To do something new, try creating a community. I used to work almost exclusively with local colleagues and clients. Marylanders felt...

Understanding the difference between real-world data and real-world evidence is the key to digital medicine and AI success in healthcare...

My last substantive conversation with my grandmother was at 14, about Israel and Palestine. She died when I was 27. I missed 13 years...

Pure mental health (sometimes known as nirvana, enlightenment, or heaven) is knowing, and nonetheless deciding. I'm celebrating the...

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...

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...