R--National Institute of Biomedical Imaging and Bioengineering (NIBIB) Innovation

The National Institute of Biomedical Imaging and Bioengineering (NIBIB) has issued a Sources Sought notice under solicitation 75N98027R00015 to identify capable providers for the Innovation Funnel Clinical Validation Core. The objective is to secure independent third-party technical, analytical, human factors, and clinical validation services to assess prototype diagnostic devices, recommend optimizations, and support regulatory filings. Key requirements include the capacity to conduct at least 50 analytical or clinical validation studies within a 12-month period, access to BioSafety Level 2 or greater facilities, and the ability to prospectively collect human clinical samples and manage biobanks. Interested respondents must submit a capability statement not exceeding five pages, using at least 12-point font, by December 4, 2026. The evaluation will focus on documented experience from the past three years, a demonstrated process for collaborating with inventors and regulatory experts, and up-to-date knowledge of FDA regulatory guidance for the diagnostic industry. Submissions must include professional CVs for technical and medical experts, descriptions of available facilities and equipment, and administrative details such as SAM registration and UEI numbers. Legal support for non-disclosure and material transfer agreements is also required.