In the labyrinths of diabetes device history, at that place are endless examples of great ideas for gadgets that never got cancelled the establish. But what virtually that D-tech that in reality got FDA commendation operating theatre was complete-but-guaranteed to, yet never made it into the hands of people with diabetes?

Yep, several products underwent the whole development and regulatory review process and ended up getting scrapped anyway, ne'er seeing the light of day.

Today, we wish to share a couple of these stories from the "lost and never-launched" file out. (We'atomic number 75 pretty convinced in that respect are more out there, now all but irrecoverable by time.)

Let's start with some "almost-lost tech" news that was a hot subject at the big Sophisticated Technologies & Treatments for Diabetes (ATTD) conference that took place recently in Milan, Italian Republic:

Word on the street is that Medtronic is flirt with the approximation 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 bend off insulin delivery. That's been available foreign the States for a year nowadays and has been practically-anticipated present, especially since it would include a more accurate Enlite 3 CGM sensor.

Regrettably, we hear that FDA shot down Medtronic's meekness for that in December, which apparently sure MedT that they would do best to just pass over that propagation and launch their Minimed 670G Hybrid Closed-loop system organization As projected in 2017. Rumor has that Medtronic's thinking twice about putting to a greater extent R&D into the 640G, since it would essentially become an orphan device jolly presently after launch.

From a business perspective, this makes sense — but IT's non totally the case, the company says.

Medtronic spokeswoman Amanda Sheldon tells us this via email, on the heels of returning from ATTD:

"I can partake in with you what we have made populace. We hold 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 thusly well that we take over in real time completed recruitment and expect the trial to complete in the next month.

"We were acknowledged an expanded access program (EAP) so people with diabetes could stay on this system following the study. We conceive we can defer (to FDA) in Whitethorn of the 2016 civil year. Imputable successful recruitment with MiniMed 670G, we think we are better suited to subject MiniMed 670G now (due to innovation and functionality) and MiniMed 640G aft. The difference in submission timelines is exclusive a matter of months."

So, spell MedT says right today it International Relations and Security Network't preparation to toss the 640G digression present in the States completely, it does seem they be after to leapfrog that set up with an even more side by side-gen closed loop gimmick. Of course, we would for sure understand — even if we'd be bummed to see it — if Medtronic rather just scrapped the 640G and left over it behind, since the prognosticative algorithm will be weaved into the new hybrid closed closed circuit in any case.

Yes, Abbott successful an insulin pump. Actually, according to this National Institutes of Health publication, they updated it and apparently got a whopping ternion versions of the supposed FreeStyle Aviator through the FDA over the early decade. They just never released it.

We found this film of an instruction manual for their planned pump at the clock time:

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  • 1st Gen FreeStyle Aeronaut: FDA approved in December 2005. Interestingly, this first Abbott heart was a proclaim device based off a Medtronic design. Thanks to the reporting of our acquaintance and D-chirrup David Mendosa a decade ago, we learned that Abbott had bought the technology from DEKA Research &ere; Development, a private company founded away Dean Kamen who actually 1st invented the insulin pumps. "The Aviator is what Abbott calls its early insulin pump. Holly Kulp told Maine that information technology has some unusual features. She is Divisional V.P., 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 solely 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: Food and Drug Administration approved in January 2008. This one had an reinforced user interface supported substance abuser feedback.
  • 3rd Gen FreeStyle Aviator: FDA cleared in February 2009. This had an integrated FreeStyle Fat-free blood sugar meter that was built into a alleged "Aviator Companion" hand-held device with a separate user user interface just in case you didn't want to pull out the pump.

We reached dead set Abbott to find come out of the closet more about the reasoning behind the Aviator's demise, and as expected a party spokeswoman responded with: "For business reasons, we decided not to commercialize this product. The business enterprise rationale is confidential."

So, why do we think this never materialized?

Symptomless, Abbott seems to have destined this Aviator for use alongside its Sailing master CGM, which of course ran into problems of its own before being pulled from the market in 2009. Thus, shortly after the 3rd-gen Aviator got FDA's nod, the Navigator's Fate was at issue here in the States and Abbott eventually just scrapped the pump along with its CGM.

That's what we heard from around the diabetes diligence, too. Sources we've talked to read 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 look the light of day.

The instantly-mythical Solo Micropump was creating excitement roughly Phoebe or six years ago, about the time Roche Diabetes Care bought the device from Zion-based Medingo. The big pull down was that unequal the OmniPod (which remains the first and only patch pump connected the marketplace to this day), the Solo promised to be detachable and allow you to manoeuvre information technology directly from buttons happening the pump then you didn't always suffer to trust on the remote controller.

This device actually got FDA favourable reception in 2010 just ahead Roche acquired it, and 'Mine editor AmyT actually got to wear the twist in May of that year. Her finding of fact: "I liked it. A nice design and comforted to wear. Smaller or essentially better than OmniPod? I wouldn't say so, no. The big matched reward is, after all, existence able to detach. That will follow some breakthrough freedom for us OP users who hatred to waste expensive pods and insulin."

So, it had potential.

Then Roche bought the device and assured everyone information technology would eventually be released — at the latest, old in 2012.

Wellll…. that ne'er happened.

We heard top establishment at Roche say at a Social Media Summit in 2012 that they had a kickoff-propagation epitome for the Solo, merely chose non to establish IT because it didn't have an integrated glucose meter — which on the face of it 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 damaged the Roche plan to bring United States of America a time-integrated Solo pump.

What we don't get is wherefore this never got fixed, and why Roche didn't bring at least a primary-generation of the Alone 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 (erst the Flavor, 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 society decided to just bury that proto FDA commendation, and go well-nig their core business.

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Sadly, many a folks forget close to Roche's heart completely because market penetration is so squat here in the States. The Accu-Chek Combo that can communicate with a fingerstick meter is their latest model from 2012. We do see rumbles that a new system bequeath be coming presently — in Europe leastways, where they already sustain the Accu-Chek Insight insulin ticker system (an upgrade to the Jazz band), and plan to develop their own CGM to integrate therewith technology.

Will we e'er see the Solo spell pump make out to market? Operating theater any pregnant-conspicuous dapple heart to compete with OmniPod for that matter? We wouldn't bet on Alone at this point.

Overly bad, because the more choices in D-tech we have, the better.

Naturally, the diabetes device industry is a business and has to perpetually consider market potential for any given product. Still, failures abound.

"Devices that haven't been Food and Drug Administration authorised, but companies have spent tons of money on and not pursued? The list is just ridiculous," said Dr. Aaron Kowalski, a fellow typecast 1 and Foreman Mission Officer of JDRF. "We're speaking billions of dollars, and there are so many reasons why this happens."

Kowalski says sometimes it could be a affair of competition being likewise strong, or the cost of commercialization and launch organism overly overlooking in order to fulfil with a potential product in a specific market. Sometimes, the technology power just not work.

"I'm unaware of companies shelving things because they'Ra 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 biotic community, we're hyper-critical on how the companies do business, merely we're not going to get refreshing innovation if they can't make money off a new merchandise. It's a double-edged brand."

From a patients' POV, it's hard to see money and resources wasted on products that we never even get the chance to taste — that perhaps would glucinium great additions to our diabetes toolbox.