Imagine a bra that you (or ladies you know) could purchase over the counter and wear for one day to screen for breast cancer. This bra would be lined with temperature sensors that monitor variants indicative of cancer. It would not emit radiation or squish sensitive parts like a mammogram. Even women with dense breast tissue could count on reliable results.
This exact invention by First Warning Systems is slated for clinical testing to determine its efficacy. “It’s a very novel, very promising technology,” says Joshua Ellenhorn, an expert in surgical oncology and a clinical professor of surgery at Cedars-Sinai Medical Center in Los Angeles. Ellenhorn is leading the trial.
For the trial, women who have an abnormal mammogram will wear the bra prior to receiving the traditional course of diagnosis and treatment, starting with a biopsy. The sensors inside the bra will collect temperature data, which will be transmitted either wirelessly or manually to a computer or device. The digital database diagnosis will then be compared with the diagnosis from the mammogram and biopsy. Only 20 percent of women with abnormal mammograms are diagnosed with malignant tumors, and this study will test the device’s accuracy at pinpointing that 20 percent.
“This is entirely new technology. There really isn’t anything like it,” Ellenhorn says. He and the company’s leaders are waiting for FDA approval to begin the trial, which they hope to complete by next summer.
“The idea that a woman could get her own home study to determine whether there’s a breast abnormality is a major advance. … Anything that makes it easier to screen for cancer, and for the particular cancers that we know that we can help, is going to be a major advance,” Ellenhorn says.
If the trial determines that this is indeed a breakthrough device, it could have implications for other forms of cancer, especially those that occur near the skin’s surface.
The development of devices like this mark a turn toward more personalized medicine. While routine home visits are a thing of the past, and while paperwork and clunky policies make it impossible to drop in for a doctor to quickly examine a symptom, mobile devices are ushering healthcare into a more patient-focused era.
The First Warning Systems bra is itself a symptom of the movement toward digital medicine and the use of mobile technology to track everything from sleep to glucose levels — and, in the not-too-distant future, much more.
The most basic and ubiquitous devices are health and fitness trackers like the Jawbone UP and Fitbit, which track sleep and exercise via sensors worn on the wrist. These devices compile data in well-designed smartphone apps that display charts and graphs detailing sleep and daily activities. They can be paired with other apps to track diet, caffeine consumption, and more.
The idea behind health and fitness trackers is that raw data about personal habits can be used to set goals for even better habits. In fact, some apps will congratulate you for going to sleep before a certain hour for several nights in a row or will remind you to get up and take a walk when you’ve been sedentary for too long. For many people, information can be a powerful motivator.
These devices seem cutting-edge today, but they’ll be this industry’s floppy disks in no time. In 2013, “sports, fitness, and wellness” represented 75 percent of devices shipped worldwide, with North America representing over half of the market for wearable and wireless mobile health devices, according to ABI Research. By 2018, this will slow to 55 percent, analysts say, while wearable and wireless monitoring devices for managing medical conditions and related activities will rise significantly.
The medical potential for currently available handheld medical devices and those in development is impossible to underestimate. Take, for instance, the AliveCor Heart Monitor, released in early 2013 for prescription usage and approved for over-the-counter sales in February. The device is a smartphone case with sensors that track a user’s heart rate through his fingers or chest.
It converts electrical impulses from the body into signals that are processed by the accompanying app. Perhaps most useful to health professionals, it can then generate an electrocardiogram (ECG). The ECG can be stored on the smartphone app and shared with healthcare providers. For cardiologists and their patients, this device could be a game changer.
“[Smartphones] are literally the remote controls of our lives,” says Dave Albert, founder and chief medical officer of AliveCor. The ability to take that “ubiquitous connectivity” and harness it to deliver personalized healthcare, he says, is a “powerful concept.”
Richard Wong, a cardiologist with Cardiology Consultants Medical Group of the Valley near Los Angeles, was an early adopter of the technology. After hearing about AliveCor from a colleague, he started using it and was impressed by the quality of the data.
Wong primarily uses AliveCor for patients with a known or suspected arrhythmia, an umbrella term for an irregular or erratic heartbeat. Some patients have symptomatic arrhythmia, where they feel a sensation in their chest, while others have no symptoms.
