The phrase “the Internet of things” has been used to describe the new paradigm of ubiquitous connectivity rapidly becoming a reality. Appliances, vehicles, phones, watches, and even clothes are joining computers in connecting individuals to the Internet. As consumers embrace mobile technology at a blistering pace, a new class of products has emerged: wearable technology, or “wearables” for short.
Wearables are essentially electronic devices and sensors small enough to be incorporated into clothing, jewelry, and personal accessories such as glasses, watches, or shoes. Notable examples include the Fitbit®, the Apple Watch, and Google Glass. Although many wearables are consumer-oriented novelties at this point, the potential impact of this technology in activity-related medical fields such as orthopaedic surgery is staggering.
Most wearable technology today is in the form of personal fitness devices. The PricewaterhouseCoopers Health Research Institute reports that, in 2014, 45 percent of wearables were fitness bands, and 77 percent of wearable owners were using their devices to exercise smarter. However, it is inevitable that money and resources will shift toward development of wearable medical devices.
At a recent tech gathering for wearables manufacturers and designers, Kabir Kasargod, director of business development for Qualcomm Life, told the audience, “I would move away from fitness and go hardcore into health. That’s where the money is.” His employer, Qualcomm Life, develops semiconductors for use in wearable technology. He urged developers attending the conference to “go from the children’s table to the grown-up table … if you’re serious about this, embrace the FDA. Learn how HIPAA (the Health Information Portability and Accountability Act) works … there’s a tremendous dearth of innovation here.”
The U.S. Food and Drug Administration (FDA) regulates all medical devices used to diagnose, cure, treat, or prevent medical conditions or disease. Obtaining FDA approval and complying with its myriad regulations can be challenging, to say the least. In fact, some experts have advocated for collaboration between pharmaceutical companies and device manufacturers to help the latter navigate the regulatory burden created by the FDA.
Even a company as large as Google has expressed dismay at navigating healthcare regulation, and has shied away from serious investment in the field. As medical innovation writer David Shaywitz said, “It’s pretty amazing that a company that doesn’t think twice about tackling absurdly challenging scientific projects (eg, driverless cars) is brought to its knees by the prospect of dealing with the byzantine regulation around health care.”
A survey of more than 200 medical technology companies found that the average time from submission of an application for FDA medical device approval to the time it was approved was 10 months, and time from first communication to approval took an average of 31 months. This stands in stark contrast to the average of 7 months needed from first communication to approval of similar devices in Europe. The report goes on to say that the average cost of bringing an FDA-regulated medical device to market is approximately $31 million, with $24 million of that spent on costs related to FDA approval.
Fortunately for physicians, there are several ways to harness the benefits of wearable technology that don’t necessitate FDA involvement. For example, the FDA recently issued guidance exempting many types of devices from their oversight, including the Fitbit, Apple HealthKit, and other similar activity and health trackers. This should enable continued innovation with products that aren’t produced for diagnosing or treating medical conditions.
Furthermore, physicians who develop and use mobile medical applications in their own practices have always been exempt from FDA clearance, and software and devices used for research purposes usually don’t fall under the umbrella of the FDA.
Uses in orthopaedic surgery
The potential uses for wearable technology in clinical orthopaedic surgery can be roughly classified into the following four groups: prevention, diagnosis, treatment, and outcomes tracking. Although these categories may overlap, it is possible—or rather hopeful—that additional categories will evolve in the future.
Prevention—As physicians, our first role should be to help prevent disease or injury. Wearable technology provides unique ways to do this. For instance, researchers at the University of Arizona have developed fiber optic socks that detect foot ulcers in diabetic patients, potentially preventing the sequelae of infection and amputation that often follows unnoticed ulcers in this population.
Several types of wearable sensors can detect stride and gait abnormalities in runners, indicating increased injury risk. Similar technology could be used to detect risky knee mechanics to prevent anterior cruciate ligament (ACL) injuries. Motion sensors could also be used on spinal cord injury patients to ensure the use of proper techniques to prevent pressure sores.
Diagnosis—Data gathered from wearable devices can be combined with clinical data for diagnostic purposes. Helmet-embedded sensors are already providing vital information in National Football League players and aiding in diagnosis of concussion. In the future, implantable biosensors in prosthetic joints could provide early diagnosis of infection, possibly enabling surgeons to perform a polyethylene exchange instead of a two-stage revision.
