Brian Curtis

Material Changes for FDA Regulated Medical Devices

Changes in formulations of materials used for manufacturing patient-contacting medical devices or device components often require submission of a new 510(k) by the device manufacturer.  This is because formulation changes can affect the biocompatibility, material properties and performance of a device. The FDA defines material formulation changes to include the following: – Changes to the chemical composition […]

Material Changes for FDA Regulated Medical Devices Read More »

Animal Derived Materials in Medical Devices

Definition: Animal Derived Materials (ADMs) include any substance derived from the body of any animal, including fat, flesh, blood, milk and eggs.  ADMs are used in polymers to stabilize formulations, enhance properties and aid in processing.  Recent medical device regulatory trends have increased demand for polymers free of ADMs. Purpose: Provide an understanding of Animal Derived Materials

Animal Derived Materials in Medical Devices Read More »

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

Silicones in Medical Devices Read More »

ProPell™ Low Friction Compounds

Definition: ProPell™ low friction compounds use non-migratory additives to enhance the surface of polymer components and reduce friction.  This technology is particularly beneficial in soft polymers, such as polyurethanes, which are inherently tacky and have high frictional properties.  ProPell™ polymer compounds are USP Class VI compatible and well suited for extrusion and injection molding of medical

ProPell™ Low Friction Compounds Read More »

FDA and ISO Standards for Medical Devices

The Food and Drug Administration (FDA) requires that medical device manufacturers establish and follow quality systems to help ensure products consistently meet applicable requirements and specifications.  The quality system regulations (QSR) for FDA regulated products are known as current good manufacturing practices (CGMP).  These requirements were first implemented in 1978 under the Federal Food, Drug

FDA and ISO Standards for Medical Devices Read More »

Bioresorbable Polymer Compounds for Implantable Devices

Definition: Bioresorbable polymers are inherently biocompatible, yet hydrolytically unstable.  This allows for applications in temporary implants that are intended to be absorbed and metabolized by the body.  A range of physical and degradation properties allows these polymers to be used for applications that include orthopedic fixation, vascular stents, tissue engineering and controlled drug delivery.  Common bioresorbable

Bioresorbable Polymer Compounds for Implantable Devices Read More »

Foster Appointed Distributor of Resirene SMMA Copolymers for Healthcare Market

PUTNAM, CT  USA – (December, 5 2017) – Foster Corporation, a leader in polymer solutions for healthcare markets, has been appointed exclusive distributor of Resirene CET® styrene methyl methacrylate (SMMA) copolymers for the United States and Canadian medical markets effective November 1, 2017.  Foster will also offer custom compounds based on SMMA copolymers, including custom colors and impact modified

Foster Appointed Distributor of Resirene SMMA Copolymers for Healthcare Market Read More »

Nano Particle Reinforced Polymer Technology for Medical Devices

Definition: Nano clay particles can be added to medical plastics in low loadings to improve rigidity while preserving elongation and surface finish.  This is advantageous in thin wall applications, such as catheters which require improved rigidity for pushability.  These non-organic, platelet-shaped particles can also improve barrier, thermo-mechanical, flame resistance and processing properties of medical polymers. Purpose: Provide

Nano Particle Reinforced Polymer Technology for Medical Devices Read More »