As companies race to develop the first fully-automated insulin delivery system, a group of tech-savvy patients are hacking their own artificial pancreas systems. And industry is just starting to take notice of this highly motivated grassroots movement.
“They want more choice. They want more freedom. And, essentially, they want it now,” JDRF research director Dan Finan told Drug Delivery Business News.
But, as Finan pointed out, people making DIY diabetes technology end up using devices that aren’t regulated or secure. That’s where the JDRF’s latest initiative comes into play.
Last week the organization launched an effort to encourage device manufacturers to make devices that can communicate with one another. It’s just one part of a three-pronged approach to try to accelerate the development of automated insulin delivery systems, Finan said.
“What we want to do with this whole initiative is, while still supporting traditional development, in parallel bring this whole “We Are Not Waiting” movement up above the table, to where we can encourage the use of open and secure communication systems and also we can speed access of this excellent technology to the market,” he explained.
All it takes is one search of #WeAreNotWaiting on Twitter to find groups like Loop and NightScout – open-sourced projects that help people with diabetes reverse-engineer their own insulin delivery systems.
You’ll also find individual people working to hack into commercially available devices. Just yesterday, Twitter user @JBerian tweeted, “the quest is over. The 640g comms have been cracked,” apparently referring Medtronic‘s (NYSE:MDT) Minimed 640G system.
As part of its initiative, JDRF is offering a grant to device manufacturers that support open-protocol development.
“We want to encourage device manufacturers to open that up, use something that is openly published and certainly secure, like Bluetooth, which we’re all very accustomed to in this day and age, to make sure that the communication between all the different components that are going to be a part of this artificial pancreas device are communicating seamlessly and securely in order to bring this therapy to the patients,” Finan said.
The second part of JDRF’s initiative is to address a different hurdle with medical device manufacturers – liability.
“Everyone wants to help us realize our dream of an open-protocol ecosystem and not surprisingly, the only concern they have is how is liability going to be handled in this whole ecosystem,” Finan explained.
The private funding organization is also planning to open up dialogue with the FDA and other regulatory bodies to discuss the potential regulatory pathways available for these DIY devices.
“What we launching here in the form of this initiative is really just the effort, the drive to get the players together in a room. Hammer out the details, have the hard conversations, figure out what it is we need to do in order to make this open-protocol dream a reality,” Finan said. “We feel like we absolutely can get there, it’s just a matter of having the conversations with the players like the FDA, the heads of the companies. We’re going to hire some legal experts in terms of medical devices. We’re going to basically organize a round table community drive.”
So far, his initial conversations with device manufacturers have been positive, Finan noted. Most companies want to get their technology into as many hands as possible and that competitive drive is good for the overall patient community, he said.
“When things are competitive, it’s certainly excellent for the patient, and I think it also really opens up that competitive drive for the manufacturers,” Finan said. “Essentially the feedback was that, ‘Absolutely we want to play, and we want to get our products out there to as many people as possible – and we think our products is the best.'”