An interesting Reuters article explores the funky world of wearables from head pieces designed to focus the user’s attention, ward off depression, monitor vital signs. More specifically, it looks at the challenges they face in getting clinical validation. It dovetails nicely with Chilmark Research’s remote patient monitoring report released earlier this week that highlights some specific technical challenges wearable remote monitoring devices face.
Although they generate a lot of excitement and there is a good deal of investment going into the different device developers, the article notes that it will take far more than the blessing of the U.S. Food and Drug Administration for these devices to succeed.
To win acceptance, though, medical wearables companies will need to do much more than reliably collect data from sophisticated sensors. They will also need to develop the analytical capabilities to make sense of it all, and prove in extensive studies that they can improve patient health.
“The sensors are fantastic overall for collecting data,” said Dr. Eric Topol, a digital health expert at the Scripps Translational Science Institute. It is the “data analytics and the clinical utility parts that most of the companies haven’t figured out yet.”
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Scripps is one of the institutions conducting clinical trials to assess the effectiveness of these devices. Last month, it said it would evaluate single lead electrocardiogram monitoring through iRhythm Technologies‘ wearable Zio XT Patch with a wristband sensor from Amiigo to see how it performed to do remote monitoring for A-fib. patients. Because these technologies also need to easily fit into workflows so that hospital staff are comfortable working with this technolgy, Scripps has also done studies to evaluate that. One example is a 2013 study evaluating Sotera Wireless‘ wrist worn vital signs monitor ViSi Mobile to determine the comfort level of nurses working with it.
Although there is no shortage of wearables companies that have no shortage of claims about the diverse applications for their devices, it’s frequently the most practical needs that spark the most interest, from my point of view. For example, the article highlights Empatica founder Rosalind Picard, a Massachusetts Institute of Technology professor and inventor, who developed a wristworn device to alert epilepsy patients and caregivers of a seizure and track their duration and frequency. It’s actually an area that has attracted a few companies, such as Neutun and Empatica.
The article notes that Picard’s longterm goal is to produce a device to predict seizures based on patterns identified from data in her device, but that will take more study. In the short term, for its first FDA application, Empatica wants its device to reliably detect some types of epileptic seizures and send an alert to caregivers to check on them.
