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to customer-driven corrective and preventive actions (CAPA), medical device makers are taking a fresh look at their outdated paper-based quality procedures and limited Word document and spreadsheet-based systems.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."
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. "People 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 years has been very defensively, on a site-by-site, functionality-by-functionality basis," says Simon Jacobson, senior research analyst at AMR Research Inc. "The FDA said they need a CAPA system, so they'd buy a CAPA system. They didn't have time to think about it from a strategic architecture perspective."
That fragmentation is starting to change, however, as medical device manufacturers make quality and compliance a top priority. In an AMR 2007 survey of medical device makers, 4% cited operational excellence programs, such as quality management and Six Sigma, as their second-ranked top business strategy for 2007, with a healthy 17% making it a priority by 2012.
"While compliance is an important motivator, we're seeing some evidence of a shift from implementing automated systems just from a compliance perspective to a realization that you need a systematic approach to improving manufacturing processes in order to obtain a competitive advantage," says Ron Rubenstein, director of product marketing for Sparta Systems Inc., which sells an enterprise compliance and quality system called TrackWise.
The Paper Jungle
For Ultra Machining Co., a contract manufacturer for medical device companies, automating manual and paper-based processes was as much about gearing up for compliance as it was pushing quality to gain a competitive edge. The company for years had entrusted its quality procedures to a veteran employee. But it faced huge gaps in late 2004 when that 35-year employee retired, along with a document control person and a QA manager. That scenario, coupled with the heightened complexity of achieving compliance on more sophisticated engineered components, prompted UMC to install the IQS integrated system in 2005 to automate its quality processes.
Since implementing the system for document control and data collection, UMC has cut audit times with customers in half while exhibiting the kind of consistent controls that give it an advantage over competitors, according to Don Tomann, UMC president. "Before, the lead auditor would have to run around to find the proper documents, which could be in multiple locations," he says. "With IQS, everything is linked or embedded in the program, and auditors don't have to leave their chairs."
Navigating a paper jungle was also an issue for Gaymar Industries Inc., which makes temperature and pressure management devices. The company in 2006 went live with a MasterControl document control system and has seen significant improvements in its quality processes, says Pat Burandt, Gaymar's MasterControl project manager. Specifically, Gaymar now manages its training records more efficiently, a key requirement of compliance, and has a better handle on its CAPA procedures. In addition, having documents easily accessible online reduces meeting requirements and approval processes, contributing to its ability to move products to market faster.
"Management now has a snapshot view of everything happening in this company as far as CAPA goes and what its status is," Burandt says. "Before, everything was far more ambiguous. Since there's now a focus on these quality issues, everything comes to closure much more quickly ... and [the problem of] lost documents is something that doesn't happen any more."
While eliminating the paper chase was one factor in Wright Medical Technology's decision to automate, the bigger incentive was to establish an integrated system that could provide a complete picture of a product's development and compliance standing throughout its lifecycle. The company, which makes orthopedic devices, was already using Siemens PLM Software's Teamcenter PLM platform as the system of record for its prints and design process. In 2006, it added Teamcenter for Medical Devices to trace all activities — from concept to retirement — by automatically linking compliance requirements with engineering and specification data.
Having an integrated system that can track information about a product at any point in the lifecycle is critical when you're talking about the human body. "One inside the body, the lifecycle of that product is the life of the patient, and that could be 20 to 50 years, depending on what's going on," says Amy Cooper, quality documentation supervisor for Wright Medical. "Being able to track everything, from how it was supposed to be made to how it was made, and look at that 20 to 30 years down the line in some sort of legible format was the goal."
Meanwhile, back at Optos, Booth's goal was to have a more efficient quality process — and keep her job. After Optos went public in February 2006, Booth knew the FDA audit would come sooner or later, so she pushed upper management to greenlight the purchase of the IBS CompliantPro software to get Optos' house in order. Her boss supported the implementation, but told Booth that her job was on the line if the rollout wasn't a success. Less than one year and an FDA audit later, Booth and the rest of the company stand by that decision. In fact, Optos' headquarters in the United Kingdom is now trading in another quality management platform for CompliantPro in preparation for its compliance audit.
"The integrated platform makes life a lot easier," Booth says. "There's no question here now that it is a tremendous asset."