I think this gave a solid overview of what to expect from multiple different areas of the biomedical world. As students at NJIT, we are told to choose a direct track (Mechanics, Materials, Instrumentation, Pre-Health) where our focus is very…   Read more»

Just because there are “verbal contracts”, doesn’t mean things should be less important that arguments in writing. Having a witness present (maybe someone somewhat familiar with whatever is being discussed) can allow for a (hopefully) unbiased recollection of events taken…   Read more»

When considering a “sponsored event,” especially for something in a professional field, any location (as you mentioned) that someone would go to on vacation would be unreasonable. My first thought was some tropical location that may have ABSOLUTELY nothing to…   Read more»

@ac825 I would like to add that an incredible amount of experience in the field may lead to a narrow-minded or tunnel-vision like approach to certain topics. I think someone can be counted on for projects that are directly in…   Read more»

This directly relates to the warning our professors give us at the beginning of our Capstone semesters “Don’t make group members with your friends, as your friend group may no longer stay together.” As ominous as this was, my friends…   Read more»

I would say given the structure from the charts from the power point slides, I would agree that our teams are structured more around a Functional Organization. Each member of the team is responsible for their own separate subsection, which…   Read more»

Working for a company that manufactures medical devices (more specifically, I deal with nonconforming components), some of the main documentation I deal with (when determining the Severity and Occurrence of these errors) are these DFEMAs, PFMEAs, and FMEAs. A lot…   Read more»

The Risk Management Process has a variety of different tasks that are encompassed within it. The Analysis portion that is involved includes a good amount of brainstorming where any risks that may involve a product should be listed, and their…   Read more»

When releasing a biomedical device, there is of course a lot of reward from both a monetary standpoint, as well as a personal wellness perspective as the feeling of helping others may be a reward in itself. Both of these…   Read more»

When releasing a biomedical device, there is of course a lot of reward from both a monetary standpoint, as well as a personal wellness perspective as the feeling of helping others may be a reward in itself. Both of these…   Read more»

The device I’ll discuss is the LTV 950 ventilator: Functional – One functional requirement of the device is for it to output oxygen into a patient’s lungs when they are physically incapable of doing it themselves, or they have a…   Read more»

@vthampi I would like to add to this by mentioning how even a small thing such as a misspelling, or even something as miniscule as missing an (s) at the end of a word will almost always be adjusted using…   Read more»

Two benefits of Software Validation include: 1. Ease of Updating the Software: When using a software developed in a device, depending on how the software is constructed (especially considering how user-friendly and able-ing it is), updating this software to improve…   Read more»

I would also agree with the others here that corporate responsibility is taken very seriously when it comes to medical device output. I think naturally companies are adamant about putting out a “good product,” but there are also so many…   Read more»

Coming from a company that outsources many of their different drawings, outsourcing is crucial to the manufacturing of medical devices. One of the best benefits is that on a large scale, you can train multiple different companies to be compliant…   Read more»

Clinical Research Study Manager was the job title that appeared when looking up Good Clinical Practices for me. The most common word I see in the job description is “lead” or “oversee and execute” showing the overall direction of being…   Read more»

I completely disagree that placebos are “negative” effects or “sham drugs”. I think it’s an overall depiction of how much we still don’t know about the human body, and how much we rely on pharmaceuticals/procedures when the body can produce…   Read more»

@archishak I agree that it is extremely important to have a competent team of cultured individuals to reach out to these specific populations. Not that it wouldn’t be reasonable, but I would argue that people are much more comfortable having…   Read more»