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.

Gilero provides a range of manufacturing services, including plastic injection molding and injection mold tool building. We focus solely on the medical device and drug delivery markets. Our medical injection molding facilities follow strict design protocols and process controls to ensure that all products meet the required specifications. Depending on client needs and product requirements, we can offer manual or fully automated production lines for molding and assembly.

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.

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.

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.

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.

There are many diverse types of materials that can be used in injection molding medical devices. Some useful and commonly used materials include:

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.

Medical device injection molding also has many other advantages, such as compliance with industry standards and regulations. Engineering-grade plastics can be used in the process to create parts that enhance patient safety and comply with FDA (Food and Drug Administration) guidelines. There is flexibility with injection molding, as the parts can be fully customizable to fit the user. The ability to fulfill high-volume orders with high accuracy and precision is also an advantage of injection molding medical devices. In addition, injection molding is a cost-effective manufacturing method. With automation technology and energy-efficient equipment, we further reduce our labor and utility costs.

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.

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.

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.

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.

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.

Plastic injection molding is widely used in the medical device industry. Plastics are often used alongside the injection molding process to produce prototypes and full-production units of medical devices and equipment components. As newer plastic materials and component designs are developed, injection molding medical devices has increasingly contributed to lower infectious disease rates, and lower medical costs.

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.

Injection molding is a method to obtain molded products by injecting plastic materials molten by heat into a mold, and then cooling and solidifying them. The method is used for mass production of products with complicated shapes and plays a large part in plastic processing. Injection molding for medical devices can be performed by using many sorts of materials such as metals, confections, and most commonly thermoplastic and thermosetting polymers.

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 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.

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.

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.

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 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.

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.”

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.

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.

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

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.