Stryker Deploys PLM Solution to Optimize Regulatory Compliance Process

Medical devices company establishing a common product data management platform with PTC app

Medical devices company establishing a common product data management platform with PTC app

Needham, MA — January 24, 2006 — Germany's Stryker Navigation is deploying a product lifecycle management solution from PTC as part of a project to optimize the regulatory compliance process by establishing a common product data management platform.

Stryker, based in Freiburg, is deploying Windchill PDMLink for product lifecycle management (PLM) in conjunction with the Windchill Medical Device Template. The PTC Product Development System establishes a common product data management platform for mechanical, electronic and software design with integral processes for automated design history file (DHF) and device master record (DMR) reporting, digital signature procedures, approval workflows and audit reports.

According to PTC, Stryker chose the Product Development System as its PLM backbone because it supports the processes necessary to achieve compliance with standards from the U.S. Food and Drug Administration (FDA). PTC said that the combination of Windchill PDMLink and the Medical Device Template replaces manual documentation processes and allows companies to automatically trace and record product data over the whole product lifecycle. This is a requirement by the FDA and other national authorities before a product can be commercialized in different geographies.

"Applying the Medical Device Template brings more transparency to our product development processes, especially when it comes to coordinating the mechanical, electronics and software design," said Klaus Welte, vice president of research and development at Stryker Navigation. "Furthermore, the solution reduces the number of iterations and modifications caused by out-of-date design information from different sources."

"Using Windchill as the backbone for our product development system will help us to shorten time to market by providing the tools to obtain FDA compliance earlier in the development process," said Dr. Jurgen Pross, director of product development research and development at Stryker. "We expect to see the [return on investment (ROI)] within the first year following the roll-out."

"Life sciences customers face increasing pressures in their businesses to speed time to market while meeting more stringent regulatory demands," said Mark Dorsett, vice president for portfolio consulting at PTC. "We are helping innovative customers like Stryker overcome this challenge so that they can spend more time developing great products and less time on administrative tasks."

Additional Articles of Interest

— A survey of consumer healthcare decision-makers shows opportunities for manufacturers to gain competitive advantage by focusing on some key points in their supply chains. Read more in the In Depth article "Leveraging the Supply Chain for Competitive Advantage."

— When ex-Chrysler chief Thomas T. Stallkamp considers cures for what ails American manufacturing, he chooses not to look inside the four walls of the corporation but to the extended enterprise and the relationships that bind a company to its supply chain partners. Read about Stallkamp's take on the collaboration imperative in "No Company Is an Island," the Executive Memo column in the April/May 2005 issue of Supply & Demand Chain Executive.

— Is your company getting the most from its supply management function? For a step-by-step look at how to phase in a successful "end-to-end" supply management strategy, read the article "Roadmap to a Comprehensive Supply Management Strategy," an In Depth article on