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…   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…   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…   Read more»

Prior to clinical trials biocompatibility testing should be completed in regards to ISO 10993. The types of biocompatible tests needed for a particular device can be determined by using the toxicity table. General biocompatible tests include cytotoxicity, genotoxicity, irritation and…   Read more»

Project manager for a medical device company differs from that of a building/skyscraper due to FDA regulations. Project managers of medical device company have to follow design controls and regulations which abide to FDA guidelines. A project manager of a…   Read more»

Coming from an individual who has work experience in academia and industry there are pros and cons for both career paths. In terms of moving your career forward based on your work, industry is more promising. When you work in…   Read more»

The current academic to practical course ratio provided by NJIT is not beneficial to students entering the workforce. From personal experience, I found it shocking that my bachelor’s degree did not really prepare me for the medical industry. Only 3…   Read more»

I do not have a six sigma belt certificate but I have heard about it from employees and friends. A friend of mine was able to get a job as a Lean Manufacturing Engineer because they received a six sigma…   Read more»

I have seen this first hand at work in the past month. One Senior Engineer spoke up against upper management about an issue in a major product line. That senior engineer was walking around the whole month thinking that he…   Read more»

A lot of people do tend to leave their job because they became stagnant or the work environment became to comfortable. As a new employee the managers and engineers always praise my work and give me feedback on how to…   Read more»

The results as to why people work seem to be reasonably accurate to my reasoning for staying at a job. Number one motivation to work is the challenge and excitement. If you do not feel challenged at work then you…   Read more»

I have seen first hand how the project managers motivation affects the team productivity and motivation. Whenever the project manager leaves for vacation the entire office becomes very relaxed on their workload. But when the project manager is in his…   Read more»

A lot of people may say that they are motivated to do work because of their family or wanting to help their community. I on the other hand have always been driven to push my own boundaries. I always have…   Read more»

During my Finite Element analysis course I worked on a project which had a scope of collecting data to show effects of osteoarthritis. I had a timeline of around two weeks to complete this project, so I wanted to keep…   Read more»

According to an article I read called, “The vendor selection process, How to select a vendor formally?”, there are a set of questions you must answer as a buyer: 1. What products do you require? 2. What quality levels are…   Read more»

Currently, I have been working on updating a pFMEA for Maquet products and they follow a similar 1 to 5 scale to numerically quantify a risk. A pFMEA is a process failure mode effects analysis which breaks down each process…   Read more»

In this scenario the type of change control which should have occurred is the ECO (engineering change order). This is when you make changes to the project after it has completed the design controls and project processes. The managers should…   Read more»

Surgical Mesh with Antibiotic coating is a combination product which can follow either CDRH or CDER regulatory guidelines. Based on my understanding the primary mode of action would to treat it as a class two medical device. But to verify…   Read more»

Recently, I encountered my first experience not meeting a deadline in industry due to underestimating the time needed to complete the task. The task was to obsolete a product line which should have taken around a week for me to…   Read more»

The process to perform quality assurance includes both inputs and outputs. A couple of examples of quality assurance responsibilities in terms of inputs are process improvement plan, work performance and quality management plan. Quality management plan is within the DDP,…   Read more»