High-Purity Elastomers Speed Regulatory Compliance of Speech Therapy Devices, Increase Output, and Enhance Toughness
April 19, 2010
MATERIALS: ARK Therapeutic Service Inc. now uses Medalist elastomers for the soft tips of oral probes, a complete line of chew tools, and the Z-Vibe® vibratory tool. Non-speech applications of Medalist elastomers include lids for the Sip-Tip® liquid feeding cup and the E-Z Eye Med® dispenser for eye medicine.
The company’s switch to Medalist compounds was prompted by its plan to obtain the CE mark, which requires subjecting each raw material to costly and stringent biocompatibility tests to meet European Union standards
The Medalist compounds are also easier to process. Cycle times are shorter, and there is no need for processing aids, additive lubricants, or silicone releases.
One unlooked-for advantage of the Medalist compounds was their superiority in the special type of toughness required for oral tools to endure during repetitive biting and chewing exercises required to improve feeding skills.
Recently ARK Therapeutic Services began redesigning its Z-Vibe tool to make it a one-piece product of all-elastomer construction. Until now this has been a two-part product, with an elastomeric tip and a polypropylene handle. Inside the handle is a tiny battery-powered motor that provides the vibration.
ARK Therapeutic Services began switching to Medalist compounds six months ago. The company uses three different grades from the Medalist Versatile Series, with Shore A durometer ranging from 43 to 87. As with all materials that ARK Therapeutic Services uses for oral tools, Medalist compounds are compliant with regulations of the U.S. Food & Drug Administration and are latex- and phthalate-free.
-Edited by Kelsey Anderson
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