Medical Injection Molding Services
Medical injection molding is one of the most demanding applications in plastics manufacturing. Medical device makers, surgical instrument suppliers, and diagnostic equipment producers require components that hold tight tolerances, meet strict biocompatibility standards, and perform consistently across high production volumes.
JDI Plastics is a custom injection molder based in Illinois, specializing in complex, difficult-to-mold components for the medical industry. We also provide plastic insert and overmolding services. Founded in 1995, we hold ISO 9001 certification and are also compliant to ISO 13485 standards. With more than 20 injection molding machines on the floor, we handle the full production cycle from molding through assembly, packaging, and shipment. Mold tooling is sourced and managed through JDI as part of the program, so customers work with a single point of contact throughout.
Learn more about our precision molding capabilities, secondary assembly services, medical-grade material expertise, and quality system for injection molding medical devices.
Precision Injection Molding for Medical Devices
Medical injection molding demands tighter process control than standard commercial work. Part design, resin selection, and tooling management all interact, and small deviations in any one of them can produce out-of-spec components at scale. JDI specializes in complex geometries, specified materials, and tight-tolerance designs where process variability is not an option. Tolerances are held to +/- 0.001 inch, where required. Our capabilities include:
- Tight-tolerance production molding for surgical instruments, diagnostic components, and drug delivery systems
- Multi-cavity tooling programs for high-volume disposable devices and complex assemblies
- Tooling transfer support for medical programs transitioning from previous suppliers
- Preventative mold maintenance to protect tooling life and preserve part consistency
Secondary Assembly Services
JDI operates as a single-source partner for injection molding medical devices. Once parts come off the press, they move through secondary operations and packaging within the same facility, reducing handling risk and eliminating the need for vendor coordination across production phases. Secondary services include:
- Ultrasonic welding (plastic and insert)
- Component bonding and heat staking
- Solvent bonding
- Mechanical assembly and wire/solder assembly
- Custom packaging, labeling, bar coding, pad printing, and hot stamping
Biocompatible & Medical-Grade Polymer Expertise
Material selection directly affects biocompatibility, sterilization performance, and dimensional stability. JDI works with engineers early in the design process to match resin properties to application requirements. All medical programs run on virgin resin only, consistent with FDA and ISO 10993 biocompatibility requirements. Common materials we process include:
- Polycarbonate (PC): sterilization-compatible, optically clear grades for diagnostic and surgical applications
- ABS / PC-ABS blends: impact-resistant grades for device housings and structural parts
- Nylon (Polyamide): high-strength, wear-resistant grades for mechanical device components
- PEEK and LCP: high-performance engineering resins for surgical tool applications and demanding device components
- TPE: flexible grades for grips, seals, and overmolded components
- USP Class VI and FDA-approved resins: available where specified by the device design
Quality System and Traceability for Medical Injection Molding
Quality control at JDI is built into the production process, not applied after the fact. Our quality management system is aligned with ISO 13485 requirements, and we hold ISO 9001 certification. Key elements of our medical injection molding, insert molding, and overmolding quality program include:
- Process validation documentation. IQ, OQ, and PQ protocol documentation were produced for each product to support customer regulatory submissions.
- Lot traceability. Material lot numbers, process parameters, and inspection records are retained for every production run.
- In-process inspection. Dimensional and cosmetic checks at critical production stages.
- Direct owner access. Engineers and purchasing managers reach the owner directly when program questions arise.
Request a Medical Injection Molding Quote from JDI Plastics
JDI Plastics brings the process control, material expertise, and quality documentation required for medical injection molding. Customers work directly with our expert engineers, but if needed, they are able to work directly with the owner which keeps communication fast when programs are in qualification or production timelines are tight. There are no rush fees.
If you are sourcing an injection mold for a new program, transferring tooling from an existing supplier, or looking to consolidate secondary assembly under one roof, contact us to discuss your requirements.