Solid test systems are a critical component in medical device manufacturing—and for good reason. High international standards set by the FDA and CE regulatory bodies help keep patients and healthcare professionals safe, making compliance necessary but not always easy to achieve.
Robust test equipment helps manufacturers ensure that devices can withstand external forces not tested during the assembly process. Designing these systems always presents the same challenge: engineers must learn to predict what they don’t know.
So how do they do it? Here are a few simple tricks our team uses to begin conceptualizing the type of test systems and equipment needed for each project.
Consider the physical size of your device. If the device you are working with is too small to be seen clearly with the human eye, chances are so are the defects. This means factors like precision weld accuracy, force simulation, and validation will need to be tested and will likely require machine vision assistance.
Count the number of sub-assemblies that take place in production. Intricate, manual assemblies are unavoidable in medical device manufacturing. And while error-proofing techniques can be implemented throughout the process, test systems should account for final assembly verification, inspection, and functional testing.
Determine your product volume and cycle time goals. The speed of production not only affects the rate at which defects might occur but also the tools needed to properly identify and remove them. High-speed production requires fully automated test solutions with secure defect bins. Semi-manual production calls for test equipment that clearly labels and removes rejects while maintaining traceability for further research and development.
Know your production environment. Medical devices are rarely developed and produced in the same location. Keep in mind production conditions including physical location, run time, workforce capability, and ergonomics—conceptualize where in the process these factors could cause an error and test accordingly.
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