For the symptomatic group, especially those who don’t experience symptoms often, Wong recommends an AliveCor device so patients can pick it up when they feel a sensation in their chest and record their ECG. That way, he can diagnose the problem based on data, rather than on an after-the-fact conversation.
For the asymptomatic group, Wong recommends AliveCor to record the ECG at prescribed intervals to diagnose irregularities. In general, this device is appropriate for patients who are comfortable with technology, have a smartphone, and can afford the $200 price tag, which is not covered by most insurance policies.
Heart-monitoring methods currently covered by traditional insurance policies tend to be bulky, inconvenient, and difficult to use over long periods of time, Wong says. With AliveCor, he can log in to an online portal and check patients’ progress. As of press time, he was tracking 12 patients. He can review their ECG results without an office visit.
One patient, whose heart Wong monitored with AliveCor even when the patient was out of town, had underestimated how often his heartbeat was irregular, putting him at a higher risk for a stroke. Because of this device, Wong was able to detect atrial fibrillation and then adjust the patient’s medication appropriately.
With real-time information like this, Wong says, office visits are more productive. He spends less time on diagnosis and more time determining the best treatment. Not only that, but patients using AliveCor can also avoid emergency room visits (not to mention associated costs) when a symptom that feels significant is shown to be benign. And they can track their symptoms at home to determine what triggers their condition.
While Wong’s patients have a medical need for the device, some users are merely techy health fanatics. One of Wong’s patients showed her husband the device, and he thought it was “so cool” that he bought one for himself.
In digital medicine, there is often overlap between “medical necessity” and “interesting novelty.” Unfortunately, in some cases, devices that fall more in line with medical necessity haven’t caught up with the user-friendly data displays of more novel devices.
Anna McCollister-Slipp is the co-founder of Galileo Analytics, which creates visualizations and analytics of healthcare data. She also advocates for policies and technology to streamline and improve diabetes management. She has coped with type 1 diabetes for almost 30 years, and she sees the potential for more cohesive monitoring and treatment of her condition.
She has a continuous glucose monitor and an insulin pump attached to her body. Before meals, she uses an injector pen to administer Symlin (pramlintide acetate), a synthetic version of a hormone that is critical in controlling glucose levels. And she uses a pinprick digital glucose monitor about 10 times a day for more precise moment-in-time readings. These devices don’t talk to each other. They don’t have user-friendly apps or software to track progress.
McCollister-Slipp also uses a fitness tracker, digital scale, and blood pressure monitor. Plus, the tracker helps her determine correlations between glucose levels and exercise when she cross-references the data.
While tracking and controlling her diabetes is a cumbersome and time-consuming process, even the devices without streamline data displays make her life easier. “It’s a life changer,” she says of her array of devices. “I just wish they’d invest a lot more in making the data more usable.”
Since her diagnosis, McCollister-Slipp has seen the slow evolution of diabetes treatment. While digital medicine is having a general growth spurt, she warns, “As someone who lives with a disease that’s on the cutting edge of digital health, I’m also skeptical of the hype.
“It’s pretty easy to predict that things are coming fast when you see them in early stages, but complex diseases are complex to solve,” she says. At the same time, she’s “incredibly excited” at the possibilities within digital medicine, and she plans to continue advocating for expedient changes.
So what, exactly, is digital medicine?
“Boy, that’s a good question,” says Steven Steinhubl, the director of digital medicine at Scripps Health, a leader in medical technology research, study, and mobilization. “True digital medicine is really understanding the individual and what is unique about all of us. … It’s combining a much greater understanding of each individual’s distinctive response to the changing environment around them using mobile health technologies with, when possible, their digital genomic data.”
Eric Topol, the director of the Scripps Translational Science Institute and a member of Genome’s advisory board, explored the impact of the “digital revolution” on healthcare in his book The Creative Destruction of Medicine: “This is a new era of medicine, in which each person can be near fully defined at the individual level, instead of how we practice medicine at a population level, with mass screening policies for such conditions as breast or prostate cancer and use of the same medication and dosage for a diagnosis rather than for a patient.”
