Looking Into the Future: Wearables & Implantables

The sector of digital health that includes wearable sensors is experiencing a boom. Market estimates predict growth from $1.4 billion in 2013 to $19 billion in 2018. The number of wearables sold globally nearly tripled between 2011 and 2012.

One of the best indicators of all things digital is the Consumer Electronics Show (CES) held every January in Las Vegas. While the show gets a lot of press for the latest in futuristic technologies in entertainment and personal computing, healthcare has been a growing presence at the convention for several years. Ten percent, or about 330 companies, of this year’s exhibitors were healthcare firms, which represents a 30 percent increase over last year.

“If I had to sum up [the 2014 convention] in a single world, it certainly would be wearables,” says Shawn Debravac, chief economist for the Consumer Electronics Association, host of the annual meeting. While the sector has been building slowly, it was more pronounced this year with more companies displaying products and more established companies entering the category.

United Healthcare and other payers exhibited in large booths at this year’s CES, and Dubravac expects that trend to follow the pattern set by other industries. For example, car manufacturers really didn’t exhibit at the show until a few years ago but, this year, nine of the top 10 vehicle manufacturers were displaying their wares. Companies from both the health and vehicles sectors are coming to CES because “technology is now playing a more central role in the services they’re bringing to end consumers,” says Dubravac.

Too much hype?

High-profile electronic conventions put a lot of hype on wearable computers and gadgets, says Isabel Pedersen, PhD, Canada research chair in digital life, media & culture at the University of Ontario Institute of Technology.

However, wearables have been around since the 1980s and “a lot of respectable schools worldwide have been working on this for long time.” The technology got a consumer life with the announcement of Google Glass last spring, she says. “Google Glass very quickly got everybody’s attention.”

Coverage of Google Glass really brought “heads up” displays and the concept of wearable computers into the mainstream. The technology, for now, is a solution in search of a problem, Pedersen says. For it to have significant impact on the industry, “everyday people will have to embrace the idea as a platform.”

It took the public about 10 years to become socialized to the idea of the handheld smartphone platform and we’re only at the beginning of the wearable computer platform. First, people embrace certain gadgets and monitoring devices— but a complete platform is necessary before major change can happen, she says. “Wearable platforms will happen but we need many variations, successes and failures to get there.”

Currently, fitness trackers are changing the conversation, Pedersen says, and people are getting used to the concept. The devices also are putting forward the idea that responsibility for monitoring biofeedback belongs with the individual rather than outside health services. “People are beginning to latch onto that idea. Fitness tracking is the way it will begin to infiltrate the health industry," she notes.

How well healthcare will integrate these new technologies depends on the organization’s leadership, interest, bandwidth and level of tech savvy, says David Collins, director of mHIMSS. While wearables are gaining traction, he says healthcare organizations that have done well with EHR adoption and other information systems will lead the pack. “For forward-thinking organizations, this is the next step.”

Collins, too, sees fitness trackers leading the way to more wearable technology. With the Affordable Care Act and the push toward accountable care, he also sees these devices playing a role in patient engagement, “which is certainly a priority.” The devices are relatively noninvasive and those that require few steps and operate “behind the scenes” will have higher rates of uptake and, therefore, offer more benefits to all stakeholders involved.

‘A slippery slope’

The proliferation of these devices won’t escape scrutiny of the federal government, however. But, how to regulate “is a slippery slope,” says Collins. The government purposely left some flexibility in the guidance “because of this exact discussion.” The FDA probably will periodically revisit new technologies and revise its guidance as necessary as the agency doesn’t want to “lock itself in a box” on its scope of regulation, he adds.

The annual HIMSS conference similarly has seen a rise in the number of mobile companies exhibiting. “What used to be science fiction and cool gadgets from the movies are no longer just from the movies,” Collins says. “People outside of healthcare are getting engaged with devices and integrating them into what they do.”

These less intrusive and obtrusive tools are a “new realm for healthcare,” he says. A t-shirt with sensors for sleep apnea rather than a big, loud machine is being produced and piloted. That’s just one example that offers cost savings and convenience. “It’s a win-win for everybody.”

These types of wearables represent a cultural, generational shift, Collins says. And while the potential for big benefits to patients and providers is there, Pedersen says changes in digital life can present some negative changes. “If we overemphasize medical monitoring, an individual could become oversocialized to be constantly wary that he or she might get a disease or become ill.” Users of wearable technologies could become obsessed or paranoid.”

However, wearables are passive and, therefore, “they focus their attention on you not vice versa,” she says. That passive monitoring “is supposed to liberate the wearer from concentrating too much on the device” and could mean that users don’t pay as much attention to the device much the way we do with our phones.

Looking ahead

As the technology advances, there easily could be certification of devices and experts, Collins says. As EHRs grew, there was a lot of focus on certified EHR technology and training programs.

The industry may have to standardize elements “so people feel some assurance and integrity with what’s out there. The interest in the technology is there and I think we’re going to continue to see the technology be adopted and along with that, people who know how to answer questions and integrate it. It’s going to be interesting to watch.

Collins says telehealth is the forerunner of wearables and even that concept has been around a long time but is still evolving.

Sensors are enabling a number of services and applications, Dubravac says. And, while “interest [at CES] was profound, I would say we’re in the exploration and experimentation stage. There are yet-to-be-discovered applications that will truly redefine the way we work and live and play. We’re literally at the tip of the iceberg of what’s yet to come.” 

Eric Topol on exciting new technologies

The rapid rise of iPods, iPhones and similar devices over the past eight years shows that “things can change drastically and radically in a very short period of time,” says Eric Topol, MD, director of the Scripps Translational Science Institute and chief academic officer for Scripps Health in La Jolla, Calif., speaking at the Digital Healthcare Innovation Summit in November 2013.

