NIH Technology Accelerator Challenge (NTAC) for Maternal Health Announcement

Announcement of Requirements and Registration for the

NIH Technology Accelerator Challenge (NTAC) for Maternal Health

DEPARTMENT OF HEALTH AND HUMAN SERVICES

NATIONAL INSTITUTES OF HEALTH

NATIONAL INSTITUTE OF BIOMEDICAL IMAGING AND BIOENGINEERING

Authority: 15 U.S.C. 3719

Date of Announcement: December 7, 2021

DESCRIPTION

Subject of the Challenge: Improving maternal health is a strategic priority area of research for the U.S. National Institutes of Health (NIH)¹ . Despite progress over the past decade, rates of maternal deaths due to complications arising from pregnancy or childbirth (referred to as “maternal mortality”) continue to exceed global and national targets. As of 2017, the United Nations (U.N.) estimated the maternal mortality rate to be 211 maternal deaths per 100,000 live births around the world, well above the U.N. Sustainable Development Goal of reaching fewer than 70 maternal deaths per 100,000 live births by 2030² . For every maternal death, another 20 women suffer serious injuries, infections, or disabilities³. Typically, the causes of maternal death are postpartum hemorrhage, pre-eclampsia, and bacterial infections (e.g., sepsis), as well as aggregated indirect causes (including pre-existing conditions like HIV, malaria, diabetes, and anemia)⁴ . According to the World Health Organization, fatalities are skewed where 94% occur in low and lower middle-income countries in part due to limited healthcare resources and infrastructure; Sub-Saharan Africa and Southern Asia accounted for roughly two-thirds and one-fifth, respectively, of all global maternal deaths in 2017⁵ . The average maternal mortality rate across all low-income countries is 462 deaths per 100,000 live births versus 11 in high-income countries. However, rates of maternal morbidity and mortality continue to rise in the United States, with approximately 700 maternal deaths occurring each year – more than in any other developed country⁶. Wide racial and ethnic gaps exist in the U.S.; non-Hispanic black women experience a maternal mortality rate (44.0 deaths per 100,000 live births) that is 2.5 times higher the rate for non-Hispanic white women (17.9) and 3.5 times the rate for Hispanic women (12.6)⁷. What these numbers convey is an unacceptable state of maternal health both here and around the world that calls for immediate action and, among other changes, innovation in the detection and diagnosis of the largely preventable causes of maternal mortality.

Readily available point-of-care (POC) diagnostics to detect known and treatable causes of maternal mortality and morbidity are essential tools in any effort to prevent pregnancy-related death and disability. While such diagnostic devices are available for infectious diseases like HIV and malaria, there are no available low-cost multiplexed POC tests for diagnosing hemorrhage, pre-eclampsia, and bacterial infections that can be used in a low resource setting4. Additionally, there exists a need to link accurate, affordable maternal POC diagnostics to digital health platforms to minimize the dependency on human resources and infrastructure and to enable faster and more effective clinical action improving antenatal and intrapartum care. Taken together, diagnostics that aid clinicians in determining when to provide better care to patients will likely have implications in improving maternal outcomes.

The National Institute of Biomedical Imaging and Bioengineering (NIBIB) at the NIH supports and encourages the development of new diagnostic technologies important for global health. With the support of its partners, NIBIB is launching the NIH Technology Accelerator Challenge (NTAC) for Maternal Health (NTAC: Maternal Health) and offering up to $1,000,000 in cash prizes to spur and reward the development of low-cost, point-of-care molecular, cellular, and/or metabolic sensing and diagnostic technologies to guide rapid clinical decision-making, improve patient outcomes, and ultimately prevent maternal morbidity and mortality. More broadly, the goals of the NTAC series of prize competitions are to stimulate the design of new diagnostic technologies to transform public and global health and to accelerate the full development of those products urgently needed for use in low-resource settings.

To win NTAC: Maternal Health participants must: (1) submit their design for a point-of-care diagnostic test or platform technology with initial feasibility data or references addressing at least two of the four priority conditions listed below affecting maternal health during antenatal and intrapartum periods; and (2) submit a robust description of the proposed path for translation and further development of the diagnostic technology for use in global health settings. Additionally, diagnostics should be fully integrated digital health platforms. The four priority conditions and specific examples are as follows:

1. Infection: viral, bacterial, or parasitic infections; sepsis; post-procedural infections
2. Hypertensive disease: pre-eclampsia; eclampsia
3. Hemorrhage: acute anemia: iron deficiency anemia; coagulopathy
4. Placental issues: angiogenic or other markers of placental disruption

