What You'll Learn
This comprehensive guide reveals the 10 patterns most predictive of medical device commercialization failure, regulatory delay, and market underperformance.
Each red flag includes:
- Real-world context from our case studies
- Specific indicators you can identify early
- Failure correlation data and probability estimates
- Strategic implications for decision-making
The 10 Red Flags:
- Reimbursement Strategy Developed After Regulatory Submission
- Single-Site Clinical Evidence for Multi-Site Adoption Claims
- Founder-CEO With No Prior Regulatory Experience
- Manufacturing Partner Selection Before Design Lock
- Market Size Projections Based on Diagnosis Prevalence
- No Physician Champion or Clinical Advisory Board
- Competitive Analysis That Ignores Off-Label Use
- Regulatory Pathway Selection Based on Speed, Not Strategy
- Burn Rate Exceeds 18 Months Before Revenue Generation
- Quality System Designed for Compliance, Not Scale