Chicago, IL (PRWEB) May 11, 2015
FMI, Inc. reports that the applications for implantable silicone continue to grow in each short- and lengthy-term implantable health-related devices. With its extended track record of biocompatibility, healthcare-grade silicone is being utilized in a wide range of implantable devices with essential functions, such as defibrillators, heart pumps and surgical reconstructive elements.

“Medical device makers are continually innovating, with more powerful technologies packed into ever-smaller sized devices, which is particularly accurate for lengthy-term implantable devices,” explains Frank Sullivan, president of FMI, which specializes in ultra clean healthcare silicone molding. “Silicone’s potential to be molded in any shape and even micro-molded into miniature parts permits it to be utilized in a selection of new devices.”

According to market place researchers, The Freedonia Group, “U.S. demand for biocompatible supplies is forecast to increase four.9 % annually to $ 5.6 billion in 2018.” In its report, Biocompatible Supplies, Freedonia forecasts, “ Engineered resins – particularly thermoplastic elastomer, silicone, sulfone, and polyketone components – will command the quickest income and volume growth based on quality and safety positive aspects in high worth-added catheters and implants.”

“The biocompatibility of silicone is a real benefit for health-related device manufacturers, as it has been tested extensively and proven protected for implantable devices that can function inside the body for a lifetime,” says Harold Sant, vice president of Operations for FMI. “Many device components can be redesigned with implantable silicone, replacing synthetic components whilst sustaining the same functionality.”

FMI has published an ebook for health-related device makers to describe the developing applications for silicone-molded parts in implantable devices. The ebook supplies an overview of the qualities of implantable silicone, its utilizes in medical devices, the compounding and molding processes involved, the science behind medical-grade silicone, and the overriding importance of patient safety.

Silicone that is utilized in implantable devices have to go via rigorous testing. The kind of health-related-grade silicone utilized depends on no matter whether the portion will be employed for brief-term implantable devices (Class II – 29 days or much less) or lengthy-term implantable devices (Class III – 30 days to indefinite use). FMI estimates that implantable silicone represents only a fraction of the total amount of health-related-grade silicone employed in medical devices, but implantable silicone is crucial for implantable devices.

Silicone molding is utilized to generate precision components by molding a complete implantable portion, molding a element of an implantable device, or over-molding a portion of the device or the exterior of the device. The ebook explains the various molding processes employed as well as cleanroom manufacturing to ISO requirements. The benefits of implantable silicone incorporate its ability to supply insulation from electrical present to protect sensitive elements of an implantable device, such as pacemaker leads, from corrosive bodily fluids and to provide flexibility and long-term durability for implantable devices that have to conform to the body, such as catheters and shunts.


ABOUT FMI Health-related SILICONE MOLDING
FMI is a leading supplier of healthcare-grade silicone elements made primarily for use in implantable Class II and Class III health-related devices. Because 1989, FMI has been helping healthcare device producers develop new products and expand their global market attain. FMI operates cleanroom facilities close to 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 started operations in 1946 in Chicago and also has a facility in Suzhou, China, which opened in 2004.





