Reports founders can cite in a capital-raise deck or a board memo. Written to a research standard — footnoted, dated, sourced — so you don't have to defend the number when a partner pushes back.
Bringing a product to market has become an economics problem before it is an engineering problem. Regulatory and legal hourly rates have outrun CPI by roughly 12 percentage points over the last decade, and total-cost-to-market for a 510(k) IVD runs $4M–$23M to first meaningful revenue — three to ten times the $1–2M floor most founders start budgeting against. The reports below document each finding with source-level detail a founder can defend at their own capital-raise or in front of a board.
Sourced, dated, footnoted. Every claim is backed by a citation you can carry into a capital-raise deck, a board memo, or a partner-negotiation table.
A realistic accounting of what it takes to bring an In-Vitro Diagnostic from bench to market — the fees, the timelines, the counsel, the labs, the reagents, the FDA/CLIA/CAP overlap, and the surprises. Realistic totals: $4M–$12M for a simple 510(k), $8M–$23M for a novel 510(k) or De Novo, up to $75M+ for a companion diagnostic. Written for founders sizing the raise + operators sizing the runway.
A one-page chart + accompanying analysis showing how legal and regulatory-affairs hourly rates have outrun CPI by ~12 percentage points over the last decade. The pricing pressure founders actually feel when they cost out a submission.