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  • djr32 started the topic Revising a Gantt Chart in the forum Project Management Process and Medical Device Development 8 years, 7 months ago

    In 2015, the FDA approved the ReShape Integrated Dual Balloon System. This is a device that is a weight-loss system of a gastric balloon that occupies in the stomach. The system consists of two attached balloons that are filled and sealed separately. The device works by taking up space in the stomach, which makes the patient fill full and thereby losing weight. The balloon system is removed after 6 months.

    Suppose you are working in the company that manufactures these balloon systems. One of the tests is to ensure the balloon system does not pop in an artificial casing that mimics the stomach after 10 days of placements. However, your team finds out that the balloon pops immediately after placement.

    As a result of the missed milestone, what are some factors the project manager has to account for when revising the Gantt chart?

    Reference:
    https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm456293.htm