I was definitely opened up to what the medical device industry is like. I don’t regret taking this course as one of my electives for mechanical engineering. Although there were points that were hard to relate, I was able to…   Read more»

I completely agree with what you mentioned, but is a witness for an oral agreement actually enough to back up a claim in court? I know it is better than nothing and a written agreement is definitely preferred, but does…   Read more»

I definitely agree with this. Although I haven’t had any experience in a non-welcoming culture, I definitely feel a welcoming culture promotes better work and employee retention. No matter how hard the work got, I at least did not have…   Read more»

One thing I noticed within the company that I work for is how quickly organizational behavior can change. The overall attitude of the company was fantastic until the CEO was replaced and the organizational structure was changing. With people losing…   Read more»

Between each of the three organization types listed in the lecture, it is hard to say which is the most effective. I think it primarily depends on the size of the company or other factors. As a side note, even…   Read more»

This is very true. A group discussing the possible risks should not solely consist of safety employees or solely any other department. While conducting a risk analysis, there should be a wide variety of people that can input ideas from…   Read more»

I definitely agree that having multiple risk assessments along the development process is essential. Along with this, however, I think it is also very important that that risk analysis meetings are more than just one meeting. By this I mean,…   Read more»

I definitely agree with this. For most people, if a doctor prescribes you a medicine, and tells you how to take it, the patient is highly likely to take the medicine. Even if the patient was to read a warning…   Read more»

I am also on the side that all of the parts of the DDP are equally important. Everyone needs to know the scope of the project like the back of their hand, as well as what their duties are as…   Read more»

One thing that is very important when creating a Gantt chart is to recognize when the project should be done by and budget the time accordingly. By this, I mean that it should not be scheduled that a specific part…   Read more»

As everyone has already mentioned, taking minutes at meetings are obviously important. I was the secretary of the executive board of my fraternity for a few years and one of my responsibilities was to take the minutes. It is important…   Read more»

There are many places within design control that can result in failure. This can either be in the early development stages of development or all the way at the end when the product is communicated with the public and released….   Read more»

In mechanical engineering, design inputs are otherwise known as design constraints. In simpler terms, design constraints state the mandatory criteria that must be met from the final product design. All of the topics that have been previously stated: functionality, performance,…   Read more»

With my background of mechanical engineering, the process of Design controls for medical device development is very similar to our product design process. The process steps are as follows: define the problem, brainstorm, research and generate ideas, identify criteria, select…   Read more»