Your Regulatory Team is Doing Everything Right. That May Be the Problem.
Binita S. Ashar, MD, MBA, FACS, MAMSE · Founder, Clarity Surgical Advisors · Former FDA Office Director
The most experienced regulatory teams know how to read precedent. They know which predicates were accepted, how FDA has historically evaluated similar technologies, and which arguments have worked before.
That expertise matters. But in surgical robotics, aesthetic and reconstructive devices, and other technologies where performance depends on workflow, user technique, software, or complex clinical context, precedent is only a starting point.
These products don't fit neatly into what came before. The comparator may be imperfect. The endpoint may not capture what actually matters in use. The failure modes may not resemble those of prior devices in the category. And the regulatory questions may have less to do with what FDA accepted before than what this specific technology will do in actual clinical practice.
Over twenty-five years at FDA, I saw sophisticated companies make the same mistake:
They mistook regulatory precedent for how FDA will evaluate risk, use, and evidence for their device.
That is where otherwise strong programs begin to drift. It shows up as questions the team did not anticipate, requests for data that do not seem to follow precedent, or late recognition that the evidentiary story and the clinical reality were never fully aligned.
The companies that navigate this well are not simply the ones with deep knowledge of prior submissions. They are the ones that can assess the product the way FDA will: this device, these claims, these users, these risks, and this clinical setting.
For genuinely new technologies, that distinction matters.
The problem was that no one in the room could see the whole picture.
Binita S. Ashar, MD, MBA, FACS, MAMSE · Founder, Clarity Surgical Advisors · Former FDA Office Director
In twenty-five years at FDA, I reviewed surgical device submissions from some of the most sophisticated companies in the world. Companies with deep regulatory teams, experienced clinical investigators, and genuine scientific innovation behind their technology.
The submissions that failed were the ones where something wasn't aligned. The clinical evidence told one story. The intended claims told another. The proposed labeling reflected how the device performed in a controlled study setting, not how it would actually be used in a community hospital on a Tuesday afternoon. The regulatory pathway assumed a level of clinical consensus that didn't yet exist in the real world.
Individually, each piece looked reasonable. Together, they didn't hold.
What made these situations particularly difficult was the denial phase. Someone in the organization usually sensed the problem. A VP of Regulatory Affairs who couldn't quite articulate why the FDA feedback felt off. A clinical lead who privately worried the study population didn't reflect real surgical practice. A CEO who had been told everything was on track and had no reason to question it.
But sensing a problem and being able to name it clearly enough to interrupt a program that has momentum, budget, and internal champions are two entirely different things. Most organizations don't have someone in the room with the independence, the authority, and the specific pattern recognition to say: this isn't going to hold together the way you think it is. And even when they do, that person often can't get the room to move until the consequences are already arriving.
By the time a company came to FDA with a submission that had this kind of misalignment embedded in it, the path to resolution was almost always longer and more expensive than it needed to be. Not because FDA was unpredictable. But because the earlier decision points had already passed.
I left FDA to work on the other side of that dynamic. The situations I find most useful to engage with are the ones where someone already suspects something isn't right, where the program is at a consequential decision point, or where a company needs a view from outside the room that isn't attached to any internal narrative about how things are supposed to go.