The question is how much help you need to fix it.
There are three ways to work with me. They're designed as a progression, but you can start wherever you are.
You bring the problem. I bring fifteen years of pattern recognition across surgical robotics and advanced interventional devices — including eight years inside Galen Robotics, from Johns Hopkins prototype to FDA clearance. We work through what you're facing and you leave with a clear sense of what needs to happen next — and whether working together longer makes sense.
This is not a sales call. You pay for my time and you get my full attention.
$500
One hour. Booked and paid in advance.
Consultations point naturally toward the coaching program for companies that need more sustained work.
It's for funded companies with a working prototype that know their regulatory and product structure needs work.
One hour a week. Six months. Asynchronous support between sessions.
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, can execute, and can defend.
Which pathway. Why. What it means for your roadmap and timeline. By the end of this step, your team has a documented regulatory strategy they can take into any investor or FDA conversation.
Back to first principles. Intended use. User needs. Indications. System boundaries. This becomes the foundation everything else is built on. Your team owns it.
ISO 14971-aligned, built correctly from the start. Hazards. Harms. Risk scenarios. Controls. Not a checkbox exercise. 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 product 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.
By the end of six months, your company has a clear, actionable plan to get your product in front of the FDA and ready for market. Not a collection of files. A plan your team understands, can execute, and can defend.
If you don't have that plan at the end of the program, I keep working with you at no additional cost until you do. One condition: your team shows up and does the work.
$10,000–$25,000 /month
Six-month minimum commitment. Price varies by company stage and scope.
The coaching program naturally leads to the fractional path for companies that need continued embedded support.
They need someone inside the program.
This engagement is for companies that need both the strategic thinking and the hands-on execution. I work directly inside your product and regulatory program — not as an advisor watching from the outside, but as an embedded senior resource doing the work alongside your team.
This is the natural next step for companies that have completed the coaching program and need continued embedded support, or for companies at a stage where the scope demands more direct involvement from day one.
$25,000–$75,000
Scope and duration determine the engagement structure. Start with an application.
You're building a surgical robotics or advanced interventional device.
You have a working prototype.
You have funding. You have a team.
You're serious enough about getting to market that you're willing to invest real money in getting the structure right.
I work with a small number of companies at a time. That's by design. The work requires full attention and the advice only stays honest when I'm not overextended.
If that's you, apply below.