@mmd55 I think that part of the delay in the approval process, specifically for new devices that require PMA, is in the classification system that the FDA has for ‘new’ devices. As opposed to drugs, which have a pretty standard…   Read more»

While I have not switched from a more traditional engineering role to a regulatory role, I have interacted heavily with regulatory partners and I believe that there is great benefit to gaining regulatory experience. Most specifically, regulatory in a global…   Read more»

@cb447 I think the choice between academia and industry is really based on the personality of the individual. When choosing my own career path (ultimately went for industry), I considered what brings me satisfaction on a daily basis. Do I…   Read more»

@anthonynjit I think that statistics are not a sure way to determine safety as it is completely dependent on how the study is set up that the data is being extracted from. If the study is not robust, the data…   Read more»

Certain animals have a higher “moral status”, such as non-human primates, due to their similarity to humans. Intelligent animals illicit greater sympathy from people and are therefore more greatly contested when used in research, as opposed to cattle and livestock…   Read more»

I think its interesting that the question is about FDA Consultants, because there will certainly be a regulatory affairs division in any medical device company and any projects related to new or existing products will require regulatory sign-off on any…   Read more»

There are many qualities required for a good project manager, but I think it all boils down to the level of emotional intelligence that the manager can display. There are 5 key components of emotional intelligence, that if mastered, result…   Read more»

@herreravanessa This definitely resonated with my experience as an undergraduate student in BME. Its really important to try as many different experiences as possible, especially in a ‘jack of all trades, master of none’ type of degree like BME. There…   Read more»

@aaq2 I agree that practical courses provide greater awareness in an industry application, however I do believe that the academic courses for a Master’s degree may be even more important. The purpose of the Master’s, at least for me personally,…   Read more»

I believe it would be beneficial to integrate greater software expertise in the BME curriculum. Currently, BME coding is limited to MATLAB, and while it is a fantastic software that has many research applications, I have found that I was…   Read more»