Brian Curtis

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 […]

FDA Regulatory Requirements for New Medical Devices Read More »

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

The Versatility of Medical Thermoplastic Urethanes Read More »

Sterilization Technologies for Medical Devices

Definition: The three primary methods for sterilizating medical devices include radiation, ethylene oxide and steam.  Device type, quantity to be sterilized and packaging are a few considerations for selecting the appropriate method.  Polymers used in the device components must also be considered, since some can degrade or diminish in functionality from the sterilization process. Purpose: Provide an

Sterilization Technologies for Medical Devices Read More »

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

The Language of Medical Catheter Polymers Read More »

Overview of Medical Polymers

Definition: Thermoplastics play a critical role in modern medical devices.  Amorphous and crystalline thermoplastics offer distinct performance properties.  Within these categories are a variety of specific polymers suitable for a wide range of device components. Purpose: An overview of amorphous and crystalline thermoplastics, along with specific examples and attributes for each category. View Presentation

Overview of Medical Polymers Read More »

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

Regulatory Considerations for Medical Polymers Read More »

Color Additives for Medical Device Plastics

Definition: Pre-color compounds and color concentrates for medical applications are most commonly manufactured using two categories of color additives: FDA Food Contact Pigments, and FDA Medical Device Pigments.  The selection of one pigment classification over the other may affect the FDA approval process for medical devices. Purpose: Selection of pigments suitable for medical device plastics View Presentation

Color Additives for Medical Device Plastics Read More »

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

Material Price v. Component Cost Read More »