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

Working toward a noble mission has consequences on our personal lives. When is the personal sacrifice worth it? This week Astronaut Frank...

FDA doesn't like "pilots." Instead, should they run IT "trials?" FDA, like most of the government, needs better IT. They're working on...

Achieving revenue for digital medicine in the U.S. is far from straightforward. Policymakers and industry institutions are working toward...

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),...