Description
Overview
The National Heart, Lung, and Blood Institute (NHLBI), of the National Institutes of health (NIH), hosted a two-day hybrid workshop May 8-9, 2023 to explore new innovations and technologies focused on addressing the major causes of maternal morbidity and mortality (MMM). The workshop brought together panelists from academic institutions, clinicians, small businesses, technology developers, federal funding and regulatory agencies, private investors, and payors from within the healthcare system. The presentations provided an overview of solutions in development and spurred conversation to facilitate new and effective innovations. These new innovations aim to promote maternal health equity, engage communities, and decrease MMM across populations. Videocasts are available for both Day 1 and Day 2 of the workshop.
Co-Sponsors
- NIH IMPROVE Initiative
- NIMHD
- NCCIH
- NINDS
- NIBIB
- NIAID
- ORWH
Agenda
Background
The U.S. ranks 50th in the world in MMM rates and outcomes with hypertension as the leading cause of maternal mortality. Preeclampsia, stroke, hemorrhage, obstructive airway events, and mental health represent some of the top concerns in maternal health. Many deaths associated with these complications are preventable in nearly 80% of cases. Technologies and approaches that facilitate early screening and diagnosis are pivotal in improving MMM outcomes. This workshop brought together stakeholders from a wide variety of backgrounds to examine how innovators, funding bodies, regulatory agencies, and payors can work together to improve MMM outcomes.
The overall objectives of the workshop were:
- Explore key scientific innovations in the diagnosis and treatment of MMM associated conditions and understand the areas that are ready for translation.
- Provide an overview of the process to get an innovation to market through partnerships with regulatory and reimbursement agencies, as well as provide resources and educational opportunities to facilitate the innovation process.
- Enhance equity and reduce disparities related to race/ethnicity, geography, and other social determinants of health (SDOH) through implementation science and community-based engagement.
Key questions for the workshop were:
- What new innovations and scientific advances in maternal health research can lead to new solutions to reduce MMM?
- What are the challenges in developing, validating, and translating MMM solutions?
- How can solutions be leveraged to reduce MMM in underserved and minority populations?
Summary
Given the dismal statistics in rates of MMM in the U.S. there is tremendous room for improvement. Over the course of this workshop, numerous advocates and experts from various disciplines discussed new innovations to improve maternal health outcomes in an effective and equitable manner. Navigating the path of innovation from development to market can be complex, but experts from regulatory and funding bodies and payors responsible for reimbursement provided information and advice on how to best work with these partners to ease the process and provide the best end-product possible.
The panels from the first day of the workshop covered clinical outcomes, technological innovations, community engagement, implementation science, and identified barriers and gaps for maternal heart, lung, blood, and sleep health, as well as mental health and substance use disorder (SUD). A common theme was to lead with empathy and encourage communication during development all the way through implementation of an innovation. Communication and partnerships were emphasized as important to developing a comprehensive innovation. Communities and stakeholders must be engaged early and often when innovating.
Community-engagement enables innovators to gather perspective and guidance, ensuring that an innovation helps those for whom it is intended. Listening to the lived experiences of a community and involving community members to develop “technology for us, by us” was highly encouraged. Involvement of community members and multiple stakeholders in various areas of expertise can improve development and facilitate sustainable implementation. By building these partnerships, innovators do not need to have all of the answers themselves, but rather can lean on others’ experiences to improve the innovation.
Additionally, panelists highlighted the use of technology to connect patients and end-users to resources that improve maternal health outcomes. Newer digital platforms and artificial intelligence (AI) technologies are useful not only to patients and users, but also to researchers and physicians to screen for health risks and collect data. It is important, however, to ensure that data is leveraged in a responsible and equitable manner so as not to exacerbate inequities or create new ones.
The panels on the second day of the workshop addressed the topics of government funding, regulatory considerations, the role of payors and reimbursement, and private investor funding. Panelists encouraged engagement with these stakeholders early and often so that innovators understand the unique challenges and interests of each respective group. Effective communication with partners and stakeholders allows innovators to lean on their expertise to develop, implement, and sustain an innovation.
