Case Study: Complex Medical Device
August 2, 2024
SMC Ltd. helped a large surgical device developer bring a highly complex balloon kyphoplasty device to market quickly, while improving quality.
Read More
Medical Thermoplastic Injection Molding Services
VALIDATED PRECISION, SCALED FOR MEDTECH SUCCESS
Scalable, High-Precision Thermoplastics for Medical and Drug Delivery Devices
Precision molding expertise for single-use and combination products.
Every single-use medical device we manufacture begins with the science of precision thermoplastic molding. SMC Ltd. specializes in molding complex geometries and tight-tolerance components used in drug-delivery systems, diagnostics, and other healthcare applications.
From concept through commercial production, our vertically integrated approach combines advanced molding technology, cleanroom environments, and automation to deliver consistent, compliant, and scalable solutions across global facilities.
All thermoplastic processes are validated to IQ/OQ/PQ protocols, ensuring repeatability and full regulatory compliance. Through scientific molding practices, we maintain optimal process control and part integrity—producing premium components with every press cycle.
What We Do
Full-Spectrum Thermoplastic Capabilities Engineered for Medical Performance
With device applications, cosmetics are often as critical as dimensions. Upfront, we will work with you to establish expectations of parting lines, witness lines, ejector locations, gate locations and knit line concerns.
Most often, the molded part is just the start of the manufacturing process. Following the molding process might be a pad printed or laser-marked logo press side, or the component might go directly into an assembly or sub-assembly. With our knowledge and planning of the assembly process, we build into the molding operation any needed part orientation upon ejection from the mold.
Our thermoplastic molding processes are designed for the tight tolerances, cleanliness, and regulatory standards required in medical device manufacturing.
Clean Manufacturing Environments
- Class 7 cleanrooms for critical medical and drug-delivery components
- Class 8 cleanrooms and white rooms for less stringent assemblies
- Controlled environments that ensure particulate-free molding and assembly
Advanced Molding Capabilities
- Insert molding for integrated components
- Micro molding for ultra-small, high-precision geometries
- Two-shot and multi-material molding for complex assemblies
- Gas-assist molding for lightweight, void-free parts
- Hot-cold molding and conformal cooling for cycle efficiency and surface finish
- Micro channels and fine-feature molding for diagnostic and fluidic applications
WHY SMC
Thermoplastics Expertise That Scales from Design to Production
From early material selection through automated assembly and full-scale production, SMC integrates every phase of thermoplastic manufacturing. Our vertically aligned process ensures consistency, compliance, and speed to market, reducing transfer risk while maintaining the highest standards of quality and precision.
Material Expertise
- Early collaboration with your engineering team to optimize manufacturability and performance
- Specialization in engineered resins, including high-temperature, glass-filled, and bioresorbable materials, for strength, clarity, and sterilization compatibility
- Design for Manufacturability (DFM) reviews that streamline validation and transfer, reducing long-term production risk
Integrated Operations and Automation
- Complete range of secondary operations under one roof
- Capabilities include laser marking, bonding, welding, precision trimming, packaging, and in-line vision inspection
- Automated systems for full or sub-assembly of components, minimizing handling and variability
Prototype Through Commercial Scale
- Flexible tooling and automation for smooth transitions from development to global production
- Rapid prototyping, bridge tooling, and process validation (IQ/OQ/PQ) within harmonized FDA- and ISO 13485-compliant quality systems
- Scalable manufacturing that ensures consistent performance across every site
Thought Leadership
Explore Case Studies, Articles and Other Resources
Our contract manufacturing capabilities, focused on single-use and disposable medical devices, include innovative autoinjector platforms designed for subcutaneous or intramuscular injection. These platforms can be customized to your drug formulation.
