I think an extremely important aspect of project initiation is how uncertainty is communicated to the team. Analyzing which aspects of the project are...

One factor that has not been discussed is how learning curves can affect the cost and resource estimates. Many tasks in medical device development can...

  I agree with the points regarding communication that have been mentioned so far. Something else I would like to add is that the PM has to mak...

The decision to go back to a previous phase is not based on a simple threshold of error. In real life, the discussion is about the cost of fixing the ...

The way I think about the difference between the two is accountability versus coordination. Design controls are what establish the accountability for ...

I agree with the points everyone has made so far. However, one thing I noticed is that everyone is assuming that falsification is happening intentiona...

Most of the discussion so far has been about avoidance, but I want to bring into question whether avoidance is actually the dominant strategy in medic...

I also agree that this qualifies as a major change in the device. If the EMA is questioning whether the current method to sterilize is safe and whethe...

What I deduced from this week’s lecture is that slack is calculated flexibility that comes from understanding ES, EF, LS, and LF. Slack will be strate...

I love the examples that everyone has given so far! I want to build on this by directly connecting to project management tasks and seeing the FS and S...

I think this question highlights how uncomfortable the reality is that if a project is technically feasible and can actually help the market in a spec...

What stood out to me from this week’s lecture slides is how different project management phases are from design control phases. In project management,...

I think one issue that has not been discussed enough is how developmental life cycles influence team behavior and risk tolerance, along with the timel...

  I agree with how business needs and customer satisfaction are treated as separate priorities and should be intertwined when creating a plan. ...

If I were the PM in this situation, I would take the results from the pre-clinical trials and definitely change the plan to address the situation. Con...