In 2009 Johnson & Johnson company Lifescan showed off a blood glucose meter that connected to the third generation of the iPhone on-stage at Apple's World Wide Developer Conference. It was -- and remains -- one of the most high profile demos of a mobile health device. Of course, the most notable thing about that demo was that unlike most everything else you see on-stage at iPhone launch events, that Lifescan meter that connected to the iPhone never made it to market.
Anita Mathew was the Lifescan executive demonstrating the meter at the Apple event. Now, more than two years later, Mathew has left Lifescan and founded a startup called Glooko that has developed and brought to market a similar technology. Glooko, which has no affiliation to Lifescan, recently began selling a cable direct-to-consumer on Amazon for $40 that connects six of the most popular glucose meters (including Lifescan's) to iPhones. The cable enables users to log their glucose data in a no frills app that is considered a Class I device under FDA's MDDS guidelines.
"To be a Class 1 device, you have to put quality systems and testing in place to show that the information at point A [the meter in this case] is equal to information at point B [the Glooko app]," Mathew explained to me in a recent interview. "Information in your meter is exactly the same as information in your app from the cable -- if there are 500 readings on the meter then there are 500 readings on the phone."
Glooko's humble start allowed it to get to market quicker.
"We hope to do more over time," Mathew said. "This is a starting point. Our goal is to provide more features to our app, so we are not going to stop app development with this first version. We are planning to offer our patients things like charts, graphs, and coaching, all things that would make this a Class II device."
With its seed round of funding, however, Glooko was able to create a Class I device, compatible with Apple's devices as well as six meters -- and get it to market.
"Yes, our current paradigm is just a logbook," Mathew said. "One differentiated piece is that we don't have manual entry of blood glucose numbers. Those numbers are sucked out of the meter into [the app] via the cable," she said. "Why do that and not just do what Glucose Buddy does? It's a point of difference, for one, but also, if you talk to enough physicians out there, there is some skepticism among that group when a patient brings a hand written log book to them. They wonder, is it accurate enough? Did they forget to write down numbers? Or write 58 instead of 85? Or is it inaccurate because they could potentially make up numbers because they are afraid that their doctor is going to get upset with them?"
One question I always have for those creating diabetes management solutions for the iPhone platform is: How many potential users could their app or meter have? In other words, how many people with iPhones also have diabetes?
"Of course, Apple won't give you that figure," Mathew said. "My estimate is that if you believe one in three people will have a smartphone and Apple has a quarter of that -- you are talking about 1 million to 3 million people within the iPhone market might have diabetes. The market gets bigger when you layer on the iPad and iPod touch devices, which are kind of trending among older populations who are replacing their PCs with iPads, for example. We don't have a native iPad app yet but that could change if there seems to be demand for it."
My last question for Mathew was whether she thought Lifescan might resurrect the cable project that she demo'd for them at the Apple event two years ago. She was understandably hesitant to say much about her former employer, but she did say:
"Absolutely. They could do it. Would Lifescan build a cord that works with other meters? Probably not. They may. It is possible. But all of the meter companies have taken the same stance and that is that their cables will only work with their own meters."
I am often asked about the Lifescan project at industry events. The moderator of the panel I was on at the Partners' Connected Health Symposium even opened our panel discussion by asking about that phantom product. After more than two years, it is a relief to finally see a version of that project come to market.