The key differences between public and private companies mainly revolve around how exclusive both are and how each succeeds with respect to their public disclosure. A public company has full access to the public market in that any entity can…   Read more»

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 should consider which aspects of either an LLC or a Corp. appeal to the company’s…   Read more»

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 immunotherapy. A look at Novartis’s financial statements show a gross profit margin ranging from 65-67%…   Read more»

I currently work in manufacturing at a cell-therapy company, and my duties during the production process includes collaboration with the quality department in real-time as the process is occurring. This is done by taking samples of cell solutions during a…   Read more»

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 said to give each department time to prepare the required data/documents for…   Read more»

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 lack of a quality system can easily compromise the well-being of a patient, which according to…   Read more»

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. It does not sustain life so it may not require a PMA, but it is an…   Read more»

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 IOC’s perspective on the 510(k) process over the past 35 years. The IOC points out that…   Read more»

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 combination device) that has proven substantial equivalence under a 510(k) (1). It is intended for adults diagnosed…   Read more»

Most would agree that animal testing is indeed unethical, the real question should be: to what extent can we reduce the unethical treatment towards animal models in order to produce a viable medical device? The method of euthanasia for example,…   Read more»

Biocompatibility testing occurs in the forms of cytotoxicity, irritation, hemocompatibility, sensitization, carcinogenicity, or any other biological effect listed on the ISO-10993-1 toxicity test matrix. For obvious reasons, the quantity of testing done is proportional to the extent and duration to…   Read more»

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 to come in when ordered”. The long distance can also pose an issue to the product’s…   Read more»

The upside of the broadened coursework associated with BME is the versatility one acquires throughout their academic career. Having background experience and education in fields such as medicine, computer coding/programming, assembling circuitry, or failure testing of materials can be only…   Read more»

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 9:1 is 9, 8:2 is 16, 7:3 is 21, 6:4 is…   Read more»

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. Now this position was not a career by any means, but it did…   Read more»

Questions that I would ask fall under subdivisions of the four main questions asked: 1) To further expand on the business need, I would ask how profitable/lucrative the medical device is when taking into account the patient demographic along with…   Read more»

When considering the challenges between managing a project for a medical device and constructing a skyscraper, one must take into account the safety of both deliverables in the event of the worst case scenario, both of which can have dire…   Read more»

The first thing that comes to mind when managing a portfolio is one of the last, most important steps during the Closing Phase, which is to log everything you have done and learned so that they can be applied in…   Read more»