Articles
Telephone Interview With Anton H. (Tom) Clemens
5854 Schumann Dr., Madison, WI 53711
(608) 273-9772
October 19, 1999
clemanto@hotmail.com
How long have you been in the United States?
Since ’65.
Did you go to work for Ames right away? Yes.
It was part of Miles Labs. I had gotten to know the former Miles management,
which at that time was made of primarily by the former owners, the
families who started Miles Labs. Miles Labs became a public company,
I think in the late ’50s. But when I joined them quite a few of its
officers were family members. I met them in Switzerland, and they
made me an offer that I couldn’t refuse to start the instrument program
for Miles. And that was within the Ames Division, which was called
the professional products division.
Anton
H. Clemens (right) was the inventor of the first blood glucose meter
while he was the director of the Ames Instrument R&D Department
of the Ames Division of Miles Laboratories Inc. in Elkhart, Indiana.
Here he is shown talking to George W. Orr, Jr., Group Vice President,
Professional Products Group (left) and Walter Ames Compton, M.D.,
President and Chief Executive Officer of Miles Laboratories Inc. (center).
This photograph appeared in the 1969 Annual Report of Miles Laboratories
Inc., page 21.
What sort of instruments? They were heavily into histology…
The [Ames] Reflectance Meter was actually kind of a hobby of mine,
which marketing really didn’t want to have any part of. We had the
Reflectance Meter done, prototypes done, ready for evaluation and
I was still ordered at the time by management to quit working on it.
[Anton Clemens reviewed the transcript and wrote me on October
20, "We had several prototypes of the Reflectance Meter completed
for field trials during the middle of 1968, long before project approval,
and the delay to production was out of Instrument R&D’s control.
My comment about having been ordered to dump an entire project even
after we had already completed several prototypes for field evaluation
was the arlier mentioned TEC {Tissue Embedding Center}, which only
became retroactively approved after a large National Distributor had
found out about it and placed a sizable order with the then newly
formed Miles Lab Tek Division.]
When was that? I think we had the first prototypes
done around ’68. There was the new products development committee,
which was made up of several different marketing, from finance, manufacturing,
and R&D. I had proposed this as a product because I very strongly
believed that from an engineering viewpoint it doesn’t make any sense
whatsoever to take a blood sample to a lab and then have an answer
at best in 3-4 hours after and then make any judgment on the diabetes
management on the basis of that. I said that if so if it has any merit
it should be done on the spot and at the site of the individual and
therefore should also be battery operated. One of the higher ups in
project management, in fact the highest up, said, "No. If at
all it should not be battery operated, it should be line operated."
So after we had the first Reflectance Meter on the market…I think
it came to the market in ’71. Then they took the device to Japan and
had a Japanese company make a line operated one, the so-called Eyetone,
which was a big flop, and everything went back to battery operated.
The most effective person in marketing to recognize
this right away was Charlie Suther. Charlie Suther was the only one
initially to side with it.
The chairperson for this new product management committee
was a lady, Helen Free. She also was dead set against it. So I placed
a bet when we had technical approval. And I said, "Helen, within
one year after introduction of this device to the market Dextrostix
sales will at least double."
Now, at that time, Dextrostix sales worldwide were just
a little more than half a million dollars. Sales not profit. $600,000.
She agreed with the wager, which was a bottle of champagne. I won
the bet but I never got the bottle.
She and her husband invented the Dextrostix? Actually,
that’s not true. The one who invested Dextrostix was a man by the
name of Ernie Adams [Ernest C. Adams]. Ernie Adams worked for
Helen Free.
The Ames Division was started to become a diagnostics
product line and was given the name Ames, because Ames was the middle
name of the then president of Miles, Walter Ames Compton. He was a
member of one of the founding families of Miles Labs. Walter Compton
was an M.D., and during his internship became fully aware of the Benedict’s
solution to test for urine sugar, in which the urine had to be cooked.
It must have been a very messy procedure. And since he was fully aware
of the effervescent technology of Miles Labs -- Alka-Seltzer -- and
in this effervescent process heat also develops, so he had the idea,
but also had the wherewithal within the organization to develop a
urine test based on tablets. The Glucotest. So Ames had become conditioned
to having urine tests that were based upon the tablet format. And
it was Ernie Adams who came up with the idea of putting them on sticks,
because it was so much easier to handle. And then when had a few more
tests developed in the stick format, Ames then asked him, "Ernie,
can’t you put it in the tablet format?" But Ernie Adams never
got credit for what he did within the Ames organization or in the
field in general. Ernie was a very bright individual but was a very
shy man and very poor communicator.
