Medical Materials Blog

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. 1. Facility Registration – Device manufacturers and distributors in the US must register their facility with […]

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The Versatility of Medical Thermoplastic Urethanes

Thermoplastic urethanes (TPUs) fall within a class of materials known as thermoplastic elastomers (TPEs).  Yet, TPUs comprise a class of materials unto themselves due to versatility in the polymer chemistry.  As such, there are many types of medical TPUs, with distinctly different properties. TPUs are copolymers of hard and soft segmented molecular chains that exhibit

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The Language of Medical Catheter Polymers

Durometer is arguably the most common polymer attribute discussed by medical catheter engineers.  For example, an ‘80A thermoplastic polyurethane (TPU)’ reference includes the durometer: 80, A scale. A measure of polymer hardness, durometer is directly applicable to certain catheter requirements. Soft polymer tips minimize vascular trauma. Harder catheter liners are necessary to resist abrasion from

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Regulatory Considerations for Medical Polymers

Polymers used for medical devices must meet regulatory requirements specific to the application and geographic region.  Engineers and product designers should be aware of these regulations when specifying polymers for use in medical devices. 21 CFR Color Additives Color additives include dyes and pigments derived from vegetables, animals, minerals or other sources that impart color

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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.’ Specific gravity is the ratio of the density of the thermoplastic to the density of water (i.e., SGP = DP/DW).  The density

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Polysulfones in Healthcare Applications

Elastomeric polymers offer flexibility to navigate complex anatomical pathways via catheters.   Modulus, a measure of strength relative to elongation, is the material property that provides a relative comparison of flexibility for these materials. A low modulus implies greater flexibility and is often correlated with lower hardness (Shore scale A and/or D). However, many structural medical

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