|Manufacturers and molders typically need to balance properties for specific medical device applications to achieve certain functional and aesthetic requirements. By working collaboratively with a resin supplier throughout the product design and development process, they can ensure that the plastic used to mold parts and components not only meets their needs but will be suitable to the end user.|
Medical molders continually are challenged to expand their role into areas such as product design, material selection, and parts and product qualification. As their function evolves, many are taking a process approach to their business. They are considering all of the activity surrounding the molding process, determining who and what impacts the process, and soliciting the involvement of the impacted parties or stakeholders. This approach and emphasis on collaboration is crucial to driving efficiencies and ensuring a successful end result, making it well worth taking the time to connect with the molder from the outset and facilitate/encourage communication with other parties involved in the product development chain along the way.
One of these parties is the resin supplier, who provides the plastic used to mold the parts and components. There are two key reasons for including the resin supplier early and often in the development process:
- For the expertise, insights, and past experiences they alone can provide
- To allow the resin supplier the opportunity to gather important information about the OEM’s end use application and make appropriate resin recommendations
Recommendations for Product Selection
As commodity resins continue to be replaced by more advanced, high-performance materials to satisfy the complex needs of the medical device market, it is often a challenge for molders to keep up to date with technology. The resin provider, who works with plastics every day, can provide recommendations on the latest innovations and preferred solutions for medical devices. Although OEMs and molders must decide on the appropriateness of the resin for a particular application, with an understanding of specific application requirements—product performance needs (e.g., durability, flame retardancy), requirements for sterilization (e.g., gamma, electron beam, autoclave), and environmental exposure concerns (e.g., UV light, chemicals)—the resin supplier can suggest material alternatives the OEM and molder may not have considered. In addition, the resin supplier can evaluate and suggest whether or not products that are currently being used seem to be most appropriate, guarding against possibly using an over-engineered product, which might add unneeded expense.
|The timely and accurate flow of information is essential to the development of successful medical applications. The OEM drives the process by sharing information with the molder, designer, and resin supplier, who provide potential alternatives based on compliancy requirements.|
Medical device OEMs are subject to stringent regulatory requirements relative to the devices they manufacture, and the ability to comply is influenced by materials used in production. Aware of this, molders need to go “downstream” to make certain the materials supplied by the resin provider are aligned with production standards and requirements for the medical device market and the specific application, as determined by the OEM. Are the materials biocompatible? Are they properly certified according to ISO and USP standards? Have the materials undergone required regulatory evaluations? Are processes aligned to comply? If the supplier is kept in the loop, from as early in the process as possible, he will make certain to deliver what is required<md>quality medical grade resins produced under stringent quality guidelines, controlled conditions, and validated processes. In addition, the supplier can put processes in place to ensure a consistent, predictable, sustainable supply, which is critical in the medical industry.
|Involvement as early as possible in the product development process is essential for the resin supplier in order to gather input on application requirements and product performance needs. Singularly focused on the materials component of the design process, the resin supplier is in the best position to offer insights and solutions for complex material challenges.|
As part of regulatory requirements, documentation of quality assurance is needed throughout and after the life of the medical devices manufactured. As with most processes, it is easier to establish a method to gather this information upfront during the manufacturing design process than to attempt to recreate a paper trail after the fact. A molder needs to have a relationship with its resin supplier in order to make sure this evidence can be produced and delivered to OEMs and/or regulatory bodies, as needed, in a timely and accurate manner. Sometimes a molder will be disconnected from its supply chain, making the procurement of documentation, if it has not been anticipated, stressful and challenging. Typical documentation for the industry needs to include Management of Change processes (i.e., lot traceability, formulation lock, notification of change, and extended record and sample retention).
Expectations for Collaboration
Involvement of the resin supplier, early in the process, clearly makes a difference. Obviously, molders are capable of understanding the aforementioned issues, but the fact is, the resin supplier, singularly focused on the materials component of the design process, is in the best position to offer input and deliver on elements that fall into this area of responsibility.
It is important to select a resin supplier that offers medical sector expertise, is familiar with the unique challenges of medical device OEMs, and aligns processes to a customer’s needs and expectations. The importance of staying engaged and encouraging collaboration with the molder and others in the production cycle to maximize efficiencies and ensure success is paramount.
Kersten Terry is technical services & development specialist and Cheryl Weckle is senior development specialist for Styron, a global materials company. They are part of the Technical Services & Development – Medical Applications department. Terry and Weckle can both be reached by contacting Styron at 888-STYRON1 or firstname.lastname@example.org.