Custom Medical Device and Component Technology

MOLDING. EXTRUSION. ASSEMBLY.
Helix Medical has been a leading custom manufacturer for the medical device, health care, pharmaceutical, biotech, and IVD industries since 1984. Manufacturing capabilities include silicone molding (LIM), thermoplastic molding, extrusion, assembly, packaging, and sterilization. Headquartered in Carpinteria, CA, Helix Medical operates an FDA-registered medical device facility, certified to ISO 13485 and ISO Class 7 & 8 cleanrooms, with operations in North America and Asia, and global product distribution.

Capabilities
Custom manufacturing capabilities include LSR/HCR silicone and thermoplastic medical devices and components. Molding capabilities include silicone (LIM), thermoplastic, compression/transfer, insert, over molding, two-shot molding and micro molding using an extensive array of medical grade/implant grade silicones and thermoplastics. Extrusion capabilities include single to multi-lumen tubing with varying profiles up to a 1¼ -inch outer diameter, as well as solid and striped radiopaque tubing which provides precision and tolerances suitable for the most demanding applications.

Thermoplastic injection molding is available at our Baldwin Park Operations and Asia Operations through APEC, A Division of Helix Medical. APEC specializes in two-shot molding, insert molding, and high-end hot runner valve gate molds, and rapid prototyping. Our Gloucester Operations facility in Gloucester, MA specializes in liquid injection molding and thermoplastic injection molding as a component to a silicone-based part.

Helix Medical offers a wide range of value-added services from sterilization, assembly, and packaging to annealing, thermoforming, and pad printing.

HelixMark® Silicone Tubing and Fluid Handling Components
Our HelixMark® brand of platinum-cured silicone tubing and fluid handling components, USP Class VI biocompatibility, for the pharmaceutical, biotech, and IVD industries are available in an extensive array of types and sizes including standard tubing, multi-lumen tubing, braided reinforced tubing, color stripe tubing, close tolerance tubing, and peristaltic pump tubing, as well as stoppers and gaskets.

Silicone Molding article in MDDI

Categories this company is listed under in the North American Suppliers Directory:

• Contract Manufacturing and Packaging Services: Company Features: FDA Registered (575 companies)
• Contract Manufacturing and Packaging Services: Contract Services: Assembly (1491 companies)
• Contract Manufacturing and Packaging Services: Contract Services: Extrusion (279 companies)
• Contract Manufacturing and Packaging Services: Contract Services: Molding (727 companies)
• Contract Manufacturing and Packaging Services: Contract Services: Pressure/Thermoforming (185 companies)
• Contract Manufacturing and Packaging Services: Contract Services: Rapid Prototyping (831 companies)
• Tubing: Materials Used: Silicone (116 companies)
• Tubing: Tubing Types: Class VI (132 companies)
• Tubing: Tubing Types: Coextrusions/Paratubing (94 companies)
• Tubing: Tubing Types: Heat-shrink (78 companies)
• Tubing: Tubing Types: Multilayer (87 companies)
• Tubing: Tubing Types: Multilumen (112 companies)
• Tubing: Tubing Types: Radiopaque (103 companies)
• Tubing: Tubing Types: Reinforced (91 companies)