Why the iWatch won't measure glucose levels

A multitude of reasons why the iWatch will not monitor user glucose levels.

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Any company that wants to sell a medical device must adhere to a regulated auditing process. The C8 product was probably as non-intrusive of a device as you can get. It was not categorized as an "implantable" device. At worst, a patient would be exposed to a laser light source (no stronger than a typical laser pointer).

C8 had to follow all sorts of procedures to ensure it would successfully pass an ISO 13485:2003 audit. For example, engineers couldn't file bugs with the existing bug-tracking tool, because the bugs were fair game for an auditor. This process was very time-consuming...

I don't think Apple is the type of company that would be comfortable working through an full medical device audit process. I don't think it would fit within the company's technology culture either (having worked there for a time).

An iWatch that measured other biometric data while steering clear of glucose measurements would undeniably fly through the watchful eyes of the FDA much more quickly.

Apple doesn't rush out new features before they're ready for prime time

Apple's success is rooted in its ability to deliver incredibly polished products that do a few things extraordinarily well. Apple's laser-like focus is why iOS didn't receive copy-and-paste functionality until iOS 3 and multitasking support until iOS 4.

So even if we assume that CGM is on Apple's iWatch roadmap, the notion that this feature will appear in the first iteration of the device is highly improbable. Simply because Apple hired an impressive team of biomedical and sensor technology experts doesn't mean the first iteration of the iWatch will be a magical, all-knowing sensor device.

Apple's initial efforts to develop an in-house mapping solution provides an illustrative example.

Apple first began putting together its internal mapping team in July of 2009 when it acquired a geo-mapping company called Placebase. And yet, Apple's standalone Maps app wasn't released until September 2012, a full three years later. What's more, many of the innovative features that made Placebase's mapping technology so unique have yet to re-appear in iOS.

That said, Apple's hiring spree of sensor experts shouldn't reflexively be construed to mean that the iWatch will monitor a myriad of health vitals out of the gate. Apple is a remarkably patient company, and again, keep in mind that many of Apple's biomedical and medical sensor hires have barely been at the company for six months.

Remember the backlash over Apple Maps? Now imagine how amplified that would be if Apple released a faulty device purporting to measure a serious health vital like glucose levels. Apple wouldn't even consider such a feature unless it was supremely confident that the technology worked flawlessly.

Apple's MO is simple - it methodically adds features to its products, slowly but surely improving its product line with each successive release. So while it stands to reason that Apple has a lot of  brilliant folks working on incredibly innovative sensor technologies, there's no strong evidence to suggest, or historic evidence that would have us reasonably conclude, that the initial version of the iWatch will be an advanced sensor supermachine.

Keeping iWatch expectations realistic

As a result, I think there's a lot of merit in MobiHealthnews writer Brian Dolan's assertion that the iWatch's "technological capabilities will be simpler than rumors have indicated."

As is Apple's style, expect it to measure a number of health-realted variables exceptionally well as opposed to measuring every conceivable vital sign under the sun. Indeed, Dolan's own sources relayed that Apple's recent hires, at least for now, are there to "ensure that the health sensing capabilities of the device" are accurate.

Former C8 CTO Rudy Hofmeister concurs on this point, arguing that any wearable device Apple releases will likely focus on "general health and fitness" rather than medical vitals.

So can we expect the iWatch to measure glucose levels? Don't bet on it.

Addressing rumors of Apple's alleged pursuit of non-invasive CGM, John L. Smith writes:

The participation of funding by big companies with no experience in glucose monitoring is sometimes pejoratively called “dumb money.” In the same way that inventors can become enamored by the prospect of helping people with diabetes (and coincidentally “cashing in” on the result), companies like GE and Motorola have made what turned out to be unwise investments in this area. Apple and Samsung, and possibly Google might be on the same trail, trying to create a watch that measures glucose noninvasively. 

One way to see who else is interested in noninvasive glucose is to see where the technical principals go after a company shuts down. An Apple-watching blog, “9 to 5 Mac” reports that Apple hired several experts in the field of non-invasive blood monitoring sensors from C8 MediSensors, and also hired employees who had worked at Senseonics and InLight Solutions. Time will tell if this turns out to be a fruitful pursuit for them.

Wearable technologies down the road

The technological and usability advancements seen from the original iPhone to what we have now with the iPhone 5s are nothing short of astounding. This, of course, goes back to Apple's penchant for slow, careful, and measured improvements.

So while the iWatch at first glance may not be the medical marvel some are understandably hoping for, what's truly exciting is that Apple, according to a bevy of circumstantial evidence, is seemingly focused on a brand new product category.

Indeed, Apple's interest in wearables is hardly a well-kept secret. Tim Cook last year told Kara Swisher and Walt Mossberg that wearable technologies is a profoundly interesting space "ripe for exploration." Cook also added that the "whole sensor field is going to explode. It's a little all over the place right now. With the arc of time, it will become clearer."

Coupled with Apple's  formidable team of biomedical engineers and medical sensor experts, the iWatch may prove to be the first step in what will one day, but not at first, be a revolutionary device.

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Copyright © 2014 IDG Communications, Inc.

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