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 […]

As pressure to accelerate grows across medtech, many teams are discovering a paradox: the harder we push for speed, the more we introduce delays, misalignment, and rework. In this webinar, Bryan Gilpin and Terri Kapur explore what’s really getting in the way—and how to build a foundation for true development speed.

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 […]

How workflow, IT integration, and reimbursement gaps stall promising devices—and what to do about it In 2011, when the early AI engine IBM Watson won a three-game exhibition tournament of Jeopardy, besting two human contestants who were widely considered to be the greatest ever to play the game, it was considered a real breakthrough for […]

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. […]

The Hippocratic Oath and its famous dictum, “First, do no harm” (primum non nocere), have been part of the medical world for centuries, a telling sign of medicine’s long-standing commitment to prioritizing the welfare of the patient.  But what it meant to “first, do no harm” back in the day when care was dictated almost […]

In emergency medicine, minutes matter. But behind every “rapid response” clinical innovation is years of disciplined systems thinking, engineering rigor, and regulatory foresight. One of the most complex challenges facing trauma care today isn’t treatment, it’s access. Plasma, a critical component in emergency transfusions, has traditionally been constrained by freezing, storage, transport logistics, and slow […]

Life changing Class III next-generation driver for the implantable Total Artificial Heart (TAH-t)

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 […]