For the simulation the company involved did do their diligence in finding a second backup vendor, however the second vendor had a major cost increase when compared to the first vendor which is where the issues arise. If the vendors…   Read more»

When a vendor evades responsibility for their product there are multiple approaches that a company can take to fix the problem. Depending on the contract signed a company can take the legal approach if the product quality does not match…   Read more»

Outsourcing clinical trials is likely just the most efficient way to conduct a clinical trial for a majority of companies, as the resources necessary for conducting trials could be too expensive to maintain if they won’t be constantly in use….   Read more»

I think another strategy for improving employee engagement would be to assign responsibilities that an individual can solely be responsible for. When responsibilities are split between multiple people it can become a little too easy to step back and let…   Read more»

There are a lot of challenges unique to clinical trials. This is especially true for multisite clinical trials which not only have to administrate a clinical trial but also coordinate between multiple sites to minimize the deviation in execution. When…   Read more»

While having a broader specification range seems better at first it does come with multiple problems. As others have said, having a wider specification range than necessary will create problems in the consistency of your product. Additionally, having a wider…   Read more»

 I also think it would be best to go with an entirely different supplier, both for the reasons you mentioned as well as others. Quality issues or a disaster at the manufacturing site would result in using the same supplier…   Read more»

I would say the three that are the most important are time management, cost management, and risk management. I think these three are all interconnected and effects on one tend to cascade negatively onto the others as well. Time management…   Read more»

Essentially, all reasons that were given that could affect the schedule variance are just different types of risks. Others have already brough up risk management as a tool to mitigate these risks therefore reducing the impact of those risks on…   Read more»

The way work is split between multiple PMs can be difficult to figure out and the best way to do it definitely depends on the specific project. The cleanest way to do it in my opinion is to split the…   Read more»

I also think that in the context of medical device development projects transformational leadership is the most effective. Transformational leadership allows for not only innovation but also encourages individuals to contribute to the project to their own strengths. However, I…   Read more»

Ideally teams should rely on both historical data and expertise when estimating tasks but in practice this may be difficult, especially when historical data is sparse or somehow biased by other factors that may not be applicable to the current…   Read more»

While I do agree that while generally SOPs would be the easiest document to change, it is certainly not always the easiest. It heavily depends on the scope of not only the SOP but also the impact of the changes….   Read more»

While it may be beneficial to take a risk to shorten the projects time frame, this decision depends heavily on the magnitude of the benefit, and the size and impact of the risk being incurred. In the example displayed by…   Read more»

I have seen a lot of great responses in this thread especially about the challenged PMs face especially about information. One challenge I think PMs will face when working on projects is simply failing. It is very likely that as…   Read more»

I agree that communication is the primary tool that you should use to handle these types of issues. To keep people on schedule you may have to have regular check ins on project progress so that you can first identify…   Read more»

In addition to all the earlier points, in a regulated industry such medical devices rigorous documentation is required at many of the project stages. Falsifying progress would mean lying on official documentation at some point, which would be a far…   Read more»

I pretty much agree with the majority opinion here on project monitoring. I also think the biweekly meeting is great idea that suits the majority of the monitoring needs without being overbearing. For updating the project plan, while theoretically there…   Read more»

I agree with your point that withholding project financial information from a PM seems extremely detrimental. Reading this thread I did see some seemingly reasonable answers as to why this practice would be implemented but it seems like ultimately the…   Read more»

I agree with many of the posts in this thread about creating buffer in the schedule being one of the most effective and definitely one of the simplest ways to reduce the risk to the task being late. Jb678 brought…   Read more»