A lesson learned?

A lesson learned?

Yesterday news hit that Apple has presold over 2 million of the new iPhone 5 and as has become standard operating procedure consumers who were unable to preorder the phone are already camping out at Apple stores for its arrival this Friday.  As Diabetic Investor reported when Apple introduced the new version of their wildly popular phone, not all is well when it comes to the 5 as it comes with a different adaptor than the previous versions of the phone.  A fact which basically will kill any chances the iBGStar glucose monitor from Sanofi (NYSE:SNY) had.

Now Diabetic Investor has not spoken with the good folks at Sanofi but if their executive team believes that consumers will still buy this device, which retails for around $80 and now has to be used with an adaptor which cost $30, they are smoking crack. Never mind that Diabetic Investor believes that the iBGStar is not approved for use with this adaptor and that at minimum the FDA will ask for something. The fact is this product was doomed from the start when the folks at AgaMatrix who make the iBGStar for Sanofi, designed the product to be used only with the iPhone and then compounded their mistake by using the 30 pin adaptor and not use the earphone port to attach the device to the phone.

Not only would this simple design change protect the product from Apple doing exactly what they did, it would have allowed the device to be attached to almost any phone. Simply put it would have expanded the market opportunity for the product and given Sanofi something truly special rather than being a one trick pony.

The real question is will other companies learn from this experience. As everyone knows Diabetic Investor has never been all that thrilled with the coming convergence of diabetes devices and consumer devices such as mobile phones. It’s not that we don’t believe in the theory of interconnected diabetes management, we do. However, unlike the folks in the diabetes device world, we live in the real world and understand that the vast majority of patients with diabetes live here as well. That while it would be nice if their meter attached to their phone, uploaded their readings to an app which in turn would share their readings with their physician or educator, who in turn would analyze these readings and then report back to the patient with suggestions on how they could better manage their diabetes. It would be far nicer if these patients actually understood what these readings meant so they might actually regularly monitor their glucose in the first place.

The iBGStar debacle also points to another unmentioned but very real risk with this movement, consumer devices such as the iPhone are not regulated by the FDA and diabetes devices are.  The life cycle of an IPhone or Android device is about six months, which is about how long it takes the FDA to begin reviewing a new diabetes device. The fact is by the time FDA gets around to actually approving a diabetes device which works with or attaches to a consumer device like the iPhone, the consumer device which the diabetes device is approved to work with no longer exists.

Now this problem could be partially solved by not attaching the diabetes device to the consumer device but enabling these two devices to communicate via Bluetooth technology. Just as almost every phone has a port for headphones they also come equipped with Bluetooth technology.  Diabetic Investor sees two problems here, cost and functionality. Based on interviews with several of the diabetes device companies the main reason they have not added Bluetooth technology to their devices has nothing to do with the technology itself but the added cost of this technology. With pricing pressure continuing to intensify and margins shrinking by the day, this investment just doesn’t make sense. Secondarily, think of what happens if the two devices don’t communicate, which as anyone who’s used a Bluetooth headset knows does happen more often than not. At least when the Bluetooth headset isn’t work or isn’t charged the consumer can continue to use the phone, the same cannot be said for the diabetes device.

Is it any wonder the FDA is struggling to come up with reasonable guidelines for these coming interconnected devices? Does it surprise anyone that the last thing Apple or any consumer device company for that matter, wants is for their devices to be regulated by the FDA?  This is the reason a glucose monitor will not be built into any phone. It’s the same reason why insulin pump companies who would love it if their pumps could be programed and used with a mobile phone are working feverishly to turn this dream into reality. The only problem is this dream could well turn into a nightmare when after spending millions on development the FDA says thanks but no thanks.

The fact is glucose monitors, continuous glucose monitors, insulin pens and insulin pumps may be de facto consumer products but they are still treated as REGULATED medical devices. This fact is not going away and the very nature of the regulatory process makes it next to impossible to keep pace with the life cycle of a consumer product. But this is just half the problem with this entire move towards interconnected diabetes management, the other half being the very nature of diabetes.

Like it or not the fact is most patients with diabetes don’t understand what they have and aren’t equipped to handle the demands of even simple diabetes management.  If we’ve said it once, we’ve said it a thousand times the vast majority of patients want to live their lives with NOT for their diabetes. They want simple NOT complex solutions. They don’t care if their glucose monitor comes in pretty colors or has the ability to communicate with an iPhone. Fact is most patients can’t even name the monitor their using even when that monitor is held in their hands.

Yet, the demands of diabetes management are also foreign to the companies who make diabetes devices.  These companies continue to foolishly believe that technology is the answer to their prayers and that somehow all this whiz bang technology will magically change what’s going on in the real world. They continue to ignore the fact that with all the so-called advancements in glucose monitoring average testing frequency hasn’t change one bit. Insulin pump companies can’t seem to grasp the fact that even with introduction of so-called “smart pumps”, most patients want simpler systems that are easier to learn and that the pump itself is truly just a minor part of why more patients don’t use an insulin pump.

The sad thing is these companies could have their prayers answered if they would spend a fraction of their R&D budgets on educating patients instead of coming up with even more advanced technology that only a handful of patients actually use. That’s the amazing thing about patient education as study after study has shown; it’s the most effective tool for improving patient outcomes. That educated patients regularly monitor their glucose levels because they UNDERSTAND what these results mean and how they impact THEIR lives. Educated patients are more compliant with their therapy regimen which translates into GREATER sales of diabetes drugs.

Still no matter how many studies come out proving this, companies continue to pray at the altar of technology, pledging blind allegiance to what in fact is a false prophet. To paraphrase Crash Davis, explaining this simple concept to diabetes companies is like trying to explain a fungo bat to a Martin.