The Clinical AI Product Manager's Handbook
Ten Gates — An Operating Manual
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This title uses virtual voice narration
Virtual voice is computer-generated narration for audiobooks.
Do not read this cover to cover. Open it at the gate you are standing in front of.
This is the operating companion to The Clinical AI Product Playbook. The book argues; this operates. Same ten gates, same frameworks, same vocabulary — no narrative, no persuasion, no first person.
Every module is self-contained. Each framework is defined at the point of use, so you can clear Gate 7 without having read Gates 1 to 6, and without having read the Playbook.
Ten gates, one module each
1 Legitimacy — is this a problem you are allowed to solve at all?
2 Evidence — what may you claim, and what would falsify it?
3 Supply — where does the data come from, and what does it permit you to claim?
4 Architecture — what is the product, as distinct from the model?
5 Trust — what does the system do when it does not know?
6 Adoption — will the recommendation survive a real clinical shift?
7 Regulation — what is your device status, pathway and change plan?
8 Integration — can you get inside the system of record, repeatably?
9 Economics — who pays, for what unit, against what alternative?
10 Disposition — what is this asset for, and can it be transferred?
Three conventions, and twenty-five ground rules
- Hard rules that name their own violation, stated with the template they govern.
- [CALIBRATE: …] markers where a number must be measured in your own organisation. This handbook supplies no benchmarks — base rates in clinical AI are not public, and a fabricated one gets quoted back at you in diligence.
- Six standard roles, used identically in all ten modules, with a RACI per gate.
An operating companion, not legal, regulatory or clinical advice. Regulatory positions stated were current as of August 2026 and should be confirmed against the current instrument before they are relied on.
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