News

ProMed Advances Liquid Silicone Rubber Molding for High-Precision Medical Devices

ProMed, a leading contract manufacturer specializing in silicone and plastic components for regulated industries, announces significant advancements in liquid silicone rubber molding (LSR) technology tailored to high-precision medical devices. These enhancements are set to reinforce ProMed’s position as a trusted partner for medical device manufacturers seeking reliability, quality, and regulatory compliance in their silicone components. Liquid silicone rubber molding has become a critical process in medical device manufacturing due to its unique combination of biocompatibility, durability, and flexibility. ProMed’s investment in state-of-the-art molding equipment and process optimization techniques ensures that components meet stringent specifications for dimensional accuracy and material purity, key factors in the production of implantable devices, surgical tools, diagnostic equipment, and wearable health technologies. The company’s approach focuses on meticulous control of molding parameters, including injection speed, cure temperature, and pressure profiles. This precision enhances part reproducibility, minimizes defects, and ensures consistent performance across large production volumes. Such consistency is vital in medical applications, where even minor deviations can affect patient safety and device functionality. In addition to technical upgrades, ProMed emphasizes compliance with the rigorous regulatory landscape governing medical silicone components. All molded parts undergo thorough testing and validation in alignment with ISO 10993 biocompatibility standards and USP Class VI certifications. This comprehensive quality assurance process extends through every phase of production, from raw material selection to final inspection, helping customers confidently navigate FDA and international approvals. ProMed’s expertise in LSR molding also includes advanced techniques such as multi-shot molding and over-molding, which enable the creation of complex, multi-material components that improve device ergonomics and functionality. These capabilities support innovation in next-generation medical devices by allowing integrated designs that reduce assembly steps and improve durability. The company’s highly trained engineering and manufacturing teams collaborate closely with customers during product development, offering material selection guidance and design for manufacturability reviews. This partnership approach helps optimize durometer selection and geometric design, balancing flexibility and rigidity to meet specific clinical requirements. Early involvement in the design process reduces tooling complexity and accelerates time-to-market. Material traceability and batch documentation are integral to ProMed’s manufacturing operations. Electronic batch records and lot tracking systems facilitate rapid root cause analysis and support detailed regulatory audits. This level of transparency enhances supply chain reliability and fosters trust among device manufacturers and regulators alike. ProMed’s advancements come amid growing demand for silicone-based medical components capable of withstanding harsh sterilization methods, including steam autoclaving, ethylene oxide, and gamma irradiation. The company’s molded parts maintain mechanical integrity and chemical resistance after repeated sterilization cycles, ensuring long-term performance in critical clinical environments. The company continues to invest in research and development, exploring new silicone formulations and processing technologies that further enhance product performance while controlling costs. Emphasis on lean manufacturing and continuous quality improvement enables ProMed to deliver high-value solutions without compromising compliance or reliability. As medical device manufacturers face increasingly complex regulatory challenges and market pressures, ProMed’s expanded capabilities in liquid silicone rubber molding provide a competitive edge through precision, consistency, and robust quality systems. This advancement underscores the company’s commitment to supporting the evolving needs of the healthcare industry with innovative manufacturing solutions designed to improve patient outcomes and device reliability. For medical device companies seeking a manufacturing partner that combines deep expertise with flexible, scalable production capabilities, ProMed’s leadership in LSR molding represents a compelling option. The company’s comprehensive service offering extends from prototyping and small-batch runs to high-volume production, making it well-suited for both established products and emerging technologies. By continuously pushing the boundaries of what is possible in medical-grade silicone molding, ProMed remains dedicated to delivering components that meet the highest standards of purity, precision, and performance required in the most demanding healthcare applications. About ProMed: Since 1989, ProMed has been recognized as a leading Contract Manufacturer of complex, intricately designed molded silicone and plastic components and assemblies for highly regulated industries.  ProMed’s expertise extends across applications for short-term and long-term implantable devices, drug-releasing combination devices, and specialized materials and processes for aerospace, defense, and automotive applications.  We collaboratively work with our customers from prototype through production, providing over 30 years of experience related to design for manufacturability, material selection, tool and fixture design, process development, manufacturing, and other value-added services that result in cost-effective solutions with superior quality.