Atrium Medical Corporation Reduces Engineering Change Order Cycle by 48% First Year after Deploying Product Lifecycle Management Solution
 
 

Atrium Medical Corporation Reduces Engineering Change Order Cycle by 48% First Year after Deploying Product Lifecycle Management Solution

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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%.

 
 

 
 

Challenges

A word from Atrium Medical Corporation

  • “With Oracle’s Agile solutions, we’ve standardized, automated, and improved our product lifecycle management processes. Within the first year alone, we reduced our change order cycle by 48% while managing significant growth in engineering change order requests.” – Thomas McDonnell, IT Director, Atrium Medical Corporation

  • Manage fast-paced growth and maintain quality, customer satisfaction, and profitability as the medical device company expanded its product set and geographic reach
  • Ensure continued compliance with U.S. Food & Drug Administration (FDA) regulations and with ISO 13485 standards, which outline a comprehensive management system for medical device design and manufacturing
  • Improve change management processes to reduce the risk of regulatory issues―40% of which in the medical device industry are related to ECOs
  • Accelerate and further standardize the ECO process―including the ability to audit change history―even as the company experienced rapid growth in ECO requests
  • Optimize quality management processes across the company’s diverse product set, which includes stents, drainage devices, and vascular graft technologies

Solutions

Oracle Product and Services

  • Worked with Oracle Insight to understand Atrium’s PLM objectives and define an IT platform to help it optimize product collaboration and quality management―which support both compliance and profitability management objectives
  • Gained a prioritized process and solution roadmap for deploying a new PLM infrastructure based on best practices and Oracle Insight’s experience with similar organizations
  • Deployed Oracle’s Agile PLM applications, including Agile Product Collaboration and Agile Product Quality management, to standardize and speed ECO processes, improve internal and external collaboration and communication, accelerate time to market, and achieve product innovation at lower cost
  • Centralized and automated core ECO processes, enabling electronic collaboration to accelerate processes and improve ability to audit change histories
  • Reduced ECO cycle time by 48% even as the number of ECOs increased nearly 15%
  • Expanded design capabilities by connecting quality and product information
  • Instituted electronic signature and tracking, which is compliant with FDA 21 CFR Part 11 requirements
  • Created a foundation for closed-loop corrective and preventive quality-event management, which enables root causes analysis, to optimize the quality of current and future products

Resources