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Welcome to the Inaugural Issue of the Evidence Edit!

The topic for January is: What do I mean by evidence in digital health and why does it matter?

For years I have been researching the emerging Women’s Health Innovation + FemTech market (aka health technology addressing biologically female healthcare needs.) In 2019 I gave a presentation to the Duke Department of OB-GYN on FemTech. Among the faculty there was a lot of interest in new tech for their patients, but it was paired with raised eyebrows. The doctors wanted to know, “How do we know any of this WORKS?!”

That was a very good question. And one I couldn’t get out of my head. They needed more clinical evidence.

What do I mean by evidence?

When I am looking for evidence of efficacy (aka does it work) for FemTech companies, I look at:

• ​Clinicaltrials.gov : Have there been any clinical trials registered and conducted? What kind of trials? (Not all are created equal.)
• ​PubMed and Google Scholar: Are there any published research findings that indicate improved clinical outcomes?
• Company websites: If the company is new, do they have any language around pilot studies? Are there any claims that their product works? How do they back those claims?
• ​FDA website: Has the product been reviewed by the FDA and do they have anything to say about it? Many that have been reviewed are marked as 501(k) which means they are clinically equivalent to other treatments already available and proven safe and efficacious.

This is not a perfect system, but it helps significantly to get a pulse on which products work. I’ve run into issues if the company isn’t located in the United States, or selling within the United States and therefore wouldn’t be on clinicaltrials.gov or the FDA site. I’m trying to figure out how to close those gaps and appreciate any tips or sources of information.

When does evidence matter?

Does every Women’s Health Innovation/ FemTech product need evidence? No, it doesn’t. For example, if a period tracking app is just a digital calendar, it doesn’t really need to be studied. However, if a period tracking app is acting as a digital birth control, or predicting days of ovulation, then I definitely want to see the data. If people are making decisions about their actions based upon the app’s algorithm, the evidence and efficacy matter!

If an app is promising clinical outcomes, then SHOW ME THE EVIDENCE. This is not only important for individual results, but also for potential reimbursement by insurance companies and prescription by physicians. The Digital Therapeutics Alliance has a short list of apps considered equivalent to traditional clinical treatment and I hope to see this grow. (Also, there are a few missing related to women's health...but more on that later.)

Which area of women's health is most promising when it comes to evidence?

I’m not in a place to give definitive numbers yet, but based upon looking at my database, pelvic health and fertility products are the most promising – particularly companies with wearables that sync with an app. I really admire Renovia’s work on their Leva product. Their website notes, “Leva combines unique motion sensor technology with personal coaching to help women strengthen their pelvic floor and decrease the symptoms of stress, mixed and urgency incontinence, including overactive bladder.” (They have conducted an RCT! - the gold standard for research.)

​Ava Women is one of the OG fertility tech companies -- I even used their v1 product in 2019 -- and they are committed to conducting their own research. Some of the research is secondary findings based upon data contributed by users (a typical place to start for young companies) but lately they have been running more prosective trials and recently published on how their sensors can identify a woman's fertile window with 90% accuracy. ​

I hope you enjoyed the first issue of The Evidence Edit. February’s topic will be the Pleasure Issue for Valentine’s Day.

Until next month–

Katie D. McMillan, MPH

NB: I started researching FemTech while I was at Duke, then crowdfunded the work the Spring of 2022, and most recently have partnered with MDisrupt to build a searchable digital health intelligence database.

Learn Something New:

• FREE Courses from FDA’s Office of Research on Women’s Health: ORWH e-learning courses give users a thorough and up-to-date understanding of sex and gender influences on health and disease and NIH requirements on factoring sex as a biological variable into research designs.

Conversation Starter:

• Did you know…It will take 132 years to close the gender parity gap. ​

Resources:

• ​What’s a Digital Therapeutic? ​
• ​CB Insights: How tech is making women’s healthcare more equitable and accessible. ​
• ​What’s the difference between FemTech and Women’s Health Innovation?​
• ​A History of FDA guidance and regulations related to Women’s Health​
• ​Women’s Health Innovation Summit Recap​

• What's happening in pleasure tech and babymaking tech?
• Could better digital health evidence improve insurance coverage of new products?
• Do home diagnostics and wearables provide valuable data to patients and providers during pregnancy?
• Is it worth your $$? How consumers can evaluate D2C FemTech products

You are reading The Evidence Edit: A monthly newsletter on science + women’s Health + technology written by Katie D. McMillan, MPH, CEO, Well Made Health, LLC​

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