Closing the loop
This morning we learned that Johnson and Johnson (NYSE:JNJ) has teamed up with Dexcom (NASDAQ:DXCM) and the Juvenile Diabetes Research Foundation’s artificial pancreas project to develop a closed loop insulin delivery system. Using their Animas insulin pump and Dexcom’s continuous glucose monitoring system the JDRF hopes to develop a system that will basically mimic a normal’s person’s pancreas.
According to press release issued by the company today; “If all goes well, a commercial model could be on the market in four years, said Aaron Kowalski, research director of the Juvenile Diabetes Research Foundation’s artificial pancreas project.”
While Diabetic Investor doesn’t want to stop innovation there’s no small amount of irony here as the announcement comes only days after we learned the FDA will be conducting a panel meeting to review insulin pumps. It’s also worth noting that Medtronic (NYSE:MDT) the current market leader in insulin pumps who also has CGM is not part of this process. This is also ironic as Medtronic has publicly stated for years their ultimate goal is to develop a closed loop insulin delivery system.
So before everyone gets too excited consider the following items;
1. As exciting as this technology sounds, it is still technology and as we have seen in the past sometimes technology fails. With a closed loop system there are several links in the chain and all it will take is for one link to fail.
2. Should the patient really be taken out of the loop? Diabetic Investor has interviewed several noted pump advocates, including several noted diabetologiests and endocrinologists, who believe the patient should NOT be taken out of the loop. They have no problem with providing the patient with more resources to make better dosing decisions but they also see a great deal of risk in letting a machine all the decisions.
3. Who’s going to pay for this system? Insulin pumps already cost upwards of $9,000 per year and given the focus on lowering healthcare costs it’s not a given this system will be embraced by insurers.
4. Will the system really provide better control? In the end this real goal of any new therapy or device, helping the patient achieve better outcomes. Based on numerous studies well trained pump patients are already achieving better control. Quite frankly it’s not the device that needs to be changed all that much, rather it’s the pump patient who needs to be properly trained on how to optimize their pump experience.
5. What’s the regulatory path? Diabetic Investor can only imagine the requirements the FDA would ask for to approve this type of system. As noted earlier with all the moving parts here we can only imagine the hoops the FDA will make companies jump through to get this system to market. It could four years just to figure what the requirements are.
Diabetic Investor hates to rain on JNJ’s and Dexcom parade but the fact is as whiz bang as this system sounds we’re not convinced it will succeed in the marketplace and more important yield better patient outcomes.