Back on track. But to where?
I received the new pump, as expected last night. What a relief it was to hook it up... As I said in yesterdays post my replacement pump is a Paradigm 511. This is one version lower than my regular pump (I use the Paradigm 512.)The 512 is much better.
For example, the 511 doesn't have a bolus wizard. It's interesting how a simple feature such as a bolus wizard can improve my quality of life. By calculating (instead of me guessing) boluses for each meal, it impoves my control. And improved control means improved quality of life.
These kind of shortcomings can be expected when new insulin pumps are launched. The 511 was after all a leap forward from the 508. And Medtronic improved it by launching the Paradigm 512 "shortly" after. Then they launched the 515 giving even further improvements and better usability.
But I live in the wrong country. The Paradigm 515 is not available in Western Europe!
Why? I have called Medtronic about this and apparently it has to do with the regulatory offices. Just like the US has the FDA , so does Europe have its own agencies. In France it is called AFSSAPS.
So what do these offices do? One thing they do is to create barriers to innovate products. Everything has to be approved in the name of safety. This takes time, and costs money for the companies involved. For users (like me) it means getting access to products later. The development of new features is slowed down.
Their justification is to protect the users from hazards, and thereby save life. However, the software gets thorougly tested by the company that make it. Any faults would be damn expensive for a medical company. Word spreads quickly, leading to reduced sales. In addition, willing and ambitious lawyers are plentyfull around negligence cases.
It is seldom mentioned how many tragedies could have been avoided had the FDAs and the AFSSARS' of the world disappeared. How many lives could have been saved? Launching products to the market 5-10 years before (new insulin pumps, but also new cancer drugs, vaccines etc) can save lives. In addition it would mean lower costs for introducing new treatments, and it would open up the market for smaller companies. More competition would be the result. more choices and lower prices for the end consumer.
But is this limited to only Europe and the US? No! In Australia, for example, they are now using the Minimed 508. This is the dinosaur of insulin pumps! Poor bastards. But atleast they get to practice their math at each meal...
8 Comments:
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I was looking out for diabetes diet related information. Sorry, I have see that your Back on track. But to where? isn't a perfect match. But, anyway, I am glad I have stopped by even though this isn’t a perfect match. What you have in your content is very interesting for most people.
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Have you found me yet over at www.diabetesmine.com?
Nice site you have here. I lived in Europe myself for 6 years. Never did understand the sister system to the FDA. In Germany, some things come out faster, but many others are SLOWER. Aack!
Anyway, good luck with your family & your D-control!
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Just to let you know, that Australia actually has all the current pumps that you do in the USA. We have the Minimed Paradigm 522/722 and CGMS, and the Animas and Deltec Cozmo pumps.
When you wrote this blog, Australia was already using the Minimed 512s, not the 508 as you say. I'm not sure where you got this information.
I live in Australia btw, and am pumping, thats how i know :)
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