I work as a product engineer at a company which has a matrix organization and the one constant is disagreements between departments. Whenever we have a major project we have meetings with the lead of each department to discuss the…   Read more»

As an undergraduate I had to form a project team for a senior design project and I formed a group with two other friends. I worked with these two friends previously on other projects and we worked extremely well with…   Read more»

At Getinge, the sample size is determined mostly from the risk index. Since Getinge’s main acute therapy product is Intra-aortic balloons the risk index significantly changes the sample size while running a protocol. Recently, I was helping a senior engineer…   Read more»

As a co-op at Getinge I was able to work on a project associated with updating the PFMEA (process failure mode effects analysis). This one document lays out each process for creating the final medical device for each product line…   Read more»

The ISO 14971:2012 risk management requirement is not clear because one cannot define” as far as possible.” The risk management team can find ways to mitigate, eliminate, prepare for risks which can have an economic effect on the medical device….   Read more»

Deviations that come from the verification step of a design control always causes a havoc at work. Recently, I was trying to qualify a modified fixture for use on the production floor. The drawing was completed, the fixture was built…   Read more»

I am a production engineer at Getinge, and last week was my first time leading a design review meeting. The preparation for my design review meeting was intense since I was covering phases I-III in one meeting. I had to…   Read more»

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…   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…   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…   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…   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…   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…   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…   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…   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…   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….   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…   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…   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,…   Read more»