I think celebrating short-term victories and using small rewards helps keep the team motivated as well, as having rewards helps the team feel good about the work they have put in if it’s over a long period of time, since…   Read more»

I agree with what everyone has said so far about how to get a more diverse group to participate in clinical trials. However, I think more factors need to be considered. A major issue with “diverse recruitment” is that it…   Read more»

The PM definitely does have a large role in fully understanding the project and then applying this understanding to planning the clinical trials so it goes smoothly. However, I want to bring up other unpredictable aspects of clinical trials that…   Read more»

I agree with what has been said so far in the thread, as taking legal action is a good last resort due to how long it takes and how many delays it can cause, and the vendor and other team…   Read more»

I agree with what everyone else has said so far, especially the information regarding the classes of recalls. I wanted to touch more on the deeper implications of a recall, as a recall shows deeper problems in the project itself….   Read more»

I agree with what everyone has said so far, where the bottom-up budget is ideal, but certain situations require top-down budgeting. I wanted to open the floor to more nuanced conversations regarding budgets themselves, since the way the budget is…   Read more»

I would like to bring in some nuanced perspectives from what has been said so far. I agree that there are certain things that should be completely disclosed to the public; however, I think the timing of the transparency matters…   Read more»

I agree with what njq3 has said about planning and surprises, as unexpected events can throw the trajectory of a project completely off course. Additionally, for planning, things like troubleshooting, the time it takes to coordinate, or back-and-forth in regulation…   Read more»

I agree with what the previous posts are saying, as it truly depends on the situation and project context for what project management style will be the best fit. However, I have a more unique angle to bring. I think…   Read more»

I loved reading about the experiences that everyone has had with their work. I haven’t worked in a medical device company, but I have a different perspective from the people who actually use the medical devices from the big companies….   Read more»

I agree with all the responses so far. Verification checks whether the device meets the specifications that were outlined. This happens during development. Validation checks whether the device meets the user’s needs and happens closer to the end of the…   Read more»

I think monitoring should not be treated as checkpoints, but instead be a system where you can stay up to date on how the project is going and predict roadblocks from the start. Dr. Simon always talks about feedback loops…   Read more»

I like the questions that mmk68 poses, as this is a real issue that I have seen and encountered before. The first step to preventing major damage from a delay that is out of your control is for the PM…   Read more»

  Most of the discussion so far has been about how the board of directors usually steps in at a high level. However, I think their real influence comes from how change is handled during a project. I agree that…   Read more»

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 uncertainties to the team and company is just as, if…   Read more»

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 the first time. This would require…   Read more»

  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 with maintaining a structure…   Read more»

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…   Read more»

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 prove that the device was developed responsibly. This includes the…   Read more»