The key differences between public and private companies mainly revolve around how exclusive both are and how each succeeds with respect to their publ...
A medical device company with only 50 employees and $10 million in revenue would classify as a small business (less than 100 people) and therefore sho...
The company I chose to analyze is Novartis since they came out with a breakthrough product known as the KYMRIAH in 2017 that specializes in immunother...
I currently work in manufacturing at a cell-therapy company, and my duties during the production process includes collaboration with the quality depar...
Both medical device companies I have worked at announce all FDA audits in a company-wide email a few days prior and the day of the audit. This is sai...
It goes without say that the implementation of a QC/QA system in a pharmaceutical/medical device company is a vital necessity. With costs aside, the ...
An antibiotic-releasing hip stem would undergo a 510k pathway as it classifies as a Class II combination device of a drug and device-based product. I...
The article posted with this week's lecture: "Medical Devices and the Public's Health" by the Institute of Medicine (IOC), gives an overview of the IO...
An online search for a blood-glucose monitoring-system came across the FDA-approved Bluestar app by Welldoc. It is a Class II device (not a combinati...
Most would agree that animal testing is indeed unethical, the real question should be: to what extent can we reduce the unethical treatment towards an...
Biocompatibility testing occurs in the forms of cytotoxicity, irritation, hemocompatibility, sensitization, carcinogenicity, or any other biological e...
The main pitfalls with outsourcing to a long-distance university would be delays in the project, as mentioned in lecture, in that "animals take time t...
The upside of the broadened coursework associated with BME is the versatility one acquires throughout their academic career. Having background experi...
I usually decide if a ratio of this sort is acceptable based on its quantification. For example, the value of a ratio of 10:0 is 10*0=0, a ratio of 9...
The closest I've come to working in academia was at the NJIT CHEN building for about 2 years, where I simply assisted PhD students in their research. ...