Dexcom & Medtronic — Are product differences rooted in corporate culture?

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.

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The “We are not Waiting” movement and the DIYPS (do it yourself pancreas system) all seem to be using Medtronic pumps (older models) to vary basal rates dynamically based on CGM input. The iLet Bionic Pancreas adds glucagon in a bi-hormonal approach.

Back to your original question posed in your headline. Yes, from various sources that I have followed over the years, it seems that Dexcom’s ability to quickly iterate has in part been due to its small company culture’s flexibility to sense process flexibility telegraphed by the FDA and quickly acted upon by Dexcom.

In fact Dexcom was even caught on its heels when the FDA appeared ready to move on creating more flexible rules for “secondary displays” such as the iPhone and Apple Watch. Dexcom had just released its Share app and the Share cradle and I think was surprised by the FDA’s willingness to move more quickly than the company had planned for.

Medtronic meanwhile seems slow to introduce the 640 predictive low tech into the US market. It’s not alone in its less than nimble approach with the FDA. Animas, a division of Johnson and Johnson, took three years to introduce the Vibe pump to the US after it had been available internationally for three years. Abbott Diabetes rolled out its flash glucose monitor LIbre in Europe last year and has had problems scaling its production to meet demand. Perhaps more capable management of its FDA relationship would have enabled it to introduce the Libre to the US more quickly.

Yes, I think the grassroots “We are not waiting” citizen developers have added a sense of urgency to Diabetes-tech rollouts and the prize will likely go to the more nimble when dealing with regulatory bodies. Medtronic is more rooted in the “way it’s always been done” culture while Dexcom seems able to move quickly when the opening presents itself. Animas and Abbott are more like Medtronic in this way. I believe their respective product offerings will reflect this difference in corporate culture. We need more player like Dexcom in this space.

Made me think of the Jeffrey Brewer Google hangout we had a while back, and his description of how Bigfoot changed their way of thinking about the FDA approval process. The industry-wide assumption is that it has to be highly adversarial, leading to practices like getting products approved overseas first in order to gain leverage over the FDA, all of which slows things down enormously. He’d started with the same assumption but then they actually questioned it, met with the FDA and found them eager and willing to be engaged in the development process from the start so that they’d wind up with something approval-ready in the first place. Sounds like an example of what you’re talking about.

As a note, it takes no time difference or any added difficulties at all between getting a device certified in Europe or getting it certified through the FDA. Any delays are solely marketing related, a decisions to submit in one area first before another possibly due to costs, or caused by incorrect filing of necessary details, which I doubt is the latter. That actually came from someone in one of these companies during a nice chat about why some companies choose to do releases in one market before the other.

FYI, Glooko announced this week that Insulet will be providing their hardware/software to users and providers to help integrate pump and Dexcom data. I’m not using Omnipod right now, but it sounds like they’re looking at ways to jumpstart connectivity.

I think product differences are indeed rooted in corporate culture. In the 90’s, MiniMed Technologies, a relatively small company (founded in the 80’s by Alfred Mann) changed the T1D landscape with their innovative, small, lightweight, menu-driven pumps. In 2001, just about the time when I started using my first MM pump, Medtronic acquired MiniMed and has since, as far as I can tell, contributed almost nothing to pump technologies. I am pretty sure the current MM pump core - the motor that drives the plunger, as well as the pump electronics and firmware, are essentially the same as in the original MiniMed pumps from the 90’s. With the exception of the upcoming 670G, Medtronic pumps still look and feel like pagers from the 90’s. That’s not necessarily so bad - there isn’t really that much to be improved in the core pump technology anyway. But, I do not like where Medtronic seems to be going. They are trying to integrate their (still inferior) CGM and more and more stuff on the pump itself, as evident in 670G. In my opinion, a much better approach is pursued by Insulet, where the pump is just a dumb but convenient and presumably reliable device, while CGM and all other smarts (ultimately including various AP features) are elsewhere - in smart phones and the cloud. This should allow for faster improvements and hopefully faster approval cycles.

