Minneapolis, MN–November 30, 2011–Teamwork is critical when making thermoplastic material decisions for medical devices. Diversified Plastics, Inc recommends that medical device manufacturers work closely with suppliers and injection molders when selecting plastic material during product development. By involving all parties early in the process, the original equipment manufacturer (OEM) can shorten the product development time and best determine the appropriate materials that will be needed.
“Some medical device companies have their material selected by the time they start working with the plastic injection molder,” says Joni Davis, sales engineer at Diversified Plastics. “If the OEM is developing a new product, they may have a material in mind, but would like to know about alternatives. At this point it’s desirable to have the OEM design engineer meet with the material supplier and the molder. With all parties involved and contributing at the very beginning of product development, the overall development cycle will speed up.”
“Many medical device OEMs are small and do not have plastics experts on staff,” adds Josh Blackmore, global healthcare manager at RTP Company (www.rtpcompany.com), a thermoplastics supplier. “What these companies are looking for is not only expertise in plastics, but knowledge of regulatory approvals. They want someone who will come in and do a complete review of the design and performance of resin selections. Because of changing requirements and regulatory restrictions, the plastic the OEM might have used in the past may not meet performance specifications or be the most economical, and by working with the materials supplier early in product development, material performance and costs can be optimized.
When evaluating medical devices, the U.S. Food and Drug Agency (FDA) examines important quality aspects and regulatory requirements, such as safety, performance and dependability of the product. The FDA does not pre-approve thermoplastic materials for use in medical devices, they only approve complete products. To assist OEMs in product development, many plastics materials manufacturers go ahead and test certain formulations, taking the compounds all the way through biologic testing so they can provide an engineer with a paper statement of biocompatibility of the raw material itself. This doesn’t mean the FDA approves the material, but it gives the engineer confidence the materials they are selecting will pass device testing.
Another reason to consult material suppliers and molders early is to reduce the risk of selecting the wrong plastic that ultimately might fail in testing. “Feasibility studies can be part of the early process,” says Blackmore. “Some OEMs will look to the material supplier for finite element analysis or mold flow analysis or some other type of testing. If it’s a conductive part, they want measurements taken on how static dissipative the material is. All the early studies and tests serve to reduce risk and ensure the final device works as intended.”
For the injection molder, knowing the OEM’s requirements from the beginning of product development helps them optimize mold design and manufacturing processes. “The medical device industry is constantly changing, creating many nuances in molding,” says Davis. “This is why, as an injection molder, it is so important to work with the medical device OEM and the materials supplier early in product development. This relationship is not only important at the beginning, but throughout the development process all the way through to FDA approval of the product.”
“The relationship between material supplier and molder is intimate—especially if all parties are brought into the project early on by the OEM,” adds Blackmore. “In the development of almost every medical device there are multiple phases where samples are produced for OEM testing. It’s during these phases where the supplier-molder relationship is critical because the molder relies on getting the right answers from their resin supplier.”
About Diversified Plastics, Inc.
Diversified Plastics is an injection molder of high-precision, close tolerance, small- to medium-sized injection molded components for medical device, filtration, aerospace and a variety of other industrial markets. The 34-year-old company is a full-service injection molder, from design assistance and mold construction, to intricate molding, sonic welding and clean room assembly. Diversified Plastics is ISO 13485:2003 and 9001:2008 certified, and UL registered.
The company works within FDA 21 CFR 820 specifications, using IQ, OQ, PQ and other validation requirements. Diversified Plastics has extensive experience molding PEEK, Ultem, polypropylene, polycarbonate and many other medical grade resins, including FDA-approved dyes.