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Who Is to Blame When DIY Medical Devices Fail?

Night Watch
 The developers of the Nightscout, an open-source remote-monitoring system, are working with the FDA on the presubmission process to officially clear it for market approval.

The do-it-yourself (DIY) movement has never been more popular in the medtech industry than in recent years, as the needs of consumers continues to become more and more specialized. But does such a decision come at any cost to those simply seeking to improve their devices?

Just last month, Wired ran a story on one of these DIY pioneers, a man named John Costik. When his son Evan was diagnosed with type 1 diabetes, John had to constantly monitor his son's blood-sugar level every couple of hours to make sure it didn't reach dangerous levels. It didn't take more than a few months before John was in search of a continuous glucose monitor, one that would send the readings to a pager-like display that John could keep on him.

As Evan got older, he began leaving the house more and more, as children so often do. Unfortunately this meant the display unit needed to go with him, forcing John to rely on teachers, school nurses, and coaches to constantly monitor the device in case Evan's blood-sugar level reached dangerous levels.

John quickly found himself riddled with anxiety over trusting that others would monitor his son's condition efficiently. This of course led him to reevaluate his options once more. It wasn't long before John developed a solution on his own, an Android app that let him monitor Evan's blood-sugar levels on his phone, regardless of his location. John finally found a solution that truly met his specific needs.

A community has even sprung up to help foster consumer hacks to diabetes equipment and CGM devices. On Twitter, the group has staked out the #WeAreNotWaiting hashtag and the Nightscout website, which describes is mission as thus:

Nightscout (CGM in the Cloud) is an open source, DIY project that allows real time access to a Dexcom G4 CGM from web browsers via smartphones, computers, tablets, and the Pebble smartwatch. The goal of the project is to allow remote monitoring of the T1D's glucose level using existing monitoring devices.

John is just one of many consumers in need of a medical device with specific needs that hasn't yet been made available. Recently an associate professor of biomedical engineering at Boston University developed a bionic pancreas for his son, a system that involves a smartphone app that wirelessly connects to a blood sugar monitor and two infusion pumps.

Then there's Jason Adams, who developed a technology similar to Costik's wireless monitor for his daughter. These stories have been encouraging, and show the resolve and determination of consumers who refuse to live within the bounds of their devices, especially when they have a wealth of technology at their fingertips.

However, such solutions do raise the question: how can medical device companies meet the quickly-evolving needs of consumers while achieving regulatory approval?

As the DIY movement continues to pick up momentum, the obvious caveat is that the very need for DIY hacks is a symptom of a growing problem, which is the inability for devices to be updated and improved in a timely fashion. And don't think the FDA isn't keeping a watchful eye on these hackers as well. In fact, the developers of the Nightscout, the open-source project that gives patients remote access to data from the Dexcom G4 CGM, are in talks with the FDA.

For now, the FDA isn't too concerned with other individual DIY modifications. In fact, recently Courtney Lias, director of the division that oversees glucose devices and other monitors at the FDA, said it's a good thing that parents are looking for solutions that provide better care for their children, and that it's unlikely the FDA would ever take action against them. It will only be when these customized devices begin to be distributed widely--and for profit-- that the FDA will begin to take exception.

There's also a personal risk that comes with sharing your own customized device with others. Costik eventually posted his open-source code online for other users to take advantage of, which eventually spawned a Facebook group that instructed thousands of parents on how to tune their devices to stream data onto their smartphones.

The concern is if one of these devices malfunctions. What if a parent thinks their phone is programmed to alert them when their child's blood-sugar reaches dangerous levels, but they aren't notified? This is when lawsuits happen, and these aggrieved parents won't be coming after the FDA. They could be coming after the creator of these hacks, people like John Costik.

Ultimately, the decision to pop the hood and tinker with these medtech devices is a serious one. On the one hand, users are looking to customize their devices in an effort to drastically improve the quality of their treatment. On the other, these DIY hackers must understand the personal risk involved in sharing their innovative ideas, as they truly can mean life or death to someone else.

Refresh your medical device industry knowledge at MD&M West, in Anaheim, CA, February 10-12, 2015.

Kristopher Sturgis is a contributor to Qmed and MPMN.

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