Medical Plastic Injection Molding
Medical injection molding includes the manufacturing of medical components and devices using medical grade plastic materials that are durable, reliable and meet FDA regulations. The medical plastic injection molding process is cost-efficient, and ideal for high volume production runs and applications requiring consistency and tight tolerances. Medical injection molding is also used for medical device prototype development for the FDA approval process and for use in laboratory testing.
Stack Plastics can create any number of specialized plastic injection molded medical parts, either as subassemblies or as components for more complex instruments. We are ISO 13485:2016 certified for medical injection molding for all types of components and assemblies and have the expertise working with a wide range of medical grade plastics and injection molding processes.
Medical Injection Molding with Stack Plastics
Using our medical injection molding processes, Stack Plastics produces delivery devices for stents, implants, sutures, and more. We also offer assembly services for subcomponents of larger, more complicated medical devices. In addition to medical injection molding, we manufacture plastic moldings that house other, non-plastic components or mechanisms.
Our medical insert molding processes can create housings for medical devices including:
- Surgical instruments and blades
- Dental instruments
- Medical equipment components
- And more
Stack Plastics utilizes state-of-the-art vertical medical plastic injection molding workstations dedicated to this process. We have also forged solid relationships with several trusted vendors who supply us with top quality metal components for medical plastic injection molding projects due to our experience in the industry.
Catheter Molding Capabilities
Our catheter molding capabilities incorporate insert molding, micromolding, and overmolding processes, along with special biocompatible resins. We can produce catheter tips, luer fittings, joints, markers, manifolds, and more through precision catheter molding, with ceramic or metal components and assemblies included, as needed.
Medical Device Prototype Development
Medical device prototype development requires creating fully functioning components for use in testing for FDA approval processes. Stack Plastics uses state-of-the-art methods and utilizes the best medical grade plastic materials for our medical device prototype development services. We understand the strict regulations required by the medical and healthcare industries and will take every measure to ensure your prototype meets Class I, II or II FDA medical device classification required for your application.
Medical Molding Using Medical Grade Plastic Resins
Stack Plastics utilizes a variety of unique materials for medical plastic injection molding, making it possible for us to provide the ideal medical plastics for your project's needs. We use various engineering resins for our medical injection molding that offer excellent mechanical properties, high tensile strength to resist breakage, and high temperature load ratings to avoid deformation due to heat exposure during sterilization.
Medical Grade Plastic Materials
The medical grade plastic materials we use for medical injection molding have high molecular weight and feature chemical and heat resistant properties. Each type of thermoplastic used for medical molding also features different advantages and qualities you will want to review before selecting a material for your injection molding application.
- Polycarbonate: naturally transparent and commonly used for medical tubing, this medical grade plastic features high tensile, shear and flexural strength. It also provides high heat resistance, low moisture absorption, and is stronger than acrylic.
- PEEK: an exotic medical grade plastic resin that is highly resistant to chemicals, resists cracking and fatigue and can be sterilized via autoclave. It is FDA approved for food contact and has a UL 94 V-0 flammability rating.
- Ultem™: used for medical devices and be sterilized via autoclave. It resists environmental stress and cracking, provides excellent dimensional stability and exhibits superior strength and stiffness.
We also use several specialized medical grade plastics with built-in resins and fillers, such as fiberglass carbon fiber, talc, or custom color compounds, to give the completed medical moldings mechanical advantages or other unique properties.
Considerations for Selecting Medical Grade Plastic Materials
There are several grades of plastic available for medical device injection molding and medical device prototype development. Each material carries unique properties that determine how it will perform in its intended application and operating environment. Considerations for selecting the right medical grade plastic material for your application include:
- Strength: Plastic resins provide varying levels of strength, so it is important to make sure the medical grade plastic material you select provides the strength properties required your application.
- FDA Requirements: Medical devices that are being implanted have different requirements than those being used for tubing, medical instruments, and other external uses. Review the FDA requirements for your application prior to selecting a material.
- Resistance to Chemicals and Heat: Chemical and heat resistance are two critical considerations when selecting a medical grade plastic material, especially if your finished components must be able to withstand sterilization via autoclave, gamma ray or chemical methods.
- Operating environment: Operating conditions determine requirements for strength, temperature resistance, chemical resistance, corrosion resistance, exposure to radiation, and other factors. Make sure the medical grade plastic material you select can withstand the conditions of your operating environment.
- Molding Method: Medical injection molding and medical insert molding are two methods commonly used for medical device prototype development but not all plastic materials are compatible with both methods. It is important to determine which method you will be using before selecting a medical grade plastic material.
Stack Plastics has the knowledge and expertise to help ensure the right medical grade plastic material is used for your medical device application. We’ll consider your design, molding method and application requirements to make sure you receive a finished product that performs as required.
Medical Plastic Injection Molding in An ISO Certified Facility
Our expertise with engineering resins and specialized medical plastics ensures that your medical injection molding products will meet your exact specifications. We are ISO 13485:2016 certified for comprehensive quality assurance management in the manufacturing of medical devices.
Contact us with your design requirements and we will help you determine which medical molding process and material are best for your application. Some parts might not be suitable for medical injection molding and if that is the case, we will help you find a process that will work for you.
Our goal is to provide medical molding and medical device prototype development solutions that are within your budget while delivering products that meet the design requirements of your application. We also understand the importance of providing medical grade plastic materials that are biocompatible and adhering to regulatory requirements for medical molding.
To complete your medical injection molding or medical device prototype development project, Stack Plastics provides various secondary services including:
- Assembly using pneumatic or manual methods to join molded parts
- Ultrasonic bonding to create a durable bond between two or more components
- Pad printing to add logos, instructions and other designs on the surface of your molded parts