RADx Tech Fetal Monitoring FAQs - POCTRN
RADx Tech Fetal Monitoring Program FAQs
Purpose of the Rapid Acceleration of Diagnostics Technology (RADx Tech) for Fetal Monitoring Challenge
What is the RADx Tech Fetal Monitoring Challenge?
The Rapid Acceleration of Diagnostics Technology (RADx® Tech) Fetal Monitoring Challenge will award up to $2 million in prizes to accelerate the development of innovative and accessible diagnostic and monitoring technologies that directly detect and measure physiological parameters of fetal health status in order to reduce the risk of fetal morbidity and mortality and thus improve fetal and neonatal health outcomes.
Why is NIH conducting this challenge?
Globally, there are approximately 2 million stillbirths every year with over 40% occurring after the onset of labor, the majority of which could be prevented with better quality and respectful care during childbirth. Within the United States, 21,000 families suffer a stillbirth each year. Fetal mortality rates continue to vary by race and ethnic origin within the U.S., being highest for Native Hawaiian or Other Pacific Islander and Black women, followed by American Indian or Alaska Native women. What this demonstrates is an unacceptable state of fetal health outcomes both within the U.S. and around the world that calls for immediate action and, among other changes, improvement in the diagnosis and monitoring of the physiological causes of and factors associated with fetal morbidity and mortality.
In low-resource settings, a Pinard stethoscope is the most common device used for assessing fetal health status by monitoring fetal heart rate (FHR) via auscultation in both the antepartum and intrapartum period. Fetoscopes are accessible and low-cost, but can be difficult and time consuming to use. This difficulty results in health care providers forgoing the intermittent auscultation of FHR recommended during labor. In high-income settings, electronic fetal monitoring (EFM) is the standard of care. However, EFM technology, including continuous cardiotocography (cCTG), has remained largely unchanged over the last several decades. Consistent evidence gained over the last 60 years demonstrates that cCTG does not reduce the rate of fetal acidemia, cerebral palsy, or perinatal death. Additionally, Cesarean rates in the U.S. have increased from less than 5% in the 1970s to greater than 30% in settings where EFM is routinely used. The global health community is concerned about the already rising rates of Cesarean births in low-resourced settings and how the introduction of EFM may further exacerbate this issue.
The combination of these factors further points to the need for technological innovations in determining fetal well-being across multiple physiological parameters during antepartum and intrapartum periods of pregnancy. The RADx Tech Fetal Monitoring Challenge seeks to spur and reward the development of innovative and accessible technologies that can help improve fetal and neonatal health outcomes through earlier and more accurate diagnosis, detection, monitoring of fetal health status and appropriate intervention.
What is a challenge (a.k.a., prize competition), and how does NIH utilize this open innovation mechanism?
The RADx Tech Fetal Monitoring 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.
Description of Devices and Technologies
What technology categories will be considered?
Technologies developed in this Challenge must directly measure one or more parameters of fetal health status during the late antepartum and/or intrapartum periods of pregnancy. Technologies should provide actionable information that can be used for clinical decision-making and be implementable at either the point of care or in a home-based setting. Examples of desired technologies include, but are not limited to, wearable devices, smartphone-enabled diagnostic tools, integrated sensing and/or imaging technologies, digital health platforms, and in vitro diagnostic devices or tests.
How and where are these technologies intended to be used?
Technologies developed through the RADx Tech Fetal Monitoring Challenge are intended to be implementable at the point-of-care by a clinician or healthcare technician/provider in a hospital, clinic, or a community healthcare setting, or in an at-home setting by a caregiver or even ultimately the pregnant person themselves. Technologies must have strong potential for accessible, cost-effective use and impact in low-resource settings, such as low- and middle-income countries as well as areas of high-income countries where there is limited access to quality prenatal healthcare.
Of note, although the RADx Tech Fetal Monitoring Challenge is focused on solutions for the late antepartum and/or intrapartum periods of pregnancy, it is likely that some of the technologies developed for this challenge may have utility in earlier stages of gestation as well, but only those that yield clinically actionable information in the later stages of gestation or during labor and delivery will be considered within scope.
How will these technologies be assessed?
Please review the complete evaluation criteria available on Challenge.gov. In summary, Innovators in this Challenge will have the opportunity to compete across three (3) Phases.
Phase 1: Complete and applicable submissions from eligible Innovators will be evaluated by an Evaluation Panel and NIH Judging Panel composed of scientific/technological, clinical, and commercialization experts using the Scientific/Technological; Clinical; Impact in Low-Resource Settings; Commercialization & Regulatory; and Innovation.
