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History on Wearable Health Devices

            Wearable devices are moving from the general “workout” aid area into a completely new area of health and physical therapy use. Looking back, the 1980s had Jane Fonda’s workout tape; the 1990s brought popularity to the Thigh Master; the 2000s introduced us to the P90X workout; and, the 2010s are seeing a major wave of health-inspired wearable devices designed to encourage people to walk more, get more healthful sleep, and be generally more fit all around. A recent report from Endeavour Partners found that one-third of American consumers who have owned a wearable “health/exercise” aid device have ditched it within six months, citing poor battery life or a lack of medical relevance as the reason. Tech powerhouses like Apple and Google are learning from the mistakes of others and are on the verge of introducing a new wave of “wearables”, this time removing any mystery around the medical relevancy of their devices by working with the FDA to obtain clearance for various products as certified medical devices.

            Some emerging wearables, such as Google Glass, do not currently fall into the aforementioned category of potential medical devices as they are not intended for anything other than recreational use and are merely an extension of display placed in front of a user’s eyes. Similarly, devices like FitBit or Nike’s FuelBand may monitor and store user health data, but are not able to make treatment recommendations.

            However, there is still value to these devices: Google Glass, for instance, could allow a surgeon to call up charts or zoomed in diagrams while still having both hands free to operate with. Similarly, an oil rig worker with heavy gloves and tools could pull up technical drawings while at a hazardous worksite while again having both hands free to do their intended tasks.

            Given these are two examples where safety is a top concern, these devices must still be certified against strict regulations and have proper post-market surveillance in order to safeguard end-users (as well as manufacturers from potential product liability lawsuits should the product malfunction).

Medical Device Lines Become Blurred

            However, the proliferation of these types of devices – devices that track and store or display data but don’t analyze it – has become so widespread that earlier this month the FDA released a draft guidance document stating that the agency proposes to stop enforcing the regulatory requirements applicable to several types of devices and software that transfer, store, convert, format and display medical data. The reason? A need to focus time, energy and resources on “wearables as medical devices,” as these products could ultimately have major impact – both positive and negative – on patient health.

            Take for example the rumors swirling around Apple’s iWatch, which is poised to deliver much more than its FitBit-esque competitors. Rather than merely displaying or pushing data to a smartphone, the iWatch could be capable of analyzing data and notifying health care professionals if certain thresholds are breached via its HealthBook and HealthKit applications. Diabetic? Thanks to Apple’s recent hire of hardware developer Nancy Dougherty – who specializes in sophisticated sensors – the iWatch may be able to track glucose levels in the blood, alerting users of when it may be time to take insulin. This tech revolution would turn the iWatch into a full-blown medical device and a tool that could mean the difference between life and death for someone with diabetes or another life-threatening disease.

            Another example of a wearable that may soon be considered a certified medical device is the ‘smart contact lens’ that Google is working on in partnership with Novartis. Though the wearable tech was introduced earlier this year as a way to track various health metrics, the addition of sensors that test and relay glucose levels contained in tears changes the manner in which the device must be regulated and monitored.

            Similar to the iWatch’s potential health implications for those who suffer from diabetes – about one in every 19, according to the American Diabetes Association – a false read from a smart contact lens could prove extremely detrimental.

            The danger of wearables as medical devices is that they could potentially cut out the healthcare-providing middle man. For instance, a patient suffers from high blood pressure and has scheduled appointments every two to three weeks to have blood pressure taken by a healthcare professional. Now, they have been given an iWatch for their birthday, which may be able to track blood pressure. They suddenly no longer see the need in making appointments. The trusty iWatch starts reporting that their blood pressure has gone down to a healthy level and they start to feel really good about themselves; that is until, they have a heart attack. In this scenario, the user’s iWatch could have been malfunctioning all along, reporting false blood pressures that a healthcare professional could have identified. As a result, the user ends up in the hospital and Apple winds up in the middle of a major product liability lawsuit.

Still a Long Way to Go

            Potential risks aside, these technological breakthroughs could be a huge step forward in managing chronic diseases – if the wearables are properly regulated, certified, and tracked by the FDA. This brings challenges to OEMs like Apple, a company that is known for its high quality and attention to detail from a consumer product perspective, but not medical device (yet). For Apple as a medical device manufacturer, the iWatch must look to comply with many industry-specific regulations; this includes (but is not limited to) the FDA’s Title 21 CFR Part 11, which confirms that its electronic records and signatures are considered to be trustworthy, reliable, and equivalent to paper records.

            As medical device manufacturers, Apple and Google will be under extreme pressure to maintain the highest level of quality in every facet of their operations. An investment in quality management software (QMS) can help alleviate some of that pressure by streamlining and automating operations by defining, tracking, managing, and reporting on the core activities and processes vital to their success.

            One process that will be vital to both Apple and Google’s successes will be the ability to properly execute supplier audits. Supplier audits are invaluable in ensuring all suppliers are in compliance with regulatory guidelines, and that any issues or regulatory non-conformances are addressed in a timely manner.

            A QMS can help ensure appropriate corrective and preventative actions (CAPA) are addressed by tracking and managing all reported issues and assigning responsibility to specific employees to ensure no issues fall further through the cracks.

            The need for supplier audits (and QMS to help track and streamline the audit process) has increased recently for electronics and medical device manufacturers with the introduction of the Dodd-Frank Act. The Act requires any company that might be using conflict minerals (tungsten, tin, tantalum, and/or gold mined predominantly from the war-torn Democratic Republic of Congo [DRC]) to disclose its entire supply chain. In 2013, Apple reported under the Frank-Dodd Act that it used 205 smelters, 21 of which got metals from the DRC, and four of the 21 DRC smelters had not yet been verified by third-party auditors as conflict-free. As Apple continues its pursuit of status as a medical device manufacturer, a QMS that helps gather complete data from its supply chain partners will be extremely important.

            To navigate various compliance needs and be successful, Apple, Google and any other manufacturers looking to enter the world of medical devices should carefully weave quality and safety processes as part of a product’s entire life cycle and extend it out to the value chain. When government regulatory bodies get involved in the process, having the proper systems in place and using the right technology to maintain proper records will be essential for product quality, reliability, safety, and consumer satisfaction.

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