The medical device industry relies heavily on plastic injection molding to manufacture various components and products economically while meeting stringent quality and performance requirements. As major players in this specialized field, medical injection molding companies must demonstrate extensive expertise.
Jako profesjonalista medical injection molding manufacturer, I analyzed numerous firms across the USA that offer injection molding services for medical applications. Based on key factors like years in business, range of capabilities, certifications, and clientele, I shortlisted the top 10 medical injection molding companies that consistently deliver high-quality solutions.
Why Partner With a Specialized Medical Injection Molder?
Before diving into the list, it’s important to understand the benefits of engaging an experienced medical injection molder instead of a standard plastics manufacturer.
Domain Expertise
Leading medical injection molders possess specialized knowledge regarding suitable plastics, precision tooling, quality standards, and other niceties vital for manufacturing medical parts. This focused proficiency enables efficient prototyping and development.
Regulatory Compliance
Top medical injection molding companies hold key certifications like ISO 13485 and follow robust quality systems ideal for medical devices. This expertise significantly reduces compliance risks.
Precision and Repeatability
With innovative technologies and scientific molding techniques, the best medical injection molders achieve tolerances up to ±0.001″ and ensure consistency in device performance and quality over production volumes.
Controlled Environment
Specialized medical injection molding companies operate cleanrooms that safeguard sensitive solutions against contamination. Some even offer unique capabilities like silicone molding and insert molding within controlled environments.
Now let’s examine the top 10 medical injection molding companies in the USA today.
10 najlepszych firm zajmujących się medycznym formowaniem wtryskowym w USA
1. Phillips Precision Medic
With over 44 years of experience manufacturing for the medical space, Phillips Precision Medic is among the most trusted partners for OEMs seeking injection molded medical products. The Minnesota-headquartered company runs multiple production sites spanning over 163,000 square meters.
Phillips Medisize holds key certifications like ISO 13485, ISO 9001, and operates cleanrooms up to ISO 7 standards. It possesses comprehensive capabilities spanning design, tooling, injection molding, assembly, and supply chain optimization for medical devices and combination products. The firm focuses on solutions for diagnostics, drug delivery, surgical tools, wellness applications, and digital health platforms.
Podstawowe możliwości:
- Formy wielokomorowe
- Insert molding
- Overmolding
- Micro-molding
Industries Served: Diagnostics, surgical, drug delivery systems, wellness
2. HTI Plastics
For over 35 years, HTI Plastics has been providing custom injection molding solutions tailored for the medical and pharmaceutical ecosystem. Headquartered in Ireland, the company has production facilities in the USA and Costa Rica as well.
HTI Plastics is ISO 13485:2016 and ISO 9001:2015 certified, demonstrating its commitment to quality and medical device regulations. Its 150 presses range from 55 to 610 tons, enabling high-precision injection molding of parts from 0.5 grams to 450 grams.
The company serves customers worldwide, specializing in tight tolerance components used in diagnostic instruments, drug delivery devices, ventilator systems, and other medical equipment. HTI also supports quick turn prototypes along with validated mass production.
Podstawowe możliwości:
- Two-shot and insert molding
- Closed-loop process control
- Class 7 and Class 8 clean rooms
Industries Served: IVD, endoscopy, diagnostics, ventilation
3. Accumold
Established in 1985, Accumold provides rapid injection molding solutions for precision medical components leveraging quality practices compliant with ISO 13485 standards. Its 142,000 sq. ft. facility in Iowa houses over 100 injection molding machines along with comprehensive secondary processes.
Accumold possesses in-depth expertise in manufacturing plastics-based medical devices and diagnostic equipment. It offers services covering concept prototyping, mold design, precision injection molding, metrology, laser processing, pad printing, and automated assembly.
With capacity for volumes ranging from 1,000 to 100 million+ parts annually, Accumold supports medical OEMs in launching new products rapidly without minimum order quantities. It also provides secure supply chain solutions including ITAR registration.
