I think risk assessments are absolutely necessary no matter the situation. Medical devices in particular can cause harm to a patient if something bad were to happen or if something goes wrong with the device. Let’s say you propose a…   Read more»

Obviously, the biggest advantage of risk management assessments is that they keep people safe from potential hazards or dangers that can cause harm, injuries, infection or anything else that could harm a patient. they also help make the device more…   Read more»

One example that comes to mind of a hazard in a hazardous situation where it can cause harm is dealing with chemicals in a lab without proper equipment like goggles, gloves or lab coats. That is why people stress lab…   Read more»

Ok so I think this could go both ways. I think over validation can be strategically beneficial at times as a proactive measure in case of any future regulations that need to be addressed. however, the other side of it…   Read more»

I think the biggest issue is that the device would fail in the market. If a product is poorly designed or has insufficient design controls, the product wouldn’t really meet client needs. i think it would also have insufficient risk…   Read more»

I am currently taking another Medical Devices class and we actually covered this in the first lecture. Validation is the process where there is objective evidence that client needs are met. It’s basically me asking, did I make the right…   Read more»

As you’ve mentioned, people who don’t have a clinical background can work in this profession but it could be more “challenging” than someone who does have a clinical background. I think having a clinical background gives people an upper hand…   Read more»

I think one of the biggest advantages to clinical studies is that we get access to better healthcare practices with a new drug or device. clinical studies are the most reliable way of testing whether a new drug or device…   Read more»

I think a double blind study is better or rather more reliable than a single blind study because it removes the bias from any side. In a single blind study, only the patient is unaware of what they are taking…   Read more»

I think the best or at least most effective way of marketing something is having someone famous who a lot of people know promote that product. Also, most people are on social media, so the majority will be engaged if…   Read more»

From what I noticed about Brand Coloring is that different fields use a specific color. For example, healthcare companies usually use the color blue and I can understand why since when I think of blue, I think of calmness and…   Read more»

At the moment, I am actually planning on continuing my career path into the business side with marketing getting my MBA as I originally thought that would open up more for me as a career path. My thought process was…   Read more»

I personally don’t think more business classes should be offered as required classes but definitely an option for electives. You can do so many things with engineering that you don’t always end up in industry. It is certainly helpful for…   Read more»

I think this could go both ways honestly. On one hand, I would prefer working at a start up company because there is more room for growth and learning and better flexibility. However, this could mean longer working hours or…   Read more»

I like this topic because I am actually planning on getting my MBA from NJIT right after my undergrad. As part of the BS/MS program, I had the freedom to choose which master’s degree I wanted and I chose MBA…   Read more»

People expect good quality products and as you’ve said, if QA/QC didn’t exist, there would be more flawed or faulty products on the market reaching the masses and could lead to harmful situations. Quality Assurance is about preventing issues from…   Read more»

Quality Assurance is about building processes to prevent any issues with the product is process oriented. Quality Control is about identifying issues with the product and is product oriented. Quality Assurance is preventative in nature while Quality Control is more…   Read more»

This is really thought provoking. This basically saying you either pay now to prevent any issues or pay later in lawsuits. I can see why quality can seem like a burden because it costs you. However, I think a better…   Read more»

This is a very thought provoking question! I do not believe that products that are FDA approved are 100% safe. The FDA is trying to minimize any risks as much as possible, but I definitely don’t think every single product…   Read more»

Great question! I would say clinical trials are important for medical devices to show how they perform and if they are safe and effective to use without presenting any risks. Medical devices are also user dependent so clinical trials also…   Read more»