Originally Published EMDM
October 2003
INDUSTRY NEWS
Product Life Cycle Management System Geared to Device OEMsA product life cycle management (PLM) system allows medical device professionals to manage product portfolios from research and prototype development to regulatory approval and market acceptance.
Agile Software Ltd. (Bracknell, Berks, UK) has launched Agile MD at a time when “the global market for medical devices is rapidly growing,” says president and COO Jay Fulcher. “Time-to-market problems, cost of documentation, compliance, and outsourcing complexities are all critical business issues.”
Medical device companies such as Hologic (Bedford, MA) are currently using the system to achieve key PLM business goals. “Lengthy product introduction time, document control process issues, and regulatory compliance have always been challenges in the medical device industry,” says Dave Rudzinsky, CIO at Hologic. “Agile has created a complete solution that can really help manage a product from conception through the end of its life.”
Agile MD can reportedly improve cycle times up to 60% and achieve reductions of 25% in operating costs and 5% in direct materials costs. It can also ensure compliance with US FDA’s 21 CFR Part 11, which prescribes the accepted use of electronic records and signatures.
“The medical device and instrumentation market depends on its ability to rapidly innovate its product offerings. At the same time, it must support rigorous FDA requirements for electronic documentation,” says Gisela Wilson, director of product life cycle management solutions at IDC, an analyst firm based in London. “IDC believes that Agile MD can help manufacturers develop and maintain competitive product portfolios.”
For more information, contact Agile Software Ltd., Venture House, Arlington Sq., Downshire Way, Bracknell, Berks, UK; phone: + 44 1344 742800; fax: + 44 1344 742900; e-mail:
info@agile.com; Internet: www.agile.com.
Rita Emmanouilidou
Copyright ©2003 European Medical Device Manufacturer
