In-Depth: Digital health innovation in fertility and women's health – not so niche anymore

By Heather Mack
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Note: MobiHealthNews will be taking tomorrow off for the holidays. We'll be back on Monday with a week of special issues looking back at 2016 and ahead at 2017, and back to our normal coverage on January 2nd. We wish you and yours a happy holiday season.

While the shift to value-based care has driven digital health innovation overall, the tech-enabled advances haven’t necessarily touched every sector equally. In an industry still demonstrably dominated by men, digital tools specific to women have, for the most part, been a niche category. But the field of digital women's health, which some entrepreneurs are calling “Femtech”, may be at a tipping point.

This year, we’ve seen a more robust representation of tools like ovulation-tracking apps and wearables as well as digital marketplaces and supportive resources for women seeking fertility services. This has come in the form of more funding, a higher profile at conferences and in media coverage, and a larger footprint in research collaborations. Additionally, more women are getting into tech, heading companies, investing and, perhaps most importantly, talking more publicly about topics that have historically been regarded as “private.”

On the high tech end, there's Celmatix  – which uses big data and genomics to improve assisted reproductive technology –  and Prelude, which launched in October to help couples leverage technology to improve fertility services. But in the past year, we've also seen a lot of consumer-focused digital tools for fertility and reproductive health. To name a few, we’ve seen companies including Bloomlife, Clue, Ava, OWHealth, and Progyny raise money; Kindara and Progyny bringing in some notable new staff; the launch of Ava’s a fertility-tracking wearable and companion app; two at-home sperm testing kits for male fertility; research partnerships; and a desire to integrate with adjacent spaces like smart baby monitors or feeding devices and apps.

As the field matures, we’ve also seen more apps and companies expanding from initial offerings such as period-trackers to become valuable research partners on fertility and women’s reproductive health as a whole. Rather than only using apps and trackers to avoid pregnancy, women are also turning to them for help in conceiving a baby, and in turn offering up a trove of reproductive health data to researchers.

Why now?

“There are a lot of things happening. There are more women in the workplace than ever, women who are delaying having children, couples consciously making decisions and more mainstream media coverage on the struggle to have children,” Karin Ajmani, president of healthcare services at digital fertility concierge service Progyny, told MobiHealthNews in an interview. “The fact that there is this national conversation happening is having an impact such that this shame or veil is being lifted from this very natural, biological process.”

It doesn't hurt that fertility services are a big business – the global assisted reproductive technology market hit $22.3 billion last year, and is expected to reach $31.4 billion by 2023. But even though the World Health Organization classifies infertility as a disease, access to fertility services has been historically difficult and expensive.

“A big part of the problem (opportunity) is that most health plans don't cover fertility (80 percent to 85 percent of clinic revenue is private pay). Without health plans working to negotiate down pricing, and because demand for a child is quite inelastic, the treatment costs are just insane,” Rock Health Founder Halle Tecco wrote in an email to MobiHealthNews. “Upwards $25K per IVF round. In fact, one of the biggest indicators for costs is if a clinic has any competition! That's why clinics in big cities are often more affordable than those in rural areas.”

So it’s easy to see where digital tools that make the process easier, more affordable and more informative can come into play, and it’s not all apps. Creating a user-friendly, educational marketplace to access or peruse fertility services has been the goal of a few entrepreneurs.

“It's definitely big enough for venture-sized returns,” Tecco wrote. “One in 6 U.S. couples struggle with infertility (closer to 1 in 5 in metropolitan areas). And again, these are highly motivated consumers.”

The popularity of other digital health tools has also paved the way for this field to take off, said Flint Capital Partner Andrew Gershfeld. 

"With the rising interest in wearable tech people are using to track their health, female health/lifestyle topics are skyrocketing in this category," Gershfeld, whose firm is an investor in cycle-tracking and women's digital health company OW Health, told MobiHealthNews in an email. "For VCs, this field is really hot."

We noticed this space getting more attention a few months ago, when an all-women panel discussing women’s health took the stage at TechCrunch Disrupt for the first time since the event started 11 years ago.  As more women are combining full-time careers with family instead of either/or, it has ignited the need for sophisticated tools to manage their lifestyles, but also made many people realize that research and innovation in reproductive health tools isn’t very current.

 “A lot of research out there is really out of date, so when a woman or couple goes to educate themselves, they may not have gotten the best information about how to proceed with getting pregnant,” Deborah Anderson-Bialis, cofounder of IVF concierge app FertilityIQ, said at the time.

What’s out there?

With the high prevalence of fertility challenges in the developed world, finding consumers who are wanting for clarity and assistance isn’t the tricky part. But for a woman or couple embarking on a journey towards fertility, they have to contend with a fragmented, overwhelming market and, often, a dearth of personal understanding about which fertility services are right for them.

