Activity

  • As we learned earlier in the course, emotional intelligence determines approximately 70% of success, which without a doubt applied to the MiniSim. The only real way to fail the first part of the MiniSim was to take a condescending approach to your liaison knowing that she had the least friendly characteristics in comparison to the rest of the team. Failure to properly communicate a delay can not only result in the project being dropped, but also a setback in one’s personal career.

    In terms of increasing project risk by cutting down experimentation time, it may initially seem undesirable, but may prevent excessive time and money from being exhausted. Cutting down the pre-clinical time from 16 weeks to 4 weeks was ultimately a success based solely on the fact that the project’s product was already prominent on the market. Therefore, since this product has already had extensive research conducted on it, your company CaPoss was able to save time and money by trimming down the preclinical stage. This doesn’t go to say that this is always the case, as cutting corners always presents risk. That being said, it is rarely ever worth shortening a project’s time frame to the extent that significant background knowledge is present.

    The calcium phosphate product we worked with in the MiniSim was a Class II device, but would there be a way to shorten a Class III bone void filler’s pre-clinical duration in the same manner that we shortened this one? Do you think it would be justifiable to apply emotional intelligence towards an FDA inspector in this case to pass/approve the Class III device? In this MiniSim, many of the team members had friendly, outgoing personalities. Would this project run as smoothly if the majority of team members had more isolated characteristics?