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Published 24 August 2026

Author(s): Komodo Health

You've seen it before: an AI pilot that works in testing, then stalls the moment someone asks you to reproduce the result. The cause usually isn't the model—it's what wasn't built around it.

Komodo Health built this framework from its deployments at Genmab and Ipsen, identifying three components that separate AI that scales from AI that stalls: reproducible methods, modular workflows, and governance built to keep pace with regulation.

FDA guidance is tightening. EU AI Act enforcement is approaching. Build this infrastructure now, and you can prove compliance the moment someone asks. Wait, and you'll retrofit it under pressure.

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