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Wearable technology in the medical devices sector

June 2013

With Google Glass creating interest in the media, attention is shifting to the possibility of a new generation of technology that is not just portable but wearable. However, it is not just in the area of interactive information services that developments in wearable technology are taking place. Advances are also being made in the area of wearable medical devices. In fact, the market for wearable devices is reported to have already reached a value of $2 billion in 2011, with predictions that this will triple by 2016. The latter figure would represent some 100 million health related devices sold, even before sports and fitness related devices are included.

As with other kinds of device, the developments that have enabled growth in this area are improved and standardised wireless technology and the ability to build small, sophisticated electronic systems. But what is meant by wearable medical devices? The answer is that the term covers a wide variety of products but they are generally devices worn on the body for a prolonged period that are able to capture and process data about the patient's physiology and then calculate the correct medical response before notifying the patient.

MonitorAn example of a wearable medical device is the continuous glucose monitor (CGM) used by diabetes patients. CGMs can alert the patient when their glucose levels are rising or falling too quickly, predict in advance an oncoming high or low, or simply allow the patient to keep track of their glucose status throughout the day. Patients can, therefore, learn to adapt their lifestyle, to the extent possible, around their diabetes.  In addition to providing this real time feedback, the data collected by a CGM can also be used with the appropriate software to establish a record of how the patient reacts to exercise, food and insulin. The profile of a patient's disease that can be assembled in this way is then useful to clinicians advising on treatment.

CGMs are wearable in the sense that they are typically attached to the patient by a disposable sensor placed under the skin. This is connected to a wireless transmitter which conducts information to a handheld device able to process and display the relevant information to the patient.

There are, however, still limitations. For example, CGM devices can require calibration by traditional fingerstick methods more than once a day, and because the data collected comes from interstitial fluid rather than directly from the blood, information relayed by the monitor can often lag a few minutes behind what is actually happening in the body. The goal in glucose monitoring is, therefore, to develop permanent bio-implanted devices able to measure blood-glucose levels directly.

Other devices being developed include monitors of heart rate, respiratory rate and other vital signs. And, whilst these have medical applications, they are also being seen as having an increasing role in training for athletes, as well as in general fitness applications for healthy individuals. Developments in wearable medical devices are also expected to enable remote monitoring, such that a patient can be monitored by a hospital from home with treatment initiated without the patient having to first report to a clinician. Other devices can simply be used to remind a patent when they need to take their medication.

In more general terms, the need to monitor the vital signs of patients recovering from illness away from hospital is expected to gain in importance as the percentage of the population over 60 in many developed countries grows. Attention to the need for wearable devices will, therefore, be motivated by public finances in addition to the improvement of treatment.

Notepad and penHowever, whilst wearable devices promise solutions, they also raise regulatory difficulties. Chief amongst them is the need to protect personal data. The management of this issue will be a particular challenge for hospitals that are gathering and monitoring data remotely.

Moreover, it is clear from examples such as the CGM, that the accuracy, reliability and safety of wearable medical devices will be of paramount importance. This is the concern of medical devices regulation. The existing European medical devices directives are already undergoing substantial recasting, with the current expectation being that two new Regulations will come into effect some time from 2015.

A recent response from the Medicines and Healthcare products Regulatory Agency to a public consultation on the current recast of the legislation already concedes, however, that there is a great deal of uncertainty about how software in medical devices in general should be regulated. Furthermore, there is debate about the extent to which non-medical devices should be regulated where they are invasive. This suggests issues will arise about the regulation of borderline wearable devices in which it is difficult to determine whether the devices should be subject to regulation as medical devices, or more properly considered as a recreational, fitness tools. The concept of remote monitoring also poses challenges for the definition of 'near-patient testing' under the regulation of in vitro diagnostics, as does the involvement of hospitals in in-house manufacturing of such systems.

As technology develops at a rapid pace in this area, it should be expected that regulation and its interpretation will need to change and adapt accordingly.

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Heartbeat monitor
Paul England

Paul England      

Tim Worden

Tim Worden

Paul and Tim look at the issues around wearable technology in the medical sector.

"Whilst wearable medical devices promise solutions, they also raise regulatory difficulties."