Smartwatch Vendors Look to Add More Healthcare Features for Use in Medical Trials

Apple has partnered with the musculoskeletal healthcare company Zimmer Biomet to take part in a clinical study to determine why certain knee and hip replacement patients recover faster than others. This is being done with its mymobility app that is specifically designed for patients within the trial and uses Apple’s Watch and iPhone to connect patients with their surgical care team. It is hoped that the app, combined with activity monitoring before and after the process of a hip or knee replacement, will help monitor these patients and ensure they get the care that they require. The Apple Watch Series 4 was chosen specifically for this U.S. study due to the inclusion of an Electrocardiogram (ECG) sensor that allows it to monitor particular heart information without the need for a medical device. Its fall detection feature is also likely to be of use by alerting the user and their doctor to a fall that may be related to the surgery. Streamlining the care for knee and hip replacement patients is vital, as 1 million of these surgeries occur annually in the United States alone; this number is expected to rise to 3.5 million by 2035. This is putting pressure on the U.S. healthcare system, both in terms of the number of patients and the financial implications.

The up-to-10,000 U.S.-based patients in academic centers, hospitals, group practices, and ambulatory surgery centers included in the trial will use the mymobility app alongside the Apple Watch before and after their knee or hip replacement. It is unclear how the smartwatches are being funded, but they are being provided to the patients for the study. Zimmer Biomet researchers will use activity and health data from the smartwatch as well as patient feedback to determine how effective Apple’s Watch and the app are at monitoring patients and at ensuring that the knee or hip replacement is a success. Patients will be able to share their data with their doctor without requiring in-person visits and will have access to support, guidance, and therapy reminders before and after their surgeries.

Smartwatches are increasingly being used for medical purposes due to the increasing number of health-tracking sensors and features included and the ability to seamlessly connect patients to medical professionals—either directly from a cellular-connected smartwatch or via a connected smartphone. These wearable devices are being used within medical trials to determine if their use can aid with patient monitoring, health tracking, and rehabilitation. The aim is to limit the number of patient visits and prevent any major health issues by detecting signs before they occur, ultimately saving medical costs and further complications for the patient.

The number of activity and healthcare-tracking features—such as heart rate monitoring, steps, calories burned, fall detection, and sleep quality—being loaded onto smartwatches designed for consumers (as opposed to the bulky, unappealing medical devices that consumers may be reluctant to use) are increasing, making them ideal for medical purposes. There are still issues with the high price point of smartwatches (for example, the Apple Watch Series 4 is US$399 and up, whereas purpose-built ECG watches, such as AliveCor’s KardiaBand, are far cheaper at US$99). However, they will likely be a more popular option due to the extra features, the already high adoption from consumers who do not want a medical device that draws attention to them, and the ability to get the devices directly to the user immediately. Smartwatches can also send this information directly (or via a connected smartphone) to the medical professional, allowing them to track a large number of patients without requiring hospital or clinic visits. This not only saves time (as the medical professional can monitor many patients simultaneously) but also provides a continuous stream of healthcare information, rather than just how the patient is at the time of a visit.

The Apple smartwatches have and will be included in a number of medical trials for a variety of purposes. These include identifying irregular heart rhythms in those with potentially serious heart conditions (such as atrial fibrillation); monitoring physical activity and providing coaching to combat post-transplant weight gain; and testing an app designed for patients with Type 2 diabetes.

Other medical studies using smartwatches from other brands include the following cases.

• The Polar M400 smartwatch was used in a study to determine the smartwatch’s effectiveness, alongside a social cognitive theory–based health intervention, in promoting healthy physical activity and eating behaviors in college students over the course of 12 weeks. Physical activity (e.g., the number of steps as well as duration of moderate and vigorous activity) and energy expenditure were monitored. The aim of the study was to reduce the prevalence of obesity in those aged 20–39, which (according to the study) was at 60% in the United States due to low physical activity and poor diet, particularly among college students. The study ran from September 2017 to May 2018 in the United States with results expected soon.
• Garmin smartwatches (alongside Garmin chest bands) are currently being used in a study to determine the ease of detection of atrial fibrillation because it increases the risk of a later stroke. The aim is to determine if atrial fibrillation can be detected by a smartwatch, making it easier to diagnose and to ensure that future strokes are prevented. The trial began in June 2018 in the United States, with 120 patients with atrial fibrillation scheduled to have electrical cardioversion at the University of Kansas Health System, and will finish in January 2019.

Smartwatches will continue to be developed, with new sensors and features being added, making them more and more suitable for medical trials and deployments and allowing doctors to continuously monitor their patients’ health by getting alerts to any issues. ABI Research expects smartwatch shipments to increase from under 40 million shipments in 2018 to nearly 110 million in 2023—a Compound Annual Growth Rate (CAGR) of 22%. Smartwatches have commonly been used to provide the user with a convenient way with which to access smartphone notifications and are increasingly being used by individuals to track their general health and well-being. The continued addition of healthcare sensors and features are allowing them to be further used within medical trials and deployments.

In addition to Apple adding ECG tracking to its smartwatch, other vendors are also looking to offer devices with more healthcare-tracking features. Earlier this year, Samsung filed a patent for blood pressure tracking via the wrist using light technology, which would be smaller and less obtrusive than traditional arm cuffs. The company will need to get the required medical approvals within different regions—such as clearance from the U.S. Federal Drug Administration (FDA) in the United States and CE certification in Europe—for such a feature, but if it is passed, it would provide a more convenient blood pressure tracking method that could be used by patients to inform doctors of their health.

Smartwatch vendors are also continuously improving their algorithms in addition to their features. This allows current features, such as sleep tracking, to be improved and to provide more information that can be used for healthcare purposes. In the case of sleep tracking, obtaining more information about the wearer’s sleep patterns can be used to provide information on the likelihood of sleep apnea as well as to improve overall sleep quality. Other features like fall detection (a feature that was previously found in medical and personal emergency response devices) are also being utilized on smartwatches. These were often rejected by patients, as the devices are recognizable as a medical device and draw attention to the fact that the wearer is being monitored.

Smartwatch vendors should consider adding the above healthcare-tracking metrics, as well as others, to their devices to allow them to be used for medical purposes; however, other important smartwatch features, particularly battery life, must also be improved. If a smartwatch is to be used continuously for medical purposes, a long battery life is vital to provide this monitoring and to prevent the device from failing. Other issues, such as the cost of the devices, may also limit the uptake; however, patients often prefer to use consumer grade smartwatches, as it is less obvious to those around them that they are being monitored. To add these features, manufacturers must look to partnerships with medical companies or hire personnel with the required knowledge and experience.

Medical clearance, such as FDA and CE certification, will be a requirement for certain medical features. This can be a time-consuming process often taking months and even years; companies such as Apple and its ECG feature currently have approval for use in the United States but not in Europe or elsewhere. To get FDA clearance for the ECG feature, Apple was required to provide data from a heart study involving patients with and without atrial fibrillation. The app was found to have a 98% accuracy rating. This approval is particularly required as the devices will be used professionally, so it is vital not only to have an understanding of the process but also to realize what is needed from the device. Medical approval should also ensure that inaccurate readings are kept to a minimum. Occasionally, it is likely that false or inaccurate readings will be taken, which is often expected. If numerous inaccurate readings are provided, it is possible that the medical approval could be revoked, so it is vital that vendors looking to offer smartwatches for medical purposes ensure that the technology is accurate to prevent this from happening.