Prime examples were molding non-communicating passageways through a plastic manifold, molding critical tolerance pacemaker components, and even molding around glass formations without breaking or cracking. Our advanced injection molding equipment makes even the most difficult projects possible.

Meeting stringent regulatory requirements is a non-negotiable in the medical device industry. Injection molding excels in this regard. The ability to use FDA-approved materials and consistently produce parts that meet these standards ensures compliance from the outset.

We have been serving the medical industry for nearly 40 years, specializing in handling complex, multi-part programs and medical device molding for a variety of customers. Our direct contact with doctors and other medical professionals gives us insight into their needs and helps define and assist with final product solutions.

Medical injection molding is a manufacturing process that produces plastic medical devices and components. It involves melting plastic resin pellets and injecting the molten material into a mold to create a specific shape. This process allows for precise control over the product's size and shape and is subject to strict quality and regulatory standards.

Mold Design is a crucial step in the injection molding process.  Once you’ve finalized your part in CAD software for fit and function, it must then be transformed into a design for molding to ensure the capture of all the specified details.  In some cases, certain features of the part design may not be manufacturable via the injection molding process.

However, there are other types of plastics called thermosets that also can be used for injection molding, but the process is far different. These materials are most likely not going to be used for medical molding as they cannot be recycled as easily as the thermoplastic materials.  Because of this, you don't see thermosets used as often as you do thermoplastics. A good example of a thermoset is your car tires. This is where they cannot be melted down and reshaped into something.

Medical injection molding is a core technology of Aberdeen Technologies and represents a cutting edge solution to the manufacturing needs of healthcare companies who produce medical molded devices. As an insert molding manufacturer, we provide assistance to device manufacturers who approach us with new product concepts and ask us to mold parts for clinical trials and marketing evaluations.

We provide assistance throughout each stage of your program, from design recommendation through mold tooling fabrication, prototyping, first article approval, process validation, full scale production medical molding, and transfer of turnkey system to customer facilities if requested.

Some of the most common materials used in medical devices are: Polypropylene, ABS, Polyurethane, Polyvinylchloride, Polycarbonate, Polystyrene, Polysulfone, Acetal and Polyethylene.

Injection molding is a very common way to form plastic parts and components. Depending on the material, the parts can be very strict with their tolerances as well as easy to process. Injection molding is one of the most common types of forming plastics. It is used in a variety of industries and not just for medical injection molding. In fact, you probably have a wide variety of injection molded parts all around you and simply don't know it. Your basic pens, your keyboard, and even your phone have injection molded components in them. ​

The most common types of materials used in medical insert molding are thermoplastics. These are materials that can be heated up into a molten state and pushed through a barrel into a mold. These molds can simply be open and shut type designs, which are what you would expect for, say a simple product such as a cake mold. Or they can be very complex with moving side parts called slides. Of course, the simpler the mold the better for maintenance and longevity. However, complex parts will need these complex designs in order to produce the desired part.

Injection molded parts can undergo a variety of post-processing operations, such as assembly, machining, laser marking, pad printing or surface finishing, to meet the exact requirements of the medical device.

Once these new devices are produced, we assist our customers in transitioning the project into the production phase. Quality and customer satisfaction are our primary goals, and Aberdeen can work with both high and low quantity requirements with over 700 square feet of cleanroom injection molding space.

Sometimes the components need to be manufactured separately and then assembled. This is very common in many cases and this can be done by hand or robot.

One of the most significant advantages of injection molding is its design flexibility. Engineers can create complex, customized components with minimal tooling changes. This adaptability is essential in a field where the demand for innovative and unique medical devices is ever-expanding.

Aberdeen’s primary goal is total customer satisfaction for even your most challenging projects. Our company culture is one of honor, respect and service with the highest degree of competence and professionalism that you will find anywhere.

At PTI, we have over 16,000 square feet of ISO Class 8 cleanroom space that we utilize in our injection molding process to ensure as little contamination as possible.  We adhere to strict protocols that meet the demands the medical industry requiring ISO 14644 Cleanroom specifications, including bioburden and electrostatic discharge (ESD).

