I think an extremely important aspect of project initiation is how uncertainty is communicated to the team. Analyzing which aspects of the project are uncertain is important, but communicating these u...

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 involve processes that the team will be doing for...

  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 make sure the technical work is being completed, along ...

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 issue now versus the cost of allowing the issue to...

The way I think about the difference between the two is accountability versus coordination. Design controls are what establish the accountability for the device. Everything needs to be documented to p...

I agree with the points everyone has made so far. However, one thing I noticed is that everyone is assuming that falsification is happening intentionally. In a real-life situation, with capable leader...

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 medical device development. Avoiding risk sounds ideal ...

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 whether it changes the surface of the product, which you...

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 strategic if the PM understands how early and late times...

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 SF relations in play. I think your confusion comes ...

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 specific clinical area, it does not immediately seem t...

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, the lecture discussed how phases can overlap and ...

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

  I agree with how business needs and customer satisfaction are treated as separate priorities and should be intertwined when creating a plan. I think they should be embedded in the project propo...

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. Continuing without making adjustments to the plan wou...