Submissions of diagnostic technologies may address additional conditions of relevance to maternal health; however, only those submissions that address at least two of the four priority conditions listed above will be considered for cash prizes. A strong submission to this Challenge will include a diagnostic technology design with the following characteristics:

• Technical validity demonstrated by initial feasibility data or references
• Platform potential – potential to adapt or extend the device to at least two of the priority conditions
• Measures parameters that could be used to track disease state and/or response to therapy
• Uses mobile device or portable attachment to a mobile device
• Low-cost, accurate, reliable, and accessible
• Self-contained and highly portable
• Allows rapid data collection and time to result
• Integrates prior context about the patient and environment in the test result
• Scalable to population delivery

Additional details about optimal diagnostic technology criteria and design considerations are provided in the Judging Criteria and Submission Requirements sections.

Partners: The Bill & Melinda Gates Foundation (Gates Foundation) shares a commitment to global health and is cooperating with NIBIB to consider additional support for the Challenge winners and honorable mentions. The Challenge is co-sponsored by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and the NIH Office of Research on Women’s Health (ORWH).

Dates:

• Challenge Launch: December 7, 2021
• Submission Start: January 5, 2022
• Registration Deadline: April 1, 2022
• Submission Deadline: April 22, 2022
• Judging Start: May 2022
• Winners Announced: July 2022

Statutory Authority to Conduct the Challenge: NIBIB is conducting this Challenge under the America Creating Opportunities to Meaningfully Promote Excellence in Technology, Education, and Science (COMPETES) Reauthorization Act of 2010, as amended [15 U.S.C. § 3719].

This Challenge is consistent with and promotes the general purpose of NIBIB which, as described in 42 U.S.C. 285r, is to conduct and support research, training, the dissemination of health information, and other programs with respect to biomedical imaging, biomedical engineering, and associated technologies and modalities with biomedical applications. This Challenge will reward and spur the development of sensing and diagnostic technologies to facilitate and guide clinical decision making to improve maternal health.

PRIZES

Amount of the Prize: The total prize purse from NIBIB for this Challenge is up to $1,000,000. NIBIB will award a first-place finalist up to $500,000, a second-place finalist up to $300,000, and a third-place finalist up to $150,000. One or more semi-finalists may be awarded up to $50,000 each at the discretion of NIBIB depending upon the availability of unawarded prize purse funds. NIBIB may recognize additional participants with non-monetary honorable mention awards.

Following the selection and awarding of the NIBIB prizes, the Gates Foundation has indicated its intent to review the submissions from Challenge finalists, semi-finalists, and honorable mentions for potential additional support. The submissions considered by the Gates Foundation for additional support, based on potential for impact in low-resource settings, may be eligible for some combination of grant funding and in-kind support in the form of consultations and partnerships for clinical data collection, software development, scale-up and manufacturing.

Award Approving Official: The Award Approving Official for prizes offered by NIBIB will be Dr. Bruce J. Tromberg, Director, NIBIB.

Payment of the Prize: Prizes awarded under this Challenge by NIBIB will be paid by electronic funds transfer and may be subject to Federal income taxes. HHS/NIH/NIBIB will comply with the Internal Revenue Service withholding and reporting requirements, where applicable. NIBIB 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.

Follow-on grant funds or other support offered by the Gates Foundation will be provided directly by the Gates Foundation, at the Gates Foundation’s discretion. If the Gates Foundation fails to provide any of the funds or other support it has proposed to provide, neither NIH nor NIBIB have the legal authority to provide those funds or support on their behalf. For more information, please contact the Gates Foundation.

RULES

Eligibility Rules: To be eligible to participate in and win a NIBIB prize under this Challenge, a Participant (whether an individual, group of individuals, or entity):

a. Shall have registered to participate in the Challenge under the rules promulgated by the National Institutes of Health (NIH) and the National Institute of Biomedical Imaging and Bioengineering (NIBIB) as published in this announcement;

b. Shall have complied with all the requirements set forth in this announcement;

c. In the case of a private entity, shall be incorporated in and maintain a primary place of business in the United States, and in the case of an individual, whether participating singly or in a group, shall be a citizen or permanent resident of the United States. However, non-U.S. citizens and non-permanent residents can participate as a member of a team that otherwise satisfies the eligibility criteria. Non-U.S. citizens and non-permanent residents are not eligible to win a monetary prize (in whole or in part). Their participation as part of a winning team, if applicable, may be recognized when the results are announced. Teams comprised entirely of non-U.S. citizens and/or non-permanent residents, or entities not incorporated in and not maintaining a primary place of business in the United States, will be eligible to be recognized with an honorable mention.

d. Shall not be a federal entity or federal employee acting within the scope of their employment;

e. Shall not be an employee of the Department of Health and Human Services (HHS, or any other component of HHS) acting in their personal capacity;

f. Who is employed by a federal agency or entity other than HHS (or any component of HHS), should consult with an agency ethics official to determine whether the federal ethics rules will limit or prohibit the acceptance of a prize under this Challenge;

g. Shall not be a judge of the Challenge, or any other party involved with the design, production, execution, or distribution of the Challenge or the immediate family of such a party (i.e., spouse, parent, step-parent, child, or step-child).

h. Shall be 18 years of age or older at the time of submission.

