Following up on yesterday’s top story: Apple’s iPhone 3.0 update, which included a number of mHealth implications, we caught up with LifeScan’s Director of Communications Dave Detmers today. Detmers discussed the company’s demo at Apple’s event yesterday and fleshed out the background story on its Bluetooth-enabled blood glucose monitor that synchs up with the iPhone 3.0 OS. LifeScan is a Johnson & Johnson company focused primarily on diabetes monitoring devices and software.
During our interview Detmers noted that the demonstration yesterday was of a prototype application that LifeScan created specifically for the event to show what medical devices can do when connected with iPhone 3.0. Detmers stressed that the demo was not meant to represent a fully-defined commercial product that is imminent. Apple asked LifeScan just a few weeks ago to create a prototype for the event and LifeScan was all too happy to participate, but a product like the one shown is not on the verge of a commercial launch.
Detmers explained that LifeScan still has some work to do to discover what the marketplace needs and what iPhone users with diabetes want from a connected solution that interacts with their iPhone. How do these particular iPhone users differ from others that use other connected BGM devices? If and when a system like the one Lifescan demo’d yesterday does come to market, Detmers noted that it would have to be vetted by all the typical medical clearances–like HIPAA compliance and other security and privacy best practices.
Read more for the rest of the interview with LifeScan’s Dave Detmers…
Even though the demo yesterday was not of a commercially imminent product from LifeScan, it seems to include at least the functionalities of a number of LifeScan products already on the market, right?
Exactly. What we are bringing to the party is we are taking our knowledge and leadership in blood glucose monitoring along with our leadership in wireless communication of blood glucose results through [our partner] Animus Electronic and taking those tools and combining them in an offering that is unique to the iPhone application. That said, there’s still some refinement that needs to take place for that platform and that application so that the offering provides the most value. Fundamentally, what we’re trying to do is integrate diabetes management solutions as seamlessly as possible into people’s lifestyles. In the case where people are very reliant on their handheld then the more functionality we can put in there, then the more likely that it will fit their lifestyle and be utilized. The goal is to shift the burden from people feeling like they are managing a disease to just having this be part of their overall lifestyle management and make it as easy as looking up restaurant information on their phone or updating their calendar. It’s a case of integrating the most valuable tools to help people make diabetes less of a burden.
Can you flesh out why you think diabetics who already have or may want to use an iPhone for diabetes management might want different blood glucose monitoring functionalities in a connected device vs. those using other solutions?
Well, again, it’s still very early for us. What are role here is to understand the value proposition for people with diabetes who rely on these handheld devices. People with diabetes have very different needs and varying levels of engagement with technology and even meters. We have meters that our extremely simple that just offer you a simple result and that’s it–no charts or graphs. Then there are people who are very data intensive and they want to see trends and share information and the like. We also have differences based on therapy type–people who are on insulin typically need to test their blood before meals and our self-adjusting the amounts of insulin they are about to take depending on the food they are about to consume. That may be different from someone who is on oral medication and is maybe controlling their diabetes more through diet and exercise. We have 8 percent of the population in this country with diabetes and that runs the gamut from children to adults and includes all of these different therapies. Take a cross section of that 8 percent with Apple’s install base of iPhone users and then we can begin to understand how people with diabetes who are also very engaged with these handhelds could benefit from different tools. What’s going to help motivate them, inform their decisions and so forth. One of the things we are intrigued by is the concept of community. One of the things we said during our presentation yesterday was that often times people feel very alone in their diabetes, but there is an opportunity for people to share their experiences, learn from others and gain support. What we are really talking about is transmitting the glucose results and allow others to view that in ways that are meaningful, including sharing the info with a family member or healthcare professional. How do we take this experience further to make it much more meaningful in people’s daily lives and management of their disease.
Earlier you had mentioned a need for gaining the necessary clearances for an iPhone connected blood glucose monitor. We have previously written about the FDA’s interest in determining the best way to assure the safety of medical devices, including modules or accessories to the iPhone. What’s your take on the FDA regulating a system like the prototype LifeScan demo’d yesterday?
My understanding is–and this is just speculative–to me this is analogous to what we are doing and have already done with our OneTouch Diabetes management software. You can look at a Windows-based computer as a general purpose computing device. Our software, which allows you to upload diabetes information and let’s you create charts, graphs and analysis. That software required a 510K submission and clearance by the FDA before we went to market. It does not affect the computing device on which it was uploaded. I think our view is that the iPhone is just another platform to which people would upload software. Now, it would be a different story if you said you wanted to integrate a blood glucose monitor into the iPhone’s hardware. At that point you’re talking about pushing the iPhone into the realm of a medical device. But you have to first determine if there are any diabetics who would want that–where do they want their blood glucose monitors to reside? It’s a question of integration. But for regulatory issues the big question is: At what point does a general computing device become a medical device? What we showed yesterday and the path that we are on at the moment is a software application that facilitates the transmission of data to an application that resides in the iPhone’s environment.
The prototype included sharing the information gathered with a doctor or other caregiver–how would you go about doing that?
That hasn’t been determined yet, but because of the new push capability on the iPhone, users of iPhone 3.0 OS will have the ability to share information that way. Take our current diabetes management software: If a patient chooses to send their reports or a summary of reports to their doctors then they can do that. Yesterday we described the example of having a high school-aged daughter with diabetes and you’re a parent who wanted to make sure they were testing and doing it appropriately. The child can test their glucose, then decide what they’re going to have for lunch, make the necessary calculations to insure their insulin levels will be managed and then send all that information to the parent who can have peace of mind knowing she did test when she was supposed to. The ability to transfer information is there, but it’s still a question of what functionalities around that do you want to offer. If a patient is transferring it directly, that’s different than having a physician access that information. If I’m going to create a data warehouse that would be different. This is just another aspect we need to figure out and see what the marketplace wants.
What about uploading and then sharing the information via Google Health or Microsoft HealthVault?
Right, that’s another way. In that case though the appropriate clearances would be needed to ensure that the company hosting that data has the appropriate protections and so forth.
Finally, how did it come about that Apple tapped you to present your application on-stage yesterday?
That’s interesting. During the event before [LifeScan] presented, Apple mentioned that one of areas that was an interesting one for development was for medical devices. Diabetes is clearly one of the most prevalent chronic conditions in this country–I just saw a statistic that diabetes affects 8 percent of the population in this country. My understanding was that Apple had talked to the leading makers of blood glucose monitoring devices and as a result invited LifeScan to participate in their event. We were only too happy to oblige, because we thought it was a tremendous opportunity.