BD Custom Manufacturing delivers medical-grade plastic extrusions built to meet the rigorous demands of medical OEMs. We specialize in the production of custom PVC and polyethylene profiles and can work with projects of any size.

Using advanced medical extrusion technologies, we produce certified, traceable components from ISO-compliant resins. Each part leaving our facility is built to the strictest standards for dimensional tolerance and healthcare regulations.

What Makes a Plastic Medical Grade?

Medical-grade plastics must be safe for clinical or body-contact use, as defined by exhaustive regulatory criteria. ISO 10993 standards outline several essential biocompatibility tests, including cytotoxicity, sensitization, and hemolysis, with each addressing highly minute application risks and exposure times. For high-contact parts, USP Class VI certification and FDA clearance requirements necessitate even more stringent medical manufacturing protocols.

Regulatory Standards and Required Properties

Plastic extrusions must meet multiple performance and safety standards, such as ISO 10993 biocompatibility testing. They must also support various sterilization methods without degrading, such as:

  • Ethylene oxide (ETO)
  • Gamma radiation
  • Plasma
  • Steam autoclave

At BD Custom Manufacturing, we provide plastic extrusions that feature high chemical resistance and dimensional stability and support clean processing controls. We can accommodate a range of sizes, lengths, thicknesses, and configurations to meet the varying needs of the medical industry.

Medical Industry Applications

Medical plastics extrusions are essential for diagnostic, therapeutic, and wearable medical devices. BD Custom manufactures core components for these and other applications to meet precise biocompatibility and dimensional requirements.

Common Components

We custom-extrude key OEM components that integrate seamlessly into regulated device assemblies, including medical device brackets, tubing, braces, and more.

Tubing and Braces

Flexible tubing and profile braces are important for fluid systems, supports, and patient-contact wearables. We custom-tailor extruded tubing to a broad range of specifications, including wall thickness, softness, and strength sufficient for a broad suite of clinical demands.

Brackets

Extruded brackets support various medical device housings and internal assemblies. They can provide strong dimensional stability and resistance to repeated or intense sterilization techniques.

Medical-Grade Materials We Use

At BD Custom Manufacturing, our medical-grade thermoplastics are carefully selected for durability, sterilization methods, and biocompatibility.

Biocompatible and Sterilizable Plastics

The following materials can be used to meet numerous performance and design requirements:

  • Polycarbonate. Offers high heat resistance and clarity for enclosures and connectors.
  • ABS. Strong and chemically resistant for structural parts.
  • PVC and polypropylene. Lightweight, flexible, and easily sterilized.
  • TPU and PEBA. Flexible and abrasion-resistant for tubing and braces.

All processed resins that we deliver meet ISO and FDA requirements and support numerous sterilization methods.

Contact BD Custom for Medical Plastic Extrusions Today

BD Custom specializes in medical extrusion technologies that produce precise, compliant plastic components for OEMs. Our ISO 13485-certified processes and rapid tooling help bring regulated products to market quickly. Each production run also includes material certification, batch traceability, and full compliance documentation.

Whether for prototyping or fully scalable production runs, we offer the expertise and capacity to deliver on time and, whenever possible, under budget. Contact our team to request a quote  and discuss your medical manufacturing project with our plastic extrusion experts.