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.

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 […]

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 […]

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 […]

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 […]

In the rapidly evolving landscape of medical device development, risk management is a fundamental process that ensures patient safety and regulatory compliance. An effective risk management strategy not only identifies potential hazards early but also streamlines development by reducing costly redesigns and regulatory hurdles. Understanding Risk Management Risk management, as defined by ISO 14971, is […]

Developing safety-critical medical devices is a complex process that requires careful planning, rigorous testing, and cross-functional collaboration. The stakes are high—not only because of regulatory and market risks but also because patient safety depends on every design decision. Below, we explore key strategies that can help ensure the success of safety-critical medical device development. Understanding […]