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与国家生物医学成像和生物工程研究所（NIBIB）和NIH主任办公室合作，旨在利用RADx技术计划的创新漏斗设计-NIBIB用于加速COVID-19测试技术的开发，商业化和实施-以加速诊断设备，可穿戴设备，或其他遥感技术，可以减少居住在产妇护理沙漠的个人在产后第一年（即从分娩之日或怀孕结束）的SMM/MM。创新漏斗方法使用阶段门控，基于里程碑的奖励支付来压缩传统的技术开发时间轴。这是通过并行地采用专家团队来解决科学/技术、监管、临床和商业化要求以通过无缝管道来验证、去风险、按比例放大、制造和部署新颖的测试来实现的。 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用于家庭或护理点（POC）的诊断设备或测试等技术。创新者产生的解决方案应允许在获得护理提供者的机会有限时进行连续性监测，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），这些疾病被认为与分娩后或妊娠结束后第一年期间的高严重发病率和死亡率相关。