- Essays··10 min read
The Validation Report Nobody Reads at 23:00
Labcorp's nationwide rollout of PathAI's digital pathology platform is technically coherent and operationally incomplete. The press release announces a capability — one that omits the 60-case CAP validation set, the 57% LIS integration failure rate, and the data-drift risk that falls on the lab manager who answers the scanner page at 23:00. The gap between the announcement and a reliable first sign-out is measured in months of workflow redesign, not marketing copy.
digital-pathologyai-in-medicinehealthcare-deploymentlab-operationsRead - Essays··8 min read
The PCCP Constraint
The Predetermined Change Control Plan is FDA's mechanism for letting AI-enabled medical devices update without a new submission. It is not a solution to the adaptive-AI problem. It is a scoping exercise written in advance. The modifications a vendor can ship without re-filing are precisely and only those the engineer defined eighteen months before knowing what the field would ask for.
medical-aifda-regulationpccpdigital-pathologyRead