Medical Design Briefs - June 2024 - 19

Design Briefs
Elastomer Material Flexibility Optimizes
Performance
Flexibility enables optimizing performance and meeting new challenges.
By Michael Hebert, Trelleborg
he global medical device market
offers opportunities for innovation-driven
growth. Demand for
smart, new lifesaving and life-enhancing
technologies is perhaps stronger than
ever. Manufacturers around the world
looking to capitalize on this eager global
market face a long list of challenges
- some big, some small. Supply-chain
disruptions, labor shortages, rising materials
costs, and other headwinds are leading
to delays in both engineering and
manufacturing processes. Despite these
challenges, the world demands medical
device manufacturers' best. A surging
geriatric population, implications of a
global pandemic, and the mortality rates
for heart disease, cancer, obesity, and
other conditions are all contributing to
strong and sustained market demand.
One study predicts a compound annual
growth (CAGR) of 5.4 percent will push
global sales of medical devices to nearly
$658 billion (USD) by 2028. Of course,
the road to success will be littered with
familiar roadblocks - and some that are
entirely new.
Worldwide supply-chain unpredictability
presents perhaps the greatest
of these challenges. The availability of
raw materials, componentry, and subassemblies
introduces greater volatility
for both engineering and manufacturing
teams, seriously threatening go-tomarket
plans. Manufacturers that can
respond quickly and nimbly to these
challenges will be better able to meet
their customers' needs and gain an advantage
over competitors.
When specifying a high-performance
material for a medical device application,
temperature, chemical environment
and compatibility, hardness, compression
set resistance, and certification
considerations quickly build stringent
material requirements. Expert suppliers
consult with OEMs to think creatively,
support product development, and collaborate
to find solutions that will deliver
necessary results.
T
Medical Design Briefs, June 2024
Elastomer material flexibility optimizes performance and meets new challenges. (Credit: Trelleborg)
Material Scientists Optimize
Performance and Provide
More Options
Engineers designing new generations
of devices rely heavily on addition
cure silicone elastomer (LSR
or HCR). It's often a default choice
in the medical design and manufacturing
process for good reason: it's
one of the simplest formulations to
provide great stability, temperature
tolerance and a low compression set.
Silicone elastomer is one of many elastomers
our customers specify for projects
requiring unique properties. For
example, LSR is a common material
choice because of its excellent overall
biocompatibility (toxicological and
biological).
Even if an engineer knows there
are alternatives worth exploring, the
pace and pressure of the innovation
process typically dismiss any curiosity
that could lead to the exploration of
alternate materials. However, increasingly
demanding applications have
prompted further exploration of all
non-silicone elastomeric alternatives,
including large families of customized
organic elastomers.
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The Pros and Cons of Using
Silicone Elastomer
Perhaps the most compelling attribute
of silicone elastomer for engineers is familiarity.
It's a known quantity with a history
of compliance with most regulatory
requirements and delivering predictable
performance on the manufacturing line
and in the field. It's a pure and uniform
material that's inherently inert and biocompatible
- which is especially important
for medical applications.
This reality is magnified as medical device
engineers face greater pressure to minimize
costs and get products to market faster.
As product development schedules are
compressed, engineers are more likely to
rely on familiar materials like silicone elastomer.
But, as with most long-time default
options, it's not always a perfect fit for new
applications. There are many recent cases
where new product designs unexpectedly
fail during the prototyping stage. Engineering
teams typically look to make product
design tweaks first, but in many cases, a justless-than-perfect
material can cause these
hard-to-detect problems. Reexamining both
material and design can save teams from
spending time and money trying to solve a
core design flaw that may not exist.
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Medical Design Briefs - June 2024

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