Precedent will only take you so far. FDA is thinking about your technology.
Binita S. Ashar, MD, MBA, FACS, MAMSE · Founder, Clarity Surgical Advisors · Former FDA Office Director
The most experienced regulatory teams in the surgical device industry are very good at reading precedent. They know which predicates were accepted and why. They know how FDA has historically evaluated evidence for their device category. They have deep institutional knowledge of what has worked before.
That expertise matters. For a certain class of technology, though, it is not enough.
Surgical robotics, AI-enabled devices, advanced energy platforms, technologies that sit at the intersection of software and surgical practice — these don't fit cleanly into what came before. The predicates are partial at best. The clinical workflow is different. The failure modes are different. The questions FDA will ask are not the questions it asked about the last device in the category.
Over twenty-five years at FDA, I watched sophisticated companies with strong regulatory teams fall into the same pattern. The team builds its strategy around what FDA has accepted before. They study the landscape carefully, identify the strongest predicates, and construct an argument grounded in that history. It is a reasonable approach. Often it is the wrong one.
"FDA is not thinking about what it accepted before. It is thinking about what your technology actually does, and what happens when something goes wrong."
FDA is not thinking about what it accepted before. It is thinking about what your technology actually does, and what happens when something goes wrong in the hands of a surgeon who trained on something different, at a hospital that adopted it six months ago, in a patient population that looks nothing like your study cohort.
That gap between what precedent suggests and what the technology actually requires is where strategies come apart. Not all at once. It shows up as unexpected questions, requests for additional data, feedback that feels inconsistent with the precedent the team was relying on.
The companies that handle this well are not necessarily the ones with the deepest knowledge of prior submissions. They are the ones who have someone in the room who thinks the way FDA thinks about new technology — not about the history of the device category, but about this device, these claims, and this evidence.
For technologies that are genuinely new, that is the preparation that matters.
I work with surgical device companies, including those managing complex multi-product portfolios, as a strategic advisor at moments where regulatory strategy needs to reflect not just what has worked before, but what a specific technology will actually require. If this describes a conversation worth having, please contact me.