Smart Health (SH)
The need for a significant healthcare transformation has been recognized by numerous organizations, including the President's Council of Advisors on Science and Technology (PCAST), National Research Council (NRC), Institute of Medicine (IOM), Computing Community Consortium (CCC), the National Academy of Engineering and the Office of the National Coordinator for Health Information Technology (ONC). The Smart Health subtopics aim to support the early stage development of novel devices, components, systems, algorithms, networks, applications, or services that will enable the much needed transformation of healthcare from reactive, hospital-centered, and indemnity-based to proactive, person-centered, preventive, and cost-efficient. The SH subtopics are not aimed at supporting clinical trials, the clinical validation of information technologies, or medical devices or studies 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-of-concept 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.
SH1. Business Models for User-Centered Healthcare
Proposed projects should include transformative business models that are enabled by novel technologies and are designed for the benefit of healthcare providers, consumers, patients and/or their caregivers. Such technology-driven business models will: reduce the cost of health care; facilitate the shift of public and private incentives toward patient-centric goals; empower patients and healthy individuals to participate in their own health and treatment, such as educating customers, accessing, and visualizing health data and knowledge; reduce the impact of socio-economic status, gender, and ethnicity in the participation of people in their own health treatment. Overall, these new business models are expected to improve health-related behaviors; improve patient-physician communication, patient engagement, and care coordination. Proposed projects must a) focus on the development of technology that enables such novel business model(s); and b) demonstrate the expected economic benefit of the novel business model in user-centered healthcare.
SH2. Digital Health Information Infrastructure
Proposed projects may include technologies that will enable: interoperable, distributed, federated, and scalable digital infrastructure; languages and tools for effective sharing and use of electronic health record data, data representation for such including semantic metadata, and networked applications that access such data; continuously extensible universal exchange language for current and future health and wellness data originating from diverse sources in multiple formats; data methods for controlling and maintaining data integrity, provenance, security, privacy, and reliability of original as well as aggregated data, providing trustworthy patient identification and authentication and access control protocols, and maintaining sensitivity to the legal, cultural, and ethical issues associated with universally accessible digital health data in the U.S.; or systems methods for measuring and optimizing operations to improve quality and productivity of healthcare delivery systems. New Medical Cyber-physical systems that reduce disparities in the access to high-quality and cost-efficient healthcare are strongly encouraged.
SH3. From Data to Decisions
Proposed projects may include methods and algorithms that: aggregate multi-scale clinical, biomedical, contextual, and environmental data about each patient (e.g., in EHRs, personal health records - PHR, etc.); enable unified and extensible metadata standards; serve as decision support tools to facilitate optimized patient-centered, evidence-based decisions; evaluate the safety, effectiveness, efficiency, and clinical outcomes of mobile health applications; integrate patient information with delivery systems performance and economic models to support operations management decisions; support inferences based on individual or population health data, multiple sources of potentially conflicting information, while complying with applicable policies and preferences; enable the secondary use of health data to support the assisted and automated discovery of reliable knowledge from aggregated population health records and the predictive modeling and simulation of health and disease. Proposals are encouraged to integrate technological, behavioral, socio-economic, value-driven actions, ethical, and systemic factors that interfere with patients' collaboration in care teams, adherence to treatment, and wellness regimens.
SH4. Interoperability of Health Record Systems, Medical Sensors, Devices and Robotics
Proposed projects may include protocols and interface standards to enable interoperable, temporally synchronized, medical prosthetic and embedded devices and devices for the continuous capture, storage, and transmission of physiological state and environmental data; assistive technology systems and devices for improved health and healthcare that incorporate sensory inputs and computational intelligence ranging from internal and external sensors, wearable prosthetics, and cognitive orthotics to surgical-assist robots and social robots; sensors, analysis tools, and activators needed to assess and limit adverse environmental effects on health and wellbeing; simulation and modeling methods and software tools that aid in the design and evaluation of sophisticated medical devices and how they communicate to medical information systems in the clinic, home, and in and around the person.
Biomedical Technologies (BM)
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-of-concept 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. Biomedical Engineering
Proposed project should focus on using engineering approaches to develop transformative methods and technologies that will solve problems in medicine. Proposed projects may include devices and systems that provide new strategies for the prevention, diagnosis, and treatment of health conditions (such as sensors, actuators, implantable and bioelectronic devices for therapeutic monitoring or diagnostic purposes, theranostics,or electroceuticals); advance end-of-life or palliative care; reduce drug counterfeiting; and enable new and more efficient risk-management methods to better address safety issues of drugs and medical devices; motion or structural biomechanic technologies for the improvement of human motion, and sensors, actuators, and intelligent systems for surgical robotics. Proposers are encouraged to form an interdisciplinary team that includes relevant engineering as well as biology/health-related expertise.
BM4. 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.
BM5. 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.
BM6. 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.
BM7. 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.