High-Impact Technology Demonstration Evidence Ladder

High-Impact Technology Demonstration Evidence Ladder

A demonstration can establish that an event occurred under selected conditions. It cannot, by itself, establish repeatability, robustness, usability, safety, operational readiness, or broad benefit.

The evaluation ladder used by this package separates seven questions. Existence asks whether the claimed event occurred. Repeatability asks whether it can happen again under recorded conditions. Robustness asks what happens when inputs, environments, users, or hardware change. Usability asks whether intended users can complete a meaningful job over time. Safety asks what failures and affected parties have been considered. Deployment asks whether maintenance, access control, monitoring, incident response, and accountable ownership exist. Adoption asks whether the system provides enough value within its real costs and constraints.

The ladder is a Venture Step synthesis. NIST's AI Risk Management Framework supports continuous governance, mapping, measurement, and management rather than one-time confidence from a demo. OSHA's robotics overview shows why non-routine work such as setup, maintenance, and testing belongs in the evidence record for physical systems. FDA's implanted BCI guidance illustrates the separate nonclinical and clinical questions that apply to investigational implanted devices.

The method does not replace a regulator, clinical investigator, safety engineer, accessibility specialist, operator, procurement process, or affected user. It is a routing tool that identifies what the selected demonstration did not answer and names the next evidence threshold.