I agree as a large company Medtronic likely moving slower but I suspect Dexcom just happened to come up with a sensor design that is more accurate and this is the heart of why Dexcom is generally superior (even accounting for Dexcom’s continual efforts to improve and put out new versions every few years). The engineers involved surely know if this is true or not but for me this is as good an explanation as any. I am further guessing that patents are further hampering medtronic’s ability to improve.

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While I agree with almost everything you said, I just have two “nitpicky” comments:

Dexcom didn’t “just happen” to come up with a sensor design that is more accurate. Perhaps it wasn’t your intent to make it sound like Dexcom was just lucky (and I may be reading too much into this), but I believe that things rarely “just happen.” IMO the Dexcom CGM system is so superior to Medtronic’s because it was the result of hard work and sheer genius.

While it may be part of the explanation, I believe that patents are only a small part of why Medtronic’s efforts to improve move at a snail’s pace. I think whoever said the reason is because Medtronic is “caught up in its own underwear” hit the nail on the head.

I consider Medtronic CGMs so inferior to the Dexcom system that I doubt I will have my daughter take advantage of their single-hormone closed loop system when it becomes available.

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i hate to ask this. but what is Medtronic ??.

feel stupid that i have to ask this.

Medtronic is a pump company - the one with the biggest market share in the US, in fact. They manufacture the minimed pumps. See Medtronic: Diabetes Products And Therapy Options.

(They also manufacture what many PWD consider a CGM that is vastly inferior to Dexcom’s.)

Not to hijack the thread but…

How long did you use Medtronic’s CGM? Did you use both the Sofsensor & Enlites? Why exactly do you consider it inferior to Dexcom?

Just curious because we’re considering a switch.

Actually, Medtronic is much more than a “pump company”. Medtronic became a pump company when it acquired the MiniMed company back in 2001.

Quoting from the Medtronic wikipedia article  …

“Medtronic is composed of six main business units which develop and manufacture devices and therapies to treat more than 30 chronic diseases, including heart failure, Parkinson’s disease, urinary incontinence, Down’s syndrome, obesity, chronic pain, spinal disorders, and diabetes”

Medtronic’s oldest & largest business unit is cardiac rhythm disease management (CRDM). It is an indication of just how large the Medtronic company is that, while Medtronic may have the largest worldwide market share as a pump maker (I think?), the Medtronic Diabetes unit is probably not the largest of Medtronic’s businesses.

To say that Medtronic is a “large corporation” is actually quite an understatement.

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thanks for telling me what they are. but i’m happy with my Dexcom & my Omnipod.

I would speculate that Medtronic has folks with job titles like Product Manager/Life Cycle Manager where part of their job is to guess (okay, forecast!) revenues, costs for each pump/device for the “life” of the device. When/if presented with a newer, more innovative device from the Product Development gang, there’s gonna be a fair amount of pushback if the newer device is going to take market share and revenue from the older device and possibly prevent the older device Product Manager from meeting the corporate targets.

The Product Manager or maybe someone in the CFO office will come up with an analysis that has some scenarios stating the case for wild innovation vs. incremental improvements with the same basic platform. Frequently, the incremental improvement argument will carry the day in the boardroom.

Add to that the potential pushback from engineering on how to “produce” the new product if the engineering group doesn’t have the budget because they are filled with making small incremental improvements to the older device. Replay that for each group that needs their role in a new device, from Regulatory (FDA approval team), to Clinical (to get all the trials done), to Vendor Management (who will our subcontractors be for motors, circuit boards, etc.), to the Technical Writers, Marketing, etc. and you can see how a big company gets mired in their bigness.

Dexcom has it much easier in some ways. They have a vision of producing the top CGM that will be the “go to” device for AP developers; the CGM that will eliminate the need for fingerstick testing (how big is THAT market?). They are producing a version of the top CGM today. However, they know going in that today’s G(n) device is going to be toast in maybe 2 years max, so they have to keep innovating and improving to get to those goals, or they will go out of business (and/or their investors will go away).

So I don’t see the differences as corporate “culture” as much as it is a difference in the type of company.

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