I can see how this could be a common problem in industry, especially when Project Managers get requests from stakeholders not directly involved in planning or executing the project. One day you are on...

There are many reasons why a certain product or process will require changes during its life cycle. One example could be cost. To attain certain tight tolerances, material purity, or other favorable p...

There are plenty sources of input to pool from when developing the Design Input Document (DID). Other than the marketing department you should be collecting information from external such as consumers...

I do not think this is a problem as there have probably been hundreds of medical devices approved using predicate devices and which have probably benefited society due to the faster track of class 2 d...

I currently work as a manufacturing engineering co-op for a medical device company which is most like a functional organization. Each department has their own managers (Manufacturing, Quality, Purchas...

I think there are different situations with the labeling which could result in either immediate corrective action or even a recall. As we have have heard before, labeling is one of the three core comp...

While this could make it easier to globalize healthcare and allow for easier import/export of drugs and devices, I think it will make it harder to bring new products to the market in the first place. ...

I do think that interpersonal skills are a tremendous asset in the workplace, I do not think that people can just fake their way through without a good basis of technical understanding. Going so far t...

To me, this is probably one of the hardest part of the design process. There are many problems associated with creating tolerances for various aspects of the product. On the one hand if you make the t...

I do think these restrictions are a bit too harsh. Sure expensive steak and wine dinners are not the most useful allocation of resources but I also do not think someone is swayed into a huge business ...

Dr. Simon, As someone who has been working at a medical device company for almost a year, I found this extremely relevant and helpful. It sort of reinforced some of the ideas I already had about the r...

This is an interesting dilemma you brought up. I think you should divulge as much information as possible under the protection of the Non-Disclosure Agreement since it will be very difficult for the C...

I think as a project manager you would want a matrix structure. Project-based structure lacks efficiency in that there can be members of the team who are specialized in certain areas, but that area is...

While these two are similar, I think education really separates these two levels of management. Being an engineer I am more inclined towards being involved in middle management as those are the people...

I currently work as a manufacturing engineering co-op for a medical device company which is most like a functional organization. Each department has their own managers (Manufacturing, Quality, Purchas...