What is known about the efficacy and safety of tech products for reproductive health?

$6,001
Raised of $6,000 Goal
100%
Funded on 5/26/22
Successfully Funded
  • $6,001
    pledged
  • 100%
    funded
  • Funded
    on 5/26/22

About This Project

FemTech describes technology to improve women's health. From ovulation bracelets to pelvic floor therapy apps, over 400 FemTech products have launched in the last 10 years to augment the field of reproductive healthcare. Few of these products are evidence-based or have undergone rigorous trials to prove that they work and are safe for patient and provider use. Our goal is to conduct a systematic review of FemTech published research to understand if the evidence supports clinical use.

Ask the Scientists

Join The Discussion

What is the context of this research?

Gender bias in healthcare is a well- documented barrier to equitable healthcare for females, and is manifested through “underrepresentation of women in health studies, trivialization of women's physical complaints, and discrimination in the awarding of research grants.” With the continually advancing speed of technology development over the last 15 years, entrepreneurs have had access to tools to address overlooked and underfunded reproductive health concerns in new ways, through FemTech. Many of these new software and devices label themselves as “wellness”, which would not subject them to FDA approval. This means clinicians and patients are left wondering which technology would actually help address medical needs. A systematic review of FemTech research would answer those questions.

What is the significance of this project?

The Lancet published an article on International Women's Day, 2022 stating that, "The substantial lack of investment in women's health is a major challenge in achieving health equity." We know that there are clinical use cases, such as endometriosis, pregnancy, and cancer, where data science and novel technologies are being applied to improve health outcomes. However, based upon our initial review, the trials conducted on FemTech are funded by the companies who created it. The field of women's health needs an independent audit of the published research to ensure patient safety. Our systematic review for reproductive healthcare providers will help them better understand FemTech and its use for patients in combination with traditional clinical care.

What are the goals of the project?

The first and most important aim of our project is to list, evaluate, and systematically review the evidence for every FemTech app and device on the market. We will create our database by examining lists curated by FemTech Insider and FemTech Focus, as well as a list compiled by our FemTech Expert. From there, we will eliminate companies that do not have peer-reviewed studies on the efficacy, safety, and usefulness of their products. Our team will determine a ranking of the quality of the study based upon common scholarly agreement on the strength of types of research. We plan to author a systematic review article detailing our findings for publication in a reproductive health journal.

Budget

Please wait...

The funds for our Student MSPH Research Assistant, Emilia Mathura, will cover 100 hours of her time and expenses to conduct research and co-author our findings in the form of publication which will be submitted to a women's health scientific journal.

The funds for our FemTech Expert Study Coordinator and Editor, Katie D. McMillan, will cover 40 hours of her time to create the study protocol, determine research criteria, and co-author our article for publication.

Our UNC Faculty Advisor, Dr. Erin Teeter Carey, is donating her expertise to provide clinician feedback on the research study design and systematic review findings, as well as co-authoring the report of our findings.

Endorsed by

I think this project offers to answer very important questions about the validity and efficacy of certain wearable/remote monitoring devices. Katie has a long-standing commitment to this field and I'm very hopeful for meaningful, practice-guiding results.
As a urogynecologist I frequently treat patients who could truly benefit from devices, apps, and tools that medical tech offers, but we have little reliable information about whether they truly deliver what they promise, or are worth any investment. This review will provide us with valuable and reliable comparisons of what's out there, and could lay the groundwork for definitive testing of promising tech.
Femtech can often feel like the wild west. Experts like Katie and her team will bring the knowledge and experience to guide patients and providers in safely adopting and utilizing these advances.
There's much hype around "Digital Health." Katie and team are putting their foot down to ensure that hype can be separated from reality when it comes to reproductive health and women's equitable access to quality tech products. That starts with a systematic review of current medical literature, the scope of this groundbreaking project! I have full confidence in Katie's leadership and resolve to see this through and fully expect to read the results in what will probably be my first purchased copy of a gynecology journal. :)
This is a very important project for providers, and most importantly, for patients. As someone in this field, I recognize the wide and confusing gap between what products are driving better outcomes and what are not. Katie and the team are great leads for a project like this given their experience in the space. They combine clinical experience with know-how of how the FemTech space works.

