In the labyrinths of diabetes device history, there are endless examples of great ideas for gadgets that never got off the ground. But what about that D-tech that actually got FDA approval or was all-but-guaranteed to, yet never made it into the hands of people with diabetes?
Yep, some products underwent the whole development and regulatory review process and ended up getting scrapped anyway, never seeing the light of day.
Today, we want to share a couple of these stories from the "lost and never-launched" file. (We're pretty sure there are more out there, now all but forgotten by time.)
Let's start with some "almost-lost tech" news that was a hot topic at the big Advanced Technologies & Treatments for Diabetes (ATTD) conference that took place recently in Milan, Italy:
Medtronic's Predictive 640G with Enlite Sensor?
Word on the street is that Medtronic is flirting with the idea of tossing aside its plan to release here in the United States its Minimed 640G -- the next gen pump-CGM combo with Enlite sensor that can predict hypos 30 minutes in advance and automatically turn off insulin delivery. That's been available outside the States for a year now and has been much-anticipated here, especially since it would include a more accurate Enlite 3 CGM sensor.
Unfortunately, we hear that FDA shot down Medtronic's submission for that in December, which apparently convinced MedT that they would do best to just skip over that generation and launch their Minimed 670G Hybrid Closed Loop system as planned in 2017. Rumor has that Medtronic's thinking twice about putting more R&D into the 640G, since it would essentially become an orphan device pretty soon after launch.
From a business perspective, this makes sense -- but it's not entirely the case, the company says.
Medtronic spokeswoman Amanda Sheldon tells us this via email, on the heels of returning from ATTD:
"I can share with you what we have made public. We have had ongoing discussions with the FDA about our product pipeline and the cadence of submissions, including MiniMed 670G and MiniMed640G in the U.S. MiniMed 670G (trial) enrollment went so well that we have now completed recruitment and expect the trial to complete in the next month.
"We were granted an expanded access program (EAP) so people with diabetes could stay on this system following the study. We believe we can submit (to FDA) in May of the 2016 calendar year. Due to successful recruitment with MiniMed 670G, we believe we are better suited to submit MiniMed 670G now (due to innovation and functionality) and MiniMed 640G after. The difference in submission timelines is only a matter of months."
So, while MedT says right now it isn't planning to toss the 640G aside here in the States completely, it does seem they plan to leapfrog that launch with an even more next-gen closed loop device. Of course, we would certainly understand -- even if we'd be bummed to see it -- if Medtronic instead just scrapped the 640G and left it behind, since the predictive algorithm will be weaved into the new hybrid closed loop anyhow.
Abbott Aviator Insulin Pump?
Yes, Abbott made an insulin pump. Actually, according to this NIH publication, they updated it and apparently got a whopping three versions of the so-called FreeStyle Aviator through the FDA over the past decade. They just never released it.
We found this picture of an instruction manual for their planned pump at the time:
- 1st Gen FreeStyle Aviator: FDA approved in December 2005. Interestingly, this first Abbott pump was a predicate device based off a Medtronic design. Thanks to the reporting of our friend and D-peep David Mendosa a decade ago, we learned that Abbott had bought the technology from DEKA Research & Development, a private company founded by Dean Kamen who actually first invented the insulin pumps. "The Aviator is what Abbott calls its new insulin pump. Holly Kulp told me that it has some unique features. She is Divisional Vice President, In Vivo Worldwide Marketing for Abbott Diabetes Care. 'It is designed to be easy to use, easy to wear, and easy to learn.' At the time in 2006, Abbott only had prototypes and was exploring how to commercialize the Aviator in line with its still-FDA-pending Navigator CGM that was on the market from 2008 to 2011.
- 2nd Gen FreeStyle Aviator: FDA approved in January 2008. This one had an improved user interface based on user feedback.
- 3rd Gen FreeStyle Aviator: FDA cleared in February 2009. This had an integrated FreeStyle Lite blood glucose meter that was built into a so-called "Aviator Companion" handheld device with a separate user interface in case you didn't want to pull out the pump.
