By signing up, you agree to our Terms of Use and Privacy Policy. We may use the info you submit to contact you and use data from third parties to personalize your experience.

Fictiv can produce injection-molded products for a wide range of medical applications. We have the resources, know-how, and manufacturing network to deliver the injection molded parts that you need, far faster than other manufacturers. And, we deliver 95.4% of orders on time and to spec, thanks to our network of highly-vetted partners, on-site quality engineers, and robust quality management system. Create an account and upload your medical device design today! Along with your quote, you’ll receive expert design for manufacturing (DFM) feedback and guidance to ensure you get great outcomes.

The U.S. FDA (Food and Drug Administration), and the EU MDR (Medical Device Regulation) both divide medical devices into three classifications, where Class I refers to the lowest-risk medical devices and Class III refers to the highest-risk. The EU MDR further breaks down Class II devices into two subcategories: IIa and IIb.

Medical injection molding can be used for prototyping or low-volume production, but it’s often used in high-volume manufacturing for medical devices. In part, that’s because products can be injection molded at-scale with consistent quality and with minimal human intervention. Here are some common examples of injection-molded medical products:

For designers, it’s important to remember that not all polymers are suitable for medical devices. However, injection molding supports the use of many different materials, typically commodity plastics but also specialty plastics and polymer blends. Designers can also choose medical plastics that have specific trade names like ULTEM®, a polyetherimide (PEI) that can withstand repeated cycles in an autoclave. Below are some common injection molding plastics and their salient characteristics:

ICOMold by Fathom is digital manufacturer on the cutting edge of advanced injection molding. We are able to manufacture almost any plastic part to fulfill any purpose by utilizing the latest machinery and computers. We employ a variety of molding techniques to create custom parts to the client’s specifications. Complex, intricate, and highly detailed parts are easy to make thanks to an array of sophisticated, computer-controlled machines. ICOMold specializes in injection molding technology but can also create parts and prototypes using Computer Numerical Control (CNC) machines. We have the expertise and machinery to easily CNC machine prototypes or small batch runs.

By signing up, you agree to our Terms of Use and Privacy Policy. We may use the info you submit to contact you and use data from third parties to personalize your experience.

ICOMold is part of the Fathom Digital Manufacturing network. Fathom has a nationwide network of manufacturing facilities that are on the cutting edge of fabrication. Direct Metal Laser Sintering (DMLS) is a new technology in plastic injection molding that utilizes metal 3D printing to create molds. This technology is ideal for building tooling that would otherwise be impossible to machine by conventional means. DMLS allows our experts to build a mold from the ground up. Conformal cooling lines can also be incorporated into the tooling, increasing the life of the mold, reducing cycle time, and ultimately saving the customer money.

ICOMold by Fathom is an injection molding company that embraces new technology in plastic injection molding to make better parts for a wide variety of applications.

Access a wide breadth of capabilities through our highly vetted network.

Injection molding starts with a mold. A rigid mold, typically made of metal, is created with a cavity on the inside. Melted plastic is injected into the mold. The mold is then opened and the finished piece is ejected. The applications for plastic injection molding are nearly limitless. Simple carrying bags, packaging, accessories for the computer, automobile parts, toys, and parts for consumer electronics can all be manufactured using advanced injection molding from ICOMold. Plastic injection molding technology can be used to make simple items like a fork or complicated, life-saving medical items.

The business of plastic has always been forward thinking and ICOMold is no exception. From the early days of plastic, the inventors and chemists were looking for an easier, less expensive way to create products that would stand up to the rigors of everyday use better than their traditional counter parts. The first well-known, mass-produced plastics were cellulose and Bakelite. Cellulose is plant-based material while Bakelite is a fully synthetic product. Injection molding was invented in 1872. Early injection molding companies produced small, simple items like buttons, combs, and collar sticks. The injection molding industry took off in the 1940s during World War II due to the demand for cheap, mass-produced items as part of the war effort. New technology and machines over the last few decades has made plastic injection molding more efficient and cost effective.

ISO 10993 focuses primarily on the biocompatibility requirements for medical devices. It encompasses products that are designed to come into direct or indirect contact with the body. The goal of ISO 10993 is to reduce the risk of adverse effects on patients when exposed to materials that include, but are not limited to, injection molded plastics. ISO 10993 compliant materials are non-toxic, do not affect the immune system, or do not potentially cause cancer.

Our trained employees ensure your parts will be delivered on time and to spec.

Plastic injection molding is used in many different applications within the medical industry. Examples include enclosures for medical equipment, the overmolding of surgical tools, and spinal implants. Designers have a choice of materials, but the selected plastic must meet the application’s requirements. For example, plastics that will be sterilized with steam need to resist high temperatures and moisture, while those that will come into contact with patients must be biocompatible, meaning that they’re not harmful to living tissue.

