It should all depend on what the agreement is being made about. I hope we are not talking about an agreement that involves a medical device creation. If this has to do with a medical device I will str...

First, I make sure we spell out what is to be held confidential; we must agree to how long this information will be held confidential. We must also agree to the consequences of violating the terms of ...

Prof. Simon: perhaps it will make more sense to say if I had not taken this course, I would unknowingly have passed up on a great learning experience as a Biomedical Engineer. It was critical to learn...

Quite recently Dr. Simon organized us into project teams. And strangely, I became a part of one before I knew it. The approach of forming the team was weird. Personally, after experiencing with the Fu...

Folks, if there is any problem in a "Matrix Organizational Structure" it won't be because of the structure. I have almost grown up in a functional type organizational structure where there is always a...

Hello 9275: Our Medical Device Development class brings to reality things I never knew before, the Matrix Organizational Structure, for instance. It's quite exciting; I hope you'll agree. In my opinio...

Hello Viraj: I see you are interested in the identification of risk and its prioritization; me, too. Never had experience dealing with medical device risk analysis. And you are right "Managing risk ea...

I shall assume that by value you are referring to the impact you assign a risk. If using a matrix to measure the value of a risk is not sufficient I shall wonder what value you are concerned about. I...

Somehow this topic interests me. Especially when participant nk229, posting coded 1461 seeks to express the dilemma of attempting to assess pharmaceutical drug risks as a major concern. That it is a c...

To understand the importance of an input source leading to the design of a medical device, it only suffices to recall Dr. Simon's lecture Marketing - week 7. This lecture examines the volume of sales...

Truth is: I have never worked in industry to participate in Design Review Meetings. However, if such a meetings is to produce any useful results for the company it must be aimed at ensuring that a pro...

Hi Fady: let's, for a second, suppose that the auscultation, acoustic medical device, the stethoscope - known to be in use since 1816 - just got introduced to FDA for approval, what classification wou...

Hello Folks: Simply put, haven't had much experience dealing with Gantt charts; but after studying Gantt charts, the take of each individual on this topic conjured a few ideas into my mind; I just ha...

Heh Folks: You've all provided quite some reading; I was tempted to just get by; but Gantt charts are a little more tempting than the don't give a damn attitude. Simply put, haven't had much experie...

Hey folks: The initiator of this topic, hg93, defines DDP as including certain named elements in an attempt to draw our attention to the fact that certain aspects used to determine the inclination of ...