Continuing the discussion from Started new Pump:
I realize it is perhaps natural to attribute the lag in innovation at Medtronic to the US FDA. The argument that government regulation cripples innovators is an easy one to accept, probably even more so if one lives near or under the heavy bureaucratic thumb of the EU. But Dexcom is supposedly also under the same FDA limitations yet finds a way to introduce updates to their product line much quicker than Medtronic appears to be able to do.
Now no doubt some of this is a result of the difference between the product lines. Medtronic has chosen to couple their pump & CGM line. They are now a “system” which apparently now can only move forward … or not … in lockstep. The level of testing scrutiny for an insulin pump, which injects an ostensibly “dangerous” drug, is no doubt much greater than for a passive glucose monitoring device.
Yes, perhaps. I expect that is certainly part of it. It may even be one of the reasons Dexcom has focused on their CGM and does not sell a pump on their own, choosing instead to partner with Medtronic competitor pump companies.
But my view of Medtronic is influenced by the time I spent with a (very) large computer company back in the 1990s. The employees, even the highly placed managers, all knew that the company seemed to be mired down and only able to move forward technologically at a snail’s pace relative to the larger industry. The observation that the company was too “caught up in its own underwear” is actually a comment one CEO of the company made at the time.
I suspect something similar is happening at Medtronic and holds them back. What happens in very large companies/buracracies is that you have a process, a way of doing things. You also have a history of how you’ve always done things. It’s tradition, but it’s also much more than that. Development becomes preoccupied first with internal processes and can only react to the external realities within and through those limitations.
Medtronic has dealt with the FDA for decades. They have a process for that. Why change it? Medtronic probably has always picked a path and then incrementally enhanced their way along it, making lots of money in the process. Why change that? I suspect from a corporate process perspective, Medtronic is gobsmacked by what Dexcom does. Medtronic must improve through tedious increments because, well, that’s just how they do it. It is “who they are” as a company, no?
If the other pump companies are unable to match Medtronic’s approach to vary basal insulin dosing dynamically based on feedback from a CGM, then Medtronic will eventually win out. This is certainly how Medtronic probably sees it.
But technology and “connectedness” is changing the world. That certainly seems to be the direction that Dexcom is leaning in. I am less certain it will take as long to upgrade “smart pumps” to be more than just a monitor for the CGM. Along those lines I am very interested in Tandem Diabetes pursuit of a dynamic firmware upgrade capability for their pumps. If they are successful then that possibly coupled with one of the other “Artificial Pancreas” research efforts might bring changes to market much quicker than Medtronic is counting on.
I also suspect a lot of the finickiness of Enlite CGM results from a combination of limitations from the physical design and, possibly, manufacturing quality control issues. But Medtronic has chosen the physical dimensions of its product path and appears unwilling/unable to deviate from them.
I guess we’ll see how it actually plays out. If Dexcom is successful at influencing the medical community and Medtronic loses its “brand loyalty” as always the best choice, the consequences of that may be much harder for them to recover from than the company is capable of comprehending.