From my understanding, you would need to first have a patent to protect your ideas. An NDA protects you from other people that get involved in the project. You may need to have both to fully protect y...

The restriction of physician's gifts is a guideline for companies to follow to avoid being accused of bribery or influencing their decision to be involved with a project. While it is a bit strict and ...

I believe from the point of view of a project manager, it can be the most challenging to work in a matrix organization. This comes from the conflict of everyone having at least two distinctly separate...

I currently work in a functional organization, which to my understanding is the most traditional form of business organization. There are functional managers of each department, such as Manufacturing,...

When forming a project team, it is important to consider someone's skill as well as their personable skills. It is important to get along well with everyone on the team. It is not always ideal to choo...

I think in the context of any other field, As Far As Possible is daunting and almost unattainable. However, in medical devices and anything else regulated by the FDA, it is necessary. The goal of the ...

It seems like a fair trade-off, especially for more established companies that know what their goals and needs are. However, for new companies like start ups, it would make sense to have some way to r...

Our company uses FMEA, which only differs from the acronym for FMECA by the one word "criticality". In an FMEA, the Failure Mode Effects Analysis addresses potential risks of the product, whether in p...

The ultimate goal of the FDA is to ensure that products are safe and effective. These are the two most crucial factors of a medical device. For design control systems, the FDA is making sure that ever...

I am currently in Capstone I, and we have completed the phase of customer needs and business requirements. This phase is very similar to the process in industry, as we are learning in the course. Thro...

I support @bb254's description of the process of design review meetings. While I am not yet an engineer, as a co-op I am often tasked with preparing the data and materials before an engineer's design ...

As mentioned above, design review meetings happen at various points during a project, usually towards the end. In my experience in production engineering, however, design review meetings are conducted...

Currently in capstone this semester, I see the importance of the business requirements. We have yet to create test plans for our device. Through the detailed business requirements, someone not familia...

In my experience with minutes, it is important to keep them handy and organized, especially in anything involving a group and a long term project. For our capstone group, our advisor encourages or eve...

Every individual has the right to his or her own body, along with whatever may come from a study of it. In the case of Henrietta Lacks, she should have of course been given the right to refuse, as wel...