Originally Published MPMN
October 2003
INDUSTRY NEWS
Software Assists Manufacturers with Product Life-Cycle Management
Melody Lee
Product life-cycle management (PLM) software designed specifically for the medical device industry assists companies in managing records in each stage from product R&D to phase-out. AgileMD, produced by
Agile Software Corp. (San Jose; www.agile.com) can help medical device companies to manage business issues. Time-to-market problems for new product introduction; product profitability, including cost of documentation; regulatory compliance; and outsourcing are some of the tasks managed by the program.
"This market depends on its ability to rapidly innovate its product offerings, and at the same time, support rigorous FDA requirements for electronic documentation," says Gisela Wilson, director of PLM solutions for IDC, a global market intelligence and advisory firm. "IDC believes that AgileMD can help medical device and instrumentation manufacturers develop and maintain competitive product portfolios."
The solution is specifically geared toward increasing revenue by accelerating time to market, increasing profits by reducing operating and direct material costs, and ensuring regulatory compliance. With an eye on the entire product life cycle, AgileMD manages the medical device product record through R&D, clinical trials, regulatory approval, new product introduction, market acceptance, and phase-out.
According to the company, customers currently using the solution have increased revenue by improving cycle time up to 60%; increased profits from operating and direct materials cost reductions of 25% and 5%, respectively; and complied with 21 CFR Part 11, prescribing the accepted use of electronic records and
signatures.
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