Medical Device Industry

The global medical devices industry is fairly large, intensely competitive and highly innovative with annual worldwide sales in 2009 in excess of $220 billion. The U.S. accounts for approximately 41% of this market. 

Every product designed and manufactured must be reliable and robust.  In the design and development of all classes of products, thousands of materials and assembly techniques are carefully considered to ensure repeatable performance, patient safety, and optimal profit.  At each step of development and improvement new elements and methods must be qualified through extensive and costly testing.  Manufacturers of cardiovascular, ophthalmic, surgical instruments, needles and the like must rely on vendors and engineers who are familiar with the medical device manufacturing landscape and intimate with its risks and requirements.

Expertise

Engineering for manufacturability is our specialty.  From our roots in transfer engineering of intra vascular catheters, needle assemblies, hand held corneal topography equipment and surgical instruments, COG Engineering ventured into the sales and support of various adhesives and equipment used in the medical device industry.  COG Engineering provides technical solutions as suppliers and engineers.

• USP Class VI UV Curable Adhesives and Epoxy
• Clean Room Ready Assembly Fixtures
• Functional Testing
• Component Design
• Assembly Process Development and Documentation
• Proof of Principle
• Installation, Operation and Process Qualification
• Solvent Bonding
• RF Welding Design
• UV Curing Stations
• Solid Modeling of Devices and Assembly Stations
• Failure Analysis
• EMI Shielding
• Conductive Bonding
• Adhesion Promotion

Medical Device Applications

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  Cardiovascular Catheter -Multi lumen extrusion design, insert molding, balloon bonding, connector and luer fitting design, injection molding, UV bonding
• Ophthalmic Diagnostic - Housing design, injection molding, wire harness assembly, strain relief, component alignment, potting
• Glucose Sensing - Needle/hub bonding, assembly tooling, electronic assembly, housing design, injection molding, encapsulation
• Laparoscope - Optical Bonding, pad printing, ferrule and component design,  CNC machining, alignment, failure analysis
• Pace makers - Encapsulation, strain relief, wire bonding stabilization, packaging design, EMI shielding
• Ophthalmic laser - Optical alignment and bonding, failure analysis, field test equipment, assembly tooling
• Imaging catheter - Fiber alignment and bonding, reinforcement, extrusion design, connector design, injection molding, custom material formulation
• Blood Oxygenator - UV bonding and sealing, coating, printing, pressure testing, injection molding design
• Tracheal Tube - Injection molding and tubing design, UV bonding, solvent bonding, assembly tubing, pad printing, packaging design
• Brachytherapy Balloon Catheter - UV bonding, solvent bonding, multilumen and component design, balloon bonding, balloon design, instrument design

Success Stories

An Irvine company manufacturing an effective wound closure hydrogel was growing rapidly.  In an effort to expand their product's clinical applications their R&D team had developed a new delivery device and demonstrated its efficacy.  When they came to COG Engineering they were looking for UV materials, process knowledge, catheter assembly expertise, and equipment recommendations.  They needed to transition their product into production quickly without sacrificing quality or efficiency.  COG Engineering focused on the bonding steps. COG quickly examined the design of the components with manufacturing in mind.  We tested various materials and process parameters, and provided valuable recommendations for component modifications and equipment selection. 

COG Delivered: 

• Unbiased UV adhesive bonding report
• UV curing parameters
• UV Equipment comparison
• Assembly instructions
• Custom assembly tooling
• Installation Qualification
• Operation Qualification
• Safety and Manufacturing Training
• Continuing Manufacturing Support

EMI UV provides a variety of USP Class VI certified UV adhesives and Epoxies.  Why EMI?  Versatility, knowledge and service.  Describe your application and performance requirements, COG will listen, and EMI will deliver solutions.  EMI UV is registered ISO 9001