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.

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

High quality tooling ensures the precise and consistent production of molded parts. Our in-house team of tooling experts specializes in injection molding design, mold flow analysis and tooling for microfluidic applications. Using advanced tooling technologies, the tooling team can develop molds with complex geometries, tight tolerances, and intricate designs, specifically for industries that demand a high degree of quality and precision.

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.

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.

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.

We specialize in Design for Injection Molding (DFIM), ensuring optimal manufacturability and part quality. As an ISO-certified provider of engineering and custom injection molding, we prioritize DFIM to mitigate risks like wall thickness issues and part damage from ejection methods, resulting in smoother production and higher-quality outcomes. Our approach integrates DFIM into the product development process, optimizing designs to reduce costs, simplify production, and enhance overall quality. Our expert engineers collaborate closely with clients to anticipate issues and maintain design intent, ensuring seamless execution and superior results.

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.

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.

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.

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.

Our advanced infrastructure redefines industry standards, with robust capacity, stringent certifications, and precision-driven automation for unparalleled efficiency and consistency in injection molding.

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.

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.

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.

Choose SCHOTT MINIFAB for precision injection molding, without compromise.  Request a quote or kick off your project by consulting with one of our engineering experts.

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.

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).

As a contract manufacturer of diagnostics and life science research consumables, we go from pilot line to high volume quickly and efficiently.

We understand that achieving optimal product performance begins with selecting the right molding technique early in the design phase. At SCHOTT MINIFAB, we ensure that our clients have access to the precise tools needed to bring their innovative designs to life. From standard to precision, vario-thermal, and 2K injection molding, we offer a diverse suite of molding technologies, chosen to address specific project requirements. Explore our table below for a comparison of features across different molding techniques.

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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.

SCHOTT MINIFAB is a global leader in precision injection molding. We excel at delivering parts with precision features and tight tolerances. We focus on high-volume products for regulated markets where quality is non-negotiable.

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.

We offer a wide array of materials for your injection molding needs: Polycarbonates (PC) Polymethyl Methacrylate (PMMA) Polypropylene (PP) Cyclic Olefin Copolymer (COC) Cyclo Olefin Polymer (COP) Thermoplastic elastomers (TPE) with 2K Compatibility Styrene-ethylene-butylene-styrene (SEBS) ...and more, if you have a specific need let's discuss.

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.

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.

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.”

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.

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.

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.

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.