FDA used to be the choke point to get to market. FDA accelerated, and now payment is the primary problem. FDA is offering TAP, a free...

By the time you get to the FDA, do you forget to tell the whole story? Reaching an underserved population. Extra evaluations on patient...

It is scary to develop a regulatory submission that doesn't match conventional wisdom. If the innovation is worthy, do it anyway. You can...

A few tips when crafting a (FDA CDRH) regulatory submission. Use Q-subs, it's like free FDA consulting Follow directions, get the basics...

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...

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...