Ava Science is a FemTech company best-known for their fertility-predicting wearable device that collects biometric data from a woman’s wrist in order to track ovulation. The device predicts fertility with 89% accuracy (according to published clinical trial data) and is among one of the most well-funded FemTech startups out there, having raised a cumulative $47M. So what’s next? Lea von Bidder, Ava’s CEO, explains the data-driven vision for the company, which is currently one of the few medical device wearables that is approved for collecting digital biomarkers. The startup is eager to capitalize on that first-mover advantage in the women’s health space, and is looking at other ways to use their data. Lea talks through her plans for exploring a full-range of women’s health applications, from non-hormonal birth control to new products that might appeal to women during pregnancy or menopause.
The highly anticipated unveiling of the Apple Watch Series 4 caused a news and social media sensation. Apple coined the iconic timepiece as the “guardian of your health”, with health tracking functionalities such as the ability to detect atrial fibrillation (AFib) by a self-performed electrocardiogram (ECG). But from patients’ and carepartners’ perspectives, there is a long road to a universally accessible, seamlessly implemented, mass-adoption, and meaningful use for this wearable technology.
Many experts, such as Dr. Eric Topol a cardiologist at the Scripps Research Institute, and other reports, were quick to highlight concerns about the consequences of false positives. The Apple Watch was criticized as a source for unnecessary anxiety. A letter from the Center for Devices and Radiological Health (CDRH) of the FDA, which cleared the ECG app as a class II over-the-counter (OTC) device, highlighted the risks to health and potential mitigation measures that the Apple Watch posed. Unfortunately, the vast majority of concerns in the public domain haven’t emphasized the risks to health due to poor implementation, integration, and adoption strategies of digital tools and wearables.
The current health care system needs to be significantly refreshed as it is not positioned to simply drop in advancements, such as those offered by the Apple Watch Series 4, into everyday patient care. Having Dr. Ivor Benjamin, president of the American Heart Association (AHA), endorse the Apple Watch at the Apple Keynote Event did wonders for the mass marketing appeal. It would’ve have been more credible and demonstrated more value if he stated that the AHA devised a strategic clinical practice implementation guide for cardiologists, created patient education materials for using the Apple Watch, partnered with payers to incentivize doctors to adopt the technology, and reimburse for virtual consults to support remote patient monitoring (RPM).
The growth in business cases for new models of healthcare delivery and integration of digital health technology is reaching the point of convergence — creating powerful synergies where there was once only data silos and skepticism.
We have not quite achieved this synergy yet, but opportunities emerging in 2015 will move the industry much closer to the long-awaited initiatives in connected, value-based care.
Individuals are constantly hyper-connected to a variety of technology networks and devices. Wearables will continue to enter the market, but their features and focus will go well beyond fitness. Even the devices entering the market now are more sophisticated than ever before. Some are now equipped with tools like muscle activity tracking, EEG, breath monitoring, and UV light measurement.
It will be fascinating to watch how consumer electronics, wearables, and clinical devices continue to merge and take new forms. Some particularly interesting examples will be in the categories of digital tattoos, implantable devices, and smart lenses.
As the adoption of wearables continues to grow, we will continue to see more value placed on accessing digital health data by healthcare and wellness organizations. This will be especially important as healthcare shifts towards value-based models of care. The need to gain access to the actionable data on connected devices will only grow as innovation creates more complex technologies in the market.
There is no question that 2014 was an exciting and eventful year for digital health. Even with all of the advancements and innovations in 2014, this year promises to be even better. The growth in business cases for new models of healthcare delivery and integration of digital health technology is reaching the point of convergence — creating powerful synergies where there was once only data silos and skepticism.
Maybe we have not quite achieved this synergy yet, but the trends emerging in 2015 will move the industry much closer to the long-awaited initiatives in connected, value-based care.. To understand the convergence that is taking place in digital health, we need to examine the key emerging trends in technology, healthcare and business.
Connecting to Smart Clinical Devices
Technology has advanced to the point that we are constantly hyper-connected to a variety of networks and devices. We have handheld diagnostic tools on our person continuously generating an astounding amount of data.
