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Injection Molding

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Injection Molding for Medical Devices

Seisa produces durable and reliable medical-grade components that meet our client’s satisfaction and make them competent in medical device markets through medical injection molding.

The method is the go-to procedure for manufacturing state-of-the-art medical supplies because it offers countless advantages.

Our medical device injection molded parts and prototyping services stick to the highest accuracy, precision, and quality levels. We offer a wide range of presses, exceptionally engineered for the application of medical devices.

With our extensive knowledge of the medical device industry, we can assist our clients in ensuring that the standardized, engineered, and high-performance injected devices are to international standards.

Our Medical Injection Molding Capabilities

From plastic prototyping to production molding, SEISA’s custom injection molding service is perfect for manufacturing high-quality molded parts in a rapid lead time. Powerful manufacturing facilities with solid and precise machines ensure the same mold tool for making compatible parts.   
   
In addition, we deliver expert consultation on each injection molding order, including mold design guidance, materials, and surface finishes section for your end-use applications and shipping methods. 

Cleanroom Injection Molding

Seisa is an FDA-registered injection molding company with ISO 13485 certification and IQ, OQ, and PQ verification. All our cleanroom manufacturing processes are completed in-house, allowing for complete control of all factors of production.

Overmolding

Covering plastic, metal, and rubber over each other via chemical bonding, our overmolding decreases assembly time and gives our parts greater solidity and flexibility.

Insert Molding

Our Insert molding operation consists of molding thermoplastic material around a preformed element to form a finished part that includes multiple materials.

Micromolding

Seisa is a leader in the highly technological field of medical micro molding and micro injection molding. We can produce little parts with complicated details and features that would be impossible to manufacture by other standards.

Material Selection Guide for Medical Injection Molding

Material selection for medical injection molding is of utmost importance. We at Seisa Medical always offer you the finest services. The proper material defines the safety and durability of the product. It is essential not only for reducing costs but also to make profits. Our team of experts can help you choose suitable material for your needs.

The prosperity of medical plastics in stock reduces your material purchasing time, speeding up your project progress.  

As noted above, many plastics are open for medical injection molding operations. Each plastic keeps distinct qualities that impact how it performs in exact applications. Some of the critical factors in evaluating when choosing between the material options include: 

Strength

The selected material should deliver the power required to support the application.

Industry standards

It should fully comply with FDA and medical industry standards relevant to the final element.

FDA Requirements

Medical devices planted have unique needs than those used for tubing, medical instruments, and other purposes. Check the FDA conditions for your application before selecting a material.

Operating conditions

The material should adjust to all the application environment requirements. For example, if the finished part is subjected to chemical or high heat procedures (e.g., in sterilization operations), the material should offer good chemical and temperature resistance. 

General use

The material should be selected concerning who will use it and how it will be used. For example, surgical devices should be lightweight, functional, and ergonomic.

Plastic Injection Molding Machine Selection – Why Is It Important?

For Seisa, choosing a suitable plastic injection molding machine is one of the essential rules for manufacturing parts with the highest quality.

Having the proper devices and the best technology allows us to provide our customers with products that can compete globally and meet regulatory standards.

This will enable them to offer more detailed products and simultaneously build a reputation as a quality manufacturer.

Our Custom Injection Molding Services

High Efficiency

With certified domestic factories and a robust supply chain strategy, we accelerate the product development process and bridge the production of your injection molded parts as quickly as possible.

Consistency and High Quality

Owing to certified factories, performing in-process checks and dimensional verification after the production guarantee the custom molded parts are consistent in quality regardless of the complex shape with high accuracy.

Injection Molding Specialists

We are working with our specialists, who have 40+ years of experience in the injection molding industry, to complete backtracking from prototyping to production efficiently.

With no minimum order amounts and a free prototype tool with on-demand manufacturing orders, we’re your partner to get to market faster for projects like:

  • Lower-volume or difficult-to-forecast products
  • Early-in-development projects
  • FDA Class I and II devices
  • Components requiring involved supply chains
  • Development phases that require design flexibility
  • Parts in which we can use early process learnings to production
  • SKUs that could help from a secondary source
  • Design verification testing, clinical trial proposals, and regulatory body submission

Injection Molding in the Medical Field

The primary necessity for injection molding of medical plastics is biosafety, and chemical solidity since these items will come in contact with the human body and/or drugs, and the materials must not induce harm to the human body or leave toxic substances in organs and tissues.

Our Medical injection molding is used for many medical products, including:

  • Ablation catheters
  • Atherectomy catheters
  • Plastic components for Catheters (access, diagnostic, guiding)
  • Endoscopic snares
  • Enteral feeding sets
  • Guidewires and introducers
  • Micro-catheters and specialized catheters
  • Mother-infant care products
  • Cytology snares and brushes
  • Dental accessories
  • Thrombectomy
  • Tubing sets
  • Orthopedic devices
  • Plastic components for delivery systems
  • Surgical Accessories
  • Urology catheters

Contact us with your design requirements, and we will assist you in determining which medical molding process and material are most acceptable for your application. Some parts might not be suitable for medical injection molding; if that is the case, we will help you discover a process that will work for you.

Injection Molding FAQ

Q. How do I know if injection molding for medical devices is the proper process?

A. The part’s geometry, the number of parts needed, the tooling budget, and the application part used will influence the decision to inject mold the characteristics.

Q. What material should I use for my project?

A. Most material is application specific. If you need material specified for your application, SEISA can help and offer guidance. Often several resins can be sampled, but the customer has the last approval before proceeding.

Q. How much will a mold cost?

A. One of the most frequent questions for customers looking to source plastic injection mold is, «How much will a plastic injection mold cost?» It’s one of the essential questions since the actual mold describes the most critical cost in upfront production costs. Tight-tolerance, precision molds completed from the best steel available should last many years. Many aspects go into deciding the total cost.  

Q. What certifications should I need to look for a medical device molder?

A. Specific certifications verify a supplier’s commitment to quality and KAIZEN. They display that buyers and procurement specialists are dealing with a manufacturer that has achieved the highest standards in the industry. As buyers develop more sophisticated, they want to see more accountability and quality reviews throughout their supply chain. At Seisa, we use essential quality manufacturing standards to deliver innovative plastic injection manufacturing solutions for our clients and continuously look for ways to improve and purify our processes. 

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