Medical Injection Molding
ICOMold has the state-of-the-art plastic injection molding facilities available for your medical injection molding jobs. We know that quality is of the utmost importance and we take that commitment seriously. We are the low-cost leader for high-quality injection molded plastics with a fast turnaround.
Instead of having to wait months to get your medical injection molded parts we can have your parts ready in as little as 15 days.
Get a Medical Injection Mold Quote
Getting your medical device part created is a fairly straight forward process. The first thing to do is to register and upload a CAD file. Once you submit a CAD file our instant quote system will evaluate your design and give you an estimate. If satisfied, our engineers will review your CAD file and confirm the quote. Once you accept the confirmed quote we will start the manufacturing process.
Selecting The Proper Medical Grade Plastic 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 for injection molding, 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.
Resistance to Chemicals and Heat
One of the most important aspects to consider is the type of heat and/or chemicals is your medical device going to have to endure. Will your medical device be subject to standard sterilization methods, or will it have to endure more harsh cleaning methods? Such harsher cleaning methods are high-heat and water pressure (like an autoclave), radiation, chemicals and high intensity ultra violet light. Failing to take these conditions into account can dramatically reduce the life of your medical device.
Fungus, algae and other microbes can grow on untreated plastics. This can lead to unsightly discoloration, unpleasant odor and plastic degradation. If you know your medical device will be subject to an environment where these might be a concern, then an anti-microbial additive can be mixed into the plastic resin. Anti-microbial additives can be added during the injection molding process. This can reduce or inhibit microbial growths when a microbe touches the surface. A medical device that promotes microbial growth will require more frequent sanitation. This can lead to more down time and possible shorter device life.
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The conditions that your medical device will be exposed to will determine the requirements of your medical grade plastic material. Some conditions that need to be considered are chemical resistance, corrosion resistance and exposure to radiation and temperature. Failing to take your operating environment into consideration can cause faster degradation of your medical device.
The FDA has different requirements for plastic materials based on how much contact with the human body the device has. These can be divided into 3 broad categories. The category with the most regulations are plastics used in medical devices that are implanted into the human body. These medical devices have a long list of requirements, such as certified non-toxic and materials proven not to break down over the lifetime of the implant. These parts must also be manufactured in a certified clean room.
The next category of medical devices are completely external and only come into contact with the skin. These medical devices have more lax FDA requirement and can be manufactured at most injection molding companies.
The last category of medical devices are those that have limited human contact. An example would be a cardiac monitor where a person is only interacting with the buttons. This category of medical devices has the most lax FDA regulations when compared to the other categories.
Medical Grade Plastic Materials
The medical grade plastic material used for injection molding is one of the most important choices you can make and should be thoroughly researched. Choose the wrong plastic material and you could end up paying more for features that you don’t use, or worse, have your device fail because the material isn’t suited for your demands. Below are just a few of the many medical grade plastic materials.
This medical grade plastic has high shear, tensile, flexural strength and is stronger than acrylic. This material also absorbs very little moisture and has high resistance to heat. Since by default this plastic is transparent, the most common use is medical tubing.
This medical grade resin has been approved by the FDA to come into contact with food and has shown to have high resistance to fatigue, chemicals and cracking. Peek can also withstand exposure to steam and high water pressure, which makes it a good choice for parts that will be cleaned using an autoclave.
This plastic resin is similar to PEEK. While it does have a lower usable temperature and impact strength, it is less expensive than PEEK. If your medical devices don’t have to sustain as high temperatures, this plastic resin could be a good fit.
Nylon material is widely used due to its strength, toughness, chemical resistance and wear resistance. Nylon can withstand a large degree of chemicals but it is weak to strong acids and alcohol. Nylon has good heat stability, as it can be used in environments with heat as high as 185°C.
Questions To Ask When Selecting Plastic Injection Molding Materials For Medical Devices.
Will the plastic material work with the design?
One of the considerations is, will the plastic material work with your medical device. For example if there are thin walls in your design, you will need to make sure the plastic material that is chosen can support that. Understanding how materials behave is important in optimizing your medical device for functionality, performance and durability. This is especially important during the injection molding process, as plastic materials have different melting points and shrinkage.
What is the environment the medical device will be operating in?
You will need to evaluate what elements your medical device will come into contact with. Will your device come into contact with bodily fluids, harsh chemicals, high temperature sanitation or other elements? Once you determine what environment your medical device will have to endure you will be able to figure out what plastic material would work best.
What are the physical forces the device will need to withstand?
Will your medical device require a certain degree of tensile strength, elasticity, wearablity and hardness? Consider conducting finite elemental analysis (FEA) testing. A FEA test can point out potential failure points or weak spots. Some FEA software databases may already have information on many of the stress /strain specs of plastic materials.
How Long Does a Medical Injection Mold Last?
Our medical injection molds will typically last well over 100,000 cycles. Moreover, ICOMold offers a lifetime warranty for these injection molds. As long as we continue to make the parts for you, we will maintain and refurbish the tool as needed at our own cost.
ICOMold provides a dedicated project manager and engineer for your injection molding production. Please check out ICOMold’s Online Project Management System.
Injection Molding Production Highlights
> Instant mold and part quote
> Low cost, quick build and quality production
> ICOMold's Lifetime Warranty on Medical Device Molds
> Online project management
> Trouble-free part modifications
> No size limitations
> Any commercially available material and surface finish
What is the process for injection molding production?
ICOMold’s instant online plastic injection molding quote and mold frame sharing technology enables us to simplify and shorten both the quoting and tooling manufacturing process for custom plastic injection molding.
- Load your 3D CAD file to get an instant mold and part quote
- Upon order confirmation, ICOMold starts the mold and part order process
- Tooling design review by ICOMold engineers
- Upon design approval, ICOMold begins building your injection mold
- Customer examines samples for approval
- Part production begins
Go to our plastic injection molding and CNC machining case studies to see how we helped customers with their projects.