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Company insight


Thermoplastics shapes for medical devices


Mitsubishi Chemical Advanced Materials (MCAM) is the only global supplier of thermoplastics shapes that is backward integrated with engineering thermoplastics resins manufacturing and forward integrated with stock shapes, injection moulding, machined components, and advanced engineering services. Here, Eric Tech, MCAM’s strategic growth manager for healthcare, explains what these capabilities mean for medical device developers.


Can you give us an idea of the range of products you offer for medical devices? What are some examples of how they can be used? Eric Tech: Mitsubishi Chemical Advanced Materials’ (MCAM) Life Science Grade (LSG) portfolio consists of ISO 10993/USP Class VI pre-assessment tested thermoplastic shapes developed for the fabrication of medical devices, surgical instruments, and diagnostic equipment. Customers have found that it meets their requirements for a range of applications (>24 hours fluid and tissue contact) and a wide variety of sterilisation and performance needs. Typical applications include surgical instruments, target devices, diagnostic equipment, robotics and lab equipment. The MCAM MediTECH Implantable Polymers division manufactures thermoplastic shapes compliant to ASTM F648 and ISO 5834-2 for UHMW-PE, and ASTM F2026 for PEEK for use in Class III Implants (>30 days). Implantable polymers, such as UHMW-PE and PEEK, can be used for surgical orthopaedic implant applications including large joint orthopaedics, knee and hip implants, spinal cages, and suture anchors.


How are you developing new materials and manufacturing technologies to respond to changing regulatory environment and industry trends in device design? At MCAM, we focus on combining our knowledge of the global regulatory landscape, industry segments, point of care research, and customer engagement, which drives our R&D strategy. This allows the company to identify unmet needs and industry trends, which drives the development of innovative products


and technology solutions to medical device developers.


Once an unmet need is identified, MCAM can initiate a fast-track process of research, testing and support to beta test solutions before commercialisation to make sure they are properly validated. Equally, MCAM’s fully integrated supply chain enables full collaboration with our R&D and materials teams throughout the product development cycle, so MCAM customers experience a significant reduction in time to market. MCAM’s exclusive SPRINT (a technology platform for rapid injection moulding of functional parts) and free-form injection moulding manufacturing technology can help medical device manufacturers compress prototyping development down to three to five days, and provides an accelerated path to 510K approval and production. In addition, our unique clean compounding system (CCS) of manufacturing thermoplastics shapes significantly reduces gels, inclusions, and black specs, resulting in much higher quality devices and improved productivity through the fabrication process.


How do you approach challenges around sterilisation across such a wide portfolio? We look at sterilisation needs from the regulatory level to the point of use. As an example, because of issues around healthcare-acquired infections (HCAI) and the spread of Covid-19, chemical wipes and disinfectants have been getting more aggressive. To keep up with this, we have continued to enhance our chemical and environmental stress cracking (ESCR) testing protocol, which helps customers make informed decisions about suitability for use. In addition, MCAM has initiated ultraviolet C (UVC) testing protocols to


Medical Device Developments / www.nsmedicaldevices.com


understand the cosmetic and mechanical effects on our portfolio from UVC and other technologies to develop new products. From an application standpoint, MCAM engineers engage the sterilisation requirements at the application level using a traditional critical to quality (CTQ) application screening process. After confirming the intended use device classification and global regulatory requirements, the design life cycle, cosmetic and mechanical requirements of the product are taken into consideration. Ensuring MCAM understands the latest industry sterilisation needs like UVC, combined with maintaining an updated sterilisation database for our portfolio. This allows us to provide customers with a variety of product options and support data for device manufacturers to determine suitability for use in their applications with high confidence, reduced risk, and improved safety.


How have you adapted to Covid-19-related supply and demand disruptions? MCAM’s Covid-19 recovery plan includes an improved customer communication and forecasting plan that helps align global supply channels to manage through the recovery cycle and provide global surety of supply. MCAM is engaged with global channel partners to update transportation, inventory, and capacity to make sure customer expectations are exceeded while being resilient during the recovery. Frequent communication, forecasting and demand planning not only allows MCAM to meet historical demand, but also new customer demands as the industry recovers globally. ●


www.mcam.com 93


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