NIBIB, INNOVATION FUNNEL FOR MATERNAL HEALTH -RADx

NIBIB，孕产妇健康创新漏斗 -RADx

• 批准号: 10710441
• 负责人: MARK MARINO
• 金额: $ 33.8万
• 依托单位: VENTUREWELL
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-01 至 2024-02-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10710441
• 关键词: Address; Award; COVID-19 testing; Cardiomyopathies; Cardiovascular Diseases; Caring; Cellular Phone; Clinical; Detection; Development; Diagnosis; Diagnostic; Diagnostic Equipment; Diagnostic tests; Health Services Accessibility; Hemorrhage; Home; Individual; Maternal Health; Maternal Health Services; Maternal Mortality; Mental Health; Monitor; Morbidity - disease rate; National Institute of Biomedical Imaging and Bioengineering; National Institute of Child Health and Human Development; Output; Postpartum Depression; Postpartum Period; Pregnancy; Pregnancy Outcome; Prize; Publications; Publishing; RADx; RADx Tech; Risk; Sepsis; Speed; Technology; Testing; Time; TimeLine; United States National Institutes of Health; Vision; base; care providers; commercialization; design; diagnostic technologies; diagnostic tool; innovation; mortality; novel; payment; point of care; programs; remote sensing; scale up; sensor technology; severe maternal morbidity; technology development; wearable device

NICHD, in partnership with the National Institute of Biomedical Imaging and Bioengineering (NIBIB) and the NIH Office of the Director, aims to leverage the RADx Tech program’s innovation funnel design—which was used by NIBIB to speed the development, commercialization and implementation of COVID-19 testing technologies—to accelerate the development of diagnostic devices, wearables, or other remote sensing technologies that can reduce SMM/MM for individuals residing in maternity care deserts during the first year of the postpartum period (namely, from day of delivery or end of pregnancy). The innovation funnel approach uses stage-gated, milestone-based award payments to compress the customary technology development timeline. this is accomplished by employing, in parallel, expert teams to address scientific/technical, regulatory, clinical, and commercialization requirements to validate, de-risk, scale up, manufacture, and deploy novel tests through seamless pipeline. Successful outputs from this Challenge may include technologies such as wearable devices, smartphone-enabled diagnostic tools, integrated sensor technologies, and diagnostic devices or tests for use at-home or at the point-of-care (POC). Solutions generated by innovators shall allow continuity of monitoring when access to care providers is limited and extend diagnostic and monitoring capabilities to support timely return to maternity care when necessary. Priority conditions for prediction, detection, diagnosis, and monitoring during the postpartum period may include cardiovascular diseases (such as cardiomyopathies), hemorrhage, sepsis, and mental health conditions (such as postpartum depression), which are recognized as associated with high rates of severe morbidity and mortality during the first year after delivery or end of pregnancy.

NICHD 与美国国家生物医学成像和生物工程研究所 (NIBIB) 以及 NIH 主任办公室合作，旨在利用 RADx Tech 项目的创新漏斗设计——NIBIB 使用该设计来加速新冠病毒的开发、商业化和实施-19 种测试技术——加速诊断设备、可穿戴设备或其他遥感技术的开发，这些技术可以在第一年减少居住在产科护理沙漠中的个人的 SMM/MM产后期（即从分娩之日或怀孕结束），创新漏斗方法使用分阶段、基于里程碑的奖励支付来压缩通常的技术开发时间表，这是通过并行雇用专家团队来解决的。通过无缝管道验证、降低风险、扩大规模、制造和部署新颖测试的科学/技术、监管、临床和商业化要求。 本次挑战赛的成功成果可能包括可穿戴设备、智能手机诊断工具、集成传感器技术以及家用或护理点 (POC) 使用的诊断设备或测试等技术。在获得护理人员的机会有限时允许持续监测，并扩展诊断和监测能力，以支持在必要时及时返回产妇护理。 产后期间预测、检测、诊断和监测的优先条件可能包括心血管疾病（如心肌病）、出血、败血症和精神健康状况（如产后抑郁症），这些疾病被认为与严重的高发病率相关。分娩后或妊娠结束后第一年的发病率和死亡率。