Midlife Innovations Driving Long-term Improvements in Female Health

Overview

The RADx® Coordination Center at Cimit, on behalf of the National Institute of Biomedical Imaging and Bioengineering (NIBIB) and The National Institutes of Health (NIH) Office of Research on Women’s Health (ORWH) announces Midlife Innovations Driving Long-term Improvements in FEmale HEALTH (MIDLIFE Health) to accelerate the development of innovative technologies, including but not limited to wearables, biomarkers, diagnostics, imaging, therapeutics, prevention pathways and repurposed tools, that improve health outcomes of women-during midlife.

MIDLIFE Health consists of three assessment phases, with a total of $3,225,000 in planned awards, which includes $1,000,000 from the NIH Office of AIDS Research (OAR) to support technologies relevant for women with HIV, in addition to in-kind technical, clinical, and commercialization support to maximally accelerate progress. Only those Innovators selected to win in each phase will be permitted to advance to the subsequent phase. In addition to the elements described in detail below, eligible applicants must demonstrate a working prototype to address health conditions and/or symptoms experienced by women in midlife. The program is particularly interested in innovations addressing understudied conditions and those unique to specific populations, such as women living with HIV.

Background

The mission of ORWH is to support and integrate research on women’s health and sex influences across the NIH scientific enterprise to advance discovery and improve health across the life course. In partnership with the National Heart Lung and Blood Institute (NHLBI), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Institute of Dental and Craniofacial Research (NIDCR), National Institute on Minority Health and Health Disparities (NIMHD), National Institute of Nursing Research (NINR), Office of AIDS Research (OAR), Office of Behavioral and Social Sciences Research (OBSSR), and Agency for Healthcare Research and Quality (AHRQ), ORWH seeks to leverage the RADx® Innovation Funnel to catalyze solutions that help identify, understand, prevent and treat women’s midlife health conditions through technologies designed for real-world implementation. MIDLIFE Health will also accelerate actionable tools for women that support better health, informed decision‑making, and overall well‑being during midlife. These innovations can be developed to empower women directly, support healthcare providers, or enhance interactions between both.

Approximately one in four women are currently between the ages of 45 and 65 years old (US Census Bureau), a period typically referred to as midlife. Midlife is a pivotal period often accompanied by a host of unique symptoms, as well as an increased risk for emerging chronic diseases, many of which could be prevented or mitigated by timely interventions introduced during these years.  For example, even though up to 80% of women experience disruptive symptoms such as hot flashes, sleep disturbances and mood changes during the menopausal transition, only 20% seek medical care for relief and only 15.6% currently take prescription medication for management. This gap is due to many factors including stigma and lack of awareness, resources, and physician knowledge.

Midlife is an inflection point when women experience increased vulnerability to chronic health conditions such as cardiovascular disease, musculoskeletal disorders, oral health challenges, and behavioral health concerns. During this period, hormonal changes, evolving lifestyle factors, and caregiving responsibilities may intersect with increasing risks for chronic conditions and psychosocial stressors, while existing health disparities may persist or become more pronounced over time and shape nursing, oral and dental health, and other healthcare needs, including the prevention and management of communicable diseases such as HIV. Research advances and innovations aimed to improve women’s health during midlife remain underfunded and overlooked, leaving millions of women without the support and solutions that they need. Most available therapies for midlife women’s health continue to center on estrogen-based approaches, leaving a significant gap in effective treatments that address the wide range of biological pathways driving midlife symptoms and long‑term health risks. In addition, many existing therapies and innovations have not accounted for differences between women in factors such as skin tone, hair density, and anatomy, and any potential impact of these factors on intervention effectiveness, acceptability, and applicability for all women.

Midlife brings heightened awareness and concern about overall health despite successful achievements taking place concurrently in other domains during these years.  As such, there is significant variation in women’s midlife transitions and experiences. Compared to midlife men and younger women, women in midlife tend to have more frequent interactions with the health care system due to onset of chronic conditions, preventative screening, menopause-related symptom management and other related health outcomes. Women seek care for midlife health concerns across a wide range of healthcare settings, including primary care practices, obstetrics and gynecology clinics, specialty care settings such as cardiology, rheumatology, behavioral health and oral health clinics, community health centers, telehealth platforms, retail health clinics, and workplace-based health services. Because care for midlife health needs is often distributed across multiple settings and providers, women may encounter fragmented care pathways, inconsistent information, and challenges coordinating treatment and preventive services. Further, many women in midlife become caregivers for aging parents and family members, in addition to caring for children, which leads to additional system touchpoints. Due to their regular system touchpoints, women in midlife represent a high impact population for innovation.

