The essence of medical injection molding is the production of medical components and devices using durable, reliable and FDA-compliant medical-grade plastic materials. The medical plastic injection molding process is cost-effective and well suited for large-scale production operations and applications that require consistency and close tolerances. This molding process is also used for medical device prototyping and laboratory testing during the FDA approval process. Elimold is a leading supplier of injection molded components for medical plastics. We can provide medical-grade plastic materials and medical device prototyping and mass production.
Advantages of Medical Plastic Injection Molding
Medical-grade plastics are a must-have material for many types of medical products, especially some medical products that need to be implanted in the human body, which must be produced using medical-grade plastic materials. In addition, their versatility and ability to combine with metals to create enhanced medical product features. However, if you want to produce medical-grade plastic products, you need to use the injection molding process. The medical injection molding process is a highly specialized manufacturing technology used to produce precision, high-quality plastic parts for the healthcare industry. This process is essential for manufacturing medical devices, tools, and packaging that require strict adherence to safety and performance standards.
Medical injection molding typically uses medical-grade thermoplastics such as polypropylene, polycarbonate, and polystyrene, which are widely used due to their biocompatibility and sterilizability. The process begins with designing the part using computer-aided design (CAD) software. Before full production, injection mold design engineers often create prototypes to evaluate form, fit, and function. After the product’s manufacturability analysis is completed, the production injection mold is initially made, and the mold is usually made of steel or aluminum and designed according to the part specifications. The mold consists of two halves that fit together to form the plastic cavity.
Medical injection molding is essential in the healthcare field, which can produce reliable, safe, and effective medical products to enhance patient care. The main advantages of this process are:
- Precision and consistency: Injection molding allows for high-precision manufacturing, ensuring that each part consistently meets strict specifications.
- Complex geometries: It can produce complex designs and complex shapes that are difficult or impossible to achieve with other manufacturing methods.
- High-volume production: This method is ideal for large-scale production because it can quickly and efficiently manufacture a large number of parts.
- Material Versatility: A wide range of biocompatible plastics are available for a variety of medical applications, from syringes to implants.
- Cost-Effectiveness: While initial setup costs may be high, the lower unit costs of large-scale production often provide an economic advantage in the long run.
- Easy Sterilization: Many of the materials used in injection molding can be easily sterilized, which is critical for medical applications.
- Customization: Injection molding allows for easy customization of components, allowing manufacturers to meet specific customer needs or regulatory requirements.
- Durability: Molded parts often have excellent mechanical properties, which contribute to the overall durability and reliability of medical devices.
Why is Plastic Injection Molding Important in the Medical Field?
Plastics have a wide range of applications in modern medicine. Medical devices made from injection plastics help reduce healthcare costs, infectious diseases, and pain management. High-tech polymers are used in medical device prototyping, often to create improved prosthetics and devices that reduce the risk of infection. Medical plastic injection molding directly improves patient safety and the ability to save more lives. Medical injection molding processes can be used to create delivery devices for stents, implants, sutures, and more. Large, complex medical devices and related components can also be produced.
Medical Device Injection Molding Rapid Prototyping
The initial stages of a full-fledged medical device development often require the creation of fully functional components through rapid prototyping to be tested during the FDA approval process. Elimold uses state-of-the-art methods and medical grade plastic materials required for medical device prototyping services. We know the strict regulations required by the medical and healthcare industries and will take all steps to ensure that your prototype meets the FDA Class I, II or Class II medical device classification required for your application.
Medical Molding of Medical Grade Plastic Resins
Elimold has the advantage of using a variety of unique materials for injection molding plastics, allowing us to provide the ideal medical plastic for your project needs. We also use a variety of engineering resins in medical injection molding that have excellent mechanical properties, including high tensile strength to resist cracking and high temperature load ratings to avoid deformation due to heat during sterilization. ZED by Autoclave. It is FDA approved for food contact and has a 94 V-0 flammability rating. In addition, we also use several specialty medical grade plastics with built-in resins and fillers, such as fiberglass fibers, talc, or custom color compounds. This provides some mechanical advantages or other unique properties for the application.
Types of Medical Device Injection Molding Materials
Medical grade plastic materials used for medical injection molding have high molecular weight, chemical resistance, and heat resistance. Each thermoplastic used for medical molding also has different advantages and qualities that you need to review before selecting a material for your injection molding application. Below are several material names and properties commonly used for injection molding of medical products (please contact Elimold for more materials).
- Polycarbonate: Naturally transparent and commonly used in medical catheters, this medical grade plastic has high tensile, shear, and flexural strengths. It also has high heat resistance, low moisture absorption, and is stronger than acrylic.
- PEEK: A special medical grade plastic resin that is highly resistant to chemicals, cracking, and fatigue and can be sterilized by autoclave. It is FDA approved for food contact and has a UL 94 V-0 flammability rating.
- Ultem™: Used in medical devices and sterilized by autoclave. It resists environmental stress and cracking, provides excellent dimensional stability, and offers excellent strength and stiffness.
Things to consider when selecting medical injection molding plastic materials
There are many types of plastics available on the market today that can be used for medical device injection molding and medical device prototyping. Each material has unique properties that determine how it will perform in the intended application and operating environment. Considerations for selecting the right medical grade plastic material for your application include:
- Strength: Plastic resins offer varying degrees of strength, so it is important to ensure that the medical grade plastic material you select offers the strength properties required for your application.
- FDA requirements: The requirements for implantable medical devices differ from those used for tubing, medical instruments, and other external uses. Before selecting a material, review the FDA requirements for your application.
- Chemical and heat resistance: Chemical and heat resistance are two key considerations when selecting medical grade plastics, especially if your finished part must withstand autoclave, gamma irradiation, or chemical sterilization.
- Operating environment: Operating conditions determine the requirements for strength, heat resistance, chemical resistance, corrosion resistance, radiation exposure, and other factors. Make sure the medical grade plastic material you select can withstand your operating conditions.
- Molding Method: Medical injection molding and medical insert molding are two commonly used methods for medical device prototyping, but not all plastic materials are compatible with both methods.
- Therefore, it is important to determine which method you will use before selecting a medical grade plastic material. Of all the medical injection molding companies in the industry, Elimold has the knowledge and expertise to help ensure that the correct medical grade plastic material is used for your medical device application. We will consider your design, molding method, and application requirements to ensure that you receive a finished product that meets your requirements.
Contact Elimold Now for Custom Medical Injection Molding
Contact Elimold to learn more about our medical plastic injection molding services or request a quote today. We are the leading medical plastic injection molding and medical prototyping company experts. Our expertise in engineered resins and specialty medical plastics ensures that your medical injection molded products meet your exact specifications. We are ISO 13485:2016 certified for comprehensive quality assurance management in medical device manufacturing.
When you contact us, let us know your design requirements and we will help you determine the best medical molding process and materials for your application. Some parts may not be suitable for medical injection molding, if this is the case, we will help you find the process that is right for you.
Our goal is to provide medical molding and medical device prototyping solutions within your budget while providing products that meet your application design requirements. We also understand the importance of providing medical grade plastic materials that are biocompatible and meet medical molding regulatory requirements.