“This is a highly emotional, stressful and expensive process,” Maja Zecevic, CEO of online, on-demand fertility consultation service Opionato in San Francisco told MobiHealthNews. “And one of the things we notice the most is women are being offered services that don’t even make sense for them at the time.”

For example, Zecevic said, many women are convinced to try in-vitro fertilization from the get-go, even though there may be certain factors at play that could render it unsuccessful for that particular person.

Where Progyny aims to offer a comprehensive “shopping” experience of sorts, Opionato wants to arm consumers with information by connecting them with experts. Based on health records and personal information the consumer provides online, Opionato creates a summary of the consumer’s fertility profile and talks them through the complex process of choosing services. Opionato is relatively new and is considering partnering with other similar outfits to maximize services, but nothing is definite at this point.

As someone who went on her own fertility services journey herself, Zecevic said the sheer amount of information being thrown at a consumer can be overwhelming, and success rates at fertility clinics may be misleading for each individual.

“We do a lot of hand-holding, a lot of phone conversations and communications, because establishing trust is critical to the success of each patient,” she said. 

Trust is also crucial with the highly personal data consumers are handing over to companies like Opionato or apps like Ava, Flow or Clue. In July, fertility tracking app Glow hit a hitch when they had to warn users of a privacy loophole that could expose personal data.
 
For the most part, Zecevic said, consumers have been very forthright with sharing information.

“They want quality services, not quantity, and you are dealing with something that is this deep, innate, biological desire,” she said. “People want to help and they want to share.”

Progyny, which raised almost $15 million this year, has been busy trying to assist women and their partners on their fertility journey. They launched their benefits services in early 2016, and quickly added provider partners and started working with self-insured employers. In June, the company launched an all-encompassing app called Progyny Mobile for users to access all of the company’s services. A few months ago, the company rebranded itself, offering concierge services for in-vitro fertilization, egg freezing, adoption and fertility benefits (and updated website). Just this month, the company also welcomed former WebMD head David Schlanger as their new CEO, and Ajmani said the company has nearly tripled the number of users it had last year.

San Francisco and Switzerland-based Ava launched its fertility-tracking wearable in July and raised almost $10 million in November. The Ava bracelet is enabled by sensors to detect the fertile window in woman’s cycle in real time, recording nine physiological factors that correspond with the rise in hormones indicating the onset of ovulation. Shortly after the launch, Ava concluded a clinical study at the University Hospital of Zurich that showed the device accurately detected an averaged of 5.3 fertile days per cycle with 89 percent accuracy. Building on that, the company has begun a second study at the same hospital with a larger sample size (around 200), which will all go towards helping the company advance the capabilities of its device.

Berlin-based Clue, which recently raised $20 million, starts at the beginning: the company offers a period-tracking app, which they have steadily worked to get “smarter” by adding more and more categories to track. Initially, the company wanted to track ovulation cycles, but so many people were using it to track other aspects of their reproductive health that they were driven to improve their machine learning capabilities to give women a more holistic view.

San Francisco-based OW Health, a digital health company focused on women’s health, raised $1 million this month to expand the use of its cycle-tracking app, Flo. Launched in October 2015, Flo is designed to help women track and smartly predict their menstrual cycles, ovulation and fertile days. Users access a calendar to schedule cycle reminders and record a host of health information including mood, contraceptive methods, PMS symptoms and sexual activity. Flo has about 2 million active monthly users – nearly half of whom are in the United States and Canada – and the company lists Brazil, Germany, Italy and Russia among its user base.

Planned Parenthood also launched a new cycle-tracking app called Spot On for women to track their period and manage their birth control. Spot On allows users to track their flow; monitor their symptoms, like fatigue, cramps, bloating, and stomach aches; record their daily activities, like travel, exercise, and nutrition; and log their mood. The app also offers users discreet birth control reminders and offers personalized advice if the user makes a mistake with their birth control. The types of birth control that Planned Parenthood provides information about include the pill, patch, ring, shot, IUD, and implant.

San Francisco-based Nurx, a telehealth company that offers prescriptions for birth control and HIV-prevention medication Truvada through an app, raised $5.3 million. Users download the app or go to the Nurx website and select the brand of contraceptive they prefer. They then answer health-related questions, and a licensed clinician (employed by Nurx) reviews the information before sending a prescription to a partner pharmacy. Cofounders Hans Gangeskarand Edvard Engesaeth were inspired to create Nurx as a means of removing barriers to birth control and HIV prevention medication, which are only available with prescriptions. The app launched in December in 2015 and Nurx completed Y Combinator in March of this year. 
 
Of course, reproductive apps and devices aren’t just for women. In June, Sandstone Diagnostics received FDA 510(k) clearance for its Trak system, an app-connected home test for male fertility. Trak's device aims to disrupt the current model for testing male fertility which is viewed by many as awkward and inconvenient. The device received over-the-counter clearance as a Class 2 medical device.

