A working prototype. A small team that believes in it. Investors who wrote checks because they saw what you saw.
But the structure behind the product isn't there yet. The regulatory pathway isn't fully defined. The risk file is incomplete. Requirements are scattered across spreadsheets and slide decks. And somewhere in the back of your mind, you know that if someone looked hard enough, they'd find the gaps.
I help founders building surgical robotics and advanced interventional devices turn that prototype into a product program that can stand up to the FDA and survive investor diligence.
I know what that process looks like from the inside. I've walked it.
Apply to Work With DaveFDA De Novo
Clearance — July 2023
$25.5M
Series A
35 Patents
Licensed from Johns Hopkins
15 Years
Surgical Robotics
A founder has cleared the hardest technical hurdle. The device works. The science is solid. The team has built something genuinely impressive.
Then the investor update comes. Or the design review. Or the first serious FDA conversation. And suddenly it's clear that the documentation behind the device doesn't match the device itself. User needs are vague. Risk controls aren't traceable. The V&V plan is a placeholder.
Nobody meant for it to get this way. The team moved fast because they had to. But fast and structured aren't the same thing. And in this industry, the gap between them is measured in funding rounds and submission timelines.
The companies that make it are not always the ones with the best technology. They're the ones with the most defensible product programs. The ones that can walk an FDA reviewer and a diligence team through their development logic and have it hold up.
That's what we build.
You don't hand me your program and wait. Your team does the work. I coach them through doing it correctly, in the right sequence, so what gets built is something they understand and can defend.
Which pathway. Why. What it means for your roadmap. By the end of this step, you have a documented regulatory strategy you can take into any investor or FDA conversation.
Back to first principles. Intended use. User needs. Indications. System boundaries. Everything else gets built on top of this. Your team owns it.
ISO 14971-aligned, built correctly from the start. Not a checkbox. A risk file your team understands and can maintain.
User needs and risks translated into clear engineering requirements, traceable all the way through to your test plan. The connective tissue of a defensible program.
A V&V framework that demonstrates safety and performance. And a development story that holds up in the boardroom the same way it holds up in a regulatory submission.
I do.
I've been working on surgical robotics and interventional device commercialization since 2011. That's fifteen years of watching what works, what breaks, and what the FDA actually cares about versus what teams assume it cares about.
The deepest chapter of that was eight years as co-founder and CTO of Galen Robotics, taking a Johns Hopkins University prototype through three hardware generations, feedback from hundreds of surgeons, two cadaver studies, and FDA De Novo clearance in July 2023 for the world's first cooperatively controlled microsurgical robotic assistant. A 35-patent portfolio licensed from Johns Hopkins, fully granted by the time we cleared. $25.5M Series A. I provided the core leadership and direct effort that got that device across the line.
I know what a clean design history file looks like. I know what a defensible risk framework looks like. I know what an FDA reviewer is actually looking for, and I know what a Series B diligence team will find if the structure isn't there.
When you work with me, you're not getting advice from someone who has studied this. You're getting coaching from someone who has done it.
Companies I've worked with
In partnership with ongoing research at Johns Hopkins University Laboratory for Computational Sensory Robotics.
This is for funded surgical robotics and advanced interventional device companies that have a working prototype and know the regulatory and product structure isn't where it needs to be.
It is not for companies that are pre-prototype. It is not for general medtech startups looking for broad business advice. And it is not for founders who are not ready to do the work.
If you're serious about getting your device to market and you want someone who has actually done this in your corner, let's talk.
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