How to choose the right medical plastic product injection molding company: 15 questions to guide you

• How to choose the right medical plastic product injection molding company: 15 questions to guide you
  • 15 Questions to Help Purchasing Personnel Choose the Right Medical Injection Molding Company
  • In-depth understanding: Determining the final medical injection molding project partner
    • they have the right technology?
    • Can they provide design support and modification capabilities ?
    • Internal mold design , engineering (DFM+Moldflow) and manufacturing capabilities
    • Do their factories have suitable cleanrooms?
    • they have a quality assurance process?
  • Capability comparison between medical injection molding manufacturers of different sizes
  • Outsource your medical injection molded parts projects
  • in conclusion
  • FAQ

Medical injection molding is primarily used to produce plastic components and products for various medical devices , which are widely used in the healthcare industry. However, the medical industry has a low tolerance for errors and is subject to stringent regulations regarding related plastic products and equipment . Therefore , the injection molding process for medical plastic products must be carried out in factories that meet industry regulatory standards and completed under strict supervision to ensure that the project meets market demand and is profitable. Consequently, medical product development and manufacturing companies need to find a reliable and professional injection molding company for medical products . This task is very challenging for their in-house purchasing staff . Having worked in the injection molding industry for many years and with experience dealing with healthcare product companies worldwide, I’d like to share some of the questions they ask and the key information they gather when evaluating potential injection molding partners . This should help purchasing staff new to the industry or those developing new suppliers to address these challenges.

15 Questions to Help Purchasing Personnel Choose the Right Medical Injection Molding Company

Medical devices and products must meet stringent standards and regulations to be marketable and profitable. This requires careful evaluation of multiple companies offering injection molding services before selecting the right one. If you’re unsure where to begin or how to start, you should consider some factors when choosing a suitable manufacturer. The following 15 questions can help you quickly assess whether a potential medical injection molding partner meets your requirements :

Does the manufacturer have a strong technical team?	You need a manufacturer with a strong technical team. A highly skilled team can design molds according to your specifications. Experienced technicians can ensure that the molds are ready and that mass production can begin.
Did you discuss your needs before production?	Before production begins, be sure to take the time to communicate. Explain your goals and needs so the manufacturer understands your expectations. Initial discussions can help resolve pre-production errors before actual production begins.
Does the manufacturer have the latest production tools?	Examine the equipment used by the manufacturer. Advanced equipment such as high-end CNC machine tools and EDM machines are extremely useful in manufacturing high-performance molds. The right equipment determines the right product and shortens production time.
Do you have a reliable project manager?	A reliable project manager is crucial. They will keep everything on track. Furthermore, they will ensure that molds are designed on time and projects stay within budget.
Does the manufacturer have experience in manufacturing similar medical products?	It is advisable to ensure that the manufacturer is familiar with products similar to yours. Their industry expertise can streamline the mold-making process, saving you time and money.
Can manufacturers meet the demands for rapid production and high quality?	If your project needs to be launched in the shortest possible time, then choose a manufacturer that can meet the shortest turnaround time. However, ensure that quantity is not prioritized over quality. Therefore, choose a manufacturer that can deliver quickly and provides consistent product quality.
Do they have extensive experience and knowledge in the medical industry?	You must partner with manufacturers who have extensive experience and whose product categories are similar to yours, because manufacturing companies have people with enough knowledge and experience to effectively handle operational issues and streamline processes.
What equipment and technology does the manufacturer use?	High-quality equipment and technology are core requirements for achieving optimal results. Inquire about the tools and equipment used in production. New, well-maintained machines not only produce high-quality medical products but also accelerate production.
What kind of quality control does the manufacturer use?	Strict quality control is crucial for medical injection molded parts and must be strictly adhered to. The quality management procedures established by the manufacturer must comply with industry standards and specifications such as ISO.
Can they deliver your order on time?	As a purchasing agent, you must determine the supplier’s production capacity and whether it can supply the order within the scheduled time. Otherwise, you risk being accused of negligence.
Are the costs transparent and clearly explained?	Make sure you get a detailed quote so you know what you’ll need to pay. Ask the manufacturer how the cost of designing and manufacturing a mold of a specific shape and size is broken down into various service prices.
Is the manufacturer easy to communicate with?	Clear communication plays a crucial role throughout the process. Your manufacturer must listen to your needs and respond quickly to your questions. This ensures you stay up-to-date and helps improve the efficiency of the entire process.
What do other customers think of them?	You should consider soliciting customer feedback from manufacturers and reading about their experiences working with your company, as this reflects their impressions of work quality and communication. As with any industry, it’s best to review their product portfolio before ordering a project from them.
Will their location affect your shipping costs?	In reality, shipping costs and time are always affected by location. Buying from a nearby manufacturer results in relatively cheaper shipping and faster delivery of your parts.
Do they provide after-sales support?	Confirm that the manufacturer provides satisfactory after-sales support, as post-use mold maintenance is crucial for maintaining its optimal performance. Therefore, you should invest time and effort in selecting a suitable manufacturer. In addition, call them, visit their factory, and ensure they can meet your requirements.

