Quality departments are often seen as standing in the way of innovation or creativity. However, their primary directive is protection. Protecting the company from FDA/NGO intervention. Protecting the company from releasing bad products. Protecting the business in general. But as described in the scenario posed by Dr. Simon, the quality…[Read more]

Ultimately the difference between quality and R&D comes down to who each group answers to. Quality is responsible to the FDA, whereas R&D is responsible to the business. R&D strives to find innovation and solutions for products, services, and devices. Quality strives to ensure that all endeavors meet with FDA regulations. Ultimately, both…[Read more]

The importance of accuracy and precision when it comes to the FDA stems from concerns over safety. If a device or drug is not accurate or precise, there is no way the FDA can allow that level of variability and unknown be used by the general population. Additionally, precision and accuracy are needed if a new device or drug is to be used over a…[Read more]

In addition to the list above, it should be noted, that not only is there differing regulations on pharmaceuticals, there are also differing regulations on medical devices. And it is interesting, but there are other parts of the world that are stricter on some things than the United States. As an example, I worked at a small med device company…[Read more]

The FDA is strict largely for the protection of the general public. Without these measures in place, there is a greater ability for dangerous products to make it out into the market. I believe the crux of the issue lies with the potential of this strictness to hamper innovation or experimental drugs and devices. I believe that there is adequate…[Read more]

In order to determine what biocompatibility testing a device needs, ISO 10993 can be referenced. There are various tests and requirements that need to be evaluated for each medical device based on its intended use and duration of use and location of use. The most broadly applied tests are cytotoxicity, sensitization, and…[Read more]

Where I work currently, there was such a failure during the early phase 2 clinical trial period for an investigational drug. The drug had performed remarkably well during animal testing trials. However, when it was used on the intended patient population during limited phase 2 clinical trials, there was a marked increase in adverse events…[Read more]

Animal models are critical to the advancement of science. They are employed in the development of drugs, vaccines, and even medical devices. They have been used for hundreds of years and will be used for hundreds of years to come. However, there is hope with the development of more powerful computers and modeling software, renewable cell lines,…[Read more]

In a perfect world, managers would have all the technical knowledge that all the engineers under him/her have. This is not realistic or feasible. However, a good manager makes the effort to be involved in all the projects their employees have going on, at least on an overview level. The more involved a manager is in understanding the operations…[Read more]

I do not see any scenario in which missing a milestone can be considered a success. I understand that a milestone not being met because “something came up” with respect to safety may seem like a blessing in disguise. But truthfully, missing a milestone because of an oversight or lack of due diligence earlier on in the process (initialization and…[Read more]

The primary difference between project management for medical devices and other non-medical companies is the adherence to regulations set forth by the FDA. Due to the fact that medical devices are ultimately intended for human use, there are much tighter regulations placed on safety. As someone who works in such an environment, safety and…[Read more]

I believe that the 70:30 ratio is a little lopsided. The ideal ratio of informative to practical courses should be 50% informative and 50% practical. Among the most useful informative course taught at NJIT, the ones that feature labs are the most helpful. Of course learning theory and formulas is important, but seeing the practical application…[Read more]

My advice to current biomedical engineering students would be to find any form of work in engineering, or any STEM field in general. While the work may not directly use your skill set, getting experience in the field is more valuable than anything you can gain from a class. I currently work for a large pharmaceutical company, and while my…[Read more]

The primary difference between academia and industry is the route to success and the degree to which work is structured. When it comes to the route to success, industry typically defines it as bring a product to market that is profitable and innovative. In academia, success is usually defined via the acquisition of funding and generating…[Read more]

I personally have zero desire to be a manager. It could be a function of the experiences that I have had with managers that I have worked for currently and in the past. While there is a large salary increase to be had at the manager position, it comes with a tremendous amount of responsibility and pressure. Not only is their pressure from above…[Read more]

Much of what Chris mentioned in this post is something that resonates with me at my current position. While not always manifested in the form or a promotion, I do see accolades and preferential treatment being heaped on the same individuals by upper management. The work that they do is no better than anyone in their department, and is often…[Read more]

I have seen it myself sometimes the area disconnect, when I worked in consumer, I saw the constant push on the release of product from upper management, but never the recognition of a great job. I have seen that contracts to external manufacturers were implemented just because of the good relationship they had with an individual in upper…[Read more]

I would liken an employee’s feeling about a job to the product life cycle. It is phasic, moving from introduction, through growth, maturity, and ultimately decline. In much the same way, there is excitement and positive feelings during the introduction and growth phases of a given job. Eventually maturity is reached at a given position, and the…[Read more]

I tend to agree with the overall results of the study. The top four reasons for working at a specific company are very much the same reasons I have for working somewhere (not necessarily in that order). Most people work to get a paycheck, which is perfectly valid and reasonable, but if you can get excitement and challenge from the work you are…[Read more]

Many of the things that motivate others are similar to what motivates me. In addition, one of the biggest things that motivates me is the simple acquisition of knowledge. Through school, through work, through experiences, I hope to learn and gain as much as I possibly can. Every skill, every fact, every technique, every mistake, is useful in…[Read more]