Not as easy as it seems

Momma Kliff used to say that just because something that is difficult to achieve does not mean you shouldn’t try, just be prepared to deal with the difficulties in achieving it. As usual Mom was spot on when it comes to the quest of developing an insulin delivery system which is controlled via a patient’s smartphone. Ask any patient who uses the OmniPod from Insulet what feature they crave most and universally it’s smartphone control. Yet Insulet isn’t the only company seeking this functionality.

Before we proceed let’s get a few pesky facts out of the way;

1. Smartphone control is not just patient friendly (one less device to carry around) it’s also good business (one less device to manufacture). Think of how much easier it is for Dexcom patients to use their phone to see their readings and how much money Dexcom saves from not having to send their patients a separate receiver.

2. Although a separate device can communicate with the cloud doing so on a phone allows for greater connectivity between apps.

3. Given that smartphones have become embedded in our lives there is little chance that a patient will accidentally forget to carry their device with them at all times, something that does happen just ask any patient who uses the OmniPod. Nothing more maddening than leaving your PDM at home, in the car or wherever when you need to bolus.

There is no question having this functionality will be a major plus for patients and companies like Insulet. However moving to smartphone control is not as simple as it may seem. Remember this is not like the Dexcom app which merely collects data, this is an app which controls the delivery of insulin. And as we keep noting insulin may be a life sustaining drug it is also a lethal drug when dosed improperly.

Now this is going to sound crazy to many who want this functionality yesterday, but this is one time we believe the company’s working on this and the FDA should proceed with caution. That the we want it yesterday movement those who like to hack into systems and get them to do things they were not designed to do should slow their roll. Let’s be clear the we want it yesterday folk have been a net positive for patients who use an insulin pump. Thanks to the good work done by this dedicated and passionate group insulin pump therapy is getting more patient friendly. We are better off for their efforts.

However this is one step which requires a prudent methodical approach overseen by the FDA. As we noted in the past one issue with the we want it yesterday folk is what happens when something goes wrong. And as we have said many times when it comes to medical devices something always goes wrong. The biggest issue with interoperability is the nightmare it creates when questions come up, just who is responsible for what. Does the problem lie with the hardware, the software, the app or elsewhere? And just who controls this trouble shooting process?

While attending CES we spoke with several people connected to Apple, Google and Samsung the leaders of smartphone technology. One issue that arose in every discussion was security, how to design an app or area of the phone which is secure. While it seems almost unthinkable that anyone would hack a phone and dose insulin without the patient’s knowledge, it wasn’t that long ago when it was unthinkable that a group of terrorist would intentionally fly a plane into a building.

Thanks to growing use of digital money all the phone people believed that these cyber security concerns would be solved.

Another solvable issue seemed to be battery life or put another way preventing the app which is secure and controls the delivery of insulin from draining the battery life of the phone.

Still there are some concerns which can only be addressed by the FDA and how the regulatory pathway they develop for these systems which are under development. For example, what happens when the patient is getting ready to deliver a bolus and a call comes in? Does the call go to voicemail, is the bolus not initiated if the patient answers the call? What happens when the patient’s phone is out of range? Does the app need to be active 24×7 or only active when the patient tells it to be active? What happens when the phone dies or when it malfunctions?

As we noted earlier this is not like the Dexcom app which collects data a relatively simple process. Yet even this simple process has created somewhat of a nightmare for Dexcom given the frequency which Apple and Google update and change their respective operating systems. Although they don’t publicly disclose such detailed information it’s no secret that the Dexcom customer service people handle more than a few calls directly related to the app, issues which are beyond Dexcom’s direct control.

This is also much different than a system like the Control IQ or 670G which is self-contained environment relatively free from outside influences. Yes there are connectivity issues, but they are all contained in one platform neither Tandem nor Medtronic has to worry about how a patient playing Candy Crush or getting an Uber impacts insulin delivery.

Let’s be very clear the issues surrounding smartphone control are not insurmountable. However there is no need to rush this process as beneficial as it will be to the patient and any company who successfully navigates these treacherous waters. This is one time when the we want it yesterday folk should put patient safety ahead of speed to market. There is no question this is going to happen, but it does not need to happen right this very second.

As Momma Kliff said often to her  impatient sons; “The important thing is to get the job done RIGHT not fast.”