The most senior medical-device regulator in the country spent most of fifteen years deciding which products reached patients and which ones went back for more data. This week he took a seat on the other side of the table. Dr. Jeffrey Shuren, who ran the FDA’s device center, joined the accelerator MedTech Innovator as an advisor to early- and mid-stage startups. My read is that this is genuinely good for founders, and the reason is narrower than the announcement makes it sound. An insider sharpens how you read the agency’s signal. He does not take the hardest part of the work off your desk.
What an insider changes
MedTech Innovator runs the largest accelerator for device, diagnostic, and digital-health companies, and it brought Shuren on to advise on regulatory strategy, policy trends, and market access. Its CEO, Paul Grand, said the point was to help portfolio companies avoid costly delays. That is the right word. Delays.
Most founders treat an FDA interaction as a question-and-answer session. You ask, the agency answers, you proceed. It does not work that way. A pre-submission meeting is closer to a strategy presentation. You are showing the agency how you intend to define the product, and in how it responds, the agency is showing you where it thinks the risk sits. The skill is reading that signal correctly. Misread it and you can spend a year building tests around a premise the agency was quietly waving you off of. Someone who sat in that chair for years reads it the way you read your own native language. That is the genuine saving here, and most of it is the money you would have burned walking down the wrong path.
What it can’t change
There is a line an advisor cannot cross for you, and I learned where it sits the hard way. At Galen, we ran a pre-sub for our de novo. We told the FDA we would do a 16-subject cadaver study with residents and show that the robot let them nail the maneuvers that are hard to do by hand. The agency wrote back: sounds great, go for it. We ran the study, submitted it, and in substantive review the first question was whether we planned to market to residents. The thing they had approved in writing two months earlier was now the thing they were questioning.
So I went to Johns Hopkins with my hat in my hand. I got a free OR and cadaver heads, and I re-ran the whole study with 16 attending surgeons in two weeks. One was a last-minute fill-in, an otolaryngologist who does balloons and tonsils and will never do microsurgery freehand. She nailed a microsurgery skills test she had failed as a resident. That one data point was the strongest evidence we had that the device did what we claimed. But notice what no advisor could have done for me. The study population was our claim to own, and a pre-sub yes did not bind the team that reviewed the file months later.
The part you still own
Here is the distinction that matters whenever you put a regulatory heavyweight on your board or your cap table. The framing of the product is product strategy, and it belongs to you, not to the regulatory team. Galen could have been defined two ways: as a remote-control telemanipulator competing with da Vinci, or as a stabilizer that improves a surgeon’s access at the end of a 40-centimeter instrument. Same hardware. The first framing invites a clinical-outcomes trial and a high evidence bar. The second invites an engineering and usability bar that is cheaper, faster, and far easier to control. And that one decision sets everything downstream: the indication language, the study population, the predicate logic, the marketing claims you can make after clearance. Every one of those has to stay consistent with the framing, or the file falls apart. An advisor like Shuren can tell you how a reviewer will read your framing. He cannot pick it for you. If a consultant is picking it, you have the wrong person in the product seat.
Dave’s take
The founders who get the most from a regulator-turned-advisor are the ones who walk in already owning their framing and use the access to test how the agency will read it. The ones who get the least are hoping to hand the whole problem to a famous résumé. Access reads the signal. It does not write your product definition, and the product definition is the document that decides whether the rest of the file holds together.
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Dave Saunders is the founder of Base Reality Group and a Fractional CPO for hard-tech founders. He was a founder and operator at Galen Robotics, where the surgical-robotics platform earned FDA De Novo authorization in 2023, and he managed a 35-patent portfolio licensed from Johns Hopkins. He wrote Founders Who Finish and publishes The Build. More about Dave →