Over the past few years, regulatory compliance has become a key issue for the enterprise. This is especially true for medical device manufacturers, which must meet rigid compliance and quality standards set out by regulatory bodies like the U.S. Food and Drug Administration (FDA). The FDA, for example, mandates that medical device companies must have separate processes in place to ensure compliance, from corrective and preventive action systems to control systems for product design, materials, records and documentation, and production facilities and equipment. Meeting these rigorous compliance and quality requirements can impact time to market, costs, competitiveness, revenue, and profitability.
San Jose, California-based Stryker Endoscopy is aware of how complex FDA compliance mandates can be. The company is one of the fastest-growing divisions of Stryker Corporation, a US$6 billion medical device and orthopedic manufacturer. Stryker Endoscopy manufactures equipment that is utilized in minimally invasive surgery, including high-definition video equipment, digital imaging and capturing equipment, communications equipment, and instrumentation.
“When you think about compliance, for most finance and IT executives, Sarbanes-Oxley lights up in their heads,” says Glenn Boehnlein, vice president and chief financial officer of Stryker Endoscopy. “For us, being a medical-device company, FDA compliance is every bit as big, if not bigger.”
Stryker Endoscopy is implementing Oracle’s Agile product lifecycle management (PLM) applications to help the company address its compliance mandates. Agile PLM applications provide one central solution for aggregating, analyzing, and acting on product quality issues, from customer complaints to manufacturing deviations to adverse-event information or supplier corrective actions.
“We selected Agile PLM because it was important for us to be on the latest technology platform for our compliance documentation and reporting,” says Boehnlein. “Currently, we are under divergent systems for this type of documentation. Agile will allow us to be under one system. It will also allow a common format across all divisions at Stryker Endoscopy, which will be useful for us in terms of making sure that we have consistency in our compliance efforts.”
In addition, Agile PLM applications provide the infrastructure to meet the requirements outlined by the FDA’s quality system regulations, as well as providing a platform for full compliance with Title 21 of the Code of Federal Regulations, Part 11.
“One of the things that we looked at in terms of a new product lifecycle management system was, 'What’s going to allow us to be faster?’” explains Boehnlein. “I need something that allows me to access documentation faster, can allow collaboration of that documentation, and can get us to a faster design solution so that we can get new products on the market more quickly.”
Stryker Endoscopy is also considering Oracle’s governance, risk, and compliance (GRC) suite, to act as a technology foundation for all its compliance efforts. Oracle’s GRC applications help reduce cost and complexity by managing multiple GRC requirements with one platform, safeguarding a company’s brand and reputation through information reliability and data protection, and providing insight into the status of GRC activities.
“As compliance becomes more pervasive throughout your business, not only in terms of the FDA and Sarbanes-Oxley but also state and local agencies and the U.S. Securities and Exchange Commission, you need one place where you can bring all those rules, procedures, and processes into a reporting environment,” says Boehnlein. “We’re focusing on Oracle’s GRC suite to potentially be that product for us.”