Atrium Medical Corporation is a leader in medical device technologies for interventional cardiology and radiology, chest trauma care and thoracic drainage, vascular surgery, and general surgery. The company, which was recently acquired by Getinge Group, produces more than 2.7 million sterile medical products annually and distributes them in more than 60 countries.
Atrium adheres to ISO 13485 quality standards, which define a comprehensive management system for medical device design and manufacturing. It is also committed to advancing discovery and driving product development and manufacturing innovation. To continue to meet these objectives as it grew rapidly, Atrium looked to accelerate and further standardize engineering change order (ECO) processes for its medical devices, as well as create a closed-loop corrective and preventive quality-event process to enable root cause analysis and drive improvement, moving forward.
Atrium worked with Oracle Insight, which assessed the company’s product lifecycle management (PLM) processes and helped it define an effective IT platform strategy to optimize product collaboration and quality management. The medical device manufacturer deployed Oracle’s Agile PLM solutions, including Agile Product Collaboration and Agile Product Quality Management, in 2010―standardizing processes, improving collaboration and communication, and accelerating ECOs and time to market. In the first year of deployment, Atrium reduced ECO cycle time by 48%, even as the number of change orders increased nearly 15%.