Based in Carol Stream, IL, Aberdeen Technologies, Inc. provides medical device injection molding services, producing high-precision plastic components for the healthcare industry. They adhere to strict regulatory standards, offering capabilities for FDA-approved devices, clean-room manufacturing, and sterilization, supporting both production and prototyping needs.
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Medical Injection Molding Companies
Last updated: January 2026
This directory lists 93 medical injection molding companies across the United States, from specialized regional providers to large-scale national operations.
Buyers in the medical injection molding space are primarily solving challenges related to stringent regulatory compliance, achieving sub-micron dimensional tolerances on complex geometries, and ensuring material biocompatibility for patient contact applications. The ability to consistently control particulate contamination within an ISO Class 7 or 8 cleanroom environment, coupled with expert Design for Manufacturability (DFM) feedback tailored for sterile or implantable devices, differentiates a capable molder from a general industrial one.
Supplier types in this sector range from highly specialized cleanroom molders focusing solely on implantable components with intricate micro-molding capabilities, to full-service contract manufacturers offering integrated assembly, packaging, and sterilization management. There are also niche molders specializing in specific polymer types like PEEK or resorbable materials, and larger enterprise-level partners capable of managing global supply chains and high-volume, multi-cavity tooling projects across various therapeutic areas.
Company Directory
93 companies nationwide
Based in San Marcos, CA, ACI Medical, LLC provides custom injection molding services, focusing on medical, industrial, and consumer products. Their modern CAD/CAM tool room handles low-cost aluminum tooling. They utilize FDA resins and offer secondary operations, including assembly and part printing.
Advanced Plastiform, Inc. offers medical injection molding services, focusing on efficiency, precision, and timely delivery for medical device manufacturing and healthcare components. The company also provides injection molding and thermoforming for other sectors, including automotive, construction, transportation, and material handling applications.
Based in Houston, TX, AJ Medical Manufacturing is an ISO 13485 and FDA registered contract manufacturer specializing in medical devices and components. They utilize an agile and vertically integrated manufacturing approach to shorten time to market for customer partners.
Based in Houston, TX, American Medical Molding LLC specializes in ISO 13485 certified medical injection molding. They operate a Class 8 cleanroom, manufacturing components for medical disposables, surgical devices, drug delivery, and wearables. Services encompass complex overmolding, automation, secondary operations, and full verification and validation studies.
Based in Minneapolis, MN, Aprios specializes in precision injection molding for the medical device sector. The company is ISO 13485 certified, FDA registered, and operates ISO Class 8 Clean Rooms. Their Vista, California facility features JSW electric presses, providing local production for critical clean-room components and DFM for medical devices.
Based in Tempe, AZ, Aptyx specializes in complex injection molding, extrusion, and coating services. The company provides cutting-edge solutions, including medical device assembly, for diverse industries. Aptyx focuses on partnering with clients to deliver advanced manufacturing capabilities for demanding applications.
Arterex provides comprehensive medical device contract manufacturing, from components to Class I, II, and III devices. Capabilities include high-precision, tight-tolerance injection molding, tubing extrusion, and metal fabrication. Certified ISO 13485, FDA registered, and operating clean rooms, Arterex serves clients globally from facilities in North America, Europe, Asia, and North Africa.
Lafayette, LA-based ASH Industries provides ISO 13485 certified medical injection molding services, utilizing an ISO Class 7 cleanroom. They offer plastic, metal, and silicone molding, in-house tooling, overmolding, DFM, and secondary operations. Their team supports prototyping and low-volume production.
Based in Cincinnati, OH, ASPEC provides custom plastic injection molding and tooling services. They offer full-service options including design, mold build, fabrication, and machining, working with high-grade materials. Serving diverse industries like medical, aerospace, and automotive, ASPEC produces molds up to 30″ in length for various applications.
Atalys provides vertically integrated medical device contract manufacturing services. The company specializes in highly engineered tooling design, mold making, and extreme precision plastic injection molding for the medical device industry. It produces highly engineered components and precise parts for critical surgical applications.
