Plastic Injection Molding for Medical Device

Plastic Injection Molding for Medical Device is a growing, cost-effective method of manufacturing devices and parts. Along with its ability to produce complex designs that meet the stringent cleanliness requirements, medical-grade plastic injection molding offers high tensile strength as well as chemical and high-temperature tolerances. Since its inception, medical devices that are manufacturing with injection-molded plastic have contributed to a reduction in medical costs and increased patient safety.

Plastic Injection Molding for Medical Device manufacturing of components and devices using medical grade plastic materials that are durable, reliable and meet FDA regulations is the essence of medical injection molding, while manufacturing medical devices manufacturers need to consider the ISO standard  set for the devices. As a ISO 13485 medical device consultant we guide manufacturers to implement correct QMS for their unit.  Medically graded plastic injection molding is utilized in manufacturing components such as medical components, beakers, test tubes, and laboratory equipment. These molds have the ability to meet the specifications and requirements of the medical device industry.

The Plastic Injection Molding for Medical Device process is cost-efficient, and ideal for high volume production runs and applications requiring consistency and tight tolerances. This molding process is also used for medical device prototype development for the FDA approval process and for use in laboratory testing. The major factor for driving the the global Plastic Injection Molding for Medical Device market is growing demand for plastic based products to effeciently drive the R&D in the pharmaceutical and biotechnology industries.

Medical products are molded per ISO 13485:2016 Standards in our modern 2,000 sq. ft., Class 10,000 (ISO Class 7) cleanroom, or in one of our Class 100,000 (ISO Class 8) portable cleanrooms. Inspection, assembly, and packaging operations also take place in our cleanroom facilities. If needed, we can assist with part sterilization and hermetic packaging requirements as well.

Benefits of Plastic Injection Molding for Medical Device

Since medical device plastics provide increased versatility and can be combined with metal to create enhanced medical product attributes, medical grade plastics have become the preferred material for numerous types of electronic medical devices. Some of the advantages that medical injection molding companies can provide, include:

• Improved ergonomics
• Reduced weight
• Increased functionality
• Lower cost
• Decreased burden of sterilization

Types of Plastic Injection Molding for Medical Device

There are basically two categories of injection molding products that are typically produced for the medical market: certification-intensive products and those that are not extensively regulated. Original Equipment Manufacturers (OEM’s) create devices that are classified by the FDA according to the nature of their function, and the function of a medical product is what dictates every aspect of its production, including how its plastic parts will be molded.

According to the FDA, the highest level of medical device class is Class III. These are usually true medical devices that have contact with the body, are implanted in the body, or deliver fluids to the body, like IV tubing, implants, and IV needles. When they involve injection molded parts, they usually must be produced in a clean room environment from the beginning of manufacture to finished use. An example would be a single use, sterile syringe.

Selecting The Plastic Injection Molding for Medical Device  Materials

There are many different grades of plastics available for injection molding and each one has strengths and weaknesses that need to be considered. Below are a couple factors that need to be top of mind when choosing a plastic material for your medical device.

When choosing a medical grade Plastic Injection Molding for Medical Device , it is important to select one that has the proper strength. Plastic resins come in many different strengths, so it is important that you choose one that fits the specification of your medical device. Choosing a material that is not strong enough can result in the medical device failing during use.

Since inception, the use of plastics within modern medicine has steadily increased. Medical devices that are manufactured from injection molded plastic have contributed to a reduction in medical costs, infectious disease and pain management. High tech polymers are used within medical device prototype development and are commonly used to create improved artificial limbs and devices that reduce the risk of infection. Medical plastic injection molding directly leads to increased patient safety and the ability to save more lives. Operon Strategist a medical device consulting company provide regulatory consulting services to the manufacturer to make their path easy and hurdle free.