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

A project manager’s motivation level will of course affect the team he/she manages. Lazy project managers beget lazy project teams, aggressive/motivated project managers beget aggressive/motivated project teams. Of course, individual personality has a great deal of influence beyond just the…   Read more»

As had been mentioned above, an engineering change order (ECO) will be required since the device design controls portion of the process has already been completed. Since the device now requires a recall, the design review process will likely need…   Read more»