Frustrated by a slow regulatory process, some patients and concerned parents are modifying medical devices to respond to unmet needs.
For example, the consumer-developed NightScout system hacks Dexcom glucose monitors to allow the readings to be sent Internet-enabled devices, allowing parents to remotely monitor their diabetic children's blood sugar levels. Users have been praising the system on Twitter, sharing stories of how NightScout allows their children to participate in more activities and allows parents to worry less.
The stories are shared mostly under the hashtag #wearenotwaiting, emphasizing the system arose from frustration with the current Food and Drug Administration-approved offerings. "These parents are clearly crying out for ways to access their children's devices in a way that isn't available," Courtney Lias, an official from the FDA's Center for Devices and Radiological Health, told The Wall Street Journal.
Glucose monitors aren't the only devices to be hacked; some patients are hacking their hearing aids so they play music or even DIYing their own prosthetics, according to the Journal. These at-home innovations may be helping to drive commercial innovation by revealing consumers' wants and needs in medical devices, Howard Wolpert of the Harvard-affiliated Joslin Diabetes Center told the Journal.
"This grass-roots initiative and drive is very important in accelerating the development of these technologies," he said. "It is also important that the processes for approval can be accelerated so that this can be done in a way that there is an element of regulatory oversight."
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