Mobile medical apps that run on such consumer devices as smartphones and tablets represent a rapidly growing and lucrative device market for innovative companies that do their homework before diving in, an expert in the field says.
Mobile apps built to run on commercial smartphones permit devicemakers to use established hardware and provide only the software, Tim Gee, principal and founder of Medical Connectivity Consulting, said. But that means building the expectation of rapid hardware changes that are not under the manufacturer’s control into the engineering process, he added.
An iPhone update could trigger a letter to the FDA or, in some circumstances, a new 510(k), Gee warned. Operating systems can also change, with patches coming out as often as weekly.
This chance to use off-the-shelf technology is “a real opportunity and … also a real challenge,” Gee said.
There are more than 40,000 medical apps available to download to portable devices, but which ones are going to need FDA approval?
Currently, the FDA has proposed policing only those apps that use supplemental attachments to transform a mobile platform into a medical device and others that act as accessories to an already regulated medical device. But that could change.
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