(Updated May 2019)
When choosing an injection molder to manufacture plastic medical devices or other specialty projects, there are several key factors that must be considered in order to choose the right company.
Of course, you will want to understand their injection molding capabilities to ensure they can create a mold for the product properties and characteristics you desire - keeping in mind the right injection molder will be well positioned to grow with you as your demand and product line increases. You will also want to ask about their mold turnaround timeline to ensure they meet your schedule requirements – bearing in mind that oftentimes a quick and cheap mold is not a high-quality mold!
But you will want to dig deeper than just determining their capabilities and turnaround timeline. You need to have a firm understanding of their quality program and the extent of support they offer throughout your project – these are the areas where excellent injection molders stand out from their competition.
1) What Quality Management System/Quality Standards do they Follow?
It is critically important to assure there is a robust Quality Control system in place. This shows the company monitors the effectiveness of their supply chain and demonstrates traceability related to regulations of materials and finished goods. Correct documentation, data monitoring and storage is critical to any quality injection molding manufacturing process.
Ask your injection molder what quality management certifications they have to determine if their certifications meet your requirements. For instance; FDA registration or ISO 13485 are common requirements for medical devices and components. Quality certification assessments are performed by trusted and unbiased auditing companies – allowing a more “apples to apples” comparison of the injection molding partners you are considering.
If these systems are in place, they require a certain amount of documentation, assessing and minimizing of risks, as well as product realization. These types of quality certifications also show that this injection molder takes their business seriously, which means they have higher-than-average quality standards.
2) Can They Support your Entire Product Life Cycle?
Can they offer you a single source for procurement? This requires having a company that can provide services from the design phase through production - then have it immediately shipped out the door from the factory. An integrated design and production team can provide sustaining engineering capabilities to better address improvements and changes to the product as feedback returns from the field for proper device operation. Additionally, working with a single-source manufacturer, any changes can be made, reviewed, and implemented within a short time frame – saving you time and money!
Regarding design, will they provide design and development services either as your design team - or enhance your in-house staff? Do they offer insight and recommendations based on their own experience and knowledge of industry best practice – applying this information to a design for manufacturability analysis of your project. When designing new projects, your molder should always assess manufacturing variables that affect component quality and durability like wall thickness, draft and surface finish.
Regarding tooling, do they offer in-house tooling services? Utilizing an injection molding partner with in-house tooling capabilities, including use of the latest EDM machine tooling technology, has many benefits and can save time and money. Be sure to clearly understand where the tooling is manufactured as some companies only broker deals between you and an overseas mold fabricator – and there are often big differences in molds created in the US versus overseas.
Does the injection molder have the ability to handle the fluctuations in demands starting at the prototype level and scaling up to high-volume production? Also, do they offer value-add services such as assembly, packaging, pad printing, and other secondary operations to complete your project, saving you time, resources and money. These secondary operations also streamline your production schedule and efficiency.
Also, your injection molder should provide inventory management solutions for your project such as Kanban shipping, Just-in-Time Approach and Blanket Orders.
3) What Project Support will I Receive Once I’ve Made My Choice?
Does the injection molder have a Project Management Office comprised of a group of professionals who focus on defining the scope and maintaining the standards you have set for your project from the design phase through to production?
They also follow every project related task from start to finish. This keeps decisions and implementation moving in a consistent manner toward the project goal. PMO is also responsible for all communications about the project to the customer, as well as internally.
Does your injection molder provide mold maintenance programs because all injection molds require maintenance at some point in order to continue to function properly? Regular maintenance and cleaning of your injection mold is required to maintain part quality, consistency and cycle time. This mandates a regular inspection and maintenance program that keeps molds in top condition, while detecting problems early. On-site tooling maintenance is a must if you wish to protect your investment and keep your injection mold running.
Will you receive customer service support; this provides you support and feedback to demonstrating value, better collaboration and more proactive responses from your injection molder.
Crescent Industries is an employee-owned injection molding company that has been setting the standards for injection molding quality and production for over 70 years. We are an injection molding partner with a broad scope of experience and industry-leading knowledge providing support through entire life cycle of your project.
For additional information, please click below to get our white paper "Tips to Assist You in Selecting an Injection Molding Partner".