There have been some recent discussion about the revelation that Apple is working on a device that would monitor a person’s blood glucose. This device would be non-invasive; i.e. it wouldn’t require lancing a finger to draw blood. Jean-Louis Gassee has a nice overview of the discussion and what’s known about the project.
As someone who’s been diabetic for a while, projects like this catch my attention. The first thing to realize about it is this: it’s not the first time someone’s tried to do this, not by a long shot. I can think or three or four in the last decade, in fact. None have ever gotten to market.
Why? Because something like this is considered a medical device and so needs to go through a licensing and approval with the Federal Drug Administration, and the equivalent in any other country they want to sell it in. That can be a long and expensive process. The previous products I’ve seen announced that were trying this have never made it through that approval or shipped.
Apple’s not the only company looking into this. This piece from Practical Diabetes found 40 devices under development, 24 for intermittent testing and the rest for continuous testing for users of insulin pumps. One of the products under development is Glucowise, but it is still unapproved in the U.S. so not shipping here. Here’s how they describe how they’re doing this:
The glucose levels are extracted by a non-invasive technique which transmits low-power radio waves through a section of the human body, such as the area between the thumb and forefinger or the earlobe. These areas have adequate blood supply and are thin enough for waves to pass through the tissue. These signals are then received by a sensor on the opposite side of the GlucoWise device, where the data about the characteristics of the blood within the flesh are collected and analysed.
Other approaches include testing saliva or tear fluid or the moisture you exhale as you breath. I expect Apple’s approach is similar to Glucowise. I’ve also seen attempts made to do this using infrared light.
While I’m hopeful Apple will make this happen, I think it’s safe to think it’s going to take a while to jump through these hoops, so any product built out of this project is likely some time way. The Glucowise product is aiming at 2018 for US approval and sale, so even though it was approved in Europe in 2016, the path to approval here in the U.S. is a lot longer and complicated (and expensive). I think we need to assume it’ll take Apple at least two years or more in the clinical testing phase to get through FDA approval, and possibly longer, so this is a long term play for them. Since it doesn’t seem they are in clinical testing yet, I think it’s safe to predict we won’t see a product here until 2020 or later.
The requirements for certification are going to define some aspects of this product. For instance, it won’t be built into a watch, because then the watch would need to undergo testing and certification. Instead, it’ll be a separate device. Many of these devices report data via bluetooth to a supporting device like your phone, which fits nicely with Apple’s product model. It might be possible for Apple to build something like this into a watch band if they (as has been rumored) add intelligent connections to watch band connectors in future generations, but the standalone device makes sense, especially for a first generation product. I really like the look of that Glucowise product and I’d expect Apple do to something similar, but in an Apple way.
That will allow Apple to build the product and get it approved without it impacting how its consumer products are created. As a medical device, it’s not something you’re going to iterate every year or two; it’s something we should expect will stay in the product line for a while before being updated. The regulatory realities around a medical device dictate Apple build these products differently than its consumer products. After all, lives are at risk if they aren’t reliable.
I was fascinated that Tim Cook came out and admitted this device existed and was in development. That’s very non-Apple, but thinking about it, the regulatory testing and evaluation process with the FDA will not be private, so in some ways, what he may have done is let us know about it rather than let it turn into a hype-able leak when the FDA filings got noticed. I wonder if that means they’re almost ready to start the clinical trials for this. I hope so.
As someone who tests at least three times a day, I am really hoping to see these non-invasive devices hit market. I’ll be on-board as soon as they’re available and proven. But having watched this kind of product attempt to get to market before, I’m also setting my expectations on it conservatively, because the track record is for it to take a lot longer than you might want, and in the past, these products simple haven’t made it through the FDA approval process. And that’s something Apple can’t sidestep, so this product will happen when it happens.
Oh, and Apple, if you want someone to join the trials and test the device for you, just send over the NDA. I’m looking forward to buying it the day it’s released.