Polymer solutions for medical device manufacturing
Applying relentless attention to technical and regulatory compliance, Mitsubishi Chemical Group offers a full spectrum of polymer solutions for Healthcare, including biocompatible, implantable thermoplastic shapes.
As a leading international chemical company, we leverage our global footprint and highly knowledgeable teams to provide comprehensive polymer solutions for medical and life science applications.
In partnering with Healthcare OEMs and engineers, Mitsubishi Chemical Group offers the combined power of high performance materials, expert compliance guidance, and a global network of modern manufacturing sites including cleanroom facilities and automated technologies. As such, we support our customers with the sophisticated engineering capabilities, global supply chain management, and quality assurance they need to manufacture medical devices that improve patients' lives.
Providing a quick and efficient supply of implantable thermoplastic shapes, from ready-made, pre-assessed stock shapes to customized and semi-finished products
As part of our larger offering for the global Healthcare industry, we provide biocompatible materials and production technologies that embed safety and performance into the manufacture of implantable thermoplastic shapes. With a comprehensive line of fully traceable, biocompatible materials, as well as the global manufacturing infrastructure to ensure business continuity and surety of supply, the MediTECH® division of Mitsubishi Chemical Group gives engineers and OEMs reliable access to the broadest portfolio of implantable thermoplastic shapes on the market, including leading Chirulen®, Extrulen®, and Zeniva® products.
Safety risk management is an essential requirement in the development of a medical device as part of the overall conformance assessment that the device works as intended. We are committed to an ethical approach in the supply of our materials, with robust quality systems, full traceability, and a flexible offering that will support your risk management process and assessment requirements.
- Market’s largest portfolio of implantable UHMW-PE and PEEK shapes with complete traceability from resin to stock shape
- Materials and formulations pre-assessed for long-term body and tissue contact
- Expert technical support and regulatory assistance
- Global footprint and manufacturing locations support business continuity and product availability via globally integrated distribution agreements
- ISO 13485 certified machined parts manufacturing locations
- Sustainable & ethical business practices
MediTECH Zeniva® PEEK is a high-performance biocompatible polymer used primarily for spinal fusion cages, suture anchors, craniomaxillofacial reconstruction, and total knee replacement, as well as dental implants such as abutments, crowns, bridges, and frameworks. Unlike implants made of metal alloys, Zeniva® PEEK implants exhibit a modulus similar to cortical bone – improving the comfort of the patient and extending the lifetime of the implant with greater stability and reduced wear.
Extrulen® and Chirulen® UHMW-PE
MediTECH is a leading supplier of Extrulen® and Chirulen® UHMW-PE products for orthopaedic implants, offering the superior physical and mechanical properties of these premium grade polymers combined with superior cleanliness and consistency. Both ram extruded Extrulen® and compression molded Chirulen® can be enhanced with antioxidants and crosslinking.
Near-net shapes via Direct Compression Molding
MediTECH’s newest process capability is Direct Compression Molding (DCM), a technology that enables the production of shapes with dimensions close to that of the finished product. Compared with machining of stock shapes, DCM offers customers in the healthcare industry a production method that optimizes the part yield and reduces the full production process operations. Do you have plans to start a new DCM program? Get in touch. Our experts will help you define the best approach.
Antioxidant enhanced Extrulen® and Chirulen® UHMW-PE
Antioxidants in UHMW-PE products have the potential to extend the wear life of implants through the reduction of oxidation in both standard and crosslinked parts. Both Extrulen® and Chirulen® can be enhanced with antioxidants to reduce oxidation potential or to neutralize free radicals generated in crosslinking via irradiation. MediTECH can provide industry standard vitamin-E based products, and custom-blend specific antioxidants or differing antioxidant concentrations to meet new industry needs
Crosslinked Extrulen® and Chirulen® UHMW-PE
Crosslinking of UHMW-PE productions has been demonstrated to increase the wear resistance of manufactured parts. For example, the balance of wear and mechanical strength is affected by the level of crosslinking and is specified by the energy dose provided. MediTECH can supply products across the full span of irradiation levels to meet customer specific preferences. The crosslinking methods are also customizable with Gamma, E-Beam, and X-Ray potentials to meet customer requirements and application needs.
Expert support through design, development, and production – all at a global scale.
The human body is complex, and so is navigating the approval and regulatory process for bringing new medical devices to market. We help our Healthcare customers evaluate material data (including our biocompatibility pre-assessments) to provide them with a robust and tailored selection of candidate materials for their application and the regulatory requirements to which they adhere.
The MediTECH implantable offering includes products that are produced under ISO 13485 and pre-assessed for biocompatibility, assisting the OEM in the selection and application of our products, while also providing full traceability from raw material to stock shape. And with manufacturing locations in both Europe and North America, our globally integrated distribution agreements ensure reliable product availability.
Get in touch with our specialist teams by filling in the contact form. We’re ready to meet your next challenge.