Plastic Medical Injection Molding: An Expert Overview

by Gilero October 5, 2023

Updated October 5, 2023

What is Plastic Injection Molding? 

Injection molding is a method to obtain molded products by injecting plastic materials molten by heat into a mold, and then cooling and solidifying them. The method is used for mass production of products with complicated shapes and plays a large part in plastic processing. Injection molding for medical devices can be performed by using many sorts of materials such as metals, confections, and most commonly thermoplastic and thermosetting polymers.

How is Plastic Injection Molding used in the Medical Industry? 

Plastic injection molding is widely used in the medical device industry. Plastics are often used alongside the injection molding process to produce prototypes and full-production units of medical devices and equipment components. As newer plastic materials and component designs are developed, injection molding medical devices has increasingly contributed to lower infectious disease rates, and lower medical costs.

What Are the Benefits of Plastic Injection Molding Medical Devices? 

Medical device injection molding also has many other advantages, such as compliance with industry standards and regulations. Engineering-grade plastics can be used in the process to create parts that enhance patient safety and comply with FDA (Food and Drug Administration) guidelines. There is flexibility with injection molding, as the parts can be fully customizable to fit the user. The ability to fulfill high-volume orders with high accuracy and precision is also an advantage of injection molding medical devices. In addition, injection molding is a cost-effective manufacturing method. With automation technology and energy-efficient equipment, we further reduce our labor and utility costs. 

Considerations for Injection Molding Medical Devices  

• FDA Regulations- FDA regulations for cleanliness and sterilization are a critical consideration for medical components, both in the parts that are being made and in the manufacturing process. The material you select must meet those standards, and the manufacturing partner must be able to pass an audit or other regulatory requirement for medical-grade approval. 
• ISO certification and compliance – At a minimum, any facility producing medical components must meet ISO 13485:2003 standards with further compliance to Class I, II or III required, depending on the products being manufactured. Confirm that your manufacturing partner is aware of the standards related to your application and that the facility can meet and sustain compliance via audit. 
• Material properties– The material chosen for medical components and devices must display specific physical properties to be suitable for these applications. These include: the ability to be sterilized, suitability for extreme environments, and durability.  

Materials Used for Injection Molding Medical Devices  

There are many diverse types of materials that can be used in injection molding medical devices. Some useful and commonly used materials include: 

• Silicone 
• Polycarbonate 
• Polyethylene
• Polypropylene
• Thermoplastic
• Glass-filled polymer

What Are Gilero’s Plastic Injection Molding Services? 

Gilero provides a range of manufacturing services, including plastic injection molding and injection mold tool building. We focus solely on the medical device and drug delivery markets. Our medical injection molding facilities follow strict design protocols and process controls to ensure that all products meet the required specifications. Depending on client needs and product requirements, we can offer manual or fully automated production lines for molding and assembly. 

Our Injection Molding Services: 

• Cleanroom injection molding 
• Gas-assist, two-shot, insert and over molding 
• Pad printing & screen printing
• Annealing, heat staking, ultrasonic welding & curing
• First article inspection and capability analysis
• Injection molding process validations
• Real-time process monitoring

Our Injection Mold Tooling Services: 

• In-house mold toolmaking 
• High precision machining 
• Rapid tool iterations & modifications 
• Quick turnaround prototyping 
• Mold flow analysis 
• Scientific molding process development 
• Single cavity pre-production injection molds 
• High cavitation hot runner mold systems 

About the Author

Gilero Gilero specializes in the design, development, and contract manufacturing of medical, drug delivery, and diagnostic devices, bringing innovative healthcare solutions to market. The team combines engineering expertise with a deep understanding of regulatory requirements.