Re: Skull Model

From: Ulrich G. Kliegis (Ulrich.Kliegis@kiel.netsurf.de)
Date: Sun Jan 19 1997 - 12:19:22 EET


> From: Scott Turner <scott@scicontech.com>
> To: "'rp-ml@bart.lpt.fi'" <rp-ml@bart.lpt.fi>
> Subject: Skull Model
> Date: Sat, 18 Jan 1997 11:33:04 -0800

> I would like to commend those involved in helping this ONE child
> with your act of charity and compassion. However, I would also pose
> the question as to why this technology is not available to every
> child facing such challenging surgery. I have been building
> anatomical models for UCLA at a financial loss since 1989, and in
> this country I have seen little or no penetration of this technology
> into medical practice in the U.S.

Scott,
Here, I am absolutely congruent with your opinion. I have made
several thousands of anatomical models in the past years, in varying
environments. As in every related business, we also made a relatively high
number of models for 'free', which means, somebody else had to pay
for it. OK, we did this without questioning in any case where the
patient came out of an environment where reimbursement is a totally
unknown word, like the little girl from Ukraina, for whom I was happy
to process the CT data without charge, using MATERIALISE's fine
software, and if we talk about charity, it has to be mentioned here
too, that KL TECHNIK in Munich built the model without charging for
it. We do this in dozens of cases, and we will continue to do this.
But on the other hand, the machinery, the software, the work has to
be paid for from some source.

Here in Europe, it was a very hard way to get where we are, and none
of the medical RP companies has become a real high flyer so far.
Problems with the material, shrinkage, unresolved questions of
toxicity and other hazardous properties of the used chemicals etc.,
and last not least the high cost, prevented a faster growth here.

>
> I would challenge those in academia who monitor this list to explain
> why their colleges in medicine are not embracing and exploring RP
> technology. There are RP Systems in many engineering schools
> throughout the U.S, but few in medical schools. Why is it that
> little of the grant moneys acquired by medical education
> institutions is earmarked for RP research? The only answer I can
> think of is that they do not see it as having much potential
> benefit. It is obviously not a high priority.

You have to figure in the power of attorneys here. The unfamous White
patent, its varying owners some of whom paid vast amounts of money to own that
document did everything to deterr people from producing models for
the mass market. One California based company scared off everyone who
tried to enter that arena. Ironically, the prior art that makes this
patent factually invalid is very little known and came up only two or
three years ago.

On the other hand, prefinancing a solid study where the surgical
outcome improvement can be shown (americans must be very different
from the rest of the world, the FDA does not accept studies not done
in the US as valid material), have not been done. The reasons are the
same as the ones described above. No manager who has his senses
together and does not want to run the risk to be fired would have
payed a single dollar for the advancement of a technique where he
would run the risk to loose a plurality of kilobucks, so to speak,
even if the company would win the trial.
Next point: I guess the officials in the insurance companies who have
to decide on such extra expenses are even less aware of technological
advancements than their european colleagues. And as long as
there is no big player lobbying for a reimbursement code for models,
I don't see any real progress coming. Maybe pretty pessimistic, but
realistic.
I myself had the experience of having made a model for a little girl
(a US citizen) (a skull case too.)
We made it for free, since it was a study to persuade the doctor of
the benefits of the technique in this case.

Now, hold your breath:

The making of the model was delayed for technical reasons. Since this
case was absolutely uncritical timewise (a connatal growth disorder,
no acute reasons to regard the case as an emergency) there was no
medical problem coming from this delay.
I received the copy of a letter of the father of the girl that he wrote to the
doctor. It came out that the father was an attorney, and words like
sueing for damages etc. turned out to be his way of making pressure.
Would YOU ever do a case again under such circumstances? As a doctor?
As a manufacturer? I think more than twice now.
Such a letter from a german attorney would not moved anything, but
then, we do not let them rule our country alone.
>
> Having seen first hand how much product development has changed
> since 1986 when this technology was first introduced, to today, I
> can only imagine how much medicine would change if this same
> technologies was available to EVERYONE.
>
Completely right. A hospital in Austria who purchased one of the
systems I was responsible for some time ago produced models for more
than 600 of their own cases in three years. That is more than one case per working
day. They plan every surgery (craniofacial) on a model, even the
seemingly simple ones. See my recent publications on models as an
instrument of quality management in surgery. Most surgery is begun
without having a documented (stress that!) plan of how to arrive at
the end. Would you build a house without having a plan? Without an
engineer having calculated the statics?

> I am proud that if needed I or someone I knew would have RP
> technology available to them. I am also ashamed that its not
> available to the many who need it everyday, and have never heard
> about, or don't know how to get it.
Again, right.
One manufacturer of RP machines told me that their prices are purely
market driven. IOW, they could be made much cheaper. A friend of
mine built his own stereolithography machine from scratch, complete
for 60,000 US$. Now figure that.
>
> Lastly, for those of you in Europe please ignore this message. I
> believe RP technology is being incorporated into medical research
> much more than here in the U.S.
>
Nope, we do NOT ignore it. Materialise and my former company invested
heavily not only in the development of the technique but also in the
introduction of this technique into clinical medicine, and all
without the assistance, sometimes even against the interests of large
companies who competed for the budget (mostly successfully :(( ). And
the US is the potentially most interesting market for this. It is
very hard, however, for a small european company to get hold of a
solid position in the US without the backing of a major partner. We
have the technology, we have the clinical experience, and we have the
data.

It can be shown immediately how a model, even if the price is high,
will amortize itself within less than an hour of operation time. But
ignorance and different interests stand against that.

Another unresolved question: Who in the clinical environment is the
right partner? The surgeon? The radiologist? Both claim
understandably that it is their domain - and potential source of
income - or trouble, depending on the situation.

Is modelling just making three dimensional x-rays? If so, ok, then
its the job of the radiologist.
But then the surgeon deserves to earn on the surgery planning too, not to
mention that surgery planning should be mandatory, and not doing so
should be called malpractice. Stuff for a different thread in a
different mail list.

I'll give a talk on this at the upcoming SPIE conference on Medical
Imaging in Newport Beach.
See: http://www.spie.org/info/mi97_home.html

Anybody interested should feel free to contact me.

Best regards, and sorry for getting this a bit longer. I did not have
the time to write a shorter letter (J.W.Goethe).

Ulli Kliegis

nordcom medical systems GmbH
Kiel

business email to nordcom@t-online.de
private (this message is both private and business to the set reply -
to address)
phone: +49 431 331144
fax: +49 431 331146

------------------------------------------
Ulrich G. Kliegis
Phone (x49) 431 33 11 44
Fax (x49) 431 33 11 46
http://kiel.netsurf.de/homes/Ulrich.Kliegis/Welcome.html
Don't flame me, I'm only the keyboard player...



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