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Re: [IP] Re: Paradigm "upgradable"

> Ryan,
>    Your points are well taken, but what we don't (and probably never
> will) know is how much of the system resources of the 511 are
> currently used.  The code for the wizards and the other new features
> of the 512 are going to require a signigicant (as far as embedded
> systems go) amount of storage.  I hope that Medtronic had the
> foresight to build the 511's with enough memory to handle future
> upgrades.  If that is indeed the case, then $450 sounds like an
> awful lot of money to upgrade a firmware image, which by my
> experience is a process that usually takes less than two minutes.

The upgrade process for any pump, whether or not it is minimed, is 
under FDA scrutiny. This means that the company must put the pump 
through it's entire certification procedure before it is returned to 
the owner. It's not as simple as changing out some software code. The 
regulatory layer that has been added require a great deal of 
documentation and tracking that is not required of ordinary 
electronic appliances and it costs $$. 

A good example of this is the aircraft industry. Light planes use 
many components that are identical to ones used on autos, the only 
difference being that they are "certified" for aircraft use. That 
means that there is a paper trail through the entire manufacturing 
and distribution channel so that a failure can be traced to its 
origin. i.e. About 20 years ago BC (before children) when I had a few 
bucks, I co-owned a plane with 2 other guys. We had to replace the 
alternator and purchased a new one that was identical to the one in 
my car. It cost 3 X as much as the same alternator purchased at the 
local auto supply (I checked), simply because it was certified for 
aircraft use.

What's the point of this.... there is a significant overhead to 
manufacturing medical devices that is entirely regulatory. I'm not 
making commentary on whether or not is is needed (I think most of it 
is), only that it costs money and we get to pay for it.

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