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  • The first thing that I would do is identify what issues are currently being faced. In this case, the product was clumping and the CMC was leaking out. With that identified, small fixes would be the next step(changing storage temperatures, etc). Simultaneously, research should be conducted in changing larger aspects of the product (carrier system, etc). If the smaller fixes resolve the issue, then that is great and you can move on to the next step in the device process. If not, you will already be looking at larger issues and saving time.