Free email sprint · 3 days
Build your FDA pathway argument — and find the one feature that forces a harder pathway — in 3 prompts, over 3 days.
“Generative” doesn't force De Novo. What forces a harder, slower pathway is letting the model hold the clinical decision — and the teams that clear fastest bound the AI around a deterministic core and ride a predicate. This sprint builds that argument for your device, then finds the feature most likely to break it.
- Three short emails, one prompt each — run in your own AI platform, against your own device.
- You leave with a drafted pathway argument and your single biggest pathway risk.
- Written by Ross Prior (Saolyn), from The State of AI in Medical Devices 2026 with Kelly Coverdale (Cover Biomedical).
Start the sprint
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What the three days cover
- 1
Map where your model actually decides
The pathway turns almost entirely on whether the AI holds final clinical-decision authority, or whether a deterministic rule or a human sits between the model and the patient. Day one maps your device function by function and finds where, if anywhere, it decides unsupervised.
- 2
Build the pathway and the predicate case
A named pathway, and the part teams hand-wave: the legally-marketed device you're substantially equivalent to, on what grounds, and the evidence a reviewer will expect. “Probably a 510(k)” is not a strategy.
- 3
Find the pathway-breaker, and bound it
The single feature most likely to force a harder, slower route — and a concrete way to wrap it around a deterministic or human-supervised step, with the trade-off named rather than discovered in review.