Proper testing is needed to verify the efficacy of any and all consumer devices. This testing is especially important for medical devices, as devices such as SeaSpine's spinous process fixation device needs FDA approval in order to be used. Tests according to ASTM standards are needed for FDA applications, thus testing fixtures that are compliant with the ASTM standards defined by the FDA as well as testing data are needed to make full submissions to the FDA.

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Proper testing according to ASTM Standards allows for similar products to be compared based on quantitative data as opposed to qualitative data. The standardization of testing allows for medical devices to continually be improved over time, leading to improved devices for consumers and patients.

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With testing fixtures capable of testing extra-discal single-level spinal constructs in every axis defined by ASTM F2624, SeaSpine has the capability to fully test newly developed spinal constructs and develop reports that they can submit to the FDA to get their approval to bring their devices to market.

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As a result of this project our team was able to learn how to use Fusion 360 to collaborate on multi-part assemblies, learn how to use 3D printed prototypes to make improvements to models, learn how to utilize GD&T to develop engineering drawings for manufacturing, and learn how to work with manufacturers to bring our designs to reality.

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