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by Beth Stackpole, Contributing Editor Posted on Monday, January 07, 2008 11:04:28 AM   | Abstract: | Driven by FDA regulations, medical device manufacturers are rethinking key business processes and implementing integrated systems to bolster their quality management practices. |
For years, as a quality manager in the medical device arena, Leticia Booth lived in fear of a Food and Drug Administration audit. Then, in October 2007, Booth came face to face with her biggest nightmare. Optos, the Marlborough, MA-based retinal imaging device manufacturer where she works, received five calendar days' notice of the FDA's planned on-site inspection of the company's production facilities and business processes to ensure regulatory compliance. Though the visit wasn't unexpected — Booth knew it would happen two years in advance — even the company's diligent, nearly yearlong preparation, which included implementing a quality management system from IBS America Inc., didn't allay her trepidation. When the day finally arrived for the FDA audit, the scheduled two- to five-day inspection was a wrap in just under four hours. The result: Optos passed all of the compliance benchmarks with flying colors. "Our records were impeccable. Our documents were impeccable. Everything was absolutely spotless," Booth says. "It was easy to do with [IBS] CompliantPro because everything was automatic and we weren't chasing down paper and paper-based signatures." Like Optos, many manufacturers in the medical device arena are ready to give up the paper chase when it comes to quality management practices. Spurred on by ever more stringent FDA directives that regulate everything from how companies develop and manufacture products to how they respond to customer-driven corrective and preventive actions (CAPA), medical device makers are taking a fresh look at their outdated paper-based quality procedures and limited Word document and spreadsheet-based systems. They are implementing software platforms to modify and streamline quality-related business processes in an effort to improve the efficiency and reliability of their compliance efforts. Recent headlines have helped to elevate quality issues to C-level concerns. On the heels of Boston Scientific's struggle with the FDA in 2006 over its corporate compliance and quality management systems, leading medical device maker Medtronics Inc. in fall 2007 came under attack for problems with its defibrillator leads, again highlighting the complex quality management issues in this sector. Medtronics in October voluntarily suspended its Sprint Fidelis defibrillator leads, halting sales, at least temporarily, of a major product line and spawning a public relations crisis. The FDA, meanwhile, under pressure from the medical community and politicians, stepped up its investigation of Medtronics and announced that it would consider additional regulations to govern what some say are gaps in compliance standards for this sector. As a result of such high-profile activity, many medical device manufacturers are actively pursuing new systems and business process changes that can inject more traceability and efficiency into their quality management and compliance processes. While numerous FDA regulations govern the way medical devices are designed and manufactured, the most significant include 21 CFR Part 11, which addresses signatures and the electronic record, and Part 820, a sweeping set of directives encompassing the methods, facilities, and controls used for the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use. There's no doubt that, in the medical device industry, compliance is a tall order. "In the medical industry, there is no way to get around the FDA," says Matthias Grossmann, CEO of IBS America. "They'll come in and audit you, and if they find deficiencies, they'll shut down your production until you fix it. The business risk is a lot more real and much more significant than in a lot of other industries." Page : 1 2 3 ... NEXT |