How to Ensure Zero Out-of-Box Failures for Medical Device Manufacturing

Out-of-box failures can stem from a myriad of factors. For bent needles or cannulas, the geometry of the final product has to conform to the exact dimensions required for its intended use. Similarly, process parameters can be sensitive to variations in temperature and humidity (especially when it comes to filling or dispensing exact volumes).  Poorly maintained machines, environmental factors, and human operators can contribute to out-of-box failures.

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Controlling each of these variables across batches requires extensive quality control measures that detect and intervene when products pass through different assembly stations.

Here are some examples of what automated quality validation checks can include:

• Vision-guided systems that measure the dimensions of an item before releasing it to downstream manufacturing stations
• High-precision dispensing equipment that maintains the required volumes across each tube or vial that passes through the system
• Precision scales that perform in-process weight measurement and validation to control the dispensation of dry or wet compounds
• Vision system and sensors to confirm a component’s presence, position, and orientation at critical assembly steps
• Indexing solutions that ensure the process meets the design parameters (like heating and cooling) during each operation
• Custom inspection solutions and equipment where standard, off-the-shelf devices aren’t suitable for a specific application 

These solutions can integrate with a robust machine design that addresses each of the quality checks required during manufacturing. Automated reject functions can remove defective raw materials or products as they fail to eliminate added additional downstream value and only allow compliant devices to leave the line.