Quality is a huge part of any successful business operation. From my experience working in a hospital, when there is a meeting and it is time for Quality to report there are always huge sighs. Maybe it is just because…   Read more»

I don’t think the FDA is being too strict. With anything that is new, there has to be accountability. The regulations that are put in place, forces companies to be ethically sound when proposing new technology that can have negative…   Read more»

In the 1950s there was a pharmaceutical company (Chemie Grunenthal) created sleeping pills from thalidomide. It was advertised as safe for everyone to use, including pregnant and nursing mothers. The drug gained popularity fairly quickly and spread from West Germany…   Read more»

What kind of regulatory pathway would be required for an antibiotic-releasing hip stem? The regulatory pathway that would be required for an antibiotic-releasing hip steam is first being reviewed by and approved by the Center for Devices and Radiological Health…   Read more»

What kind of regulatory pathway would be required for an antibiotic-releasing hip stem? The regulatory pathway that would be required for an antibiotic-releasing hip steam is first being reviewed by and approved by the Center for Devices and Radiological Health…   Read more»

If I am working with a biomaterial that has never been used before, I shall do every single test that I can think of. Starting with all of the ISO 10993-1 standards. The reason being is the amount of liability…   Read more»

Animal testing is not ethical … ever. Following that same thought process, however, neither is digging up the ground to place buildings there instead. Causing air pollution by driving a car is also unethical yet millions of people do it…   Read more»

Having multiple project managers on a single project will cause some level of confusion. Everyone has their own preferences on the way tasks should be done even if they agree on the specific task. Because of individual thought processes, disagreements…   Read more»

I believe that the initiating phase is the most important phase. While every phase is important in its own way if you don’t progress through the initiating phase the project will never begin. A poorly executed initiating phase will also…   Read more»

To answer this first, the word “portfolio” would have to be defined in regards to project management. “Portfolio: A portfolio is a collection of Project, programs, subportfolios, and operations managed as a group to achieve strategic objectives.” What does this…   Read more»

My best advice that I could give a Biomedical Engineering Student (and anyone for that matter) is to find a mentor. A mentor will be able to give you knowledge and show you skills that will help propel you forward…   Read more»

Overall I believe there should be a split in practical vs informational courses. The informational courses should have the majority percentage (either 60/40 or 70/30), however. The informational courses form a baseline knowledge of the field. If you only have…   Read more»

Academia & Industry are more similar than is realized at times. There are differences (i.e. pay) that can cause someone to choose one over the other, but the two overlap in some places. Politics: Working with other individuals and being…   Read more»