FMI Medical Silicone Molding is dedicated to producing medical-grade silicone components for Class II and Class III medical devices. In fact, custom silicone moldings are the only products we manufacture and health care is the only industry we serve. That singular focus allows us to provide the highly customized components that medical device manufacturers depend upon for patient safety, efficacy and reliability.

FMI specializes in custom-molded, precision silicone components for implantable and disposable medical devices.

Our engineers work with each client to determine the best molding process, tool design, and manufacturing controls for the application, in keeping with the client’s material preferences and plans for manufacturing and assembly.

CUSTOM SILICONE MOLDINGS REQUIRE DIFFERENT SILICONE MOLDING PROCESSES

Our engineers recommend the optimal molding process for each application, based on the silicone material specified by the manufacturer and the expected production volume.

Our processes include:

• Liquid Injection Molding
• Transfer Molding
• Compression Molding
• Micromolding
• Silicone to Metal Bonding / Insert Molding

FMI also operates a state-of-the-art mixing and molding operation dedicated exclusively to infusing silicone with desiccant.  More implantable medical devices are incorporating desiccants to absorb moisture from the body to ensure the long-term function and safety of the device.

Medical grade silicone is the material of choice for medical device components that require high performance and safety when in short or long term contact with the human body.

OUR COMPONENTS ARE PRODUCED IN AN “ULTRA-CLEAN” FACILITY

Nearly 75 percent of the silicone components we produce are Class III implant-grade components.  Our custom silicone components are produced in our advanced ultra-clean Class 5 clean room facilities, going beyond the basic requirement of Class 7 clean rooms for medical device component manufacturing.

FMI produces:

• Long-Term Implantable Silicone Components for Class III Medical Devices
• Short-Term Implantable Silicone Components for Class II Medical Devices
• Disposable Silicone Components for Class II Medical Devices

A FOCUS ON SILICONE MOLDING QUALITY

Since 1989, FMI has built its operations with one goal: to produce the highest quality silicone components for medical devices.  Our quality philosophy begins with the tightest process controls and the rigorous use of quality tools from design through production. Additionally, to ensure patient safety, we provide 100 percent inspection of every single component before it ships.

We incorporate best practices, a defined process, and continuous improvement to deliver zero defects and reliability with on-time delivery and global distribution.

• Design & Engineering
• Rapid Development Program
• Process Validation
• Assembly & Secondary Operations
• Logistics / Distribution
• Manufacturing Management / Sustainability

US AND CHINA MANUFACTURING

We are proud to be the first U.S.-based medical silicone molding operation to be established and validated in China, with a strong record of quality shipments since 2011. Our facility is located in one of the premier industrial developments in China, with a robust infrastructure and room for expansion.

Whether a U.S.-based client chooses to manufacture in China, the U.S. or both facilities, our U.S. staff members oversee each project, serving as liaison to our managers in China as required. All projects, whether manufactured in the U.S. or China, are quoted in U.S. dollars to avoid currency exchange issues.

• Dual Capabilities - FMI maintains dual tooling and molds and advanced manufacturing systems in both facilities to ensure quality and availability.
• Security - We safeguard our clients' proprietary data and intellectual property on a secured hard drive, with limited, authorized access.
• Competitive Costs - Our China operation combines lower-cost, highly skilled labor with the same advanced molding practices as the U.S., providing an attractive offshore option, particularly for companies that ship to Asia and the Pacific.
• Wholly Foreign Owned Enterprise (WFOE) in China - FMI does business in China as a WFOE, which offers such advantages as the ability to operate without a Chinese partner, protection of technology and intellectual property, and no special requirements for import/export licensing.

FMI USA

Certifications: ISO 13485

Capabilities:

• Clean room manufacturing for ISO Classes 5, 6 and 7 (100, 1000, and 10,000)
• 20,000 square-foot manufacturing, warehouse and distribution facility
• Special silicone/desiccant mixing and molding technology, automated assembly, automated measurement system

FMI China

Certifications:  ISO 9000: 2008; ISO 13485

Capabilities:

• Clean room manufacturing for ISO Class 7 (10,000)
• 6,000 square-foot manufacturing, warehouse and distribution facility
• Automated measurement systems
• Secured information systems and paperless operations to protect intellectual property
• Skilled labor force with managers fluent in English
• Commitment to international safety standards
• Ability to import U.S. medical-grade silicone as needed
• Expertise in import/export requirements, inventory management, and logistics worldwide

Download eBook: When Manufacturing in China Makes Sense for U.S. Medical Device OEMS

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