Steinhubl offers the example of high blood pressure, a common chronic condition. “There’s going to be dozens, if not more, genetic conditions that may be contributing,” he says. Digital medicine helps to identify and track certain genetic factors that can be determined through blood samples and linked to important physiological variations in continuous blood pressure records identified through smartphone-linked blood pressure monitors.
As Steinhubl’s and Topol’s comments show, it is impossible to separate digital medicine from genomics. Both aim at a more detailed understanding of the human body, both are too all-encompassing to apply a narrow definition, both try to collect as much information as possible, and, perhaps most notably, both focus on the individual.
One mobile information system called BaseHealth compiles genetic, medical, and personal information into one platform to provide doctors and patients a comprehensive view of the individual. It is among the best examples of digital medicine as the physiological chronicling of the individual. If information is power, BaseHealth shows that the packaging of that information can hold that much more power. With this application, genetic, clinical, and lifestyle data are compiled into a nuanced picture of an individual’s health, allowing for preventive care.
“I strongly believe there is a lot we can do about preventable diseases,” says Hossein Fakhrai-Rad, co-founder, CEO, and president of BaseHealth. “Our focus is mainly on common complex diseases. We want to deal with diseases that you can do something about,” he says.
At Scripps, a third of clinical trials originate from device developers who need to test their products. The other two-thirds are aimed at integrating digital medicine as a method of gathering information to treat a specific patient population.
Scripps is conducting one study that uses a wireless device to track atrial fibrillation, which is an abnormal heartbeat, and collecting patient blood samples to cross-reference genetic patterns and determine markers that may contribute to the condition. Studies like this can provide useful information about risk factors to enable preventive medicine. Scripps is also testing a handheld ultrasound machine that could be used in addition to, or eventually instead of, a stethoscope. Instead of listening to the heart and blood vessels to determine a problem, doctors could see blockages and leaks for a more verifiable diagnosis.
Scientists at Scripps are also conducting a study called Wired for Health that uses a wireless glucometer, blood pressure cuff, and ECG device (AliveCor) to test the management of certain chronic conditions. The study aims to determine if the use of such devices reduces the number of doctor and emergency room visits and saves on healthcare resources while improving patient care.
Mobile medical devices and apps are regulated primarily by the FDA, which classifies them according to patient risk if something should malfunction. The higher the risk, the more stringent the regulation. No risk, no regulation. While it sounds simple, there are still gray areas as to what qualifies as a medical device and what constitutes a greater risk.
“Devices that are more intrusive or where the level of resolution matters to the physician’s decision, those are the things that are edging toward more potential harm to the patient,” says Darrell West, the vice president and director of Governance Studies and the founding director of the Center for Technology Innovation at The Brookings Institution. At the same time, he says, “the regulatory situation has been complicated for device manufacturers because they have not been sure what devices are subject to regulation and which ones require FDA approval.”
The FDA released a guidance document for device developers last year, but in an industry so new and fast-paced, the kinks are still being worked out, according to several people involved in development.
Additionally, the FDA process is long, and the testing required is expensive, says Alisa Chestler, an attorney at Baker Donelson in Washington, D.C., who handles healthcare cases and represents physician practice groups that are integrating digital components into their care. There is also uncertainty about how digital medical devices affect legal risk to doctors and manufacturers. For example, what if a physician is monitoring a patient’s vital signs remotely but doesn’t see a negative sign quickly enough to address it before a related decline in that patient’s health? Is the doctor legally at fault? This remains unclear.
With the inherent legal land mines and regulatory snafus, Chestler offers simple advice: “If it’s done the right way, it’s done the right way.” In other words, with due diligence from everyone involved, technology will progress. As for what that “right way” is, it’s impossible to nail down an answer. “Unfortunately, it’s a consult-your-attorney kind of answer,” she says.
While there are many hurdles and unanswered questions in bringing these devices to the marketplace, pioneering companies are smoothing the paths for companies that will follow, says Matt Hendricks, a partner at Pharmica Consulting, which advises device creators. “Once those initial companies get through,” he says, “they really set the standards for what’s to follow. … In my opinion, the benefit to be gained is far greater than some of the potential liabilities.”
In the current healthcare system, doctors are reimbursed by insurance companies when they send a patient to labs for testing. Though digital medicine carries the potential for healthcare savings, the economics would have to shift to make much of the technology work out financially.
