Medical device performance is inextricably linked to the characteristics of the plastics used. Enhanced properties such as strength, flexibility, transparency, biocompatibility, and temperature and chemical resistance ensure patient safety. They are also mandated by the stringent regulations and classifications of the Food and Drug Administration (FDA) and The U.S. Pharmacopeial Convention (USP).
Working with an injection molder experienced in the intricacies of producing complex medical devices is essential to mitigating patient risk and keeping products in compliance with federal and industry standards. The molder’s depth of knowledge lends itself to the proper selection of medical-grade polymers and matching them to usage conditions prioritized in the medical industry – like microbe-resistance, high heat tolerance and sterilization.
Coupled with materials selection is the molder’s expertise in production processes and part geometry that use the resins to their best advantage in providing:
Durability: Medical devices used in-home or in emergency vehicles are becoming commonplace, and their portability places increased emphasis on device toughness and reliable performance when used by traveling healthcare workers.
Chemical Resistance: Medical devices must withstand repeated sterilization using harsh chemicals like bleach or hospital-grade disinfectants, and exposure to oils, greases and other lubricants during medical procedures.
Antimicrobial Agents: Antimicrobial agents, such as silver ions, can be mixed into the plastic melt, resulting in final injection-molded plastic components and medical devices that have microbe-resistant surfaces that effectively eliminate bacteria. For example, hip implants used to be made from metals with antimicrobial coatings that, over time, would wear off. Implants molded from resins containing antimicrobial agents, on the other hand, continually stand up to bacteria without affecting other properties of the resins.
Thermal and Electrical Characteristics: Due diligence must be undertaken to determine plastic material properties at melting temperatures, sterilization temperatures and in extreme environmental conditions that include both temperatures and humidity. Electrical factors, like conductivity and insulation or the need to dissipate accumulated static charge, must also be considered.
Keeping these factors top of mind, in addition to leveraging the experience of a complex injection molder like Kaysun to identify and use medical grade resins, is key in producing medical devices that consistently perform to customer expectations and medical industry standards.
Learn more about how medical applications benefit from expert injection molding in our whitepaper, The Importance of Scientific Molding in Medical Device Manufacturing. Download your free copy now by clicking the button below.