RADx Tech Maternal Health FAQs - POCTRN
RADx Tech Maternal Health Program FAQs
Purpose of the Rapid Acceleration of Diagnostics Technology (RADx Tech) for Maternal Health Challenge
What is the RADx Tech for Maternal Health Challenge?
The Rapid Acceleration of Diagnostics Technology (RADx Tech) 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.
What are the unmet needs?
The U.S. maternal health crisis is exacerbated by the fact that more than 7 million women of childbearing age live in counties with either no or limited access to maternity care. Of those, 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 have no hospital offering obstetric care, no birth center, and no obstetric provider (March of Dimes, 2020). This lack of access to care puts the pregnant person and their child at high risk of serious health complications and increases the risk for maternal and infant morbidity and mortality.
Description of Devices and Technologies
What are the priority conditions targeted by this program?
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.However, health technologies that detect other conditions directly associated with maternal health will be considered.
What technology categories will be considered?
Technologies may include 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).
What are the optimal solutions for:
- Digital Technologies: 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.
- Diagnostic Devices: 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, 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.
How are these technologies intended to be used?
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 maternal health continuum of care (e.g., from preconception, throughout pregnancy, and during the perinatal period), and Innovators may also be eligible to apply for National Institutes of Health (NIH) funding through other relevant funding opportunity announcements within and outside the NIH IMPROVE Initiative.
How will these technologies be assessed?
Complete proposal submissions from eligible Innovators received in advance of the submission deadline will first undergo an administrative triage step to review Innovator eligibility to compete in this Challenge as well as proposal completeness and applicability of scope. Innovators who clear this initial triage review will subsequently be required to participate in an up to one-hour long teleconference or video conference meeting with a subset of the Viability Panel. The proposal submissions will then be evaluated by the full Viability Panel composed of scientific/technological, clinical, and commercialization experts using the Evaluation Criteria listed at Challenge.gov. Submissions will be reviewed on a rolling basis in the Viability Assessment Phase. Additionally, prizes will be issued for this phase 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. The Viability Panel will provide go / no-go recommendations to the NIH Judging Panel as to which submissions should advance to the Deep Dive Assessment phase. The NIH Judging Panel will review these recommendations and select the winners, pending final decisions by the Award Approving Official. Only those Innovators that have been selected as winners of the Viability Assessment phase will advance to the Deep Dive Assessment phase of the Challenge. NIH does not intend to provide Innovators with individual reviews or summaries of reviewer feedback in this or any subsequent phases of the Challenge.
To be competitive for the RADx Tech for Maternal Health Challenge, what stage of development should the technology have achieved?
To be competitive for the RADx Tech for Maternal Health Challenge, eligible Innovators 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. Those technologies with the highest potential to be available on the market within the next 3-5 years will be most competitive. Technologies at the design or idea stage will not be considered responsive to this announcement and are unlikely to be selected to advance.
Application and Technology Advancement Process
How will the Challenge support technology advancement?
Technologies will follow a staged approach for development. Submissions will be rapidly reviewed and assessed for viability and continued participation in the Challenge. Projects that are selected to win cash prizes will also receive in-kind technical, clinical, and commercialization support to maximally accelerate progress. NIH will closely monitor progress of each project selected to advance throughout the competition.
How will the submission process be administered?
The Challenge registration and submission portal is administered by the Consortia for Improving Medicine with Innovation & Technology (CIMIT) serving as the RADx Coordination Center and operating under a contract with the NIH.
What is a challenge (a.k.a. prize competition), and how does NIH utilize this open innovation mechanism?
The RADx Tech for Maternal Health Challenge is a challenge, also referred to as a prize competition, which is a separate and distinct award mechanism from grants, contracts, and cooperative agreements that the NIH uses to stimulate innovation in biomedical research and development. Teams and Entities participating in this Challenge will compete for cash prizes to be awarded across the multiple phases of the Challenge. Additionally, NIH reserves the right, in its sole discretion, to (a) cancel, suspend, or modify the Challenge, or any part of it, for any reason, and/or (b) not award any prizes if no submissions are deemed worthy.
Challenges are tools for incentivizing the achievement of scientific, technological, and other categories of innovation by offering monetary or non-monetary awards to challenge participants who demonstrate success. They are a mechanism that allows the public to solve problems presented by federal agencies and receive awards for the best solutions. Challenges also enable NIH to establish an ambitious goal without bearing high levels of risk or having to predict which team or approach is most likely to succeed, and then to pay only for the successful solutions. NIH has used challenges to spark new ways of thinking, solve tough problems, stimulate innovation, and advance its core mission of turning discovery into health. Challenges enable NIH Institutes, Centers, and Offices to establish ambitious goals without bearing high levels of risk and pay only for results. This mechanism also affords NIH the opportunity to engage innovators across the country who have a wide range of skill sets and diverse backgrounds, but who may not typically contribute to NIH research activities. With a focus on proven results, challenges empower untapped talent to deliver unexpected solutions to tough problems.
How is competing in a challenge different from applying for a grant, contract, or cooperative agreement from NIH?