Participation Rules:

(1) A Participant (whether an individual, group of individuals, or entity) may not use Federal funds from a grant award or cooperative agreement to develop their Challenge submissions or to fund efforts in support of their Challenge submissions unless use of such funds is consistent with the purpose, terms, and conditions of the grant award or cooperative agreement. Participants 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, organization, or entity. If a Participant uses Federal grant or cooperative agreement funds and wins the Challenge, the prize must be 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).

(2) Federal contractors may not use federal funds from a contract to develop their Challenge submissions or to fund efforts in support of their Challenge submissions.

(3) By participating in this Challenge, each Participant (whether an individual, group of individuals, or entity) agrees to assume any and all risks and waive claims against the federal government and its related entities, except in the case of willful misconduct, for any injury, death, damage, or loss of property, revenue, or profits, whether direct, indirect, or consequential, arising from participation in this Challenge, whether the injury, death, damage, or loss arises through negligence or otherwise.

(4) Based on the subject matter of the Challenge, the type of work that it will possibly require, as well as an analysis of the likelihood of any claims for death, bodily injury, property damage, or loss potentially resulting from Challenge participation, no Participant (whether an individual, group of individuals, or entity) participating in the Challenge is required to obtain liability insurance or demonstrate financial responsibility in order to participate in this Challenge.

(5) By participating in this Challenge, each Participant (whether an individual, group of individuals, or entity) agrees to indemnify the federal government against third party claims for damages arising from or related to Challenge activities.

(6) A Participant (whether an individual, group of individuals, or entity) shall not be deemed ineligible because the Participant used federal facilities or consulted with federal employees during the Challenge if the facilities and employees are made available to all Participants participating in the Challenge on an equitable basis.

(7) By participating in this Challenge, each Participant (whether an individual, group of individuals, or entity) warrants that they are sole author or owner of, or has the right to use, any copyrightable works that the submission comprises, that the works are wholly original with the Participant (or is an improved version of an existing work that the Participant has sufficient rights to use and improve), and that the submission does not infringe any copyright or any other rights of any third party of which the Participant is aware.

(8) By participating in this Challenge, each Participant (whether an individual, group of individuals, or entity) selected to win a prize under this Challenge grants to the NIH/NIBIB an irrevocable, paid-up, royalty-free nonexclusive worldwide license to reproduce, publish, post, link to, share, and display publicly the Title and Summary components of the submission on the web or elsewhere. Each Participant will retain all other intellectual property rights in their submissions, as applicable. To participate in the Challenge, each Participant must warrant that there are no legal obstacles to providing the above-referenced nonexclusive license of the Participant’s rights to the federal government if they are selected as a winner. To receive an award, Participants will not be required to transfer their intellectual property rights to NIH/NIBIB, but winning Participants must grant to the federal government the nonexclusive licenses recited herein.

(9) Each Participant (whether an individual, group of individuals, or entity) acknowledges that NIBIB will provide winning submissions and their contents in full to the Gates Foundation.

(10) Each Participant (whether an individual, group of individuals, or entity) agrees to follow all applicable federal, state, and local laws, regulations, and policies.

(11) Each Participant (whether an individual, group of individuals, or entity) participating in this Challenge must comply with all terms and conditions of these rules, and participation in this Challenge constitutes each such Participant’s full and unconditional agreement to abide by these rules. Winning is contingent upon fulfilling all requirements herein.

(12) As a condition for winning a cash prize in this Challenge, each Participant (whether an individual, group of individuals, or entity) that has been selected as a winner must complete and submit all requested winner verification and payment documents to NIBIB within 10 business days of formal notification. Failure to return all required verification documents by the date specified in the notification may be a basis for disqualification of a cash prize winning submission.

