(Updated June 2019)
It is no surprise that medical device manufacturers must adhere to critical medical quality standards. The stakes are high when building and deploying medical devices used to treat patients and their illnesses around the globe. Thus when manufacturers are sourcing their injection molds for parts needed in their devices, the most pressing concern must be to first identify suppliers with proven track records of success and that are fully equipped with excellent facilities, quality controls, and highly specialized personnel. Consistent delivery of highly precise and durable parts is essential to minimizing the financial loss and disastrous medical toll of a failed component or device. Taking a Total Cost of Ownership analysis approach to anticipate the direct and indirect life cycle costs when selecting the right injection molding company is the best business practice to select the most cost effective and reliable molding company to partner with.
What is the Total Cost of Ownership? Investopedia defines it as, “the purchase price of an asset plus the costs of operation. When choosing among alternatives in a purchasing decision, buyers should look not just at an item's short-term price, which is its purchase price, but also at its long-term price, which is its total cost of ownership. The item with the lower total cost of ownership is the better value in the .
How can OEMs estimate the Total Cost of Ownership when evaluating a proposal from an injection molder? The quoted upfront tooling and per piece costs definitely need to be factored in, but those two items are just the beginning. Other information such as freight costs, release quantities, as well as both the class and cavitation of the tooling need to be weighted as well. For example, a higher quality mold will cost more than a lower grade, but will eventually save customers many times over in less unexpected downtime, and lower defect and scrap rates.
Then there is the value of the other assets an injection molder brings to the table. For instance, some contract injection molders provide superb engineering support—a necessary resource for Design for Manufacturing (DFM) reviews. Such expertise can help a customer keep production costs under control while at the same time meeting the necessary performance requirements. Besides engineering support, supply chain solutions (such as just in time shipping or free delivery within a certain radius) can provide large cost savings for an OEM.
Read more: Total Cost of Ownership
Below are four key steps to take when sourcing a cost effective injection molding supplier:
1. Verify required and relevant medical certifications to validate Quality Controls. Any facility that is involved in the production and distribution of medical devices intended for use in the United States is required to register annually with the FDA per Title 21 CFR Part 807. An ISO 9001 certification is based on Quality Management Principles to ensure that customers get consistent, good quality products and services, which in turn brings many business benefits. The ISO 13485 certification is a sector-specific application of 9001 which specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. The ability to perform clean room injection molding in a certified ISO 8 clean room and clean room assembly and packaging services in a certified ISO 7 clean room is often required in the production of medical parts. FDA registered and ISO-certified companies have proven their rigorous testing and inspection procedures in pursuit of delivering flawless parts and should be sought out.
2. Get it right the first time. Easy to say. Not always easy to do. By selecting actively engaged injection molding part suppliers with the relevant expertise and experience to guide and support a medical device manufacturer through the design, prototyping and tooling process, the chance of getting it right the first time will improve dramatically. The design phase is a crucial time when choices made substantially affect the future success of mold production. Tooling design engineers with extensive knowledge of part designing, material selection, mold designing, part fill simulation and material expertise will closely partner with their customers during the design phase. They will gain a comprehensive understanding of the required functionality and desired output of a given part therefore they can provide substantiated feedback on how to simplify the mold design without sacrificing its quality or functionality which can in turn reduce tooling costs. Many engineers are trained in scientific molding principles and certified by RJG and GSP which are recognized international leader in injection molding training, technology, and resources. Providers should also include 2D and 3D part and mold design models, 3D printing, 3D mold fill simulation during the product development phase to identify and correct potential flaws or constraints in the molds to ensure manufacturability and consistency.
3. Ensure sustained quality production of your molds throughout its lifetime. It is not merely sufficient that a medical part supplier be able to design and fabricate the desired injection mold. The supplier must be able withstand the test of time in delivering sustained high quality, precise and uninterrupted production of your mold. Maintaining stringent process validations to include IQ, OQ, PQ evaluations and planned periodic tooling equipment maintenance will help prevent products from being manufactured that do not meet specifications. Unexpected halted production caused by equipment malfunctions, emergent repairs or molds failing specifications requiring tooling redesign will indirectly effect total cost of ownership by lowering time to market of the medical devices.
4. Select a provider that can scale production. Projecting the rising demand of the medical device as it enters the marketplace reveals another consideration in selecting an appropriate injection molding supplier. Will the supplier have the necessary man power and equipment to manage larger orders? What are the additional maintenance costs associated with increased cycles and time in operation of the tooling equipment? At what point will more robust tooling devices need to be constructed to meet demands of production? Based on production levels and cycles, the Society of Plastics Industry (SPI), has categorized standard injection molds into five classifications which should be used to guide quotes and orders into uniform mold types. Having the correct mold type is crucial to achieving quality, production, and cost objectives. If the supplier is unable to scale the mold, the costs and risks of a mold transfer to another supplier can be considerable. Identifying these costs associated with the increased volume demand should be addressed as part of the quoting process.
Not all molders can meet the regulatory and quality needs of the medical device industry, nor can all of them deliver significant total value over the lifetime of a plastic part. By both thoroughly evaluating molding quotes and focusing on the above four steps, OEMs can arm themselves with the tools they need to properly evaluate the total cost of medical injection molding and select an injection molder who can meet their plastic medical component needs.
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