Not so long ago, wearable devices were something of a niche technology. Fitness monitors enabled exercise buffs to the number of steps they’ve taken. Hard core enthusiasts used these devices to track vital statistics, such as heart rate and respiration. But even though wearable trackers offered features and functions that went well beyond older monitoring technologies, in the eyes of the Food and Drug Administration, they still fell short of the higher standards required of medical devices. But now, wearable products with medical applications are finding their way to the market. The progress of wearable technology in a relatively short period of time is paving the way for a future where wearables play a major role in health care.
Heart monitoring is an example of a medical need well-suited to wearable technology. Heart monitors in hospitals are not portable. While portable monitors exist, these monitors are big, bulky, and uncomfortable. In recent years, startup companies have developed smaller heart monitors that are durable and wearable. IRhythm Technologies developed a water-resistant wearable sensor called the ZIO patch. This patch can be worn for two weeks, offering the advantage of continuous monitoring with minimal interference in a patient’s daily life, Medgadget explains.
Wearable medical devices are becoming even smaller and more wearable than adhesive patches. The BioStamp Research Connect System is an even thinner patch that has the capability to measure a wide range of data, such as the range of motion of a joint, which can be an indication of recovery from injury. The evolution of wearables to a thin, flexible patch such as the BioStamp is the result of new circuitry available in thin, flexible printed circuit boards, Modern Healthcare explains.
Beyond the technological advances driving wearable technologies in health care, health policy is also nudging the market toward adoption of wearables. One of the provisions of the Affordable Care Act links healthcare reimbursement to the ability of healthcare providers to show the value of their care, and the ability to keep patients healthy. That means that hospitals will need to improve the way they diagnose, treat, and monitor patients, according to Reuters. One way to achieve those goals is to employ wearable technologies. Julie Ranck, a healthcare consultant, tells Reuters that she expects that more wearable devices will be developed for chronic conditions in coming years because monitoring will be the best way for healthcare providers to obtain the data necessary to show whether or not their treatments are improving chronic conditions.
The FDA recognizes the sea change in the capabilities and medical applications of wearable technologies. Last year, the agency last year opened draft guidance on wearable technologies, which differentiated between “low-risk” wellness devices, such as smart watches and fitness trackers, and wearable devices used for diagnosing a medical condition. That distinction clarified the blurred lines that had held back some device makers from pursuing innovative new products and cleared the path for medical device developers to pursue new products with a little more regulatory certainty. Wearable technology is already here. But as far as we’ve come, we’re just scratching the surface of what the technology will bring to health care.
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