Pathway Medtech offers medical device injection molding services for companies large and small, from start-ups to large biomedical and healthcare corporations.
Injection molding is a manufacturing process for producing parts by injecting molten material into a mold. Injection molding can be performed with a wide variety of materials, including metals, glasses, elastomers, and most commonly thermoplastic and thermosetting polymers. Material for the part is fed into a heated barrel, mixed, and forced into a mold cavity where it cools to form the desired shape.
The advantages of injection molding are its versatility in design and the ability to produce large quantities of parts with tight tolerances. However, there are some disadvantages to this process as well, such as the high initial cost of the tooling required to produce the parts.
That’s why it’s smart to team up with Pathway Medtech for your medical injection molding needs!
The History of Medical Device Injection Molding
Injection molding has been around since the late 1800s, but it wasn’t until the 1950s that the process began to be used for medical applications. One of the earliest examples of medical injection molding was the production of plastic catheters.
Since then, medical injection molding has become one of the most popular manufacturing methods for producing medical devices and components. This is due to the many advantages that injection molding offers, such as its versatility in design, ability to produce large quantities of parts with tight tolerances, and low cost per unit.
Today, medical injection molding is used to produce a wide variety of medical devices and components, including syringes, blood pressure cuffs, IV bags, hearing aids, and much more.
Pathway Medtech has over 30 years of experience in medical injection molding, and our team of experts are ready to help you with your next project!
Contact us today to get started.
Examples of Medical Injection Molding Projects
Pathway Medtech has worked on a wide variety of medical injection molding projects, including the production of:
- Syringes
- Blood pressure cuffs
- IV bags
- Hearing aids
- And much more!
Other classic biomedical applications for medical injection molding include:
- Catheters
- Stents
- Implants
- Surgical instruments
These types of medical devices are created utilizing medical injection molding because this process provides the necessary precision and repeatability to produce high-quality parts.
If you’re interested in learning more about our medical injection molding services, or if you have a project that you would like us to quote, we’re ready for you.
Types of Injection Molds
There are two main types of injection molds:
- Thermoset Molds
- Thermoplastic Molds
Thermoset molds are made from materials that cross-link when heated, such as epoxy or phenolic resins. These materials cure or harden when they cool, so they can only be used once.
Thermoplastic molds are made from materials that soften when heated and harden when cooled. This means that they can be used multiple times.
If you’re not sure which type of mold is right for your project, our team of experts can help!
Medical Injection Molding Materials
There are a wide variety of medical injection molding materials available on the market today, each with its own unique set of properties. The most commonly used medical injection molding materials include:
- ABS (Acrylonitrile Butadiene Styrene)
- PC (Polycarbonate)
- PE (Polyethylene)
- PP (Polypropylene)
- TPE (Thermoplastic Elastomer)
The material you choose for your project will depend on the specific requirements and applications. For example, some materials are better suited for products that need to be sterilized, while others are better for products that will come into contact with human skin.
Pathway Medtech has experience working with each of these options and can collaborate with your team to determine the appropriate choices. Our experience as a medical device manufacturers in California will set your project on the right path.
3 Common Classification of a Plastic Injection Mold
Pathway Medtech understands the different types of plastics and how they are used. Here are three common classification of a plastic injection mold:
– Amorphous Plastics
– Semisynthetic Plastics
– Synthetic Plastics
Amorphous plastics do not have a definite shape or crystal structure. They tend to be glassy, brittle, and difficult to process. However, they have good optical clarity and can be transparent. Examples of amorphous plastics include acrylics and polycarbonates.
Semisynthetic plastics are made from natural products that have been modified chemically. They tend to be strong and durable, but can be difficult to process. Examples of semisynthetic plastics include Bakelite and vulcanized rubber.
Synthetic plastics are made entirely from synthetic chemicals. They can be easy or difficult to process, depending on the specific material. Examples of synthetic plastics include polystyrene and nylon.
Pathway Medtech has experience working with all types of plastics and can help you choose the right material for your project. These choices will vary based on the application you desire, your overall budget, and other factors.
ISO 13485:2016 Certified
Pathway Medtech is ISO 13485:2016 certified, which means that we meet the highest standards for quality and safety in the medical device industry. This certification is your assurance that our team will work diligently to produce products that meet or exceed your expectations.
As a provider of medical injection molding services, we are committed to providing our clients with the best possible experience.
How ISO 13485 Makes A Difference
The ISO 13485 standard is an internationally recognized quality management system (QMS) for the medical device industry. It is designed to help organizations ensure that their products and services meet the needs of their customers and other relevant stakeholders.
To be certified, organizations must demonstrate their commitment to quality by meeting a set of requirements related to product design, development, production, installation, and servicing.
The benefits of certification include improved customer satisfaction, reduced risk of product recalls, and increased market access. In addition, certified organizations are better positioned to comply with regulatory requirements.
Our ISO 13485 certification means your medical plastic injection molding project is in good hands!
Clean Rooms For Medical Plastic Parts
Pathway Medtech operates two clean room facilities totaling over 4,000 square feet. Our rooms are temperature and humidity controlled to ensure a contamination-free environment.
We also have an extensive selection of clean room equipment, including:
– Injection molding machines
– Material handling equipment
– Packaging equipment
– Assembly equipment
Our clean rooms are ISO Class 8 certified (formerly Class 100), which means they meet the highest standards for cleanliness. This is important for products that need to be sterile or free of contaminants.
Process Validation Services
Process validation is a critical step in the medical device development process. It is essential for ensuring that products meet their intended purpose and function.
Pathway Medtech offers comprehensive process validation services, from design verification and validation to process capability studies. We also offer mock recall services to help you prepare for the worst-case scenario.
Our team has extensive experience with FDA regulations and guidelines, so you can rest assured that your products will meet all requirements.
We understand that every project is unique, so we tailor our services to meet your specific needs. Our goal is to help you bring your products to market quickly and efficiently.
Get An Injection Molding Sample Quote
Pathway Medtech provides high-quality medical injection molding services to our clients at competitive prices. We understand that cost is a major consideration in any manufacturing project, which is why we offer a free sample quote for all new projects.
This way, you can get an accurate estimate of the cost of your project before committing to anything. To get started, simply fill out our online form or contact us today and one of our San Diego contract manufacturing experts will be in touch shortly!