Process validation is the best way to ensure the production of safe parts, to reduce rejection rates, to prevent part failures in the field and to ensure the part meets with application, specification and regulatory obligations.

Having served the medical industry for nearly 40 years, we understand medical device manufacturing.   Plastic Injection Molding remains one of the best manufacturing methods for achieving precision and cost-efficiency as well as maintaining patient safety.

Careful selection of materials is extremely important within the medical industry. Materials must meet FDA and other regulatory standards, ensuring patient safety, biocompatibility, sterilizability and durability.  As Injection molding allows for a vast selection of both thermoplastic and thermoset materials to choose from, there is certain to be a material suitable for just about any application.

With streamlined production processes, injection molding can significantly reduce time-to-market for medical devices. This is crucial in a rapidly evolving industry where innovations can make a significant impact on patient care and outcomes.

Injection molding for medical devices represents the perfect synergy of precision engineering and advanced manufacturing technology. Its benefits, from precision and consistency to cost-efficiency and regulatory compliance, make it a top choice for design engineers and medical device manufacturers. The process empowers engineers to innovate, create intricate components, and bring lifesaving devices to market faster than ever before. The future of medical device manufacturing is being molded with precision, and injection molding is at the forefront of this revolution.

Process Validation as defined by the FDA is “The collection and evaluation of data, from the process design stage throughout production, which establishes scientific evidence that a process is capable of consistently delivering quality products.”

In many cases, our medical device customers look to process validation to ensure quality parts.  After all, patients lives depend on PTI to deliver high quality parts each and every time.

The injection molding process generates minimal material waste compared to other manufacturing methods. This not only contributes to cost savings but also aligns with the increasing focus on sustainable and environmentally friendly manufacturing practices.

Many medical devices must be in direct contact with the human body. Injection molding allows manufacturers to choose biocompatible materials, ensuring patient safety. These materials can be sterilized without affecting their properties, making them suitable for a wide range of medical applications.

The process is capable of making FDA approved medical devices that are both durable and reliable. This type of molding can also be used to make prototypes to send and get the much-needed FDA approval. Medical injection molding can be performed in a clean room and the components can be sterilized without harm as well. Let's take a look at injection molding.​

In the medical field, we often see metal combined with the plastic part. This is called insert molding and is a very common practice for injection molders to do. You see this all over the medical arena from needles to EKG hook up leads and more.

Furthermore, we have over 5,000 square feet of controlled environment space.  This segregated area is temperature controlled and pressurized, and can accommodate part decorating, assembly and packaging needs.

Injection molding offers unmatched precision and consistency in the production of medical device components. The process allows for intricate designs and tight tolerances, ensuring that each part is identical to the next. This uniformity is crucial in the medical field, where reliability and precision are paramount.

Injection molding is scalable, which means it can cater to a variety of production volumes, from small-scale prototypes to mass production. This scalability offers manufacturers the flexibility to meet different market demands.

The high initial tooling costs can be a barrier to entry for some manufacturers. However, once the molds are in place, injection molding is incredibly cost-effective for large production runs. The ability to produce a large number of parts in a short time reduces unit costs significantly, making it an ideal choice for mass production.

Injection molding allows medical design engineers the freedom to design complex or intricate parts, a vast selection of suitable materials and the consistency to produce both low and high volumes of devices.

At PTI, we collaborate with you to achieve the best possible design for manufacturability.  In fact, we have a FREE guide to help you with this.

Injection molding produces parts with a high level of structural integrity, ensuring they can withstand the rigors of their intended application. These parts are less prone to defects and offer superior performance over their lifecycle.

PTI Engineered Plastics provides medical device manufacturers with full-service advanced product development delivered in a compressed timeframe. With superior design for manufacturability, tooling, and molding capabilities, PTI turns product visions into reality and gets your product to market first.