Based in Salt Lake City, Biomerics is a vertically integrated medical device manufacturer and contract partner. They offer end-to-end capabilities, from raw polymers to finished devices, including polymer and metal expertise. The company specializes in engineering and manufacturing complex interventional components and devices.
Based in Houston, TX, Biotex Inc. is an ISO-certified and FDA-registered CDMO specializing in medical device design and manufacturing. With 25+ years of expertise, they transform innovative ideas into life-changing solutions, leveraging their robust design, engineering, and manufacturing capabilities for patient care.
Based in Miamisburg, OH, BMF Devices offers comprehensive plastic injection molding services, leveraging over 40 years of experience. They provide in-house mold creation and part production, utilizing 28 presses from 40 to 1,000 tons. BMF specializes in quality-controlled manufacturing for diverse industries, including medical devices.
Boedeker Plastics, Inc., based in Shiner, TX, is a USA-owned and ISO certified custom injection molder specializing in high-performance plastics. They provide precision manufacturing for critical applications, including medical and life sciences devices. With expertise in engineering-grade thermoplastics, the company serves demanding sectors like aerospace, semiconductor, and industrial equipment.
Based in Hutchins, TX, Cary Products is an ISO 9001:2015-certified plastic manufacturer specializing in custom injection molding and thermoforming. They provide durable solutions for various industries, including medical, automotive, and HVAC sectors. The company leverages advanced 3D design and extensive tooling capabilities for precise part production.
Based in Tracy, CA, Central Plastics Manufacturing is an ISO 13485 certified medical molder with a Class 8 clean room and CE molding facility. They specialize in plastic injection molding for diverse medical components, including single-use devices, catheter housings, diagnostic consumables, and surgical instrument parts. They utilize medical-grade plastics for healthcare applications.
Based in Meadville, PA, C&J Industries specializes in high-precision medical injection molding and plastic contract manufacturing. They offer a full range of services, including assembly, decorating, and tooling, for medical and pharmaceutical sectors. The company is ISO 13485 and FDA registered, utilizing Class 7 & 8 cleanrooms for medical device component production.
Based in Menlo Park, CA, Control Plastics and Metals provides custom plastic injection molding and metal components. They specialize in medical devices, offering prototyping and production services for over 40 years. The company is ISO 9001 and 13485 certified, and FDA registered, ensuring quality for critical applications.
Based in Auburn, NY, Currier Plastics provides custom injection molding solutions for medical devices and pharmaceuticals. They operate ISO Class 8 cleanrooms and are ISO 13485 certified, ensuring high-quality manufacturing in controlled environments for sensitive applications within the healthcare market.
Based in El Cajon, CA, Damar Plastics is an injection molding manufacturer specializing in plastic injection and blow molding services. The company offers design, mold manufacturing, and value-added solutions, catering to customers in San Diego and Southern California, including those in the medical device industry.
D&M Plastics, LLC, based in Burlington, IL, provides plastic injection molding for medical and dental parts. They manufacture high-precision components adhering to strict FDA standards, producing elaborate designs quickly and cost-effectively. The company is ISO 9001:2015 and ISO 13485:2016 QMS certified.
Based in Carlisle, OH, Eagle Mold Co., Inc. provides plastic injection mold design and build services, alongside plastic injection molding, CNC milling, and EDM. They serve diverse markets including medical, automotive, and aerospace, with featured projects like laboratory tubes and microfluidic plates.
Based in Cincinnati, OH, Elite Precision Plastics specializes in contract and private label plastic manufacturing. They provide American-made plastic products for healthcare institutions, pharmaceutical/biotech, and military/aerospace industries, ensuring precision quality and end-to-end capabilities.
Genesis Medical Plastics specializes in converting implantable PEEK and other medical polymers into precision injection molded and machined components, stock shapes, and film. Serving the medical device industry, they support projects from prototype to full-scale production. The company is ISO 13485 and FDA registered.
