That didn’t take long

That didn’t take long

According to a post on the DiaTribe web site Bigfoot BioMedical has purchased the assets of recently closed insulin pump maker Asante. The site states;

“Tonight, we learned that Bigfoot Biomedical has purchased all of Asante’s insulin pump resources, just two weeks after Asante closed down its business. The startup’s current plan is to pair the existing Asante pump body (disposable component) with a new custom-built, Bluetooth-enabled controller (the “brain” of the artificial pancreas), which would receive CGM data and tell the insulin pump when/how much insulin to give. Bigfoot’s ambitious goal is to be in a pivotal trial with this automated insulin delivery system by the end of 2016.”

Bigfoot is the brainchild of former JDRF CEO Jeff Brewer long a strong supporter of the artificial pancreas project.

While Diabetic Investor hopes Bigfoot can succeed with their rather ambitious goal we remain skeptical that a true closed loop insulin delivery system will be commercially viable.

The issue as we see it is not that a true closed loop system won’t benefit patients rather can such a system make money. Yes we know this is a minor point to many in the diabetes world who view such a system as the ultimate piece of technology but it does matter if these people want such a system to stick around. As we have said many times diabetes besides being a chronic disease state is also a business and if systems don’t make money businesses don’t survive.

Also as we have pointed out on numerous occasions the insulin pump business is one of the most difficult to run. The fact is building an insulin pump is not the hard part, the hard part is running an insulin pump company. With a true closed loop system this level of difficulty increases tenfold.

No we aren’t trying to rain on anyone’s parade but consider the hurdles faced here. First getting such a system through the ultra-conservative FDA won’t exactly be a walk in the park. Next there is the issue of getting such a system covered by payors, payors who increasingly are looking at lowering their costs. While no one knows what a closed system will cost it’s a safe bet that they won’t be cheaper than systems already on the market. There is also the question of market size. Even with the many documented benefits of insulin pump therapy the insulin pump market is growing in the low single digit area.

Now proponents of closed loop will state that patients will achieve better overall outcomes plus have a better quality of life. That may be true but the fact is patients on existing insulin pumps can and do achieve better overall outcomes. Yes would it be nice if patients didn’t have to think about their diabetes management but the fact is payors don’t care about quality of life. What payors care about is money and closed loop systems aren’t going to be cheap.

Lost in this quest for a closed loop system is what happens when something goes wrong and given that a closed loop system is medical device something will go wrong. Looked at realistically a closed loop system is basically a combination of technologies and algorithms. Now anyone who has reviewed the FDA’s databases knows that insulin pumps are not immune from failing. Yes for the all the quality control measures put in place by pump manufacturers insulin pumps do fail. The same goes for continuous glucose sensors.

Think of it this way with the current crop of sensor augmented insulin pumps if something goes wrong the patient has the ability to take action, to prevent a small problem from becoming a big one. Take away this capacity and turn over control of insulin delivery to a machine there could be devastating consequences. Keep in mind that insulin is a lethal drug when not properly dosed.

The fact is the system doesn’t even have to malfunction to create a problem. What happens if the CGM sensor is improperly calibrated?

The way Diabetic Investor sees it a true closed loop insulin delivery system is the ultimate in whiz bang way cool technology. Yet just as we see Afrezza as a niche product same goes for a closed loop insulin delivery system. Like Afrezza there will be a handful of patients who will benefit from the technology. Yet like Afrezza a true closed loop system will have limited commercial viability.  We know our view is contrary to many in the diabetes world but that’s nothing new.

Like Afrezza our view has nothing to do whether such a system would benefit patients. Our view is based on the business of diabetes and as we have noted with Afrezza not every new drug or device no matter how cool it is translates into a sustainable business. There is a reason they call this the business of healthcare something all the supporters of a closed loop system would be wise to remember.