- Olympus selected VxWorks-based Wind River Platform for Medical Devices and Wind River Test Management for its ESG-400, a high-frequency surgical generator.
- Wind River’s automated software testing framework supported Olympus through the complex U.S. Food and Drug Administration approval process.
- Time-to-quality and regulatory submission reduced by 20% for ESG-400.
ALAMEDA, Calif. — Nov. 7, 2012 — Wind River®, a world leader in embedded and mobile software, has announced that Olympus Surgical, the technology leader in the field of minimally invasive surgery, chose Wind River Platform for Medical Devices and Wind River Test Management to help reduce development cycle time and costs for its latest high-frequency surgical generator, the ESG-400.
In addition to wanting to be first to market with the ESG-400, Olympus needed to aggressively manage costs to stay on budget; IEC 62304 certification and U.S. Food and Drug Administration (FDA) approval were also required to validate the product’s safety. To meet these objectives, Olympus selected Wind River Platform for Medical Devices, part of a comprehensive software portfolio that is built on the Wind River real-time operating system, VxWorks®, as well as Wind River Test Management, the company’s automated software testing framework.
By leveraging Wind River Platform for Medical Devices, Olympus reduced the overall development cycle time by 15% and entered the market much sooner, while lowering costs by approximately 15%. With Wind River Test Management, Olympus was able to accelerate time-to-quality (the time it takes to successfully execute all tests that cover the requirements) by 20% and reduce the time to regulatory submission by 20%.
“Wind River delivered a total solution that included not just software, but also strong customer support, education, and professional services organizations to ensure the successful market launch of an FDA-approved product,” said Lutz Kersten, department manager, R&D surgical therapy software, Olympus Surgical. “Wind River’s software helped us develop customized documentation in accordance with IEC 62304 and FDA guidance. We passed the software audit easily and quickly–and launched the FDA-approved product to the market ahead of schedule.”
“Wind River has enabled Olympus to continue its heritage of meeting first-to-market goals and delivering a high-quality product to the medical market,” said Santhosh Nair, general manager of intelligent platforms at Wind River. “We provided Olympus with a complete solution and services customized to best meet their needs, allowing them to stay focused on their core competencies–developing cutting-edge, differentiated applications.”
More information about Wind River solutions for the medical market is available at www.windriver.com/solutions/medical.
About Wind River
Wind River, a wholly owned subsidiary of Intel Corporation (NASDAQ: INTC), is a world leader in embedded and mobile software. Wind River has been pioneering computing inside embedded devices since 1981 and its technology is found in more than 1 billion products. Wind River is headquartered in Alameda, Calif., with offices in more than 20 countries. To learn more, visit Wind River at www.windriver.com or on Facebook.
Wind River is a trademark or registered trademark of Wind River Systems, Inc. and its affiliates. Other names may be the trademarks of their respective owners.
Director, Global Communications