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 […]

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 […]

Insights from the MassMEDIC Webinar with Bryan Gilpin and Terri Kapur Every medtech leader I talk to is under pressure to move faster. That pressure is real, and it is not going away. But across the industry, we keep seeing the same thing play out: the harder organizations push for speed, the more they can […]

If it were simply about the engineering or the science, this job would be so much easier. Effective med device R&D leadership is not just about the black and white of the data. It is also about bridging the communication gap between what needs to be done and why it matters to the company. Sometimes the […]

New product development processes that are overly siloed are stifling medtech innovation. Here’s why and the steps you can take to get engineering, clinical, regulatory, marketing, and manufacturing all working in parallel from day one.

A wise leader once told me: going fast is great, but real success lies in predictability. As we discuss the “4Ps” of R&D leadership, Planning, People, Process, and Projects, it becomes clear that Predictability is the true differentiator for organizations striving to meet their commitments and outperform competitors. Skillsets Are Democratized, Judgment Is Not Today, […]

Device complexity in the era of cyber-interdependent safety systems (CISS) is creating a widening gap between device planning and execution. Here’s what to do about it. It’s estimated that there are 3-4 million smart infusion pumps now deployed across the  medical world. They are among the most successful new product introductions of recent years and […]

If it were simply about the engineering or the science, it would make things so much easier. Effective medical device R&D leadership isn’t just about the data. It’s about bridging the communication gap between what needs to be done and why it matters to the company. Sometimes the programs or projects are clear. But medium […]

An Interview with Mike Magliochetti I’ve known Mike Magliochetti for years. He’s the kind of person who makes you think harder in a conversation than you expected to when you sat down. So, when he told me he had written and published a book, Dancing Between the Toes of Elephants, about his transition from medtech […]

From smart devices to systems that learn AI in medtech has moved beyond experimentation. Today, it’s embedded across clinical workflows, driving real impact. But we’re seeing a clear shift in what success looks like next. In this perspective, we explore how the future is no longer about isolated intelligent devices. It’s about connected systems that […]