Medical Device Qualified Supplier Directory
Qualifications: ISO 9001, ISO 13485, FDA Registered, Supplier to Medical Manufacturers, Exhibitor in at least 2 MD&M and/or MEDTEC shows
Markets Supplied: North America, Europe, Worldwide
Since 1945, Minnesota Rubber and Plastics has built a worldwide reputation as a leader in advanced technologies. They are a global solutions provider in the development and launch of complex products from high tolerance medical components and assemblies to final sterile packaged devices for the most demanding applications using medical-grade elastomers, LSR and thermoplastics.
Minnesota Rubber and Plastics’ experience in advanced material formulation enables them to be compliant with FDA, EC 1935/2004, NSF 61 and 51, plus ISO 10993, and ISO 13485 to meet your unique product requirements. Their 70-year-plus history in the design and manufacture of complex devices makes them the preferred partner for industry leaders throughout the world.
The company’s reputation is founded on its unique science-based approach that has made it a preferred manufacturing partner for industry leaders in North America, Europe and Asia. It is well known for its ability to provide cost-effective solutions to technically demanding applications.
High-tolerance medical components and assemblies are what we work with every day at Minnesota Rubber and Plastics. Our experience in design, sealing, material formulations, and manufacturing complex medical devices has made us a preferred partner for industry leaders throughout North America, Europe, and Asia. The next time your medical component or assembly seems impossible, consider Minnesota Rubber and Plastics as your global solutions provider.
- Advanced Surgical and Orthopedics
- Vascular access
- Structural Heart
- Gene Therapies
As a manufacturer of high precision components and assemblies, FDA Class 1, 2, and 3 products, Minnesota Rubber and Plastics specializes in finding solutions to tough applications which require the molding and assembly of close tolerance components. We offer a wide range of technical services and production capabilities from Design for Manufacturability (DFM) to Lean Six Sigma best practices, producing close tolerance injection molded components, assemblies, and final sterile packaging.
Our range of processing capabilities extend from Thermoplastics to Rubber including, Liquid Silicone Rubber (LSR) and Gum Stock Silicones, or High Consistency Rubber (HCR).
Our specialty processes and services include:
- High performance plastics such as PEEK, Torlon®, Aurum® PI and more
- Custom Seals and Shapes
- Insert Molding in Thermoplastics, Rubber and Silicone
- Two shot molding
- LSR Molding
- Rotary Seal Rings and Thrust Washers
- Rubber to TPE Conversions
- Metal to Plastic Conversions
- Bonding for plastic to metal, plastic to rubber and plastic to plastic
- Over molding
- Hotplate, rotational and ultrasonic welding
- Adhesive bonding, hot stamping and machining
- Product testing, assembly and packaging
- Unified project management
We have dedicated and highly experienced Product Design Engineers that are ready to collaborate with you on providing Product Design Assistance to ensure successful and timely launch of differentiated solutions. Our product design engineers conceptualize and evaluate ideas by combining science and technology to create value. Their development role is facilitated by digital tools that allow them to visualize and analyze new designs, materials and products.
Our experience in computer aided design allows us to accept files from all CAD systems. Internally our primary CAD system is I-DEAS®. We also work with PRO/Engineer®, Solidworks®, Unigraphics® NX and AutoCAD®.
Our FEA software is especially well suited for conducting non-linear FEA on elastomeric or plastic components. FEA allows us to solve problems regarding component stress, strain, displacement, friction, thermal and impact issues as well as manufacturing simulations such as part removal from the mold.
Mold flow analysis optimizes the mold design process, the mold and the products design to improve quality and reduce cost as well as time-to-market. We utilize SIGMASOFT® Software by SIGMA Engineering GmbH of Aachen, Germany. This is a powerful molding analysis package which is capable of analyzing thermoplastic and thermoset molding.
Over 1,000 active custom compound formulations with agency approvals. Fully functional R&D facility for new material development, supplier/material evaluations and testing, including compounding and prototyping capabilities.
REDUCING FRICTION Quniton® serves as a highly lubricious material compound with performance capabilities uniquely designed to improve and withstand application needs. Formulated to have a low coefficient of friction, it resists bonding or sticking to a wide range of materials diversifying interface capability.
Engineering and Design Services for Medical Device Manufacturers
From proposal, through design to prototyping to final production, our state-of-the-art design engineering services provide timely answers to difficult design issues. Leveraging tools and expertise such Design for Manufacturability (DFM), Finite Element Analysis (FEA) and Mold-Flow analysis allow us to offer design alternatives quickly and precisely, while our tool development and secondary press operations are second to none. Finally, prior to committing to production, our prototyping services provide you with production quality sample parts for final testing.
Our turnkey engineering and design services include:
- Mechanical design and DFM review
- Materials analysis; specialty elastomer compounds
- Design and development
- Prototyping services
- Metal-to-plastic and plastic-to-plastic conversions
- Non-linear FEA and mold-flow analysis
- Laser marking and pad printing
- Ultrasonic welding
- Functional and leak testing
- Rapid mold design and development with complete prototype services
Comprehensive facilities and integrated capabilities include:
- Rubber and LSR molding
- High performance bonding — metal to plastic, metal to rubber, plastic to plastics and plastic to rubber
- Custom material formulation
- Injection molding of engineered and high-performance plastics
- Sterile packaged assemblies and sub-assembly
- Custom designed seal geometry
- Insert molding
- Rubber to TPE conversions
- Metal to plastic conversions
Global Manufacturing in ISO Certified Clean Rooms
Your custom-molded rubber and thermoplastic components can be manufactured and supported at any one of several locations we have around the world: United States, Mexico, France and China. Our worldwide manufacturing facilities operate under strict ISO guidelines. We hold ISO 13485, ISO-TS 16949 and ISO 9000 certifications. We operate class 10,000 (ISO 7) and Class 100,000 (ISO 8) clean rooms, and have FDA registered sites in the USA and China. These facilities operate under a corporate-wide Environmental Management System registered to the International Standards Organization veries ISO-14001.
For more information contact Minnesota Rubber & Plastics