A new male fertility kit and companion app from Medical Electronic Systems, which makes commercial-grade automated semen analyzers, allows men to test their semen at home using their smartphone. The test is called YO, and features a clip-on mini microscope that users attach to their smartphone, plus a sample collection cup, a testing slide, a plastic pipette and a special liquefying powder. Users start by opening the app and assembling the supplies, then get to work producing a sample. The next steps involve mixing the materials and pipetting it on a slide for the smartphone sensor to read before a video of the live sperm appears. The idea is to give men an idea of their fertility status without having to walk into a doctor’s office and do the highly personal and oftentimes embarrassing process there. With the YO test, a man can just do it at home and show it to a doctor later.

“The explosion of apps and wearables dedicated to optimizing the chance of pregnancy is evidence that people crave more awareness of their fertility status. However, the bulk of these new technology tools cater to women. No other company is tackling male reproductive health in this manner,” Marcia Deutsch, CEO of Medical Electronic Systems said in a statement.

As the apps and services continue, so too does a more complete understanding of just what’s going on in reproductive health.

Research

When Apple debuted HealthKit in 2014, cycle-tracking wasn’t one of the features offered, even though it seemed like it should be a natural option for women keen on the existing apps out there. It was added later, but its initial omission sent a strong message to women innovating in the space: more research and focus on women’s reproductive health was needed. And apps can create a whole category of data that's never really existed before.

“The amount of research that is finally going on now should have been happening 10 years ago,” Lea von Bidder, CEO of ovulation wearable and app company Ava, told MobiHealthNews in an interview. “But now it’s really exciting, because we are getting to a point where we are adding to the scientific research. We are not just looking at whatever data is out there and trying to make it more convenient. We are actually adding to the knowledge.”

Von Bidder said her company has found researchers more than willing to work with them, because the large data sets gleaned from wearables and apps is unlike they’ve ever had to work with. As such, fertility research is funded less than many other parts of medicine (the National Institutes of Health, for example, spent $72 million on infertility research in 2015, compared with billions for things like infectious disease and immunizations).

“We’re a small company, we’re a young company, and unless there was such a demand for this information, we’d have a hard time getting researchers’ attention,” von Bidder said. “Especially in the medical field, where you have big players in research, a small company could never hope to work with them, but where we are, we can really make an impact.”

A huge part of it is the ease in which consumers can now participate in research. Previously, figuring out exactly what is going on with each individual woman’s cycle or a couples’ fertility requires a lot of journaling, doctors’ appointments, temperature taking and waiting.

“As a doctor, you want to help your patient and you want to get them out the door, happy about a solution, but for a long time in fertility, there was nothing good,” von Bidder said. “When we wanted to get into research, we got a lot of good feedback from the medical community because I think even they were aware of the lack of options they have.”

Additionally, companies in this space tend to be more apt to collaborate and share ideas, Von Bidder said. The relatively small pond of digital health tools for fertility and women’s health has also brought a different attitude to entrepreneurs in the space.

“Everyone seems to have a different approach – they are very vision-oriented and everyone has a more personal reason for getting into this field,” she said. “Especially since so many people who work in this space are women, it’s a very rewarding place to be in.”

Crossover appeal

Many entrepreneurs in this space also recognize the opportunity for their services to dovetail into digital tools in related health sectors, such pregnancy, baby-monitoring and breastfeeding. These related digital health sectors have also been heating up lately.

Ovuline, which makes a suite of women’s and family health apps, raised $10 million in new funding in October and renamed the company “Ovia Health.” The company has also been expanding into enterprise operations, with payer customers including Blue Cross Blue Shield of Massachusetts, Optum, General Electric and Activision.

Bloomlife, which raised $4 million in August, offers a smartphone-connected pregnancy-tracking wearble. The direct-to-consumer offering for women in the third trimester of a pregnancy. The sensor, worn on a woman’s belly and affixed via an adhesive patch, detects contractions and displays statistics on a companion app about their duration and frequency. But future generations of the device will include much more information, including some functionality that will require FDA clearance, CEO Eric Dy told MobiHealthNews at the time of the funding.

Smartphone-connected breast pump startup Naya Health got FDA clearance for its pump system in June, a couple months after they raised $4 million. Naya’s The Smart Pump it uses a hydraulic system instead of air to collect breast milk. As a result, the pump is more comfortable and quieter, according to the company. Some data from the system, including how often a mother pumps, is sent to a companion smartphone app, called Naya Health Tracker. The app also allows users to track pumping sessions, record their child’s feedings, and manage breastmilk inventory by telling users which milk in their fridge needs to be used first. The company is developing an Apple Watch app as well.

