Download PDF Engineering for Women's Health April 25, 2022 Volume 52 Issue 1 The articles in this issue describe the latest technologies for detection of breast and other cancers, approaches to reduce the incidence of premature births, and remote monitoring for pregnancy, a development of particular interest as the pandemic discouraged many people from going to a doctor’s office or hospital. Guest Editor's Note Enhancing Engineering Approaches to Understand and Treat Women's Health Wednesday, March 30, 2022 Author: Marta Villarraga The field of biomedical engineering has been emerging over the last few decades. While its contributions may be less visible than engineering applications in cars, trains, bridges, electrical grids, and buildings, it is no less critical. And it is rich with opportunities for development to enhance health through knowledge, diagnostics, and treatment. Those of us involved in that field get excited every day about researching and solving problems directly related to the human body. There are many interesting areas of study and applications of engineering, whether focusing on a disease type or on specific organs. One area that is slowly getting more attention is women’s health, particularly conditions that affect reproductive organs or female anatomy and physiology. Some of the products available to evaluate women’s health conditions were developed many years—even centuries—ago, but research and development in this area have lagged compared with other areas, and much of the attention has focused on male subjects. Fortunately, that is starting to change, although much more needs to be done. Government Initiatives Women’s health is an increasing area of focus in US government agencies, including the National Institutes of Health (NIH) and the US Food and Drug Administration (FDA). NIH has identified health issues or conditions that are unique to women, including urinary tract health, gynecological issues and disorders, pregnancy, fertility, contraception, menopause, and osteoarthritis. Recently, in response to a congressional request, the NIH Office of Research on Women’s Health sponsored a Women’s Health Conference on maternal morbidity and mortality, chronic debilitating conditions, and cervical cancer. The FDA Center for Devices and Radiological Health (CDRH) created the Health for Women Program in 2016. It focuses on issues related to the performance of medical devices in women, improved analysis and communication of sex- and gender-specific data to ensure the safety and effectiveness of medical devices, and development and implementation of CDRH programs focusing on women’s health issues. The CDRH Health of Women Strategic Plan (January 2022) lays out the goals of a “modern program to explore the unique issues related to the performance of medical devices in women, not only in the reproductive health space, but across a woman’s lifetime” and highlights the importance of medical devices to “optimally align with the considerations of usability and performance in women.” The plan outlines three priorities: (1) sex- and gender-specific analysis and reporting to improve and better understand performance of medical devices in women, (2) an integrated approach to analyze current and emerging issues related to the health of women, and (3) a research roadmap that not only considers the gaps and unmet needs of women’s health but also promotes the advancement of regulatory science in this space. Such government initiatives can inform funding and policies to advance science and engineering developments in support of women’s health. Industry Products involving the application of engineering and scientific principles to address women’s health include those for breast reconstruction, diagnostic imaging (e.g., for breast and cervical cancer), prenatal monitoring, urogynecological applications, breast pumps, and wearables, among others. “Femtech” comprises the technologies, services, and products that address health concerns that solely, disproportionally, or differently affect women and girls. A new term has evolved for this growing industry: “femtech,” which comprises the technologies, services, and products that improve female health and wellness by addressing concerns that solely, disproportionally, or differently affect women and girls. Digital health, artificial intelligence, and machine learning are also being explored for application in this space. Organizations The Society for Women’s Health Research (SWHR; https://swhr.org/) was founded in 1990 to inform science, policy, and education as part of its vision to “Make women’s health mainstream.” In addition to influencing the inclusion of women in clinical trials at both NIH and FDA, SWHR creates interdisciplinary science networks for researchers, clinicians, and patients with diverse perspectives and publishes peer-reviewed articles. The nonprofit FemTech Focus (https://femtechfocus.org/) brings together healthcare professionals, entrepreneurs, and investors, and maintains a database of companies categorized by product type and subsection. In This Issue The articles represent a small sample of engineering approaches to better understand women’s health, ways to monitor or treat conditions, and the use of data to improve the effectiveness of existing tools. In the opening article, Alexa Baumer, Alexis Gimovsky, Michael Gallagher, and Megan Leftwich discuss an engineering framework based on synthetic analog models to study the biomechanics of pregnancy and childbirth, with an emphasis on the role of a prematurely softened cervix in preterm birth. By combining synthetic modeling with clinician input, they created material silicone synthetic models to mimic clinically relevant material properties for cervical