I believe my answer would change based on the characteristics of the company I am looking to start up, but in general I would be most comfortable starting up a Limited Liability Partnership (LLP). The advantage I see with the LLP is that there is less liability on each individual such as myself because there are more owners, but there are not an…[Read more]

The difference between private and public companies is that private companies do not trade their shares and stocks to the public, so they can maintain all of their finances internally without having to submit financial reporting for their investors to look at. They also do not have to deal with Securities and Exchange Commission, which means less…[Read more]

A good way to improve relations with the Quality department and other departments such as the R&D department, is to spend more time in the planning phase. Here you can create a more detailed outline of what is expected from each department, what each department will do and what risk and problems each department may run into. If you can anticipate…[Read more]

I do not think that Quality is a burden and that companies should focus on hiring the right quality personnel so that they do not need an excess of quality employees. Without Quality a company puts a lot more stress and pressure on themselves to make sure that on top of their own jobs, that quality methods and regulations are followed as well as…[Read more]

I believe that both departments are necessary and need each other in order to work. Quality is very important because it helps with FDA regulations and making sure that the company and the employees do not get sued or fired for not following regulations and not following the management process correctly. R&D works with making the products that the…[Read more]

Yes, the FDA currently regulates e-cigarettes as well as all tobacco products. May 5, 2016 was when the FDA ruled on electronic cigarettes.…[Read more]

In the medical device department I think that accuracy is making sure the device will perform the necessary actions that it is set out to do, and precision is making sure that the test results you get are consistent with each other and that you are not getting any extreme results or findings in your research. Accuracy is important because if a…[Read more]

From my past experience working at two different medical device companies it always seems that the FDA is extremely tough and is very difficult to work with. I do think that FDA is slowing down the process by dragging out different stages of approval and testing. However, I do not think that FDA is being too strict. When it comes to medical…[Read more]

In any situation like this you should guard against pitfalls such as budgeting. With a lab so far away it will cost more money to visit the lab and to meet with the laboratory members for meetings. You should also generally guard against time to make sure that your project will finish before the end date or close to the end date that you have…[Read more]

I would rather do research that will affect the current generation. With current research you have a defined end goal that you can work towards, so you know if your research work is heading in the right direction or if it is heading towards a brick wall. When doing research to help future generations you do not necessarily know if the research…[Read more]

From my personal views I believe that animal testing is necessary for scientific research especially in medical devices, where the devices will be implanted on humans. At this time there is no simulation that can show how the medical device will truly behave in an individual so there must be an alternate form of testing that can prove that a…[Read more]

From my previous internship experience I had multiple managers when working on my project. This lead to some conflicts as the managers were not always up to date as to what the other manager had told the team to do or they were unaware of the stage in the process they were working on. With too any managers, information can get lost and may not…[Read more]

Give an example of a time when you encountered an obstacle while working on a project that could have resulted in not reaching the deadline.
What phase of the project life cycle should you have focused on more to have prevented this issue?
How did you overcome this obstacle and what did you do to keep your project on track?

During my Undergrad at…[Read more]

I do think that the Planning Phase of the Project Life Cycle would be the most important phase of the project since it determines the outcome of the other phases. Poor planning can extend the time it takes to complete tasks in a project or to complete the whole project. With poor planning a project can fail do to budget failures that were not…[Read more]

Arguments that go in favor of Academia is that it gives you more security with your job position since you have the ability to gain tenure. This takes off a lot of stress from worrying about losing your job due to budget cuts and the company needing to release employees. Also, it allows you to do research into the topic that you care most about…[Read more]

If I were to give advice to Biomedical Engineering students I would say to get involved in research as soon as possible. This will give you critical hands on skills that you may want to use later on in your field. It will also help develop a solid resume that you can use to get a better internship or job later on. I would also advice them to not…[Read more]

I believe that there should be a ratio of 6 academic classes to 4 practical classes. At the graduate level a large majority of the courses you have taken already have been focused on academia. Academia is very important to set a base of knowledge that you need to know in order to apply it to practical situations. However, once you get into the job…[Read more]

When looking to decide if we should outsource work and let a CRO do it you must look at your technical and time availability. If your project team is running really behind on schedule because you chose to take your time, then it may be best to outsource your work so that you can finish your product on time and not lose any more sponsorships and…[Read more]

Project management techniques are different for different sized companies because bigger companies have a lot more workers to take care of and a larger budget that could potentially be wasted or misallocated. Even though both companies will have project managers or functional managers looking over their team, bigger companies will have more…[Read more]

When preparing your budget for a clinical trial you need to first have a well defined schedule broken down. The schedule should be made first so you can see where money will have to be spent at certain times and then you can budget to make sure that you will have adequate money at that time. To prepare the schedule I believe you must allow ample…[Read more]