FOIA SBIR Human Subject Protocols into IRB Validation Package
- Organization
- NSF SBIR program funding medical device R&D with human subject components but no regulatory template support
- Sector
- SBIR microfluidic PIs facing imminent human subject research requirements
- Location
- Location unspecified
Source reference
Executive summary
Current state
NSF awarded DELEON TECHNOLOGIES $305K SBIR Phase I funding to develop a disposable microfluidic chip for urine analysis, creating a classic "SBIR Valley of Death" scenario where government-funded technical capability exists without commercial infrastructure for FDA clearance, manufacturing scale, or data monetization.
Market catalyst
SBIR microfluidic projects involving human subject research (like DELEON's urine analysis) must navigate IRB approvals and FDA protocols but lack standardized templates - each PI reinvents the wheel at high cost and risk of rejection
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