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% over the past year, which is not ideal, but implies that the company’s costs are only about one-third of…[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 cell expansion process and delivering those samples to QC for viability and sterility…[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 presenting to the FDA, but at the same time it also acts as an alert for the staff to be aware of their actions and…[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 lecture can result in a business not only going under, but also result in its personnel being…[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 implantable device that intimately interacts with human tissue, so at the very least, pre-clinical and clinical data is required.…[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 for a medical device of a moderate risk to enter market, it must prove substantial equivalence to a predicate…[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 with type II diabetes that is defined as “prescribed mobile therapy” that was successfully…[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, is done in a way that is as most pain-free as possible (i.e. IV anaesthetics, controlled-atmosphere…[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 which the medical device interfaces with the…[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 integrity during transporting (blood cell-based products can lose viability over long durations of travel despite…[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 beneficial in the eyes of an employer, especially when it…[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 24, and 5:5 is 25, so the higher the value, the more equality there is among both types of courses. I think this quantification rule is applicable since both…[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 provide a sense of pursuing a path in an academic environment. The main advantages would be the flexibility of one’s personal schedule…[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 how effectively it provides a solution to a medical complication. If the device treats a condition…[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 consequences on human life. I personally believe that the safety of medical devices requires a lot more…[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 the strategy of future projects. A portfolio simply refers to one’s collection of previous programs and respective projects in a way…[Read more]