Proving the Business Case for the Internet of Things

Contraceptive app approved as medical device

Steve Rogerson
February 14, 2017



In what is claimed to be a world’s first, inspection and certification organisation Tüv Süd has approved an app to be used for contraception.  Developed by husband and wife team Raoul Scherwitzl and Elina Berglund, it also acts as a tool for fertility tracking and planning pregnancies.
 
Their company, Natural Cycles, was founded in Switzerland but is now based in Sweden. Clinical studies have shown the app can detect and predict ovulation with precision comparable to that of the contraceptive pill.
 
It already has more than 150,000 users in 161 countries.
 
Studies on natural family planning have been scarce, particularly when supported by mobile applications, which is why Natural Cycles conducts fertility research with experts within the field of reproduction, fertility and contraception. Two clinical studies have been published about the application.
 
The first showed that the Natural Cycles algorithm is as accurate at identifying ovulation as clinical methods such as ultrasound. The second has shown that Natural Cycles, when used for contraception, is as effective as the pill.
 
Tüv Süd has approved Natural Cycles as a class IIb medical device intended to be used for contraception. This puts the app in the same category as the condom, incubators for babies and dialysis devices.
 
The regulatory approval adds a clinically tested contraception for women to choose from other than the pill, IUDs, condoms and so on. The IIb medical device classification is important news for the millions of users of hormonal contraception. Many women around the world are interested in a non-hormonal, non-invasive method of contraception, and now they have a clinically verified and regulatory approved option to choose from.
 
Natural Cycles works by detecting a woman’s ovulation and calculating her fertile days by taking factors such as her period, temperature, cycle irregularities and sperm survival into account. Women are required to take their temperature in the morning and enter it into the app.
 
The algorithm behind the app in turn gives them a green or a red day, depending on whether they need to use protection. On a red day, fertility is likely and there may be a risk of pregnancy so Natural Cycles recommends to use protection. On a green day, the woman is not fertile and can enjoy more sexual freedom without protection if she wishes to do so.
 
The app does not protect against STDs in any way and is more suitable for women who are in committed long-term relationships. It is available to download on Android and iOS or can be accessed on the web.
 
Natural Cycles has its headquarters in Stockholm, Sweden, with 20 employees. The company has raised $8m in venture capital from Sunstone Capital, Bonnier Media Growth and e-ventures. This capital has helped grow a team, aid international expansion, and fuel further investment in product development and clinical studies.
 
It has reported sales of more than $4m since launching in August 2014.
 
Co-founder Berglund was part of the Nobel Prize-winning team to discover the Higgs boson.