The question is how much help you need to fix it.
There are two ways to work with me. Start with the conversation that fits where you are.
You bring the problem. I bring forty-plus products of commercialization experience across telecom, cloud, and medical devices — including eight years inside Galen Robotics, from Johns Hopkins prototype to FDA De Novo 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 six-month coaching engagement for companies ready to commit to sustained work.
A six-month commitment for funded hard-tech founders who want decades of operating experience applied to the specific decisions in front of them.
One sixty-minute coaching session per week. Asynchronous support between sessions. We move through the five topics below in the right sequence for where your product is.
I'm not doing the work for you. I'm coaching your team through doing it correctly, drawing on forty-plus products commercialized across telecom, cloud, and medical devices — including the FDA De Novo clearance I helped lead at Galen Robotics.
Back to first principles. Intended use. User needs. Indications. System boundaries. Decide what the product actually is, and let everything else flow from that decision. Your team owns it.
Bridge the gap between prototype and shippable. Manufacturing readiness. Supplier strategy. Design-for-manufacturability. IP coverage. The path from one working unit to a product that scales.
ISO 14971-aligned risk management and design controls installed early, as discipline rather than paperwork. Regulatory strategy defined: 510(k), De Novo, PMA, or your industry's equivalent. For MedTech founders, strategic roadmapping that uses a simpler first filing as a predicate for richer ones to follow.
User needs and risks translated into clear engineering requirements, traceable all the way through to your test plan. The connective tissue that survives regulatory review and investor diligence.
Align the commercial story with the technical and regulatory reality. Position the product so it can be sold, funded, and scaled, not just cleared. A development story that holds up in the boardroom the way it holds up in a submission.
By the end of six months, your company has a clear, actionable plan to get your product to market — with regulatory clearance where that applies. Not a collection of files. A plan your team understands, can execute, and can defend. If you don't have that plan, 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.
You're building a hard-tech product — medical devices, surgical robotics, diagnostics, defense hardware, climate hardware, industrial robotics, physical-AI, or another regulated or safety-critical category.
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, by design. The work needs full attention, and the advice only stays honest when I'm not overextended. If that lines up with where you are, apply below.