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How Medical Device Testing Ensures Your Newly Engineered Product Works

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Designing and engineering new medical products is an exciting way to help the medical community. However, you want to be certain that your product works, that it is durable, and that it does not break at a critical time. The best way to ensure your product has the best outcome is to send it to a medical device testing lab. The lab provides mechanical, structural, and functional tests, per your specifications.

Mechanical Tests for Moving Parts

If the product you have designed has moving parts, you want to be sure that your product will move effectively. Take a surgical clamp as an example. It essentially moves like a scissors with a pivot point in the middle and a locking mechanism. Creating a new type of surgical clamp requires testing of the scissors movement and the locking mechanism. After dozens of tests on a few of your prototypes and the lab will ascertain if you need to go back to the drawing board or if your clamp passes the mechanical testing stage.

Structural Tests for Durability

Because medical equipment and supplies are used on human beings, the last thing you want is for your product to break or cause a patient injury. In the structural testing phase, the components of your product are met with several pounds of pressure per square inch, or PPSI, from all directions. Although the testing technicians are essentially beating your prototypes with hammers, it is much more refined than that. The machines are controlled through computer programs to move around and deliver a specified amount of pressure, while the results are recorded on an onscreen data sheet.

Functionality Tests

Obviously, you want your new product to work. In the final stages of testing before your product can be manufactured, you can request functionality tests. If there are any electrical or computerized components, then these are tested during this stage. Every component is tested individually and then your product is reassembled to test it as a whole and complete item. 

Past the Tests and Passed the Tests

After all of the medical device testing has passed your new medical product, you can look ahead to the next step. The data from the tests will help you steer your device into further research and development and approval by the FDA, or assist you in finding a manufacturer and investors for production. In the interim between engineering and design of your product and the FDA's approval and launch, be sure to patent your item to protect it.


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