Funding of innovations can come from both public and private sources in the form of government funding and private investors. Government funding partners discussed several programs available to innovators and small businesses. The programs provide funding opportunities for early research, getting an innovation to market, and access to mentorship programs with other resources and networking opportunities.
Private investors discussed what they are looking for in an innovation or innovator. They emphasized having a clear description of what an innovation is, what it does, and who will benefit from its use. Private investors may also consider whether they are the right ones to bring an innovation to market and what makes a particular innovator different than others they could fund. Overall, investors wanted to see that an innovation can make an impact on people’s lives while also producing a return on investment.
When dealing with regulatory bodies, innovators must have a clear description of what an innovation is and what it does. The innovation must also demonstrate an improvement to the standard of care. Panelists emphasized that regulation in the maternal health space considers two patients both during pregnancy and postpartum resulting in a higher bar set for safety.
Determining who will pay for an innovation within the U.S. healthcare system is very important and this is where payors come in. Payors are often healthcare companies with an interest in whether or not an innovation will actually improve the lives of patients. Panelists from payor backgrounds provided advice for innovators including engaging with payors early and often to understand any possible challenges to reimbursement. Additionally, panelists emphasized greater focus on innovations that facilitate early detection and diagnosis of conditions that may cause birth complications.
Throughout the workshop, poster sessions and pitch talks allowed innovators opportunities to share their innovations. These included new devices for screening and monitoring purposes; new treatment methodologies; digital platforms and smartphone apps to connect patients with care, provide resources, and monitor for mental health or physical complications; and AI or machine learning-based approaches for quick screening, detection, and treatment of mental health or other challenges. Results and summaries from cohort studies involving cardiovascular diseases and other maternal health concerns were also presented.
Conclusion
New technologies and innovations are intended to solve big problems and close gaps in maternal health outcomes in a way that is relevant and appropriate to communities. Throughout the workshop, panelists reinforced prioritizing empathy, communication, community engagement, and building partnerships with stakeholders. Keeping these priorities in mind, participants and attendees can facilitate better development, implementation, and sustainability of equitable innovations across diverse populations. Pregnancy is not without risk, but by building multi-disciplinary partnerships and developing new innovations with empathy, it is possible to significantly mitigate risks and improve maternal health outcomes.
Key opportunities and themes from the workshop:
- Adjust diagnosis and treatment criteria for hypertension and obstructive sleep events in pregnant people to increase early screening rates and improve outcomes.
- Improve screening and monitoring for prenatal and postpartum mental health and physical care.
- Develop and validate technologies and treatments for use with pregnant people and include pregnant people in clinical trials.
- Engage communities and include diverse perspectives early and often throughout development and implementation of innovations.
- Tailored interventions relevant to diverse communities and cultures should be advocated for and explored in order to minimize inequities.
- Traditional data collection has missed or excluded marginalized communities, but alternative methods of data collection, analysis, and application can make sure all communities are represented in the data to expand the understanding of the maternal health reality.
- Consider generational differences and outer setting issues for implementation of an innovation such as access to broadband, payment policies, and power sources that may be needed.
- Partnerships and multi-disciplinary teams should be utilized to provide expertise in multiple areas, increasing the likelihood of a successful innovation.
- Digital platforms can educate both patients and providers, providing resources to improve screening and treatment for mental health and SUD.
- Innovators need to have a clear description of what an innovation is and what it does, and must be able to explain this effectively.
- Early engagement and communication with funding program managers, regulators and payors can help innovators understand their respective interests, potential pain points, and improve the innovation.
- Maternal health innovations must consider two patients (the pregnant person and the fetus or child) when examining safety and efficacy profiles or clinical trial enrollment.
- Innovations must actually improve the lives of those served and add value to patients for payors and investors to be interested.
Contact
For more information, contact Ilana Goldberg (ilana.goldberg@nih.gov).