I think it is more important to determine why the milestone was missed. Sometimes milestones are missed due to unforeseen circumstances. This was the case at a previous internship that I was at. There was a problem with contamination, and…   Read more»

First and foremost, I would avoid taking sides and try to remain neutral in these situations. I also believe that it is important to listen to each person by themselves first to get an accurate idea as to how each…   Read more»

In short, a project manager is broad and can be a part of any industry. Clinical project managers on the other hand are simply a subset of project managers that are doing healthcare or clinical research specific work with regulatory…   Read more»

To ensure efficient team member contribution, I would delegate tasks as well as deadlines to each individual as well as daily meetings. I would also offer each member the ability to have open conversation with each other. If someone finishes…   Read more»

My favorite way to work is by projects so a project based organization would be awesome. I enjoy the drive and pressure that comes with doing a project. However, this does not seem to be a long term stable working…   Read more»

A project manager can be skillful about aligning business needs and customer satisfaction by doing many things. The project manager needs to be able to define the project scope so business goals can translate into real customer values. They need…   Read more»

FDA reevaluation depends on the type and impact of the change to the product. Not all upgrades require a full FDA review, but some upgrades do. Basically, if a change could affect safety or its intended use, a new 510(k)…   Read more»

I agree with many of my classmates’ responses that a DHF should be treated like a living document. It is not something that should be done at the end of the project but something fabricated as the project is ongoing….   Read more»

I would prefer to work under a project manager that primarily communicates in person as I like that connection, and it makes me feel more involved in whatever project is being worked on. Having an online project manager is impersonable,…   Read more»

A product life cycle, from my understanding, describes the lifespan of a product from its creation until its retirement and is driven by business and operational needs while a project life cycle describes the temporary phases that a project goes…   Read more»

I prefer to have a small team as the project feels a lot more personable to me. With a large team, while I am a lot more focused on a certain area, my heart is not in the project as…   Read more»

After doing some additional research tied with this question, I believe that I can provide some additional information from jal58’s response. The FDA does not issue renewable licenses for medical devices. Instead, each manufacturer just has to ensure ongoing compliance….   Read more»

I believe that a good project manager needs a lot of exposure to industry so they should have extensive work experience in research & development or systems engineering. However, I’m going to focus my response on college work. For an…   Read more»

In my opinion, a project manager in the biomedical field does not need to have a lot of technical expertise. Instead, they must have a good set of interpersonal skills and be able to read and extract information such as…   Read more»