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.