Based in Forest, VA, HDA Technology provides medical device product development and contract manufacturing services. They specialize in precision injection molding, cleanroom molding, overmolding, and insert molding for the medical device and life science industries.
Based in Riverside, CA, Hi-Rel Plastics & Molding, Inc. offers custom plastic injection and blow molding services. They are ISO 13485:2016 certified for medical devices and operate an ISO 7 (Class 10,000) clean room. With 40+ years experience, they provide prototyping and solutions for complex designs.
Based in El Paso, TX, Plastic Molding Technology (PMT) is a custom processor specializing in precision injection-molded parts. They have extensive experience manufacturing components for medical device companies, providing reliable and high-quality solutions.
Based in Palatine, IL, JDI Plastics provides high-quality, FDA-compliant medical injection molding services. The company specializes in high-tolerance molding for intricate medical devices, utilizing thermoplastics, elastomers, and biocompatible polymers. They focus on precision, reliability, and custom designs to meet the healthcare industry's specific demands.
Based in San Jose, CA, MOS Plastics, a division of KS Group, specializes in diagnostic device and medical injection molding. They are a preferred supplier, providing critical components for the medical industry. The company is known for its expertise in high-quality, precision molding for demanding applications.
Majors Plastics, Inc. specializes in custom injection molding, offering cleanroom molding compliant with ISO 14644 class 7 (Class 10,000). They provide hyper-clean components for medical and pharmaceutical suppliers, encompassing overmolding, secondary processing, and specialized cleanroom packaging. Their proven processes ensure particulate-free molded products and rigorous quality assurance.
Based in Wood Dale, IL, Matrix Plastic Products, LLC specializes in high-precision plastic injection molding and moldmaking. They are ISO 9001 and ISO 13485 certified, utilizing GMPs and cleanroom capabilities. The company focuses on manufacturing critical plastic components and mold tooling with surgical precision for the medical device industry.
Based in Dallas, TX, Meridian Products Corporation provides plastic injection molding, insert molding, and overmolding services. The company produces complex and intricate parts for industries such as aerospace, automotive, electronics, and medical components. They utilize advanced techniques to meet client requirements and quality standards.
Based in Dallas Fort Worth, TX, Metro Custom Plastics provides comprehensive plastic injection molding services. They work with various thermoplastics, molding parts up to 5 pounds using 230-650 ton clamping forces. Capabilities include up to 64-cavity molds, reshoring, assembly, engineering, and drop shipping for production.
ASPM specializes in plastic injection molding and manufacturing, offering comprehensive support from product design to mold maintenance and repair. Operating a robust 24-hour facility, the company serves diverse industries, including medical, aerospace, automotive, consumer electronics, and electric vehicles.
Based in Butler, WI, MRPC is an FDA-registered and ISO 13485 certified contract manufacturer focused on medical devices. They specialize in custom plastic, liquid silicone rubber (LSR), and two-shot injection molding services, complemented by cleanroom assembly and comprehensive tooling solutions for the medical industry.
Based in Morgan Hill, CA, Paramit is a contract manufacturer specializing in medical devices and life sciences. The company provides a range of manufacturing services including plastic injection molding, micro-molding, and cleanroom assembly for complex systems and instruments, ensuring high-quality production.
Based in Thousand Oaks, CA, Polymation provides injection-molded plastics, specializing in designing, building, and mass producing high-quality plastic components. They serve a range of industries, including medical, dental, and commercial. The company focuses on precision parts through close collaboration and in-person consultations with clients and engineers.
Based in Upland, CA, Precision Molded Plastics, Inc. is a vertically integrated plastic injection molding company. They provide custom mold and tooling, part manufacturing, and various value-added services. With over 45 years of experience, they serve diverse sectors including medical, aerospace, food and beverage, and construction.
