It’s definitely a delicate relationship between quality and R&D, but as long as you all understand the common purpose nothing is truly impassable. I have had to work with the J&J quality team specifically regarding the claims we make on our products. I was in charge on writing the documents in which we had substantiations for any claims we made…[Read more]

Although it is cynical I think there exists one reason and one reason alone that companies do not strictly follow the FDA guidelines and do not change their protocols, money. If we continue with Dr. Simon’s analogy of the speeding ticket, yeah it hurts the reputation but people are very quick to forget and there is so much money to be made that…[Read more]

In my role at J&J I have worked heavily with many different types of documents. The easiest way to improve document control is to make sure that everyone understands what the documents are and why they are important. When I first started at my position I was eager to learn a lot about the function of the company, so I spent a lot of time talking…[Read more]

Any medical device must be both accurate and precise. Lets take a simple blood pressure cuff. If I put it on my arm and test it 10 times there should only be slight differences between each of the measurements. The device must also be accurate. This is important for the FDA because if they are approving a device to be used on or in the body then…[Read more]

I don’t know much about drugs being banned in different countries but available here in the United States, but I have some experience with ingredients that are banned in certain countries. I work for J&J consumer R&D and when we are developing a new product we have to make sure that the ingredients we use will be considered safe in any country we…[Read more]

The balance between safety and speed through the system is something that is hard to balance, and whilst I think the process takes too long I would much rather a system that takes longer but makes sure that the products that are released are safe, rather than have a system where things can get cleared faster but might be unsafe.

There are other…[Read more]

I have a bit of R&D experiences in industry, but it is not inside the lab. I do work closely with those in the lab itself, so I will talk a bit about that. The time given is a great deal less than in academia, but the access to varied resources is much greater. I work for J&J Consumer. I have spent a great deal of time talking to someone creating…[Read more]

I believe that animal testing is a necessary evil. I worked in academic research where I studied traumatic brain injury. Whilst I worked with models that I made, some people in the lab worked with rats to study the effects of blast trauma on brain tissue. As much as we do not want to do it, it is a necessity because we cannot study on humans. But…[Read more]

I have conducted academic research and now work in industry research. The major difference for me is the end results. Academic research always puts out new knowledge and whilst there are time frames they are usually a lot longer. When I was doing my research I was given the topic to investigate and a time frame that was was much greater than what…[Read more]

Due to the nature of my co-op I have worked with a number of project managers. They have all had different styles, some good and some bad. The worst I have worked with was purely focused on output and would not help in getting there. They would send emails demanding where parts of the project were without asking how she could help to get whatever…[Read more]

I agree with what a lot of people have said here, in so far that the best managers are those that can blend their managerial and engineering skills to benefit the project. Having someone who is great at the managing but cannot understand the technical part of the project is pointless as they wont be able to communicate the importance of the…[Read more]

I think the executing phase is the most important. A lot of people believe planning to be the most important. It is but one cannot plan for all the eventualities and problems that will arise in the project. But once that project makes it into the execution phase then it becomes critical that those who are in charge of the actual execution of the…[Read more]

A mix is definitely an necessity, but I think the courses cater more towards different end goals. In my opinion those practical courses teach you skills that will be more beneficial if you want to go into industry and the academic courses teach you more about things that would help when doing research in a lab. Lets compare two classes, this one…[Read more]

It seems that the two different paths would attract people who are of different mind sets.

The argument that attracts me to academia is being on the cutting edge of new knowledge. Being the first person to discover something and to be able to publish it under my name is something that sounds quite nice to me. But I have spent some time working…[Read more]

The diversity of the BME degree is definitely a double edged sword. On the one hand it shows that you are capable of learning many things that are only tangentially related, but it means you are a master of none of those things. This can be good or bad depending on who is hiring. If the company you applied to is looking for someone with a variety…[Read more]