The Food and Drug Administration awarded a $12 million definitive contract to The Medical Device Innovation Consortium for enhancing infrastructure for real-world data sources and real-world evidence generation in medical devices on September 30, 2026, under a firm fixed-price structure with no set-aside.
The award derives from the FY26 FDA Broad Agency Announcement for Advanced Research and Development of Regulatory Science, posted November 21, 2025, which solicited basic and applied research and development proposals to support regulatory science and innovation across FDA-regulated domains. The originating BAA emphasized three charge areas: modernizing the development and evaluation of FDA-regulated products, strengthening post-market surveillance and labeling, and invigorating public health preparedness and response. Place of performance is Arlington, VA. The contract extends through September 29, 2028.
The Medical Device Innovation Consortium, a nonprofit organization, operates exclusively as a prime contractor with no subcontract engagement. SCI-reported invoiced revenue on federal service contracts above $150,000 totaled $12.3 million across FY2022–FY2024, delivered by a team of approximately 7 to 8 FTEs in FY2023 and FY2024. Government-paid hourly rates on SCI-reportable prime contracts ranged from a 10th percentile of $120.08 per hour to a median of $200.70 per hour. The vendor's customer base is monolithic, with all recent awards derived from the FDA's Center for Devices and Radiological Health, reflecting specialization as an FDA technical partner.