RADx® Tech Fetal Monitoring Challenge - CIMIT MAIN

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null RADx® Tech Fetal Monitoring Challenge

NIH Rapid Acceleration of Diagnostics Technology (RADx® Tech) Fetal Monitoring Challenge

Overview  Prizes  Timeline  Eligibility  How To Participate  Evaluation Criteria  Resources  Sponsors  FAQs

Overview

The Rapid Acceleration of Diagnostics Technology (RADx® Tech) Fetal Monitoring Challenge will award up to $2 million in prizes to accelerate the development of diagnostic and monitoring technologies to reduce the risk of fetal morbidity and mortality and thus improve fetal and neonatal health outcomes. Successful technologies developed in this Challenge will directly measure one or more parameters of fetal health status during the late antepartum and/or intrapartum periods of pregnancy. These parameters will be used to 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/tablet-enabled diagnostic tools, integrated sensing and/or imaging technologies, digital health platforms, and in vitro diagnostic devices or tests. Importantly, technologies must have a reasonable likelihood of market entry within the next 5 years and 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 high-quality prenatal healthcare.  

Innovators participating in this Challenge will initially submit a proposal describing in detail their fetal health diagnostic or monitoring technology, anticipated clinical impact, and plans for continued development and implementation in low-resource settings. Winners of Phase 1 will receive a $5,000 cash prize each and be invited to deliver a live presentation and technology demonstration in Phase 2. Winners of Phase 2 will receive a $75,000 cash prize each and advance to the Phase 3 technology development sprint where they will de-risk and further mature their technologies with support by a RADx Tech Project Team of healthcare technology commercialization and content experts. Winners of Phase 3 will receive cash prizes ranging from $50,000 - $750,000 each.  

Please visit challenge.gov for additional details and official rules.
*The deadline for submissions for this challenge has passed.

Prizes

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

Timeline

September 8, 2023: Challenge launched

September 18, 2023: Submission portal opens (Submission portal is now closed.)

October 5, 2023: Informational webinar 

November 17, 2023 at 11:59PM ET: Phase 1 submission deadline

December 15, 2023 (anticipated): Phase 1 winners announced

January 30, 2024: Phase 2 technology presentation and demonstration event

March 2024 (anticipated): Phase 2 winners announced

March - August 2024: Phase 3 technology development sprint 

October 2024 (anticipated): Phase 3 winners announced

Eligibility

Participation in the Challenge is open to Innovators that can demonstrate the feasibility and readiness of their technology to directly detect, diagnose and/or monitor fetal health status during the late antepartum and/or intrapartum periods of pregnancy. Innovators must already have developed a working prototype with data demonstrating the proof of concept. Technologies at the conceptual design or idea stage will not be considered responsive and are unlikely to be selected to advance.  

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. 

How to Participate

  1. 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. 

  2. Watch a recording of the informational webinar. NIH and its partners hosted a public webinar on October 5, 2023 for interested participants to learn more about the RADx Tech Fetal Monitoring Challenge and to get their questions answered. 

  3. 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. 

  4. 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 entry no later than November 17, 2023 at 11:59pm Eastern Time. 

Evaluation Criteria

Phase 1 

Scientific/Technological: 

  • Does the submission sufficiently describe the biological, chemical, and/or physical principles of the diagnostic or monitoring technology, and mechanisms of sample or data collection, analysis, and reporting of results? 
  • Has the technology been demonstrated to accurately detect, diagnose, and/or monitor one or more conditions affecting fetal health status during the late antepartum and/or intrapartum periods of pregnancy? 
  • Does the submission provide sufficient feasibility data and other evidence to demonstrate proof of concept of the technology, including validation of the approach? 
  • To what degree can the diagnostic or monitoring technology be effectively integrated with a digital health platform, either with existing or new software and hardware, to enable faster clinical decision making and reduce the dependence on healthcare resources and infrastructure?

Clinical: 

  • What is the likelihood of the technology to yield an improvement in fetal and neonatal health outcomes and ultimately help prevent fetal morbidity and mortality? 
  • Does the implementation of the technology have real-world clinical utility; i.e., can it deliver clinically-actionable information?
  • For home-based technologies: is the technology able to generate results that directly inform decision-making by a caregiver in a home-care delivery setting or by a physician in a telehealth setting, or inform when a pregnant person should seek additional obstetric care?
  • 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? 

Impact in Low-Resource Settings: 

  • Does the submission include a rigorous and robust plan for continued development of the diagnostic or monitoring technology for broad implementation in low-resource settings?
  • Does the submission provide evidence of, or reasonable plans for, engagement of individuals and communities in low-resource settings to ensure that the solutions being pursued truly reflect their needs and enhance user acceptance?
  • What is the likelihood of the technology to meet the requisite specifications, including cost, for sustainable implementation in low-resource settings?

Commercialization & Regulatory:

  • Is the technology likely to be available on the market within the next 5 years?
  • Assuming the technology works as anticipated, how well can it be manufactured and implemented at scale in an economically viable way?
  • Are the plans to obtain required clearance and approval from the applicable regulatory agency, such as the U.S. 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?

Innovation:

  • 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 represent the innovative implementation of existing technology?

Resources

For additional information, contact the Challenge sponsors at NIBIBchallenge@mail.nih.gov.

Sponsors

The National Institute of Biomedical Imaging and Bioengineering (NIBIB), the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), and the Bill & Melinda Gates Foundation (Gates Foundation) are co-sponsoring this Challenge. The RADx Coordination Center, operated by CIMIT under a contract with NIH, is providing challenge management and support services.

Frequently Asked Questions (FAQs)

Please review the FAQs available here.

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