> Date: Mon, 20 Jan 1997 01:12:04 -0500
> To: firstname.lastname@example.org
> From: George Sachs <email@example.com>
> Subject: Re: Medical Uses of RP
I agree wholeheartedly with everything you wrote. Maybe my european
background and way of thinking. Some remarks on some points you
> They no
> longer have blank checks and have to cost justify everything they
> do, they have to worry about lawsuits, about FDA regulations, about
> justifying every proceedure, every test, and in their minds it may
> be safer and easier if along with everything else, they don't
> propose the latest "cost saving technology of the month".
Doctors are willing to improve their methods wherever it is possible.
But it is a good habit in medicine that new methods are not primarily
selected by media coverage, much less by marketing approaches of
third parties. What I missed in this thread so far is the thought if
the father of the chid would be willing to jump on the marketing
waggon at this time. Even with the availability of a planning model,
craniofacial surgery remains a potentially life threatening
enterprise. The surgeon who gets this planning model should really
know what he is doing, and I am sure he will be responsible enough to
really consider what he is going to do. I take the liberty to talk
about this after having made many models of skulls that most of the
readers of this forum would probably not recognize as a part of human skeletons. I
participated in a number of the subsequent surgeries and claim to
know what I am talking about. Media coverage is the least thing that
comes to mind when you see the concentrated, maximally careful work
of the surgeons. What comes to mind is the necessity of validated,
multi center studies, outcome measurement, long term observation of
the results compared to other, not model related techniques, and so
on, like modern medical progress has been working successfully for decades.
I participated in one study done with a well known institution in St.
Louis. Interested parties can look up an abstract in the 96
proceedings of the RSNA, titled
"Complex Orthopedic Consultation for Acetabular Defects in Revision
Arthroplasty" Authors: Lopes, Robertson, Kliegis, Sutherland.
A basic medical principle is the question for the indication, iow,
when is what measure necessary to do? Quite clearly, it can be
assumed that there is a wide range of relative and absolute
indications for performing the planning on a model. But then the
question is if today's RP models are the optimal fit for these needs.
Production times of several days and cost (if you take the real cost)
of several thousand dollars are simply unacceptable for a medical
mass product. Bring the cost of an individual model down to, say, 200
dollars, and you are in business. It can be done. The cost can be
justified in any case today where the operation would not be possible
(with the same result) without a model. OR cost range in the 5,000 to
10,000 dollars / hour area. All specialized surgeons who use models
todays have long waiting lists. All good reason to promote models for
Yes, there are other ways to do it too, but they are complementary to
The only solid way to get this introduction started is to really run
controlled studies, invest in these (yes, that means many, many
upfront dollars!) and show the result. Notabene, result. Not success.
The validation, if it can be called a success, must be open in a study.
It can be expected, though.
> or its possibilities. When studies clearly show that the outcome of
> surgery with RP will be greatly improved while not affecting cost,
> or even better that costs go down, then you will see insurance
> companies willing to provide RP as a valid adjunt to current
-- Words about altruistic help snipped off. --
> I can only hope the "fun" of helping someone using this "neat"
> technology is really contagious and will be repeated many times, by
> many companies and that it will not be used for personal promotion
> (which then is not charity). My hat's off to all those participating
> in the experiment however!
Please do not forget that there are companies who invested in
providing a professional product for this market. What quality
assurance measures will be taken to guarantee that the model will be
precise (if an implant has to be fabricated, the geometrical
precision of the model is an essential!)? Is the toy company (I
appreciate their willingness to help, but they move into a segment where the
rules of the game read different) a medical device manufacturer? Do
they have FDA approval to provide this service (even if it is for
free!)? In Germany, the insurance companies demand now that medical
expertise is involved in all critical steps of the data processing
and the quality assurance in modelling. Pure engineering labs don't
have a chance any longer in this market. Interpreting a CT image and
drawing the right conclusions on the anatomy is a bit different from
tranlating a drawing into an IGES file. Just a few years of medical
I hope the case of this patient will evolve into an unlimited success
for the patient, the parents, and their friends. Everything else is
business, and should not be mixed up with the human right of health and
help. Please respect the privacy of the patient.
> George Sachs
> Paradyme Systems
Ulrich G. Kliegis
Phone (x49) 431 33 11 44
Fax (x49) 431 33 11 46
Don't flame me, I'm only the keyboard player...
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