Understanding The
Complexities Of Medical Grade Polymers

Jennifer Green
Technical Marketing Manager,
Medical Polymers
Lubrizol Life Science Health, Medical Device, USA |
The appropriate selection of component
materials is often very important in the development and
sustainability of a medical device. For many devices, that
selection often begins with a designer’s consideration of
a range of known medical polymers.
So, What is a Medical Grade Polymer?
While the question seems simple enough,
it may surprise you that a globally accepted, agreed-upon
definition and standard does not exist.
Globally, the vast majority of polymers
produced are used in industrial and consumer segments,
with only a small percentage the polymer volume being used
in medical devices. In order to
differentiate |
grades supplied into the medical device
market, raw material suppliers distinguish these material as
“medical grade.” Currently there is no regulatory definition
of a medical grade polymer and no prescriptive regulatory
requirements for raw materials used in medical devices, so
material suppliers and others in the medical device industry
have assigned their own meaning to “medical grade polymer.”
Consequently, polymers designated as medical grade from
different suppliers are not necessarily equivalent in
performance, quality and associated support. This situation
can create confusion and uncertainty for the device designer
when selecting materials.
When it comes to specifying medical device
materials, considerations need to be given not just to product
specification and required performance attributes but the
robustness of quality systems, manufacturing consistency,
management of changes and understanding the possible
implications on a finished device so the process is well
managed by the supplier and
effective communication systems are in place.
In this article, the Lubrizol Life Science
Health (LLS Health) team examines the complexities surrounding
medical grade polymers and what you should know when selecting
your medical device materials.
Considerations When Selecting Medical
Polymers
Medical device development is often a
long-term endeavor, requiring rigorous testing, quality
control systems, and compliance to an ever-evolving set of
regional and global regulatory requirements. As the need for
new and innovative medical devices grows, the need for
materials (especially polymers) to support device development
becomes stronger.
The choice of polymer for a specific device
application is often based on many considerations. For
example, an interventional guidewire may need a polymer
coating to provide a cushioning tip, biocompatible hydrophilic
surface, radiopaque character and abrasion resistance while
maintaining manufacturing efficiencies in the guidewire
production process. Selection of a material for a pacing or
neuromodulation lead may hinge more on a material’s
blood/tissue biocompatibility and resistance to degradation
inbody (oxidative and hydrolytic resistance) over many years,
its dielectric properties, its physical strength and
flexibility and the ability to produce the material in
thin-walled constructions and assemble over electrical wires
and other components.

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