As stated above, the sons would have to start a new business. In my opinion, this would be a good thing. The sons could start a partnership. The sons would probably not have to pay business income tax under a partnership and it would open the door to discuss just how the business is going to be run in dept. They would have to determine how the…[Read more]

There are a few reasons why the courts would pierce the corporate veil. One example that I wanted to elaborate on was failure to follow corporate formalities. Of the several ways listed that courts would pierce the corporate veil, I believe that this one is the most likely to effect small business owners. Due to the company being small, it might…[Read more]

I always made friends with the QA people because they had such large control over your job/project. I think them having so much power improved their relationship with other departments because if you piss them off, your job/project will probably get delayed. As I wrote in another post this week, they can stop/slow down jobs if they see a problem…[Read more]

When dealing with the quality department, I think one of the main issues I had was how much the result varies due to the person in the quality department you are dealing with. I know this is a problem lots of places due to even professionals having differences in opinion or a different perspective of a problem but there are some QA people who were…[Read more]

The most experience I have working with Quality Assurance and Quality Control is when we replaced a non-nuclear valve on the submarine. They perform a cleanliness test on the valve before installing it. It was just a simple test where right before you install it, you use water and just some paper to see if there is dirt. If there was a certain…[Read more]

As everyone has stated above, e-cigarettes and cigarettes are regulated by the FDA. I do think e-cigarettes are different than cigarettes due to lots of people I have come across using them to quit smoking. This is exactly how the FDA feels(https://www.fda.gov/TobaccoProducts/Labeling/ProductsIngredientsComponents/ucm456610.htm). The FDA feels…[Read more]

Band-aids with Neosporin bandages (the band-aids that come with the Neosporin already applied) are a combination product. It’s primary mode is it protects your wound and also helps treat it. This would be under the CDRH because it is first a medical device and it would be class 1. The regulatory pathway would be like the one outlined on slide 31.…[Read more]

I would think this is a combination drug/device. The primary mode of action would be the function of the hip stem so structural support. This would be under the CDRH and be class 3. The regulatory pathway would like the one outlined on slide 36 and 31. The pathway in chronological order is RFD, “Pre” Pre-IDE, Pre-IDE, IDE, Pivotal Trials, and…[Read more]

I would prefer to create research that helps current generations. I believe that technologies and information builds upon itself so if you help current generations, you are helping future generations as well. For example, if one creates a cure with immunology to some form of cancer (actually happened), this opens the door to use immunology to cure…[Read more]

While working at General Dynamics Electric Boat, I helped design and develop new technology for submarines. I worked with Lockheed Martin, the Naval Research Laboratory (NRL), vendors and people who report to congress for money. I was the person who brought everyone together. The way you get industry research done fast (not always the best…[Read more]

In industry, research is done based on an immediate need for the product. Unless there is a problem that has to be solved, usually the research isn’t pushed in industry. In academia, research is done based on an immediate or future need for the product. In academia, they solve problems that might be current or might be a future problem that we…[Read more]

While working at General Dynamics Electric Boat, I was given a project to develop a new technology for submarines. While testing in the Monitoring and Controlling phase of the project, we realized that the device didn’t meet certain standards. We had to redesign the device, make another prototype, and get it installed in a particular submarine…[Read more]

I think there are many challenges to doing project management for medical devices vs other projects. One of the main challenges would be that there might not be a medical device to base your work off of. Other projects have history and its easy to modify something that you know has a history of working and is documented. Medical devices are…[Read more]

While working at General Dynamics Electric Boat, I worked on several projects that had different project managers for different portions of the job. There are pros and cons to this approach. The good thing is that people are experts on their portion and have more experience and insight. This helps to foresee problems and mitigate them. The bad…[Read more]

I would argue that working in academia would give someone the opportunity to work on something that is meaningful to them. In academia, one can do research, take sabbatical, teach or write a textbook (and have the credentials to get it sold). It makes it so you have time to work on things that are meaningful and interesting to you and have greater…[Read more]

I haven’t worked as a biomedical engineer but I have worked as a nuclear engineer for 5 years. My advice would be more general. During internships and later when you work, don’t be afraid to be aggressive. I mean that in every way. Don’t be afraid to be take charge of projects, be the leader, be loud, etc. I know this might sound abrasive but I’m…[Read more]

I think the 3 out of 10 ratio for practical classes versus 7 out of 10 for academic classes is perfect. The student will pick up and learn things on the job and just needs a few classes to get him or her started. The student will never get the academic classes again so I think its a good idea for the majority of the classes be academic. There is a…[Read more]

I think “praise” and “challenging work” are connected. If people are not stimulated they will not be motivated to work on the said project and there will be no praise. I think the take away is that people want to work on “challenging work” that gives them stimulation and that they can get excited about. I believe that if you are not challenged,…[Read more]

I believe that they are disconnected because its teamwork vs. individual but I believe they are connected in a strange way.‘individual effort’, ‘making the numbers’, and ‘agreeing with the boss’ leads to ‘teamwork’, ‘achieving challenging stretch goals’, and overall ‘candor’. When the company or teamwork wins, the individual wins. When the compan…[Read more]

I believe that they are disconnected because its teamwork vs. individual but I believe they are connected in a strange way.‘individual effort’, ‘making the numbers’, and ‘agreeing with the boss leads to ‘teamwork’, ‘achieving challenging stretch goals’, and overall ‘candor’. When the company or teamwork wins, the individual wins. When the compan…[Read more]