Top 10 Medical Plastic Injection Molding Companies Worldwide

We believe you would wish to purchase your medical plastic injection molded items from the top and most technologically equipped manufacturers. Therefore, we must offer appreciation to the world’s top manufacturers in this special niche industry. In this article, we shall introduce the world’s top 10 medical plastic injection molding manufacturers and brief you on their capabilities, services, and medical applications.

1. List of Medical Plastic Injection Molding Companies Worldwide

To help you, we hereunder list the top 10 world medical plastic injection molding companies that have left an imprint in terms of technical precision, government regulations compliance, and reputation for manufacturing world-class medical parts.

2. Top 10 Medical Plastic Injection Molding Companies Worldwide

Here we will provide top medical plastic injection molding companies known to have world-class manufacturing facilities, technical knowledge, and commitment to providing high-quality medical components.

Top 1: Holly Plastic Parts

Holly Plastic Parts is a premium medical plastic injection molding facility with over 25 precision molding machines operating under ISO Class 8 cleanrooms. With the ability to manufacture over 5 million molded parts per month, the company facilitates mass production of medical consumables, diagnostic cartridges, and surgical instrument components. ISO 13485 and ISO 9001 certified, Holly maintains rigorous quality control over its molding and assembly processes.

Holly offers turnkey services from DFM (Design for Manufacturability) to tooling, mold design, scientific molding, and secondary operations such as ultrasonic welding, printing, and packaging. Holly employs in-house engineering personnel, and it creates concepts, thus giving faster development with fewer defects to the customers. They also have traceability and document systems according to FDA and EU MDR regulations.

Notably, Holly Plastic Parts collaborated with a European diagnostics company during the COVID-19 pandemic to produce high-volume rapid test cassette housings with over 30 million units supplied on schedule and under severe regulatory circumstances. Leveraging its established track record and agile plant, Holly provides services to European, North American, and Southeast Asian OEMs and contract manufacturers.

Website: https://www.hollyplasticparts.com/solution/medical-plastic-injection-molding/

Year established: 2000

Location: China

Products:

• Medical enclosures
• Diagnostic cartridges
• Surgical device housings
• IV components
• Custom medical parts
• Assembly-ready components

Top 2: Providien

Providien is a five-United States- and Mexico FDA-approved precision medical plastic injection molding and assembly contract manufacturing company. It possesses more than 150 injection machines and more than 70,000 square feet of Class 7 and Class 8 ISO cleanrooms. Providien uses it to produce high-volume quantities with orders in excess of 10 million parts per month. It is ISO 13485, ISO 9001, and FDA approved and is completely compliant with highly regulated healthcare regulatory requirements.

Providien offers vertically integrated services like tooling, manufacturability (DFM) design, insert molding, micro molding, and device assembly. It does in-house IQ/OQ/PQ validation, traceability, and testing so that its customers are in a position to make regulatory filings. Providedien also offers low-volume pilot production and prototype development, which is ideal for startups and iterative product development.

Highlight achievements include working with one of the world’s top ventilator firms during the COVID-19 crisis, when Providien expedited production of precision molded parts within two weeks to meet emergency orders. Record delivery without sacrificing quality has earned them the status of preferred supplier to Class II and Class III medical device OEMs.

Website: https://providienmedical.com/

Year established: 2010

Location: Carlsbad, California, USA

Products:

• Catheter components
• Surgical device housings
• Diagnostic equipment casings
• Medical-grade enclosures
• Inserted molded parts
• Cleanroom-molded assemblies

Top 3: Seaskymedical

Seaskymedical is an experienced Chinese medical injection moulding Class I and Class II device component supplier, with more than 20,000 square meters of ISO Class 7 cleanroom factory and more than 60 high-precision mould machines. Seaskymedical possesses more than 8 million parts monthly production capacity, as per the requirements of ISO 13485, ISO 9001, and FDA, and provides traceable, biocompatible, and clean production.

Seaskymedical offers packaged services including mold design, prototyping, cleanroom molding, assembly, and EO sterilization packaging. Seaskymedical engineering staff offers DFM optimization, mold flow analysis, and regulatory documentation to help medical OEMs attain time-to-market savings. Seaskymedical also offers in-house tooling and 3–4 week rapid-turn mold manufacturing.

