A vision statement is what the company wants to accomplish and the mission statement is how the company does its business. I think that these statements are important for a company to have because it represents what they intend to do and how they will provide for the people.

For Johnson&Johnson:

Vision: “Caring for the world, one person at a…[Read more]

I agree that social media has become a popular way of advertising in today’s society. There is also the idea where sellers involve the customers in the product production/improvement. Sellers of products now allow customers to send them comments on their product, which allows them to know what the people like and dislike. Based on the comments,…[Read more]

I think it all depends on the type of business you would like to pursue. For instance, if I wanted to pursue a company that produced medical devices, I’d want to have ownership of a C-Corp. With medical devices, you’d want to be able to expand your business, have shareholders anywhere, and the company’s life isn’t dependent on one owner. Also,…[Read more]

In order for the court to pierce the corporate veil, there must have been an unlawful situation within the corporation. For instance, if the corporations assets have been used for personal finances as opposed to using it just for the purpose of the corporation, the court might become suspicious of this type of activity. In a case like this, they…[Read more]

I agree with @asimbana, both departments have different objectives, which is why you’d find R&D and Quality on different ends. I think that they both have the right idea, and they are just doing their jobs, but it can be conflicting when it comes to the actual production and finalizing of products. These are the types of situations that should…[Read more]

I can see how people might think quality is a burden, because of all the testing and extra work that is required to make sure a product is safe. However, I do think it is necessary because like you said, its better to have a quality check in the beginning rather than the product failing and having your company lose millions of dollars. I believe…[Read more]

An example of a combination product is a cell seeded scaffold, which is used to repair tissue damages. I believe that this product falls under the CBER regulation because it is designed to be therapeutic and aid in damaged tissue, which requires clinical testing before it can be used. The regulatory processes that needs to be done according to…[Read more]

The FDA does in fact regulate electronic nicotine delivery systems, such as e-cigarettes, hookah pens, and vapes [1]. I think that e-cigarettes are different from normal cigarettes in terms of regulation because, with e-cigarettes its tobacco-less, and it contains just some of the chemicals as normal cigarettes [2]. With normal cigarettes, it…[Read more]

As the others stated above, its essential to follow the ISO 10993 table in regards to implants, or orthopedics. However, when it comes to neural biomaterials, or drugs used to aid in other areas of the body, you should also consider performing an ADME test. This will allow us to see whether the drugs have acceptable absorption, distribution,…[Read more]

One way in which research is approached in academia is that professors, post-docs, or grad students have the flexibility in developing there own idea or project. If the idea is worthy enough they are able to receive grants and carry on with their project. As for working in the industry, the company has their own ideas on what they want to figure…[Read more]

I think that the most important phase in the project life cycle is the planning phase. The planning phase is what lays out everything about the project and how to get it done. If this is done correctly then everything else will most likely go smoothly. If planning is done poorly, then its highly possible that something can go wrong in the…[Read more]

An obstacle I encountered while working on a project was not doing certain tasks correctly, and having to redo them. This ended up causing delays in completing the project because certain tasks had to get done before you can do the following tasks. Before the task was repeated a second time, the mistakes were evaluated so that it doesn’t happen…[Read more]

The challenges presented in project management for medical devices compared with project management for building a school or skyscraper, is that products or treatments need to be reviewed several times before being used or sold to people. This ends up taking a very long time for the product itself to be available. Because medical devices is…[Read more]

I agree, I prefer the industry over academia. Although I do not have experience in industry, I do have experience in academia and I have found myself working very hard when it comes to research. There were days where I spent about 10 hours in lab trying to produce data, and sometimes its not always successful and you find yourself at square one.…[Read more]

I don’t think that this a good ratio because students should be more prepared for the industry when they graduate and leave school. Academics is great and is a good bases for understanding the concepts of medical device, but learning theories and having the knowledge of it isn’t enough. Without practical experience, you are basically being…[Read more]

The argument I’d present for working in Academia would be time flexibility. In Academia, you have the leisure to work on projects at a time that is easiest for you, rather than a fixed 8am to 5pm schedule everyday like in industry. I have experience working in Academia and I’d say that this was the greatest advantage I had. I’d walk into the…[Read more]