In my opinion, I think that it really depends on the milestone that you missed and what the results would’ve been had you not missed the milestone. Missing a milestone could make the project run easier because you are focusing…   Read more»

Agreeing on the project goals is important because the team needs to understand the purpose behind the project and what is expected to come out of their efforts. If every team members understands what the project goals are, they will…   Read more»

Another important measure that is important when considering the medical device is how frequently the device will be used by the user or how long the device will last. For instance, if the device is an electronic device, important questions…   Read more»

Input from any different department (e.g. Marketing, Regulatory, Engineering) can only help in improving the efficiency of the device. There many be someone who doesn’t offer a feasible specification but it can always be rejected. Asking for input from any…   Read more»

In case of an emergency, an unapproved medical device could be used if there is some enough that is has created positive results and has been tested in trials. As someone previously stated, there are about 4,000 patients each year…   Read more»

Picking a project team is probably the most crucial task and hardest challenge for a project leader. There is no absolute right/wrong answer when picking a team as individuals have different strengths and weaknesses which can either strengthen or weaken…   Read more»

I do believe that the medical device community is progressing towards a global system of regulating medical devices. I think that as more countries get more industrialized and gain more technology, countries will “go with the flow” and adopt regulatory…   Read more»

The quality plan is needed for many different reasons. The quality plan document verifies the internal and external standards and procedures. Besides that, the document also provides some insight as the business’ quality management system because it requires one to…   Read more»

Some advantages of the Functional Organization is that the departments operate somewhat independently of each other so coordination between members of a department is much easier because they can only rely on each other during a project. All decisions are…   Read more»

The way that I think about a project proposal document is that it is a formal way of persuading the leaders of your company, such as CEOs, managers, and stakeholders, that your project is worth investing in and that it’s…   Read more»

I think that this would depend on the information on the labels of the products. If there were important safety information or details regarding use, then the product should be recalled because customers will complain about the product if it…   Read more»

I think that the company should fund the project if it has sufficient funds. If the firm doesn’t have enough to fund two or more proposed projects, then the one that offers the least risk or requires less money should…   Read more»

I believe that it’s extremely important for an employee to be able to pick a good group of people for a project team because doing a project is a team effort. Not only does it matter that each individual member…   Read more»

The reason why formulating the project idea is the hardest part is because it is the foundation for the entire project. The project that you run is meant to turn your ideas into reality. Without a solid idea, you cannot…   Read more»

I think that the BME curriculum does not reflect the author’s perspective because there are virtually no courses that teach interpersonal skills. However, I think that the investment is still justified because it’s important for future engineers to know the…   Read more»

I actually agree with the statement that interpersonal skills should be valued more than technical skills or book knowledge. My reasoning is that in my experience, people who are skilled at dealing with people and know how to work with…   Read more»

Verbal means any communication that involves words, which means that oral and written agreements are both verbal agreements. I think you meant “what is the difference between Oral and Written Agreements?” An oral agreement is harder to prove because it…   Read more»

In my opinion, I understand why this may seem pretty awkward and I don’t think it’s a problem at all to pay for the physician’s wife but I do see the reasoning behind it. The physician could bring more colleagues…   Read more»

Overall, I thought that the content of this course was excellent. One thing that I particularly found helpful were the lecture presentation slides. The content in the slides were pretty clear and concise. This is my first online course in…   Read more»

For my team, I completed the DID and my partner completed the RA document. We haven’t had our first meeting yet due to conflicts but so far the project is going quite smoothly. One of the challenging things about working…   Read more»