Design and install a new, complete manufacturing system to assemble, test and label a medical device with sound ergonomic principles and in-process checks to verify that all components in the assembly comply with rigid quality standards. Recording the data from post process testing operations is required on 100% of the devices and is used to verify that the operating parameters are within established limits.
PROBLEMS WE SOLVE
Our customer needed a method to assemble, test and label a medical device. They needed a manufacturing system in order to launch their product to market, first, under a tight timeline with sound ergonomic principles and in-process checks to verify that all components in the assembly complied with rigid quality standards. Recorded data from post process testing operations was required on 100% of the devices.
TOOLS WE USE
This manufacturing system employed lean cell technology in a main assembly machine that incorporated an indexing dial to transfer assembled components between operations. Manual loading was coupled with machine vision systems to verify that the correct components were loaded and assembled properly. The assembly process concluded with the pressing operations which were pneumatically monitored to ensure the forces and distances the tooling travelled was within the process limits.
Accepted devices were labeled with a LASER marker and vision inspected before entering postprocess testing. Subsequent vision inspections verified the device was within dimensional specifications. Functional testing then verified that resultant forces, from a variable input load, met the design criteria. Finally, the device was electrically tested in a system that automatically connected, tested and disconnected the device.
This custom machine included these technologies:
- Integrated Vision Dimensional & Profile Inspections
- LASER Marking System
- Press System Force and Distance Transducers with Automatic Calibration
- Reaction Force and Electrical Testing
SOLUTIONS WE PROVIDE
Originally, this device was not stable until all assembly operations were completed. Due to this instability, the device was impossible to assemble by hand. Therefore, this new system transferred components through the assembly process while being held in dedicated fixtures.
The previous testing system for this device was unreliable and inconsistent. The new system offered a self-calibration routine that automatically calibrated the monitoring equipment during scheduled intervals. Post process testing was included in the assembly cell to verify that the device complied with rigid quality standards.
As a result, this customer was able to meet their scheduled product launch ahead of their competitors and thereby secure a valuable footfold on the market share.
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