Based in Fredericksburg, OH, Quality Plastics specializes in custom injection molding, serving the medical device manufacturing industry. They offer comprehensive solutions from engineering and prototyping to assembly and packaging. The company provides clean room capabilities for critical component production.
Based in Weatherford, TX, RIM Manufacturing, LLC specializes in custom Reaction Injection Molding (RIM) services. They provide comprehensive support from part design, mold manufacturing, and production to secondary processing and assembly. Certified to ISO 9001:2015 and ISO 13485:2016, they are equipped for high-quality manufacturing, including medical devices.
RenyMed, a full-service injection molder based in Baldwin Park, CA, specializes in the Medical Device industry. The company provides creative technical solutions and high-level quality engineering expertise for medical plastics processing, offering streamlined rapid prototyping, production, and validation processes.
Based in Houston, TX, RMC Plastics provides custom injection molding services for precision plastic and rubber parts. With over 50 years in operation, they serve nationwide clients, including the Medical, Oil & Gas, and Consumer Products industries. They guide material selection and tooling options.
Based in Port Richey, FL, Seaway Plastics provides ISO 13485-certified injection molding services. The company specializes in manufacturing solutions for medical devices, utilizing controlled manufacturing environments to meet industry standards.
Based in Miramar, FL, SIMTEC Silicone Parts specializes in medical and healthcare LSR injection molding. They utilize advanced, highly automated manufacturing with ISO 13485 certification and a class 8 clean room. The company produces high precision silicone components, including 2-shot and multi-shot parts.
Based in Kearney, NE, Springboard Manufacturing offers ISO 13485:2016 certified custom medical injection molding and assembly services. They specialize in state-of-the-art plastic molding, including overmolding and insert molding. The company produces medical device components, such as for stents, implants, and sutures, utilizing diverse thermoplastic materials.
Based in Hanover, MA, SRC Medical is an ISO 13485:2016 certified manufacturer specializing in medical injection molded products. Founded in 1972, the company provides high-quality, precision molding solutions for the medical industry.
Based in Kenton, OH, Pleasant Precision, Inc. is a contract manufacturer offering injection molding, mold making, and extrusion. The company operates a Class 100,000 cleanroom and uses electric injection molding machines to produce high-quality parts. They hold IATF 16949:2016 certification, assisting clients from product design to finished goods.
Based in Macomb, MI, PTI Engineered Plastics, Inc. offers ISO 13485:2016 certified and FDA registered plastic injection molding services for medical devices. The company provides medical device manufacturers advanced product development, leveraging over 40 years of experience for complex parts in applications like endoscopy, cardiovascular, and drug delivery.
Based in Merrimack, NH, TechNH specializes in custom plastic injection molding, with primary expertise in medical devices. The company supports healthcare advancements through precision engineering and superior quality, leveraging over four decades of experience manufacturing components for medical technology companies.
Based in Riverside, CA, Trademark Plastics provides full-service custom plastic injection molding as a vertically integrated contract manufacturer for the healthcare industry. Featuring Class 8 cleanrooms and 51 injection molding machines, they deliver high-precision prototypes and turnkey solutions. The company is ISO 9001 and 13485 certified.
Utah Medical Products, Inc. offers subcontract manufacturing and molding services for the medical device industry. With ISO 13485 certified and FDA Registered facilities in Utah, they specialize in silicone/liquid injection molding (LIM), thermoplastic injection molding, and insert/over-molding for electronic and plastic medical components.
Based in Valencia, CA, Valencia Plastics, Inc. specializes in plastic injection molding and custom mold creation. For nearly two decades, the company has served the medical industry by providing injection-molded components and products. They also offer blow molding services and maintain ISO 9001-2015 and cGMP certifications.
Based in Lyndhurst, NJ, Vantage Medtech is an FDA registered and ISO13485 certified medical device contract manufacturer. They offer integrated solutions for small to large scale builds, with accessible on-site engineering support. Capabilities include production scalability, supply chain management, and global distribution for high-quality medical device manufacturing.
