Sigil AI offers a library of synthetic clinical agents that simulate human users—including cognitive, motor, and visual impairments—to run thousands of formative usability tests on medical device software automatically.
Funding
Funding not disclosed
Founders
Product
Problem
Medical device developers must demonstrate safety through extensive usability testing, but recruiting specialized clinicians is time‑consuming, costly, and often fails to capture realistic user errors, creating bottlenecks in FDA compliance and product launch timelines.
Solution
Sigil AI provides a library of synthetic clinical agents that emulate human users with cognitive, motor, and visual impairments. These agents interact with device software interfaces at scale, generating thousands of formative usability test runs automatically. Each interaction is logged, and the platform flags hazard‑related use scenarios while producing ISO 14971‑compliant risk documentation. By replacing manual clinician recruitment, Sigil AI accelerates safety validation, reduces testing costs, and helps teams de‑risk FDA submissions without sacrificing realism.
Target Audience
Primary customers are medical device manufacturers and software teams that need to conduct formative usability studies and meet IEC 62366‑1 compliance for FDA submissions.
Features
- Synthetic agents model memory limits, distraction, and instruction forgetting to reproduce human error patterns
- Motor impairment simulation uses Fitts’ Law algorithms to inject tremor and neuropathy effects into cursor movements
- Visual processing module evaluates contrast, target size, and layout readability from a pixel‑level perspective
- Automated logging of every click, hesitation, and error with real‑time hazard flagging
- Built‑in generation of ISO 14971 risk linking, use‑error logs, and formative study protocols for risk management files
- Scalable execution of thousands of usability scenarios overnight, enabling rapid iterative testing