January 30, 2022

Have you heard of “FemTech”?

The word refers to a variety of mobile apps and medical devices, products and services that use technology to improve women’s reproductive and sexual health.

From ovulation bracelets to pelvic floor therapy apps, more than 400 new FemTech products launched in the past 10 years. The sheer number of offerings inspired a team of UNC-affiliated researchers to review hundreds of FemTech companies — and their associated clinical trials data — to start building a comprehensive Guide to FemTech for Clinical Care.

Katie McMillan

Katie McMillan

“We started this research because we believe in the possibility of technology to close gaps in health care delivery and we think women can be empowered to address very personal health issues with tools readily available in the market,” says Katie D. McMillan, MPH, the CEO of Well Made Health, LLC, and a 2013 alumna of the Department of Maternal and Child Health at the UNC Gillings School of Global Public Health. “However, the clinical evidence of the efficacy of different FemTech products is difficult to find and understand — for providers and patients alike. We want to provide transparency so everyone can feel safe using these new tools to solve women’s health problems.”

Mia Mathura

Mia Mathura

McMillian partnered with current medical student and aspiring OB-GYN Emilie “Mia” Mathura, MSPH, who was a graduate student at Gillings at the time. Mathura built her master’s thesis around the role that FemTech can play in advancing health equity, and Gillings School Associate Professor Alison Stuebe, MD, served as her faculty adviser. The team sought interdisciplinary faculty involvement from Erin Carey, MD, MSCR, an associate professor in UNC’s Department of Obstetrics & Gynecology who remains involved in the work.

Dr. Erin Carey

Dr. Erin Carey

“We all connected in 2022 due to our shared interest in women’s health, technology innovation and entrepreneurship,” McMillan explains. “Once we determined the scope of the project, we crowdfunded the research on the experiment.com platform. There was a rigorous review process. When we went live, we achieved 100% of our fundraising goal with support from more than 40 backers.”

From the start, the researchers suspected that many of the FemTech offerings would lack evidence for clinical use. When new software and devices are labelled as “wellness” products, they are not subject to FDA approval. The main goal of the review was to verify, through an independent audit, which technologies had been proven safe for patients and could effectively address medical needs.

“My time at Gillings, especially while working on this project, taught me how to understand research at a macro level,” Mathura says. “I’m excited to help promote tools that will support other OB-GYNs and my future patients.”

Since the first stage of the project wrapped, McMillan has been approached by MDisrupt, a startup that is building a massive digital health evidence database. She has shared the FemTech data collected in this project and is building on the foundation for a robust and up to date collection.

McMillan also has multiple updates planned for 2023, and has already published about promising tools for breast cancer and her framework for evaluating clinical evidence on consumer health products. She recently attended the Digital Medicine Conference to share preliminary findings on pelvic health companies, which she will submit to a peer reviewed journal for broader dissemination.

Contact the UNC Gillings School of Global Public Health communications team at sphcomm@unc.edu.

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