Podstawowe możliwości:
- Ultra-precision injection molding
- Laser marking and engraving
- Automated inspection and packaging
Industries Served: Drug delivery devices, surgical tools, IVD components
4. Nypro Healthcare
Part of Jabil Inc., Nypro possesses over 55 years of experience manufacturing precision plastic solutions for medical applications. Its multiple production plants provide 700,000 sq. ft. capacity complemented by 2,500 injection molding and secondary process machines.
Nypro Healthcare maintains compliant quality systems suited for cost-effective, large-scale medical device manufacturing combined with reliable supply continuity. The company offers services encompassing product conceptualization, mold design, precision injection molding, secondary ops like pad printing, laser welding, and automated assembly.
With specialty molding capabilities for long-fiber thermoplastics and silicone, Nypro serves medical device firms and OEMs seeking high-precision disposable solutions. It focuses on diagnostic instruments, drug delivery systems, surgical components, and minimally invasive tools.
Podstawowe możliwości:
- Multi-component molding
- Silicone molding
- Automation and metrology
Industries Served: IVD devices, endoscopy, drug delivery, wound care
5. Tessy Plastics
Tessy Plastics brings over 70 years of engineering expertise catering to single-use medical devices and diagnostic equipment. Its 140,000 sq. ft. plant in New York houses advanced injection molding capacity complemented by sophisticated automation.
Certified under ISO 13485 standards, Tessy possesses integrated capabilities covering conceptual design, material formulation, mold fabrication as well as secondary assembly. It provides validated solutions from simple components to intricate medical device sub-assemblies integrating multiple materials.
Tessy Plastics specializes in disposable medical products leveraging resin formulations tailored for healthcare applications. The company serves medical OEMs seeking high-precision injection molded parts production with assured supply continuity.
Podstawowe możliwości:
- Multi-material molding
- Insert and overmolding
- Automated metrology and testing
Industries Served: IVD devices, dental tools, drug delivery systems
6. Spectrum Plastics Group
For over 60 years. Spectrum Plastics Group has been providing plastic fabrication solutions for medical device development and manufacturing. Its multiple production facilities in the USA offer 450,000+ sq. ft. space complemented by 700+ injection molding presses and secondary process equipment.
Spectrum Plastics holds ISO 13485 certification and follows robust quality practices supporting cost-efficient manufacturing coupled with reliable volume capacity. The company has helped over 300 medical device firms translate their visions into compliant finished solutions.
Spectrum’s validated offerings span concept design, formulation development, precision injection molding, laser processing, advanced metrology, and clean room assembly. The company focuses strongly on single-use diagnostic devices and surgical tools.
Podstawowe możliwości:
- Micro-molding expertise
- Multi-shot molding
- Design for manufacturability
Industries Served: Endoscopy, IVD products, wound care devices
7. MedPlast
Operating from 8 manufacturing sites across the USA, MedPlast has helped develop and launch over 500 medical devices since its founding in 2000. With 450 presses from 55 to 770 tons capacity, it focuses on mid to high-volume precision plastic components.
A key strength lies in MedPlast’s specialization in manufacturing and assembling intricate medical device sub-assemblies that integrate multiple processes, technologies, and materials into one. Its locations follow ISO 13485-certified quality frameworks benchmarked to global standards.
MedPlast’s comprehensive expertise includes initial concept, design refinement, material formulation, tooling fabrication as well as final testing and validations for getting compliant finished devices to market rapidly.
Podstawowe możliwości:
- Multi-shot molding expertise
- Insert and overmolding
- Scientific molding practices
Industries Served: Drug delivery, surgical tools, wound care devices
8. Vesta
Vesta provides comprehensive solutions in medical-grade plastics components encompassing development, injection molding production, secondary fabrication, and fully finished device assembly. Its four plants offer a combined 34 molding presses from 55 to 500 tons.
Up to ISO Class 8 cleanroom capabilities, sophisticated resin formulation knowledge, and ISO 13485 alignment enable Vesta to translate intricate plastic medical device designs into reproducible and scalable solutions. Prototyping services provide wider design refinement latitude while production volumes scale flexibly.
