RADx Tech for Maternal Health Challenge Final - POCTRN
null RADx Tech for Maternal Health Challenge Final
NIH Rapid Acceleration of Diagnostics Technology (RADx® Tech) for Maternal Health Challenge
The U.S. maternal mortality rate is the highest of any developed nation in the world and more than double the rate of peer countries (Commonwealth Fund, 2020). In addition, thousands of individuals suffer severe maternal morbidity each year, with short- and long-term consequences. The U.S. maternal health crisis is exacerbated by the fact that millions of individuals have little or no access to maternity care; more than 2.2 million women of childbearing age live in areas of the country referred to as “maternity care deserts,” defined as counties that lack hospitals offering obstetric care, birth centers, and obstetric providers (March of Dimes, 2020). While a diversity of approaches are needed to address this crisis, innovative technology solutions are a prime candidate to enable extension of care and ultimately improve maternal health outcomes by increasing monitoring, detection, and diagnosis of the leading causes of maternal morbidity and mortality.
The National Institutes of Health is offering up to $8 million in cash prizes to accelerate development of technologies to improve maternal health outcomes for those who live in areas lacking access to maternity care. The Rapid Acceleration of Diagnostics Technology (RADx® Tech) for Maternal Health Challenge prioritizes home-based or point-of-care diagnostic devices, wearables and other remote sensing technologies to improve postpartum healthcare in these regions. The postpartum period is defined as the first year after giving birth or the end of a pregnancy, and it accounts for a large proportion of maternal deaths in the United States. Successful technologies will enable extension of postpartum care by empowering postpartum individuals, their caregivers or healthcare providers with actionable health information they can use to inform decisions about when to seek additional care. 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 associated with high rates of severe maternal morbidity and mortality during the first year after delivery or end of pregnancy.
Diagnostic technologies that are in the prototype stage or further along in development will be evaluated using the RADx Tech “innovation funnel” approach, which compresses the technology development timeline by using expert teams to simultaneously address scientific, technical, regulatory, clinical and commercialization requirements across milestone-based stages. The RADx Tech for Maternal Health Challenge will consist of three phases, and only those Innovators selected to win in each phase will be permitted to advance to the subsequent phase:
- Viability Assessment Phase – Following an administrative triage, proposals will be reviewed by a Viability Panel of scientific/technological, clinical, and commercialization experts and evaluated against the Evaluation Criteria.
- Deep Dive Assessment Phase – A Project Team of healthcare technology commercialization and content experts will engage directly with each Innovator to assess the prototype technology across the Evaluation Criteria and will work with NIH to identify key risk factors for accelerated development and implementation and establish ways to mitigate these risks.
- Technology Assessment Phase – Progress made by Innovators in furthering the development and de-risking of their technologies will be evaluated at two points throughout this phase: at an interim milestone point and at a final point at the end of the phase following the independent testing and verification of the technology’s performance and usability.
The total prize purse for this challenge is $8,000,000. Prizes will be awarded following the successful completion of each phase of the challenge in the following amounts:
- Viability Assessment Phase - $20,000 per winner; up to 25 winners
- Deep Dive Assessment Phase - $75,000 per winner; up to 12 winners
- Technology Assessment Phase – prizes will be disbursed across the following stages within this Phase:
- Interim Milestone: up to $300,000 per winner; up to 12 winners
- Testing & Verification: up to $500,000 per winner; up to 6 winners
September 1, 2022: Challenge launched
September 15, 2022: Submission portal opens
September 22, 2022: Informational webinar
November 1, 2022: Submission deadline
October – November 2022: Viability Assessment Phase
November 2022 – January 2023: Deep Dive Assessment Phase
January 2023 – January 2024: Technology Assessment Phase
March 2024 (estimated): Winners announced
Participation in the Challenge is open to any U.S.-based Innovators that can demonstrate the feasibility and readiness of its technology to accurately predict, detect, diagnose and/or monitor conditions affecting maternal health during the postpartum period. Innovators must formally register and compete as either an independent Team (i.e., registering as a group of individuals competing together but not on behalf of an established organization, institution, or corporation) or as an Entity (i.e., registering as a group of individuals competing together on behalf of a legally established organization, institution, or corporation). Innovators may include, but are not limited to, teams of individuals, start-ups, small- or mid-size businesses, large businesses, non-profit organizations, and academic or independent research institutions. Innovators intending to use Federal grant or cooperative agreement funds, if permissible, must participate in the Challenge as an Entity on behalf of the awardee institution or organization.
