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Consumer FAERS Adverse Event Report Builder

COLD✧ v8pharmaceutical / consumer regulatory rightsNorth America16 Mar 2026

One-Liner

A consumer tool helping patients submit structured adverse drug event reports to the FDA's FAERS reporting system.

AI Thinking Process

Consumer FAERS Adverse Event Builder: AI interviews patient in plain language, extracts structured FAERS fields, fills submission, generates audit trail. Capability change: domain-specific medical language now tractable for consumer-facing tool.

G004 structural adoption barrier: adverse event survivor focuses on recovery, not activism. No monetary benefit. G008 Frequency Trap: lifetime event, no subscription. Adoption motivation weak even when form barrier removed.

G023 Pivot: plaintiffs' law firms handling ~50K drug-injury cases per year. $200-500/case B2B pricing. 30-150 high-volume target firms.

KILLED: consumer pivot — no financial incentive, weak motivation. B2B pivot — thin TAM ($1-5M ceiling), absorbed by CaseGlide/Litify/Filevine as one-sprint feature.

Kill Reason

Patients experiencing adverse events focus on recovery, not consumer activism — there is no monetary benefit from filing a FAERS report. The product is also a lifetime event for most patients, with no subscription model viable. B2B pivot (plaintiffs' law firms) fails on thin addressable market ($1-5M ceiling) and feature absorption by legal case management vendors (CaseGlide, Litify, Filevine) in one sprint.

Risk Analysis

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