After facing stringent and costly testing requirements, a manufacturer of speech and occupational therapy products decided to look elsewhere for new materials. ARK Therapeutic Services Inc. (Lugoff, SC) makes devices that are used by therapists who are helping patients correct oral motor problems by stimulating the muscles associated with movements of the lips, tongue, and jaw.
When the company sought a CE mark, it was faced with expensive biocompatibility tests. As a result, ARK Therapeutic Services switched to Medalist medical elastomers, manufactured by Teknor Apex Co. (Pawtucket, RI). “Every grade in the Medalist range of compounds has already been pretested for cytotoxicity, one of the three biocompatibility categories required [to obtain a CE mark],” says John Lowsky.
Lowsky adds that the company can use four different Medalist compounds to make the same amount of applications that previously required eight or nine grades of other elastomers. They use the compounds for the soft tips of oral probes, a line of chew tools, the Z-Vibe vibratory tube, lids for the Sip-Tip liquid feeding cup, and a dispenser for eye medicine.
The Medalist line of elastomers for medical manufacturers include 28 standard high-purity elastomer compounds. It also includes a body of test data and resources for designers and processors. The elastomers are available with Shore A hardness from 5 to 87 and come in clear, translucent, and opaque formulations.