When lives are on the line, medical device manufacturers need parts that meet strict standards for cleanliness, consistency, and reliable performance. Medical injection molding makes life-saving devices possible by meeting the precision and tracking requirements set by the FDA.
What is medical injection molding?
Medical injection molding is a specialized process used to produce plastic components for medical devices and equipment. It involves using medical-grade resins and operating in tightly controlled environments to meet strict requirements for cleanliness, accuracy, and safety for the human body.
What types of parts are made using medical injection molding?
Common examples include:
- Surgical tools and instrument housings
- Catheters, connectors, and fluid delivery components
- Implantable device components
- Diagnostic device enclosures
- Wearable medical device parts
- Single-use or disposable items like syringes and caps
Each application may have unique requirements for cleaning for medical use, strength, or chemical resistance.
What are the requirements for high-risk medical device parts?
High-risk devices (Class II and Class III) must meet rigorous standards:
- Tight tolerances to ensure performance and patient safety
- Materials safe for the human body that meet ISO 10993 or USP Class VI
- Cleanroom manufacturing (typically ISO Class 7 or 8)
- Full material tracking for materials and processes
- FDA and ISO 13485 compliance
Molded components often go through multiple rounds of design validation and testing before being approved for use.
How does Mako Plastics support medical injection molding?
We combine experience with precision. Our team works closely with design engineers to review part geometry, material selection, and DFM (design for manufacturability) best practices before tooling begins. We offer:
- Cleanroom-ready production
- Advanced tooling and tight-tolerance capabilities
- Expertise in FDA-compliant resins and additive-free materials
- On-time delivery for high-volume production or short runs
- Full documentation and quality control
What materials are used in medical-grade molding?
Typical materials include:
- Clear, strong plastic (polycarbonate) – Tough and transparent
- Lightweight, chemical-resistant plastic (polypropylene) – Flexible and widely used
- PEEK – High strength and heat resistance for implants
- TPU/TPE – Flexible and safe for the human body
- ABS – Used for diagnostic equipment housings
We help customers select the best material for cleaning method, mechanical performance, and compliance.
How does DFM impact medical molding?
DFM is critical. When engineers design parts with molding in mind, it reduces costly revisions and improves production yield. In high-risk medical use, it helps make sure parts are produced the same way every time—without defects.
We assist with:
- Wall thickness and flow analysis
- Gate and venting optimization
- Draft angles and part ejection
- Mold flow simulations
- Tolerance stack-ups
Do you offer support for prototyping or low-volume production?
Yes. We offer rapid tooling and short-run production services to help customers validate designs and accelerate FDA submission timelines. This is especially useful for startups or R&D teams working on next-gen devices.
What quality standards do you meet?
We support quality systems in line with:
- ISO 13485 (medical devices)
- FDA 21 CFR Part 820
- GMP (Good Manufacturing Practices)
We inspect and document every part to meet customer requirements and can provide full material tracking when needed.
Ready to quote your next medical injection molding project?
Mako Plastics delivers consistent, clean, and compliant parts—whether you need a few hundred units or full-scale production. Let’s talk about your application and how we can help you move from concept to production with confidence.
