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ConsumerMed Connected Device Makers: Yay or Nay on FDA?

Connected consumer medical products have gone mainstream, but device makers are still taking different routes to market. Here's why some companies have sought out FDA oversight while others skip it.

August 26, 2016

4 Min Read
ConsumerMed Connected Device Makers: Yay or Nay on FDA?

Nancy Crotti

The MonBaby baby monitor from MonDevice snaps onto a baby's clothing.

Jørgen Behrens starts every day the same, reading reviews on Amazon and the App Store. The business leader of personal health solutions for Royal Philips wants to see what customers think of his company's new line of connected health devices.

Philips joined the fray of manufacturers marketing connected health-monitoring devices directly to U.S. consumers on Aug. 1, launching a line that includes a "health watch," upper and lower arm blood pressure monitors, body analysis scale, and ear thermometer. Each device syncs to the the company's HealthSuite app.

Like an increasing number of personal health device manufacturers, Philips sought FDA regulatory review for them. It is marketing the devices to people over 50 who are juggling jobs, kids, and aging parents, and have developed poor eating, sleeping, and activity habits as a result. They're at risk for chronic disease, and they know it.

Hear more on this topic with a case study on "An FDA-Approved Device: Was It Worth It?" at BIOMEDevice San Jose, December 7-8.

"Our ambition is not to focus on the young and the beautiful trying to get fit, but rather people who have a serious stake in their health and are interested in understanding their health better," Behrens said. "They're getting to the age and the type of lifestyle where things are getting a bit more critical and they have to monitor."

Philips has been monitoring patients' health for years, but doesn't want its marketing for these devices to sound clinical or scientific. Instead, it encourages customers to take small steps toward better health and to maintain them over time to effect change.

"We try to make it very engaging and also very manageable," Behrens said.

Consumer interest in connected wearables continues to climb. Nearly 1 in 3 Americans will use a wearable device by 2021, according to research firm Forrester, ZDnet reports. Sales could grow from $4.2 billion in 2015 to $9.8 billion in 2021, with smartwatch sales accounting for $21 million of that total.

Philips expects to sell most of its devices online, although it plans to add retail stores going forward. A newer, much smaller company called Qardio is making a connected health device splash at a very large retailer--Target. The discount giant began setting up "Connected Care" sections within 550 stores in April to market health trackers directly to consumers, from new parents to baby boomers and beyond, according to a report in Twice. Target declined comment, but San Francisco-based Qardio was eager to talk.

The QardioBase is a smart scale from San Francisco-based Qardio.

The company is aiming its QardioArm ($99) blood pressure and heart rate monitor at baby boomers, along with its yet-to-debut QardioCore chest-worn ECG monitor, in hopes that younger folks will age into the devices. Its smart scale, QardioBase ($169), is geared toward younger customers. The Qardio app keeps track of all the data these devices generate, and soon users' physicians will be able to do the same through an app called QardioMD.

"The problem with connected health generally is consumers have a lot of information but they don't know what to do with it," said Qardio spokesman Steven Hirsch. "If a patient is using the Qardio app to regularly monitor their health, that information is automatically available to your doctor . . . A ton of doctors are on board and they are excited about the technology, because there's truly nothing else like it."

Qardio wanted FDA clearance to show its customers that those measurements are accurate and reliable for regular health monitoring, he said.

Even babies have new options for wearables to monitor their health. Startup MonDevice (New York) also won space in Target's connected health section. Its inaugural product, MonBaby, is a baby monitor that tracks breathing movements, sleep position, activity, and proximity while sending alerts to an app on the parent's smartphone. Unlike other wearable baby monitors that require parents to buy special clothing, MonBaby has two parts that snap together onto the baby's clothes, with a shell underneath and a button on top.

MonBaby initially required parents to be in the same room or the next room for optimal signal coverage. This year, the company introduced MonBridge, an add-on application that expands the monitor's range by transforming a Bluetooth signal into WiFi.

MonBaby ($169) is available through the company's website, and several online retailers. MonDevice has not sought FDA review for MonBaby as it is not a medical device, but that may change.

"FDA approval is not something we would rule out completely and may be something we'll explore as we continue to find new applications for the MonBaby," a company spokeswoman wrote in an email. "We might see coming an improved version of the MonBaby device some time next year, as well as new baby and senior devices."

Nancy Crotti is a freelance contributor to MD+DI.

[Images courtesy of MONDEVICE and QARDIO]

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