While women are increasingly utilizing health technologies, they face unique barriers to engaging with health technologies, such as concerns about privacy, trust, usability, and a historic lack of products tailored to their needs and lived experiences. Overcoming these barriers requires direct engagement with women, as well as integrated approaches that consider the roles of healthcare providers, employers and insurers. Recently, there has been a rapid rise in commercial and public‑facing health messages and products aimed at women in midlife. Because many of these offerings have not undergone rigorous evaluation, their effectiveness remains uncertain and may inadvertently slow progress toward improving women’s health.

Despite the lack of validated and effective tools and technologies to support midlife women’s health and the emergence of complex, disruptive symptoms that make menopause a true inflection point, midlife is also a period marked by growth, clarity, renewed purpose, and strengthened connections. Women are increasingly advocating for themselves during midlife, and seeking access to resources, tools and communities that have been shown to enhance health management and improve quality of life. However, not all women have easy and affordable access to these tools or communities, leaving many without the support required to navigate this pivotal stage. To fully realize these positive dimensions, innovations intentionally designed to cultivate resilience and sustain the thriving aspects of midlife are urgently needed.

Advancing midlife women’s health will require more than innovative technologies; it will take a coordinated effort to bridge persistent gaps in evidence, access and real-world adoption. Leveraging cross-agency partnerships and direct engagement with women and their communities will enable this initiative to catalyze solutions that improve outcomes for women’s midlife health, including by offering wraparound support and robust verification throughout the innovation process.

This innovation funnel encourages innovators to identify and tackle barriers such as fragmented care pathways, limited provider and patient education, challenges accessing healthcare, and imbalances in technology access. Opportunities exist to integrate new tools into routine care, foster interdisciplinary collaboration, and prioritize usability and eliminating disparities from design through implementation. Ultimately, the goal is to generate scalable, marketable, rigorously validated solutions that respond to women’s unique needs, circumstances, and goals to empower women in midlife, improve health outcomes, and set new benchmarks for quality and responsiveness to all populations in women’s health innovation.

Program Description

The NIH is planning to award a total award amount of $3,225,000 to accelerate the development of woman-focused technologies to address midlife health, which includes $1,000,000 from the NIH Office of AIDS Research to support technologies relevant for women with HIV. MIDLIFE Health invites applicants to develop innovative approaches to understand, monitor, and support women’s midlife health. Proposed diagnostics, treatments and interventions should be both evidence-based and designed for real-world adoption and use directly by women and/or by healthcare providers.  Successful technologies will empower women and their support networks with actionable health information and personalized interventions, enabling informed decisions about when and how to seek additional care. Solutions focused on understudied female midlife health conditions and/or symptoms, as well as solutions co-designed with women to ensure accessibility, relevance, and sustained engagement will be prioritized.

Potential innovations may include, but are not limited to:

