Kenmode Precision Metal Stamping Company Profile

Precision Metal Stampings for the Medical Device Industry

Custom Medical Stampings

For over 50 years, Kenmode, an ISO 13485:2003 certified metal stamping company, has been delivering parts requiring extremely complex geometries and assemblies with zero defects.

Kenmode produces a wide range of precision metal stampings for the medical device industry including:

• Micro-miniature metal stampings
• Insulin pumps
• Metal stampings for Implantable devices
• Metal stampings used in surgical devices including endoscopic, laparoscopic, and others

Kenmode understands the strict standards of the medical industry and we ensure that each part will meet or exceed those standards, time after time. Our large engineering and design team assist in part design and prototypes for testing and FDA submission. We then help translate that knowledge into precise production tooling solutions. Our automated in-line inspection and tooling technology and rigorous process controls enable us to produce a range of medical stampings from micro-miniature parts to larger components and assemblies.

Visit the Kenmode Precision Metal Stamping blog for helpful articles like Implantable Medical Devices Spur Metal Stamping Innovations and 5 Tips to Smooth Transition from Medical Device Design to Manufacture.

Metal Stamping Capabilities

Kenmode provides comprehensive metal stamping services from custom design and rapid prototyping through in-house tooling, production, and assembly with specific capabilities beneficial for medical stamping applications:

• Custom design engineering
• 3D tool design
• Rapid prototyping
• In-house tool build
• Precision metal stamping
• 3D high-speed hard milling
• EDM machining
• Exporting
• Inventory Management

Secondary Operations most appropriate for the medical device industry include:

• Forming and laser welding
• Precious metal plating: pre-plating, post-plating, and spot-plating
• Relationships with certified overmolders of medical grade elastomers and polymers
• Specialty cleaning and deburring
• Electropolishing
• Passivation
• Assembly
• Sterilization
• Custom packaging

Insert Molding

Kenmode has been working with the insert molding industry for years, with a record of success in delivering the most complex part configurations with high performance and high efficiency, for a wide range of applications.  We employ our 3D CAD design and engineering expertise to improve processes and drive down costs from the start.

Medical Stamping Specialty Materials

Kenmode has experience working with a wide range of metal stamping materials especially those most often used by the medical device industry:

• Stainless steel
• Titanium
• MP35N
• Platinum iridium
• Niobium
• Tantilum
• Aluminum
• Copper
• Custom shaped wire
• Material thicknesses range from .0015 to .125+

Advanced Technology
Kenmode utilizes advanced technology to streamline metal stamping processes and achieve its goal of zero defects.

• One of the largest Bruderer and Minster shops in North America
• High-speed precision presses
• In-die protection systems
• In-die technology that creates a knife edge eliminating secondary operations
• In-tool assembly of two or more components § In-line vision inspection equipment

Quality Control

When you ask Kenmode how many people in the organization are dedicated to quality, the answer is always the same: "everybody." Sure, Kenmode has a dedicated quality department, but the machine operators, tool makers, design engineers, and even the administrative staff understand and appreciate that quality is an important aspect of their job -- a reflection of Kenmode's corporate commitment to quality. Quality begins with Kenmode's commitment. It's made possible through:

A company-wide quality system
All employees within Kenmode can access relevant project data through Kenmode's company-wide information system. Data access ensures quality commitments are understood and implemented by every team member associated with a project. Team members have instant access to information:

• Job Scheduling and Tracking
• Blueprints with Revision History and Archive
• Work Instructions
• Quality Control Plans / Reports
• Level I and Level II Documentation for ISO Standards
• Calibration Database for Inspection Equipment, Gauges & Measuring Instruments
• Internal System Audits and Monthly Quality System Reviews
• Raw Material Inventory
• Die Maintenance History
• Equipment Preventative Maintenance Database

Mistake-proof quality processes
At Kenmode, we understand that zero defects is no longer just a goal; it's a mandate. We have developed processes that incorporate quality controls into every phase of a project -- from design through shipment -- so quality issues and surprises are virtually eliminated.

• APQP (Advanced Product Quality Planning)
• CPPD (Collaborative Product and Process Design)
• DFM (Design for Manufacturability)
• SPC (Statistical Process Control)
• DQ/IQ/OQ/PQ
• GR&R (Gauge Repeatability & Reproducibility)
• FMEA (Failure Mode and Effects Analysis)

Sophisticated quality control equipment
Kenmode has invested in advanced technology to ensure parts meet stringent quality control requirements -- and that means zero defects.

• Coordinate Measurement Machine (CMM)
• Statistical Process Control System
• Optical Vision Systems
• Custom Gauges for Individual Parts
• Advanced Sensor Technology

ISO certifications
Kenmode is proud to have completed and attained several ISO certifications. These certifications are a testament to Kenmode's stringent quality systems and customer commitment. Certifications are internationally recognized management system standards developed by the International Organization for Standardization (ISO).

• ISO 9001:2008
• ISO/TS 16949:2009
• ISO 13485:2003