A product risk can occur due to a defect in the drug release mechanism in a drug delivering device. Under FMEA a drug delivering device would be a Concept Design / Hardware risk where the probability of success of design needs to be monitored throughout the developmental process. Hardware risk can be monitored using a modeling software where the designs would be evaluated by the software and would be able to point out the probability of success of the hardware. In case of failure of design, we can propose a different design concept and analyze it for market requirement, functionality and risk factor.