Purchasing Controls Can Limit Liability, Expert Says

As devicemakers increase their dependence on third-party suppliers and contractors, focusing on quality instead of costs is not only good for regulatory compliance purposes but also makes good business sense, according to a former FDA associate commissioner and industry consultant.

“In the long run, an effective, efficient quality supplier program is more cost effective than the liability and exposure you may face should a problem arise that affects your finished product,” Steven Niedelman, former FDA deputy associate commissioner for regulatory operations and vice president at Quintiles Consulting, said.

“It’s not just about pricing. It’s not just about low-cost countries, and it’s not just about getting product as quickly or as cheaply as possible. But rather having confidence that you’re getting the component, the material — in some cases finished devices — that meet your quality needs,” Niedelman said at the FDAnews Fifth Annual Medical Device Quality Congress.

The most critical element of any outsourcing operation is the contractual agreement, Niedelman said. Agreements are not just financial contracts. They need to be tight and detail specifications and quality.

Another important aspect of a good purchasing controls program is being notified when suppliers make changes to materials or component specifications. Even the simplest change can result in large-scale recalls. “You need to be aware of any change they make,” Niedelman said.