Silicone Products


You saw a need and designed a tool to fit the job. Now you want to get the idea from working notion to working reality. Medical products require high-grade materials that are durable, flexible and comply with Federal regulations. Using Silicone Products for the production of your product is a perfect choice.

Silicone, in various forms, is used throughout every field of medicine. Tubing, lubricants, cosmetic implants, storage devices and a long list of others are found in abundance in every hospital, clinic and private practice. Check the Internet and you will find a wide range of companies that specialize in providing Silicone Products and related services.

About Silicone

Silicone Products are synthetic polymers. They can be fluids, gels and rubbers. Silicone Products are chemically inert, thermally stable, and resistant to oxidation. The main characteristics of Silicone Products are:
  • Fluids: virtually insoluble in water

  • Gels: retains form without external containment

  • Elastomers: extremely durable, flexible and strong
Silicone Products combine the temperature and chemical imperviousness of glass with the usefulness of plastic. There are three basic categories of Silicone Products:
  1. Hyperpure Polycrystalline Silicon—computer chips, electronic devices

  2. Silanes—chemical compounds, electronic industry

  3. Siloxanes—fluids, emulsions, compounds, lubricants, resins, rubbers
Getting Your Product Made

The first step in getting your medical device design manufactured for use is to find a qualified Silicone Product fabricator. There are many resources on the Internet. Well-known companies such as Dow Corning offer fabrication services. You will also find fabricators local to your area. Of course you want to find a company with an excellent track record in medical device fabrication and proven ability to work within budget and deliver on schedule.

The Silicone Product manufacturer should be able to provide design assistance and engineering resources. A company with a comprehensive supply network, a regulatory compliance program, and an understanding of emerging technologies will be most capable of bringing your vision to fruition. A good source for finding companies is GLOBALSPEC a specialized search engine that focuses on engineering and technical information.

Manufacturing Services for Silicone Products

There are three types of fabrication services available for the manufacture of Silicone Products:
  1. Molding—achieved by Liquid Injection (LIM), Transfer, or Insert. In each process liquid silicone is delivered into a mold and vulcanized. Molding is used for items such as seals and gaskets, balloons, manifolds, and breathing cannulas (to name a few).

  2. Extrusion—the extrusion process takes ribbons of Silicone Product and converts them into tubing or profiles. Extrusion produces such items as catheters, drain tubes, cooling clips and inflatable seals.

  3. Assembly—during the assembly process your product is finalized. Your Silicone Products molded and extruded in earlier processes are combined with non-custom parts as specified during the design. Assembly should include complete functional testing of all parts
  4. .

The fabricator should maintain a high standard of quality control throughout all processes. Silicone Product manufacturers and fabricators must comply with FDA regulations, be NSF registered and should meet ISO 9002 certification standards.

By MS Kauffman           


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