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 path from prototype to market isn't fully defined. Risk, requirements, and the manufacturing roadmap 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 hard-tech founders move from prototype to product without losing momentum or investor confidence.
I've walked that road from the inside. I know where it bends and where it breaks.
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 product 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 regulatory conversation. And suddenly it's clear that the documentation behind the product doesn't match the product itself. User needs are vague. Risk controls aren't traceable. The verification 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 hard-tech, the gap between them is measured in funding rounds and submission timelines.
The companies that make it aren't always the ones with the best technology. They're the ones whose product program holds up when a regulator or a diligence team starts pulling on threads.
That's what we build.
Inside a six-month coaching engagement, we move through these five topics together, in the right sequence, at the right depth for where your product is. The work your team produces is something they own, understand, and can defend.
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.
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.
I do.
Forty-plus products commercialized over thirty-five years. The original consumer Wi-Fi hotspot, designed at Bell Labs and shipped by Apple as the AirPort. The TNT access concentrator at Ascend Communications during the dial-up era. A 30-million-line operating system, TAOS, that I productized into a $500M-per-year business unit before Lucent acquired Ascend for $24 billion.
In 2011, surgical robotics found me. Fifteen years and counting. The deepest chapter was eight years as co-founder and CTO of Galen Robotics, taking a Johns Hopkins 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 that got that device across the line.
My interest has always been the same. The little gears that bring technology together, and the work on the other side of the fence to get it into customers' hands. The industries change. The problem doesn't.
I know what a clean design history file looks like. I know what a defensible risk framework looks like. I know what a regulator 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 hard-tech founders with a working prototype who know the structure behind the product isn't where it needs to be. Medical devices and surgical robotics are where my depth is — the methodology travels to diagnostics, defense, climate hardware, industrial robotics, physical-AI, and other regulated or safety-critical hardware.
If you're pre-prototype, looking for general business advice, or hoping someone else will do the hard part for you, this isn't a fit.
If you're serious about getting your product to market and you want someone who has actually done this in your corner, let's talk.
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