Tech Companies Working On Contraception Face A New Landscape After Roe

The Dobbs decision creates windfalls for some and roadblocks for others when it comes to companies working on new fertility tech.

In 2016, when cofounder of period-tracking app Clue Ida Tin coined the term “femtech” for technology specifically focused on reproductive and menstrual healthcare, global investment in it was at around $503 million. That investment grew to over $1.1 billion in the first nine months of 2021, according to Pitchbook. And while abortion bans and restrictions in the US might harm business for some startups working on new contraception products, for others, it’s creating an urgent need for innovation. Companies that deal with private health data, like period trackers and fertility awareness apps, are already facing heightened scrutiny and skepticism from users. But other companies, like biomedical companies creating new medical products or apps that aid in providing access to different forms of contraception, may be seeing new interest and increased demand.

Contraception is an especially difficult area for tech companies to break into because of the risks and regulations involved. Many medical startups face regulations and FDA approval processes, and testing contraception typically involves trials on healthy people, with a risk they could end up unwell — or pregnant. But there is growing demand for more contraception options, and for more accessibility to the options that already exist. Unlike many other countries, the US doesn’t have over-the-counter birth control pills (In July, Paris-based company HRA Pharma applied for approval in the US for the first over-the-counter pill). According to one study, as of 2018, 17% to 53% live in a contraception desert (numbers vary by state) — areas where the number of health centers offering a full range of reproductive care is not enough to meet the needs of the people who live there. People with low incomes and people of color are more likely to live in these areas.

The Lowdown, founded in 2019, is a platform for reviews and advice where users discuss side effects and benefits of different types of contraception, and it connects users with medical consultations and prescriptions for birth control. Users can participate in surveys and leave reviews, which the Lowdown uses along with medical professionals to provide medically vetted information. Founder Alice Pelton said they have seen a 60% increase in US-based users since the beginning of May. “I can only attribute this to the Roe v. Wade leak in early May,” Pelton said in an email. After the Dobbs decision in July, and US users surged again. Before Roe was overturned, the company was already discussing adding reviews of abortion experiences, and it says it will likely add them later this year.

Natural Cycles and Clue are both fertility awareness methods, and both therefore recommend using additional contraception like condoms on high-risk days. However, they are buoyed by algorithms and data that should make them more effective for the typical user than just tracking a period on a calendar would be. For instance, Natural Cycles also considers the user’s basal body temperature, which is one indicator of fertility. As of Aug. 2, users can also measure their temperature with the Oura ring.

Apple also recently announced its new Apple Watch Series 8 will be able to track temperature changes that can indicate ovulation — though Apple says these ovulation windows will be retrospective, and the feature is not FDA approved to use as contraception. Apple’s data will be encrypted and stored on the devices themselves, making it more secure than apps that share or sell data. This could be more appealing for users who are worried about period- and ovulation-tracking data being shared with law enforcement.

Natural Cycles, which is currently the only FDA-approved fertility tracking and birth control app on the market claims its effectiveness with typical use is 93%, and Clue says theirs is 92%. However, in the past few years, users of Natural Cycles raised questions about its effectiveness after they got pregnant while using the app. (In 2018, the Swedish Medical Products Agency found that the app’s failure rate was in line with the company’s effectiveness rate, but it asked Natural Cycles to make the risks of pregnancy clearer, which it did.)

Natural Cycles also shares anonymized data with researchers for clinical studies with user consent. Their on-staff research teams work with researchers from institutions, who must sign a data privacy agreement. When Clue sends data to researchers, it is anonymized as well, so no data point can be traced back to an individual person.

However, the security of these datasets is the subject of a lot of scrutiny and concern as states move to criminalize birth control and abortion. Users are afraid that information about their cycles could be shared with law enforcement. This data could, for example, become evidence of a pregnancy that ended. “Women's health as a whole has been stigmatized. But now there's a potential for it, not only to be stigmatized, but criminalized, so that creates a huge problem in terms of are users going to trust these tech companies with their data. And are companies going to be as interested to get into this space,” Oriana Kraft, Founder of the FemTechnology Summit said.

