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Silicone materials are utilized in
many medical devices; pacemaker leads, hydrocephalus shunts,
heart valves, finger joints and intraocular lenses. Silicones
have good physical properties, can be processed into a multitude
of forms, and are largely considered bio-inert. Adding color to
silicone materials that are extruded, molded or calendared for
medical devices is common. Medical device companies aid the
healthcare community by differentiating models and sizes by
color and/or improving the aesthetics of the device with the
addition of a corporate color. The incorporation of pigments is
often a challenge to the device producer both from a processing,
consistency, and regulatory perspective. This paper will clarify
pigment-processing options to produce consistent colored
devices. Regulatory support of materials used in medical devices
is a mandate in the medical device industry and this paper will
outline basic requirements.
Key Terms: Silicone, pigment, medical device |
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Brian Reilly is
the Healthcare Materials Product Director for NuSil Technology
LLC, the eighth largest silicone manufacturer in the world. He
received a B.S. in Biological Sciences from Cal Poly San Luis
Obispo and has been with NuSil for over 15 years.
He began his
career in Research and Development, where he formulated and
developed silicone elastomers and adhesives before moving onto
marketing and sales. Brian is now directing NuSil’s efforts in
the Healthcare industry. |
Brian Reilly
Healthcare Materials Product Director
NuSil Technology LLC |
