Foster Reports Polymer Companies’ Increased Interest in Implantables

Putnam, Conn.-based Foster Corp., a custom medical polymer provider, has reported increased interest in implantable medical device applications by polymer suppliers.

The company based its findings on a combination of customer surveys, experience, and information it has amassed over the years, company spokesperson Kris Jommersbach told Medical Device Now. Foster’s CEO Larry Acqualulo then became interested in compiling all the information, and conducted some additional research as well.

According to the report, there was an exodus of implant material suppliers following several high profile litigations in the 1990s, including for breast and temporomandibular joint implants. Many material suppliers restricted supply for implant applications due to perceived risk and limited return. With the 1998 passage of the Biomaterials Access Assurance Act, created to protect implant material suppliers from civil liability, many suppliers have re-entered this growing market. Polyetheretherketone (PEEK), ethylene vinyl acetate (EVA), polyethylene (PE), and bioresorbable polymers are now considered the materials of choice for implantable devices.

An increasingly common strategy by polymer companies for managing supply risk, Foster reports, is to develop specific grades with enhanced manufacturing and testing standards for implant applications. Foster itself has been collaborating more with material suppliers to ensure applications are served with the appropriate grades. Foster estimates that 9 out of every 10 custom formulations require reporting of end use application to a material supplier for at least one of the constituents.

“The use of polymers in temporary and permanent implant devices is rapidly growing,” said Acquarulo. “Material suppliers who strategically positioned themselves for this market ten years ago have benefited and paved the way for new suppliers and materials today. FDA [U.S. Food and Drug Administration] 510(k) clearances of PEEK-related devices are an excellent example. Companies introducing a new medical device for human use in the U.S. market must first receive clearance from the FDA, and the most common process is referred to as a 510(k). In 2001 there was only one FDA 510(k) clearance with PEEK polymer featured in the registered name of an implantable device. In 2011 there were 17 such clearances, and this year there were 6 in the first quarter alone.”

“Another example is the explosion of medical implant applications using bioresorbable polymers,” he continued. “According to the United States Patent and Trademark Office database, the number of patents issued referencing bioresorbable and medical grew from 48 in 2005 to 311 in 2011, a rise of 548 percent. In 2012 there have been 229 related patents issued year to date.”

Photo of fine polymer tubing courtesy of Foster Corporation.