• Wearables, Remote Monitoring, and Symptom Tracking
• • Wearable neuromodulation technologies designed to address cognitive symptoms associated with the menopausal transition.
  • Symptom-tracking platforms that continuously capture joint pain, bone-density risk factors, sleep, and vasomotor symptoms.
  • Novel tools or technologies for early detection and management of heart, lung, blood, and sleep (HLBS) conditions.
  • Wearable or remote-monitoring platforms designed and validated for women with HIV that combine sleep, physical activity, vasomotor symptoms, cardiovascular measures, and patient-reported outcomes to distinguish menopausal symptoms from HIV- or treatment-related conditions and identify emerging health risks.
• Super Intelligence, Imaging, and Predictive Analytics
  • A smart, data‑powered system that connects oral health data with whole‑body health information, including comorbidities and complications for midlife women living with HIV or other chronic diseases.
  • Deep-learning approaches to imaging (e.g. bone density scans, joint MRI, skin aging/photoaging markers, etc.) to support early detection of
  • Technologies that integrate HIV-specific clinical and treatment data with menopause symptoms, patient-generated data, and cardiometabolic, bone, and other midlife health measures to support risk prediction, personalized management, and coordinated care for women aging with HIV.
• Digital Therapeutics and Disease Management
  • Novel tools or technologies to manage sickle cell disease in women in mid-life, especially during the peri-menopause transition.
  • Tools that provide early detection of women’s cancers.
  • Sensing technologies that continuously monitor biomarkers associated with metabolic health, substance use, infection risk, or hormonal transitions
  • Technologies that integrate dental, behavioral, medical, patient-generated or other relevant data to support risk assessment, diagnosis, monitoring, treatment selection, referral or coordinated care.
  • Digital tools to support menopause management for women with HIV, including symptom assessment, treatment selection, polypharmacy review, potential interactions between HIV therapy and menopause therapy, and referral to appropriate HIV, gynecologic, or specialty care.
• Interventions and Prevention Strategies
  • Novel non-hormonal interventions for vasomotor symptoms, sleep disturbances, or cognitive symptoms.
  • Drug-device combinations that improve the delivery, monitoring, or personalization of treatment.
  • Novel or optimized hormone-based therapies, including androgen approaches, for women with HIV to address sexual health, menopausal symptoms, body composition, or other midlife health needs while accounting for HIV therapy, drug interactions, and long-term safety.
• Telehealth and Virtual Care Delivery
  • A telehealth platform that expands access to comprehensive midlife care, including HIV management, menopause care, mental health services, or chronic disease management, for women in rural communitie
  • Employer- facing telehealth solutions that offer midlife transition support and care adjacent to coaching for weight, sleep, and bone/joint health.
• Clinical Workflows, Interoperability, and Care Coordination and Navigation
  • An interoperable EHR-based workflow that automatically coordinates referrals between HIV care, gynecology, primary care, and behavioral health, reducing missed screenings and improving continuity of care.
  • A tech-enabled community health worker or peer navigator program/platform that improves engagement in preventive care, menopause management, chronic disease screening, and HIV care.
  • An algorithm that compiles and combines data from various platforms and sources and harmonizes data into common domains allowing women to capture health information from disparate sources and derive insights to render that information actionable.

Responsive submissions must:

• Focus on at least one understudied midlife health condition (e.g., non-vasomotor menopausal symptoms, perimenopausal depression and anxiety, osteoporosis, cardiovascular disease, autoimmune disorders, metabolic syndrome, musculoskeletal pain, cognitive changes, sexual health issues, drug use, sleep disorders, oral health issues).
• Involve (or have clear plans to involve) women in midlife with lived experience, and their support networks, throughout all stages of product development, with community partners holding decision-making authority across multiple major project stages, clearly defined roles and shares of project effort, named leads and deliverables, resources commensurate with their contributions, and shared responsibility for interpreting results and guiding community implementation and dissemination.
• Involve (or have clear plans to involve) clinicians, including advanced practice professionals (e.g., physicians, dentists, nurses, mental health professionals, pharmacists, physical therapists) in solution development.
• Identify and propose solutions to address potential barriers to adoption (such as integration, technology access, health literacy, stigma, and provider education).
• Have a likelihood to reach market in 3-5 years.
• Commit to delivering working prototypes and instructions for use for verification testing by April 2028.
• Provide analytical and/or clinical performance data.
• Demonstrate potential to extend, improve, or enhance care for women in midlife.
• Show potential for efficient integration into the intended use settings.
• Incorporate existing standards and consider regulatory requirements and reimbursement strategies where appropriate.
• Include proposed milestones and deliverables for further technology development and optimization that are quantitative, and with clear go/no-go criteria.
• Have a reasonable IP strategy.

Highly competitive submissions should: 

• Demonstrate an interdisciplinary approach, ideally combining multiple fields or disciplines.
• Describe the structured innovation pathway. This includes describing the concept of moving from validation to operational adoption and financing.
• Be capable of efficient integration into the intended healthcare environments and workflow processes (i.e.,easily used by healthcare professionals as part of their routine protocols), or capable of overcoming barriers to the entry of novel approaches within current clinical care settings.
• Provide usability data and/or evidence of user-centered design.

