Revolutionizing women's health technology through innovation
As more scientists and innovators work toward addressing the gaps in women's healthcare, women's health technology and the ongoing innovation in tech will be critical tools.
Many leaders across the healthcare industry have pointed out the need for a greater focus on women's health research and innovation. There are several gaps that exist in the global understanding of women's health, from gynecological cancers to women's chronic disease experiences. However, investing in new and progressing women's health technologies can help address many of these gaps.
At the 2024 World Medical Innovation Forum, panelists and moderators discussed the women's health technology revolution, highlighting existing gaps in women's healthcare, ongoing innovation and directions for future growth.
"It's a really exciting time for women's health, is what I'll say. We are at a precipice, at least from the investing perspective, where there's just been an explosion in the number of companies being formed and the amount of investment despite a venture capital downturn. We are actually at a seven- to 10-year low right now in VC investing. Yet women's health investing is still elevated compared to pre-COVID levels. Also, there's increased fund and corporate interest," noted Alice Zheng, partner at Foreground Capital and a panelist at the conference.
Women's health
Understanding women's health and the gaps in women's health is vital to grasping the women's health technology revolution and defining new directions for innovation.
Kaveeta Vasisht, M.D., PharmD, associate commissioner for women's health at the U.S. Food and Drug Administration, participated in the conversation as a panelist and explained the progress the FDA's Office of Women's Health has made in women's health.
"Our understanding of women's health and the definition of women's health has evolved as a community. Of course, reproductive health and gynecologic health are critically important. [However,] what we've realized is that with the evolution of scientific understanding, males and females are not the same."
Vasisht was careful to differentiate between sex and gender, explaining that while sex is biological, gender is more of a social construct. However, both contribute to how people experience disease and respond to treatments.
Many conditions disproportionately impact women, including osteoporosis and autoimmune diseases. Additionally, some diseases behave differently in women, and these diseases require as much attention as those that affect women more.
"Women are more likely to die from a heart attack. Women with diabetes are more likely to have serious complications," Vasisht explained. "What we do in the Office of Women's Health is to make sure everybody's thinking about that. We need to understand the biological differences so that clinical trials can be better informed. Now, the FDA looks at sex differences. Those of you who have been engaged in product development know this -- throughout the medical product pipeline, in terms of when the data comes in preclinical, we do look at the sex differences in the animal [trials]. If a medical product is going to be developed and used in both men and women, there has to be representation of male and female animals."
Female representation in clinical trials
Aside from gender representation in preclinical research, panelists also emphasized that gender-diverse clinical studies are crucial for advancing women's health research and revolutionizing women's health technology.
"People look at the distribution of a clinical trial makeup, meaning what percent of the study included women. They look to see the demographics; they look to see the age distribution; and they look to see how that compares to the males that are enrolled in the study to make sure that there's no disproportionate response that could be ascertained or an incorrect response potentially that could be ascertained," explained one of the panel moderators, Tazeen Ahmad, managing director of U.S. equity research covering small and mid-cap biotechnology at Bank of America.
Ahmad explained that over the past five years, clinical trial investors have been paying more attention to those factors and considering how the study's gender distribution may impact outcomes.
"They're always talking about making sure that the population of clinical trials represents how a drug will be used. I consider that a step in the positive direction," she continued.
Women's health technology innovation
Despite women's health research challenges, industry leaders and innovators are looking for new ways to leverage technology for women's health. According to the Bill and Melinda Gates Foundation, advancing women's health technology includes developing next-generation contraceptives, AI-enabled ultrasounds, future-ready diagnostic tools and more.
Nawal Nour, M.D., chair of the department of obstetrics and gynecology at Brigham and Women's Hospital and associate professor at Harvard Medical School, discussed how the COVID-19 pandemic forced ob-gyns to consider how technology could work for remote patient monitoring throughout pregnancy.
Nour mentioned that COVID-19 in the OB-GYN field was unlike many other fields since pregnant patients could not simply avoid going to the hospital or healthcare facilities.
Ultimately, we want to get innovative, safe, and effective products to women. And the only way we're going to really understand is if they're in the clinical trials and the community is a great place to recruit. We can have a paradigm shift in the clinical research infrastructure housed in big academic medical centers.
Kaveeta Vasisht, M.D., PharmDAssociate commissioner for women's health, FDA
"It really got us to look at the pregnancy as a whole. How often do they actually need to come to the hospital? How can we deliver home care for our pregnant patients? And then it got us to start translating it, much like the other departments, how do we provide care at home all the time? If you think about yourselves as patients, do you want to visit a hospital? Do you want to stay in the hospital? Do you want to come to the emergency department? So, we are thinking from a diagnostic perspective as we look at some of the ultrasound fields. For example, can we do these ultrasounds in areas close to home?"
She added that researchers are exploring nonstress tests that involve monitoring the baby at home and minimizing in-patient monitoring.
Beyond obstetrics and pregnancy care, Nour mentioned advancing technology for gynecological care and diagnosis. As more researchers focus on women's health, developing disease models and diagnostic tools for diseases that impact women or those that affect women differently is critical.
One disease that requires more attention is endometriosis.
"We're still in the process of building that model because endometriosis is not a cancer, it's not a pre-cancer, but it doesn't make it a benign disease. It's a very malignant disease because it impacts the quality of life of women," explained Keith Isaacson, M.D., director of minimally invasive gynecologic surgery and infertility at Newton Wellesley Hospital and associate professor of obstetrics, gynecology and reproductive biology at Harvard Medical School. "There's very little funding from the NIH or industry for diseases in women's health that are non-pregnancy or non-cancer related. So it's hard to get funding for endometriosis and adenomyosis, which again impacts so many more women as far as pain, bleeding and infertility than any of the other diseases combined."
As innovation continues in women's health technology, understanding the factors that drive innovation, such as existing research gaps, barriers to care, and financial motivators, is critical to achieving the end goal.
"Ultimately, we want to get innovative, safe and effective products to women. And the only way we're going to really understand is if they're in the clinical trials and the community is a great place to recruit. We can have a paradigm shift in the clinical research infrastructure housed in big academic medical centers," concluded Vasisht.
Veronica Salib has covered news related to the pharmaceutical and life sciences industry since 2022.