“All of mobile health is going to be hamstrung until the [shift of] financial incentives, which right now incentivize us to do more,” Scripps’ Steinhubl says. “Mobile health is really designed around the idea of: Let’s make this more convenient for individuals. Let’s get real-world information from their homes instead of having them come into the office.”
Healthcare systems are designed around “sick care,” he says, rather than health maintenance, which is the goal of devices from the Jawbone UP fitness tracker to the breast cancer-screening bra.
Recently, however, there has been a shift toward reimbursing healthcare providers for preventive measures that limit patients’ visits to the hospital. It’s the bud of the sweeping changes Steinhubl deems necessary for digital medicine to become an integral part of mainstream care.
“A lot of the stuff that we do in our office visits now is no different than in the 1930s,” he says. A nurse directs patients to hop on a scale, then fastens the blood pressure cuff around their arm. Next, the doctor enters with a stethoscope to check the heart and lungs. Breathe in, breathe out. Your grandma had the same checkup. “The difference was in the 1930s, about 40 percent of healthcare was in the individual’s home,” Steinhubl says. “I think what mobile healthcare allows us to do is to bring healthcare back to the home. … It’s not the same as the horse and buggy or the doc going to the house, but it’s going to feel that way.”
Digital medicine not only brings healthcare back into the home, but it also brings technology into the body. Its outgrowths range from devices that make healthcare more convenient to devices that make the human body function better from the inside out.
The following is not science fiction, though it may read that way. Fiorenzo Omenetto, David Kaplan, and Hu Tao, all bioengineers at Tufts University, and Michael McAlpine, a Princeton nanoscientist, created a bacteria-sensing “tooth tattoo” made of electrodes and chemical sensors mounted on a thin layer of engineered silk.
The silk is made to dissolve within 15 to 20 minutes of application, leaving behind the sensor, which is read and powered by a tiny attached antenna that communicates with a handheld device.
The device can detect bacteria that cause periodontal disease. Because of its size (slightly too big for a human tooth), it was tested on cows. More work must be done before the device can undergo clinical testing, but because so much about humans’ overall health can be determined from saliva, which contains biomarkers for many diseases, the implications are vast. If the sensor could be adapted to red-flag those biomarkers, it could be the beginning of a semi-permanent health monitor — like a fitness tracker for your insides.
It’s not a stretch to imagine that these “tattoos” could be applied on the skin to track other measures of wellness.
“If you think of all the body monitoring that is happening right now with exercise monitors, it’s very interesting to think about how these are becoming so popular, but they don’t really tell you much, if anything, physiologically. Imagine if you had that information,” Omenetto says. For example, a simple skin-mounted device could constantly monitor glucose levels to help people make better food choices.
Omenetto and his colleagues are collaborating with John Rogers at the University of Illinois at Urbana-Champaign on dissolvable bioelectronics mounted on silk. In 2010, they tested a silk-mounted brain-monitoring device on a cat. The material molded closely to the brain, as it does to teeth, fruit, and other materials. Devices like this have the long-term potential to both monitor activity and well-being and administer treatment targeted from the inside. A group of scientists, including Omenetto, are also developing small edible sensors that can be applied to perishable foods to alert consumers when they are going bad.
While the future could hold an app that tracks the freshness of the contents of your fridge, other devices are likely to change healthcare and wellness tracking in the short term. Breath analytics is among the next frontiers. While we generally know breathalyzers as the gold standard in field sobriety testing, similar devices could be used to screen patients for certain types of cancer and other diseases.
Steinhubl at Scripps plans to launch a trial of an “electronic nose” that works with a smartphone app to diagnose lung cancer. The device is made by Vantage Health, a company associated with Nanobeak Inc.
“You can imagine, if it progresses to where we’re good enough, every time you talk on your cellphone, you could potentially be screening for cancer,” Steinhubl says. “A device like this, refined over time, could potentially eliminate the need for mammograms or colonoscopies.” It could even put the cancer-screening bra out of business.
Still, there’s a long road ahead before digital medical devices become ingrained in mainstream care. There are obstacles — not everyone has a smartphone, not everyone is tech-savvy, and for those who are, healthcare in general must become more innovative and adaptable before these devices will be the norm.