Based in Russells Point, OH, World Class Plastics Inc. offers custom injection molding services. They engineer high-quality plastic parts for medical supplies, equipment, and dental retainers. Capabilities include tight tolerances, cavity pressure control, and molding diverse materials like Acrylic, ABS, Nylon, and Polycarbonate with clamping forces from 50 to 750 metric tons.
Based in Longmont, CO, WP Manufacturing is an ISO 13485:2016 certified plastic injection molding company. They provide comprehensive contract manufacturing services, including custom injection molding, mold fabrication, and component assembly. WP Manufacturing offers full-service support from prototype to production, ensuring quality and traceability.
Saint-Gobain Medical designs, develops, and manufactures custom medical components and engineered systems. The company provides a range of solutions for medical devices, specializing in high-performance materials and complex geometries. They serve the broader medical industry with their manufacturing capabilities, focusing on innovative and reliable components.
Based in Tempe, AZ, Molded Devices, Inc. provides over 50 years of expertise in plastic injection molding and medical device contract manufacturing. They offer cleanroom manufacturing, medical assembly, insert and overmolding, dip molding, blow molding, and tube extrusion. The company supports medical product design and development, serving diverse industrial and healthcare OEM needs.
Based in Clinton Twp, MI, Xcentric Mold offers extensive expertise in serving the medical industry. The company specializes in producing high-quality injection molded parts and prototypes, ensuring precise solutions for various healthcare applications and project requirements.
Based in New Albany, OH, AdvancTEK specializes in plastic molding solutions, including injection molding, reaction injection molding, and thermoforming. The company provides non-invasive medical products such as MRI and CT scanner housings, bins, and containers, serving a variety of industries prominently featuring the medical sector.
Based in Kerrville, TX, All Plastics specializes in custom plastic scientific injection molding. The company serves the Pharmaceuticals and Medical markets, among others including Consumer and Industrial. All Plastics holds ISO 13485 certification, demonstrating its commitment to quality management systems for medical devices.
Based in Sterling, MA, BMP Medical offers ISO 13485 certified custom plastic injection molding for medical and diagnostic OEMs. They provide high-volume production with 19 machines and Class 8 cleanroom capabilities. The company manufactures various medical plastics, including vials, PCR kits, and biopharma packaging.
Comar is a contract manufacturer specializing in plastic packaging and medical solutions. The company partners with clients to develop high-impact products for health and wellness applications, transforming concepts into reality. Comar leverages 75 years of experience in manufacturing a range of custom and stock solutions.
Based in Amelia, OH, DEIMLING/jeliho Plastics is a custom thermoplastics injection molder and contract manufacturer established in 1976. The company specializes in highly engineered molded components and assemblies. They actively produce components for the medical device and equipment markets, supporting the healthcare system.
Based in Newbury, OH, DEM Medical is an FDA-registered manufacturer of medical devices. They provide end-to-end support from concept creation and rapid prototyping to medium-volume production, including custom injection molded components. The company ensures high quality standards with a robust QMS for consistent results.
Based in Vista, CA, Distinctive Plastics, Inc. (DPI) specializes in technical injection molding services for medical device manufacturers. The company utilizes Class 8 Clean Room workstations, equipped with HEPA filtered, positive airflow, for precision plastic molding. DPI is ISO 13485:2016 certified and FDA Registered.
Based in Menands, NY, Extreme Molding specializes in silicone injection molding for medical components and life science products. The company holds ISO 9001:2015 and ISO 13485-2016 certifications, and is QRS-compliant. They offer full-service production, including assembly and packaging, for healthcare and high-end consumer product markets.
Based in Akron, OH, Ferriot Inc. is a full-service contract manufacturer offering custom injection molding services. With nearly 100 years of experience, the company provides integrated solutions from engineering to final assembly. They specialize in manufacturing diverse products, emphasizing quality and capabilities for life-related applications.
