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

I read an article that suggested people think "optimizing" and efficiency efforts are synonymous with cost-cutting and worker burnout. I...

With my recent change of employment status (from employed to self-employed), people have asked me, "What do you do?" I sometimes answer...

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...

I entered the world of medtech cybersecurity five years ago, not because I was a cybersecurity professional (though I play one on TV),...

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

I recently took a ride in a driverless car through the streets of San Francisco, courtesy of my friend, a Waymo employee. The car pulled...

A series of “thinking cap questions” about luxury healthcare, software subscription models, and promoting versus preventing progress What...

"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....

Lane Desborough shared this article with me, in response to a conversation about datasets and what CGMs can tell us. The article asserts...

Throughout human history, technology has surprised us with delightful innovations that save, extend, or improve the quality of our lives....

Opening up the market; FDA and the gift of MDDTs FDA recently updated its guidance on submitting a Medical Device Development Tool (MDDT)...

On August 10, Lane Desborough and I are going to kick off a webinar about accelerating diabetes technology development through...

I read Atomic Habits on the recommendation of (seemingly) all the self-improver readers I know. It's a great book, short and readable,...

I recently picked up The Oldest Book in the World by Bill Manley based on a WSJ review and nostalgia for my undergraduate days in the...