Last week, a virtual who’s-who of about 500 researchers and scientists working on diabetes technologies gathered in Bethesda, MD, for the 12th annual meeting of the Diabetes Technology Society. More than 70 presenters gave talks, mostly introducing new research, over the course of three days.
Myself and DOC consultant/advocate Kelly Close both gave talks about the power of patient-led social media (!)
But the most exciting things this year, to my mind, appeared to be “moving the needle” (he, he) toward industry standards for data and device interoperability. Don’t get toooo excited; these things take time. But there’s a research group out of Canada that seems to be setting things in motion!
Plus, on Thursday morning, just as Dr. Jeffrey Shuren of FDA had finished his keynote and was receiving the 2012 Diabetes Technology Leadership Award on behalf of his FDA division, the Center for Devices and Radiological Health, he announced that the agency had just published the long-awaited final guidance document on Artificial Pancreas Technology!
AP Gets Final Guidance
JDRF has been working closely with FDA on getting its final word out on the parameters for AP base technologies and study design, so the experts can move ahead with more sophisticated trials. Apparently the agency first insisted on creating two separate guidance documents, one addressing low-glucose suspend (LGS), and another addressing the riskier notion of automated
insulin dosing. But now they’ve combined both into a single guidance document that will allow AP research to move ahead more quickly. Nice!
I spoke briefly with Aaron Kowalski of JDRF immediately following the announcement. His group hasn’t had a chance to “dig in” to the 63-page document yet, but he’s quite confident that the guidance will put an end to “unreasonable” delays like forcing researchers to validate the basic function of an insulin pump before launching an AP study.
“It shouldn’t be much longer now. The FDA is really ‘over’ their concerns about LGS at this point,” Aaron told me. Woot!
Friends of Industry Standards, Unite
A few days before the meeting, I received an email invite to a “special meeting about the development of standards for AP technology.” It was an evening break-out session hosted by the Centre for Global eHealth Innovation from Toronto General Hospital and the University of Toronto, and supported by JDRF.
This group seems to be doing amazing stuff! They’re already hard at work on a platform for diabetes data interoperability, and are collaborating with all the meaningful industry standards orgs: the IEEE 11073 device group (focused on hospital medical devices, and now also on personal heath devices), the Bluetooth Low Energy (LE) special interest group for health apps, and Continua Health Alliance (a group dedicated to promoting interoperability of personal health solutions).
And they invited every one of the circa 80 researchers and industry folks in the room to get involved with their standards effort! Apparently Roche is already working with them. Executives from Medtronic and Dexcom in particular were implored to get on board. The developer on hand from JnJ Animas seemed more keen on improving the interoperability of their own set of products (! — perhaps he was the only one brave enough to say so).
Oddly, there was some confusion half way through the meeting about whether the group was discussing true “plug and play” interoperability of pumps, meters, and CGMs – which developers say is still a long way off since the algorithms work so differently – or whether we’re just shooting for devices that “talk to each other” (data communication) at this point. It was the latter, and thankfully, some plucky researchers pointed out that interoperability of the data patients get from their devices is about six years overdue!
There were several FDA folks in attendance, of course, and most were cautiously optimistic about how the agency could contribute to the creation of standards, rather than waiting on industry to “do all the work.” But one Patricia Beaston of FDA was a voice of negative caution and push-back. Her comments seemed almost geared at frightening industry over “considerable risks.” Oy…
I understand she is no longer working directly on AP topics at FDA, and I’m going to step out on a limb and cautiously note that may be a good thing.
Dr. David Klonoff, founder and director of the Diabetes Technology Society, noted that his group has been advocating for standards for some time. A similar cross-industry meeting about standards creation was held about 5 years ago at the DTS Meeting, “but the only thing everyone could agree on back then was that no one wanted to collaborate on standards.”
“Now seems to be the time,” he told me in a conversation following the meeting. “The acceleration of artificial pancreas technology development seems to be the impetus.”
Great, I thought, but I sure as heck hope we patients won’t have to wait the long wait for a “fully mature, market-ready” artificial pancreas system to get the kind of basic data sharing that the rest of the world enjoys on their smartphones daily!
Lessons from Other Industries
Lane Desborough of Medtronic actually gave a little talk about his experience with industry standardization in the oil and gas industry. He pointed out the “inevitable need for standards as an industry matures,” and shared this list of pro’s and con’s from the industry perspective with the experts present:
- Faster innovation
- Higher value
- Lower costs
- Set-based concurrent engineering (basically, economies of scale in developing new stuff)
- Achieve more permutations (more varieties of the technologies/devices)
- Shift to higher-value activities (engineers don’t have to keep reinventing the wheel)
- Skill gaps
- Winners & losers (the market changes)
- Unintended emergent properties (sometimes one change causes other unexpected changes)
- Co-opetition, IP issues (who owns what?)
- Liability (if multiple players develop a system together, who’s responsible when the system goes down?)
“It completely changes the landscape of an industry when you introduce standards,” Lane said.
And again, I’m going to go out on a limb here and say that’s probably a good thing… Kudos to the Canadian Centre for Global eHealth Innovation team for pushing the U.S. diabetes industry to do what is right and necessary and overdue.
btw, all of this will be a core topic at the DiabetesMine Innovation Summit coming up this Friday at Stanford University. Stay tuned for updates.
Also, be sure to stop by again tomorrow for my report on a brand new metric for glycemic variability introduced by Dexcom at the DTS meeting!