and sometimes even casual observations of
biofunctions were applied in favour or in
opposition of the application of a polymer
as a biomaterial. During that first period,
which I call “the period of understanding” between 1970 and 1990, scientists
and engineers tried to elucidate the basic
mechanisms of biomaterial and tissue
interactions and identify those polymers
or metals that offer the least pronounced
interaction with liquids, tissue or organs
in animal or human organisms.
This era was followed by the “period of
parameters,” which lasted approximately
another 20 years from 1990 to 2010. That
is when medical device scientists tried to
find out how to characterise the interaction between biomaterials and body parts.
During this period, ISO 10993 Biological Evaluation of Medical Devices and
innumerable publications appeared that
targeted biocompatibility parameters and
their manipulation and optimisation. In
addition, at that time the biocompatibility
FIGURE 2: A perspective on the development of medical devices.
Relative achievements
1985
Future device properties
Today’s compounds/
product properties
System solutions
1. Individualised
therapies
2. Noninvasive
sensor technology
3. Regenerative
medicine
1990
2000 2010
Year
2020 2030
properties of biomaterials were already
used to discriminate among polymers for
marketing purposes. This often happened
without an in-depth understanding of
the underlying mechanisms and possible
related clinical consequences. Simultane-
ously, sterilisation issues arose and poly-
mer and device stability following gas
sterilisation with ethylene oxide or a high-
energy intake by steam or irradiation had
to be assessed. Furthermore, the long-term
performance of medical devices that are
implanted or attached to the body needed
attention, because cost
constraints led to the
idea of reusing medi-
cal devices. All of those
investigations produced
a better understand
ing of the results of
repeated exposure
of a biomaterial,
whether under the
extreme situation of
contact with protein-containing body
fluids (whole blood or serum) or to oxi-
dising cleansing agents. As an example,
Fresenius Medical Care, a manufacturer
of dialyzers for blood purification and
haemodialysis, decided to stop the reuse
of filters in its dialysis clinics based on
observations of adverse clinical events in
patients after reuse.
Individualised therapies
“How the Sum of Its Parts Gets Greater
Than the Whole” is the title of a paper
Year Milestones
1990: Omron established nearly 30 years with a mission
to provide world’s best quality products to support healthy,
comfortable living. A wide range of health/medical care
products for homes and professionals includes accurate,
user-friendly blood pressure monitors.
2006: 50 million Omron Blood Pressure Monitors
(BPM) sold.
2009: 100 million BPM sold and Omron launched two new non-invasive blood pressure monitoring modules (NIBP), easily integrated into medical OEM systems. The
M3600 hospital grade module features full redundancy and comprehensive automatic
measurements. The lower cost M1200 module is for high accuracy home and telemedi-cine environments. Both modules maximise patient comfort and ease of measurement.
VISIT THE EMDT TIMELINE AT:
www.emdt.co.uk/emdt-timeline
