Well, that only took 20 years to achieve. It’s a little hard to congradulate them on that effort. But, the wheels of progress turn slowly, I guess.
Wow, that’s amazing! They are going to have an insulin pump interact with a CGM. Who would’ve ever thought of such an idea!
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It’s not clear from the article what they mean but it does not sound promising:
[It will] use Abbott’s own FreeStyle Libre sensors and work exclusively with Medtronic’s smart insulin delivery systems and software.
That doesn’t sound like true pump/controller/CGM interoperability which, in theory, the FDA has already approved:
eCFR :: 21 CFR 862.1355 -- Integrated continuous glucose monitoring system.
IRC the non-bespoke Abbott sensors are already approved, along with Dexcom sensors and the Eversense 365, as “iCGMs”.
Here’s the somewhat limited aim:
I still want to see this done by full ISO standards using fully disclosed protocols for inter-operation and the time is right; we have done it, it’s a done deal. A deal that the manufacturers are desperately, tortoise like, trying to deny isn’t done:
Sounds like selling the “sizzle” rather than a real advancement! I had assumed the FDA establishing the “i” ratings for CGMs, pumps, AIDs would have resolved the matter, apparently not! (Yes, I’m being facetious!)
Wouldn’t it be nice if “standards” for communication were world-wide and manufacturers would develop based on those standards? Then they could actually focus on actually improving the devices, have them talk to/with each other, improve the lives of those that have/need to use them, and probably at less expense to the companies thus improving their bottom line. Beats what I consider misleading, if not false, advertisement of progress.
This is the Medtronic Instinct sensor that was introduced in the US in December last year and may be launched in Europe this year. It’s basically a proprietary Freestyle Libre 3. Instead of directly integrating with Libre sensors, like Tandem and Omnipod have done, Medtronic opted for the asinine proprietary route and Abbott inexcusably (inexplicably?) went along. Abbott should have walked away from that negotiation table. Medtronic’s sensors are bad and their market share is dwindling, and Medtronic knows it. Why not tell them to fold their business if they don’t want to integrate with Abbott’s existing product? I don’t know at what price they’re selling the Instinct sensors in the US, but I hope they don’t dare sell it at a higher price than FSL 3 sensors.
I write about this extensivley to the government. I am shaming med tech. I ask, “Do patients have technical capabilities that greatly exceed those of the medical device industry? Or, are we seeing a lack of innovation as a result of the fact that it’s easier to market fix than it is to innovate? Perhaps there are simply no market forces that force innovation.”
The governement hasn’t publically posted what I wrote yet and it’s making me nervous. They posted comment from the National Community Pharmacists Association today. Those guys are on our side.
I think that is true; why should there be market forces that force innovation? How could that work?
Market forces; desire for cheaper product, desire for product improvement, desires created by marketing and politics, may be addressed by innovation but they can also be addressed by legal challenges, marketing, cost reduction and addressing product defects (e.g. by hiding or fixing them).
Most of the latter are accessible to product producers. Innovation is not; there is no known reliable way to innovate. You are asking officers of corporations who are responsible for making profits to step outside the box (“outside the office” might be more appropriate) and put money into something that time and time again produces nothing.
However:
Obviously, at least in this case; diabetes spans our population without creed, country or colour. The medical device industry employs a very small proportion of people with technical capabilities. Perhaps they employ a greater proportion of diabetics with technical capabilities who maybe are more motivated to object to approaches which are not effective but there again maybe not… (Think about it ![]()
If your comments haven’t been posted it means they don’t have an answer and are worried that they need one. That’s a good thing.
We need to remember that interoperability brings with it high costs. When MedT wanted to use a 3rd Party sensor they shopped it. Abbot and them reached a deal that gave both some form of compensation. Did Abbott pay MedT or the other way around? Likely both paid a lot for to each other to enter into the agreement.
They pay with money, contract length, agreed upon units sold, many factors play into the decision to cooperate. Nothing is 100% easy, it just takes a lot of guessing and maybe more important it will might be a 300 headed monster in the end.
Recall this deal was done more than a year ago when it was MedT and it was inherited by the new Minimed. One more thing, the side Minimed wanted interoperability years ago. MedT did not, up until last year anyway, want to parcel out a new sensor MedT wanted to stay in house.
One more thing, the MedT sensor was bad because of MedT, refused to better develop it and oversold its ability.
What people typically say is that in a sufficiently competitive capitalist market, competition is what forces innovation and quality. They also say that our markets really bit the dust on that many years ago. They say it is not just a problem in healthcare.
They have recieved about 24 comments so far, although only half have been posted publically. They just extended the deadline. Office of Public Affairs | DOJ and FTC Extend Deadline for Public Comment on Guidance on Business Collaborations | United States Department of Justice
You can read public comments here Regulations.gov by clicking on the tab that reads “All Comments on docket”. If you click on the “docket details” tab, we see that they are up to almost 40 total. That’s an improvement. There’s often a rush of people posting right before deadline. The previous deadline was 4 days from now, so we are seeing that dump of a bunch of comments froms people/organizations who waited until the last min.
Let me find you the one from the pharmacists, so you can see one on the topic of healthcare. They were number 16. Regulations.gov “NCPA” means National Community Pharmacists Association. They did a good job. Very thourough.
That means they want their free business analyst (me) to drum up more.
I’m having a tough time with that because it’s such a specific topic. People are pretty uncomfortable writing on the topic of antitrust. I’m really hopeful about a provider at the VA who I expect to submit.