Is he still living? I don’t know. Ernie would
have to be in the late 70s. Now, the Frees were the cheerleaders out
at the medical conventions. So they got a lot of credit for stuff
that was developed within Ames because those who did the development
hardly ever took part in those conventions. So those who talked about
it got the credit for it.
Later on within Ames we developed for that time at least
a very sophisticated small bench top unit, the urinalysis system.
It had a footprint of 4 square feet and was about a foot and one-half
high. It processed about a dozen tests and two samples per minute
with automatic calibration, the whole bit. It was way ahead of its
time.
There was ongoing friction primarily between the Ames
Instrument R&D Department, which I was heading, and Ames Marketing,
because they would typically want to have a new product after Boehringer
had theirs on the market. So reacting but not proacting. Ames did
not really capitalize on their pioneer position and allowed Boehringer
Mannheim to make big inroads. But then Walter Compton decided that
in order to get the best out of both worlds more or less, he decided
to have a new business unit, which was structured as a profit and
loss center. However, the prime purpose of it was to develop products
for life science research with the intent of in so doing that one
should then be able to come up with advanced designs and idea that
would filter into clinical medicine. Then I was in charge of that
unit. In order to facilitate the interaction between the development
of instruments and reagents to achieve good ‘systems’ performance
I was, at that time (Ames) Director of Instrument R&D and Associate
Director of (Ames) Reagent R&D.
And then out of this, out of Life Science Instruments,
that was the name of it, we then put together the first prototype
of what eventually became a commercial artificial pancreas, the so-called
Biostator® GCIIS (Glucose Controlled Insulin Infusion System). When
we had the first production prototype ready, FDA came down with device
legislation, and although we had a legitimate order from Washington
University in St. Louis to place one, our corporate lawyers didn’t
feel that this was right. They wanted to live up to the spirit of
the law and in the process it cost us 4-5 years. In order to make
this program survived we then established an assembly unit in Germany
and we assembled about 200 units in Germany for distribution throughout
the entire world. That changed more than anything the understanding
of glucose control with the visible results that from thereon type
1 diabetics were treating themselves with multiple injections per
day instead of one long acting insulin injection. I had 5 or 6 patents
on the Biostator system.
How many patents do you have altogether? In
the U.S., about 30. I had about a dozen in Europe, before I came here.
Are you a scientist or an engineer? I am an
engineer. I have been in the medical field since ’51. I came to Ames
in ’65. I left Ames and set up this different business unit within
Miles Labs. My official retirement from Miles Labs was in ’87.
Do you consider yourself retired now? I am a
buyout retiree, but I will retire when I am 6 foot under.
Are you self-employed? Yes.
Was the meter called the A.R.M. or the Ames Reflectance
Meter? Both. In trying to get a trademark established at the time,
and it may have been because there wasn’t such a big push behind it,
there wasn’t a big expectation, they did not go for a catchy name
that would be a trademark in its own right, since Ames was trademarked
they used the Ames name as a vehicle to trademark the A.R.M.
When did you first start working on it? It was
at my very first desk [at Ames]. That must have been during ’66.
In ’68 the first prototype. But it didn’t come to
market until about ’71? Charlie thought it was ’70. That’s possible.
I have the patent here. "Patent issued in ’71." I could
go back, I may have some numbers in the files. But usually to have
a patent issued a year after the introduction is not unusual. So it
is likely that it was introduced in 1970.
This
was an early prototype of the Ames Reflectance Meter, made when they
were considering the use of aluminum extrusion for the case to minimize
the tooling cost. This case configuration was also used for the patent
application filed on April 22, 1968.
Photo courtesy of Anton H. (Tom) Clemens, the inventor of the Ames
Reflectance Meter.
You say it was your hobby… The environment within
Miles Labs at the time was a little strange. It was not very conducive
to investment-type products, because Miles Laboratories was known
for its Alka-Seltzer, its One-a-Day vitamins, and they had some further
businesses, but all of these were consumables, which you develop once.
And then the "development cost" thereafter is really a marketing
expense, advertising and so forth…. But the design philosophy for
instruments is radically different. Number 1 you have to be prepared
for obsolescence, like it or not. If you don’t obsolete your product
yourself, the competition sure will. So therefore the moment you have
a product introduced to the market you have to have already the next
generation in the works, and if you don’t you’ll fall behind. And
the other part of it is that in the manufacturing process you need
skilled people… And you can only reduce labor content if you go very
heavily into robotics to assembly products, but the product volume
within the medical diagnostics field at that time, in the ’70s, did
not justify robotics, so you still were relying on manual assembly,
and that was something totally foreign to the mentality of the Miles
corporate culture. So it was not an easy task…
If I had waited for approval of every product, we would
still be waiting for the first product today.
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