An excellent customer testimonial is from a German purchaser of oral care products, who manufactures disposable dental unit components. Seaskymedical developed special tooling and completed product validation in 30 days, hence enabling the customer to reduce time to market. The firm also manufactures for US, European, and Asian customers for diagnostic, surgical, and patient care uses.

Website: https://www.seaskymedical.com/

Year established: 2008

Location: Shenzhen, Guangdong, China

Products:

• Disposable dental parts
• Surgical device components
• IV connectors
• Diagnostic cartridge parts
• Custom plastic enclosures
• Sterile packaging-ready parts

Top 4: Kaysun

Kaysun is a U.S. medical plastic injection molding expert with over 75 years of experience producing intricate parts for Class III and Class II medical devices. Located in a 95,000-square-foot Wisconsin building, Kaysun has over 60 high-volume injection mold presses, with electric presses to 720 tons, with capability to produce over 10 million parts per month. Kaysun is ISO 13485 certified and FDA compliant and offers traceability and qualified systems of manufacture.

Overmolding, insert molding, micro molding, and cleanroom molding are some of the strengths of Kaysun. DFM is offered in-house by engineers. Predictive analytics and mold flow analysis are used for minimizing defects and maximizing long-term reliability. Prototype through end-of-life service with full documentation support for regulatory requirements is offered by Kaysun.

One of Kaysun’s spotlight projects was the manufacture of overmolded housings for a diabetic patient’s wearable infusion pump. Kaysun assisted the customer with 12% material cost savings and FDA submission reduction, and full IQ/OQ/PQ validation support. Their expertise and regulatory compliance have made Kaysun an excellent partner for medical OEMs globally.

Website: https://www.kaysun.com/

Year established: 1946

Location: Manitowoc, Wisconsin, USA

Products:

• Infusion pump housings
• Implantable device components
• Micro molded parts
• Diagnostic device enclosures
• Overmolded sensor covers
• Sterile medical parts

Top 5: Freudenberg Medical

Freudenberg Medical is a global market leader in precision plastic injection molding for the medical sector with 11 U.S., European, and Asian production centers. It has over 150 micro and multi-shot injection molding presses and offers Class 7 and Class 8 cleanroom molding capability. With the ability to manufacture over 150 million components annually, Freudenberg Medical offers innovative programs for drug delivery, surgical instruments, and minimally invasive systems.

ISO 13485, ISO 9001, and FDA-registered, Freudenberg provides vertically integrated solutions like design engineering, tooling, molding, and end-to-end complete device assembly. Design for Manufacturability (DFM), regulatory strategy, and IQ/OQ/PQ validation processes are also provided as part of their development solutions to allow speed and compliance throughout the product lifecycle.

Among its top-profile achievements has been to develop and design a precision-molded component of a transcatheter heart valve system with one of America’s top medtech firms. Freudenberg reduced the failure rate of the component by over 90% through the iteration of mold design and material qualification. Their engineering depth, combined with capacity scalability, has made them the long-term partner of choice for Fortune 500 medical OEMs and startup firms.

Website: https://www.freudenbergmedical.com/en/

Year established: 1989

Location: Carpinteria, California, USA

Products:

• Drug delivery device parts
• Surgical system components
• Micro molded implants
• Catheter handle assemblies
• Minimally invasive device parts
• Custom cleanroom-molded parts

Top 6: MACK

MACK is a world-class plastics injection molding medical company with origins that go back to 1920. Based in Arlington, Vermont, USA, MACK operates over 100 molding machines and 12 locations in North America, which collectively have a monthly capacity of over 20 million pieces. With its FDA clearance, ISO 13485, and ISO 9001 certifications, MACK has invested in the quality know-how that it can deliver in the manufacturing of high-precision components for both diagnostic and medical device markets.

The company is a market leader in overmolding, insert molding, and injection molding and offers complete secondary support on pad printing, ultrasonic welding, and assembly. MACK believes in offering complete regulatory compliance with IQ/OQ/PQ validation support and complete documentation packages to facilitate product development for medical OEMs.

