Ascend Performance Materials and Foster Corporation Announce New Hi-Dura™ MED Nylon-Based Products for Medical Market

Putnam, CT – (December 1, 2022) – Foster Corporation’s Distribution business, a leader in material solutions for the “critical application” healthcare market segment and Ascend Performance Materials, a leader in the manufacture and marketing of nylon-based materials and technologies, are pleased to announce Ascend’s new Hi-Dura™ MED grade nylon (PA) based materials for the high […]

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 […]

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 […]

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 […]