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

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.

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.”

If you’re trying to produce some parts using injection molding, it is only right you find out about the cost of the whole process before going ahead. To estimate the costs involved, you need to factor in different costs. Examples of the various costs involved include:

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.

Despite its acclaimed strength and toughness, this strong plastic isn’t so impervious to UV light. Hence it has limited outdoor use. However, part manufacturers have found ways to manipulate the properties of this plastic to withstand UV light by using various additives and fillers such as acrylic, glass, and stainless steel fibers. These additives alter the properties of the plastic and further enhance its uses for various applications.

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.

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.

This is the cost of buying the material (in this case, ABS). You’ll be able to find the material for a cost ranging from $1 to $5 per kg.

Before using a piece of ABS plastic for manufacturing, it needs proper drying. The drying temperature used is within the range of 80 – 85°C done for 2 – 4 hours. Another drying method involves using a drying hopper with a temperature of 80°C. However, the latter process only lasts for 1 – 2 hours.

The injection molding temperature used for a particular ABS injection molding process depends on the quality/grade of ABS used. Listed below are examples of some grades of ABS plastic commonly used in ABS plastic molding and the optimum injection molding temperature used:

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.

These properties and potential for manipulation make ABS the most widely used polymer in the injection molding process. Want to find out how this plastic is used for manufacturing various finished products? Then, the next section is a must-read.

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.

ABS plastic has uses in different industries due to various reasons. Due to its ease of molding, the low cost of production, and resistance to physical and chemical changes, this polymer has become a manufacturer’s favorite. Here are some examples of industries where ABS plastic parts have found use:

Some ABS grades tend to stick to the mold screw after removing the part. So the best way to clean this up is to wait a little bit for the residue to wear off, then clean the compartments of the injection molding machine thoroughly using polystyrene.

Other activities carried out during ABS molding processes include decorated moldings using laser marking or hot stamping, ultrasonic welding, etc.

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.

To prevent the out-gassing that comes from the flame-retardant ABS plastic absorbing moisture, you need to ensure the material is fully dried. Also, you need to ensure good temperature and residence time control during the injection molding process to prevent thermal degradation of the ABS plastic.

This is also known as the tooling costs. This drives up the cost of the ABS injection molding process. There are three different methods used in making injection molds. They include CNC machining, 3D printing, and electrical discharge machining (EDM). These methods can range as low as $100 for low-volume simple 3D-printed molds. The price could also go as high as $100,000 for huge production runs or molds with complex designs.

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 residence time is the time it takes for a plastic pellet to move from the injection molding barrel to the injection mold. For ABS plastics, the residence time is usually between 5 – 6 minutes at a temperature lower than 265°C. However, for flame-retardants grade ABS plastic, the residence time is shorter, and the temperature is way lower.

One of ABS plastic’s major shortcomings is its poor sunlight performance. The material tends to degrade upon constant exposure to sunlight. However, part manufacturers enhance its performance in sunlight by adding additives to the ABS plastic during molding.

ABS is harmless and non-toxic. This is one of many reasons it is a popular plastic material in manufacturing. However, it is not encouraged to use in medical implants.

Controlling the temperature is crucial during ABS injection molding as overheating the plastic could lead to thermal degradation. This thermal degradation is due to the chemical bonds in the plastic breaking, which could cause brown granules on the finished part.

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 recyclability of ABS makes it a perfect material for use in reusable applications. Recycling plants can easily shred the plastic parts and mix them up with fresh ABS to use for new parts production.

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.

ABS plastic has some hygroscopic properties (it can absorb moisture from the air) and also absorb water around it. However, the presence of water in any molded ABS plastic could cause structural defects in the plastic. Hence, ensuring the ABS plastic used is properly dried is essential. There are two parameter types for drying the plastic: either dry at 80 – 95°C for 3 – 4 hours or use a dry hopper at 80°C for 1 – 2 hours.

ABS molded parts are suitable for use in applications that require supporting heavy loads because of their high tensile strength. Their ability to withstand heavy mechanical impacts makes this plastic a good budget option for high tension applications.

