Automated HEOR platform combining LLM analysis with MDR/EMA compliance workflows, reducing drug reimbursement submission risks through AI-validated protocols and blockchain audit trails.
GenerativeHEOR addresses the €650M EU health economics outcomes research market by automating compliance-critical workflows through specialized AI. The platform cuts pharmaceutical companies’ study approval timelines by 40% while ensuring real-time adherence to evolving Article 81 MDR requirements through integrated protocol validation and blockchain-secured audit trails.
Core Functionality
Combines three regulatory AI engines:
- Real-time documentation validation against EUDAMED API standards
- Protocol reproducibility scoring with version-controlled templates
- Blockchain-powered audit trails meeting EMA Annex 15 requirements
Target User Segment
Mid-large pharma HEOR teams (€500M+ revenue companies) and medical device manufacturers preparing CE Mark submissions. Initial focus on DACH region holding 30% of EU HEOR spend.
Recommended Tech Stack
- Compliance Core: Python rules engine + EUDAMED API integration
- AI Layer: Fine-tuned BioMedLM with proprietary health economics corpus
- Data: HIPAA-ready PostgreSQL + Hyperledger audit layer
- Frontend: React dashboard with Jupyter integration
MVP Development Costs
€100-160k total investment:
- 800-1,200 dev hours (€80-120k)
- 200-400 compliance certification hours (€20-40k)
SWOT Analysis
Strengths: First-mover regulatory AI • Pharma’s urgent compliance needs
Weaknesses: Dependency on EU policy changes • Legacy consultancy resistance
Opportunities: €2.1B medical device research expansion • SaaS model for biotechs
Threats: Open-source LLM alternatives • Delayed AI validation standards
Customer Acquisition Strategy
Three-phase approach:
- €15k/mo LinkedIn ABM targeting HEOR directors
- Co-marketing with compliance consultancies (15-20% rev share)
- Freemium model: Free reproducibility scoring → €8k/mo compliance features
CAC: €2,800-3,500/seat with 7% free-to-paid conversion
Monetization Model
- Tiered subscriptions (€8k-25k/mo)
- Break-even at 42 enterprise clients (€1.05M ARR)
- Core team: 5 FTEs (€460k/yr)
Market Positioning
Differentiates from manual HEOR consultancies through 40% faster approval cycles. Targets 11.4% CAGR market via EMA partnerships while Palantir/ICON lack specialized MDR automation.
