ProMed, a recognized leader in precision manufacturing for regulated industries, continues to set benchmarks in the application of silicone over molding for medical devices.
-- ProMed, a recognized leader in precision manufacturing for regulated industries, continues to set benchmarks in the application of silicone over molding for medical devices. Silicone over molding, a specialized process that combines liquid silicone rubber with rigid substrates such as metals or high-performance plastics, enables the production of devices that demand exacting tolerances, durability, and reliable performance. This manufacturing approach is increasingly critical for devices exposed to repeated sterilization cycles, harsh environmental conditions, and high-use scenarios in medical settings.
ProMed’s expertise in silicone over molding is built on decades of experience in materials science, tooling design, and process optimization. The company’s facilities integrate advanced molding equipment with ISO 13485-certified cleanroom environments, ensuring that every component meets stringent regulatory and quality standards. The combination of mechanical interlocks, chemical adhesion techniques, and precise injection control allows for complex multi-material assemblies that maintain structural integrity and enhance functional reliability.
In the realm of medical device manufacturing, silicone over molding supports the creation of ergonomic grips, seals, and protective housings that improve both patient safety and clinician usability. The technique provides superior environmental sealing against moisture, chemicals, and temperature extremes while maintaining biocompatibility and compliance with FDA and ISO 10993 standards. These attributes are essential for applications ranging from implantable components to wearable health monitors and precision instruments.
ProMed’s process begins with meticulous substrate preparation and positioning, followed by controlled injection of liquid silicone. Both LSR (Liquid Silicone Rubber) and HCR (High Consistency Rubber) systems are employed depending on component size, complexity, and performance requirements. The careful selection of substrates, combined with precision molding parameters, ensures that finished components deliver consistent adhesion, dimensional stability, and long-term durability. This rigorous approach minimizes potential defects such as delamination or incomplete fills and supports high-yield, scalable production runs.
The company’s commitment to quality extends beyond manufacturing. Comprehensive validation, including IQ/OQ/PQ protocols, dimensional inspection with CMM and optical systems, and rigorous bond strength testing, ensures that all products meet or exceed industry standards. Environmental testing, biocompatibility evaluation, and sterilization validation further guarantee that each component performs reliably throughout its lifecycle. These measures establish confidence in the safety, performance, and regulatory compliance of devices produced using silicone over molding.
ProMed’s focus on process optimization also contributes to cost efficiency. By integrating substrates and silicone into single-molded components, labor-intensive assembly steps are reduced, part counts are minimized, and production scalability is enhanced. High-volume and low-volume projects alike benefit from consistent quality, reduced waste, and faster time-to-market, supporting both operational efficiency and financial return for clients.
Across the medical device sector, ProMed has applied its silicone over molding capabilities to a wide range of applications, including long-term implantable devices, diagnostic equipment, surgical instruments, and wearable medical technologies. The company’s expertise allows design teams to balance performance, ergonomics, and regulatory requirements without compromising on reliability or manufacturability. By combining advanced materials, precise tooling, and disciplined quality oversight, ProMed delivers components engineered for high-stakes, high-performance environments.
As demand for complex, reliable medical devices grows, silicone over molding has become an increasingly vital component of advanced manufacturing strategies. ProMed’s leadership in this field demonstrates the company’s ability to translate specialized expertise into tangible benefits for clients across regulated industries. Consistent product quality, robust mechanical performance, and adherence to regulatory standards position ProMed as a trusted partner for organizations seeking components that meet the most rigorous requirements.
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, single use devices, drug-releasing combination devices, and specialized materials and processes for defense 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.
About the company: 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.
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Name: Kevin Roy
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