Forum specializes in medical injection molding, providing high-quality components for Class I, II(b), and III devices. With over 30 years of experience, they offer ISO 13485:2016 certified services, including Class 7 cleanroom molding and thin-wall capabilities. They work with various medical-grade materials, supporting surgical and medical instrument components.
Based in Durham, NC, Gilero provides precise plastic injection molding solutions for medical devices. The company offers tailored product development services, guiding clients from concept through commercialization. Gilero ensures high-quality, compliant healthcare products, adhering to current Good Manufacturing Practices and expanding manufacturing in Greensboro, USA.
Based in Hudson, NH, Granite State Plastics specializes in medical plastic injection molding and assembly. The company holds ISO 13485 certification and utilizes class 7 and 8 cleanrooms. They focus on the healthcare marketplace, providing solutions for surgical instruments, drug delivery, diagnostic applications, and pain management wearables.
Based in Rittman, OH, J&O Plastics provides custom injection molding services, specializing in clear plastic products for medical, consumer, and industrial applications. They mold PET, acrylic, polypropylene, SAN, crystal styrene, and PVC, offering additional services like assembly and retail direct shipping.
Based in Costa Mesa, CA, JG Plastics Group LLC specializes in precision injection molded parts and tooling for medical device companies. Leveraging over 40 years of medical molding experience and scientific molding principles, they operate a 36,000 sq. ft. manufacturing facility to produce high-tolerance components.
J&L Plastic Molding, based in Wallingford, CT, specializes in medical device molding. The company is ISO 13485:2016 certified, offering comprehensive tooling and molding solutions. They deliver high-quality, compliant plastic molding services tailored specifically for the medical device industry, ensuring precision for critical applications.
Based in Manitowoc, WI, Kaysun Corporation offers full-service custom medical injection molding. They provide engineered excellence for critical-use devices, from part and tooling design to material selection and process control. Kaysun holds MedAccred Plastics accreditation, delivering consistent value and quality for medical OEMs.
MedBio LLC, headquartered in Grand Rapids, MI, specializes in medical injection molding for biotech products. They utilize ISO Class 7 and 8 cleanrooms, including micro-molding presses, and scientific molding practices. With over 100 molding machines, ranging from 17 to 440 tons, MedBio provides comprehensive manufacturing capabilities for diverse medical projects.
Based in Ronkonkoma, NY, Natech Plastics provides integrated injection molding and contract manufacturing solutions specifically for medical diagnostics and life sciences. They specialize in engineering and producing complex consumables and instruments, supporting startups with design and manufacturing services for their devices.
Plastics Plus Technology, Inc. is a US-based, woman-owned contract manufacturer specializing in medical injection molding services. They produce devices and components, including fluid control, valves, and adapters. The company is ISO 13485:2016 certified, FDA Registered, and adheres to GMPs, offering full assembly, packaging, and process validation.
Based in Hayward, CA, Plastikon Industries provides plastic injection molding and blow/fill/seal (BFS) manufacturing for the healthcare and pharmaceutical sectors. Capabilities include prototyping, mold design, and engineering, supported by Class 100k and 10k clean room environments. They also offer secondary services like part decoration and assembly.
Plastikos Inc. provides precision medical injection molding services, producing critical components for medical devices. The company is certified to ISO 13485, ISO 9001, and ISO 14001 standards, ensuring high quality and regulatory compliance for its specialized manufacturing.
Based in Eagle, WI, Plastic Molded Concepts, Inc. provides medical plastic injection molding services. They produce components for end-use medical devices and complex assemblies, selecting engineered plastic resins for specific physical properties. The company focuses on biocompatibility and compliance for the medical manufacturing industry.
Based in Medina, OH, Progressive Molding Technologies, Inc. provides high-precision plastic injection molding services. Capabilities include product development, prototyping, tooling, and manufacturing for diverse industries. The company specializes in delivering innovative, cost-effective injection molding solutions for applications like advanced medical devices, adhering to ISO 9001:2015 quality standards.
