When I first saw this class I thought it was going to be about medical devices and how to build them. But I had no idea it was going to be an entire course on how the real world would actually be. This class has opened my eyes to exactly what I want to do when I start my life in the real world. As we said in the beginning of this class, academic…[Read more]

I agree that in the real world not everything will work out the way you want it as in working with people you are friends with. But it is also important to work with people who you know you can get along with or have good people skills. If people in your group do not know how to work or have a professional relationship this can cause a big problem…[Read more]

Since we are doing project-based organization it is very tough to answer this question. As the teams were made the project managers were given little time to go around and talk to each department and explain their project to them. Also the project managers only learned of the project right before they had to explain it to the departments. So it is…[Read more]

My team has had our first in-person meeting this week and we went over the gantt chart and what exactly needs to be done first so the rest of the project can get going. For example the DID which is actually my part because I am the marketing department on my team should be done first so that the regulatory person can get started on their parts.…[Read more]

I agree with the idea of showing the buyers how to use the device while selling it to them. Companies cannot rely on the techs or even the surgeons to sit there and read how to use a device so the best way would be for the companies to actually teach the techs or surgeons how to use a device. Doing this can now take some risk away since the…[Read more]

I do understand what you and Dr. Simon are saying but I get confused when it comes to situations the company cannot control. For example, medicines such as Tylenol or Advil are sold to the “normal” public which are not usually a group of pregnant women. So it should not be the top priority of a company to make Tylenol safe for pregnant women to…[Read more]

I understand the point Dr. Simon, but I would hope the surgeon and the techs know the risks of each item they use. They do not have to read it in the middle of the surgery but they should prior to surgery. I agree that it should not be the first resort for companies but as jnm22 said for example with medicine the companies explain on the label how…[Read more]

I agree with this point. When it becomes too much for the company they use the design controls as something they just need to get done, they do not use it to benefit their product. It becomes tedious work instead of benefitting the product. Then they begin to rush because they just want to get the paperwork done and they do not focus on actually…[Read more]

I have not created a Gantt Chart in industry but I did have to create one for my Capstone class at NJIT. I also had to create one very early on in the project and I believe this made it more difficult especially since Capstone is a two semester course so I did not actually know the exact deadlines for Capstone 2. The only dates I was sure of were…[Read more]

I am currently in Capstone 1 at NJIT. The business requirements document is very important because it is takes the customer needs given to us and puts us on a path to create a product. I do believe that all medical devices do go through these steps because it is a great way to make the best product. But almost every time the best product is not…[Read more]

I believe they are both necessary because they help you take action. These documents basically tell you what you will be building. With these documents technically anyone should be able to build your product. They both work off each other as was stated the DID is just a broad description so they are not any numbers or specifications. The DSD has…[Read more]

I have no had experience in making a Gantt Chart in industry yet but I do have to make it for my Capstone class. It seems very helpful but it also seems very stressful. From my understanding of it, the most important part to get out of it is the critical line. But I do not fully understand what that line is for. Is it where we should be in the…[Read more]

My experience with minutes for meetings was in a non engineering setting. I was a secretary of a church group and I had to write down the important dates we went over in the meeting. This was mostly done so it could be sent out to the two representatives from each church so they can give the information to the church. It was very helpful because…[Read more]

I agree! Placebo trials are important because we need a result that is not going to change. With this result we can then compare the other results to it to see if the other factor is useful. I do not see a problem with having a placebo trial I think they are very useful. I do not see anything wrong with it, I do not think it is unethical. It is…[Read more]

I understand that in a single blind study the investigator knows what is being used on the subject and that can cause a bias but in the double blind study who knows what is being given to the patients? That might be an easy question but I am still confused as to who would know what is being given to who. For example if you have the pill you want…[Read more]

I agree I do not believe a clinical background is necessary to work in this field. Engineers that have gone through the 4 plus years and are strong in their field should be able to get these jobs without clinical background. I do understand that engineers may not know how to communicate well with doctors or even the patients but this is a trait…[Read more]

This is so true because the more the video is shared on the facebook the more people will see it. Within a couple of days videos on facebook have millions of views. Social media is the easiest way to advertise lately because almost everyone has social media. No one will get rid of it just because of advertisements.

I agree that talking to the customer is a great way to market. It is the best way actually because as much as we want to make the best item we also need to know the customer needs. So for example if you are creating a medical device you need to know how the customer or the surgeon will use it. You need to know what it is for and how it will be…[Read more]

One clever way of participation that I noticed and it actually worked on me is through social media platforms such as facebook, instagram and twitter. They do not force the ad on anyone but it just pops up. Especially an ad that pops up multiple times. For example I was scrolling through instagram and I kept seeing the same ad for a game called…[Read more]

I agree working in a partnership would not be preferred. I say this because you will not always agree with your partner this can cause the partnership to go down hill at any moment. All this risk is taken on by the owners especially because funds come from their personal funds. Debtors can go after the owners personal money and lawsuits can go…[Read more]