A brewing controversy over whether infant monitors can prevent SIDS highlights an ongoing mHealth dilemma – the growing difference between what some consumer-facing wearables can do and what the consumer expects them to do.
The difference may ultimately decide a product's fate – whether it remains something of value only to the consumer, or it gains wider acceptance in healthcare circles and becomes a tool for clinicians and patients alike.
A recent story in The BMJ argues that home monitors marketed to parents of newborns are giving those parents the false impression that they can prevent Sudden Infant Death Syndrome. The vendors say they aren't making that claim, and that parents may be assuming too much from a product that's essentially a monitor, not a medical device.
According to a recent article in Time, David King, a clinical lecturer in pediatrics at the University of Sheffield and author of the BMJ story, charged that companies like Owlet, Rest Devices and Sproutling are profiting from parents' assumptions that their monitors can prevent SIDS. He said the monitors do have some value in recording an infant's vital signs, but they're consumer products, not medical devices, which are regulated by the U.S. Food and Drug Administration.
As medical devices, King argues, they would have to go through vigorous studies and randomized trials to prove their efficacy. As consumer devices, he said, they don't undergo such tests.
In contacting two of the three vendors cited by King, the Time article points out that those companies aren't specifically claiming that their products prevent SIDS.
“I have hundreds of comments from Owlet testers and none of them focus on SIDS," Kurt Workman, Owlet's founder, told Time. "They just want to know if something is wrong. That’s what pulse oximetry does in hospitals and in homes worldwide. Parents simply want something that can monitor their child pro-actively (something that video and sound can’t do). As parents we’re tired of monitors that only serve a purpose when we’re awake. We want something that can let us rest easier. That’s the purpose of Owlet and for many parents it is worth the expense.”
In a letter to Time, Rest Devices, the company behind the Mimo Smart Baby Monitor, said "Mimo was never designed to be a medical device. It’s worth noting that our founding team did clinically validate our sensors when doing early-stage development of adult respiratory diagnostic devices, and we continued to use that knowledge base once we transitioned to baby and family products. We do communicate to our customers in several different forms that our product is a baby monitor, not a medical device. It’s on our website, it’s on our packaging, it’s in our support tools—including the setup booklet that helps a parent get up and running."
While the public is enamored with wearables, healthcare providers are taking a wait-and-see approach. They're waiting for vendors – Apple, Samsung, Google and Microsoft come to mind – to prove that their products do have clinical value.
Just as important, however, will be how the public perceives these devices, and whether they'll be interested enough to buy and continue using them. With consumer-facing monitors, they'll be able to track their data, but they won't get any help in determining how to act on that data. With medical devices, they'll be able to share that data with healthcare providers who can advise them on why that data matters.
Companies like Owlet and Rest Devices are finding value with consumers who, as Workman says, "just want to know if something is wrong." That's fine (and to date no one has been able to develop any sure means of detecting SIDS before it happens). But if parents want to know why something is wrong and what to do about it, they'll have to look for something else. That's where mHealth steps in.
