Frustrated patients and their families are starting to meddle with medical devices to make them more useful, a Wall Street Journal story says.
It centers around Jason Adams, a businessman-turned-citizen hacker because he wanted to track his 8-year-old daughter’s blood glucose levels. She wears DexCom’s continuous glucose monitor, but the device doesn’t transmit blood sugar data to the internet – so Adams found a way to do it anyway.
Adams discovered NightScout, “a system cobbled together by a constellation of software engineers, many with diabetic children, who were frustrated by the limitations of current technology,” the subscription-only story says. The open-source system hacks into the DexCom device, uploads its data online and allows caregivers to check their beloved diabetics’ blood sugar levels remotely. In Adams’ case, he checks Ella’s glucose on his Pebble smartwatch.
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“It isn’t perfect,” the WSJ writes. “It drains cellphone batteries, can cut out at times and hasn’t been approved by the Food and Drug Administration. But for many, it has filled a gap.”
But it’s a long road for these kinds of device upgrades to get actual regulatory approval – which is why the FDA is allowing these unapproved uses slide by, since users are finding it so beneficial, the article says. DexCom’s working on developing a device that has this kind of functionality built in, but it could take quite a while to receive approval.
“The FDA acknowledges the frustration and doesn’t want to be seen as standing in the way of innovation,” an FDA spokeswoman told the WSJ. “The FDA notes there are different requirements in Europe for device approvals and that approvals depend on when manufacturers submit their applications to U.S. regulators.”
The WSJ article writes:
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“I have a huge bet on there being many other diseases that can be helped by these new forces in medicine,” said Joyce Lee, a diabetes specialist and associate professor of pediatrics at the University of Michigan who researches design as it relates to health care. “It is not the new blockbuster drug. It’s not the newest FDA-approved device. But it’s the free hack that the patient came up with.”
