The Advanced Research Projects Agency for Health (ARPA-H) has released a major new Innovative Solutions Opening (ISO) titled Making Obstetric Care Smart (MOCS). This is a national effort to transform maternal and fetal health outcomes through advanced, data-driven technologies. As maternal morbidity and mortality rise across the United States, ARPA-H is calling on innovators to address long-standing clinical challenges in labor and delivery with new tools, improved monitoring capabilities, and patient-centered solutions. The MOCS program seeks to modernize obstetric care with predictive insights, real-time assessment, and improved decision-making for healthier births nationwide.
Solicitation Overview
At its core, MOCS is a four-year, three-phase research and development program aimed at building next-generation diagnostic and monitoring systems for labor and delivery. The ISO outlines two Technical Areas (TAs) that reflect urgent unmet needs in obstetric care. Technical Area 1 (TA1) focuses on developing a rapid, point-of-care test that can predict the risk of intrapartum fetal hypoxia before a patient enters active labor. This diagnostic tool must offer easy-to-interpret binary and quantitative results within 15 minutes and be deployable across delivery settings. Technical Area 2 (TA2) seeks a wireless, noninvasive fetal monitoring system equipped with integrated sensors and machine learning algorithms capable of assessing fetal oxygenation status in real time and recommending the next best step to treat hypoxia.
Across both TAs, ARPA-H places a strong emphasis on end-user engagement, real-world usability, and clinical workflow integration. Proposers must partner with at least three delivery sites (one rural, one urban academic, and one birthing center) to iteratively test solutions, gather patient and provider feedback, and refine design features. Additionally, all performer teams will participate in Independent Verification & Validation (IV&V) testing during Phase 2, during which hospital systems selected by ARPA-H will evaluate usability, scalability, comfort, and trustworthiness.
Program Structure and Requirements
MOCS is structured into three phases over 48 months:
- Phase 1 (12 months): Prototyping, focused on early biomarker identification, sensor development, feasibility demonstrations, and FDA pre-submission activities.
- Phase 2 (12 months): Refinement, incorporating stakeholder feedback, expanding early testing, and implementing design controls required for later clinical evaluation.
- Phase 3 (24 months): Translation, including clinical trial preparedness, IDE submissions, Phase 1 clinical trials, and full preparation for FDA submissions.
Proposing teams must operate as multi-party teams rather than traditional prime/subcontract structures. Teams must include a full-time program manager, a clinical research coordinator, an actively practicing ACOG-certified obstetrician caring for Medicaid patients, and a clinical bioethicist. TA2 proposers must also include a malpractice attorney specializing in obstetrics. Human subjects research planning, monthly reporting, and participation in in-person program meetings across all phases are mandatory.
Key Dates for Proposers
ARPA-H has outlined several critical deadlines for MOCS:
- Teaming Page Opens – November 13, 2025: Proposers may begin forming collaborative teams and posting profiles.
- Proposer’s Day – December 11, 2025: A full-day event providing program insights, teaming opportunities, and direct engagement with ARPA-H.
- Mandatory Pre-Proposal Discussions – December 15–19, 2025: Required 30–45 minute sessions with the MOCS program team.
- Mandatory Pre-Proposal Discussions – December 19, 2025 at 12:00 PM ET: 30-45 min slots between 9 AM-5 PM ET. Scheduling requests must be submitted by noon.
- Frequently Asked Questions – January 14, 2026: All questions must be submitted via the portal no later than 01/14/26.
- Full Proposals Due – January 21, 2026 at 12:00 PM ET: Final deliverables must be submitted through the ARPA-H Solutions Portal.
Funding Expectations
ARPA-H anticipates awarding multiple Other Transaction (OT) agreements, with performers advancing through phases based on technical progress, FDA-aligned milestones, and availability of funds. While cost-sharing is not required, it is strongly encouraged, particularly given the program’s commercialization-driven metrics. The total period of performance extends across the full 48-month structure, and ARPA-H expects only a subset of performers to proceed beyond each phase.
Advancing Maternal and Fetal Health Through Innovation
The MOCS program represents one of the most ambitious federal efforts to date aimed at reshaping maternal and fetal health outcomes in the United States. By equipping clinicians and families with predictive tests, real-time monitoring tools, and data-driven intervention pathways, ARPA-H seeks to dramatically reduce unnecessary cesarean sections, prevent avoidable neonatal complications, and standardize safe, equitable care for all birthing patients. These innovations have the potential to make childbirth safer, more predictable, and more patient-centered, addressing long-standing disparities and ushering in a new era of smart obstetric care.
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