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Integrated capabilities for regulated medical manufacturing

As a partner to medical device manufacturers, we see our role as extending beyond simply supplying advanced materials. We collaborate with you to help design, validate, manufacture, and assemble components within tightly regulated environments, all without sacrificing speed, quality, or supply reliability.

Mitsubishi Chemical Group’s capabilities for the healthcare sector are integrated across material science, engineering, and manufacturing disciplines. From early-stage design support to cleanroom assembly options to production on a global scale, we help medical device manufacturers reduce risk, accelerate development, and execute production.

By aligning materials expertise with regulatory, quality, and operational requirements, we facilitate a smoother path for innovative medical devices to go from concept to market.

End-to-end engineering services for medical device developers

Design & Engineering

We collaborate with medical device manufacturers to engineer designs optimized for performance, manufacturability, and scalability. Our design and engineering capabilities include custom part development, metals-to-plastics conversion, and risk mitigation supported by proprietary FMEA tools. This approach helps reduce development risk while supporting efficient transition to production.

Material Selection & Compounding

We offer a broad portfolio of medical-grade and high-performance thermoplastics and composite materials, supported by deep expertise in polymer compounding. By selecting and blending polymers to achieve targeted mechanical, thermal, and chemical properties, we help align material performance with specific device and processing requirements. This enables more precise material choices across diverse medical applications.

Advanced Custom Synthesis

Our advanced custom synthesis capabilities support the development of specialized polymers from monomers, macromers, and pre-polymers through multiple polymerization pathways. These capabilities enable precise control over molecular structure and material performance. These custom synthesis services are well suited for highly specialized medical and life science applications.

Prototyping

We provide rapid prototyping services to accelerate design iteration and early-stage development. Capabilities such as 3D printing and metal mold printing enable fast evaluation of form, fit, and function. This allows medical device manufacturers to shorten development timelines and refine designs before full-scale production.

Polymer Shapes

Our polymer shapes can be engineered to support demanding medical applications where precision and consistency are critical. Whether through extrusion, compression molding, cast molding, or near-net-shape processes, we deliver advanced materials designed for functional performance, often key in medical applications. These shapes provide a reliable foundation for downstream machining and fabrication.

Parts Production

We manufacture finished medical components using CNC machining, injection molding, 3D printing, and plastic welding. Our production capabilities are designed to enable the tight tolerances and quality expectations typical of medical devices. This allows us to offer highly consistent part performance across both low- and high-volume production.

Cleanroom Assembly

Our assembly capabilities emphasize scalable production to support reliable global supply. We can deliver complete module builds and assemblies, including operations performed in Class 6 cleanroom environments. This integrated approach helps streamline manufacturing while enabling the strict quality and cleanliness standards of the healthcare sector.

Testing & Inspection

We provide application-specific testing and inspection services managed under internationally recognized quality standards. Our systems support compliance with ISO 13485, ISO 9001, and ISO 10993 requirements. This helps ensure product quality, regulatory readiness, and long-term process consistency.

High-Performance Coatings

Our high-performance coatings are engineered to enhance durability, surface performance, and functional longevity, often key to developers of medical device components. Using plasma spray technologies and robotic process control, we deliver coatings with high repeatability and precision. These solutions support performance optimization sought out for demanding medical environments.

Etching

We offer metal etching services for medical device components manufactured from materials such as titanium, tantalum, aluminum, and magnesium. Etching enhances surface characteristics to improve functional performance in various clinical applications and is commonly applied to implants and components requiring controlled surface modification.

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If your requirements extend beyond the capabilities listed here, our teams can work with you to evaluate custom material, design, or manufacturing needs. Contact us to discuss your application and identify the right technical approach.

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