- For Teams: Each participating Team is required to identify a Team Captain who will register and submit on behalf of the Team members. The Team Captain is responsible for all communications with the Challenge sponsors and, in the event of winning a cash prize, will be paid the prize in full. To be eligible to receive a cash prize, the Team Captain must be a citizen or permanent resident of the United States.
- For Entities: Each participating Entity is required to identify a Point of Contact who will register and submit on behalf of the Entity. The Point of Contact is responsible for all communications with the Challenge sponsors. In the event of winning a cash prize, the prize will be paid directly to the Entity, not to the Point of Contact. To be eligible to receive a cash prize, the Entity must be incorporated in and maintain a primary place of business in the United States.
- Review the full Challenge Announcement. Interested participants in the Challenge should carefully and thoroughly read the detailed Challenge description, eligibility and participation rules, judging criteria, and submission instructions.
- Register for and attend the informational webinar. NIH and its partners will host a public webinar on September 22, 2022 at 2PM Eastern Time for interested participants to learn more about the RADx Tech for Maternal Health Challenge and to get their questions answered.
- Register for the Challenge. Each Innovator should determine whether they will compete in the Challenge as either a Team or on behalf of an Entity, and then establish an account in the submission portal.
- Submit your entry to the Challenge. Ensure your Team or Entity has thoroughly responded to each of the questions and prompts and fully submitted your proposal no later than November 1, 2022 at 11:59pm Eastern Time.
Viability and Deep Dive Assessment Phases
- Does the submission provide sufficient feasibility data and other evidence to demonstrate proof of concept of the technology, including validation of the approach?
- Has the technology been demonstrated to accurately predict, detect, diagnose, and/or monitor one or more conditions affecting maternal health during the postpartum period?
- Is the technology sufficiently mature to indicate readiness to reach the testing and verification step in the Technology Assessment phase within the timeline of this program?
- Does the technology represent a scientific or technical approach that is novel, unique, and a significant advancement over the current standard of care or approaches, or the innovative implementation of existing technology?
- Does the submission clearly demonstrate how the technology will help extend care and improve maternal health outcomes for postpartum individuals living in maternity care deserts?
- Does the implementation of the technology have real-world clinical utility?
- For home-based technologies: is the technology able to generate results that directly inform a postpartum individual’s decision to seek additional care, or inform decision-making by a caregiver in a home-care delivery setting or by a physician in a telehealth setting?
- For POC technologies: can the technology be efficiently integrated into the intended healthcare environments and processes (i.e., easily used by healthcare professionals as part of their routine protocols), or can the technology overcome barriers to the entry of novel approaches within current clinical care settings?
Accessibility and User-Experience
- Does the submission provide evidence of, or reasonable plans for, early engagement of underserved communities to ensure that the solutions being pursued truly reflect their needs and enhance user acceptance?
- Does the submission include considerations about the development of sustainable, low-cost solutions for broad implementation in low-resource settings?
- Are solutions that address language barriers, or barriers to access for individuals with disability, being considered?
- Are solutions that consider societal, economic, and cultural differences being considered?
- Is the technology likely to be available on the market within the next 3-5 years?
- Assuming the technology works as anticipated, how well can it be manufactured and implemented at scale in POC or at-home settings in an economically viable way?
- Are the plans to obtain required clearance and approval from the applicable regulatory agency, such as the US Food and Drug Administration, feasible and appropriate?
- Does the submission address solutions to the likely regulatory challenges on a realistic schedule to achieve the stated goals?
Technology Assessment Phase
The timing, requirements, and evaluation criteria for the interim milestone prize and the final testing and verification prize will be announced prior to the beginning of the Technology Assessment phase and will be determined based upon the portfolio of technologies having entered the Deep Dive, their stage of development, and the work required to successfully complete the independent technology verification step.
- RADx Tech for Maternal Health Challenge Announcement
- Frequently Asked Questions
- For additional information, contact the Challenge sponsors at firstname.lastname@example.org.
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.
RADx: Rapid Acceleration of Diagnostics
In response to the COVID-19 pandemic, the Rapid Acceleration of Diagnostics (RADxsm) initiative was formed to accelerate the development, validation, and commercialization of innovative point-of-care and home-based tests, as well as improvements to clinical laboratory tests, that can directly detect SARS-CoV-2, the virus that causes COVID-19.