Medical Design Briefs - December 2021 - 16

The Three Challenges in
Biomedical QC
Testing
O
ver the past decade, the medical
device and biomaterials
industries have undergone
tremendous amounts of in -
novation and change, with a
corresponding increase in regulatory
involvement to ensure the safety and
efficacy of all products. These trends
have resulted in a growing requirement
for the full mechanical evaluation of biomedical
products from the research and
development stage through the quality
control testing of finished goods.
In the biomedical industry, quality
control testing presents a significant
challenge for manufacturers. These companies
must know what to test and how
to test it while also ensuring the quality
of their results and achieving
regulatory compliance. Failure to
successfully achieve these goals
can be extremely costly to the
organization, and significant
laboratory resources are often
committed toward mitigating
these risks. This article discusses
how a robust, optimized mechanical
testing program is key to successful
quality control testing.
Knowing How and What to Test
Although a number of ASTM and ISO
standards do exist for biomedical
products, no single test is usually enough
to fully evaluate all the different components
of a product throughout its entire
life cycle. From development to prototype
evaluation, manufacturing, and
packaging, products require many different
types of testing in order to ensure
proper functioning. It is crucial for manufacturers
to perform thorough research
into which properties they need to evaluate,
and then discuss these needs with
their testing equipment provider.
Testing of a product can be broken
down into testing of the raw materials
used, components of the final product,
and the fully assembled,
finished device. As an
example, let's look at the
different ways in which
vascular stents can be
evaluated.
Stents are mesh tubes commonly used
to increase the internal diameter of
arteries and veins. The preferred material
for stents is nitinol wire because nitinol
exhibits shape memory, a unique
biomechanical characteristic which
allows it to self-expand. Before the stent
itself is manufactured, the elongation
and tensile strength of the wire must be
Tortuosity testing quantifies the guide wire frictional
forces to simulate the action of being
pushed through a
patient's body.
16
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Medical Design Briefs - December 2021

Table of Contents for the Digital Edition of Medical Design Briefs - December 2021

Medical Design Briefs - December 2021 - Intro
Medical Design Briefs - December 2021 - Cov4
Medical Design Briefs - December 2021 - Cov1a
Medical Design Briefs - December 2021 - Cov1b
Medical Design Briefs - December 2021 - Cov1
Medical Design Briefs - December 2021 - Cov2
Medical Design Briefs - December 2021 - 1
Medical Design Briefs - December 2021 - 2
Medical Design Briefs - December 2021 - 3
Medical Design Briefs - December 2021 - 4
Medical Design Briefs - December 2021 - 5
Medical Design Briefs - December 2021 - 6
Medical Design Briefs - December 2021 - 7
Medical Design Briefs - December 2021 - 8
Medical Design Briefs - December 2021 - 9
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Medical Design Briefs - December 2021 - 11
Medical Design Briefs - December 2021 - 12
Medical Design Briefs - December 2021 - 13
Medical Design Briefs - December 2021 - 14
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Medical Design Briefs - December 2021 - Cov3
Medical Design Briefs - December 2021 - Cov4
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