Vesta possesses particular expertise in manufacturing pre-filled syringes, infusion systems, implantables, surgical instruments, and other medical solutions requiring tight tolerances. The company also offers strategic global supply chain services to ensure stable long-term device availability.
Podstawowe możliwości:
- Clean room molding capacity
- Material formulation expertise
- Automated inspection
Industries Served: Surgical tools, drug delivery devices
9. Fremont Plastics
Specializing in high precision medical devices since 1968, Fremont Plastics provides turnkey product realization services tailored for the medical industry. Its 43,000 sq. ft. California plant houses ISO Class 8 cleanrooms and advanced metrology capabilities critical for manufacturing surgical instruments and implants.
By aligning molding, secondary machining, cleaning, passivation, and assembly processes seamlessly under one quality framework, Fremont enables efficient finished device production without needing external supply chains. Services encompass concept origination, material selection, industrial design, tooling development as well as manufacturing refined prototypes and validation builds.
Fremont Plastics helps leading medical OEMs achieve faster finished device launches meeting exacting quality thresholds reliably through tightly integrated production workflows. The company possesses expertise suiting disposable devices and reusable tools manufactured from engineered plastic and metal alloys.
Podstawowe możliwości:
- Metal and plastic machining
- Clean room assembly
- Full-service program management
Industries Served: Surgical equipment, implantables
10. Multek Flexible Circuits
Headquartered in Minnesota, Multek Flexible Circuits provides advanced HDI, rigid, and flexible PCBs tailored for medical devices seeking to integrate electronics intelligence into plastics-based solutions reliably. Its solutions enable OEMs to embed ultra-thin circuitry within plastic enclosures seamlessly.
Multek possess over 50 years of experience supplying printed electronic boards globally for applications needing tight space constraints, dynamic flexing, moisture resistance, and dimensional stability. Its solutions enable reliably integrating multilayer conductive traces, thru-holes, sensitive components, and connectors inside packages preventing leaks, cracks, and failures.
With rigorous quality certifications and proprietary expertise suiting high density circuits for medical products, Multek provides unmatched means for embedding connectivity.
Podstawowe możliwości:
-Flex and rigid-flex PCBs
- Microvia HDI solutions
- Medical grade circuit fabrication
Industries Served: Diagnostic imaging systems, surgical robots
Baiwe Molding
Baiwe Molding understands the unique requirements of the medical industry, including strict regulatory compliance and the need for high-performance materials. Our state-of-the-art injection molding capabilities are designed to produce medical parts that meet the highest standards of safety, quality, and functionality.
- Certyfikaty ISO: Posiadamy certyfikat ISO 13485:2016, zapewniający, że nasze procesy spełniają rygorystyczne wymagania dotyczące produkcji urządzeń medycznych.
- Możliwości pomieszczeń czystych: Oferujemy środowiska produkcyjne w pomieszczeniach czystych do produkcji wrażliwych komponentów, utrzymując najwyższe standardy czystości i minimalizując ryzyko zanieczyszczenia.
- Ekspertyza materiałowa: Pracujemy z szeroką gamą materiałów klasy medycznej, w tym z biokompatybilnymi tworzywami sztucznymi, polimerami klasy medycznej i elastomerami termoplastycznymi (TPE), dostosowanymi do konkretnych potrzeb.
- Rozwiązania niestandardowe: Niezależnie od tego, czy potrzebujesz prostych komponentów, czy złożonych, wielomateriałowych części, nasz zespół może zapewnić niestandardowe rozwiązania w zakresie formowania, które spełniają Twoje unikalne specyfikacje.
Podsumowanie
Hope you found this guide to the top medical injection molding companies in the USA helpful! I aimed to feature well-rounded service providers demonstrating proven expertise across the product development lifecycle for medical solutions demanding precision, quality, and scale. Reach out if you have any other questions regarding vetted manufacturing partners suiting healthcare applications.
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