I completed my undergrad at NJIT and within the senior design course (capstone) I developed a better understanding of what a requirement and test plan document contains. It was grilled into my head that every time you write a document it must be clear and concise enough that anyone can understand it. The requirements document was specific to the…[Read more]

Within the medical industry it is crucial to always have the DHF updated as the progress of the project moves forward. A way to make sure that your documents within the DHF are ready for an audit is to have internal audits or a mock FDA audit. At the medical company I work at right now, we already had a mock FDA audit, ISO audit and now an…[Read more]

Currently, I work in the medical industry as a production engineer. I am working on a global project that deals with four of our product lines that will implement a global labeling change. Therefore, several engineers, managers, researchers from different locations and departments are involved in the planning and execution phases of this project.…[Read more]

Based on the patent law there are numerous ways to determine who owns the intellectual propery within research and development:
1. Employee: if they are the owner of an inventions
2. Employer: the inventions is considered work-made for-hire
The concept of work-made for-hire is when
1. There is an employee/employer relationship
2. The invention is…[Read more]

I completed my undergraduate degree at NJIT as a biomedical engineering student, the course you are referring to does not necessarily relate to clinical trials. Within capstone, we do experiments on our design, but we never went to the extent of making a protocol or following ICH Good Clinical Practice guidelines. Within capstone, we had to make a…[Read more]

The purpose of double blind studies is to prevent bias due to demand characteristics or the placebo effect. In the case of investigating the effects of a drug that cures Alzheimer’s a double-blind study is beneficial compared to a single blind study. The participants are not aware if they received a placebo or a real drug, therefore their o…[Read more]

According to Business Jargons, there are four strategic alternatives for an organizations grand strategy:
1. Stability strategy
2. Expansion Strategy
3. Retrenchment Strategy
4. Combination strategy
I will discuss the stability strategy which focuses on maintaining its current position and business operations. Usually this strategy is adopted by…[Read more]

I found an article online which expresses the importance of having a pre-launch for initiating the fuss about a product. Robert Hawthorne describes it as the art of pre-launch marketing which is composed of:
1. Company pre-launch
2. Product pre-launch
3. Crowdfunding launch
4. Direct Sales Launch
5. Network marketing launch
6. Business Opportunity…[Read more]

According to the business dictionary, a mission statement is “ a written declaration of an organization’s core purpose and focus that normally remains unchanged over time.” While a vision statement is, “ an aspirational description of what an organization would like to achieve in the mid or long term future.”
Getinge (Maquet):…[Read more]

I did some research on Johnson and Johnson, these were my findings:

Gross Profit Margin (Quarterly)= .6909 as of June 30, 2017
GPM is the ratio between how much money you make after you spend a certain amount in sales. The perfect situation is when this is equal to one, the fact that Johnson and Johnson is so close to one means they are in a…[Read more]

A mid-size company making $10 million in revenue should exist as an “Inc.” corporation vs an “LLC.” As an “Inc.” corporation the company would get more attraction from business owners to buy shares compared to an LLC. An “Inc.” can go public which is what venture capital companies look for rather than an “LLC.” By going public, the medical…[Read more]

I worked on several projects for R&D which always got delayed due to disagreements with the quality department. One major product that we produce is an intra-aortic balloon which is a class two device. Based on a CAPA that the manufacturing department received, we had to test 300 samples of a particular IAB for a leak test. If one of the three…[Read more]

Coming from an engineer working in the medical device industry, the quality department is crucial in the success of our products. Yes, at times the quality department is particular about matching certain standards which can cause delays in projects. Yes, we need to be trained every time quality documents get updated. Yes, the quality department…[Read more]

I found another article that specifies the issues with the FDA’s center of medical device and radiological health. The main reason this article was released after the writer’s wife used the Karl Storz power morcellator which spread cancer throughout her abdomen. He focuses his article on life sustaining medical device flaws. He believes that the…[Read more]

According to the FDA update from November 2014, the de novo is a sorting process that categorizes novel devices based on risk strategy. It is similar to the regulatory structure that we identify with in terms of class I, II or III. Based on the medical device amendment of 1976 the medical device classification will result in certain controls and…[Read more]

With any type of animal testing the main pitfall stems from delays. The process of ordering animals is time consuming and also limited. If you are completing an animal test on a specific animal then you would need to find multiple suppliers to purchase from because animal suppliers can run out of animals. If the animal testing is now being…[Read more]