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 various viewpoints. It is also important that one looks at when a possible risk may occur. Some people may get…[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, one can’t expect to think of all of the possible risks in a single meeting; even if a group of people are…[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 label later, they are still much more likely to trust the doctor’s judgement than what the label says. If the medicine was bought…[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 their respective department members. Communication is crucial as you cannot work as a team if you are not constructively communicating with each other. As for…[Read more]

I am 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 their respective department members. Communication is crucial as you cannot work as a team if you are not constructively communicating with each other. As for the…[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 of the project is to be done by the due date. You want to leave plenty of time for changes and adjustments that may need to be made to…[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 to note that when taking the minutes, every single word does not have to be recorded. They should be detailed, but…[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. In the early stages, a major error can be made when not listing all of the necessary design inputs. Especially in the…[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, safety, etc. fall under this category. These design constraints must be…[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 an approach, model/prototype, test and evaluate, refine, and communicate…[Read more]