Managing Automation - January 2008 - (Page 37) 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.” THE ADDITIONAL OPPORTUNITY The bigger picture goes far beyond compliance, however. Companies tweaking business processes and implementing automation in isolated areas simply to comply with a particular FDA directive are missing an opportunity to address quality strategically to gain a competitive edge. “What happens is companies pay so much attention to following regulations step by step [that] they lose track of the bigger goal, which is to follow a good quality process,” says Lori Gipp, vice president of marketing at IQS, which markets an enterprise quality and compliance management system. “Peo- ple have been compliant for years, but they’re still having quality problems. How come? If you aren’t compliant, you can’t do business, but there’s a difference between compliance and quality.” When companies bring in quality systems piecemeal to address a particular process, such as CAPA, internal audits, or statistical controls, they run the risk that incidents and, more significantly, trends will fall through the cracks. Gipp makes the case that in a siloed approach, there is no clear owner of the data. Thus, there’s no guarantee that the right people have access to the right data at the right time. In a recall, for example, there is no easy way to track down the appropriate data related to the product design or production processes to get to the genesis of the problem. However, with an integrated approach that includes connection points among all of the systems, as well as their cross-functional business processes, companies can move beyond reactive operations, fed by inconsistent and unreliable processes. Instead, they can address quality and compliance in a preventive fashion by fostering common practices and encouraging increased management visibility. “The way life sciences companies bought quality management software in the past six STRATEGY SESSIONS years has been ver y What was the primary product supply business defensively, on a sitestrategy driving the success* of your medical by-site, functionalitydevice company in 2007, and what will it be in 2012? by-functionality basis,” Improve collaboration with internal partners across R&D, says Simon Jacobson, manufacturing, supply chain, and sales and marketing. senior research ana9% 2007 lyst at AMR Research 22% 2012 Inc. “The FDA said they need a CAPA sysReplicate best practices across the enterprise using operatem, so they’d buy a tional excellence programs, such as QM, Six Sigma, and RFT. CAPA system. They 4% 2007 didn’t have time to 17% 2012 think about it from a strategic architecture Improve manufacturing performance visibility perspective.” across manufacturing sites. That fragmentation 4% 2007 is starting to change, 13% 2012 however, as medical device manufacturers Redesign of your supply chain networks. make quality and com9% 2007 pliance a top priority. 13% 2012 In an AMR 2007 survey of medical device Standardize manufacturing processes and systems. makers, 4% cited oper9% 2007 ational excellence pro13% 2012 grams, such as quality *Note: Success can relate to profitability, productivity, and revenue growth. management and Six Source: AMR Research Sigma, as their sec- p bestractices 37 January 2008
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