The Lowdown, Clue, and Natural Cycles are based in the EU and therefore follow the strictest privacy and security law in the world, the General Data Protection Regulation (GDPR). This means that the companies don’t have to respond to a subpoena or request from US law enforcement to turn over data, even if the user is based in the US. Users are covered by this law regardless of where they live. When the Dobbs decision was leaked in May, Natural Cycles also began working on developing an anonymous mode. In this mode, the company itself wouldn’t even be able to identify the user.

The Lowdown makes money by selling consultations to doctors and prescriptions, along with selling products to help people with symptoms and side effects. It doesn’t track people’s cycles and doesn’t sell data from its reviews, and while users have to sign up with an email address, they can create an anonymous account that doesn’t use their name. Clue and Natural Cycles also said they don’t sell their users’ data and instead make money through subscriptions. Elina Berglund, the cofounder and CEO of Natural Cycles, said the company is also working with its legal team on how to keep its data safe. “It's a new area to navigate, and laws are still changing. So, we want to be on top of it also from the legal side,” she said.

 A company that isn’t isn’t legally obligated to turn over data today might be in the future. 

But the legal landscape around abortion and contraception is changing quickly in the US, and things that are safe and secure now may not be soon. A company that isn’t isn’t legally obligated to turn over data today might be in the future. The period tracker Glow came under fire in 2020 when Consumer Reports found privacy and security failures that put users' data at risk (it has since fixed these issues). The fear that data isn’t safe — or won’t stay safe — creates a barrier to this form of contraception.

Beyond apps that track cycles, there are other, medical options. According to Beyond the Pill, a research program at the University of California, San Francisco, that promotes access and equity in contraception, IUDs and other long-term implants are among the most effective forms of contraception, along with tubal ligation, with fewer than one in 100 people who use these methods getting pregnant. Methods like the Pill, patch, ring, and shot, have a rate of six to nine people in 100 getting pregnant. Fertility awareness and condoms have a rate of 12 to 24 people getting pregnant in 100.

Femasys is a biomedical company founded in 2004 by Kathy Lee-Sepsick. Lee-Sepsick hopes to ease barriers for those who want permanent contraception with its product FemBloc, an in-office procedure that inserts a biopolymer liquid into a patient’s fallopian tubes. Over time, the fallopian tubes create scar tissue as the liquid solidifies, disintegrates, and then is safely expelled from the body, leaving blocked fallopian tubes behind. Paul Blumenthal, an OB-GYN who worked on FemBloc’s clinical trials, said that for people who have had children, they can often insert the FemBloc device without dilating the cervix. “The beauty of that is that we can do this without anesthesia, we can do this in the office, in an ordinary procedure,” he said. “And it's pretty quick and easy.”

FemBloc is also significantly cheaper than tubal ligation — Lee-Sepsick says it costs about half the price — and she expects it to be fully covered by the Affordable Care Act. FemBloc will be available after its pivotal trial is complete, which is required for FDA approval and is set to start in the first quarter of next year.

One benefit of permanent contraception is that it is permanent. Once the process is complete, there are no more prescriptions to fill and there is no device to remove. In an environment where lawmakers may set their sights on restricting contraception, permanent, error-free options can be especially appealing.

One benefit of permanent contraception is that it is permanent.

Different people need different things out of their birth control — some people need it to be cheap, completely private, hormonal, nonhormonal, long-term, short-term, or flexible. “This outcry for access to care, those things are extremely important,” Lee-Sepsick said. “I believe it will grow in importance and will be directly relevant for a product like Fembloc.” And, often, a person’s contraception needs change over the course of their life. This is why it’s so important to have a variety of contraception options and a safe way for people to discuss what works for them. With Roe overturned and the US market in a state of turmoil, some tech companies will stall out, while others take advantage of renewed interest and need in extremely turbulent times. ●

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