One of its long-time examples as a client is an international multinational diagnostics company to manufacture parts of point-of-care diagnosis products, wherein MACK’s turnaround and quality emphasis enabled the client to deliver product launches on time. Top medical brands across the globe have been guaranteed by MACK through long-term relationships due to its technical know-how and focus on quality.

Website: https://www.mack.com/

Year established: 1920

Location: Arlington, Vermont, USA

Products:

• Diagnostic device components
• IV components
• Wearable medical device housings
• Surgical instrument parts
• Insert and overmolded components
• Custom plastic parts

Top 7: Plastikon

Plastikon is among the leading medical plastic injection molding companies offering innovative solutions for manufacturing in the medical, pharmaceutical, and healthcare industries. With facilities since its foundation over 30 years ago and now with 13 North American, Asian, and European ISO Class 7 cleanroom-capable facilities producing over 100 million units annually, Plastikon is registered with the FDA and certified to the world’s most rigorous standards for medical device production with ISO 13485.

Plastikon offers one-stop-shop functionality in tooling development, design engineering, injection molding, assembly, and packaging. Plastikon is said to be able to assemble extremely complicated, multi-component assemblies and also offers rapid prototyping, low-volume production, and high-volume production. Plastikon specializes in offering high-quality sterile packaging to medical devices, which fall under stringent regulatory approval.

One of its success stories is the manner in which Plastikon developed and produced proprietary plastic components for an insulin delivery system, wherein they met functional and regulatory requirements within an affordable budget. Having customer satisfaction and engineering support as the company’s focal point, Plastikon becomes a partner of choice among medical device makers globally.

Website: https://www.plastikon.com/

Year established: 1982

Location: Fremont, California, USA

Products:

• Surgical device components
• Medical packaging
• Drug delivery systems
• Catheters
• Diagnostic device housings
• Overmolded parts

Top 8: Spectrum Plastics Group

Spectrum Plastics Group is a world-class medical plastic injection molding and assembly expert, delivering more than 50 years of manufacturing excellence in manufacturing higher quality molded parts to the pharmaceutical, diagnostic, and medical device markets. Spectrum Plastics, with 16 plants based in all of North America and Europe, boasts massive production capacity with more than 200 million parts produced every year. Spectrum Plastics is FDA-registered and ISO 13485-certified to deliver repeat regulatory compliance.

With cleanroom injection molding, Spectrum provides turn-key services in the form of micro molding, insert molding, overmolding, and assembly. Ancillary services like ultrasonic welding, laser marking, and packaging are provided. Technical services provided by Spectrum Plastics Group include DFM, mold design, mold flow analysis, and supply chain management to help in reducing the manufacturing process and time-to-market.

They were among the pioneers in their projects in producing molded parts specifically for a customer, which was a worldwide distributor of point-of-care diagnostic systems. Spectrum assisted them in meeting the tight delivery timelines amidst impossible delivery timelines during peak seasons. Achieving scaled-up production volumes as well as high-grade quality has made them the vendor of choice for many leading medical OEMs around the world.

Website: https://www.spectrumplastics.com/

Year established: 1964

Location: Alpharetta, Georgia, USA

Products:

• Point-of-care diagnostic components
• Surgical device parts
• Drug delivery system components
• Micro molded parts
• Medical packaging
• Assembly-ready products

Top 9: Sterling Industries

Sterling Industries is a very experienced medical plastic injection molding industry manufacturer with more than 40 years of manufacturing experience in manufacturing items for the medical, dental, and pharmaceutical industries. Sterling Industries is headquartered in Cincinnati, Ohio, and has several plant facilities and a tremendous ability to manufacture more than 50 million pieces per year. Sterling is FDA and ISO 13485 registered, which guarantees that they are capable of providing the quality and regulatory integrity necessary when manufacturing medical devices.

Sterling is an insert mold, overmold, and injection mold high-precision company offering the entire gamut of services from prototype to production in volume. It comprises multi-shot molding, ultrasonic welding, and assembly. It also offers packaging services with sterilization and secondary packaging according to FDA standards. Sterling offers low-volume and high-volume manufacturing solutions to its clients on the basis of professional expertise with high-quality material and design-for-manufacturability (DFM).

