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The design of this artificial heart would be licensed under a license agreement allowing anyone to use, modify, or build it freely.
The idea is that it would be passed around in CAD getting better and better as doctors and scientists learn about it, with an attached collection of files containing
all the discussion and debate about it.
When it's good enough someone can build it without having to pay for a license.
When it's REALLY good enough and all the "actually building it" and expensive/difficult material kinks are worked out it should be possible to have it built in hospitals everywhere.
Google Sketchup: Shed
http://sketchup.goo...716cc7079ee9dd07103
Presumably you mean something like this - only a design that someone would be prepared to insert in place of their own, beating heart. Clearly the technology exists to draw up and share designs in a collaborative manner - the tricky part is the legals, and getting people to have sufficient confidence in "open" collaborative design. [zen_tom, Oct 06 2011]
[link]
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I've been thinking of doing the same thing, only in the shed arena. |
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If I take a design off the internet, build it and it falls down in a gale - that's fine, I can build another one - but would I be as happy to experiment with surgery? |
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If that's the issue (and it is) how do you propose solving the credibility gap? |
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//When it's REALLY good enough// How do you know?trial and error is generally not the most practical approach to something life critical. Human trials for life critical devices are not simple. |
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//it should be possible to have it built in hospitals everywhere// Have you ever seen an implantable medical device manufacturing line? Very few hospitals have extensive clean room manufacturing facilities and ETO or gamma sterilization equipment, among other requirements. |
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This is true [MechE] but if it becomes a matter of saving lives they will. |
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[ZenTom] Many critical systems are built on Linux... |
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[Voice] Linux is extensively tested. Testing
medical devices requires clinical trials. Those are
expensive, unless you've got a way to make them
free as in beer. |
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Currently, the huge cost of clinical trials is borne,
on spec, by manufacturers who hope for
correspondingly huge profits selling the device.
Therefore, the designs are proprietary.
Otherwise, competitors could sell the same
device for the cost of manufacture, plus profit,
while the original developer would have to charge
a higher price, to amortize the cost of the trials. |
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//but if it becomes a matter of saving lives they
will// |
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If a hospital has ten million or so to invest, I'd rather
they spend it on better diagnostic and surgical
equipment (or personnel) than on a manufacturing
line. It's far cheaper to buy the few tens or
hundreds of implantable devices the hospital will
need than to set up their own production line. |
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It would be interesting to put the results to some stress tests to see how it would perform. |
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I think it would be more beneficial to apply this to
artificial replacement joints instead. |
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// but if it becomes a matter of saving lives they will. // |
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It's not a matter of saving lives. It never is. At hospitals,
the chief concern is saving money. |
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On the other hand, major hospitals often have a surplus
surgical theater that would be an excellent starting-point
for building a clean-room, and assembly-line production
would not be necessary. A single CAD fabricator unit would
meet the hospital's demand. |
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[Alter] A surgical theater is not a clean room, and
doesn't begin to approach the standards for one.
Surgical theaters depend on point/time of use
sterilization, that won't work for manufacturing. |
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In addition, unless your system is made of a single
material (and probably even then), you are looking
at multiple CNC systems, in addition to multiple
finishing processes for each component. This
ignores any electronics involved, the assembly
process, and testing. (I worked on a testing line
for implantable medical devices, the sale price
was somewhere around $1.5 million and it should
have been higher, we lost money developing it at
that) |
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First time I met Robert Jarvik, he was showing off an assortment of calves with artificial hearts. One in particular had gone 180 days, and was getting to be a sizable animal. Stress-test for the heart to keep up. |
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A surgical theater isn't a clean room, I know--but it's a
good place to start building one. And as for multiple CNC
fabs, cram 'em all in there. My only point was that, if
these artificial joints and organs are to be made to spec
on-site, the demand at even a very large hospital wouldn't
require a huge manufacturing facility. They still wouldn't
go for it, but it's a nice idea and not as complicated as it
seems. |
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