In the media

Wearable tech regulated as medical devices can revolutionise healthcare

Medical Device and Diagnostic Industry

18 June 2014


Wearable technology that is regulated as a medical device, instead of being simply a consumer wellness device, can help to revolutionise patient care while driving down healthcare costs.

Across the developed world, healthcare systems face tremendous challenges driven by increasing costs, increasing demand (due to changing demographics, increasing longevity and greater incidence of chronic conditions) and big improvements in addressing complex, previously untreatable conditions. Most healthcare systems are on an economically unsustainable path as healthcare consumes an ever increasing portion of the GDP.

Improvements in technology offer the most likely solution to meeting this rising demand at low cost.

Recently, there has been a lot of activity in the wearable technology space in healthcare, though most current applications are focused on wellness and health tracking. Industry reports estimate that the market will grow to over $5 billion by 2018. In this time, we expect that there will be increased activity in wearable technology that qualifies as medical devices and gathers data in a way that integrates into the patient’s health record. The technology will be user friendly, low cost, and will enable providers to offer more tailored care and advice to patients.

The Promise of Wearable Technology

Wearable technology enables constant monitoring and data collection, thus allowing providers to look at data over time and understand patterns of patient behavior. A deeper understanding of patient behavior is one of the keys to improving health, especially in managing chronic conditions that are primarily driven by leading an unhealthy lifestyle.

As constant stream of data captured from patients comes, automated tools can quickly highlight any anomalies so that providers can initiate early interventions to prevent the onset of future complications. This improves overall patient health and thereby reduces healthcare costs.

Providers can also use the data from wearable devices to identify patients that are fully compliant with their care regimen and show improvements, avoiding the need for unnecessary office visits.

Whereas a diagnosis is mostly based on a patient’s account of events and symptoms experienced, wearable technology offers an additional source of information, which will improve providers' ability to diagnose their patients. Such applications are particularly useful when the patient may not be able to directly provide information to the physician, such as with children, the elderly, or those battling mental health issues.

Another valuable functionality is to use wearable technology such as Google Glass to provide a heads-up display. For instance, anesthesiologists could use a Google Glass-like device during surgery to keep track of patients' vitals without taking their eyes off the patient. Google Glass can also be used to unobtrusively record patient behavior in cases where the act of observing changes behavior, such as in developmentally challenged children who often behave differently at home than in a specialist’s office.

Transition to Regulated Devices

To realise its full potential, wearable technology in healthcare has to cross the boundary from consumer electronics devices to regulated medical devices. Regulated wearable devices can be relied upon to provide accurate data and can potetntially be integrated into patient health records.

The regulatory framework that exists for the approval of medical devices while quite robust has proven to be challenging for many startups to navigate. As a result, they have chosen the option of providing wellness tracking devices that can be marketed as consumer electronics, rather than as medical devices under the jurisdiction of the FDA.

Fortunately, this trend is changing. The FDA has recently announced smart regulation with more oversight directed to technology that represents high risk to patients and scaling back from the traditional approach (Class I, Class II, Class III).

Another promising development is the advent of large players into the market who are promising to provide somewhat open platforms for wearable technology. Samsung, for example, introduced its SAMI health platform in late May 2014 to enable interoperability between wearable devices.

More recently, Apple’s HealthKit product announcement is an effort to position Apple as a platform for enabling wearable health applications. Other large players have similar ambitions of introducing open platforms for wearable health technology. Such platforms can have far-reaching consequences for the future direction of the wearable technology industry.

In fact, such platforms can provide some structure to the market and move technology vendors from selling specific point solutions, to easily integrated solutions that rely on common architecture and platforms. Common platforms will also encourage further innovation by reducing market uncertainty for new entrants. Using common platforms will also reduce the cost of regulatory compliance as only individual sensors will need to be FDA certified, rather than the entire solution.

To better illustrate with an example, the current developments are similar to the beginning of the PC in the 1980s. Before the PC, corporations had to purchase multiple point solutions to manage their business, such as dedicated Word Processors, complex computation programs, etc. A PC provided a standard platform upon which other vendors created software solutions such as word processing applications, spreadsheets etc., so that corporations only had to purchase a standard hardware platform (a PC). This standardisation in turn fostered great innovation as new application vendors entered the market and today we have a plethora of PC-based applications.

Wearable technology offers much promise to improve the delivery of healthcare for both patients and care providers, especially with the advent of regulated, wearable medical devices. We are on the cusp of rapid innovation being brought about by large players that are offering standard platforms for wearable technology. This will reduce the cost of regulatory compliance and propel the industry to the more stable ground of wearables as regulated medical devices instead of merely consumer electronics devices. It is high time that regulators, developers and healthcare providers embrace the potential of these new technologies to improve the delivery of care to patients.

Chris Steel is head of PA’s US IT practice and Nilesh Chandra is an IT strategy expert

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