Key Dates

Anticipated Publication Date of Challenge Announcement:

September 1, 2022

Anticipated Submission Start Date:

September 1, 2022

Anticipated Submission Due Date:

November 1, 2022

Anticipated Award Date:

December 1, 2022

Anticipated Start Date:

December 1, 2022

Related Announcements

None

Issued by

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

National Institute of Biomedical Imaging and Bioengineering (NIBIB)

Purpose

As part of the Implementing a Maternal health and Pregnancy Outcomes Vision for Everyone (IMPROVE) initiative, the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), intends to publish an announcement to invite entries for a prize competition: The Rapid Acceleration of Diagnostics Technology (RADx Tech) for Maternal Health Challenge.

The RADx Tech for Maternal Health Challenge aims 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 ultimately reduce severe maternal morbidity and maternal mortality (SMM/MM) for individuals residing in maternity care deserts.

This Notice is being provided to inform potential Innovators of the upcoming opportunity to compete in the RADx Tech for Maternal Health Challenge. Publication of the Challenge announcement and launch of the submission portal are planned for September 1, 2022. The estimated submission deadline is November 1, 2022.

NICHD intends to award a total of up to $8,000,000 in cash prizes throughout three stages of the prize competition. Additional information about the planned prize competition is included below.

Background

The most recent U.S. maternal mortality ratio, or rate, of 23.8 per 100,000 pregnancies represents approximately 860 maternal deaths in 2020.^[1] This ranks last overall among industrialized countries. Slightly more than half (52%) of all deaths occur after the day of delivery,^[2] while a number of these conditions, particularly cardiomyopathy, can occur up to a year after childbirth.^[3] Notably, many of these maternal deaths are preventable: when conditions are identified early, there are clinical interventions that can save lives. Innovative technology solutions are a prime candidate to increase monitoring, detection, and diagnosis of the leading causes of, and ultimately prevent, postpartum morbidity and mortality.

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 a 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.

Prize Competition Details

Innovators participating in this challenge will likely be expected to submit a proposal describing in detail their prototype technology, anticipated clinical impact, and plans for continued development. To be competitive for the RADx Tech for Maternal Health Challenge, Innovators will have likely already developed a working prototype of a home-based or POC diagnostic device, wearable, or remote sensing technology with data demonstrating the proof of concept.

Proposals are expected to be evaluated and advanced through three phases of the Challenge as Innovators compete for increasing cash prize amounts throughout:

1. Viability Assessment Phase: This phase will focus on determining the viability of the proposed solutions for scientific/technological, clinical, accessibility and user experience, commercialization, as well as regulatory approval. Prizes will likely be issued for this phase on a rolling basis until all available prize funds for this phase have been awarded.

2. Deep Dive Phase: Innovators selected to advance to the Deep Dive Phase will be assigned to a Project Team of healthcare technology commercialization and content experts who will assess the prototype technology across defined evaluation criteria, identify key risk factors for accelerated development and implementation, and establish milestones that mitigate these risks. Innovators who successfully complete the Deep Dive Phase will receive a cash prize and advance to the Technology Assessment Phase.

3. Technology Assessment Phase: In this phase, technologies will be rapidly de-risked with in-kind technical, clinical, and commercialization support and Innovators will compete for additional cash prizes 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 networks for potential clinical studies and implementation research support.

The Challenge announcement will likely be posted on multiple websites, including Challenge.gov and the NIH IMPROVE Initiative website, and broadly disseminated across NIH stakeholder networks.

NICHD intends to conduct this Challenge under the authority provided by Section 24 of the Stevenson-Wydler Technology Innovation Act of 1980 (15 U.S.C. 3719), as added by the America COMPETES Reauthorization Act of 2010 (Pub. L. 111-358).

SUBMISSIONS ARE NOT BEING SOLICITED AT THIS TIME.

[1] Hoyert DL. Maternal mortality rates in the United States, 2020. NCHS Health E-Stats. 2022. DOI: https://dx.doi.org/10.15620/cdc:113967

[2] CDC. Pregnancy Mortality Surveillance System. Retrieved from: https://www.cdc.gov/reproductivehealth/maternal-mortality/pregnancy-mortality-surveillance-system.htm

[3] Declercq E and Zephyrin L, Maternal Mortality in the United States: A Primer (Commonwealth Fund, Dec. 2020). https://doi.org/10.26099/ta1q-mw24

Inquiries

Please direct all inquiries to:

Antonello Pileggi, MD, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-402-5019
Email: [email protected]