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  • ih37 replied to the topic Risk Management Selection in the forum Project Management Process and Medical Device Development 6 years, 1 month ago

    The advantage to having a risk management team internally associated with a project team is the absence of “information silos”, in which departments withhold knowledge and information from one another as a norm. By having a risk management team within the project team, individual members from either department can communicate with one another in a more effective manner, which is needed at many stages throughout a project. This is why a risk management team is often part of the project team, because they are kept more in the loop with a project’s updates and development. A disadvantage to this is that the risk management team is unlikely to specialize in areas outside of their developing project. This implies that there may be a lack of experience in how to handle matters that may arise down the line. For example, a team that focuses on bone-remodeling products may not adequately know how to address risk involved with pacifying the immune system upon implantation of these products, which can result in excessive costs due to impromptu changes in design.

    The external involvement of a risk management team with a project team can be advantageous in the sense that outside knowledge from different fields is likely to be introduced when assessing a project’s risk. In the above example, an external risk management team would be more likely to propose various drugs or antibiotics to be applied in conjunction with an implantable bone-remodeling device to prevent the risk of infection. This can not only prevent catastrophe within the project, but also serve as guidance in future bone-remodeling-based projects. The disadvantage associated with having an external risk management team is that they may not be experienced with the project at hand as a result of any potential segregation. This can result in risk management introducing excessive risks and hazards that can take away from a project’s budget that will ultimately hinder the project’s development.

    We’ve learned about different organizational structures (project, functional, matrix). How might each of these organization types affect the operation of an internal risk management team working on a new pacemaker? What about an external one? In what circumstances would a project manager have to mediate interactions between risk management and the rest of a team?