The types of health devices that are connectable and disseminating data are rapidly changing. Tools are emerging like flash thermometers that do not require physical touch, which diminish contamination risks, and smart EpiPen casings that automatically alert medical professionals during an allergic reaction.
These devices are not only becoming less expensive, but they are also starting to be reimbursable by insurers. Thus, over time these devices will replace traditional, non-connected products. Clinical devices are increasingly designed as Bluetooth-enabled, allowing for the real time collection of patient data, and providing better access and outcomes for patients.
As government involvement in U.S. health care deepens—through the Affordable Care Act, Meaningful Use, and the continued revisions and expansions of Medicaid and Medicare—the politically electric watchword is “socialism.”
Online, of course, social media is not a latent communist threat, but rather the most popular destination for internet users around the world.
People, whether out of fear for being left behind, or simply tickled by the ease with which they can publicize their lives, have been sharing every element of their public (and very often, their private) lives with ever-increasing zeal. Pictures, videos, by-the-minute commentary and updates, idle musings, blogs—the means by which people broadcast themselves are as numerous and diverse as sites on the web itself.
Even as the public decries government spying programs and panics at the news of the latest massive data-breach, the daily traffic to sites like Facebook and Twitter—especially through mobile devices—not only stays high, but continues to grow. These sites are designed around users volunteering personal information, from work and education information, to preferences in music, movies, politics, and even romantic partners.
The hype around wearables is deafening. I say this from the perspective of someone who saw their application in chronic illness management 15 years ago. Of course, at that time, it was less about wearables and more about sensors in the home, but the concept was the same.
Over the years, we’ve seen growing signs that wearables were going to be all the rage. In 2005, we adopted the moniker ‘Connected Health’ and the slogan, “Bring health care into the day-to-day lives of our patients,” shortly thereafter. About 18 months ago, we launched Wellocracy, in an effort to educate consumers about the power of self-tracking as a tool for health improvement. All of this attention to wearables warms my heart. In fact, Fitbit (the Kleenex of the industry) is rumored to be going public in the near future.
So when the headline, “Here’s Proof that Pricey Fitness Wearables Really Aren’t Worth It,” came through on the Huffington Post this week, I had to click through and see what was going on. Low and behold this catchy headline was referring to a study by some friends (and very esteemed colleagues) from the University of Pennsylvania, Mitesh Patel and Kevin Volpp.
What else could lie in store? We talked with Nuance’s Nick Van Terheyden, who remains optimistic.
Nick van Terheyden, MD, CMIO, Nuance Communications
2015 will be the year well-designed interfaces will transform health IT legacy systems into sleeker, more intuitive, and cost-effective technology.
We know that good usability works hand-in-hand with accessibility to remove the burden from the end user, allowing her to focus on more important tasks— and nowhere is this more important than in healthcare. In the coming year, we will see a major uptick in the availability of secure health IT access on mobile devices that better support physicians in their natural, fast-paced environment, whether it is through clinical speech recognition technology, gestures, or touch. Physicians are consumers, too, and want and need the convenience of anywhere, anytime access to information.
We will also start to see the breakdown of silos in patient and physician technologies. The devices we rely on to track our vitals and help us stay active will begin to integrate in meaningful ways with clinical data, providing us with more awareness about our health and supplying our physicians with useful information about our health trends. Wearables will become a staple, leading to a healthier population and reducing overall healthcare costs. After all, what good is having a smart watch track all this data if it can’t help keep you healthier?
If you’re wearing a wristband that counts your steps, a patch that monitors your vital signs or a watch that tracks your heart rate, you are in the minority. And if you paid $300 or more for any of those items, you are among the nation’s quantified self-health elites.
Judging by the chatter streaming across our social media feeds, one would think every man, woman, child is sporting a health “wearable.” But in reality, these are the early days of the devices that promise to help us live longer, healthier, more active lives.
Despite the buzz, just 21% of Americans own a health wearable, according to a new consumer survey by PwC’s Health Research Institute, and only 10% of them use it daily. Even fewer consumers – 5% of respondents — expressed a willingness to spend at least $300 for a device. Many wearables today are a passing fancy – worn for a few months then tucked away in a drawer awaiting a battery charge or fresh inspiration to get up and get moving again.
