I agree with srg36 that there is always the potential for unforeseeable risks that were not visible to the manufacturer or the FDA at the time of appr...

There has been some updates to the 510(k) information in response to the IOM report to clarify that FDA includes in its 510(k) review the safety and e...

Combination product: Insulin glargine pen injector The pen injector is intended to deliver long-acting insulin used to tread adults with type 2 diabe...

Assessing the material biocompatibility of the product (including the material of construction and final device) is critical for successful commercial...

There is a great rewarding feeling when a product realization you worked on reaches hands of people including closed ones and help them live a better ...

Research in the industry is generally faster and tend to be more successful. I would attribute many factors to the difference in performing research i...

In my experience, I have encountered two project managers in a project. The project managers responsibilities were split; one was responsible for over...

Portfolio is composed of all the programs that the company has and programs are composed of projects which in turn are composed of tasks as described ...

Some of the challenges for doing project management for medical devices compared to building a skyscraper are; the requirements of highly regulated me...

My advice would be to try to get into co-ops/ internships/ part-time or full-time job if possible even if not directly related to the area you would l...

I believe the current academic vs. practical ratio of courses provided by NJIT is the right balance. I think it is primarily important to have a stron...

There are pros and cons in academia and industry careers and it will be a decision of preference in lifestyle that the person would like to live. Some...