Program Structure

MIDLIFE Health consists of three assessment phases. Only those Innovators selected to win in each phase will be permitted to advance to the subsequent phase.

Innovators will submit a proposal describing their prototype technology, anticipated use (e.g. clinical, at-home, community) expected impact, and a robust plan for continued development. Technologies at the conceptual design or idea stage will not be considered. Innovators are also encouraged to utilize a multidisciplinary approach to further develop their technology and incorporate women with lived experience throughout the project.

Phase 1: Viability Assessment
Applications will be submitted online. Following administrative triage, proposals will be evaluated by a Viability Panel of scientific/technological, clinical, and commercialization experts and against the Evaluation Criteria.

Phase 2: Deep Dive Assessment
Phase 1 awardees will participate in an interactive Deep Dive Assessment. A Project Team of healthcare technology commercialization and content experts will engage directly with each innovator to assess the prototype technology across the Evaluation Criteria and will work with the NIH to identify key risk factors for accelerated development and implementation and establish strategies to mitigate these risks.

Phase 3: Technology Optimization, Verification, and Pitch
Phase 2 awardees will participate in Phase 3. Phase 3 consists of two parts:

(1) technology optimization and (2) verification

During technology optimization, Innovators will continue to work with the assigned Project Team to further develop and reduce associated risks and be awarded up to $400,000 in milestone-driven payments. In the verification portion, Innovators will send the technologies and associated user instructions for independent verification of functional and/or analytical performance and usability.

Finally, innovators will participate in a virtual event and deliver a pitch presentation and demonstration of the technology as well as plans for further development and commercialization. Further details on the logistics, timing, and format of the presentations will be provided to the Phase 2 awardees at a later date.

Evaluation Criteria

For each Phase, an Evaluation Panel composed of technical experts with subject matter expertise relevant to the Funnel goals will individually assess each submission using the Evaluation Criteria listed below and provide scores to the Judging Panel. The Judging Panel, composed of federal employees, will recommend awardees to the Award Approving Official who will make the final award decision.  

Submission packages will be assessed using the following criteria. Each criterion will be rated on a five-point scale from “not at all” to “completely.” Ratings across criteria will be combined to produce a score for each submission. 

Phases 1 and 2 (Viability and Deep Dive Assessments)

1. Scientific/Technological
   • Technological feasibility and proof of concept: Demonstrated feasibility of the technology supported by sufficient data and evidence,
   • Technical performance: Demonstrated ability of the technology to accurately predict, detect, diagnose, and/or monitor one or more conditions affecting women in midlife.
   • Technology readiness: Maturity of the technology and evidence that it can reach the Phase III verification stage within the program’s timeline.
   • Innovation and advancement: Extent to which technology’s development utilizes a scientific or technical approach that is novel, unique, or a significant advancement over the current standard of care.
   • Interdisciplinary collaboration: Extent to which technology’s development leverages interdisciplinary expertise and collaboration.

2. Clinical
   • Clinical Impact: Demonstrated potential to extend, improve, or enhance care for women in midlife.
   • Unmet needs:Degree to which the technology addresses an understudied condition affecting women in mid-life.
   • Implementation: Potential for the technology to be useful, practical, and deployable in relevant environments.
   • Home-based technologies: Ability of home-based technologies to generate actionable information that supports informed decisions in health management, care planning, or clinical decision-making.
   • Integration into healthcare workflows: Potential for efficient integration into the intended healthcare environments and workflows (i.e., easily used by healthcare professionals as part of their routine protocols), or ability to overcome barriers to the entry of novel approaches within current clinical care settings.

3. Access and User-Experience
   • User-centered design: Extent to which the technology addresses the needs of and early engagement of women, healthcare providers, user communities, and/or nonprofits to ensure that the solutions reflect their needs and enhance user acceptance.
   • Partnership and Engagement: Extent to which women in midlife, community organizations, patient advocacy groups, healthcare providers, caregivers, and other relevant stakeholders are engaged in the design, development, testing, implementation, and evaluation of the technology
   • Reach and Relevance: Extent to which the solution considers and, if needed, address barriers to access/cultural and linguistic differences.
   • Implementation: Clarity of the pathway to implementing the technology in multiple areas within the health ecosystem.
   • Sustainability: Potential for the solution to be sustained and incorporated easily and consistently into clinical practice or women’s daily lives.

