Sometimes the tasks do get a little overwhelming in a matrix organization; however, with proper communication and task allocations, it can run a bit smoother and not seem like so much. Meetings also play a huge role in the success…   Read more»

It should be a given that in forming a project team, each member should contribute something valuable to the project. I also think that the team having a good relationship is a plus but it is important that everyone is…   Read more»

There is a tremendous difference between written and verbal agreements, especially in a legal sense. In the court of law, verbal agreements essentially pull no weight whereas written agreements offer hard evidence. I would say that people should not rely…   Read more»

There are risks associated with everything; however, it is important to determine if the benefits outweigh those risks enough to decide on if it would be worth it to accept the risks. With devices that have higher risks, I think…   Read more»

I think that risk management is a vital part of the planning phase in the medical device industry. I also believe it is important to monitor risks throughout the post market phase as well in order to ensure patient safety…   Read more»

Implementing a risk management assessment for a device can offer many benefits. For starters, it can allow for possible improvements to be made in order to minimize the risks. It also allows the team to get ahead in identifying side…   Read more»

Debating between the documentation process and the verification process, I think the verification process is the most important in design control. I say this because checking the product before it goes off to production determines if the product is ready…   Read more»

The design control process is extremely important in the medical device industry. While it may seem like a never ending process with many steps, each step is imperative to ensuring the medical device makes it to the market. By not…   Read more»

While I do not have any experience in the industry working with verification and validation, I have learned a lot about the processes in this course. Verification is the check phase of the design control process, which checks if the…   Read more»

Personally, I would choose CRO. From research throughout my job search, I did not particularly like what I saw in Big Pharma. While the earnings and benefits may be more, I feel like there are other areas in which one…   Read more»

The purpose of clinical trials for pharmaceutical drugs are not necessarily to find a cure for illnesses, but to ensure the safety and efficacy of the drug in humans before it reaches the masses. It is also important for identifying…   Read more»

I have mixed emotions on the implementation of the Right to Try act. On one hand, it sounds like a great idea to present those with life threatening illnesses an opportunity to utilize medications in their early clinical trial phases…   Read more»

In the job search process, I think it is extremely important to research the company’s mission, their financial history, revenue, stability, and reputation. I say this because I believe it can have a huge impact on your individual experience on…   Read more»

While reading this question, I started thinking of the colors of the companies that I interact with the most on a daily basis. I also googled what those colors meant and believe it is quite interesting, especially seeing how they…   Read more»

In the 21st century, another P has been added to the 4 P’s marketing strategy. This is participation, which has increased as the “push market” has declined and addresses how customers are now in control and that marketing must interact…   Read more»

My dad always tells me that you get what you pay and prepare for. I use this advice in everything that I do and believe many people should incorporate this in how they maneuver throughout their work and personal lives….   Read more»

While FDA approvals have their benefits in maintaining public health and safety, I do not believe it guarantees product safety nor do I believe that non-FDA approved products are guaranteed unsafe. As you mentioned, we have seen products that were…   Read more»

One product that I found is the Neuro Omega System from Alpha Omega Engineering. The purpose of the device is to assist neurosurgeons in identifying brain structures during functional neurosurgery and to aid in the placement of depth electrodes for…   Read more»

Because of my experience working in academia from an undergraduate/graduate research perspective, I would much rather work in industry. While I have an inquisitive mind and love the process, it can become exhausting to a certain extent because there is…   Read more»