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by Stephanie Neil, MA Editorial Staff Posted on Tuesday, December 09, 2008 12:30:07 PM   | Abstract: | Medical device manufacturers, contending with FDA-mandated traceability, as well as the need to manage suppliers and reduce recalls, are turning to quality lifecycle management as the killer app. |
| Keywords: | FDA insistence on traceability, quality lifecycle management |
Andy Jobson has been working in the medical manufacturing industry for 15 years, and every year he sees stricter FDA regulations and higher risk associated with product recalls. As quality director of Moll Industries, a contract manufacturer specializing in drug delivery and surgical instruments and devices, he says defects due to a manufacturing glitch are unacceptable to him as well as to his customers, their patients, and, of course, the FDA.
"If there is ever a defect in a manufacturing device and it causes harm to a patient, there is an FDA sequence of events that will happen, up to and including a recall," Jobson says. "And if it gets to the stage that they find a particular manufacturing process was at fault, ignorance is not an excuse."
Jobson knows firsthand what it feels like to be caught up in an FDA probe. Last year, one of his customers recalled a product for a defect that, in the course of an FDA investigation, was found to have resulted from a weakness within Moll's manufacturing process.
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