Selecting a material shapes supplier for implantable components can be a long journey that stretches from material selection to final regulatory approvals. This detailed process is why having the right supplier can make a difference in ensuring the project is successful.
In the joint bearing surface area, ultra-high molecular weight polyethylene (UHMW-PE) has been the material of choice for implantable components for many years due to excellent wear resistance, low friction, balance of mechanical property strengths, and biocompatibility. Beyond the ability to provide base material, the right partner can bring proven manufacturing capabilities, quality systems and technical support needed to make decisions on the material optimizations. These advantages to the product development process include understanding of:
Base Resin: UHMW-PE
- ASTM F648 Type 1 (Higher mechanical properties, lower molecular weight)
- ASTM F648 Type 2 (Higher molecular weight, some lower mechanical properties)
- Compression molding or RAM extrusion
- Annealing at below melt temperatures to achieve more dimensional stability
- Annealing at above melt temperatures to achieve crystallinity optimization or free radical stabilization
- Inert versus atmospheric environment options during annealing
- Antioxidants for reduction of oxidation potential during different steps of raw material and device processing
- Differing levels of crosslinking for the improvement to wear resistance while balancing the associated reduction of mechanical properties.
The final implantable device requirements will depend on the final device design, including component and material utilization, and potential predicate information. The documentation for the raw materials can include requirements for validation, testing, verification, risk assessments and evidence on the raw materials in support of use in the final application. When looking for a supplier of implantable UHMW-PE shapes, there are obvious advantages to a supplier that has a proven history in product development, quality systems, product testing, and has the following capabilities:
- Prototyping and small production batches
- Multiple global manufacturing locations, warehousing, sales, and technical support
- Testing capabilities for material, mechanical and thermal properties
- Process, product, and test method validation
- Biocompatibility results or testing provision
- ISO 13485 accredited manufacturing facilities management and product compliance
- ASTM F648, ISO 5834-2 standards
Large joint implantable components: shoulder, spine, elbow, hip, knee, ankle
In identifying and selecting a thermoplastic shapes and fabricated components supplier, orthopedic device and implant manufacturers can benefit from companies with innovative healthcare products, advanced engineering, and quality support for demanding medical applications.
Jared Tinker is MediTECH® Global Technology Manager, Mitsubishi Chemical Advanced Materials.
The MediTECH® Implantable division of Mitsubishi Chemicals Advanced Materials (MCAM) has been providing medical grade UHMW-PE products for over 30 years. It has been partnering with implant manufacturers to supply the prototyping, testing, validation and product support in order to meet the expanding needs of the medical device industry. For more information, please visit www.mcam.com.