Material Machination

When it comes to materials for orthopedic devices, OEMs specific combinations of performance characteristics, such as en- have a lot to keep up with. Metal, once the biomaterial of choice, increasingly is being replaced with durable, high-performance plastics—not only because of metal-on-metal wear issues, but due to strength-to-weight ratios and corrosion resistance. In particular, polyetheretherketone (PEEK) is receiving more interest as a viable replacement for metal in joint implants.

Plastics manufacturers constantly innovate to meet evolving market demands. Design engineers are looking for plastics with specific combinations of performance characteristics, such as enhanced strength, flexibility and bioabsorbability. They also want to use materials that already are understood and approved by the U.S. Food and Drug Administration (FDA) to streamline approvals and keep costs down. “Almost monthly it seems like a client is reacting to a market desire—sometimes existing, sometimes anticipated,” said Bing J. Carbone, president of Shelton, Conn.-based Modern Plastics Inc., a plastics distributor to the medical industry.“We stay on top of

these developments so we can provide customers with up-to-the- minute advancements on new material options and services that we can offer.”

A tremendous amount of research is being conducted on cre- ating new biocompatible compounds or improving existing ma- terials by developing new blends. Although these new materials may have fantastic properties, many companies often are cautious about embracing them because it may mean gathering more data or conducting extensive trials. Instead, they combine materials that already have a proven history of effectiveness and FDA com- pliance to create blended materials that best meet the product’s performance specifications.

The FDA also has raised the regulatory bar in recent years, es- pecially regarding component biocompatibility and supply chain management. OEMs increasingly expect their material providers to know the latest regulations and maintain top-level quality management systems that ideally include ISO 9001 and ISO 13485 certification. Material providers must constantly improve their processes, quality assurance methods and standard operat- ing procedures to stay ahead of the curve and remain competitive. Because material lead times often are extended, expert and some- times creative inventory management is required to meet short production deadlines.

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