The Advantages of Plastic Injection Molding of Medical Devices
Plastics have transformed the medical industry as they help reduce the spread of infection, stand up to sterilization procedures and help reduce the cost of medical devices and procedures for patients. Likewise, plastic injection molding is revolutionizing the manufacture of medical devices, such as implants, lab equipment, surgical instruments, orthopedics, tubing and catheters, disposable syringes and other items. Key advantages of medical-grade plastics injection molding include providing cost-effective, high-volume throughput and consistent precision, while meeting regulatory requirements.
Thanks to these benefits, as well as advances in plastic injection molding and materials science, the use of plastic injection molding to produce medical devices is expected to grow rapidly over the next decade. As a matter of fact, a report by Prophecy Market Insights (PMI) says the plastic injection molding market for medical devices was valued at $82.7 million in 2020, but is expected to reach $148.88 million by 2030. The report notes that several driving factors are contributing to the growth of plastic injection molding for medical devices, including the increasing global demand for medical devices; the cost-effectiveness of the process; advances in material sciences that have led to the development of new medical-grade plastics; and the ability of plastic injection molding to comply with U.S. Food & Drug Administration (FDA) and other regulatory agency requirements for the manufacture of medical devices.
An Overview of the Plastic Injection Molding Process
While there are many types of automated plastic injection molding machines available to suit every application, the basic process adheres to the following steps:
- A mold is created to exactly match the geometries and measurements of the medical device to be produced.
- Medical-grade plastic resins suitable for the application are fed into a heated barrel and mixed.
- The resins are then melted.
- The resulting molten plastic is injected into the mold where it cools and hardens.
- Once the plastic is suitably hardened, the part is removed from the mold.
Advantages of Plastic Injection Molding for Medical Devices
As the demand for efficient and cost-effective production of medical devices, components and instruments continues to grow, plastic injection molding provides a great solution to that challenge as plastic is less expensive than other materials and, with the right molds, medical device manufacturing can be done quickly, cost efficiently and with a high degree of accuracy and repeatability using plastic injection molding. The technique provides many advantages for medical device manufacturing, including:
- Cost and process efficiency: Injection molding is fast and allows high-volume production with low cost per manufactured part, which is especially true when devices, components or instruments are being mass produced. In addition, molds can be created to precise specifications and are reusable, offering a high degree of accuracy and efficiency in bulk applications.
- High-quality: Plastic injection molding allows even complex medical devices to be made to exacting specifications within tight tolerances and to do so consistently and repeatably, which is crucial in this field since they are placed within the human body or used for patient care purposes.
- Durability: Medical devices made using the appropriate resins and materials in a plastic injection molding process provide superior mechanical properties. They boast tensile strength, high-temperature resistance (crucial for sterilization processes) and tolerances similar to metal.
- High-volume precision and repeatability: When it comes to manufacturing medical devices, even being a few microns or millimeters off spec can render a part or component useless, resulting in scrap and waste – or worse, leading to failure in the application if the error goes unnoticed. However, plastic injection molding, especially automated processes, offers repeatable accuracy and precision.
- Compliance with industry regulations: Regulatory bodies have strict requirements for the manufacture and use of medical devices. Fortunately, plastic injection molding is an established, reliable technology that typically meets agency requirements. In addition, the controlled nature of the injection molding process makes it possible to comply with regulatory standards. Please note that FDA regulations recognize ISO standards. This means that the manufacturer must, at a minimum, be ISO 13485 certified, which includes standards for quality management systems. Other ISO standards may also apply, depending on the type of device being produced. In addition, the resins or materials selected for the device must also meet applicable standards.
Applications for Plastic Injection Molding in the Medical Industry
Because the benefits are plentiful and plastic injection molding provides low-cost, but high-quality medical devices and components, there are a ton of applications. Some of the most common medical devices are made via plastic injection molding. For example:
|Instruments and tools, such as IV tubes, catheters, insulin pens, syringes and surgical and dental instruments are ideal candidates for plastic injection molding.||Disposables are often used to reduce risk of infection, but because they are made for single use, they must be low cost. Employing injection molding techniques is a cost-effective way to produce disposable items such as blood bags, heat valves, needle housings, etc.|
|Devices and equipment used for drug delivery can be made in bulk at a low cost using plastic injection molding.||Orthopedics are another device commonly produced in plastic injection molding processes.|
|Housings and casings for medical and laboratory equipment can be made using plastic injection molding at a low cost, while maintaining strength to protect sensitive equipment.||Implantable components, surgical tools and blades, pacemaker parts and prosthetics are important patient care items that can successfully be produced to exacting specifications via a plastic injection molding operation.|
Because plastic injection molding of medical devices offers many advantages and can be used to produce such a wide variety of medical devices, components and equipment at a low cost, medical device manufacturers who adopt Robotics and press side automation to their plastic injection molding systems will find they have a competitive advantage over those who don’t.
To learn more about Robotics and press side automation for the Medical device plastic injection molding, please contact JHFOSTER. To learn more about plastic injection molding equipment, please contact DevLinks.