Sterling’s biggest project has been producing precision parts for one of the top manufacturers of dental instruments, in which they were basically being asked to enhance the product’s function and longevity. Sterling’s focus on innovation and quality has made them go-to partners with some of the top manufacturers of medical devices in the world.

Website: https://www.sterlingindustries.com/

Year established: 1984

Location: Cincinnati, Ohio, USA

Products:

• Dental device components
• Surgical instrument parts
• Diagnostic device casings
• Sterile medical packaging
• Insert and overmolded parts
• Custom medical assemblies

Top 10: Currier Plastics

Currier Plastics is a leading US medical plastic injection mold and overmold plant with over 45 years of history as a healthcare and medical device industry supplier. Currier’s headquarters are based in Auburn, New York, and they use a 100,000-square-foot facility that houses over 70 injection machines and cleanroom space. The company’s high-capacity production facility enables it to mold over 50 million medical parts annually. Currier is ISO 13485 certified and FDA registered to ensure compliance with all applicable regulations.

The firm provides full-service capability in the form of custom molding, assembly, and packaging solutions to many medical applications. Currier employs on-site engineering staff that offers innovative design assistance, mold construction, and optimization to ensure cost-effective, high-quality production. Specialties include insert molding, multi-shot molding, and precision overmolding, particularly for small and complex parts.

Some of Currier’s finest projects have been manufacturing overmolded components for one of the cutting-edge drug delivery systems with the least possible cost of production and the toughest regulatory demands. Their ability to expand and customize to meet special customer needs has made Currier an ideal business partner to a number of leading medical device manufacturers.

Website: https://currierplastics.com/

Year established: 1982

Location: Auburn, New York, USA

Products:

• Drug delivery device components
• Surgical tool components
• Diagnostic test parts
• Overmolded medical devices
• Precision medical assemblies
• Custom sterilization packaging

3. Why Choose Worldwide Medical Plastic Injection Molding Companies?

Choosing foreign medical plastic injection molding companies offers various advantages to medical equipment manufacturers, mainly in scalability, technological capabilities, compliance with regulations, and savings on costs.

First, foreign companies have gigantic production capacity and individual factories in individual locations across the world, which enable them to increase production based on high-volume requirements without affecting quality. Their ability to provide increasing production capacity in a short period of time can be a deciding factor for medical OEMs to get products to market quickly. Having strategically positioned factories on different continents, companies are able to reduce manufacturing cycles and keep shipping costs and lead time at the lowest levels possible.

Besides, foreign firms possess excellent technical ability for manufacturing complicated medical components. With many years of experience and expertise in handling plastic molding medical components, such firms experience high demand for safety, strength, and accuracy in medical devices. Most of them offer services such as Design for Manufacturability (DFM), mold flow simulation, and prototype building that allow products to reach maximum performance and function.

Second, the plastic injection molding foreign medical companies are well-positioned to be in compliance with regulations in certification and be able to achieve international standards like ISO 13485 and FDA. This makes the resulting components regulatory compliant, safe, and functional to use in the target markets.

Finally, these companies opt to deliver value for money through economies of scale, combined supply chains, and computerized production processes, thus allowing the makers of medical equipment to enjoy cost-efficient production without compromising performance or quality.

Briefly, choosing an international medical plastic injection molding business provides access to the most recent technology, the ability to make more with flexible capacity, regulatory insight, and cost savings, all of which are required to bring high-quality medical devices to the market in a cost-effective manner.

4. Conclusion

The following 10 medical plastic injection molding businesses are all world-class leaders in the global plastic injection molding business. With cutting-edge technology, strong manufacturing capabilities, and regulatory compliance orientation, they continue to develop and supply better quality solutions to the medical device industry. Highly accurate shaping, flexibility in quantity of manufacture, and commitment to achieve excellence render them strategic partners of medical OEMs globally. With growing demand for medical devices, the organizations become assets at providing the product of safe, dependable, and high-performing devices upon which the health care systems of the world depend.