There are many different ways to create plastic items. The two most popular techniques are injection molding and blow molding. ICOMold by Fathom is an injection molding company that also specializes in CNC milling, CNC lathing, and urethane casting. This allows ICOMold to serve a wide variety of clients in creating any part to fit their need, from a simple piece all the way to intricate items with complex geometries.

We exist to eliminate bottlenecks in new product development by integrating the people, processes, and platform you need to source custom parts.

By signing up, you agree to our Terms of Use and Privacy Policy. We may use the info you submit to contact you and use data from third parties to personalize your experience.

Class III medical devices are usually designed to sustain or support life and may present an unreasonable risk of injury or illness. Examples include pacemakers, defibrillators, and implanted prostheses.

Stretch blow molding is preferred for molding bottles and is extensively used in the bottling process of soft drinks, mineral water, chemicals, oil, and edibles. Extrusion blow molding equipment is utilized for manufacturing container goods for polyethylene (PE), polypropylene (PP), or polycarbonate (PC), and uses both mechanical and pneumatic systems. Extrusion molding pushes plastic through a rigid mold and can be used to make long solid or hollow items like pipes or straws.

Designers also need to select plastics that meet medical industry standards. This article examines the standards that affect the production of injection-molded medical products. By selecting materials that meet these standards, designers do more than meet requirements from independent bodies and regulatory agencies — ultimately, they promote quality, performance, and safety.

By signing up, you agree to our Terms of Use and Privacy Policy. We may use the info you submit to contact you and use data from third parties to personalize your experience.

Overmolding is an advanced injection molding process used to make parts with two different types of materials, typically one type of material over another. A good example is a game controller or cordless drill body with a hard outer shell and soft, rubberized grips. Overmolding allows clients to create complex items that may contact two different surfaces at the same time. Overmolding typically involves soft thermoplastic materials like urethanes and thermoplastic elastomers (TPE) being over molded onto hard plastic such as acrylonitrile butadiene styrene (ABS) or PC.

Milling and lathing is the process of removing material from a block or a cylinder to create a finished product, in much the same way that a sculptor would remove material from a block of stone to create a statue. Our multi-axis, high-speed CNC milling machines can produce complex prototypes and low-volume parts quickly and efficiently. CNC machining is an easy and cost-effective way to create prototype pieces without the time and expense of creating a mold. In most cases, the CNC milled part can be used for product testing. We can also use CNC machining to create small batch runs up to 500 parts. ICOMold by Fathom can mill a variety of materials and parts that can be delivered in days instead of weeks or months.

Integrated computer technology has ensured that advanced injection molding equipment can keep up with the demands of consumers. Complicated sizes, shapes, and designs can now be easily manufactured. Plastic items made with injection molding can be found in every industry. Plastic injection molded items are integral to our society and economy and can be found almost everywhere, from defense items and medical kits, to all kinds of household appliances and electronics.

ICOMold offers a wide range of secondary processes to ensure every customer is satisfied with their final order. The following is a list of the standard secondary processes available after injection molding. We will be happy to discuss any custom process or secondary processes not listed below.

Medical devices are classified according to their potential for causing harm to patients, the general public, or to other personnel who use or operate the medical device. This classification determines the degree of required regulatory oversight.

We exist to eliminate bottlenecks in new product development by integrating the people, processes, and platform you need to source custom parts.

Blow molding debuted in the 1970s, allowing manufacturers to create hollow and much more intricate items. Hollow items reduced cost and waste, giving plastic yet another leg up on conventional materials and manufacturing techniques.

Insert molding is an injection molding technology that allows metal or ceramic inserts, like brass nuts, bushings, screws, or metal filters, to be incorporated into the finished part. The metal or ceramic parts are placed in the mold and the plastic is injected around them to create the finished part.

Of course, proper product design is also critical for medical devices, so check out our free Injection Molding Design Guide for best practices — it complements the info in this article.  Download Fictiv’s Injection Molding Design Guide

Blow molding is used to create hollow plastic items. Blow injection, stretch blow molding, and extrusion blow molding are the three types of techniques used to create plastic piece with a void on the inside.

By signing up, you agree to our Terms of Use and Privacy Policy. We may use the info you submit to contact you and use data from third parties to personalize your experience.

Class II encompasses any medical device for which general controls are deemed insufficient to provide reasonable safety and effectiveness. Examples include contact lenses, syringes, and pregnancy tests. The EU MDR adds two subcategories:

Industry standards play an important role in the design and manufacture of medical products, especially medical devices. For designers, these standards help ensure that patients, the end-users of injection molded products, are not exposed to excessive risks during medical treatment. So injection molders must implement stringent processes and procedures to control all stages of production and comply with standards.

