Product architects are challenged to address security throughout the device lifecycle.
During a conference earlier this year, Suzanne Schwartz, M.D., MBA, director of emergency preparedness/operations and medical countermeasures at CDRH framed the problem of device security well: “Cybersecurity isn’t just a design issue. It’s not just at the product launch. It’s a life cycle issue. It requires a change in mindset.”
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 […]
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.
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.
