The Biomedical Technologies subtopics aim to support the early stage development of novel products, processes, or services that will enable the delivery of high-quality, economically-efficient healthcare in the U.S. as well as globally. The BM subtopics are not aimed at supporting or conducting clinical trials, clinical efficacy or safety studies, the development pre-clinical or clinical-stage drug candidates or medical devices, or work performed primarily for regulatory purposes. Limited studies with human subjects may be acceptable to the extent that they are performed in support of feasibility, proof-ofconcept studies of early-stage technologies. Proposals that request support for clinical studies will be deemed non-compliant with the SBIR/STTR solicitations and may be returned without review.
BM1. Pharmaceutical Manufacturing
Proposed projects must include new processing or manufacturing devices, components, and systems that will improve the efficiency, competitiveness, and output of the nation's pharmaceutical manufacturing sector; that will reduce the cost, risk, and time-to-market of new pre-clinical and clinical-stage drugs and biological products; or that address major market opportunities in the developing world. Proposed projects may include transformative approaches and methods in manufacturing operations, project management, process development, process engineering, analytical development, or quality control and assurance. Proposals are strongly encouraged to address the net preservation and extension of natural resources, a reduction in the use or release of toxic or harmful constituents, the use of less extreme temperatures or conditions, or a reduction in the production of waste.
BM2. Materials for Biomedical Applications
Proposed projects may include biological materials, biomimetic, bioinspired, bioenabled materials and synthetic materials, all intended for biological, medical, veterinary, or healthcare applications. Examples of proposals may include (but are not limited to) the synthesis, purification, functionalization, characterization, development, validation, processing, scale up, and manufacturing of biomaterials. Novel polymeric materials, polymers, plastics, additives, sealants, elastomers, textiles, alloys, ceramic and composite biomaterials, improved implants; coatings for therapeutic applications; or nanomaterials.
BM3. Noninvasive Imaging of Brain Function
Proposed projects may include novel, noninvasive technologies and instrumentation for imaging the structure and function of the in vivo human brain. Proposed projects should focus on developing engineering, multidisciplinary, or multi-modality noninvasive brain imaging tools that could overcome current limitations of existing techniques (such as, for example, constraints on subject motion during imaging, requirements for elaborate electromagnetic shielding from the environment, requirements for active cooling of imaging system sensors, and system resolution that is much coarser -millimeter to centimeter scale- than that required to detect activity corresponding to individual neuronal signaling). Projects may also be aimed at developing new data processing techniques or approaches to data interpretation. Technologies not aimed at brain imaging must be submitted under subtopic BM6.
BM4. Medical Imaging Technologies
Proposed projects may include (but are not limited to) novel or improved imaging technologies and/or imaging agents to advance the diagnosis and treatment of disease, and to improve prognosis. Technologies aimed at brain imaging should be submitted under subtopic BM5.
BM5. Diagnostic Assays and Platforms
Proposed projects should focus on transformational diagnostic technologies. Proposed projects may include (but are not limited to) non- or minimally-invasive sensing, the detection, screening, diagnosis, prognosis and monitoring of syndromes and diseases, software based diagnostic methods, biomarker development, disease-specific assays, personalized medicine, flexible implantable devices, lab-on-a-chip technologies, and low-cost point-of-care testing for diseases. The following projects are strongly encouraged: New technological paradigms to advance personalized medicine, precision medicine, and the diagnosis and management of rare diseases, neurological conditions and disabilities.
BM6. Drug Delivery
Proposed projects may include novel, early-stage, and transformative platforms, chemical formulations, excipients, devices, or methodology for the delivery of drugs or biological products.