Test Planning and Protocol Development
Knowing which tests you need to do and which you don’t can be difficult, particularly for early stage companies and surgeon-led start ups. KMT can help. Knowing whether your test results are good enough can be even more difficult. KMT can help with that, too. Because of our involvement with standards development and frequent interaction with regulatory bodies, we can devise the most efficient test program for your device, even if no published test methods or performance requirements exist.
Competitive Product Analysis
The hurdle that you must clear for a successful FDA 510(k) submission is “substantial equivalence.” In terms of mechanical testing, that means your device must be as strong as a previously cleared device (predicate) when tested side by side in a physiologically relevant manner. Let KMT evaluate your design compared to your predicate before you make physical parts for testing. We’ve saved clients thousands of dollars on prototype parts, and more importantly time to market, with our pre-test engineering evaluations.
Whether during a test or in the field, KMT can evaluate your device’s mechanical failure to tell you why it failed, and what to do to fix it. As engineers continually push the envelope to develop smaller devices for MIS and more cost effective devices to satisfy hospitals, failure analysis becomes even more important to help establish guidelines for what works, and what doesn’t. Whether as simple as moving a laser mark to a region of low stress, or as complex as evaluating microstructure changes to fine tune additive manufacturing process parameters, KMT can help.