Design Review 3 Tasks

After class today, we had some good conversations with each other and with another classmate about how to approach our final design. Although we do need to improve on our design for the final report, our first prototype seemed to be pretty "works-like" with the spring mechanism for the stamp. The new additions for design review 3 that we need to work on include the FMEA for the device and the regulatory strategy. Since we began the FMEA analysis during class on Tuesday, that just needs to be completed and shouldn't take too long. As for the regulatory strategy, the FDA website (fda.gov) should have plenty of information on how to classify our device. Two devices I found that we could possibly use to help us classify our device include the Fluzone Intradermal, which is a flu vaccine delivered by a microneedle, and the DermaRoller, which is a roller containing many microneedles that get rolled onto the skin. We have also mentioned in previous posts the patents that are out there now for different kinds of research with microneedles as a drug delivery system. I think this is plenty of information to start us out with a regulatory strategy for our allergy testing product.