tissue analogs and then tested these to identify failure loads of cerclage. The authors see this as a first step toward providing material information on cervical tissue that may be useful in other physical and computational models. Jessica Walter, Shuai Xu, John A. Rogers, and Jeffrey Stringer describe the role of wearables in remote monitoring for pregnancy and the growth of digital health care due to the pandemic. They identify factors that should be considered for effective wearables in pregnancy: the suite and interpretation of measurements required to improve clinical outcomes, the spectrum of environments in which the sensors are to be used, the intended users (lay consumers, experts, or both), and an adaptable device form factor. The authors briefly survey existing and emerging remote pregnancy monitoring systems, and present their own wireless sensor system for pregnant women. There is a lot of room for development and growth in this area that incorporates the challenges of integrating data analytics, data security, real-world data, engineering design, and machine learning to ensure optimal effects on women’s pregnancy health across various settings. Ridhi Tariyal and Stephen Gire present a novel concept using real-world data to improve female reproductive care with an accessible, objective, and precise diagnostic tool. The “menstrualome” is a discrete dataset of molecular profiles of cells from the reproductive tract acquired via tampons and informed by deep phenotypic annotation. Using sequencing technologies to determine the composition of menstrual effluence from tampon samples collected longitudinally, the authors’ NextGen Jane system extracts information from gene expression of samples (along with peripheral blood samples) to determine patterns in the cell types analyzed. Their approach improves signal-to-noise to facilitate identification of signatures of disease. The application includes a self-administered, home-based device for privacy and ease of use, and diagnosis that incorporates the patient’s medical history. The ability to collect and analyze so much real-world data could greatly benefit women’s health. In the next article Srinivasan Vedantham and Andrew Karellas explain the role of mammography screening for early detection of breast cancer and review the evolution of breast imaging technologies to include modalities such as digital breast tomosynthesis (DBT) and dedicated breast computed tomography (BCT). One advantage of BCT is that it does not require physical compression of the breast, a demonstrated factor in women’s lack of regular screening, with implications for early detection, treatment, and mortality. The authors note that technical challenges, clinical adoption, and data analysis will play a crucial role as teams collaborate to move this technology forward. Finally, Nicole Danos reflects on the social and ethical responsibilities of the engineering profession in supporting women’s health. In considering what hampers engineering engagement and development in this area, she observes that, among other things, basic questions are not asked or studied in a systematic way and women’s individual experiences are not acknowledged or recorded. She provides examples of engineering innovation and entrepreneurship in women’s health and well-being, and reminds us that it is important for everyone to focus on this area given the role of women in society. Conclusion I thank the authors for their insightful and valuable contributions, which provide a glimpse of the vast opportunities to apply innovative engineering and scientific approaches to increase understanding and treatment of women’s health. I hope the articles spur both new thinking and greater engagement in the possibilities for engineering application in this important area. As was noted at the NIH Women’s Health Conference in October 2021: “Women’s health matters…not because it would be nice or good or equitable, but because we are getting it wrong and it is costing lives and health and the economy.” A multidisciplinary approach can help identify key issues and advance understanding and treatment of women’s health. Acknowledgments The following experts helped improve the articles by offering thoughtful critiques: Nicole Danos, Mitchell Goodsitt, Michele Grimm, Michael House, Kathleen O’Neill, Michelle Oyen, Ronna Popkin, Jennifer Runkle, Xiangyang Tang, and Julie Yip. I also thank my colleague Anastassia Pokutta-Paskaleva, with whom I brainstormed candidate topics and authors for this issue; Ron Latanision for inviting me to edit this issue, as he recognized this as an important subject for readers of The Bridge; and Cameron Fletcher, who was instrumental in overcoming hurdles and providing guidance to ensure the quality of the issue.  See, for example, the NIH pages “What health issues or conditions affect women differently than men?” (https://www.nichd.nih.gov/health/topics/womenshealth/ conditioninfo/howconditionsaffect) and “What health issues or conditions are specific to women only?” (https://www.nichd.nih.gov/health/topics/womenshealth/ conditioninfo/whatconditions).  https://orwh.od.nih.gov/research/2021-womens-health- research -conference  CDRH Health of Women Strategic Plan: https://www.fda.gov/about-fda/center-devices-and- radiologica l-health/cdrh-health-women-program?utm_medium= email&utm_source=govdelivery#whatare  Bird CE. 2021. Women’s health matters: When, where, and why. Presentation at Advancing NIH Research on the Health of Women: A 2021 Conference, Oct 20, available at https://orwh.od.nih.gov/sites/orwh/files/docs/01-BIRD- WHC-WH-PPT-508c_0.pdf About the Author:Marta Villarraga is a principal in Biomedical Engineering and Sciences at Exponent, Inc., in Philadelphia.