Contract Medical Device Manufacturing

Medical device manufacturing is the process of producing components or finished devices used in healthcare applications. It can include design-for-manufacturability support, machining, additive prototyping, finishing, marking, inspection, and quality documentation. For orthopedic applications, manufacturing may involve complex components for spinal, trauma, large joint, and foot/ankle implants or instruments, produced through controlled processes that support applicable quality and regulatory requirements.

Medical device contract manufacturing is when a specialized manufacturing company produces medical device components or products for another company. The contract manufacturer may support planning, prototyping, production, finishing, inspection, and documentation. MoManTech provides these services for highly engineered orthopedic components, combining design-for-manufacturability consultation with CNC machining, Swiss turning, wire EDM, additive prototyping, quality control, and ISO 13485:2016-compliant processes.

MoManTech specializes in highly engineered orthopedic medical device components for spinal, trauma, large joint, and foot/ankle applications. Its capabilities support surgical implants and instrumentation, including precision-machined and additively prototyped parts. The appropriate process depends on the component design, application, material, and production requirements. The team can review a project during the design-for-manufacturability stage.

Yes. MoManTech supports prototype development and low-volume production for precision-machined components and 3D-printed parts. The service catalog identifies prototype quantities of 1–10 units and production runs of 100+ for applicable capabilities. Support can include design-for-manufacturability consultation, CNC milling and turning, Swiss lathe work, wire EDM, additive prototyping, inspection, finishing, marking, and quality documentation.

MoManTech provides precision CNC milling, turning, wire EDM, and multi-axis Swiss lathe capabilities. Its equipment includes Mazak Integrex turn/mills, Haas and Hurco vertical mills, Citizen and NexTurn Swiss lathes, wire EDM machines, and a 7-axis collaborative robot. These capabilities are used for complex orthopedic device components and can support prototyping through production, along with finishing, marking, and inspection.

Yes. MoManTech provides design-for-manufacturability consultation during the planning stage of precision-machined component development. The team applies orthopedic manufacturing expertise, advanced process technology, and lean manufacturing practices to help optimize designs for efficient production. This early collaboration can help identify production considerations before machining or prototyping begins and support improved manufacturability, value, and production readiness.

MoManTech’s additive manufacturing capabilities include metal, plastic, and composite options. Listed materials include 17-4 stainless steel, 316L stainless steel, titanium in beta, Onyx, carbon fiber, Kevlar, fiberglass, and HSHT fiberglass reinforcement. Material selection depends on the prototype or custom fixturing application and the project requirements. The team can discuss suitable options during project planning.

MoManTech operates with ISO 13485:2016-certified manufacturing and provides comprehensive quality control, inspection, and documented quality support. Its contract manufacturing services also identify FDA-regulated processes and compliance documentation. Quality activities are integrated with controlled processes, trained personnel, and defect prevention practices. Specific documentation and inspection requirements can be established according to the device program and customer needs.