Discovery Lens
C Combination Innovation
Two separate worlds finally connect — and the intersection is a product
One-Liner
A submission and documentation tool for FDA's Predetermined Change Control Plan requirements for AI-powered digital therapeutics.
AI Thinking Process
Spun off from T7 pivot. FDA finalized the Predetermined Change Control Plan guidance for AI/ML-enabled medical devices and digital therapeutics in 2024-2025. PCCP requires manufacturers to document every planned algorithm update in advance — a new compliance workflow with no established tooling. Initial pass1 conviction: 45%.
SURVIVED pass1 at 45% — regulatory wedge is real, PCCP guidance is new, buyer (DTx manufacturers) is identifiable. Memory-based competitor scan surfaced no direct PCCP tool. Queued for pass2 targeted verification.
Pass 2 targeted web verification of MedTech regulatory platform product pages: Complizen.ai — PCCP-anchored product page live as of 2026. Ketryx — PCCP compliance module live. Greenlight Guru — 5,000+ customers, active PCCP content marketing and roadmap. All three are direct competitors that Pass 1 memory scan missed because they are not in general AI training data as 'PCCP tools.'
KILLED: incumbent miss. Market is partially served and rapidly closing. Pattern: MedTech regulatory platforms must always be checked by product page, not memory recall. G160 candidate: Pass 2 must run targeted web verification on vertical-specific regulatory platform vendors.
Kill Reason
Complizen.ai and Ketryx both have PCCP-anchored product pages live in 2026 — direct competitors Pass 1 missed. Greenlight Guru is an absorbing incumbent with 5,000+ existing medical device customers and active PCCP content marketing. The PCCP submission tooling market is partially served and rapidly closing.
Risk Analysis
Risk analysis available for latest engine ideas.
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killed: Google Nest Hub's built-in Soli radar-based sleep sensing already delivers contactless respiratory monitoring in millions of households, and Withings has shipped FDA-cleared sleep apnea screening hardware. A standalone $30 WiFi module cannot match the distribution, brand trust, or regulatory standing of these well-resourced incumbents.
killed: Urine and stool analysis for glucose monitoring, cancer screening, and kidney function markers falls squarely into FDA Class II/III medical device territory, requiring clinical trials and 510(k) or PMA approval costing millions and taking years. The entire high-value use case — the reason anyone would buy this — is legally undeliverable without regulatory clearance the product cannot realistically obtain.