Existing technology that measures mechanical strain and loading forces in vitro could be used to detect intra-articular conditions conducive to joint wear in vivo. Researchers at the University of Pittsburgh Medical Center have developed an iPad app that helps to diagnose ACL tears by measuring pivot shift, and it is feasible that surface sensors in wearables could measure this data in the future.
Treatment—Wearables may make their most profound contribution to orthopaedic surgery by tracking patient compliance and providing real-time feedback during rehabilitation and pain treatments. Several studies of patients with adolescent idiopathic scoliosis have used sensors embedded in the brace to demonstrate that the effectiveness of bracing is closely related to the actual time spent wearing the brace and to prove that patients wear the brace significantly less time than they recall. This information has affected the treatment of these patients, and similar technology could be used in splints, walking boots, and casts to measure both time spent in the device and adherence to weight-bearing prescriptions.
Several researchers have used a combination of wearable sensors and mobile software to provide real-time feedback and to track progress during rehabilitation. In addition to engaging patients in their own rehab, these devices provide valuable data to physicians and therapists regarding patients’ progress. As our healthcare system seeks cost savings, these technological advancements may enable more home therapy and fewer formal visits.
Numerous devices for treating pain, including portable and adaptive TENS (transcutaneous electrical nerve stimulation) units, have arrived on the market or will be arriving shortly. With the increased prevalence of chronic pain, these products could potentially play a role both in decreasing narcotic pain medication usage and in improving patients’ quality of life.
Outcomes tracking—The movement to incorporate standardized patient-reported outcomes (PROs) in musculoskeletal research has been hard to miss in the past several years. These types of outcome instruments have numerous benefits, but are also prone to certain deficiencies. For example, each assessment provides only a single point in time, and scores rely on patient recollection and interpretation of the questions being asked.
As alluded to by blogger Jesse Slade Shantz, MD, in his discussion on wearable technology in orthopaedics, standardized outcomes scores sometimes don’t correspond with patients’ main complaints. Wearable technology could potentially combine kinematic, biometric, and sleep data with PROs to provide an even more precise understanding of true patient outcomes.
The security and privacy of the vast amounts of data collected by wearables are looming concerns as the use of these devices for medical purposes increases. Much of the data is stored in the “cloud,” which provides questionable security and HIPAA compliance. Consumer-oriented devices often provide useful information to the end-user in exchange for ownership of and the right to sell the aggregate data. Whether this model will be viable in the medical field is unknown, and extensive safeguards will certainly be needed.
In summary, industry and our own patients are deciding that wearables will be a part of their future. The degree with which we familiarize ourselves with, embrace, and help develop these technologies in orthopaedic surgery is for us to decide.
Orthopaedic surgeons should leverage existing technology as well as participate in the planning and development of future devices. Any paradigm shift in orthopaedics that involves surgeons will be better than one that takes place without their input.
Jeremy M. Burnham, MD, is a fifth-year orthopaedic surgery resident at the University of Kentucky. Jared L. Harwood, MD, is a fourth-year orthopaedic surgery resident at The Ohio State University.
- Slade Shantz JA, Veillette CJH: The application of wearable technology in surgery: Ensuring the positive impact of the wearable revolution on surgical patients. Frontiers in Surgery 2014;1. Available at: http://journal.frontiersin.org/article/10.3389/fsurg.2014.00039/pdf. Accessed July 16, 2015.
- PricewaterhouseCoopers Health Research Institute: Health Wearables: The Early Days (Whitepaper). 2014. Available at: http://www.pwc.com/us/en/industry/entertainment-media/publications/consumer-intelligence-series/consumer-intelligence-series-pwc-hri-wearable-devices-form.jhtml. Accessed July 19, 2015.
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- Shaywitz D: Google Co-Founders To Healthcare: We’re Just Not That Into You. Forbes 2014. Available at http://www.forbes.com/sites/davidshaywitz/2014/07/04/google-co-founders-to-healthcare-were-just-not-that-into-you/. Accessed July 19, 2015
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- Buddle RB: App quantifies tibial translation of ACL injured patients during pivot shift testing. Orthopedics Today 2013. Available at: http://www.healio.com/orthopedics/sports-medicine/news/print/orthopedics-today/%7Bc3d6ace3-ae4b-4cb5-ae88-6bdae0920744%7D/app-quantifies-tibial-translation-of-acl-injured-patients-during-pivot-shift-testing. Accessed July 20, 2015.
- Slade Shantz JA: Tracking Outcomes with Wearables. The Doctor Blog. Available at: http://www.thedoctorblog.com/outcomes-and-wearables/Accessed July 20, 2015.