At the previous company for which I worked, I was required to sign a non-compete agreement. While I generally believe that very restrictive non-compete agreements are very unfair to employees, especi...

As has been mentioned in previous posts, there needs to be a clear line between work and family. But I do not believe that is the primary issue. The primary issue is a matter of ethics and conflicts...

This is my second course with you, Dr. Simon. I previously took your Project Management for Medical Devices course. This course was good, but I felt the project management course was superior in con...

I believe that when forming a project team, one must always start with subject matter experts. Technical knowledge is critical in the early phases of a project. Even if the knowledge is not complete...

I believe that I am better suited for a role in middle management with my current skill set. I have a fair amount of technical expertise which would allow me to think about logistics much more natura...

I work for a company that follows a functional organization. Functional heads operate with a large degree of power governing day to day operations as well as project development. Groups are also org...

I believe the concept of as far as possible is meant to be vague. It isn't defined as a certain level of safety or risk mitigation. Because by defining the point at which risk is "adequately" mitiga...

Risk mitigation begins with end user training and education, in my opinion. After a company has done all it can to make a safe and efficacious device or product, it is up to them to educate the end u...

The companies that I have worked for that operate under any sort of regulation either purchase the standards or opt to use a subscription service. There are many regulations, and as has been mentione...

In our senior design capstone project for BME, the design inputs were developed from two sources: market research and customer needs. In order to develop design inputs, market research was conducted ...

Gantt charts provide two critical functions: timing and dependence. The overall view of the Gantt chart allows all the tasks and deadlines of a project to be looked at. These timelines can be furthe...

Meeting minutes, we can all agree, are useful in retracing and revisiting topics covered during meetings. As has been mentioned above, meeting minutes can help track some of the thought processes and...

I believe that every individual has the right to know what is going to be done to them in any sort of clinical setting. I believe that the passage of knowledge to a patient and their understanding is...

Placebo-controlled trials are very important in establishing efficacy and statistical significance during the development of a medical device or drug. It should also be noted that a placebo doesn't n...

A clinical background is a very valuable trait when considering the field of clinical research. While engineers and technical experts are capable of working in this field, and successfully so, having...