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 approval. Last month medical device maker Abbott volun...

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 effectiveness of the medical device, although no si...

Combination product: Insulin glargine pen injector The pen injector is intended to deliver long-acting insulin used to tread adults with type 2 diabetes and adults and pediatric patients (children 6 y...

Assessing the material biocompatibility of the product (including the material of construction and final device) is critical for successful commercialization. The tests should follow ISO 10993 and typ...

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 life. Both long and short term research are import...

Research in the industry is generally faster and tend to be more successful. I would attribute many factors to the difference in performing research in the industry vs. academia. As per the lecture no...

In my experience, I have encountered two project managers in a project. The project managers responsibilities were split; one was responsible for overseeing development activities at suppliers and the...

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 in this week's lecture. Companies make strategic c...

Some of the challenges for doing project management for medical devices compared to building a skyscraper are; the requirements of highly regulated medical device industry and the level of collaborati...

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 like to work. As Dr. Simon indicated, there is high...

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 strong academic background based on theoretical concept...

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 people start in academia and retire in the indust...