Expert: Use Purchasing Controls to Limit Liability

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 last month 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.

Sister manufacturing facilities owned by the same corporation might need to be considered contractors as well. “Those who manufacture combination products — even though you may have a pharmaceutical coming from your … firm — that pharmaceutical is manufactured under the drug GMP and other quality system regulations for devices. You need to have the same level of adequate controls over those pharmaceuticals as you do over the devices that you manufacture,” Niedelman said.