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There is no room for error when designing critical-use medical devices and equipment. Taking a holistic view of the part/component during the design phase—including assembly implications—allows for a thorough understanding of how all of the factors involved impact the end product. It also helps injection molders identify and correct injection molding defects in engineered plastic components during early project phases, which ultimately saves money and reduces time to market.
Critical use medical applications require devices and equipment that are protected from dust, chemical vapors, aerosol particles, airborne microbes and other contaminants that could compromise product quality, integrity and safety.
Medical OEMs make device reliability a top priority, working with complex injection molders that are experienced in scientific molding to ensure accuracy in processes and production. The higher level of precision helps minimize overall costs by allowing for identification and correction of problems prior to production.
Commodity plastics are versatile materials appropriate for a breadth of applications. However, specialty or complex injection molded parts like those required for medical, fire, and safety industries may contain requirements that mainstream polymers can’t fulfill, such as chemical resistance, fire retardant properties and mechanical grade strength.
Critical-use medical devices are essential in the performance of important and often life-saving tasks. As such, they often boast complicated designs and functionality that require the expertise of a complex injection molder to produce. However, that’s only part of the equation.
Manufacturers of medical devices and other medical applications often turn to a complex injection molder for help correcting defects in their engineered plastic components. At Kaysun, we actively seek to prevent defects before they even occur by using a design for manufacturability (DfM) approach that incorporates a comprehensive mold flow analysis and extensive plastics engineering experience to identify any potential issues in the design phase and determine the best strategy to produce defect-free parts.
The success of a medical component project, like any other, depends on accurate communication of needs and expectations, especially in injection molding design. Engineers responsible for executing the project carefully review any initial designs submitted by the customer or potential customer, looking for specific elements that could help or hinder the medical component production.
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).
Critical-use medical device manufacturers are faced with keeping pace with technological advancements and earning market share while simultaneously producing extremely precise and reliable medical products. Meeting all these challenges is a tall order, and utilizing the scientific molding process can help.