Based in Hatfield, PA, The Rodon Group specializes in plastic injection molding solutions. They provide comprehensive services tailored for the medical and pharmaceutical industries, ensuring high-quality, precision-molded plastic components. Their expertise supports vital applications in healthcare with advanced manufacturing capabilities.
Based in Allentown, PA, Sanbor Medical is a medical device contract manufacturer. The company specializes in medical injection molding, cleanroom manufacturing, and comprehensive assembly and packaging services for medical disposables. With over 30 years of experience, they provide end-to-end solutions, including design and engineering support for the medical industry.
Based in Glendora, CA, Southwest Plastics provides precision plastic injection molding, thermoset compression, transfer, and compression molding services. They manufacture custom plastic parts in the USA, offering capabilities like CNC machining, tooling, assembly, and testing for durable, high-performance components.
Spectrum Plastics Group specializes in custom plastic injection molding for diverse medical applications including orthopedic, dental, and gastrointestinal devices. They handle complex, tight-tolerance projects, producing premium, high-quality components and fully assembled medical devices using highly engineered performance medical plastics.
Based in Avon Lake, Ohio, Thogus is an established, family-owned custom plastic injection molder and contract manufacturer founded in 1950. The company provides precision injection molding for critical plastic components and high-performance applications, offering mid- to high-volume manufacturing services. Capabilities include engineering support, tooling, secondary operations, and expertise in various resins, including for radiation processing.
Universal Plastics provides custom plastic manufacturing services, specializing in injection molding, including gas assist and structural foam, from small to large tonnage presses. The company serves the medical, laboratory & diagnostic, aerospace, transportation, and general industrial markets, offering in-house painting, secondary operations, and assembly services.
Based in Livermore, CA, Westec Plastics is an ISO 13485:2016 certified plastic injection molding organization founded in 1969. They specialize in precision injection molding, mold building, clean room operations, and secondary services. Westec serves medical, aerospace, defense, consumer products, and electronics industries.
Freudenberg Medical is a contract design and manufacturing organization (CDMO) specializing in medical components and devices. The company offers vertically integrated capabilities, including precision molding and and extrusion. With deep materials expertise in thermoplastics and silicones, they support medical device and pharmaceutical innovations from ideation to full-scale production.
Based in Pepper Pike, OH, Qure Medical specializes in providing precision injection molded plastic products. The company serves the medical and pharmaceutical industries with high-quality manufacturing solutions for critical applications.
Based in Seguin, TX, Medical Components of America specializes in manufacturing small, precision medical parts. The company focuses on cost-effective production while maintaining the highest quality standards. Utilizing computer-integrated manufacturing and plastics technology, they optimize processes for efficient product realization in the medical device sector.
Thunderbird Molding provides medical custom plastic injection molding and assemblies for OEMs. The company operates a Class 7, ISO-compliant, FDA-approved clean room, ensuring ultra-clean, contaminant-free medical parts. They offer engineering support, design assistance, and on-site assembly within controlled environments, meeting stringent industry regulations and patient safety standards.
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How to Choose a Company
- Validate Cleanroom Certifications and Usage: Beyond a simple ISO 13485 certification, verify the molder's cleanroom classification (e.g., ISO Class 7 or 8 per ISO 14644-1) and understand how they maintain it, including air changes per hour, gowning procedures, and routine particulate monitoring. Crucially, confirm the specific product lines you require will be molded within that certified environment, not just secondary operations.
- Assess Validation Protocol Expertise: Insist on detailed evidence of their experience with Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for medical devices. A red flag is a supplier who downplays the rigor or cost of these protocols, or one who cannot provide examples of robust validation master plans and associated documentation packages for similar medical components.
- Scrutinize Material Biocompatibility and Traceability: For components intended for body contact or fluid path, demand documented proof of material USP Class VI compliance or other relevant biocompatibility standards, directly from the resin manufacturer. Ensure their material traceability system can link every batch of resin to specific production lots and ultimately to your finished devices.
