It is very important to get input from all of the stakeholders involved in a project. I agree with some of the statements above that when the inputs you get are vague it isn’t really a bad thing. The engineer has more wiggle room as to what they can do. It is the engineers job to take user wants and needs and turn them into measurable constraints…[Read more]

I think that gantt charts are useful for the majority of project types. They are a universal tool until the project manager puts in the specific project tasks They are a good tool for projects so that the design process can be planned out in an organized manner. You can see the large tasks and all of the sub tasks within it and identify how tasks…[Read more]

The planning phase of a project is very important. The planning phase states everything that will occur and needs to be done. This is something that everyone involved needs to see so that they know what needs to be done when and remain on the same page. It is also when costs are estimated so everything needs to be stated during project planning. I…[Read more]

I think that not doing enough research could lead to more pitfalls. The more research you do the more you can expect and prepare for when things come up. Research also includes looking into calendars and schedules of the people on your team. They all need to know the dates they are needed and compare that to their schedules to account for…[Read more]

I think what they mean by “everything is about risk” is that by measuring risk they can decide how to approach an issue, project, or aspect of a project. I think it also relates to the fact that everything has risk. There is risk or hazard involved with every step of a project. There is the risk of starting a new project and with the design…[Read more]

If someone has not asked all stakeholders to identify potential risks then their project could be have a disadvantage. They would only have the points of view of engineers and others on the project team. In order to try and supplement the points of view they don’t have would be to conduct substantial due diligence to find similar aspects and…[Read more]

I think that the risk/ benefit ratio is used throughout the product life cycle but not in cooperation with the risk management process. The risk management process is for aspects that are going to happen like coatings and packaging. They will be used but they may be altered to lower any present risk if the risk is high. I think that the…[Read more]

I do believe that my education is a proper investment even though people say that we need a larger percent of interpersonal skills. I have heard from people that were not very comfortable speaking in front of others or presenting ideas but it was something that they acquired after they left school and entered the work force. Although I wish I was…[Read more]

I agree that communication is most likely one of the most important skills needed to be a successful project manager but there are many others needed to succeed. I think that one I haven’t seen yet is organization. If the project manager doesn’t have their personal space organized then that will affect how the team functions. Things can get los…[Read more]

I have not worked in the industry before however, I believe I would be best suited for a project-based organizational structure. I think this structure would be best for me because the teams move together from project to project. When you are with a team for a while you learn each others weaknesses and strengths so you can fill each others gaps to…[Read more]

I would say that the risk of verification and validation is not completing it in the time constraint you had originally planned or not being able to complete it at all and having a project cancelled. They are both lengthy processes as you can see in the two flow charts. On the flow chart for verification you won’t know if you need to go back to…[Read more]

I agree and think that there should be more regulation on what patients are being told. If the company is not the one suggesting high intensity and extreme sports be performed then the claims of the company are not the issue and it may not fall under the FDA. If the company has gone through approval on the claims they are marketing with, then…[Read more]

For my capstone project during undergrad, my teams project was to improve an ambulatory walker. In order to assess what the user needs were we spoke to the expert assigned to our team. She has worked with many patients that use walkers and other ambulatory devices so we got her take on what needed to be improved. We also created a questionnaire…[Read more]

I think that many devices can fall between multiple sectors. The way I look at it to understand why certain devices go to the Center for Devices and Radiological Health, the Center for Drug Evaluation and Research, or the Center for Biologics Evaluation and Research is to take away one aspect of the device and then the other to see which is the…[Read more]

I would say that the Zoll LifeVest is a Class III device due to the fact that it has a high amount of risk. If the device fails there is the possibility of sudden cardiac death. I would think that the most difficult part of getting approval would be the vest incorrectly measuring heart rate and giving a shock or vest malfunction and not being able…[Read more]

I do agree with and if there were unlimited resources would like to run all the tests I could since its better to be safe than sorry. In our scenario that was not the case, so I think even though coating A gave better results earlier on both coatings got the job done. So without being able to run all the tests we would like, none of the rats died…[Read more]

I would say that the Zoll LifeVest is a Class III device due to the fact that it has a high amount of risk. If the device fails there is the possibility of sudden cardiac death. I would think that the most difficult past of getting approval would be the vest incorrectly measuring heart rate and giving a shock or vest malfunction and not being able…[Read more]

I think that they had a “pick your poison” situation. Either end the project and get more out of another while losing the progress made with these half done projects or take the risk to hire more people and have it pay off later. If they didn’t have the resources to continue the project then would they have the resources to hire more employees? I…[Read more]

I think this is a good question and agree that the definitions provided are vague. However, I think that it makes sense for the definition to be vague and the line between significant and non-significant risk to be slightly blurred. This could be frustrating for many of us that there isn’t a clear cut answer but this is why these decisions are…[Read more]

I think that the four categories are in order. I look at it as the strategy and tactics that come from upper management are the idea or planning phase. Thinking of what you want or need would be the strategy and then how are you going to get it would be your tactics. The actual action to achieve what you want would be the programs and project.…[Read more]