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.

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 […]

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 […]

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.

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 […]

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 […]

Healthcare collects more data than any industry on earth. Most of it never gets used. Here’s why that paradox persists, and what has to change. Healthcare data is growing at 36% annually, faster than financial services, faster than media. Yet the majority of what gets collected sits idle, generating cost and complexity without generating insight. […]

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 […]

In the rapidly evolving landscape of software development, Continuous Integration and Continuous Deployment (CI/CD) have emerged as pivotal practices, especially within the medical device industry. These methodologies are not just buzzwords; they are revolutionizing the way we approach medical device development, offering a beacon of efficiency and reliability in a sector where precision and quality are non-negotiable.