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ak977 replied to the topic PM: Timeline, Risk, Social Approaches in the forum Project Management Process and Medical Device Development 7 years, 1 month ago
In this simulation, there were a few paths you could take to complete the mini simulation. The first one I took, which seemed the simplest, was to have Patty and Dr. M sit together and figure out the issue. I think, overall, that is usually the best case scenario because it allows people to come together and hash things out. The reason this was even an issue was because Dr. M had previously not been presented with the information and he only came forward later in the process because that is when he found out. Having clear, direct communication lines is one of the best signs of a good project manager because if people are on the same page, it gets confusing. If the issue with the animal studies had been settled over other mediums, such as separate emails, it would have taken far longer than a simple in-person (or telephone) conversation.
However, to prevent an issue like this overall, Dr. M should have been involved since the very beginning.
In reference to your second question, there were a few outcomes, two of which I thoroughly explored. The first was that Dr. M did had his way and the project was extended. The second was the it was done in 4 months and there was higher risk because the FDA might have shut it down. I do not believe the 4 month option was worthwhile (even though it worked out this time) because the risk was too high. If the FDA had shut down the project, we’d have had to start all over again, which would have been far more costly and time consuming.