Thrive Feeding raised $500, 000 in January to develop a line of smart baby feeding products. Cofounder Brian Wadsworth told MobiHealthNews at the time that he founded the company to address what he called the “astonishing” issue of feeding problems of babies, both in scale and scope.

Owlet, which makes a smart sock and companion app for babies, raised $15 million and took on a collaborator role in an NIH study. Owlet’s offering is a tiny smart sock that fits onto a baby’s foot, intended to be worn while sleeping. It tracks heart rate, skin temperature, blood oxygenation and sleep data, which is all transmitted to the cloud and accessible through an iOS or Android app on the parent’s smartphone, or any other connected device through a web portal. It has a rechargeable battery that alerts parents via their smartphone when it is running low. The sock also connects with an independent base station that operates even without WiFi and can acts as a primary alert center, so parents do not have to rely on the app for notifications. 

Czech Republic-based Daatrics launched pre-orders of Neebo, their baby and toddler-monitoring wearable.  The small, egg-shaped wearable aims to give parents and guardians peace of mind by tracking vital signs and any sound the baby makes, flagging any abnormalities and notifiying parents via a companion app. Neebo monitors heart rate, oxygen intake, body temperature and sends information via Bluetooth to a smartphone companion app as well as central device that can be placed in the baby or child’s room.

The Future

While digital innovation for fertility and women’s reproductive health is heating up, it still faces challenges other sectors may not have to worry about. Along with privacy concerns, there still isn’t quite the mainstream attention as other digital health apps because a lot of people in technology are men.

“It’s obvious that this space is not yet as competitive as, for example, fitness,” OW Health CEO and cofounder Max Scrobov told MobiHealthNews in an email. “The interest of this space will gradually increase thanks to big investments received by several players. I think that interest will grow even more and rapidly increase after success stories or big acquisitions.”

OW Health, makers of Flo, want to do more than cycle-tracking. The company envisions offering an “ultimate solution for women’s health.” By using machine learning for predictions around ovulation and periods, the company believes they can eventually offer insights for holistic wellness.

“Every woman has an individual set of symptoms which repeat in specific phases of each cycle,” Scrobov wrote. “This can be a headache, increased appetite, bad or good moods – anything. If a user regularly enters symptoms, our neural network searches for the connection between phase of the cycle and symptoms, and corrects predictions of period and ovulation. We will implement artificial intelligence in order to give personalized advice to our users and create a personal 'health' assistant for the woman.”

While the goal is lofty, Scrobov said the field has come a long way since the company first started out.

“While we were working on this project, we faced a lot of negative reaction from IT professionals. The reason lay in the fact that most of engineers, programmers, CEOs and investors are men,” he wrote. “They don’t understand the problems and how they are solved by our product. It’s quite obvious that if this misunderstanding never existed in the first place, similar services marketed would be on an entirely different level.”

There's another reason for wanting to get into femtech, said Flint Capital Partner Gershfeld, who mentioned the "huge market" for both reproductive health insurance and big commercial partnerships.

"Moreover, female products attract an audience comparable to popular TV shows and can be acquired by big brands such as Procter & Gamble, or Johnson & Johnson," Gershfeld said. "They could have non-stop access to the users, and, in that way, save on marketing budgets."

Dr. Brian Levine, a reproductive endocrinologist and practice director of the Colorado Center for Reproductive Medicine in New York, said he sees the role for digital health tools to play in fertility is education for the consumer and enhanced insights for clinicians.

“As we move forward, I think we are going to see more high-quality apps, more evidence-based devices and more clinical grade apps and services,” Levine told MobiHealthNews in an interview. “I think it will make my practice much more exciting. People are going to come in with more understanding of fertility, more high quality data from their devices and a better idea of what they personally need, which will hopefully reduce costs.”

But Levine, who is also an expert advisor to Opionato, cautioned that not all reproductive health and fertility apps and tools are made equally well. Some information is inaccurate, and he doesn’t trust some apps that make predictions.

“Sometimes, I don’t think some of the apps realize that patients are humans,” he said. “There is no one magic app or one treatment care, and the majority of women do not even have a regular cycle. If they aren’t using machine learning, they are static and that doesn’t work with an ovulation cycle. They need to be able to offer very tailored information to be accurate."

Levine said anyone looking to embark on a fertility journey should ask as many questions as possible, including about statistics and treatment protocols, then use the apps or tools as a complement. Additionally, he reminds consumers that just because apps or trackers are widely available, expectations for success still need to be managed.

“The truth is, fertility care is really lonely, and services that offer the opportunity for patients to have access to high level, clinical expertise is what is needed,” he said.

As the space matures, some of the tech CEOs at the helm say the future lies in the power of the research being conducted now.

“We need to invest heavily in research and science to make this happen. There are a million things we need to come up with still,” said von Bidder. ”The space will grow, and at the core of this space growing is this: Women’s bodies are not going to change, but the solutions we can have for them will."