Phase 2: Phase 1 winners will deliver a live presentation and demonstration of their technology, as well as plans for further maturation and implementation in low-resource settings, to experts from NIH, the Gates Foundation, and other organizations under contract with NIBIB through the RADx Tech program. Presentations will likely be evaluated using the following rubric; however, the final evaluation criteria will be provided to Innovators at the beginning of Phase 2:
- The Innovator team demonstrates a thorough understanding of the problem and how their technology will help solve that problem.
- The Innovator team possesses the necessary skills and experience to further develop and implement the technology.
- The Innovator’s technology will deliver improvements in fetal, and thusly, neonatal health outcomes in comparison to the existing alternatives and the current standard of care.
- The Innovator team has a viable and scalable business model and a sound commercialization strategy.
- The Innovator team presents a rigorous and robust plan for continued development of the diagnostic or monitoring technology for broad implementation in low-resource settings.
Phase 3: The specific timing, requirements, and evaluation criteria for Phase 3 prizes will be announced prior to the beginning of this Phase and will be determined based on the portfolio of technologies having received Phase 2 prizes, their stage of development, and the work required to successfully de-risk them. However, Innovators can anticipate they will be assessed on the extent to which they have provided objective evidence of risk factor mitigation, advancement in technology maturation, and further refinement of commercialization strategies, among other criteria to be defined. In order to achieve the objectives of the RADx Tech Fetal Monitoring Challenge, it is critical that each Innovator actively engages with their Project Team and participates in relevant activities, and to do so in an open and transparent manner. Therefore, Innovators will also be evaluated based on their level of communication and cooperation with their Project Team (Team Lead and Project Facilitators) and NIH Challenge leads and Program Managers and their provision of pertinent information necessary to assess progress in technology development.
To be competitive for the RADx Tech Fetal Monitoring Challenge, what stage of development should my technology be at the time of submission?
To be competitive for the RADx Tech Fetal Monitoring Challenge, eligible Innovators must already have developed a working prototype of a 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 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.
Submission 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 regulatory, manufacturing, and market/user research support to maximally accelerate progress. NIH will closely monitor progress of each project selected to advance throughout the competition.
How can I submit an entry to this Challenge?
The Challenge registration and submission portal is administered by CIMIT serving as the RADx Coordination Center and operating under a contract with the NIH. To register to participate in the Challenge, Innovators will first be directed to establish an account in the registration and submission portal which can be accessed via the informational website. Innovators will be required to identify whether they are registering as either a Team or as an Entity and will need to provide the name, affiliation, and contact information of all individuals competing in this Challenge. All Innovators will also be required to acknowledge whether federal funding will be used in the development of the Challenge submission (see Participation Rule 1). All Innovators must certify they have read, understand, and agree to abide by the official eligibility rules, participation rules, and requirements for the Challenge as stated in this announcement.
Once Innovators have completed the registration step and established an account in the online submission portal at the link above, they will be asked to provide a submission Title and Executive Summary, the latter of which should include a brief description of the technology and how it will reduce the risk of fetal morbidity and mortality and thus improve fetal and neonatal health outcomes. Do not include any proprietary or confidential information in the Title and Executive Summary sections as they may be publicly shared if the Innovator is selected to win a prize across any phase of this Challenge (see Participation Rule 8). Innovators will then need to respond to a series of specific prompts across different topics that will include technology design and performance, overview of the Innovator and environment, anticipated clinical impact of the technology, and plans for continued development and implementation in low-resource settings.
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?
NIBIB, through its RADx Tech program, has assembled a national network of expert regulatory, manufacturing, and market/user research consultants and advisors who will provide in-kind and tailored assistance to each Innovator team selected to advance to Phase 3. 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.
What is the maximum award any one participant may receive?
The total prize purse for this challenge is $2,000,000. Prizes will be awarded following the successful completion of each phase of the Challenge in the following amounts:
- Phase 1: $5,000 per winner; up to 10 winners will be selected as semi-finalists to advance to Phase 2
- Phase 2: $75,000 per winner; up to 6 winners will be selected as finalists to advance to Phase 3
- Phase 3:
- 1st place = $750,000
- 2nd place = $400,000
- 3rd place = $200,000
- Runner ups = 3 prizes at $50,000 each
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 NIBIB.
Will NIH provide summary feedback to Innovators 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. All Entities participating in this Challenge are highly encouraged, but not required, to request and obtain a free Unique Entity ID, if they have not already done so, via SAM.gov as this will expedite prize payment. Additional information can be found on this website.
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.