As you all know, we at the 'Mine have been pushing for more "Apple-sque" medical devices for more than five years -- with Amy's 2007 "Open Letter to Steve Jobs" going viral and kicking off a national campaign of sorts.
So it came as quite exciting news when we heard reports that Apple is actually finally moving in this direction: exploring the idea of a new Dick Tracy-ish gadget being referred to as the iWatch that would house wrist-based health sensors -- quite possibly including glucose monitoring!
Reports say that Apple's been filing patent and trademark applications in countries like Japan, Mexico, Russia and Taiwan, and all include varying names and designs for the possible iWatch -- such as the "infinite loop" bracelet. In one patent-trademark application, the wearable wristwatch device looks like a slap watch, described as a "bi-stable spring" design where the watch strap would automatically curve snugly around any sized wrist and the ends would overlap. The display itself would be flexible, and a portion of it could be covered by the overlap and automatically turned off. The device's screen would have a "touch-sensitive user interface," compared to traditional push-buttons used on existing smart watches.
At this point, these are just rumors of what the iWatch may look like. If you Google it, you'll find tons of speculation and hundreds of possible mock-ups, with imaginations clearly running wild... In typical fashion, Apple isn't talking yet and didn't return our calls.
NEWSFLASH: FDA Clears Dexcom Share Direct
Dexcom gets regulatory approval of its 'on-the-go' mobile apps for CGM data-sharing.
State of the Union: It's Time to Cure Diabetes
President launching new precision medicine initiative to better treat, cure diseases like diabetes.
'Robotic Pancreas' Appears On American Idol
Carlos Santana's nephew Adam Lasher shows off Dexcom G4 during live performance.
But with the notion of including non-invasive glucose monitoring, this concept almost feels like a contemporary remodel of the defunct GlucoWatch. Remember, the device that Animas bought years ago and discontinued in 2007, after it showed poor results and the unfortunate effect of burning patients' skin? And also the thwarted Glucoband, that never made it to market?
But a redux by Apple that actually works... how cool would that be?!
Snagging the Expertise
The media reports that Apple's hired scientists and executives from a handful of sensor developers during the past several months -- showing the tech-savvy corporation is targeting health tracking.
And the wave of new hires includes a group of folks from the now-defunct diabetes company in California known as C8 MediSensors, which imploded in February -- less than a year after it received European approval for its non-invasive, optical CGM (continuous glucose monitoring) technology! We wrote about them in 2011 and had high hopes... And we can't help wondering why Apple would target a company whose D-technology has failed?
In a phone interview, the former chief technology officer at C8 MediSensors, Rudy Hofmeister -- who was largely the brains behind the optical CGM -- told us that C8 MediSensors broke down because the glucose-level-analysis technology was "facing issues surrounding the consistency of data readings." The company got CE Mark Approval in October 2012, but Hofmeister says that was based on old data from months earlier that had since become obsolete.
"From a technological standpoint, what we had done with this was a stellar achievement in that people thought even (what we achieved) was beyond possibility. But the problem was that the performance was marginal, and ... it was light years from where it needed to be for a product.'"
— Former C8 MediSensors CEO Rudy Hofmeister, on why their non-invasive gluocse monitoring company imploded
A string of management changes late last year and into 2013 led to indecision about where the company would go with the technology, and ultimately led to its dissolution in February, Hofmeister said. The company has apparently been re-constituted in California as Redox Biomedical and is exploring a high-figure sale that includes the IP rights on its non-invasive technology, he said. So there appears to be value yet in what they developed.
Apple had apparently been considering acquisition of C8 MediSensors before all the internal turmoil exploded, and when the dissolution occurred Apple swooped up several engineers, designers, and scientists specializing in the form of artificial intelligence that interprets health and medical data.
So perhaps it could only be a matter of time before we see some wearable tech from Apple that includes non-invasive glucose monitoring... even if it just displays data from a blood sugar monitoring app or meter device.
Conceptually Cool... But is Diabetes Really a Focus?
Yet if the reports are true, Apple's interest isn't specific to diabetes or glucose monitoring... the company also hired people formerly from companies like AccuVein and Senseonics and others that focus on sensors to monitor veins, sleep patterns, and other health aspects that could biometrics (fingerprint scanning).
Wearable technology is all the rage these days, and it's booming, thanks to cheap sensors that can be used to track things like movement and heart rates. The number of wearable fitness products has been growing at a fast pace, but an Apple offering would shake up the industry completely.
Apple CEO Tim Cook insists that a wristband product is a key target for the company down the road, and may very well be what they focus on for their wearable tech debut. Many know that Cook also serves on the board of directors at Nike and isn't shy about praising the fitness-focused Fuel Band he wears. And other Apple execs have been seen wearing that device, too. Earlier this year, Bloomberg reported that Apple was looking for a product debut in late 2013, but a recent analyst report shows it may be more like a late-2014 release. If even then...
But how realistic is this so-called iWatch, and would it really include diabetes data or BG monitoring?
Not everyone's convinced.
The former C8 MediSensors CTO thinks that a focus on general health and fitness is more feasible right now than hitting the medical market, especially since the FDA is still uncertain on how it's going to approach mHealth products. Until that gets resolved, he doesn't see any iWatch or wearable technology actually monitoring blood sugars or medical data.
"Measuring glucose for diabetes is such a tough thing to do, and we bit off more than we ultimately could handle," he said about C8 MediSensors. "Until the lab-to-reality issue is solved, we won't be getting products like this from anyone."
Fellow PWD David Kliff over at Diabetic Investor cautions people, especially fellow PWDs, not to "fall into the trap" of thinking the iWatch concept with a glucose-monitoring aspect is anywhere close to reality. He points out that no non-invasive tech has worked to date yet millions of dollars have been spent trying, and that the FDA isn't ready for this right now but the regulatory pathway would have to be cleared first. It all goes back to the "non-invasive dream" that Kliff's been critical of for years, and he worries that this Apple iWatch news could embolden other companies and small startups to continue feeding that "mirage."
More Serious Doubts
We also asked for thoughts from Sonny Vu, the former AgaMatrix chairman and co-founder who went on to start his own wearable tech firm called Misfit Wearables. Sonny said there hasn't really been any indendent verification of any iWatch or what it could include, but even if the development rumors are true, he remains skeptical. While it would be cool to see something like Dexcom CGM data displayed on a touchpad watch screen, Vu doesn't think that's coming anytime soon because the FDA is so hesitant and even Apple has been reluctant to move into the arena of medical devices -- despite its slow moves in that direction with integrations like the AgaMatrix-created Sanofi iBGstar meter.
"I seriously doubt Apple will ever get into glucose monitoring, especially non-invasively," he wrote in an email. "It doesn't really work and hasn't worked for the last several generations of science -- going all the way back to the late 60's, with probably 200+ failed start-ups in the space."
Even Dexcom CEO Terry Gregg on the CGM manufacturing end of the spectrum has the same concerns and cautions. His point: finding designers and investment money is one side of the coin, but it's completely different than being able to produce a high-quality sensor that actually works. Until that happens, no amount of money or prestige is going to get one of these concepts to the market on its own.
So, Bottom Line?
We may not be getting the Dick Tracy iGlucose smart watches anytime soon, but it sure as heck will be interesting to see where Apple goes with this development and what the next generation of iDevices (embracing diabetes?) will look like.