I have been inside enough startups to know what it feels like when the work is going well and what it feels like when it isn't. When it's going well, there's a kind of forward momentum that's hard to describe to anyone who hasn't experienced it. The team is aligned. The decisions feel defensible. You can walk into a room with investors or regulators and explain your development logic without hesitation. You know where you're going and why.
When it isn't going well, there's a different feeling. A low-grade tension that doesn't go away. You're moving fast but you're not sure the foundation underneath you is solid. You're answering hard questions from your board with answers that feel slightly thinner than they should. You've built something genuinely impressive and you're starting to wonder whether the structure behind it can hold up to the scrutiny that's coming.
Most founders I work with are somewhere in that second place when we first talk. Not failing. Not in crisis. Just aware that something is missing, and not quite sure how to fix it without slowing everything down. That awareness is a good sign. It means you're paying attention to the right things.
You can hire people to write documents. You can hire consultants to produce deliverables. What you cannot do is hand someone else the responsibility of truly understanding your device, your clinical context, your regulatory strategy, and your development logic — and have that understanding live somewhere useful when the FDA reviewer or the diligence team starts asking questions.
The thinking has to happen inside your team. My job is to make sure it happens correctly, in the right sequence, so the work your team produces is something they genuinely understand and can defend. That distinction matters to me. I'm not here to build something for you that you'll have to explain later. I'm here to coach your team through building something they own.
Not someone who has studied the regulatory process. Not someone who has advised on it from the outside. Someone who has lived inside a real program, under real investor pressure, with real consequences for getting it wrong.
I know what it looks like when a risk framework is built correctly and what it looks like when it isn't. I know what an FDA reviewer is actually looking for and what a diligence team will find if the structure isn't there. I know these things because I have been in those rooms. Eight years at Galen Robotics. Fifteen years in surgical robotics and advanced interventional devices. The world's first cooperatively controlled microsurgical robotic assistant, cleared by the FDA in July 2023.
That experience is what you're getting access to when we work together. Not a methodology. Not a framework someone else developed. The actual pattern recognition that comes from having done this.
This is the thing that keeps founders up at night, even if they don't say it out loud. You've built something technically impressive. You know that. Your team knows that. Your investors wrote checks because they believed it. But you also know that impressive technology and a defensible product program are not the same thing. And somewhere between the prototype and the operating room, the gap between them has to get closed.
The companies that make it are the ones that close that gap deliberately, early enough to matter, with someone who knows what closing it actually looks like. That's the work I do. And it's the work I care about.
I will tell you what I see. If the risk framework has gaps, I'll tell you. If the regulatory strategy needs rethinking, I'll tell you. If something your team has built is going to create problems at submission, I'd rather tell you now than have you discover it later.
That's not a pleasant thing to hear in the moment. But it's far better than the alternative — which is finding out when the stakes are higher and the options are fewer. The founders I work best with understand that honest feedback is a form of respect. They want to know what's actually true about their program, because they know that's the only foundation worth building on.
Medical device commercialization is the hardest version of this problem. The regulatory environment is genuinely complex. The consequences of getting it wrong are real — not just financially, but for the patients who will eventually depend on what you're building.
Most founders in this space are building something important. Something that belongs in an operating room because it makes surgery safer, more precise, or more accessible. That combination — high stakes, genuine difficulty, real impact — is what drew me to this work fifteen years ago and what keeps me here. I find it challenging and satisfying in equal measure. And I bring that to every engagement.
If any of this resonates with where you are right now, I'd like to talk. Not a sales conversation. Just a conversation between two people who take this work seriously. The fastest way to start is a paid one-hour consultation — $500 for an hour of my full attention on whatever you're facing. No agenda other than being useful. If it makes sense to work together longer, we'll talk about what that looks like.
You can book that conversation at the link below. Or if you're further along and ready to apply for the coaching program, the application is there too. Either way, I'm glad you found your way here.