Overview of Medical Device Injection Molding
Medical device injection molding is a specialized manufacturing process that produces high-precision, sterile components essential for healthcare applications. This process transforms medical-grade materials (plastics, metals, or silicones) into complex parts—from syringes and surgical instruments to implantable devices—by injecting molten material into precision molds. The technology is critical for meeting stringent regulatory standards (e.g., FDA, ISO 13485) while ensuring scalability, cost-effectiveness, and repeatability in production .
Key Technical Requirements and Material Selection
1. Material Considerations
Biocompatibility and Sterilization Resistance: Materials must comply with ISO 10993/USP Class VI standards to avoid toxic reactions. Common choices include:
PEEK (Polyetheretherketone): Used in implants and surgical tools due to its high thermal/chemical resistance .
Polycarbonate (PC): Ideal for transparent device…