The teams delivering the roadmap are the ones that think about verification differently Ask a medtech leadership team why the roadmap is behind and you will hear about headcount, scope creep, and regulatory surprises. You will rarely hear about verification and validation, because V&V is not usually thought of as something that determines delivery speed. […]

Sustaining Engineering: The Team That Keeps the Wheels Moving There is a part of R&D leadership that does not get nearly enough attention in leadership conversations, and yet it quietly determines whether your entire operation stays compliant, competitive, and solvent. It is sustaining engineering. I have had the privilege of leading sustaining teams across very […]

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 […]

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 […]

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, […]

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 […]