- Demand Evidence of Process Capability (Cpk): Do not settle for anecdotal assurances of quality. Request historical Process Capability Index (Cpk) data for critical dimensions on similar components they mold. For high-volume, critical-to-function parts, aim for Cpk values of 1.33 or higher on key features, and understand their methodology for maintaining and monitoring this over time.
- Beware of Inadequate Tooling and Gate Vestige Management: A common pitfall is underestimating the upfront investment in high-quality, hardened steel tooling designed for millions of cycles and precise flash mitigation. Challenge suppliers on their approach to gate vestiges and de-gating, especially for components requiring automated secondary processing or where manual removal could introduce particulate or damage a sealing surface.
Supplier Types at a Glance
| Type | Best For | Typical MOQ |
|---|---|---|
| Micro-Molding Specialist | Extremely small, intricate components (e.g., catheter tips, endoscopic device parts) requiring sub-millimeter features, ultra-tight tolerances, and specialized materials like PEEK or bioresorbables. Often involves insert molding. | 50,000 - 5,000,000+ |
| Cleanroom & Assembly CMT | Companies needing injection molding within ISO Class 7/8 environments, often combined with automated or manual assembly, secondary operations (e.g., ultrasonic welding, pad printing), and integrated packaging solutions for finished medical devices. | 10,000 - 1,000,000+ |
| High-Volume OEM Partner | Enterprise-level projects requiring multi-cavity tooling, dedicated work cells, global supply chain management, and often high-cavitation hot runner systems for disposables, diagnostic consumables, or drug delivery components. Focus on cost-efficiency at scale. | 100,000 - 10,000,000+ |
| Prototype & Niche Molder | Startups or R&D teams needing low-volume, quick-turn prototypes, bridge tooling, or specialized expertise in a particular material (e.g., liquid silicone rubber, ceramic injection molding) before scaling. | 100 - 10,000 |
Frequently Asked Questions
How do I ensure a supplier's cleanroom meets our specific product needs, beyond just ISO certification?
Beyond the ISO 14644-1 classification (e.g., ISO Class 7 or 8), a critical step is to understand the operational controls within that cleanroom. Ask about their particulate monitoring protocols, air change rates, positive pressure differentials, gowning procedures, and ingress/egress controls. Importantly, verify that your specific molding operations will occur within the certified area, not just post-molding handling or packaging, and request a tour of the facility to observe these practices firsthand.
What validation protocols (IQ/OQ/PQ) should I expect from a medical injection molding supplier, and how should they be documented?
For medical devices, expect robust Installation Qualification (IQ) to verify equipment installation; Operational Qualification (OQ) to confirm the process operates consistently within defined parameters; and Performance Qualification (PQ) to demonstrate that the process consistently produces conforming product under actual or simulated production conditions. Documentation should include a detailed Validation Master Plan, written protocols, executed reports with raw data, and a final summary report signed off by quality and engineering. Deviations must be addressed and documented.
What are the key considerations for material biocompatibility when selecting resins for medical components?
Material biocompatibility is paramount for patient safety. Primarily, you'll need to specify materials that meet USP Class VI standards or relevant ISO 10993 classifications, depending on the duration and type of body contact. Beyond certification, consider leachables and extractables profiles, sterilizability compatibility (e.g., gamma, ETO, autoclave), and any potential degradation products. Always request material certifications from the molder, tracing back to the resin manufacturer's specific lot data.
Beyond cost, what are the biggest risks in selecting a medical injection molding partner for high-volume, critical components?
The primary risks often revolve around regulatory non-compliance, inability to maintain consistent process capability index (Cpk), and inadequate supply chain control. A significant gotcha is a supplier whose tooling strategy prioritizes low upfront cost over long-term reliability, leading to premature wear, increased flash mitigation issues, and inconsistent gate vestiges that impact downstream assembly. Additionally, a lack of robust change control procedures for molds, materials, or processes can introduce compliance risks.