The project manager needs to take into careful consideration all areas of management as aforementioned. This can be accomplished with careful documentation and assessment of every area. There needs to be a change control process that tracks every change in…   Read more»

This can be a tricky question for many project managers. Often, the argument hiring internally is that familiarity with the company. This is familiarity with all aspect of the company, including people, processes, documentation, and product. Therefore, there would be…   Read more»

Often times, fatigue cannot be avoided as it is a natural part of the change process. As documentation changes and designs change, it is important that all team members are updated on these changes, and are trained to the changes…   Read more»

The types of risk mentioned in the original post of this thread, financial risk, schedule risk, resource risk, and quality risk, are all important components of the project. It is ideal to minimize risks so the project can progress according…   Read more»

Both email and Teams come with their advantages and disadvantages. Also, they are not direct substitutes for one another since they are completely different tools for different purposes. On Microsoft Outlook, there are amazing methods in organizing one’s inbox and…   Read more»

As the original post mentions, email can be an effective method for communicating without setting up time consuming meetings. This type of discernment is needed by the project manager in order to maximize working time, while at the same time…   Read more»

Based on the original post in this thread, it seems as though all projects, whether viewed as successes or failures, are actually successes. It seems as though any learning experience is a success, because some type of learning was done….   Read more»

Cross functional work is extremely important, but relies on the members of each party effectively doing their part and communicating. Often times, there is laziness in reaching out to research and development, regulatory, and the stake holders. There can also…   Read more»

Communication is of the utmost importance during the duration of a project. In my work experience, I prefer both teams and email, however, they each have their advantages and disadvantages. For informal communication, such as routine questions or checks, then…   Read more»

I am slightly perplexed as to why the original post in this thread proposed that the less time a project takes, the less beneficial the project will be. How beneficial a product is to the customer is dependent on the…   Read more»

It does seem that missing milestones is an unfortunate part of the project process. Sure, as aforementioned, missing milestones can lead to overall improvement of the product. That is, if the missed milestone was unforeseen or having to do with…   Read more»

It is clear that it is the responsibility of the regulatory departments, as well as other members of upper management, to monitor the trends that the FDA is following. Reviewing health and hazard evaluations from other companies and devices, field…   Read more»

It is important for any team member, especially the project manager, to be flexible. This means to consider other people’s opinions as important, and not to be harsh when things do not go their way. However, there should be some…   Read more»

I do not think that a project should have a separate portion called “slack time”. However, extra time should be added to various steps of the project that are expected to have delay. For example, why apply slack time to…   Read more»

There are various factors that are asked when the task is to find the root cause. Root cause analysis can be likened to a never ending nested doll stack, where one doll is opened to find another. When the engineering…   Read more»

I don’t believe it is wrong to state that there should always be a leader in the group. As life, and many novels and stories will tell us, groups tend to fall apart if there is no leader. Having a…   Read more»

Based on my experience in the biomedical industry so far, every change in the product should be traceable. Even in basic or routine analysis or documentation, traceability and having a path to demonstrate how a change occurred is necessary. It…   Read more»

While I understand the viewpoint that budget changes should be expected in a project plan, if the DSD is well specified, large shifts should not be highly expected. Shifts in budget usually occur for products that unexpectedly fail testing and…   Read more»

Flexibility and balance are needed in every aspect of life, and the same goes for companies and managers allowing both in person and remote work. Both methods of working have benefits, and too much of one method can create unhappiness….   Read more»

There are many things to do in order to ensure that proper communication takes place in the workplace. Although the following step may seem to be counterintuitive, it is extremely important and effective. This step is to listen. The wisest…   Read more»