As Genentech CEO Ian Clark recently put it, health wearables are “a bit trivial right now.” And it seems even the folks claiming to be wearing the devices can’t be trusted – reports have begun circulating of employees enlisting their more active coworkers to wear the device and collect fitness points on their behalf.
Yet wearables present remarkable opportunities for a nation and industry grappling with the twin challenges of improving health and controlling healthcare spending. Across the board, consumers, clinicians, insurers and employers express high hopes for the power of these new devices.
The great promise of wearables for medicine includes the opportunity for health measurement to participate more naturally in the flow of our lives, and provide a richer and more nuanced assessment of phenotype than that offered by the traditional labs and blood pressure assessments now found in our medical record. Health, as we appreciate, exists outside the four walls of a clinical or hospital, and wearables (as now championed by Apple, Google, and others) would seem to offer an obvious vehicle to mediate our increasingly expansive perspective.
The big data vision here, of course, would be to develop an integrated database that includes genomic data, traditional EMR/clinical data, and wearable data, with the idea that these should provide the basis for more precise understanding of patients and disease, and provide more granular insight into effective interventions. This has been one of the ambitions of the MIT/MGH CATCH program, among others (disclosure: I’m a co-founder).
One of the challenges, however, is trying to understand the quality and value of the wearable data now captured. To this end, it might be useful to consider a evaluation framework that’s been developed for thinking about genomic testing, and which I’ve become increasingly familiar with through my new role at a genetic data management company. (As I’ve previously written, there are many parallels between our efforts to understand the value of genomic data and our efforts to understand the value of digital health data.)
The evaluation framework, called ACCE, seems to have been first published by Brown University researchers James Haddow and Glenn Palomaki in 2004, and focuses on four key components: Analytic validity, Clinical validity, Clinical utility, and Ethical, Legal, and Social Implications (ELSI). The framework continues to inform the way many geneticists think about testing today – for instance, it’s highlighted on the Center for Disease Control’s website (and CDC geneticist Muin Khoury was one of the editors of the book in which the ACCE was first published).
Tech giants storming the digital health landscape will be center stage at Health 2.0’s 8th Annual Fall Conference in Santa Clara, CA. An impressive line-up of health and tech executives headline three full days of live demos and innovative sessions. Highlights include keynotes from visionary physicians Eric Topol and Patrick Soon-Shiong as well as Samsung Electronics President, Young Sohn in conversation with Health 2.0 CEO, Indu Subaiya. Leaders from Intel, Humana, IBM Watson, Qualcomm Life, Merck, athenahealth, eClinicalWorks and the Office of the National Coordinator for Health Information Technology (ONC) will showcase and discuss their latest technologies and initiatives on the main conference stage this fall. As always, Health 2.0 features over 150 live demos of new technology, 250+ speakers, 50+ sessions, more networking, and deals-done than anywhere else in health technology.
The main stage will feature the following panels:
Smarter Care Delivery: Amplifying the Patient Voice: Matthew Holt, Co-Chairman of Health 2.0, sparks the discussion on how new technology platforms, payors, and providers are working together for enhanced patient care delivery and engagement.
Consumer Tech and Wearables: Powering Healthy Lifestyles: Bringing together the most innovative wearables that are pushing individualized medicine into the future, Indu Subaiya, CEO of Health 2.0, leads this session focused on how consumers are experiencing new lifestyles centered around technology. Don’t miss the live fashion show featuring all the latest trends in digital health wearables!
Buy, Sell, Exchange: New Markets for Consumers, Employers, and Providers: Nearly a year after ACA implementation, this session will dive into the new ways benefits are being offered to consumers, how employers are buying care directly, and what new technologies are enabling change in direct care provision.
Data Analytics: From Discovery to Personalized Care: This panel focuses on how data analytics and powerful visualizations are pushing forward clinical research. Highlights will include genomics, non-invasive diagnosis tools, and integrated data collection are uncovering new discoveries, promoting personalized medicine and new care protocols.
Returning crowd favorites include 3 CEOs … (and a President!), The Unmentionables hosted by Alexandra Drane, The Frontier of Health 2.0 hosted by David Ewing Duncan, and Launch! with ten brand new companies unveiling their products for the very first time! Many more sessions and panels can be found on the Health 2.0 online agenda.Continue reading…