If you’re a fan of classic monster movies, you may recognize the vintage Bunsen burners used to boil something in a beaker and be on the verge of a great discovery. If you’re more of a medical show enthusiast, you may see how often they use syringes, vials, and specialized medical equipment in every laboratory scene. What do these have in common? Injection molding!
Medical devices and equipment manufacturers are using plastic injection molding more and more as engineering designs can create more efficient products with better engineered resins. Injection molded products from a top-shelf molder will be produced in world-class facilities that have earned the Federal Drug Administration (FDA) registration and ISO 13485 certification. You can expect that these specialized injection molders will offer relationships to create your next product idea and have connections to vendors that provide quality materials and resources.
What is Required for FDA Registration?
In order to register with the Federal Drug Administration to produce medical grade equipment and products, the manufacturing facility will need a Quality Management System established. This system will outline how the facility operates on a day-to-day basis. The guidelines are covered under the 21 code of Federal Regulation Part 820 (covering Medical Devices) and cover components that are distributed to a finished device manufacturer or devices and components that are packaged or labeled for commercial distribution of health-related purposes for an end consumer.
What is ISO 13485?
Having the ISO 13485:2003 certification means that the manufacturing facility maintains quality procedures and documentation identifying the controlling conditions used in the processes of manufacturing. These procedures include risk management and lot traceability for each step of every process used in manufacturing components and finished products. The components and devices are classified in 3 classes under FDA regulation, whether that is Class 1, Class 2, or Class 3 is dictated by critical risk factors involved with the component or device. Each level requires different levels of regulation and compliance.
What are Common Injection Molded Medical Products?
Medical device products come in all shapes, sizes, and cost ranges. Some of the lower cost products can be plastic instruments, syringes, disposable gloves and gowns, and other one-time use products for the hospital environment. You may find that plastic products have replaced many glass products of the past as the resins available are lower cost and easier to recycle when discarded after use.
On the higher end of the cost scale, high-performance resins and polymers are being utilized for pharmaceutical grade plastics. These specialized plastics are suitable for ingestion or implantation, and can provide a method for controlled release of medication. These are typically called bioresorbable, as the body can dissolve the capsules or they can remain in the human body without harm. They can stimulate bone and tissue growth, or be used in dissolvable stents for blood vessels, which makes them a new exciting opportunity for the plastics industry.
Another benefit for high-performance polymers is in the current artificial joints being created for friction-free movement and longevity of joint replacement options. Another opportunity for polymers in in the device arena as they can reduce the weight of hand-held medical equipment, improve the functionality of using the equipment, and reduce the production cost.
What are Common Resins Used in Medical Grade Products?
One common material used for medical device equipment is Polystyrene. It’s a colorless plastic that is hard and offers minimal flexibility. Some products use its transparency, while others mix pigment into the resin blend to offer color variations. One of its best characteristics is the low cost for the base material. Beyond simple lightweight tools like cutlery, it’s a good option for a rigid but light product like petri dishes, flasks, and pipettes. It is not recommended for long-term uses involving high temperatures associated with steam or autoclaves.
Polyetheretherketone (PEEK) is a thermoplastic that is resistant to high temperatures and will not degrade under extreme heat, or organic and aqueous environments. It is beneficial for uses that require good wear resistance, can survive in dielectric environments, won’t fluctuate in volume under heat, and can do well in a radiation prone environment.
Polypropylene is another common material used for medical products. It can be used in processes that require the autoclave, so it can withstand high heat for an extended period of time. It can also survive a radiation treatment and keep samples stable without risk of degradation.
Polyethyelene has a low heat tolerance which makes it a poor choice for heated environments that require minimal shape and size changes. It’s most commonly used in containers, breather patches, and packaging films, but the ultra-high-molecular-weight variety is an excellent choice for the wear surface of hip and knee joint replacements.
Polycarbonate is also an injection molded plastic you will commonly found in medical devices. It is a strong material that can withstand high impacts, offers a clear translucent material, is stable under heat and cold, resists UV light degradation, and offers flame resistance. The temperature stability and strength make it a good choice with high-pressure syringes, centrifugal force separators, blood filter housings, and other products.
Should You Consider Plastic Injection Molding for Your Next Medical Product?
Plastics offer many advantages to other materials that are commonly used with medical devices and equipment. Certain materials, when chosen for the correct application, can offer strength, heat stability, low cost, and shapes that are complicated or nearly impossible to create easily in other materials. Determining if plastics will be your best choice can be aided by an expert mold maker that also offers resin selection, turn-key assembly options, and program management to see the complete development cycle through with success. If you need expert advice from a partner that can help with your next product idea, call us (425) 339-0288 or email us at email@example.com. We can offer you advice on the best technology to use, the best materials to meet your product demands, and how to navigate through each development stage with ease.
Matthias Poischbeg was born and raised in Hamburg, Germany. Matt moved to Everett, Wash., after finishing his bachelor’s degree in business in 1995 to work for Sea-Dog Corporation, a manufacturer, and distributor of marine and rigging hardware established in 1923.
In 1999, Matt took over the reins at Sea-Lect Plastics Corporation, a sister company of Sea-Dog and a manufacturer of plastic injection molded products with an in-house tool & die shop. Matthias Poischbeg is also a contributor to Grit Daily.