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…   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,…   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,…   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…   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…   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…   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…   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…   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…   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…   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…   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…   Read more»