JUDGING CRITERIA

Basis Upon Which a Winner Will be Selected: Submissions will be evaluated based upon the following Judging Criteria:

• Technical Approach (10 points): The degree to which the submission sufficiently describes the biological, chemical, and/or physical principles of the diagnostic technology, and mechanisms of sample collection, analysis, and reporting of results.
• Analytic Performance (10 points): The degree to which the diagnostic technology is able to accurately diagnose at least two of the four priority conditions affecting maternal health during antenatal and intrapartum periods and meet optimal performance criteria described further in the Submission Requirements section (e.g., time to results, form factor, lifespan, ease of use, etc.).
• Digital Platform Integration (5 points): The degree to which the submission effectively integrates the diagnostic with a digital health platform, either with existing or new software and hardware, can be easily and effectively implemented in a clinical setting, enable faster clinical decision making and reduce the dependence on healthcare resources and infrastructure.
• Clinical Utility (10 points): The potential for the diagnostic technology to guide rapid clinical decision-making, improve patient outcomes, and ultimately prevent maternal morbidity and mortality.
• Global Health Impact (10 points): The quality, rigor, and robustness of the plans for continued development of the diagnostic technology for implementation in global health settings and the likelihood of the technology meeting the requisite specifications, including cost, for use in such settings.
• Diagnostic Innovation (5 points): The extent to which the submission describes a scientific or technical approach that is novel (including multiplexed approaches) and represents a significant advancement over existing methods or approaches.

Initially, submissions will be evaluated by a multidisciplinary Evaluation Panel composed of experts in biomedical engineering, obstetrics and gynecology, and global health, among other areas of expertise, from across the academic, nonprofit, and industry sectors. The Evaluation Panel will then provide their evaluations of individual submissions to the Judging Panel composed of federal employees from across NIH and potentially other government agencies. The Judging Panel will review the evaluations and provide recommendations for finalists, semi-finalists, and honorable mentions, if applicable, to the Award Approving Official. Final award and honorable mention decisions, if any, will be made by the Award Approving Official.

To reiterate, NIBIB 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.

HOW TO ENTER

Registration Process: This Challenge announcement can be found on the Challenge.gov website and on the NIBIB website. However, the Challenge registration and submission portals will be administered by VentureWell, a platform provider under contract with NIBIB. Participants can access the portal by going to the VentureWell challenge website and clicking on REGISTER or SUBMIT YOUR ENTRY in the sidebar.

To register, participants will first be directed to establish an account in the VentureWell Community Portal and agree to the VentureWell Terms of Service and Privacy Policy. Participants will then be required to identify whether they are registering as an Individual (i.e., on behalf of yourself), Team (i.e., on behalf of a group of individuals), or Entity (i.e., on behalf of a legally established organization, institution, or corporation) and acknowledge whether federal funding will be used in the development of the Challenge submission. All Participants must certify they have read and understand and agree to abide by the official eligibility criteria, participation rules, and requirements for the Challenge as stated in this announcement.

• For Individuals: To be eligible to receive a cash prize, the Individual must be a citizen or permanent resident of the United States.
• 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 NIBIB’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, Participants 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 NIBIB’s satisfaction, the affected submission will be deemed ineligible.

Participants must complete their registration by 11:59 PM Eastern Time on April 1, 2022. Participants who do not complete their registration by the deadline will not have their submissions considered for this Challenge.

Submission Requirements: Participants who completed the Registration Process prior to the registration deadline must submit their entries via the NTAC: Maternal Health submission portal on the VentureWell challenge website Submissions should comprise of descriptions of a low-cost, point-of-care molecular, cellular, and/or metabolic sensing or diagnostic technology to guide rapid clinical decision-making, improve patient outcomes, and ultimately prevent maternal morbidity and mortality. Specifically, each submission must include the following sections:

(1) Title

(2) Summary: A brief description of the technology design, performance, and global health utility of the diagnostic device. Please do not include any proprietary or confidential information in the Title and Summary sections as they will be publicly shared for those submissions selected to win a prize or honorable mention.

(3) Technology Design and Performance: The design for a point-of-care diagnostic test or platform technology with initial feasibility data or references addressing at least two of the four priority conditions listed above affecting maternal health during antenatal and intrapartum periods. The technology design must describe the biological, chemical, and/or physical principles of the test and the measurement, analysis, and results reporting approach. Participants may submit data collected on device prototypes and additional evidence of feasibility data that de-risk elements of the technology and approach. Submissions should address how their diagnostic test or platform technology compares to the following optimal performance criteria:

