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. […]

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 […]

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: […]

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 […]

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.

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.

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.

Bringing a new medical device to market is a complex and high-stakes endeavor. Companies face numerous challenges, from securing funding and managing product development to navigating stringent regulatory requirements. Success requires a strategic approach, combining innovation with disciplined execution. 1. Identifying the Right Problem to Solve One of the biggest factors in MedTech success is […]

Navigate Key Risks to Bring Your Product Vision to Life Every new product comes with risks—are you prepared? Learn how to navigate the challenges of new product development with our whitepaper, “New Product Development: Managing the Risks”. For additional perspective beyond this risk-management whitepaper, explore The Keys to Medical Device Project Success. This related POV […]