Knowledge Base

The single most important thing I’ve learned about digital health regulation is that it sits at the center of every other medical device concentration, and you need to understand how all the pieces fit together to be successful.

FDA’s decision sends a message that marketing addictive and dangerous products to teenagers will put you out of business. I believe this decision is helping out the public good, not punching down at an innovative tech company.

These are the top three reasons I’ve seen torpedo the design review process, and a few simple ways to fix them.

“You’re too much of a coward to fire me.”

I’ve always thought of myself as brave. Integrity, transparency, and clear communication are extremely important to me. Yet here I was, on the receiving end of an emotional resignation because I had been afraid of doing the Hard Thing. It only got worse as I realized that he was right.

How did this happen??