• Analytic performance: The diagnostic technology must be relevant for clinical decision-making and accessible for relatively lower-skilled health providers, with results that are comparable to or improve upon standard practice at a peripheral setting. The technology must have comparable analytic sensitivity and specificity to existing tests. The technology should be able to incorporate dynamic personal and population priors (e.g., medical history or disease prevalence, respectively) to improve the accuracy of the test result in clinical settings.
• Digital platform integration: The diagnostic technology should be capable of full integration with digital health platforms and/or be linked to a mobile phone for analysis, results reporting, or other functions.
• Clinical utility:

i. For infections, the diagnostic technology should address diseases relevant in maternal health and must detect the source of infection or infective agent.

ii. For hypertensive disease, the diagnostic technology should combine blood pressure measurements with other biomarkers and/or priors to diagnose preeclampsia or eclampsia.

iii. For hemorrhage, diagnosis of anemia should differentiate mild, moderate and severe anemia. In addition, it should have at least 95% sensitivity and 90% specificity in each trimester of pregnancy at the moderate anemia threshold of 11.0g/dL and the severe anemia threshold point of 7.0g/dL.

iv. For placental issues, risk of placental dysfunction or insufficiency must be addressed with biomarkers and/or priors to inform risk assessment.

• Detection: Results from a test should be interpretable by a machine.
• Consumables: Priority will be placed on diagnostic technologies that do not use consumables.
• Time to results: Results should be interpretable within 15 minutes.
• Data capture: Information should be captured digitally from the diagnostic device in <10 seconds if handheld, and <60 seconds if wearable.
• Components: The final device should be operable on a mobile phone or with a small attachment to a mobile phone. Submissions should discuss potential for miniaturization of a prototype to this end state.
• Form factor: The device should be portable, and a health worker should be able to carry it independently over varied terrain. Participants should determine the appropriate form factor for the intended use case.
• Cost: The final cost of the device should be <$500, not including the cost of the phone or tablet used for digital connectivity or for diagnosis software. Submissions should discuss the potential for cost-reduction to meet this target cost.
• Target use case: The diagnostic technology should be intended for use in zero infrastructure conditions including outdoor settings and performed by untrained lay persons.
• Lifespan of device: The final diagnostic device should last at least two years. The submission should discuss potential to achieve a two-year lifespan.
• Ease of use: The diagnostic device should have no user-timed steps, five or fewer user steps, and instructions that include a diagram of method and results interpretation.

(4) Global Health Impact: A robust description of the proposed path for translation and further development of the diagnostic technology for use in clinical decision making in global health settings. To ensure alignment with global health use cases, Participants should address the following questions:

• What changes and further development for hardware, software, or data generation would be required to meet a global health use case?
• What are potential areas for cost reduction and technologies or approaches to achieve the target use case, considering the form factor and capital cost listed in the optimal performance criteria?
• Which level of health system would be targeted?

Submission Guidelines: Only complete submissions that follow the Submission Guidelines will be reviewed. In brief, submissions must:

• Be written in English, have appropriate page dimensions (8.5 x 11 inches), use a font size of 11 point or greater, and have at least 1-inch margins.
• Be no more than 10 pages long, including any references.
• Be submitted as a single PDF file via the VentureWell submission portal  by the submission deadline.
• Include the requested sections and information as listed in the Submission Requirements.
• Format any references according to the American Psychological Association (APA) style.

Participants must submit a complete submission by 11:59 PM Eastern Time on April 22, 2022. Participants who do not submit their complete submission by the deadline will not have their submission considered for this Challenge. Submissions that do not follow the Submission Guidelines may not be considered at NIBIB’s discretion, and any material that exceeds stated page limits will be considered supplemental and will be reviewed and judged at NIBIB’s discretion. Submissions must not include HHS’s logo or official seal or the logo of NIH or NIBIB and must not claim federal government endorsement.

ADDITIONAL INFORMATION

For Further Information Contact:

References:

1. https://www.nih.gov/research-training/medical-research-initiatives/improve-initiative

2. https://sdgs.un.org/goals/goal3

3. World Health Organization, UNICEF, United Nations Population Fund and The World Bank, Trends in Maternal Mortality: 2000 to 2017 WHO, Geneva, 2019.

4. Majors CE, Smith CA, Natoli ME, Kundrod KA, Richards-Kortum R. Point-of-care diagnostics to improve maternal and neonatal health in low-resource settings. Lab Chip. 2017;17(20):3351-3387. doi:10.1039/c7lc00374a5.

5. https://www.who.int/news-room/fact-sheets/detail/maternal-mortality

6. https://www.nih.gov/research-training/medical-research-initiatives/improve-initiative/about-maternal-morbidity-mortality

7. https://www.cdc.gov/nchs/data/hestat/maternal-mortality-2021/maternal-mortality-2021.htm