Even Apple can’t beat the FDA

Even Apple can’t beat the FDA

Lately there’s been a flurry of reports about tech titan’s Apple and Google entering the diabetes device arena. Google initially grabbed the headlines with their contact lenses that measured glucose, next came reports that Apple too was working on a watch which among other things measured a patients glucose readings. While Diabetic Investor has been skeptical that either Google or Apple could get this whiz bang way cool technology to actually work, we were even more skeptical they would be able to deal with ultra-conservative nature of the FDA.

Well according to a report published on pocket-lint.com the new Apple iWatch won’t include glucose monitoring capabilities. According to a story published on February 26th, “Reports from earlier this month said Apple is developing a Healthbook app for iOS 8 that would read “glucose-related data”, though other reports claimed the iWatch will not feature built-in glucose sensing. Now Network World has jumped on the rumour mill bandwagon, suggesting a glucose-monitoring feature will definitely not be included in the iWatch because the technology is too early in its development.”

The story goes onto to state; “If Apple does improve the the HG1-c, it will still need US Food and Drug Administration approval, which requires clinical trials, meaning it could take another two years before Apple is ready to include glucose monitoring in its iWatch. Thus, as website MacRumors noted, Apple will probably just allow first-generation iWatch users to monitor glucose levels by syncing them from a glucose monitoring device or manually entering them into the Healthbook app.”

Now there are some who believe that Apple, Google and Samsung – another company set to enter this space- will somehow navigate the quirky world of the FDA better than existing players or that they will somehow convince the FDA to change their ultra-conservative snail like approach to approving new products. Now asking the FDA to change is one thing, actually getting the agency to change is whole different world. Keep in mind this is an agency that does not understand or care for that matter that tech companies live in world where the product cycle last for 6 months.  The FDA is a government agency which does not operate in the real world but the bureaucratic world of Washington D.C.

As much as we would like it if this wasn’t case the fact is the FDA and it’s bureaucratic world is one the largest obstacles to better diabetes drugs and devices. Take for example a device like the Pogo from Intuity Medical, a device that simplifies the glucose monitoring process, not a revolutionary device rather a evolutionarily device.  The Pogo is an all-in-one device which compared to the standard glucose meter which consists of a meter, test strip and lancing device. The Pogo combines all these items into one nice neat little package making glucose monitoring a more patient friendly experience. The Pogo has been subjected to request after request from the FDA, an approval process – wait for it – that began way back in 2011 – take that Apple, Google and Samsung.

We can only imagine the faces on the folks at Google, Apple or Samsung when an FDA staffer asks them to conduct another test, do another study over a situation which occurs once every century. The simple fact is no matter how crazy the request the folks at Google, Apple or Samsung have no choice but to comply, that is if they want to see their particular device every make it to market. Plus the folks at Google, Apple and Samsung better realize they can’t complain about this convoluted process publicly as the FDA will surly punish this disobedience by slowing the approval process even more. Something they did to Roche after the company acquired insulin pump maker Diestronic. For reasons only known to Roche the company publicly complained that FDA was taking too long to lift the sales ban the agency instituted on Diestronic insulin pumps. While Diabetic Investor agreed the agency was taking too long we also knew the last thing they needed was to complain about the agency during not one but two public forums. Just as sure as night follows day the FDA took their sweet time reinstating the Diestronic insulin pump which basically killed any chances it had in the market.

Now if Google, Apple, Samsung and the like can get the FDA to live in the 21st century that’s great. There’s no question that the agency is in need of serious reform, it takes way too long for devices to get approved. The question becomes can the agency understand not just where the market is but where it is going, that mobile devices need to be part of the future of diabetes management. Recently we have seen some movement in this direction, however because of the nature of diabetes management we’re not sure the process can be streamlined enough to match the lifecycle of the mobile device world.

We’re glad Apple, Google, Samsung and other tech companies have joined the quest to simplify diabetes management, excuse the play on words but there is no question that new blood and fresh perspective are needed. Still there are several hurdles to overcome, more than making sure these way cool devices actually work. This is just the first step in the process, a process which includes the FDA an agency which sees the need for reform yet has a difficult time implementing reform.