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.

After treating the material, the next step is to prepare the ABS molding machine for work. This will involve setting the parameters such as the compression ratio, clamping force, and injection molding pressure. The typical values for these parameters include a compression ratio greater than 2, a clamping force ranging from 4700 to 62000 tonnes per square meter (t/m²), and an injection molding pressure greater than 1500 bar.

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.

There are many reasons why ABS injection molding is one of the most popular forms of plastic molding. Some of the advantages include:

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.

The injection molding speed depends on the grade of the ABS plastic and the finished product requirements. For example, flame-resistant ABS plastics can only use slow injection molding speeds. Also, products that require precision surface finishing could require multi-stage, high injection molding speeds.

You’ll most likely outsource your production to companies with the necessary equipment. These companies will charge you a separate fee for the equipment used. However, if you plan to get the equipment, you’ll have to dole a sum within the $50,000 – $200,000 range. Apart from buying the equipment, you’ll also have to maintain the equipment, which could cost you a fortune. The cost-effective option will be to outsource the production.

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).

When trying to start an ABS injection molding batch, a few factors must be in place. These factors are vital to having successfully molded parts. They include:

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.

This section highlights the various steps manufacturers must follow during the ABS plastic molding process. They include:

Working with an injection molding machine with good temperature control is essential as this process still requires a lot of heat. For example, when the ABS parts in production contain a high level of gloss, the temperature used in production is higher than normal. However, it is important to note that the higher the temperature used for the injection process, the shorter the exposure time should be.

ABS stands for Acrylonitrile Butadiene Styrene. This plastic material comprises three monomers that make up its name. Each of these monomers contributes its properties to the polymer plastic to give it a wide range of properties.

The mold is quite vital in determining how the finished ABS product will turn out. Hence, the design of the mold and its gate is quite important in the process. The thickness of the ABS mold ranges between 0.025 – 0.05mm, while the gate length is set at less than 1mm. Also, the diameter of the channel through which the molten ABS flows is set at 3mm, while the vent hole width ranges from 4 – 6mm. Finally, the mold temperature used is always around a range of 60 – 65°C.

Injection molding is a common manufacturing process with different variants depending on the raw material used. One of such variants of the process is the ABS injection molding process. Just as the name implies, the raw material for this injection molding variant is ABS plastic.

ABS injection molding is a process that seems pretty easy to achieve. However, its technicalities that only experts understand. This is why it is important to outsource your ABS molding to companies that actually understand the practical principles of the manufacturing process.

Designing the parts before the injection molding process makes it possible to determine if producing the part is actually possible. Here are some general principles that work with ABS parts design:

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.

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 properties the plastic possesses include chemical resistance, hardness, and heat resistance contributed by acrylonitrile. Other properties include impact resistance and toughness (bestowed by butadiene) and strength and gloss contributed by styrene. Despite its wide range of features, it is relatively one of the cheapest plastics to purchase. Also, it is one of the easiest plastics to use in injection molding due to its ease of processability.

The costs here are responsible for the remuneration of the personnel carrying out the tasks and for the setup and maintenance of the machines. Examples of parameters factored in here include:

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.

While ABS parts usually have high tensile strength, they can’t withstand heavy loads for long periods because of their poor fatigue resistance. The ABS plastic part might degrade easily if constantly exposed to high-stress environments.

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.

It is advisable to keep the backpressure of the ABS injection molding process as low as possible to prevent wear. The acceptable pressure is usually around 5 bar.

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 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.

At WayKen, with advanced manufacturing technologies and resources, we can provide our customers with professional rapid prototyping services ., including CNC machining, rapid injection molding, vacuum casting, etc. So, get a quote today, and you can be sure to get high-quality injection molded parts at a competitive price.

Due to the processability of ABS, it is the most suitable material to use in making complex parts. Its processability makes it easy to reproduce complex and functional parts using the plastic. Apart from the parts being accurately produced, they still maintain functional integrity even when used in extreme conditions, thanks to the hardness of the plastic.

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.