Femtech is a growing portion of the technology industry, aimed at half of the global population. The purpose is to drive women "to access and use applications for managing health issues." According to Frost and Sullivan, the sector is predicted to have market potential worth $50 billion by 2025.
On August 10, 2018, Natural Cycles, a medical app with the functionality of a virtual contraception, received the green light from the U.S. Food and Drug Administration.
Natural Cycles was founded by a couple seeking "an effective method of natural contraception." In the beginning, the couple, Elina Berglund and Raoul Scherwitzl, created an algorithm for themselves to distinguish and anticipate ovulation and fertility using body temperature and menstruation details. Then, they productized it after realizing that their concept would also help other women.
Customers can choose between an annual subscription with a basal thermometer for $79.99 and a monthly subscription for $9.99. Whichever option is selected, a basal thermometer is a necessity because its sensitivity and accuracy are better than other types.
When the user takes her temperature, it will evaluate her hormone levels and her cycle to determine whether it would be a red day or a green day. Red signifies ovulation and suggests against unprotected sex. On the other hand, green implies the opposite: the user is not fertile, therefore she will not get pregnant if she were to have sex.
The app might show more red days at its initial use as it is getting know the user during the first few cycles.
Natural Cycles warns users that the app does not work as a protection against sexually transmitted infections.
Clinical studies were conducted to test how effective Natural Cycles is as a contraception. For about eight months, 15,570 women used the app. The results indicated that "1.8 in 100 women who use the app for one year will become pregnant" when it mistakes a prediction for a non-fertile day or when a different contraception fails during a fertile day.
" . . . women should know that no form of contraception works perfectly, so an unplanned pregnancy could still result from the correct use of this device," as stated by Terri Cornelison, serving as the assistant director in the women's health department for FDA's Center for Devices.
Upon the FDA's approval of Natural Cycles, controversy surrounds the app.
The app claims to be "an effective method of contraception," but it caused unwanted pregnancy for users in Sweden. From September to December of 2017, a Swedish hospital reported "37 of its 668 female patients who sought an abortion . . . had been using Natural Cycles."
For the app's defense, Raoul Scherwitzl, the co-founder, expressed no shock about women becoming pregnant while using it. Furthermore, he explained: "'We give red and green days and clear recommendations on which days to abstain and which days we consider the risk of pregnancy to be negligible.'"
Other concerns include regulation and promotion of the contraception.
Obstetrics and gynecology professor at Northwestern University, Lauren Streicher described the app as "'problematic on so many levels.'" She believes it is "taking women back in time" when "'we've already developed good, safe, reliable methods of contraception that are available to us.'"
Regardless of the debate, Natural Cycles boasts 900,000 users, which will continue to increase as the company plans to expand and become "certified as a medical device in every country."
