Women’s Health + Health Tech: A call for transparent evidence
The Digital Health industry has produced many amazing companies with good intentions, but finding the science and ROI that backs their solutions, algorithms, and devices is hard and time consuming.
I’ve been researching FemTech— technology-enabled solutions for women’s and reproductive health— for the last 6 years. A major need I uncovered along the way was that there is a huge gap between the consumer space and the healthcare space and a lot of gray in between. This leads to confusion, avoidance, and mistrust of new technologies that could dramatically improve health for people with uteruses.
I have found:
OB-GYNs, Family Medicine Doctors, Nurse Practitioners, and Midwives either haven’t heard of FemTech or digital health, don’t trust it, or have no idea what works and what doesn’t (1)
Women and birthing people are targeted with ads for period trackers, kegel trainers, and pregnancy apps, yet initial studies indicate how few companies are actually protecting data and backed by research (2, 3, 4)
Millennials and GenX are digital natives and want mobile apps and home solutions to manage their healthcare needs. (5)
An independent audit of digital health solutions across sub-clinical areas or disease states of women’s health is necessary for payers, providers, and patients to make smart purchasing decisions. This work should focus on cutting through the noise of wellness apps and prioritize digital health as an intervention.
The Women’s Health, Technology, and Evidence Gap
(NB: I have pulled information from various pieces I have written in the past to bring together a consistent narrative.)
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.
The status quo for understanding the evidence supporting women’s health technology requires combing through peer reviewed literature sources, visiting each company’s website for gray literature to interpret results and understand potential bias, and searching for user reviews on e-commerce sites. This is a time consuming endeavor that most clinicians do not have time for between seeing patients. In my experience, most women choose products based upon the quality of marketing efforts and peer recommendations without a single source of truth to review.
Women’s Health Innovation vs. FemTech
The FemTech market encompasses products that promise and deliver on evidence-based interventions that address female health needs. As I've been reviewing the market I am reminded that we really need to differentiate between "Women's Health Innovation" and "FemTech." Understanding these differences helps to narrow down the categories of products that should be subject to evaluation.
Examples of Women's Health Innovation are:
Consumer Product Goods, like absorbent menstrual undies, pleasure products, flushable pregnancy tests, and customized vitamins.
New medical devices and diagnostics to be used in clinical settings, such as breast scanners that could replace traditional mammography, or AI powered embryo selection tools.
Unique employer benefits, such as fertility benefit solutions.
Marketplaces: These are websites where consumers can see and compare a variety of different goods -- such as breast pumps -- and order which fits their needs.
New brick and mortar clinic and care models: for example, companies like Tia and Kindbody are creating less sterile, more integrated healthcare practices.
I define FemTech as a sector of digital health that includes mobile apps and devices to specifically address biologically female health needs.
Examples of FemTech are:
Telehealth: I put together a list of telehealth companies serving women's health needs.
Educational Platforms: Health information websites have long been under the umbrella of digital health, though I'd argue that they are simply internet information. There are many tagged as FemTech that educate people on things like different contraception methods, and many apps include some educational content section.
Health tracking apps: These types of apps are essentially digital calendars where you can log symptoms and other notes with the goal of generating a greater understanding of health trends. The classic example is a menstrual tracking app, but this has exampled to include lots of others like PCOS symptoms, menopause symptoms, cancer treatment symptoms, etc.
Connected Devices: These are electricity powered tools that can be in the form of a ring, a watch, a wrist tracker, a wand, a necklace, a blood pressure cuff, to collect biometrics, and are typically synced with a mobile phone all to make sense of the data and store it somewhere. This is a focus area of FemTech for evaluation if the device is used in concert with education and care provision in order to achieve a measurable health improvement.
Digital Therapeutics: According to the Digital Therapeutics Alliance, "Digital therapeutics (DTx) deliver medical interventions directly to patients using evidence-based, clinically evaluated software to treat, manage, and prevent a broad spectrum of diseases and disorders." This is the most straight-forward category for evaluation considering that DtX should have already been reviewed by the FDA.
There are a significant number of areas of women’s health being served by technology solutions.
What is the definition of good?
The foundation of all of this research and sorting to identify quality digital health solutions is to understand, at its essence, risk and reward.
Let’s talk about risk. Risk of use of digital health products is directly correlated to usefulness claims, expected outcomes, and what could happen if the product isn’t used in accordance with guidance. Essentially, we ask ourselves, what is the worst that could happen?
Digital therapeutics are defined by the Digital Therapeutics Alliance as software that delivers medical interventions directly to patients using evidence-based, clinically evaluated software to treat, manage, and prevent a broad spectrum of diseases and disorders. These are the most highly regulated category digital health from an efficacy and safety standpoint. However, they still require ROI evaluations for purchasers. Digital therapeutics are closely related to software as a medical device. However, while SaMD can encompass health IT and clinical informatics products for healthcare providers, the intended end user of digital therapeutics is the patient.
Women’s Health Risk Example:
Product #1: A simple calendaring app for entering when menstrual cycles begin and end can be useful for tracking for women. It’s a digital health product but it’s not making predictions, providing advice, or powered by an algorithm. It doesn’t need a clinical trial. It is the digital version of using a paper planner. Low risk.
Product #2: Now take a calendaring app that also incorporates biomarker data like temperature and combines it with calendar data and large datasets of women with similar cycles, stirs all that data together into an algorithmic soup, and then spits out ovulation predictions. There should be some research studies backing that the algorithm works and provides value to the patient. This product could now be classified as Software as a Medical Device, or SaMD; needs evaluation.
Let’s talk about reward. The cream that rises to the top will ideally be clinically sound, backed by scientific evidence, provide economic benefits, meet the needs of health women and their providers, offer a high quality user experience, and close equity and access gaps.
Articles I’ve written on evidence-backed women’s health technology:
Useful content from other sources
ICER-PHTI Assessment Framework for Digital Health Technologies
Interactive Guide to Validating Novel Digital Clinical Measures
DTX Evaluation Toolkit
