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High Purity Elastomers speed Regulatory Compliance of Speech Therapy Devices, increase Input and Enhance Toughness

By Laura Carrabine | April 12, 2010

A supplier of tools to aid in speech therapy switched from conventional thermoplastic elastomers to Medalist® medical elastomers from Teknor Apex Company, citing advantages in compound selection, blending, molding, and resistance to chewing and other rugged treatment.

ARK Therapeutic Services, Inc. is a company that designs, manufactures, and distributes speech and occupational therapy tools and other healthcare products. Many of its devices are for use only by professional therapists or trained caregivers to help correct sensory oral motor problems by stimulating muscles that correlate with specific movements of the lips, tongue, jaw, etc. ARK Therapeutic Services 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 company claims the Medalist compounds are 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. It credits Teknor Apex for its technical support and responsiveness, including speed in providing samples for product development. 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.

The Medalist program for medical manufacturers now includes 28 standard high-purity elastomer compounds, along with a comprehensive body of test data and resources for designers and processors. Compounds are available with Shore A hardness from 5 to 87 and include clear, translucent, and opaque formulations.

ARK Therapeutic Services
www.arktherapeutic.com

Medalist Elastomers
www.medalistmd.com

Teknor Apex
www.teknnotapex.com

::Design World::

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Filed Under: Medical-device manufacture, Materials • advanced

 

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