FMI Launches Integrated Manufacturing Information System for Medical Device Silicone Molding - Captures Real-Time Data to Improve Quality and Patient Safety

CHICAGO, Illinois - FMI has announced the launch of FMI iQ, a proprietary manufacturing information system for its medical silicone molding operations, which links real-time production data with performance metrics, quality data, employee training, and continuous improvement and risk management tools. The FMI iQ system was created to harness and integrate the power of real-time data during production to help ensure zero defects in silicone molding for medical devices.

FMI iQ uses a custom portal to allow FMI’s manufacturing, quality, and engineering staff to have instant access to three critical components of quality in silicone molding:

  1. Robust Quality Data Collection - which is collected and reported in real time, during silicone manufacturing, along with material tracking data, and regular reports on key performance indicators such as scrap, defects and trends

  2. Employee Performance and Resources - including the individual’s quality data on all silicone molded parts produced and experience on different types of equipment, as well as company policies and procedures, safety programs, and upcoming training programs, which employees can access to achieve higher levels of expertise

  3. Continuous Improvement and Risk Management - which outlines how risk is to be managed for every silicone molding project, including integrated control plans, PFMEAs, risk profiles for each part and critical to functionality indices, as well pertinent regulations

“FMI has made a major investment to ensure the highest quality in medical silicone molding by integrating individual department activities into one interface,” said Harold Sant, Vice President of Operations for FMI. “While we have been using these systems independently for many years, FMI iQ for the first time brings together all of our quality data and resources, which allows us to respond immediately to any concerns, as well as surpass our customers’ requirements for quality reporting and audits.”

FMI is unique in the silicone molding field for its quality standard of both process validation and total part validation, achieved through GRR studies, rigorous validation activities, ongoing production controls, and 100 percent inspection of finished parts. FMI’s silicone molded parts are found in a wide range of medical devices that are critical to patient health and safety, including complex, long-term implantable devices.


FMI is a leading supplier of medical-grade silicone components designed primarily for use in implantable Class II and Class III medical devices. Since 1989, FMI has been helping medical device manufacturers develop new products and expand their global market reach. FMI operates cleanroom facilities near the Chicago O’Hare International Airport and in Suzhou, China. Both facilities are ISO 13485-certified for medical devices with Class 5, 6 and 7 cleanrooms in the US and Class 7 cleanrooms in China. FMI is a wholly owned subsidiary of Flexan Corporation, which began operations in 1946 in Chicago and also has a facility in Suzhou, China, which opened in 2004.

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