Better materials understanding leads to better medical device development

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Battelle Memorial Institute Ellis

Better understanding of materials during product development could help medical device makers avoid recalls, according to a researcher at Battelle Memorial Institute, an applied science and technology development nonprofit.

Plastics resins were the most prominent material in a review of U.S. Food and Drug Administration recall data for medical devices, said Jeffrey Ellis, principal research scientist in Battelle's consumer, industrial and medical department.

About 30 to 40 percent of the recalls were material-related with plastics first and metals second.

"It is typical to get a material failure in a medical device," he said in a telephone interview.

Chemical makeup, processes, molecular structure and exposure conditions can contribute to how a material performs.

Material failures "are technical," expensive "on different fronts" and challenging to avoid, Ellis said.

A failure impacts patient safety, and can tarnish a brand and product reputation.

Doing a "root-cause failure analysis to get product back and find full-proof solution" is worth the effort, he said. "If you do it properly the first time, you would save money" and avoid production shutdowns, supply chain disruptions and lost sales.

A failure during a clinical trial "could have significant technical setbacks before a launch," he said.

Material data sheets are useful and necessary but not the final word, particularly if a different additive or colorant is added or if an end use may involve exposure to high or low temperatures.

For plastics processing, "we partner with several molders in the U.S.," he said. "A client can say who they want us to use."

Among its clients, Battelle has "one long-term relationship with a pharmaceutical company for final validation and verification and sometimes upfront analysis," Ellis said.

Ellis received a bachelor's and doctoral degrees from Ohio State University, both in chemical and biomolecular engineering. He joined Battelle in Columbus, Ohio, in June 2009.

Ellis made a Feb. 8 presentation entitled "Reducing Risk Through Materials Science: Shedding Light on Mysterious Design Failures" at the UBM Advanced Manufacturing conference in Anaheim, Calif.