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Qualcomm’s Don Jones opined about the kind of cell phones that will be used for wireless health: both consumer phones, in addition to specialized devices with sensors (or the ability to talk to sensors). Uptake of these devices will be driven by the particular application. Body area network (BAN) radios are now Bluetooth, with the market moving to low power Bluetooth LE when it’s available, but eventually Don said he sees multimodal BAN radios in consumer devices. In the mean time, there is a place for specialized gateway devices, he said.

Rob asked ATA’s Jon Linkous: “Is the iPhone a medical device?” If you look at the AirStrip application, there’s no question that is a medical device, Jon said. A device that helps a patient measure the steps they take a day (pedometer), however, isn’t a medical device, he said. (That is a debatable proposition, depending on marketing claims and how the manufacturer manages their product).  Jon expects that eventually there will be health care oriented products sold to consumers that won’t be regulated by the FDA. (It seems to me that recent trends in the FDA are going in just the opposite direction.) Don notes that being regulated by the FDA is not necessarily a bad thing, and can be a good thing in the U.S. He noted that the Pill Phone, basically a mobile app version of a book still sold in bookstores, is not a medical device. The Pill Phone’s creator, however, got FDA clearance anyway and sold it through Sprint, Verizon Wireless and AT&T. The carriers have since noted that without FDA clearance, they would not have touched the product. Jon noted that the FDA’s key focus is on patient safety and efficacy.

Since Corventis was taking a look at international markets, Mike discussed international regulatory approvals. Corventis has two products that they have run through approval processes. As long as you have either an FDA clearance or European CE mark, Mike said, approvals in other international markets are much easier — some will even accept the FDA or CE outright.

Qualcomm CEO Paul Jacobs noted in his keynote earlier in the day that the current FCC position about managing broadband and the Internet precludes creating a quality of service for things like medical device data. Offering a customizable computer as a consumer cell phone introduces a lot of variables and regulatory challenges for use as a medical device.

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This entry was posted on Thursday, October 15th, 2009 at 4:00 am and is filed under Slideshow. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.