Listen to the caring voice, the angel on the right shoulder, the gut feeling. Act on what is not only scientifically right but what is...

Complying with FDA's medtech cybersecurity requirements means doing the right thing. This will create compliance. You can create more...

We can manage risk better than we can manage uncertainty. In medtech cyber, there is a lot more uncertainty than well-characterized risk....

When technology changes drastically, the organization needs to change too Last week I spoke with a colleague who is making a career move...

If you don't toot your own horn, there's no music! Here's a story of uncovering wonderful work already done by a software engineer who...

Risk scores often distract from the valuable information needed to make decisions. Instead, use simple, elegant models better suited to...

Deficiencies in AIs; What We Can Learn No not that AI. I’m referring to FDA’s Additional Information (AI) letters. Also known as “hold...

There aren't enough cybersecurity professionals in medtech. In fact, there aren't enough cybersecurity professionals in general....

"Get it to market," a friend and colleague said, relating a story about a conversation between herself, her FDA teammates, and a sponsor...

In January 2023, Congress granted FDA new regulatory authority to require manufacturers to address cybersecurity in medical devices....

Hospitals’ Connectivity Conundrum: Hospitals have adopted the risks of connected tech, without its protections My friend recently shared...