4. Commercialization
   • Market readiness: Likelihood that the technology will be available on the market within the next 3-5 years.
   • Scalability: Potential to manufacture and implement at scale.
   • Growth and sustainability: Strength of the team’s plan for growth and long-term sustainability.
   • Intellectual property: Extent to which the team owns or licenses the necessary patents, trademarks, copyrights, trade secrets, domain names, or other IP assets.

5. Regulatory and Reimbursement
   • Regulatory readiness: Strength of the plans to obtain required clearance and approval from the applicable regulatory agency, such as the US Food and Drug Administration.
   • Regulatory risk mitigation: Extent to which the submission address solutions to the likely regulatory challenges on a realistic schedule to achieve the stated goals.
   • Payment and reimbursement strategy: Strength of the proposed payment model and reimbursement strategy to support market adoption and revenue potential.

Phase 3 – Technology Optimization, Verification, and Pitch

The timing, requirements, and evaluation criteria will be announced prior to the beginning of Phase 3 and will be determined based upon the portfolio of technologies having entered the Deep Dive Assessment Phase, their stage of development, and the work required to successfully complete the independent technology verification step.

Awards

The planned awards for this program total $3,225,000, which includes $1,000,000 from the NIH Office of AIDS Research to support technologies relevant for women with HIV. Awards will be made to the selected innovators after successful completion of each phase in the following amounts:

Teams selected to advance to Phase III will also receive a comprehensive package that includes:

• Technical and Scientific Guidance: Access to subject matter experts who provide feedback on technology development, scientific rigor, and feasibility.
• Verification: Opportunities to pilot and evaluate innovations in real-world clinical settings, including connections to clinical research networks and implementation science hubs.
• Commercialization Support: In-kind resources such as mentoring on business strategy, market entry, and sustainability.
• Regulatory and Reimbursement Consulting: Dedicated experts help awardees understand and plan for regulatory approval.
• Milestone-Based Progression: MIDLIFE Health is structured in phases, with expert teams guiding awardees through Deep Dive Assessment and Technology Optimization/Verification. Each phase includes robust review and feedback to de-risk and accelerate development.

Timeline  

This solicitation will use a single posted submission deadline. The program reserves the option to extend the deadline if needed to ensure a competitive pool.

• October 20, 2026: MIDLIFE Health launched/announced
• November 16, 2026: Submission Opens
• November 23, 2026: Informational Webinar (register here)
• January 29, 2027: Submission Deadline
• Feb-March 2027: Phase I – Viability Assessment
• April-May 2027: Phase 2 – Deep Dive Assessment
• June 2027 – April 2028: Phase 3 – Technology Optimization
• May – October 2028: Phase 3 – Verification
• October 2028 (estimated): Awardees announced

Eligibility

• Eligible applicants may include individuals, teams, nonprofit organizations, community-based organizations, academic institutions, and for-profit companies.
• Applicants must have a place of business located in the United States, which operates primarily within the United States, or which makes a significant contribution to the United States economy through payment of taxes or use of American products, materials or labor. Organizations should be more than 50% directly owned and controlled by individuals who are citizens or permanent resident aliens of the United States.
• Projects must be original and developed for this Funnel (or substantially adapted for it).
• To be eligible for funding with OAR funds, solutions must be relevant for women with HIV (FY 2026–2030 NIH Strategic Plan for HIV and HIV-Related Research)

How to Apply

Proposals must be submitted through Cimit’s CoLab platform and are due no later than 11:59pm EST on  January 29, 2027. Applicants are encouraged to thoroughly review this solicitation and the FAQs. Any questions should be sent to  RADx_MIDLIFE@mail.nih.gov.

Additional Information

An informational webinar will be held on November 23, 2026 from 3-4PM EST. Please register here.

For questions or additional information, contact: RADx_MIDLIFE@mail.nih.gov.