Medical Instrument Development: Finding a Trusted Medical Injection Molding Company
What does a capable medical injection molding company look like? Product development teams in the medical industry can’t leave anything up to chance. Medical parts require exact precision, sterile production, and airtight compliance—there’s no room for error.
JDI Plastics is a leading name in precision Injection Molding.
Our capabilities complement all medical component manufacturing supply chains with dedicated client service and advanced technology. As a US-based injection molding company, we take pride in early supplier involvement and client collaboration.
What Is a Medical Injection Molding Company?
Medical injection molding uses precision tooling and engineered plastics to produce components for medical devices. The process involves injecting molten plastic into custom steel or aluminum molds, forming complex, repeatable parts at high volumes.
It’s widely used for manufacturing syringes, diagnostic devices, surgical tools, and housings for electronic equipment. Molding is trusted because it delivers consistent output and tight tolerances required for FDA-cleared products.
Common Injection-Molded Medical Components
| Component | Typical Material Used | Application Area |
|---|---|---|
| Syringe Barrels & Plungers | Polypropylene (PP) | Drug delivery, blood collection |
| IV Hubs and Connectors | Polycarbonate (PC), PVC | Infusion systems, IV lines |
| Diagnostic Test Housings | Polystyrene (PS), ABS | Rapid test kits, point-of-care devices |
| Surgical Instrument Handles | Nylon, Polyetherimide (PEI) | Grips for forceps, scalpels, and retractors |
| Catheter Hubs | Polycarbonate (PC), TPU | Interventional and vascular access devices |
| Inhaler Components | Polypropylene (PP), LCP | Asthma and respiratory treatment |
| Implantable Device Casings | PEEK, Polycarbonate (PC) | Pacemakers, drug delivery systems |
| Diagnostic Cartridge Shells | Polypropylene (PP), COC | Lab-on-chip and automated testing systems |
| Blood Collection Tube Caps | Thermoplastic Elastomer (TPE) | Sealing and safety in specimen collection |
| Needle Shields & Safety Caps | Polypropylene (PP), HDPE | Needle protection and packaging |
Important Qualities of a Medical Injection Molding Company
Regulatory Compliance
No compliance shortcuts tolerated. A qualified molding company must meet medical manufacturing standards. Look for ISO 13485 certification, which signals the company meets international standards for medical device quality systems. FDA registration adds another layer of accountability and traceability. (1)
Cleanroom Facilities
Even a microscopic contaminant can compromise a product. That’s why cleanroom manufacturing is vital. Reputable molders operate in ISO Class 7 or 8 cleanrooms—controlled environments designed to limit airborne particles and protect product integrity.
Material Expertise
Medical-grade plastics aren’t your average polymers. A strong molding partner should understand the behavior of materials like polycarbonate (PC), polymethyl methacrylate (PMMA), polyethylene, and liquid silicone rubber (LSR).
Each has a role, whether it’s in flexible tubing, rigid enclosures, or implantable components.
They should also guide you on resin selection based on your part’s function, chemical resistance, and sterilization method.
Advanced Capabilities
Medical projects often require more than basic molding. The right company will offer services like:
- Insert molding for combining metal and plastic
- Overmolding for dual-material parts
- Micro molding for small-scale precision
- High-cavitation tooling to meet production volumes
Quality Assurance
Quality checks are a standard part of the process. A serious medical molder uses in-process inspections, statistical process control (SPC), and dimensional validation with high-precision metrology tools.
Look for documented processes that trace each step of production, from material batch tracking to final inspection reports. You want transparency and accountability baked into their operation.
Evaluating Medical Injection Molding Partners
Finding the right partner means going beyond capabilities and price tags. You want a company that’s reliable under pressure and committed to your success.
Experience and Track Record
Look for companies with a long-standing focus on medical device manufacturing. Years of experience matter—especially when it comes to regulatory compliance, design refinement, and meeting tight tolerances. A proven track record means they’ve dealt with real-world product challenges and delivered.
Ask for past project examples, client references, and any specialized projects they’ve handled in your category. That’ll give you a clearer picture of what they can actually do.
Customization and Flexibility
Your project may call for unique geometries, specific material blends, or specialized tooling. A capable partner won’t flinch at complexity.
They should help refine your design for manufacturability, offer fast prototyping, and accommodate low-volume production runs when needed. That level of flexibility saves time and money when changes pop up midstream.
Communication and Support
Consistent, honest communication matters more than most people think. You need a team that keeps you updated, flags issues early, and responds quickly when things shift.
Pay attention to how they handle your initial outreach. If they’re slow to reply or vague in answers, it likely won’t improve after you sign a contract.
Benefits of U.S.-Based Medical Injection Molding Companies
When timelines are tight and regulations are strict, staying local pays off. Working with a U.S.-based medical injection molding company comes with fewer surprises and more control over your project.
Closer time zones are another benefit to local operations. It’s easier to hop on a call, tour the facility, or make quick decisions when something unexpected comes up. You’re not waiting 12 hours for an email response or dealing with translation gaps when clarity matters most.
Then there’s the supply chain. Overseas production may look cheaper on paper, but delays at ports, material shortages, and political instability can wreak havoc on your timeline. A domestic partner keeps things moving. Materials get sourced faster. Parts arrive when they’re supposed to—without the customs headaches.
Let’s not forget compliance. U.S. manufacturers are held to rigorous standards. That’s a good thing. Your product needs to meet FDA or ISO requirements anyway, so why risk having to redo work because a part didn’t meet spec? Local partners already know the drill. You get the documentation, traceability, and process controls that medical-grade production demands—without second guessing how or where your parts were made.
FAQs – Injection Molding in Medical Products
What is medical injection molding?
Medical injection molding uses precision tooling to produce plastic components for devices like syringes, surgical tools, and diagnostic equipment. The process supports high-volume output while maintaining tight tolerances and contamination control.
What is the hourly rate for injection molding?
Hourly rates vary based on machine type, part complexity, and production volume. Most range between \$20 and \$200 per hour, depending on the project’s requirements.
How big is the medical injection molding market?
As of 2023, the medical injection molding market reached approximately \$22.5 billion globally. It’s expected to grow at an annual rate of 5.8% through 2030, driven by demand for single-use devices and precision components.
Contact JDI Plastics for a Capable medical injection molding company
Working with a trusted medical injection molding company is key to getting your product across the finish line—faster, safer, and with fewer hiccups. Look for experience, flexibility, and communication you can count on.
And if you’re working in the U.S. market, a domestic partner might give you the speed and control you need to stay ahead.
Contact JDI Plastics to learn more about our capabilities.
Reference:
ISO 13485, ISO.org, https://www.iso.org/iso-13485-medical-devices.html
