Materials


Designing for approval


Material selection is no longer a late-stage engineering decision. It often shapes the regulatory path from the start of development. Jim Banks examines how regulatory expectations are influencing materials strategy across the industry with insight from Nelson Labs’ Thor Rollins, the University of Washington’s Professor Buddy Ratner and Ryan Siskey of consultancy Exponent.


on the regulatory path H


istorically, the equation for choosing a material for a new medical device had a few simple inputs: mechanical performance, manufacturability and cost. Now, the environment facing manufacturers means material selection is as much about supporting regulatory approval as delivering optimal performance.


“For many years, regulatory strategy was treated as something that happened after the engineers had largely finished designing the device,” says Thor Rollins, VP, global market segment leader – medical device at microbiology testing laboratory Nelson Labs. “The product would be developed, the materials selected, and then the regulatory and biological safety teams would be asked what evidence was needed to get approval. That model is increasingly difficult to sustain.” Rollins says developers are now viewing the regulatory pathway in terms of decisions about


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www.medicaldevice-developments.com


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