I do not necessarily think that there are advantages versus disadvantages to these two documents as they both offer very crucial yet distinct purposes. The Design Input Document serves to provide the basic customer needs while the Design Specification Document includes the specifics of the device. However, there must be a DID for there to be a…[Read more]

Design inputs are mainly customer needs. An individual can come up with an innovative idea for a medical device, however it is the design inputs that will ultimately dictate what goes into the device itself. These design inputs are basically the desires of the end users. Dr. Simon gave us a great example of a design input: “a red door knob”. That…[Read more]

The quality of a product does not necessarily depend on how many regulatory rules there are. One can require hundreds of rules on a device yet produce a very low quality product. I believe that the steps and precautions taken during production of a device is the ruling factor in if it is of high quality or not.

With the EU having less rules, the…[Read more]

I do not entirely agree with your argument where you say that meeting minutes are not cared for by the people at the meeting. Whenever my capstone group meets with any advisor, we always have some sort of document open, documenting any comments/suggestions given by our advisor. And when it’s time to make revisions, we almost always refer back to…[Read more]

For certain experiments, I think placebo controlled trials are beneficial in helping researchers investigate the affects of a drug. Placebos are usually used in comparison to the experimental drug and act as a control. Say for example there is this new drug that can alleviate the effects of a migraine. An ideal study would be to have subjects…[Read more]

My neural engineering professor, Dr. Alvarez always would mention her lab using “double-blind” procedures in her experiments. She always stressed how efficient this method was at eliminating any type of biases between the researchers and their subjects.

A double blind study prevents the subject from knowing the treatment they are getting, while…[Read more]

I had also researched Zimmer Biomet and came upon similar statements.

First of all the mission and vision statement must be discussed and differentiated.
Many people can confuse a companies mission and vision statement yet they are both distinct yet co-related simultaneously. A mission statement is a clear and concise statement that defines how…[Read more]

The color choice used in branding can evoke different types of emotions and judgments made on the company subconsciously, which can ultimately be the determining factor in whether you spend your money on a product from that specific company. I have noticed that many medical device and healthcare companies incorporate colors that are pleasing to…[Read more]

Recently, many companies have come up with very strategic and clever ideas to market since push marketing is declining. I have noticed that many of these techniques involve a two-way communication system where the company that wants to market their product or business will hold attractive events in return for a follow/like on one of their social…[Read more]

I feel that if I were to come up with an amazing idea for a business, I would start up a Limited Liability Corporation. I feel that this has more benefits and advantages than disadvantages. The biggest reason as to why I would start an LLC is due to the fact that there is a limited liability. The owners will never get “their house taken away”…[Read more]

I definitely agree with you on selecting the right person to start a Partnership. I have seen a partnerships fail numerous times. There were various reasons as to why they failed, but the most common reason for their failure were lack of communication and responsibility. These are two very crucial things needed to run a business, and without them,…[Read more]

I decided to research Audi Group. Being one of the top automotive companies in the world and owning one, I thought it would be interesting to see how the company I have invested in is doing economically. I found a 10 year financial report that offers 10 years worth of financial statements since 2008.

Just from looking at how many cars they have…[Read more]

Although I do not have experience working in a medical device company, I do have experience working closely with an EHS specialist (environmental health & safety) during my internship a few years ago. This role ensures the safety of the employees through observing the behaviors and procedures practiced in a laboratory. They also perform audits,…[Read more]

Now think about people in the world, whom you will meet, that complain about Quality and how it’s a burden. Thoughts?

Those that complain about QA/QC are not the ones that should be in charge of such a role. Quality control and quality assurance is valuable and essential to a company in preventing any legal issues occurring. Through simple c…[Read more]

Many people may have heard of the recent recall on Sonic-Fusion’s flossing toothbrush. Just recently, this toothbrush was recalled due to “localized melting and sparking of the charging base.” There was an increasing amount of consumers reports of this malfunction, totaling to 3,800 units within a year. Many of the consumer’s had stopped using…[Read more]

In response to the question,”What effect have human differences had on you as a being productive or counterproductive?”, I believe that working with a diverse group actually allows for one to be more productive than the opposite. From my experience in working in collaborative group projects, I have found that the most of my successful projects…[Read more]

Choosing to work in academia requires one to enjoy working in the lab and doing research for most of the career, and possibly teaching. Working in this field does have it’s perks as one’s hours are flexible.

Choosing to work in industry is much different. This requires a whole different setting as well as a whole different environment. Like many…[Read more]

I believe that when it comes to animal testing, there should be ethics involved when choosing the animal to test with. From the various responses of my classmates, many have mentioned researchers come up with the least painful methods of testing. Animals from the primate family are ideal for testing due to their closeness to humans. However, many…[Read more]