The National Cancer Institute (NCI) recently released 16 Small Business Innovation Research (SBIR) funding opportunity topics under the PHS 2022-1 Contract Solicitation. The NCI’s SBIR Development Center worked with the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) to introduce two opportunities to support the development of innovative medical device development tools (MDDTs). Awarded projects will be able to apply to the FDA’s MDDT program, which aims to bridge the gap between the research of medical devices and the delivery of devices to patients.

Topic 442. Quantitative Biomarkers as Medical Device Development Tools for Cancer

Potential examples include new/high-resolution multimodal imaging as biomarkers for detection of various melanomas or difficult to biopsy tumors, or laboratory-based biomarker tests to be used to help regulatory evaluation of diagnostic and therapeutic medical products.

Topic 444. Evaluation Datasets as Medical Device Development Tools for Testing Cancer Technologies

Potential datatypes of interest cover a broad range of data produced by medical devices, especially datasets to evaluate artificial intelligence software, and include imaging (radiology and pathology), cancer genomics, proteomics, structured data extracted from unstructured EHR, and treatment outcome data.

NCI SBIR Development Center and FDA are holding a joint information session to discuss these funding opportunities, the FDA’s MDDT program, and SBIR eligibility criteria. Join experts from the NCI and FDA on Tuesday, August 24, 2021, from 2 to 3 p.m. Eastern Daylight Time.