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Biomedical Polymers and Compounds™

medical device

Silicones in Medical Devices

Silicones are widely used in medical devices because they are biocompatible, biodurable (do not degrade over time), do not produce extractables (a concern with leaching plasticizers from flexible PVC), and are unlikely to cause allergic reactions (a concern with latex).  Medical applications for silicones are far ranging from wound care gels to flexible drainage tubes to semi-rigid implants. 

FDA Regulatory Requirements for New Medical Devices

The Food and Drug Administration (FDA) requires that medical devices distributed in the United States must first meet the several requirements.  These include facility registration, device listing, device approval, clinical studies, quality systems, labeling requirements and medical device reporting.

Material Price v. Component Cost

Thermoplastics are sold by unit weight (e.g., $/lb, €/kg). However, the material cost for a plastic component must consider component volume and density of the plastic.  For thermoplastics, density is reported as ‘specific gravity.’

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