career, I was asked to run a team performance workshop I did not want to do. My R&D team was missing deadlines. Progress was happening, but communication was not. My executive leader pushed me […]
What recent FDA actions, device recalls, and enterprise breaches are telling medtech executives about the state of product security governance. On June 8, 2026, iRhythm discovered that a threat actor had gained unauthorized access to data maintained on third-party-hosted business applications. The following day, the company received a ransom demand threatening to release stolen proprietary […]
Suntra serves as the engineering and integration partner, developing a multi-sensor platform suitable for obstetric clinical use. BEDFORD, NH, June 26, 2026 – Suntra MedTech Solutions (formerly Sunrise Labs) is part of a nine-institution team, led by Carnegie Mellon University and including the Children’s Hospital of Philadelphia, awarded up to $39.3 million by the Advanced […]
Here’s what to do about it AI in medtech has moved beyond experimentation. Today, it’s embedded across clinical workflows, You built a best-in-class device. Then another. Then a full portfolio. And somewhere along the way, the software platform holding it all together quietly became the most expensive problem on your roadmap that nobody is talking […]