The Rapid Acceleration of Diagnostics Technology for Maternal Health Challenge will award up to $8 million in prizes to accelerate the development of home-based and point-of-care (POC) maternal health diagnostic devices, wearables, or other remote sensing technologies. Successful technologies will enable extension of care (e.g., empower individuals with actionable health information they can use to inform their decisions about when to seek additional care) and ultimately reduce severe maternal morbidity and maternal mortality (SMM/MM) for individuals residing in maternity care deserts during the first year of the postpartum period (from day of delivery or end of pregnancy). Innovators participating in this challenge will submit a proposal describing in detail their prototype technology, anticipated clinical impact, and plans for continued development. These proposals will be reviewed during the Viability Assessment Phase from which selected winners will advance to the Deep Dive Assessment Phase. During the Deep Dive Phase, a Project Team of healthcare technology commercialization and content experts will engage directly with each Innovator to assess the prototype technology across defined Evaluation Criteria and will work with NIH to identify key risk factors for accelerated development and implementation and establish milestones that mitigate these risks, subject to final decisions by NIH. Innovators selected in the Deep Dive Phase will receive a cash prize and advance to the Technology Assessment Phase where they will rapidly de-risk their technologies with in-kind technical, clinical, and commercialization support and compete for an additional cash prize for successful milestone completion. At the end of the Technology Assessment Phase, Innovators will submit their technologies for independent testing and verification of performance and usability. Those Innovators whose technologies successfully complete the final phase will be rewarded with a cash prize and connected to NIH-funded research networks and centers to explore collaborations on their own. Winners are encouraged to apply for additional NIH funding to continue development of their technologies, but such funding is not guaranteed and is subject to the standard competition and application requirements of the relevant funding opportunity announcements. The RADx Tech for Maternal Health Challenge is part of the NIH Implementing a Maternal health and PRegnancy Outcomes Vision for Everyone (IMPROVE) Initiative which supports research focused on reducing preventable causes of maternal deaths and improving health for women before, during, and after delivery.
Subject of the Challenge
RADx® Tech for Maternal Health Challenge
The National Institutes of Health, through the IMPROVE Initiative, is launching the RADx Tech for Maternal Health Challenge to accelerate the development of home-based and point-of-care maternal health diagnostic devices, wearables, or other remote sensing technologies to enable extension of care and improve health outcomes in maternity care deserts. This program will focus on the first year of the postpartum period (that is, 365 days from the day of birth or end of pregnancy). Solutions generated by the innovation funnel 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. Technologies developed through the RADx Tech for Maternal Health Challenge are intended to be used either by the postpartum individual themselves or caregivers (i.e., in at-home setting), or by a healthcare technician/provider in direct interaction with the postpartum individual in a community or distributed healthcare setting. Of note, although the RADx Tech for Maternal Health Challenge is focused on solutions for the postpartum period, it is likely that some of the technologies developed for this challenge may also have potential applicability in the continuum of care of maternal health (e.g., from preconception, throughout pregnancy, and perinatal period), and Innovators may also be eligible to apply for NIH funding through other relevant funding opportunity announcements within and outside the NIH IMPROVE Initiative.
Priority conditions for prediction, detection, diagnosis, and monitoring during the postpartum period include cardiovascular diseases (such as cardiomyopathies), hemorrhage, sepsis, and mental health conditions (such as postpartum depression and psychosis), which are recognized as associated with high rates of severe morbidity and mortality during the first year after delivery or end of pregnancy. Successful outcomes for this program 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). Technologies for use at the POC should be deployable across distributed healthcare settings beyond hospitals and OB/GYN clinics, such as (but not limited to) local pharmacies, community-based clinics, primary care physician or pediatrician offices, Tribally-operated hospitals and clinics, and Urban Indian Health Programs, and/or by emergency medical services. Solutions that can be developed sustainably and at low-cost to enable broad implementation in low-resource settings as well as across societal, economic, and cultural contexts will be given priority. Optimal digital solutions will incorporate design, software, and interoperability specifications, including application programming interfaces and security requirements for seamless integration with electronic health record systems to report results in compliance with the Privacy Act, and the Health Insurance Portability and Accountability Act. To be competitive for the RADx Tech for Maternal Health Challenge, eligible Innovators (see Rules section of this announcement) must already have developed a working prototype of a home-based or POC diagnostic device, wearable, or remote sensing technology with data demonstrating the proof of concept. Innovators will be required to submit detailed descriptions of the current state of the technology and provide sufficient data to demonstrate viability in order to advance through the phases of the competition. Technologies at the design or idea stage will not be considered responsive to this announcement and are unlikely to be selected to advance. For the initial proposal submission, Innovators must also provide a robust proposal for further development of the technology to meet the program’s criteria and development milestones.
