Executive Summary
Regulatory failure has cascading effects far beyond the sponsor at the center of a rejected submission. Because U.S. clearance increasingly serves as a leading indicator for international market access, an FDA delay can ripple into delayed availability in Europe, Japan, and emerging markets — affecting patient access at global scale.
Approximately 75% of medical device startups fail before reaching market, with regulatory friction a significant contributor. One-third of 510(k) submissions fail their initial Refuse-to-Accept screening. And 20% of 510(k) clearances rely on predicate devices that are over a decade old — a quiet drift that undermines the substantial-equivalence framework's intent.
This paper examines the systemic costs of regulatory inefficiency, and argues that closing the execution gap is itself a public-health intervention.
Key Findings
- Approximately 75% of medical device startups fail before reaching market, with regulatory friction a primary contributor.
- One-third of 510(k) submissions fail their initial Refuse-to-Accept screening.
- 20% of 510(k) clearances rely on predicate devices that are more than 10 years old.
- U.S. FDA clearance increasingly serves as a leading indicator for international market access — delays compound across jurisdictions.
- Predicate drift quietly undermines the substantial-equivalence framework intended to streamline device clearance.
Read the full analysis
The full white paper — including methodology, source citations, and detailed analysis of each finding — is available as a downloadable PDF.