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 Context
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.
Catalyst / Timing
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
Projected Yield
$1,995/package × 5 sales = $9,975 (minimum viable)
Structural Friction
• Vulnerability: 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 • Capital yield: $1,995/package × 5 sales = $9,975 (minimum viable) • Resource capture: Proprietary template library validated against actual SBIR requirements • Influence capture: Authority position as the 'SBIR clinical validation' expert for microfluidic devices • Sovereignty yield: First-mover in niche regulatory template market for microfluidic SBIR projects • Required vectors: Vector: FOIA & Government Document Analysis, Vector: Clinical Research Protocol Writing
Required Capabilities
Vector: FOIA & Government Document Analysis
Primary executor: Phase 1: FOIA Submission for Clinical Protocol: Submit FOIA request to NSF for DELEON TECHNOLOGIES SBIR Phase I proposal
Vector: Clinical Research Protocol Writing
Supporting vector for: FOIA SBIR Human Subject Protocols into IRB Validation Package
Execution Protocol
Execution Protocol Locked
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