There is no playbook for novel surgical devices.
I ran the FDA office that set the evidence bar for these devices.
Now I help the companies building them navigate the path the agency hasn’t written yet.
Former Office Director, Surgical and Infection Control Devices, FDA. In that role I oversaw every general surgery, plastic surgery, and infection control device marketed in the United States across nearly 25 years at the agency. I came to that work as a board-certified general surgeon. Few people have read submissions from the regulator’s side of the table and also lived with the results in the operating room. I set the evidence bar from inside the agency. I now bring that judgement to companies from outside it.
What Clarity Provides
Clarity provides independent senior judgment at the moments when regulatory strategy, clinical evidence, labeling, product risk, postmarket signals, and real-world use have to hold together.
Clarity is not a submission-writing firm, CRO, or replacement for an internal regulatory team. The work is strategic. I help teams identify risk, pressure-test assumptions, prepare for FDA interactions, and understand the decision in front of them.
Where Clarity is Most Useful
Your device doesn’t fit cleanly into an existing predicate and the submission strategy reflects that uncertainty.
You are about to take the standard regulatory path and want to know whether a faster, smarter one exists for your device.
You’re designing a clinical trial and need to know what FDA will actually require and not only what was accepted before.
Your labeling, indications, or risk mitigations need to hold up under scrutiny you haven’t fully mapped.
FDA has asked questions your team didn’t anticipate, and the path forward isn’t clear.
A postmarket safety signal has emerged and you need to understand how FDA is likely to interpret it.
Your device incorporates AI or automation and you need to know how its decisions will be audited, evidenced, and defended after deployment.
You’re preparing for an advisory committee and want to understand the room before you’re in it.
How I Work
I work with teams through focused advisory calls, on site working sessions, and preparation for FDA interactions.
My work often starts by helping a team see the decision in front of them more clearly. I review the materials they plan to put in front of FDA, including submissions, briefing documents, slide decks, and presentations. I look for regulatory and evidence opportunities they may not have recognized, especially in data they already have, FDA policy they may not have considered, or strategic options that have not yet been tested.
A large part of my work is coaching. I help teams frame the question, explain the clinical context, present the evidence, and anticipate the concerns FDA is likely to raise. The goal is not just to prepare better slides. It is to help the team walk into the FDA interaction clearer, more aligned, and better prepared.
Clarity is best suited for companies developing novel surgical, robotic, AI-enabled, aesthetic, reconstructive, or infection-control technologies where the regulatory path is consequential and not fully routine.