Sole proprietorship is a type of business owned and run by ONE person. There is no distinction between the owner and the company. The owner is entitled to all the profit the company makes and is responsible for everything. Legally,…   Read more»

One of the roles in the quality management system is regulatory affairs specialist. The specialist help in obtaining and maintaining government approval for any medical device or drugs or any related materials. They work closely with the FDA since it’s…   Read more»

I think it is very important to keep up with emerging technologies especially when it comes to the QA department as it facilitates their processes and makes it easier and more efficient. One of the ways to keep up with…   Read more»

Pergolide is an ergo line-based dopamine receptor agonist used to treat Parkinson’s disease. It was approved for use in 1988. In around 2002, detrimental side effects started emerging in patients that took pergolide. Pergolide was causing serious damage to patients’…   Read more»

I think that the FDA is being strict with their restrictions which is absolutely necessary to ensure that all innovations do not harm the population. The medical industry is mainly based on profit, so if the FDA loosens up its…   Read more»

I believe that the FDA should be responsible for the said issue. The FDA’s mission statement is to protect the public health by ensuring the safety and efficacy of drugs, medical devices, and food supply, so the FDA should have…   Read more»

People who usually work in academia doing research do it out of curiosity and for their love of science. They genuinely want to help people by making new discoveries in science. Moreover, it is a more relaxed environment where you…   Read more»

I think that testing on animals is unethical because it causes suffering to animals. Their rights are being violated. There are other alternatives to testing on animals: in vitro testing, computer (in silico) modeling, research with human volunteers, and human-patient…   Read more»

If I had the choice right now, then I would choose to go into industry. I very much dislike working in slow paced environments where I have to search for the unknown. However, I would like to go into academia…   Read more»

Since thousands of lives are being affected by medical devices, a team dynamic in a medical device project should be open and transparent. It would be great if the project manager has some background and technical skills related to the…   Read more»

I have personally never worked on a project with multiple different project managers. Although it’s not very common, but I believe that having more than one project manger has its benefits especially when they both come from different backgrounds. It…   Read more»

I think the practical courses should be increased in the program. There should be a ratio of 50/50 or at least as close as possible to this ratio especially for a Masters program. The Masters program should have courses that…   Read more»

There are advantages and disadvantages to both working in the academia and the industry. Working in the academia gives you a job security with many benefits such as exploring/traveling around the world. There isn’t a set time you have to…   Read more»

I was very hesitant about joining the BME program as an undergraduate. I initially wanted to do chemical engineering because that is what interested me at that time, but my advisor at my previous college advised me to go into…   Read more»