Changing the material of the product can definitely change how the project is classified. Even though the syringe designs may have the same design specifications causing one to say they are similar products, the difference in material really makes these two separate products. The different materials will react differently with whatever the syringe contains. This idea is somewhat similar to the scenario of the Tooth Regeneration Scaffold Project from last week’s mini sim. In that case, the drug already existed in the market. However, with this new application, the safety of the device is being called into question forcing the clinical trials the come with being a class 3 device. Changing the material of the syringe calls into question the safety of the device in the same manner.