Multi-Agent FDA Breakthrough Device (BDD) Solver

Underwrite deploying multi-agent AI systems analyzing clinical trial outcomes and standard-of-care deficits to draft formal FDA Breakthrough Device Designation requests.

Clients & Breakthrough SOWs

Active MedTech Breakthrough Retainer Clients

Monthly Priority Review Monitoring Retainer ($ / client / mo)

Custom Enterprise BDD Petition Builds / Year

Average Petition Build SOW Fee ($ - e.g. $75,000)

Annual Consulting Financials

Annual Gross MedTech AI Regulatory Billings

$996,000 / yr

Net AI Specialist Pre-Tax Take-Home Income

+$934,400 / yr (93.8% Margin)

Predictable Monthly Priority Retainer MRR

$58,000 / mo