Casco Bay Molding

About

Casco Bay Molding is a medical device component manufacturer specializing in high-volume injection-molded thermoplastic and liquid silicone rubber parts, short-run prototype silicone parts, and over-molding silicone onto plastic or metal, based in Sanford, Maine.

The company provides product development, silicone injection molding, precision machine shop services, in-line manufacturing, turnkey manufacturing cells, mold making via partner Legu Tool and Mold, and FDA registration services.

Categories & manufacturing capabilities

• Product categories: medical devices, sterilization trays, instrument handles, surgical theater strain reliefs, sleep apnea/CPAP components, surgical room bumpers, Ultem over-molded slides, custom medical gaskets, Newman sanitary gaskets, dental instruments, face shields, healthcare applications
• Filtration products: silicone-plastic screen parts, custom gaskets, filter stacks, water filtration components
• Other products: medical-grade silicone components, scuba gear, menstrual cups, conductive silicone mold rubber
• Formats & capabilities: high-volume injection molding, silicone injection molding, over-molding onto plastic or metal, turnkey manufacturing cells, in-line manufacturing, mold making (via Legu Tool and Mold)
• Materials & processes: chemically-resistant thermoplastics, Syndiotactic Polystyrene (SPS)

Production & operational capabilities

• Primary processes: injection molding of thermoplastics, liquid silicone rubber (LSR) molding, over-molding
• Post-molding processes: vapor deposition or sputtering, ultrasonic welding of plastic components, foil or filter insertion and assembly, printing/decoration (including silicone ink on silicone), snap fit assembly, stiffening element addition, part connections, die punching, retail packaging assembly
• Turnkey capabilities: turnkey manufacturing cells, in-line manufacturing, FDA registration services
• Facilities: Sanford, Maine facility; supports cold runner silicone and plastic injection molding for high-volume production

Quality, compliance & regulatory positioning

• Certifications: ISO 13485:2016, ISO 9001 (since 2003)
• Regulatory status: FDA-registered with full material traceability

Customization & collaboration model

• Development process: 12-step process for initial part and mold design review, final project development mold design review, mold testing and adjustments
• Design support: Design for Manufacturing (DFM) services to support vertically integrated operations from FDA registration to production, packaging, and distribution
• Collaboration: turnkey manufacturing options and in-line manufacturing partnerships