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There is much to consider when choosing a manufacturer for your medical devices. Your brand and reputation are on the line, so you need the highest quality processes for plastic injection molding contract manufacturing. Integration is key to ensuring quality, safety, timeliness, and accountability. Consider these benefits when looking for an integrated contract manufacturer. 

Quality Management

Since medical devices and components are highly regulated, you need a contract manufacturer who adheres to the strictest standards. Choose a manufacturer that adheres to ISO 13485 standards and maintains a registration with the Food and Drug Administration (FDA). These standards show that your manufacturer: 

  • Is dedicated to maintaining the highest quality standards
  • Is familiar with rules and regulations surrounding medical devices
  • Is serious about monitoring their processes and products

An ISO certification and registration with the FDA shows a commitment to maintaining supply chain effectiveness. Having documentation of certification and registration is also an important part of proving compliance once a product is on the market, increasing consumer trust and legal efficacy.

ISO certified manufacturers are required to follow similar quality protocols, but they may not collect, monitor, or store data in a manner compatible with your systems. Always make sure that your contracting manufacturer has a reliable ERP system for maintaining documentation in case of quality issues or FDA inquiries. 

An integrated contract injection molding manufacturer is familiar with the process as a whole, and they can control different variables within the process to help make final products more consistent. They know the limitations of their systems and equipment and can account for them proactively, to avoid impacting quality, quantity, or delivery time.

Injection Mold Building and Manufacturing Team Communication

If you’re using multiple vendors for plastic injection molding and other parts of the manufacturing process, you’re opening yourself up to communication breakdowns during the process. When you’re working with highly regulated products, like medical devices, the injection mold building team and manufacturing team need to be on the same page every step of the way.

The tool builder must understand manufacturing specifications and injection molding parameters to achieve a robust and reliable manufacturing process.. When you work with an integrated contracting manufacturer, one project team handles the process from start to finish. You can set your desired project timeline and quickly resolve problems when they arise. 

 Immediate Customer Support

When you have one team working with you through the whole process, they are more responsive when you need them. If you’re managing multiple vendors and issues arise, you have to figure out who is responsible for the breakdown and then work with them to track down a solution. Using an integrated manufacturer gives you access to better customer support and tighter collaborations. With an integrated manufacturer, you always know who to call if issues arise.

Vertical Integration to Ensure Higher Quality

Working with a contract injection molding manufacturer that uses a vertical integration strategy gives you access to a more robust team. With engineering capabilities, simulations can test, design the mold, and develop the molding process to ensure the product is manufactured efficiently and precisely.

They can also document each stage of the manufacturing process, recording and storing data in case you need it for FDA reporting or quality control. A vertically integrated contract manufacturer is a part of your team, offering insights on every step of the design and manufacturing process. Whether you need to find documentation for regulations, or you want to replicate the manufacturing process, a vertically integrated team will always operate more efficiently than disparate vendors engaged in tenuous collaboration.

Added Value

An integrated contract manufacturer offers additional services that add value for your organization. These services include post-processing such as  assembly, packaging, decoration, inventory management, testing, and quality inspection. Having these tools at your disposal can help save time and resources for a more successful manufacturing process. 

Some integrated contract manufacturers have tools like robotics that can automate parts of the plastic injection molding process. Automation helps the manufacturing team work more efficiently and helps give you a quality final product every time. These tools eliminate human error that can often occur during repetitive and tedious processes, freeing up valuable labor hours and driving down costs.

Crescent Industries is Here for Your Needs

Now that you understand the benefits of using an integrated contract manufacturer, partner with one who has the experience and understanding necessary to help with your projects. Crescent Industries has maintained relationships with our customers for over 70 years. We foster relationships based on trust and consistency.

We are a vertically integrated company with a variety of solutions to meet your needs, and we are ready to aid in all your injection molded plastic projects for medical devices and beyond. Learn more about how we can help you. 

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Topics: medical injection molding, medical device molding, medical device contract manufacturing