Flag iconProject Timeline

We plan for this project to take 3 months. This time will include defining our research criteria, conducting our market and clinical trials research and reviews, and writing and publishing our findings.

Apr 26, 2022

Project Launched

Apr 29, 2022

Project Kickoff

May 13, 2022

Define Research Protocol and Systematic Review Criteria with Librarians by May 13, 2022

Jun 17, 2022

Conduct Systematic Review Research May 14- June 17, 2022

Jul 28, 2022

Writing: Summarizing findings of systematic review  (between June 17- July 28)

Meet the Team

Katie D McMillan
Katie D McMillan
FemTech Researcher and Digital Health Consultant

Affiliates

Well Made Health, LLC, University of North Carolina at Chapel Hill
View Profile
Erin T Carey
Erin T Carey
Associate Professor

Affiliates

University of North Carolina at Chapel Hill
View Profile
Emilie "Mia" Mathura
Emilie "Mia" Mathura
Medical Student, MSPH Student

Affiliates

University of North Carolina at Chapel Hill
View Profile

Team Bio

This is powerhouse team of women in healthcare. Dr. Erin Carey brings her expertise as a top academic medicine women's health provider and researcher. Katie D. McMillan has worked with start ups, doctors, and researchers to integrate digital health technology into care delivery. Mia Mathura is an open advocate for health equity among women and people of color. Our collective cohesive yet diverse experiences make this the perfect team for this project.

Katie D McMillan

I've spent my whole career working at the intersection of healthcare and technology. I realized early on that mobile phones opened up doors around the globe for people to better understand, manage, and take charge of their health. Technology provides an opportunity to be a great equalizer by expanding access to healthcare into a person's pocket.

I love supporting healthcare innovation, particularly in women's health, with data-driven, human-centered science and beautiful design. I presented the first FemTech Grand Rounds presentation for OB-GYNs at Duke University Health System and have contributed to the knowledge of FemTech in various publications and podcast interviews.

Erin T Carey

I am an Associate Professor of Obstetrics and Gynecology and Division Chief of Minimally Invasive Gynecologic Surgery at the University of North Carolina (UNC) School of Medicine. I also serve as the Fellowship Director of Minimally Invasive Gynecologic Surgery. I completed my residency in OBGYN at the Mayo Clinic and then a MIGS fellowship at UNC. While in fellowship I also earned a Master of Science in Clinical Research (MSCR) at the Gillings School of Public Health and completed an additional year of training in female pelvic pain disorders with pain medicine.

My focus is treating the full scope of gynecologic surgical and pelvic pain issues including the management of complex pelvic and vulvar pain disorders. I've been funded by the NIH for several vestibulodynia and endometriosis projects. As a physician scientist, I strongly believe in collaborative research efforts designed to improve diagnostic and treatment options for women with pelvic pain disorders.

Emilie "Mia" Mathura

As a budding doctor & aspiring OB/GYN, I find myself eager to solve problems in healthcare. Throughout my experience working in health tech, medical school, and now public health school, I am finding that technology offers scalable solutions that bring menstruating and birthing people closer to their bodies and offers them ways to be active participants in their care. Historically, reproductive healthcare has been paternalistic and "provider-focused" rather than focused on those it is trying to serve. FemTech is changing that. Whether we are ready or not, technology is coming to the medical field. In my career, I hope to be an agent for change and a provider that moves our field toward innovation and adaptation through FemTech to bring equitable, high-quality reproductive healthcare to all.

Additional Information

We plan to submit our findings to the American College of Obstetrics and Gynecology (ACOG) through their journal as well as annual conference to educate female and reproductive health providers on clinically sound FemTech.


Project Backers

  • 48Backers
  • 100%Funded
  • $6,001Total Donations
  • $125.02Average Donation
Please wait...