Patients who suffer from chronic diseases, such as CHF, COPD, and diabetes, often experience complications that require expensive repeat visits to their doctor or the ER. The burden of chronic disease is not limited to just the cost of treatment—there is also the added cost of workplace absenteeism for the patient and potentially for their caregivers too. Or at least, that’s the value proposition made by remote patient monitoring companies to providers and payers. The appeal of remote patient monitoring is that it may help reduce some of the burden to the patient and to the healthcare system by allowing for the early detection of complications in an individual going about their regular activities. The early detection of a possible complication can mean treatment with only life style changes. Even if medical intervention is required, it may be a less serious planned procedure instead of a more intense, invasive procedure performed in an emergency room.

Remote monitoring allows for better triaging of patients with chronic medical issues and early detection of deterioration, so it’s easy to see why home monitoring solutions offered by companies such as GE, Medtronic, and Philips have caught the interest of hospitals increasingly concerned with managing readmission. As a whole, the remote patient monitoring market is a relatively new segment of the medical device industry that enjoys strong growth. However, I often get asked if the industry is on the cusp of enormous disruption by wearables sold by consumer wellness companies.

Take, for instance, the SpO2 sensor built into some versions of Samsung’s Note 4, or the heart rate monitors in many newer cellphone models. While current iterations of these devices can give inconsistent readings, their existence alone provides proof of concept. Cellphone companies are not the only ones incorporating health technology into their products; Hexoskin’s smart clothing line measures heart and lung function. These are traditional vital signs measurements, typically taken in hospitals or with remote patient monitoring equipment. Naturally, this raises some concern for current competitors in the remote patient monitoring market. With wearable and portable vital signs monitors becoming increasingly affordable and successful in the consumer market, will remote patient monitoring manufacturers be able to hold market share in the face of competition from the consumer industry? It depends a lot on the FDA.

FDA regulations dictate that consumer monitoring devices cannot market themselves for medical use. The FDA considers a product to be a medical device if it’s meant to be used in diagnostic, prescriptive, or preventative purposes for a disease—this creates a serious problem for consumer devices. To stay off the FDA’s radar, a consumer device can only offer a stream of health data: no analysis, no diagnostics, and no preventative tips. Staring at your heart rate gets boring pretty quickly.

I asked a few friends last weekend if, like me, they had stopped bothering with their wearables after a few weeks of use. Everyone agreed that the novelty of watching your wearable count the 15 km you drove as 15 km of walking wears off fairly quickly. The data from their devices became an irrelevant, uninformative stream of numbers with no context. Anecdotal as my experience is, it illustrates an important point: the value-add comes from a wearable being able to analyze data and give relevant suggestions. Unfortunately for consumer wearable companies, this is regulated medical device territory. Keep an eye out for lobbying from wearable manufacturers to allow their devices to perform more analysis on the data they collect. For now, the remote patient monitoring industry is safe—FDA regulation creates a dam that holds back a torrent of devices which could one day start to flood the market.

For more insight into patient monitoring markets, please see DRG’s research here.

Follow @ZaidDRG on Twitter for more insight on wearables, patient monitoring, and capital equipment markets.

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