Challenges are an effective tool within the NIH toolbox to catalyze biomedical innovation and complement our more traditional funding mechanisms. Grants, contracts, and cooperative agreements are typically awarded based on proposals for future work, while challenges typically award completed work that meets the criteria for winning a prize. Put another way, challenges retrospectively award prizes to winners for demonstrating successful accomplishment of the objectives set forth in the challenge. Importantly, grants, contracts, and cooperative agreements are usually awarded prospectively to an institution or organization to carry out an activity approved by the government in accordance with applicable rules, regulations, and policies, such as the NIH Grants Policy Statement or Federal Acquisition Regulations. Challenges, in contrast, typically award cash or non-cash prizes directly to individuals, teams, or entities and, except in limited situations, there are no restrictions on how the prize award is to be used.
How are confidentiality and intellectual property handled?
The information contained within submissions is treated as confidential and all reviewers sign a non-disclosure agreement when accessing the submissions. By participating in this Challenge, each Innovator (whether participating as a Team or Entity) selected to win a prize automatically grants to the NIH an irrevocable, paid-up, royalty-free nonexclusive worldwide license to reproduce, publish, post, link to, share, and display publicly the Title and Executive Summary components of the submission on the web or elsewhere. Each Innovator will retain all other intellectual property rights in their submissions, as applicable. To participate in the Challenge, each Innovator must warrant that there are no legal obstacles to providing the above-referenced nonexclusive licenses of the Innovator’s rights to the federal government if they are selected as a winner. To receive a prize award, Innovators will not be required to transfer their intellectual property rights to NIH, but Innovators must grant to the federal government the nonexclusive licenses recited herein.
Who is eligible to participate in this challenge?
Participants in this challenge must register and compete in either of the following capacities: as 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).
- 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. In the event that a dispute regarding the identity of the Team Captain who actually submitted the entry cannot be resolved to NIH’s satisfaction, the affected submission will be deemed ineligible.
- 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. As stated in the Participation Rules, Innovators intending to use Federal grant or cooperative agreement funds must register for and participate in the Challenge as an Entity on behalf of the awardee institution or organization. In the event that a dispute regarding the identity of the Point of Contact who actually submitted the entry cannot be resolved to NIH’s satisfaction, the affected submission will be deemed ineligible.
Are foreign institutions, organizations, or companies eligible to win a cash prize in the challenge?
No, any Entity (i.e., an institution, organization, company, etc.) competing in this challenge must be incorporated in and maintain a primary place of business in the United States in order to be eligible to receive a cash prize.
Can individuals who are not U.S. citizens or permanent residents participate in the challenge?
Yes, non-U.S. citizens and non-permanent U.S. residents may register for and participate in a challenge as members of a Team or Entity. However, non-U.S. citizens and non-permanent U.S. residents are not eligible to win a cash prize (in whole or in part). Such individuals may participate as part of a Team or Entity that otherwise satisfies the applicable eligibility criteria and may be recognized when the results are announced. The Team Captain of a participating Team must be a U.S. citizen or U.S. permanent resident because any cash prizes will be paid directly to the Team Captain. The Point of Contact for a participating Entity does not have to be a U.S. citizen or U.S. permanent resident; however, the Entity must be incorporated in and maintain a primary place of business in the United States.
Does each Innovator team need to do all the work to advance their technology to the market?
RADx Tech has assembled a national network of expert technical, clinical, manufacturing, and regulatory consultants and advisors who will provide in-kind and tailored assistance to each Innovator team selected to advance to the Technology Assessment phase. These Project Teams of experts will work together with the Innovator teams and 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.
We have done technology validation in-house. Would you accept our technology validation data or require further validation?
RADx Tech reviewers will review all information submitted in response to the solicitation and provide NIH with recommendations as to whether the proposed technology may require independent validation.
What is the maximum award any one participant may receive?
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 - $20,000 per winner; up to 25 winners
- Deep Dive Assessment - $75,000 per winner; up to 12 winners
- Technology Assessment – 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
Prize funds that remain unawarded after the selection of winners for each phase may be rolled over into a subsequent phase and added to those prize payments; however, any decision to increase any individual prize amounts from what is outlined above is entirely at the discretion of the NIH.
Will NIH provide summary feedback as to why a submission was not selected to win a cash prize?
No, NIH does not intend to provide Innovators with individual reviews or summaries of reviewer feedback in any phases of the Challenge. This is due to the sheer number of anticipated submissions and the urgent need for NIH to focus its efforts on advancing selected proposals. Innovators who were not selected for RADx Tech support are encouraged to consider other NIH funding opportunities.
How will winners of this challenge be paid their cash prize?
Teams or Entities selected to receive a prize at any stage or phase of this challenge will have that cash prize award paid directly to the bank account provided by the winning Team Captain or Entity. Cash prizes will be paid by electronic funds transfer directly to the Team Captain or to the Entity and may be subject to Federal income taxes. The U.S. Department of Health & Human Services/NIH will comply with the Internal Revenue Service withholding and reporting requirements, where applicable. Please note that NIH cannot provide advice or guidance regarding federal, state, or local tax implications for winning a cash prize.
Are there any restrictions on how the cash prize must be used?
Challenges are substantially different mechanisms for advancing innovation compared to more traditional NIH grants, contracts, or cooperative agreements. There are no restrictions on nor requirements for how the cash prize award is to be used, so long as no Federal grant or cooperative agreement funds were used to develop the submission or to fund efforts in support of the submission. If an Innovator uses Federal grant or cooperative agreement funds and wins the Challenge, the prize must be paid directly to the awardee (typically, an institution, organization, or corporation) and treated as program income for purposes of the original grant or cooperative agreement in accordance with applicable Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards (2 CFR § 200). However, Innovators are highly encouraged to use any prize winnings to continue competing in the challenge.