Roadblocks aside, it seems that the pace of technological development is largely determining the pace of implementation. Institutions like Scripps aim to clear the path of regulations and policies by way of research and testing. In other words, they gather more knowledge about the devices that generate more knowledge about patients.
“It’s one of these rare changes in medicine that individuals, the healthcare consumers, can get behind and enthusiastic about, that providers can look at and say, ‘I can see this as something that’s going to help me care for my patients better,’ and for payers — any definition of payer, but especially the government as a large payer — to be able to say, ‘This is actually going to not only improve outcomes, it’s going to be a lot less expensive for me in the long run, too.’ It has the potential and will; we just have to show people,” Steinhubl says.
The way healthcare providers address medicine, from diagnostics to chronic-condition management, will continue to change rapidly. “We are on the very flat part of the exponential curve, the very earliest,” Steinhubl says. “It’s really going to be remarkable.”
In other words, “What we believe today is science fiction will tomorrow be science,” says Albert of AliveCor. This digitally enhanced future will inevitably focus more on the individual. It’s the doctor’s return to the home, though the patient may see him even less.
iBGStar: The iBGStar is a blood glucose monitor by Sanofi Diabetes that connects to the iPhone or iPod touch. As with traditional blood glucose monitors, patients prick their finger and apply a drop of blood to a test strip that is analyzed by the device. With iBGStar, the reading is stored in an app on the device, where patients can track their glucose, insulin, and carbohydrates and analyze trends over time. Information from the app can be easily shared with doctors to better manage diabetes care. The device costs $70 to $75, and test strips are sold separately. (1/8)
Corventis’ AVIVO Mobile Patient Management System: This device looks like a Band-Aid, but thicker, and it adheres to the chest for continuous cardiovascular monitoring to detect, prevent, and treat a variety of heart conditions. The wireless system tracks various vascular readings — including fluid status, heart rate, heart rate variability, respiration rate, posture, and activity — and transmits them wirelessly to doctors, allowing a patient to go about his or her daily activities. (2/8)
WellnessFX: WellnessFX is essentially a mobile health dashboard. Patients can either upload their own lab results or obtain a lab order through this service and receive biomarker data within a week. The WellnessFX dashboard can be viewed on any computer or mobile device, and patients can visualize blood test results over time with descriptions of biomarkers to analyze their health. Packages range from $78 to $988, and personalized consultations are also available. (3/8)
Jawbone UP: This fitness tracker is worn around the wrist and tracks sleep and steps per day. The information is compiled in a smartphone app that generates charts and graphs to display your activity for easy analysis. Users can also log food, drinks, and exercise. The UP 24 version connects wirelessly to the app, and the UP version uploads data through a USB connection. (4/8)
Fitbit: Fitbit fitness devices track steps, distance, calories burned, and sleep. There are three versions: the Flex, which is a bracelet that you can also use to set goals; the Zip, which can be clipped to clothing or carried in your pocket but does not have the sleep or silent alarm feature; and the One, which can also be worn like a bracelet and can assess how many floors you’ve climbed. (5/8)
Metria Wearable Sensor: Billed as the golden ticket for people who want a detailed picture of their health-related habits but aren’t interested in wearing a device long term, this product is a disposable sticky patch that stays on the body for about a week. It measures sleep, activity, heart rate, respiration rate, and calories burned, and the information is uploaded through a USB connection. The idea is to record your habits for a week to learn what needs to be addressed. It is available on a limited basis through select partnerships but is planned for wider consumer release. (6/8)
AliveCor Heart Monitor: This device is a smartphone case with sensors that convert electrical impulses from a user’s fingertips into ultrasound signals, which are transmitted through the phone’s microphone. It allows patients with heart issues, as well as health-conscious technophiles, to monitor their heart health anywhere. (7/8)
Colorimetrix: This app analyzes colorimetric test strips, which change color in the presence of different solutions and are commonly used in testing urine for certain biomarkers. Users take a photo of the used test strip, and the app displays the concentration of the material being tested, which can then be stored or sent to a doctor for diagnosis. The Munich-based developer hopes to release the app by the end of the year. (8/8)