I don’t really think there is a way to spin it that missing a milestone on a project is a positive thing. I understand what you are saying, in that missing a milestone means you are in turn spending more…   Read more»

It is imperative for the specifications in the design input document during the planning phase to be accurate and clear. In order to accomplish this, there should be collaboration from many different people in order to cover all bases on…   Read more»

The planning phase is the foundation for all other phases of the project to come. A strong and detailed planning phase is essential to the success of the project. As mentioned, customer needs are a large and important role of…   Read more»

Like yzs3 mentioned, sending the documents a week in advance could be very beneficial to allow for everyone attending the meeting to have time to read over and understand what will be discussed. In addition, the document itself must be…   Read more»

I don’t think that any essential projects should be cancelled or even put on hold due to them being “less of a priority.” This slows down the overall design process. Unless however, the project is unessential, then there is no…   Read more»

I think that the world is definitely moving towards one global system for regulations of medical devices. In addition, I believe that a global system of medical device regulation will have a plethora of positive benefits on the world. For…   Read more»

In my opinion, the best time to carry out verification and validation steps would be consistently, as progress is made in the project. For example, on my capstone project, we are currently testing materials and designs as we develop in…   Read more»

Specs of the product are essential in in the Design Specification Document to ensure that testing and development can be properly executed. The specs of the product must be properly documented to allow for product development in the future. In…   Read more»

Properly selecting the members of a project team are just as important as any other step in the process, if not more important. A great product or device idea with perfect documentation and resources will never make it past production…   Read more»

This is a good question, that I wondered myself. It seems that there is a significant advantage in the timeline of developing a product if a product is labeled as class 2 rather than class 3. For products that have…   Read more»

Completely re-making the classification system seems very unnecessary to me. Granted I have no experience of using this for anything outside of this class, but I think that there are fairly specific qualifications for each class, for example any device…   Read more»

A project manager is required to be a sort of “jack of all trades” in the form that they must excel in so many areas in order to effectively get the job done. A successful project manager must be knowledgeable…   Read more»

It makes sense that if there is a defect in the labeling of a product resulting in mass amounts of missing labels, that an easy solution could be to remedy the problem for future sales, and simply inform anyone who…   Read more»

In response to the debate of whether or not there is a 70:30 ratio of importance of interpersonal skills over technical skills, jl959 makes a good point. Stating that this is not true in all cases due to different work…   Read more»