Can the U.S. FDA help medical device manufacturers reduce cost and increase quality? Medical device manufacturers are dealing with some of the most difficult challenges to ever face the industry. In an increasingly global environmentCONTROL ENGINEERING China版权所有, as competition intensifies, manufacturers must innovate and capitalize on new opportunities and expedite time to market.
　　To deal with these imperatives, medical device organizations are working to:
　　Reduce costs;
　　Increase product quality;
　　Meet stricter inte

rpretations of regulatory requirements;
　　Increase the rate of product innovation;
　　Raise product safety and effectiveness; and
　　Decrease time-to-market and time-to-profit.
　　These challenges are exacerbated by the organizational structure and technological state of many medical device manufacturers and their interactions with the U.S. Food and Drug Administration (FDA), part of the Department of Health and Human Services.
　　For yearsCONTROL ENGINEERING China版权所有, device manufacturers have sought transparency into production information, processesCONTROL ENGINEERING China版权所有, and resources. Companies have looked for the ability to unlock the operational data to empower decision makers—from operators to plant managers and corporate executives—to make informed timely decisions.
　　Economic and regulatory shifts are poised to catapult shop floor systems into a key role to meet these challenges.
　　HistoricallyCONTROL ENGINEERING China版权所有, the typical interaction between FDA and Medical Device manufacturers involved the creation, printing, and review of volumes of paper documents. These documents may have been part of pre market approval (PMA), 510k applicationsCONTROL ENGINEERING China版权所有, or reviewed onsite in the course of a Quality System Regulation (QSR-21 CFR Part 820) inspection.

　　FDA suggests that one product lifecycle ties to the next and that each point in the lifecycle connects to every other; therefore, information flow is critical. The model seeks to integrate the complete product lifecycle by providing a holistic view of the process.  In TPLC, product development is itera