We reached out to Abbott to find out more about the reasoning behind the Aviator's demise, and as expected a company spokeswoman responded with: "For business reasons, we decided not to commercialize this product. The business rationale is confidential."
So, why do we think this never materialized?
Well, Abbott seems to have destined this Aviator for use alongside its Navigator CGM, which of course ran into problems of its own before being pulled from the market in 2009. So, not long after the 3rd-gen Aviator got FDA's nod, the Navigator's fate was in question here in the States and Abbott eventually just scrapped the pump along with its CGM.
That's what we heard from around the diabetes industry, too. Sources we've talked to say that yes, an internal management change at Abbott in roughly 2008 and 2009 brought on the change in direction, putting this Aviator pump onto the Abbott shelves never to see the light of day.
Roche Solo Patch Pump?
The now-mythical Solo Micropump was creating excitement some five or six years ago, about the time Roche Diabetes Care bought the device from Israel-based Medingo. The big draw was that unlike the OmniPod (which remains the first and only patch pump on the market to this day), the Solo promised to be detachable and allow you to operate it directly from buttons on the pump so you didn't always have to rely on the remote controller.
This device actually got FDA approval in 2010 just before Roche acquired it, and 'Mine editor AmyT actually got to wear the device in May of that year. Her verdict: "I liked it. A nice design and comfortable to wear. Smaller or fundamentally better than OmniPod? I wouldn't say so, no. The big competitive advantage is, after all, being able to detach. That will be some breakthrough freedom for us OP users who hate to waste expensive pods and insulin."
So, it had potential.
Then Roche bought the device and assured everyone it would eventually be released -- at the latest, sometime in 2012.
Wellll.... that never happened.
We heard top brass at Roche say at a Social Media Summit in 2012 that they had a first-generation prototype for the Solo, but chose not to launch it because it didn't have an integrated glucose meter -- which ostensibly would put it at a disadvantage to the competing OmniPod, with its built-in BG meter.
And word is, that integrated meter capability ran into FDA delays that hurt the Roche plan to bring us a meter-integrated Solo pump.
What we don't get is why this never got fixed, and why Roche didn't bring at least a first-generation of the Solo to market. After all, Roche makes Accu-Chek glucose meters, which are pretty popular, and it also makes the Accu-Chek brand of insulin pumps (formerly the Spirit, now the Combo). So here we are 6 years later, and the Solo has gone completely dark. For some reasons we may never understand, the company decided to just bury that early FDA approval, and go about their core business.
Sadly, many folks forget about Roche's pump entirely because market penetration is so low here in the States. The Accu-Chek Combo that can communicate with a fingerstick meter is their latest model from 2012. We do hear rumbles that a new system will be coming soon -- in Europe at least, where they already have the Accu-Chek Insight insulin pump system (an upgrade to the Combo), and plan to develop their own CGM to integrate with that technology.
Will we ever see the Solo patch pump come to market? Or any full-featured patch pump to compete with OmniPod for that matter? We wouldn't bet on Solo at this point.
Too bad, because the more choices in D-tech we have, the better.
Why Diabetes Products Fail
Of course, the diabetes device industry is a business and has to constantly consider market potential for any given product. Still, failures abound.
"Devices that haven’t been FDA approved, but companies have spent tons of money on and not pursued? The list is just ridiculous,” said Dr. Aaron Kowalski, a fellow type 1 and Chief Mission Officer of JDRF. “We’re talking billions of dollars, and there are so many reasons why this happens.”
Kowalski says sometimes it could be a matter of competition being too strong, or the cost of commercialization and launch being too high in order to carry through with a potential product in a specific market. Sometimes, the technology might just not work.
“I'm unaware of companies shelving things because they're trying to hide it for IP purposes,” he says. “The stuff that doesn’t make it, doesn’t make it for a reason. Sometimes in the patient community, we're hyper-critical on how the companies do business, but we’re not going to get new innovation if they can’t make money off a new product. It’s a double-edged sword.”
From a patients' POV, it's hard to see money and resources wasted on products that we never even get the chance to try -- that perhaps would be great additions to our diabetes toolbox.