Originally Published EMDM March/April 2005
Industry News
Precertified PEEK Can Speed Development Cycle
Analee Zelaya and Caitlin Cook
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| Invibio’s PEEK-Classix polymer can be processed through moulding, extrusion, machining, and other techniques, allowing design flexibility. |
After product conception, every device designer needs a material that can help translate the idea into a market-ready reality. That translation may be hastened for some products by a precertified polymer developed by Invibio Biomaterial Solutions (Thornton Cleveleys, Lancs, UK).
Called PEEK-Classix, the polyetheretherketone plastic has recently been made available through Upchurch Scientific Inc. (Oak Harbor, WA, USA), and Ensinger GmbH (Nufringen, Germany). Exhibiting qualities of strength, stiffness, and toughness, PEEK-Classix is used in implant applications requiring blood or tissue contact of less than 30 days. The polymer is suitable for use in tubing, catheters, laparoscopes, and endoscopes. Other applications include analytical equipment, surgical instruments, and blood management apparatus.
Getting materials certified can take many months, notes Mike Callahan, president of Invibio. Precertifying the materials reduces both development time and costs associated with biocompatibility testing and regulatory approvals, thus streamlining the production process. Mike Bailey, vice president of research, development, and sales for Upchurch Scientific, explains how. “Our in-house tubing extrusion, moulding, and machining of [PEEK-Classix polymer] take the expense and hassle of [obtaining] USP Class VI and ISO 10993 material certification out of our customer’s development cycle.”
Ensinger will market the material under the name TecaPEEK Classix. Business development manager Jürg Wiedler describes the material as the “perfect [addition] to our portfolio of high-performance plastics designed for medical applications.”
Invibio also offers PEEK-Optima, a biomaterial for implantable medical device applications having blood or tissue contact for more than 30 days. Familiarity with regulatory requirements and the process of bringing products through the development cycle gives Invibio confidence in producing innovative materials, says Callahan. “Many of the people that work for us came from the largest medical device companies in the world. Our greatest strength is our expertise in the industry.”
For more information, contact Invibio Ltd., Thornton Cleveleys, Lancs FY5 4QD, UK; phone: +44 1253 866812; fax: +44 1253 851458; e-mail: lnorman@invibio.com; Internet: www.invibio.com.
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