The mindset that physicians and drug makers will never create cures because that will not gain them money is a very dangerous view to hold. While I ca...

I think companies may continue to not follow the rules even if they have a risk of receiving a 483 for the same reason that people continue to speed o...

I think a lot of people have a poor ability to visualize past the present. Those who think quality control is a waste of time and money really only se...

I absolutely believe that the FDA is not even remotely too strict. Not to blindly support the bureaucracy, testing, and red tape that comes along with...

Depending on how a device is approved by the FDA, there may actually be less testing involved to get a device approved. For example, 501 K's allow for...

As many others have said in this forum, one of the largest issues or difficulties that a doctor will face in trying to make a medical device is fundin...

The first pitfall I could see in outsourcing to a university 1000 miles away is communication. While this is not as big of a problem in the United Sta...

I think, due to the sometimes unpredictable nature of research, you don't really get to always specify if your research is for the present or future. ...

Testing on animals is a necessary evil. While alternatives do exist, such as in-vitro models, alternatives do not always provide the necessary data ne...

In all honesty, determining if missing a milestone is a success or a failure depends on why the milestone was missed. If it was missed because certain...

I have not worked in industry, but project management in academic labs is somewhat similar. I think the best project managers are those who set solid ...

Combination devices (if not proven to be substantially equivalent to other products on the market) often require multiple levels of testing and valida...

I have not worked in industry but I have worked in several labs on campus and went to NJIT for undergrad. If I could go back, I would tell myself to b...

In all honesty, I have really only worked in academia (although I would not define it as, "Working" since I did not get paid and was an undergraduate ...

In all honesty, I think it should depend on what the student prefers and on what will best supplement their education. Some students have already had ...