Complaining about the quality assurance and management in any company and considering it as a burden that can be waived, means complaining about being globally competitive and a customer long-term satisfaction. Within these days where medical devices companies are growing…   Read more»

Totally agree with other replies, having a bad relationship between R&D and Quality Department could lead to work deficiency and further delays as well as many other barriers that would hinder the workflow in its right and proper way. One…   Read more»

As a part of the Quality Unit, Document control main procedure depends on ensuring medical devices or product safety and quality. This includes ensuring the production processes security and determining restrictions needed to: accept, inspect, update, distinguish differences, know update…   Read more»

Accuracy refers to how a measurement is close to the right or acquired absolute value while precision how a measurement matches the same exact value being estimated. Both fields are independent. Which means a measurement may be highly precise but…   Read more»

Interesting topic and replies. In my research on this topic, I was surprised that India is one of the countries that still use, sell, buy many medicines that are banned in other countries due to safety and regulation issues. Japan…   Read more»

In this discussion, we can refer back to our last discussion regarding the challenges in the medical devices industry, in which most replies stated that FDA approval and regulations are the most challenging step in developing a new medical device…   Read more»

First, I would go over the manual that came with the new biomaterial and research about it, discover the chemical name, the formulation data/report, the manufacturing info, the sterilization compatibility, etc. and inquire the manufacturer if there is any unclear…   Read more»

Testing animals are the pathway for medical researchers and scientist to explore and test a medical device efficiency, a therapeutic drug effectiveness for a specific disease, or particular surgical techniques (ex. hip replacement, kidney transplant, heart transplant, etc.). As it…   Read more»

I agree with the above replies, as research in academia is more likely open-ended in a way or another, managed by a Professor. While in Industry research takes a slightly different path in which the research goal is set clearly,…   Read more»

I never worked on a project under multiple managers, but I would imagine that it would be harder than having one main manager. Although is all depends on the project and managing environment, things may get a little complicated, as…   Read more»

Many obstacles would encounter any group project. For me, I experienced a group noncooperation issue in which some group members were ignoring their assigned tasks and depending on the other members to do them. This was really frustrating for me…   Read more»

I found the above replies interesting as most people mentioned that the Regulatory compliance (FDA approval, etc.) which must guarantee the medical product safety is the main challenge in the medical device industry compared to other industries and that would…   Read more»

I agree with you, Karen. As a BME graduate student who is still looking for an internship, I started doing research since my 3rd year in my undergrad instead of wasting my time waiting for that intern/coop as it was…   Read more»

A Life Sciences Salary Survey affirmed that scientists in the US, Canada, and Europe who worked in the industry made around 30% higher than those in academia per the the-scientist website. Another disadvantage of working in academia is that in…   Read more»

I think it depends first on the person mindest whether it is academic or industry. However, being a scientist researcher in the industry may have many advantages over being a researcher in academia, not only income-wise but also in lifestyle…   Read more»

It is hard to say that is a good ratio for me, because I graduated from my undergrad BME with no practical course credit, in which I was lost after graduation. Our goal was only to maintain a high GPA…   Read more»