NIBIB, INNOVATION FUNNEL FOR MATERNAL HEALTH -RADx

NICHD与美国国家生物医学成像与生物工程研究所和美国国立卫生研究院主任办公室合作，旨在利用RADx Tech计划的创新漏斗设计--该计划被国家生物医学成像和生物工程研究所用来加快新冠肺炎测试技术的开发、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的开发，这些技术可以降低分娩后第一年(即从分娩之日或怀孕结束)居住在保健沙漠中的个人的SMM/MM。创新漏斗方法使用阶段性门控、基于里程碑的奖励支付来压缩惯常的技术开发时间表。这是通过同时聘用专家团队来满足科学/技术、监管、临床和商业化需求，以通过无缝管道验证、降低风险、扩大规模、制造和部署新型测试来实现的。 本次挑战赛的成功成果可能包括可穿戴设备、支持智能手机的诊断工具、集成传感器技术，以及在家中或在护理地点(POC)使用的诊断设备或测试。创新者提出的解决方案应允许在获得护理提供者的机会有限时继续进行监测，并扩展诊断和监测能力，以支持在必要时及时恢复产妇护理。 产后预测、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)，这些疾病被认为与分娩后第一年或妊娠结束时的高发病率和死亡率有关。

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.