All it takes is one broken link

All it takes is one broken link

Yesterday Diabetic Investor read yet another piece on the investment potential of the artificial pancreas project (APP). This was a fairly typical analysis of all the various companies now involved and those who likely will get involved. The general consensus being that the APP is no longer a pipe dream but will become reality and reality is just around the corner. While this may be true as the APP is making tremendous strides, every now and then we are remind that the APP is really a collection of both hardware – insulin pump, continuous glucose monitor – and software.

While Diabetic Investor supports the APP we have also noted that any broken link in the chain that makes up the APP can wreak havoc on the entire system. So far we have concentrated our efforts on what happens if the hardware fails – the insulin pump or the CGM and have paid little attention to what might happen if the software fails.  The fact is without this software the actual devices that make up the APP would pretty much be worthless as it’s the software that basically makes the system function.

We were reminded of this fact when our friends at Animas, the insulin pump maker owned by Johnson and Johnson (NYSE:JNJ), sent yet another letter to their users warning them over a possible software issue with their OneTouch® Ping® insulin pump. According to the letter;

“We have identified an issue with the software in the OneTouch® Ping® insulin pump, where the software did not recognize some changes patients attempted to make to their time and/or date settings on February 29, 2012 (Leap Year date). An incorrect time may result in basal insulin delivery or a recommended bolus amount that is incorrect for the actual time of day. This could result in unexpected high or low blood sugars.

Also, please be aware that there may also be a discrepancy in the download data if you are using a data management software program with a pump that was affected by this issue.”

This is just the latest issue for Animas which was issued a harshly worded warning by the FDA in late December of 2011.

Although Diabetic Investor does not see this software issue as overly serious it does show that even something that seems inconsequential when not handled properly can gum up an entire system.  Given that Leap Years do happen, one would have thought this event would have been anticipated but that’s really a story for another day. We also find it somewhat ironic that Animas is a huge supporter of the APP and hopes one day to financially benefit when it does become a reality. Thankfully for Animas that day is still a long ways off, as if that day was today Diabetic Investor isn’t sure how a patient would place their life in the hands of a company that has more recalls, warning letters and issues with their insulin pumps than Minnesota has lakes.

It’s also important that everyone reread that last sentence and pay close attention to the phrase “place their life in the hands”. While everyone looks at all the whiz bang technology associated with the APP and becomes fascinated with its potential, they often forget that while the APP can be a life changer for a patient it can also be a life ender for that same patient.  This is one reason Diabetic Investor believes the FDA will proceed slowly and cautiously with the APP, slower and more cautiously than their already incredibly slow and methodical pace. Yet here we will not complain but encourage the FDA to move cautiously as lives are truly at stake and while the APP would be a nice thing for patients to have it is not a must have. As this latest issue from Animas points out all it takes is one broken link in the chain and the whole system comes crashing down.