Industry Plays Vital Role
in Laboratory Medicine
by James J. Griffitts, M.D.
Industry exists because there is
a market for its products. One
such market, the medical laboratory, has greatly expanded with
the mounting demand for its services by a population able to pay
for them through personal income, private or governmental i n surance, or other means.
The need for professional laboratory personnel and their supporting staff also rises with the
institution of new procedures.
Dr. Grilfitts, pathologist, is president of Dade Division,
American
Hospital Supply Corporation,
Miami, Florida.
Scores of talented professionals
in medical laboratories are capable of making complex instruments, fine reagents, calibrated
glassware, and many other products offered by manufacturers, but
lack the necessary time and facili-
ties. Thus occupied, moreover,
they w o u l d be wasting precious
talents.
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The plant and offices of Dade Supply Division, Hospital Supply Corporation, Miami, Florida.
The manufacturing industry offers products which, because they
are easily available and convenient to use, are readily sold. Industry is concerned that its products
are competitively priced and that
their performance meets at least
a minimum standard in order to
gain the approval of the medical
laboratory.
Hence,
competition
among
manufacturers and suggestions
from laboratory professionals help
to insure both high quality and
prices that will satisfy the demands of the market.
Other pressures are brought to
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Industry is beholden to many
professional laboratory
people
who have devised ways for improving health care. Most of the
products sold by our own company (Dade Division, American
Hospital Supply Corporation) have
stemmed from the knowledge
and discoveries of people on the
laboratory "firing line."
To cite a few outstanding examples of the impact of scientific
discoveries on today's products:
Rabbit brain thromboplastins originating from the work of Armand
Quick; the transaminase enzyme
substrates of Karmen and LaDue;
the starch substrates of Michael
Somogyi for measuring amylase
activity; and the more recent thyroxin test technics stemming from
the work of Murphy and Pattee.
Although we ascertain the size
of our market and often refine
processes and components sub46
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A typical vial-filling operation in manufacturing of liquid products that do not require sterile
filling technics. Automated products such as these assure constant fill accuracy and uniform
vial-to-vial characteristics in a given lot number of finished product.
mitted to us by clinical laboratory
scientists in order to lessen their
cost, increase their stability, or
improve their quality; we recognize that such procedures usually
originated in medical laboratories.
For the manufacturing and
quality control of many products
for the clinical laboratory, industry retains professional laboratorians whose viewpoint is very close
to that of its customers. Thereby,
some developments also originate outside the medical laboratory, but less frequently than
within the medical field itself.
MARCH 1970
Industry's employment of professional laboratory personnel and
their involvement in professional
societies contribute greatly to
good relations between the laboratory and industry.
Perhaps the most important
contribution that industry has
made to pathology and medical
laboratories is the abundant production of instruments, reagents,
and manifold additional materials.
In recent years, for example,
the accessibility of reliable substrates and indicators for enzyme
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bear on industry in the form of
government regulation, voluntary
standards of societies, and even
specifications submitted by individual users.
For example: 1) the minimum
requirements of the Division of
Biologies Standards of the National Institutes of Health sets
standards of potency for blood
grouping and typing serums,
which must be met before distribution can be made across state
lines; 2) the cyanmethemoglobin
standard is widely accepted as a
requirement resulting from actions of professional societies, and
3) comparative inter-laboratory
surveys in clinical chemistry often
require "tailor-making" materials
for special applications.
The freedom of going into business is widely cherished by Americans, and its success or failure is
not dependent merely on meeting
imposed minimum standards, but
on supplying the best products
and services that it possibly can,
the quality of which will be
judged in the end by those w h o
use them.
reactions has enabled their accurate and timely use, even in
the smallest hospitals. In the same
way, industry has helped develop
techniques for hematology, m i crobiology, serology, and other
subdivisions of laboratory medicine.
To expand the use and thereby
the sale of a product, industry
often provides technical information with each purchase. W i t h o u t
such initiative on the part of industry, and its wide distribution
of products, information regarding countless tests w o u l d be obtainable only by the mailing of
patients' samples, or moving the
patients themselves, to distant
laboratories.
It is characteristic of America
that it enables the wide dispersal
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Even though extensive quality control systems are used during
entire manufacturing processes, the final "proof of activity" is
confirmed by multiple testing under laboratory conditions. This
is an atomic absorption instrument used to assay sodium,
potassium, magnesium, lithium, copper, iron and other elements.
A typical multi-channel automated analysis system used routinely
in assaying clinical chemistry products. Such automated systems
as well as manual technics are used in final testing and quality
assurance of individual lot numbers of finished good products.
of benefits and abilities to the remotest corners, in contrast to the
tendency in some countries to
hoard knowledge and talent within
powerful centralized institutions.
Motivated by its constant concern for its own welfare, and by
its recognition of the mounting
demand for laboratory services
and the shortage of people to perform such services, industry has
created yet another servant for
laboratory medicine—automation
— through time-saving, cost-reducing machines, so that all suitable work requested can be
speedily, even miraculously, done.
Engineering know-how
from
great industrial complexes w i l l
pay increasing heed to the needs
of the medical laboratory. The
adaptability of machines to repeti-
tive procedures on demand may
be the only means of performing
the volume of work required in
the future; and again, its quality
and the cost of its performance
will be the responsibility of the
laboratory professional.
There is another function of industry which strengthens its bonds
to laboratory medicine. Most of
industry employs advertising to
aid the sale of its products. In
directing its advertising to focal
points of its market, industry is
also promoting, to a great extent,
the dissemination of scientific information by such means as the
publication you are now reading.
Here, too, standards for performance must be upheld, and we in
industry will be guided by the
professionals.
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