What regulation gets wrong about our industry — and how founders can change that

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When I testified before the Senate committee last spring, I realized the gap between how technology works and how it gets regulated has never been wider. The senators weren’t hostile. They weren’t corrupt. They simply had no framework for what we were describing — and neither did the staffers writing the rules.

We’ve spent years building products in private while expecting policy to catch up. It won’t. And the cost of that silence is being written into law right now, in ways that will shape our industry for the next decade.

The gap isn’t technical — it’s translational

Most founders I know treat regulation as a compliance problem: something to hand off to legal once the product is built. That framing is costing us. Policymakers aren’t against us — they simply don’t understand us. And when they don’t understand something that affects patients or consumers, they regulate defensively.

“The founders who will shape the next regulatory cycle aren’t the ones with the best lobbyists. They’re the ones who showed up early enough to be treated as experts.”— Dr. Tara Ghazi

What founders can actually do

The good news is that the window for influence is still open — but it closes fast. Here’s what I’ve learned from three years of engagement with regulators at the FDA, CMS, and on Capitol Hill.

1. Engage before the comment period

By the time a proposed rule hits the Federal Register, the framework is already set. The real decisions happen in the 18 months before that — in listening sessions, pre-rule briefings, and informal conversations with agency staff.

2. Translate, don’t advocate

The instinct is to argue for your interests. The more effective move is to educate. Walk a staffer through how your technology actually works. The founders who get heard aren’t the loudest — they’re the ones who make the regulator’s job easier.

3. Build coalitions before you need them

No single company changes policy alone. The medtech regulatory wins of the last five years came from coalitions — companies with competing products who agreed that a better framework served everyone.

The founders who will shape the next regulatory cycle are the ones who showed up early enough to be treated as experts — who built enough trust with agencies that their input gets sought, not just tolerated.