Moving production of an injection molded part to an outside vendor is a big step—but one which can reap large long-term cost savings and other supply chain benefits. To help OEMs ensure a smooth and positive outsourcing transition, we’ve compiled a few tips, drawn from our decades of experience.

Be clear on your requirements, but not too firm on your design

In the earliest stages of outsourcing a new product design, it’s important to come to a clear (and documented) understanding of the purpose the new plastic device or medical component will serve, and what mechanical, optical, biocompatibility, and electrical characteristics the design must have.   

It’s best at this point not to box yourself in too much, because the injection molding or medical device contract manufacturer (CM) you will partner with (see our next piece of advice) will have ample engineering and production personnel on hand to not only provide expert Design for Manufacturing (DFM) analysis, but also co-design the plastic part or medical component with you.   

Pick the right CM partner, and engage them early

The bulk of the success or failure of an outsourcing project depends on the contract manufacturer who makes the part. That’s why it’s so important to select the best one for your industry and product type. Here are some of the requirements any potential vendor should meet:

In-house mold design expertise (including 3D mold fill simulation).

Expert mold design skills paired with the right CAD tools ensure that critical mold features (like the cooling channels, actions, and runner system) are designed to produce the highest quality parts cycle after cycle.

Materials knowledge and experience.

Your potential outsourcing partner must have extensive knowledge of the materials available for injection molding. This includes each polymer’s available grades, and broad knowledge of resin additives. In order to recommend the best material for the application during the crucial DFM review, the contract manufacturer must know the pros and cons of each material out on the market.

Regulatory compliance and relevant ISO certification.

OEMs should look for both FDA registered facilities and ISO 13485 certification if they are outsourcing medical device components. This will lower regulatory non-compliance risk in their supply chain.

Validation of the process producing the plastic device or medical component.

This requirement entails many other must-have’s, like robust quality assurance, statistical monitoring, and data collection from each stage of the process. OEM’s should demand the across the board use of Statistical Process Control (SPC) which is one of the key methods of proactively ensuring production process reliability. This in turn reduces the risks associated with unexpected downtime, high scrap rates, and the shipment of defective product to the end customer. For injection molding contract manufacturers, SPC goes hand in hand with Decoupled Molding, which segments the molding process into separate phases, each with their own windows of acceptable parameters. This improves the consistency of the molding process and thus delivers higher part quality.

Effective project management.

The key to successfully outsourcing a plastic device or medical component is picking an injection molding partner who can dedicate the resources necessary for the endeavor to succeed. For the best chance of success, OEMs will need a dedicated team, a well-planned timeline for the outsourcing project, DFM analysis and review, process development support, open and responsive communication, and validation of the external production line. This is why contract manufacturers like Crescent Industries offer a Project Management Office (PMO).

Consider Utilizing Your CM for Other Services As Well

Choosing a full-service CM as an outsourcing partner can produce multiple wins if the OEM takes advantage of their supply chain management (SCM), and value-added services. Such CMs can greatly improve their customers’ supply chain by eliminating the need for parts to travel to another facility for secondary operations such as final product assembly, adhesive bonding, or ultrasonic welding.

The benefits of outsourcing SCM include reduced inventory buildup (and their associated costs), and increased on-time delivery of the parts or components. By utilizing inventory management strategies such as Kanban shipping, just-in-time delivery and blanket-delivery orders, a full-service CM can provide compelling long-term value not just for production, but for shipping as well.

Furthermore, a qualified injection molder would already have standard operation procedures in place for the selection and qualification of suppliers, updating and maintaining approved supplier lists, documentation control, and corrective and preventative actions (CAPAs).

As a quality-driven full-service manufacturer serving industries such as medical devices, dental, and defense, Crescent Industries is the outsource partner of choice for many leading global customers in those industries.

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Topics: medical manufacturing