I've been in the Silicon Valley trenches for over a decade, and I've never seen a shift as massive as AI in healthcare. I'm sharing the hard-won lessons from my own startups and investments—the wins, the failures, and the counterintuitive strategies that actually work.
The Framework That Actually Works
Here is a simple framework for evaluating FDA approval. It's not complicated, but it requires discipline.
Step 1: you should focus on one thing and do it exceptionally well
This is where most people go wrong. They skip this step entirely and jump straight to execution. Don't do that.
Step 2: simplicity beats complexity every time
Once you have the foundation right, this becomes much easier. I've watched founders struggle with this for months when the answer was staring them in the face.
Step 3: Iterate relentlessly
Nothing works perfectly the first time. The companies that get FDA approval right treat it as an ongoing process, not a one-time project.
What I've Learned From 49 Companies
Across 234 angel investments, including Anthropic, a few patterns in FDA approval come up again and again.
The founders who handle FDA approval well understand that customer feedback is the only metric that matters.
Lessons From the Trenches
I want to share a few specific lessons I've picked up over the years. These aren't theoretical. They come from real companies, real failures, and real successes.
Lesson 1: The best time to start thinking about FDA approval was yesterday. The second best time is now. Don't wait until you have the perfect plan.
Lesson 2: Hire for attitude, train for skill. The best people at FDA approval are rarely the most technically gifted. They are the most curious and persistent.
Lesson 3: Your competitors are probably getting this wrong too. That's your opportunity. While everyone else is following the same playbook, you can zig when they zag.
This connects to broader themes around AI mental health, AI radiology, healthcare automation that I've been thinking about a lot lately.
The Bottom Line
None of this is rocket science. But it does require intentionality, consistency, and a willingness to learn from mistakes.
If you take one thing from this article, let it be this: start now, start small, and iterate. The founders who win at FDA approval aren't the ones with the best strategy on paper. They're the ones who execute, learn, and adapt faster than everyone else.
Companies that take FDA approval seriously tend to pull ahead of the ones that don't.
If you're working on something interesting in this space, I'd love to hear about it. Drop me a line.
Frequently Asked Questions
Q:What are the most common mistakes with FDA approval?
The biggest mistake I see is overcomplicating things early on. Start with the simplest version that works, get real feedback, and iterate from there. Another common trap is copying what worked for someone else without understanding the context behind their decisions.
Q:How do I measure success with this approach?
Pick one or two metrics that directly tie to your goal and track them weekly. Vanity metrics like page views or follower counts rarely matter. Focus on metrics that reflect real engagement or revenue impact.
Q:How long does it take to get FDA approval right?
The timeline varies depending on your starting point and resources. For most founders, expect 2-4 weeks for initial setup and 2-3 months to see meaningful results. I've seen teams move faster when they focus on one thing at a time rather than trying to do everything at once.
Q:Do I need technical skills for FDA approval?
Not necessarily. While technical understanding helps, the most important skills are clear thinking and the ability to break problems into smaller pieces. Many successful founders I've invested in started with zero technical background and either learned enough to be dangerous or found the right technical partner.