Wind River Customers
"Wind River helped us develop customized documentation in accordance to IEC 62304 and FDA guidance. We passed the software audit easily and in a timely manner—and launched the FDA-approved product to the market ahead of schedule."
—Lutz Kersten, Department Manager, R&D Surgical Therapy Software,
Olympus Accelerates Time-to-Market with
Wind River for Medical Devices
Olympus Surgical, a technology leader in the field of minimally invasive surgery, faced several challenges when they embarked on developing the ESG-400, a high-frequency surgical generator. The company needed to be first to market while aggressively managing costs to stay within budget. The Olympus design team wanted to stay focused on core competencies, as opposed to spending time developing software that could be offered by a vendor. Finally, the team wanted to mitigate risk: In a highly competitive medical device landscape, IEC 62304 and U.S. Food and Drug Administration (FDA) documentation are required to demonstrate that products are completely safe. In a surgical environment where errors can be life threatening, there is no room for delays or mistakes.
To address these challenges, Olympus required a mature, proven, and comprehensive solution used in safety-critical systems. It also needed support for development in a regulated environment, education services and training, and competitive pricing.
A Total Sloution
"Wind River Platform for Medical Devices offered a combination of software components that fulfilled all of our requirements, including hardware support, board support package (BSP), operating system, middleware, and networking, while ensuring robust real-time performance," says Lutz Kersten, department manager of R&D surgical therapy software at Olympus Surgical. "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."
Wind River® Professional Services developed full BSP support for Olympus' target platform, Freescale MPC5200, and provided Olympus with customized hardware support for VxWorks®, including a touch-screen driver and USB host support. Wind River Professional Services also helped Olympus achieve regulatory compliance by providing validation of the customized real-time operating system.
Olympus leveraged Wind River Education Services onsite and offsite classes that were tailored to the company's needs. Fundamentals and basic-training classes helped Olympus developers get up to speed quickly.
"During our collaboration, Wind River always kept to the proposed schedule and budget," Kersten says. "The personnel is well-trained, friendly, and highly motivated—with a focus on the right specialists getting things running for the customer. Customer support is always provided in a timely manner."