Topol has become a digital health guru of sorts, twice using his mobile medical devices to diagnose fellow airplane passengers with heart-related problems. He brought the concept to the masses appearing on “The Colbert Report” last year. Using a smartphone app, he imaged the TV show host’s inner ear canal.

These tools have the power to address a wide range of medical issues while significantly improving upon the convenience factor for both patients and providers. Mobile health technologies have the potential to change every aspect of healthcare, Topol says.

Biosensors is an area “exploding” and not just wearable sensors, he says, predicting that personal fitness trackers will be replaced with devices that do the work passively without any input by the individual.
Medication adherence, or the lack thereof, costs the U.S. healthcare system almost $300 billion a year as well as impaired and lost lives. Up to 50 percent of medications aren’t taken as prescribed, according to a study published in the Annals of Internal Medicine. The GlowCap, a pill bottle, glows when it’s time to take medicine, then beeps, then beeps louder and even calls the patient.

The first digital pill was approved by the Food and Drug Administration back in August of 2012. Made by Proteus Digital Health, the device is a silicon chip about the size of a sand particle. It contains small amounts of copper and magnesium that will interact with digestive juices to produce a voltage that can be read from the surface of the skin through a detector patch which then sends a signal via mobile phone to inform the doctor that the pill has been taken. Topol says it’s being used for patients with risky conditions, such as tuberculosis.

Less invasive devices also can save money. Medicare reimburses $3,000 for an in-hospital sleep study, Topol notes. But, newer sensor-type devices can track oxygen saturation through the night for a fraction of the cost. “A lot of these devices can cut costs pretty dramatically and they can be used for every physiologic metric you can imagine.”

The smartphone also has the ability to convert to a lab on a chip, he says. He cites Elizabeth Holmes, a college dropout who developed a way to make tests more accurate and less painful at a fraction of the current cost. With a tiny amount of blood, hundreds of tests can be done for a fraction of the cost of traditional lab tests. Holmes has a contract with 8,000 Walgreens stores and will train their personnel. “This is a big, creative disruption,” Topol says. “This is a whole different model that is really taking the individual into account.”

Along these same lines, he says the next exciting phase is a lab in the body. It makes sense, because the average car has more than 400 embedded sensors and even smartphones have 10 embedded sensors. Sensors in the body could predict and prevent unpredictable conditions such as heart attack. “Almost all of us have some minor plaque in our coronary arteries but we can’t predict when a heart attack will happen,” Topol says.

Celebrity heart attack victims, Tim Russert and James Gandolfini, had both been monitored—Russert’s stress test even came back perfectly normal just a few weeks before he died. Scientists have learned, however, that heart attack patients develop unusual blood cells. Tests have been conducted to characterize these cells in depth.

Pairing up with the Caltech Nonfabrication Group has led to the development of a sensor one-third the size of a grain of sand that can be injected into the bloodstream, Topol explains. That sensor can detect genomic signals and trigger a ringtone to warn of an impending heart attack a couple days up to a couple weeks before.

“The way we use it today, the smartphone is going to be the hub of the future of medicine,” Topol says. From a conduit of sensors to a gateway to remarkable computing power, a lab on a chip and environmental monitoring, the smartphone presents “the most radical change in the history of medicine. It will spur a medical revolution.”

Top innovations on the consumer front: CES 2014

Among the most innovative yet useful products displayed at the 2014 Consumers Electronics Show, says Shawn Dubravac, chief economist for the Consumer Electronics Association, was the Mimo baby monitor from Intel and Rest Devices. The baby wears a onesie that has two stripes down the front that act as respiratory sensors. Another detachable clip allows for another sensor that monitors body temperature, movement and body position. The outfit sends updates to a phone app.

Another product that saw a lot of interest was a smart toothbrush from Kolibree. Three sensors track where you’re brushing, how well and for how long.

“We’re starting to digitize the physical space around us,” Dubravac says. “We’re seeing software being utilized to change what the product does.” The hardware stays the same but the software changes the full application.

With the toothbrush, for example, the information already existed but capturing it digitally allows it to offer a service. “By looking at raw data feeds, the dentist can find trouble spots and then there could be interesting applications. We’re at the experimental stage. There’s a lot to come,” he says.

Cutting-edge sensing wearables

B-shoePreventing falls: With falls the leading cause of both fatal and nonfatal injuries among older adults, the B-shoe is designed to prevent falls when they’re about to occur. B-Shoe Technologies, based in Israel, has three prototypes in the testing phase of development.

The shoes incorporate pressure sensors, a microprocessor, an algorithm, a motion device and a rechargeable battery. When the sensor and algorithm detect imbalance, they prompt the motion device to perform a backward step to help the wearer regain balance. It operates only when imbalance is detected and is designed for use by seniors or by people who are injured, physically challenged, sick or in post-surgery recovery.

Monitoring hearts: A wireless adhesive patch designed to monitor the heart’s rhythms could replace the portable Holter monitor which has been in use for more than 50 years. Researchers from the Scripps Translational Science Institute, in La Jolla, Calif., compared the arrhythmia-detecting abilities of the Holter monitor with those of the new Zio Patch, an FDA-cleared wireless adhesive device made by iRhythm Technologies.

A total of 146 patients referred for evaluation of cardiac arrhythmia underwent simultaneous ambulatory ECG recording with a conventional 24-hour Holter monitor and a 14-day adhesive patch monitor.

During the first 24 hours, the Holter detected nearly 15 percent more arrhythmia events than the adhesive patch. But, because patients found wearing the adhesive patch for a longer period of time more tolerable (about 11 days on average) the new device could detect a significantly greater number of arrhythmia events (96) than the Holter (61). And, the study found that substituting the patch for an event or Holter monitor provides a 10- to 15-fold return on investment in the first 12 months.