Health Tech World talks to Elina Berglund, co-founder of digital contraception app Natural Cycles.
Natural Cycles is the first and only FDA cleared, and CE marked birth control app.
Traditional female contraception methods on the market are either intrusive, such as IUDs, or use synthetic hormones to prevent unplanned pregnancies.
Swedish company, Natural Cycles has developed a new method. The company’s digital alternative offers a personalised contraception which adapts to each woman’s individual body and gives users a tool to better understand and monitor their fertility.
Women use a basal thermometer to track their temperature, then the app’s AI algorithm uses temperature data and additional information from the user to pinpoint the ovulation day and its variation from cycle to cycle.
The company was co-founded in 2013 by Elina Berglund, who previously worked as a particle physicist at the European Organisation for Nuclear Research (CERN). The idea was born from Berglund’s personal search for an alternative contraception.
Berglund says: “Women have historically been provided with very little information about their own biology and anatomy, and this deprivation of knowledge is no longer acceptable in today’s society. Knowledge empowers women to better understand their bodies.
“I’ve always questioned the idea that women need to rely on synthetic hormones or methods like the implant, which I was using at the time to avoid pregnancy.
“When my work at CERN was winding down, I found myself at a stage in my life where I saw a future of parenthood, but I wasn’t quite ready for it yet. It was frustrating scrolling through medical advice around contraception and seeing a lack of non-intrusive options that were available.”
Berglund applied the knowledge she gained from working on the Higgs Boson project to create an algorithm for identifying women’s fertile and non-fertile windows.
It is well-known and well-researched that body temperature changes throughout the menstrual cycle. In general, a woman is only able to become pregnant on the day of ovulation and the five days leading up to it. During this window, the body’s temperature is raised allowing sperm to survive in the woman’s body.
Berglund began reading into this research and analysed her own temperature, applying her statistical knowledge to detect ovulation and map out her fertile window.
The algorithm analyses temperature readings by taking into account factors such as sperm survival, temperature fluctuation, variations in cycle length, ovulation day and the length of the follicular and luteal phase.
Berglund says she knew other women would be asking the same questions and realised that in order to make it accurate for all women, the algorithm would need to learn from each individual woman’s cycle.
Her co-founder and husband, Raoul Scherwitzl suggested turning the algorithm into an app. In 2018, this app received FDA approval and now has over 1.8 million registered users worldwide.
Berglund says: “My background in particle physics means I have a good understanding of how algorithms can nail accurate predictions. I’m well-acquainted with seeing patterns in data so I wanted to use my knowledge and apply it to real issues that I faced in my life, like contraception. After all, science is meant to improve and enhance our lives.
“A lot of work has gone into turning our idea into a product that can offer an alternative method of contraception for women, contributing to a completely under-researched area of science.
“The majority of the team, not just myself, comes from a science background so everything we do is underpinned by research. You can’t develop a medical device without backing it up thoroughly with clinical data, which is what we have strived to do consistently since the company was formed.”
The app breaks down the user’s cycle into red and green days. On ‘red days’, the algorithm has detected that the user is or is possibly fertile and should abstain from sex or use a condom. On ‘green days’, the app deems that there is no need for the use of protection.
This reliance on the accuracy of algorithms has led to controversy in recent years. Although the company states that the app’s perfect-use effectiveness is on a par with the condom and the pill (98%), numerous reports of unplanned pregnancies has led to scepticism.
Berglund says: “We do understand that our technology is novel, and scepticism is to be expected. That said, we usually find that once users begin using the app and get to grips with it, they can see that what the app does is give them insight and control over their bodies.
“No contraceptive method is 100% effective, so it’s important that each user has done their own research into different methods that might suit them. Weighing up the pros and cons of each method is a must in order to find what’s right for your individual needs.
“We’re a company founded on science, so it was always our mission for Natural Cycles to be viewed as such. The FDA certification was a top priority for us, and we are CE marked. We’ve been extensively logging data and trends since the get-go, so we’re able to present our findings to the board on demand and demonstrate the effectiveness of the algorithm, and ultimately the app itself.”
Natural Cycles keeps account of the app’s efficacy using the Pearl Index, the most common technique used in clinical trials for reporting the effectiveness of a contraception method.
Berglund says: “A big advantage of being a digital medical device for contraception is that we can follow up on the Pearl Index in almost real time using our data. This allows us to quickly react if we see any deviation in the effectiveness of our product. It also allows us to get a deeper understanding of who is the ideal user for our product.”
Natural Cycles has recently announced its submission of a 510(k) Premarket Notification to the U.S. Food and Drug Administration (FDA). The purpose of the notification is to revise its labelling so the company can expand the types of third-party thermometers that can be used with its app.
“This means that users will be able to sync the app with a third-party temperature or heart monitoring device,” Berglund says, “This allows for even more accurate data to be submitted to the app. It will also undoubtedly improve the user experience.
“New software has been developed and added to the app that converts data from wearable devices that collect biometric temperature data to a format that can be interpreted by the Natural Cycles algorithm. The quality of the data from these kinds of wearables and the seamless measuring experience is a real breakthrough for us.”