By signing up, you agree to our Terms of Use and Privacy Policy. We may use the info you submit to contact you and use data from third parties to personalize your experience.

By signing up, you agree to our Terms of Use and Privacy Policy. We may use the info you submit to contact you and use data from third parties to personalize your experience.

ISO 14644 regulates the use of cleanrooms during medical device manufacturing. It defines the various cleanroom classes from Class 1 to Class 9, where Class 1 has the most stringent cleanliness requirements.

Advanced Technology Injection Molding Injection Molding Basics Calculate Cooling System In Injection Molding Calculate Plastic Mold Shrinkage Clamp Tonnage Injection Molding Custom Injection Molding Thermoplastic Gas Assist Injection Molding Instant Quote What is Mold Manufacturing? What are Examples of Injection Molding Products? What is 3D Molding? What is a 3D Printed Injection Mold? What is ABS Injection Molding? What is an Injection Molding Press? Liquid Silicone Molding 101 Micro Molding 101 What is HDPE Molding? What is Mold Tooling? What is Polymer Molding? Precision Injection Molding Basics What is Prototype Plastic Molding? What is PVC Injection Molding?

The increase in computing power and advances injection molding technology over the last 30 years has allowed manufacturers to greatly expand the options available to clients in need of plastic parts.

The QSR (Quality System Regulations), also referred to as 21 CFR part 820, as outlined by the FDA, has many parallels with ISO 13485. In the United States, the QSR may be used as a supplement or replacement for the ISO 13485 standard.

Create high quality custom mechanicals with precision and accuracy.

By signing up, you agree to our Terms of Use and Privacy Policy. We may use the info you submit to contact you and use data from third parties to personalize your experience.

To achieve these goals, ISO 13485 outlines processes and procedures to manage risk and regulatory compliance while providing mechanisms to continuously improve the QMS whenever a gap or potential for improved performance is noted. The standard defines best practices for documentation, training, traceability, research and design, production, and how to handle non-conformances. For both the part designer and the injection molders, there are well-defined responsibilities.

ICOMold is a leader in advanced injection molding plastic technology. Plastic is a versatile material that can be used in almost every situation and it is a ubiquitous part of our everyday lives. Plastic is everywhere, from the toothbrush we use in the morning, to the plastic utensils at lunch, to the case that holds our cell phones, to essential parts in our automobiles and medical equipment.

ICOMold’s fast-turn, low-cost, high-value injection molding enhanced by joining Fathom’s manufacturing platform. Learn More

By signing up, you agree to our Terms of Use and Privacy Policy. We may use the info you submit to contact you and use data from third parties to personalize your experience.

Accelerate development with instant quotes, expert DFM, and automated production updates.

In cleanrooms, the amount and size of airborne particles are carefully controlled to reduce the chances of exposing sensitive medical components to these particles. ISO 14644 also outlines specific requirements for designing, manufacturing, and maintaining cleanrooms for optimal performance. Designers may need an injection molder with a Class 7 or Class 8 cleanroom to limit the potential for contamination during manufacturing.

The ISO 10993 standard consists of 23 parts or subsections. This includes processes and procedures for animal welfare requirements, tests for carcinogenicity, reproductive toxicity, in vitro cytotoxicity, and various sterilization techniques. USP (United States Pharmacopeia) Class VI covers similar biocompatibility requirements for plastics and, as such, is sometimes used in place of ISO 10993 or as a supplement. For designers, this standard can play an important role in material selection.

Class I medical devices are not intended to support or sustain life and will not present an unreasonable risk of illness or injury to a patient. Examples include wheelchairs, glasses, hospital beds, and test tubes.

ICOMold offers several ways to brand or print text or pictures onto a plastic item made with advanced injection molding. Conventional screen-printing is used to print the desired text or image on any plastic item with a flat surface. ICOMold employs pad printing when the object may not be easily printed by conventional means. Pad printing allows the transfer of a 2D image onto a 3D object. A silicon pad is created that acts as a flexible stamp. This stamp can then be pressed onto the object, transferring the desired image. This type of printing is can be used in place of screen printing but is ideal for items that have compound angles, textures, rounded edges, or may be spherical.

The medical device industry is tightly controlled to ensure patient safety. Listed below are some of the common standards that affect manufacturing, including plastic injection molding.

ISO 13485 outlines the requirements for a quality management system (QMS) when producing medical-grade products. It is the most common standard used in medical device manufacturing. ISO 13485 is not limited to plastic injection molding but rather covers the general requirements for all manufacturing technologies that are used to produce medical equipment. This standard was developed to ensure that consistent quality is maintained and that medical devices and equipment are produced in a safe and effective manner.