Early engagement and involvement of underserved communities (e.g., but not limited to, underrepresented racial and ethnic minority populations, individuals who are pregnant or postpartum living in rural or urban maternity deserts, American Indian/Alaska Native (AI/AN) tribes or Urban Indian Health Programs) in the design and development of the technology is highly encouraged to ensure that the solutions being pursued truly reflect their needs and enhance user acceptance. This integration of user experience and acceptance from the target populations (e.g., but not limited to, patients, care coordinators, and providers) is critical. Technologies will ideally address language barriers for non-English speakers and usability barriers for individuals with disabilities. Submissions of home-based technologies should also address how the technology could plausibly extend care to postpartum individuals residing in maternity care deserts who may also have limited access to broadband internet or cellular signals.
During the Viability Assessment Phase, Innovators will have their submissions undergo an initial administrative triage step to review Innovator eligibility to compete in this Challenge as well as proposal completeness and applicability of scope. Innovators who do not clear this initial triage review will not be permitted to continue participating in this Challenge. Innovators who do clear this initial triage review will subsequently be required to participate in an up to 1-hour long teleconference or videoconference meeting with a subset of the Viability Panel composed of scientific/technological, clinical, and commercialization experts. The purpose of this meeting is to gain additional insight into the information submitted by each Innovator in their proposal and to then report that insight to the full Viability Panel to aid in its review of the proposals. The Viability Panel will provide go / no-go recommendations to the NIH Judging Panel on a rolling basis. The NIH Judging Panel will select up to 25 Innovators to receive $20,000 each, subject to final approval by the Award Approving Official. It is anticipated that prizes for this phase will be issued on a rolling basis until all available prize funds for this phase have been awarded; therefore, Innovators are encouraged to submit their proposals early and as soon as they are complete.
During the Deep Dive Assessment Phase, Innovators advancing from the Viability Assessment Phase will be assigned a Project Team of healthcare commercialization and content experts to conduct a “deep dive” into the technology and the Innovators’ proposals for further development. Project Teams meet extensively with Innovators and conduct detailed reviews of the scientific/technological, clinical, accessibility and usability, regulatory, and commercialization potential of the technology. This fast turn-around process will take approximately one to two weeks. During the Deep Dive Phase, the Project Team will work with NIH to identify key risk factors that may impede the deployment of the proposed solution and develop de-risking plans and clear milestones that will address these risks during the Technology Assessment Phase, subject to final decisions made by the NIH. Project Teams will be composed of experts under subcontract to the RADx Commercialization Center. Based on the outcomes of the “deep dive,” the NIH Judging Panel will select up to 12 Innovators to receive $75,000 each and be advanced to the Technology Assessment Phase, subject to final approval by the Award Approving Official.
During the Technology Assessment Phase, Innovators will be accompanied by the same Project Team deployed during the Deep Dive Phase. Additional expert advisors may be added as necessary. The Innovators and Project Teams will work together with NIH to establish success criteria, deliverables, and milestones, subject to final decisions by NIH, with the aim towards demonstrating that the technology solution is feasible within the timeframe through multiple assessments, which may include analytical and clinical studies, manufacturing and quality systems assessments, and distribution and commercial/marketing potential. Additionally, training support for patients and healthcare staff should be considered. During the Technology Assessment Phase, Innovators will have the opportunity to compete for an Interim Milestone prize of $300,000 each. Near the conclusion of the Technology Assessment Phase, Innovators will be required to submit their technologies to the RADx Validation Center, an independent laboratory under contract with NIH, for testing and verification of performance and usability. The results of this independent verification will inform the selection of the up to 6 final winners of the RADx Tech for Maternal Health Challenge who will each receive $500,000, subject to final approval by the Award Approving Official.
NICHD is conducting this challenge under the America Creating Opportunities to Meaningfully Promote Excellence in Technology, Education, and Science (COMPETES) Reauthorization Act of 2010, as amended [15 U.S.C. § 3719]. Founded in 1962, the general purpose of NICHD is the conduct and support of research, training, health information dissemination, and other programs with respect to gynecologic health, maternal health, child health, intellectual disabilities, human growth and development, including prenatal development, population research, and special health problems and requirements of mothers and children [42 U.S.C. § 285g]. The Institute’s mission includes improving reproductive health, enhancing the lives of children and adolescents, and optimizing abilities for all, and its vision is “Healthy pregnancies. Healthy children. Healthy and optimal lives.” This challenge aligns with NICHD’s statutory authority and promotes its mission and vision by accelerating the development of innovative technologies that will help ensure every person has a healthy pregnancy and improve overall maternal health outcomes. NICHD and its partners are conducting this Challenge as part of the NIH IMPROVE Initiative which supports research focused on reducing preventable causes of maternal deaths and improving health for women before, during, and after delivery.
Partners: The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), the National Institute of Biomedical Imaging and Bioengineering (NIBIB), and the NIH Office of the Director are co-sponsoring this Challenge, as part of the Implementing a Maternal health and PRegnancy Outcomes Vision for Everyone (IMPROVE) Initiative.
Awarding up to $8 million in prizes to accelerate the development of maternal health diagnostic devices, wearables, or other remote sensing technologies for use in maternity care deserts.