In-depth understanding: Determining the final medical injection molding project partner

By answering the 15 questions above, you can initially screen potential partners. Now you need to learn more about them. First, prioritize factories whose primary business is in the medical field. These factories have accumulated extensive experience in medical components and can provide assistance early in the process, such as optimizing structures, offering material suggestions, developing processing plans, and reducing costs. Furthermore, these factories are familiar with the characteristics of the medical field, possess excellent quality management, have sophisticated equipment and manufacturing environments, and mature supply chains, enabling them to respond quickly to small-batch, multi-variety orders. Therefore, after this initial screening, you can determine your final partner based on the following points.

they have the right technology?

Different injection-molded part designs may require different molding technologies. For example, complex parts with high precision requirements may require thin-wall injection molding, while surgical instrument handles are produced using overmolding technology. You will need to partner with a medical injection molding company that possesses the necessary technology to support the molding process suitable for your part design. Furthermore, your chosen partner should be a company that can provide a full suite of molding technologies to ensure they can meet your evolving design and molding needs in the future. This will help you establish and maintain long-term partnerships, avoiding the tedious process of searching for an injection molding company every time you have a new innovative product design. Commonly used medical injection molding technologies are as follows (not a complete list):

Standard injection molding process	Injection molding, a traditional processing method, is widely used and offers high dimensional accuracy and high throughput, making it a popular choice in the medical device manufacturing industry. This process can be used to produce a variety of products, including surgical instruments such as staplers and trocars, as well as housings for large diagnostic equipment.
Gas-assisted injection molding process	As an upgraded version of traditional injection molding, gas-assisted injection molding involves injecting compressed nitrogen into the mold. The nitrogen flows through fixed channels, creating hollow areas that replace resin material in the thicker parts of the component. This molding process can improve the usability of medical devices through lightweighting and ergonomic design.
Rapid hot and cold forming process	Mold temperature plays a crucial role in improving the surface quality of medical plastic parts. In the injection molding cycle of medical products, rapid thermoforming technology allows for thermal cycling control of the mold surface temperature. This requires heating the mold surface before injection using specialized equipment such as a superheated water system or induction coils to raise its temperature above the material’s glass transition temperature (Tg). After the resin is injected into the mold cavity, the mold needs to be rapidly cooled before the molded part is ejected and demolded.
Secondary molding process (secondary injection molding)	If a single thermoplastic material cannot meet the requirements of the parts, secondary molding processes can use techniques such as mechanical fastening, solvent bonding, welding, adhesive bonding, and snap-fit assembly to join two or more thermoplastic materials. However, such secondary operations are particularly time-consuming, increase costs, and affect production efficiency.

Can they provide design support and modification capabilities ?

You may already have a product design plan, but having professional design capabilities and support for product design modifications is still crucial for you to successfully complete product manufacturing and achieve the desired results.

Even if you already have relatively complete design documents , you still need a design team to help add value and enhance the functionality of your product. This is because different raw materials are molded in different ways, resulting in products with varying performance characteristics. A manufacturer’s design engineering team can also provide valuable insights into raw material selection and related product manufacturing experience , ensuring your desired product can smoothly enter the production stage . Furthermore, if you have new projects, the manufacturer’s design team will help you review the product design and adjust specifications to ensure the final product performs optimally in its application .

Internal mold design , engineering (DFM+Moldflow) and manufacturing capabilities

A strong injection molding service provider should be able to support you before the mold-making process even begins, including Design for Manufacturability (DFM) analysis, mold flow simulation (if applicable), and clear advice on gate location, cooling, venting, and ejection. Good pre-engineering can reduce the risk of warpage, sink marks, weld lines, and cycle time.

When you partner with a medical injection molding manufacturer that has in-house mold-making capabilities, they can help you quickly prototype and validate your product projects in small batches . This allows you to prioritize manufacturing speed, project cost , and planning for large-scale production . Additionally, you’ll benefit from faster finished mold delivery times and sampling times (TO/T1/T2) because they have clear feedback loops, measurable acceptance criteria, and controlled engineering changes.

Do their factories have suitable cleanrooms?

Finally, cleanrooms are one of the most important factors to consider when choosing a medical injection molding company. Medical-grade products must be sterile to be considered safe. Cleanrooms are crucial for manufacturers to ensure product sterility. A cleanroom is a climate-controlled area that helps manufacturers protect their products from contaminants, impurities, and other airborne particles that can compromise the purity of the final product. For most medical products , an ISO 7 cleanroom is sufficient, but for products with lower tolerance for contamination, an ISO 8 cleanroom may be necessary. Therefore, when injection molding certain high-requirement medical products, ensure that the company you partner with has a separate cleanroom within its facility, isolated from other areas. It must be equipped with air filters. Generally, there should also be a controlled area outside the cleanroom for personnel to don appropriate cleanroom attire and undergo sterilization before entering the main cleanroom. Even if your current project doesn’t require a cleanroom for production, it’s advisable to consider partnering with such a facility beforehand, although be aware that such facilities will typically offer higher prices.

they have a quality assurance process?

Products in the healthcare industry must comply with a stringent set of regulations. Therefore, your chosen partners must ensure they have robust quality assurance processes to guarantee that every component of the product meets required standards and can be successfully marketed. You can assure your injection molding partner of their ability to manufacture compliant medical products and devices by inquiring whether they are ISO certified. ISO 13458 certification demonstrates that the company truly meets the high standards required for a successful and profitable medical injection molding process. In addition to ISO certification, check if the company is registered with the FDA. The FDA sets fairly stringent regulatory standards for healthcare products. If a company meets these standards, the reliability of its quality assurance processes is beyond question.

Capability comparison between medical injection molding manufacturers of different sizes

In terms of injection molding manufacturer company size, whether small, medium, or large, each size category has different advantages and limitations. The table below provides a basic capability comparison to help you determine the manufacturer best suited to your needs.

Classification	Small mold manufacturer	Medium-sized mold manufacturer	Large mold manufacturer
Number of employees	Typically 1-10	Typically 10-100	Typically 100-1000
Processing capacity	Most outsourcing	Combining outsourcing and in-house operations	Primarily conducted internally, with some outsourcing.
CAD design capabilities	Mostly outsourced, with very little internal design.	Some in-house design teams (2-3 designers)	Large design team (20-30 designers)
Mold manufacturing expertise	limited	Medium to high	High level of professional knowledge
Project Focus	High personal attention	Varies depending on project size	Due to the large number of projects, the rating is medium.
Reliability and timeliness	Low reliability may cause delays.	They vary and may not be consistent.	High reliability and on-time delivery
Pricing	Affordable prices	Mid-range	premium

Outsource your medical injection molded parts projects

To obtain high-quality products, it is recommended to outsource your medical plastics product manufacturing projects to a trustworthy and reliable manufacturing company. One of the best medical plastics product manufacturers is Elimold.

At Elimold, we help you create custom medical plastic molded parts to your specifications. Combining our professional engineering team and top-notch injection molding technology, we guarantee to provide you with internationally standardized plastic parts. We also offer fast delivery times and competitive prices, while allowing you to track the manufacturing process in real time. To ensure the quality you desire, when you choose our services, we will assign a dedicated project manager to track your project from start to finish. What are you waiting for? Send your designs to our backend for a free quote and competitive bulk pricing.

in conclusion

Partnering with the right medical injection molding company is the cornerstone of any successful medical parts and devices business , and a prerequisite for procurement personnel to complete their tasks quickly . However, finding the right company can be quite challenging. The manufacturing process of medical parts and devices involves many details, and the issues discussed in this article are based on my years of experience working with procurement personnel from various medical companies around the world. When you can partner with a company that meets all of the above requirements , your procurement work will be much more efficient .

Additionally, you can first identify your current needs to find suitable medical injection molding partners. At the same time, if you have the capacity, considering any future product development and expansion plans may be helpful . If you currently have a new medical injection molding project, start screening several suppliers now and evaluate their capabilities by asking the questions we discussed above.

Finally, I am an engineer specializing in medical mold design, manufacturing, and medical plastic molding at Elimold. Since our inception, we have collaborated with numerous medical product manufacturers worldwide, possessing extensive experience in medical product injection molding. We are a professional manufacturer of custom medical plastic products. Please feel free to contact us at [email protected].

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