I would want start a partnership with someone who balances me. That person would have to be someone I can communicate very well with. A well chosen partner can help offset the stress that comes with running a business. A partner will be someone you know can trust because they will always have the business’s best interest at heart.

A great…[Read more]

There are a few options when it comes to passing down a sole proprietorship. It really depends on how they want to pass it along. If they want to start the process of transferring ownership when the kids are adults, they can convert it to a corporation or LLC. This way the father can retain ownership while living and can show the ropes to his…[Read more]

I wouldn’t base my acceptance on the type of company. What I am looking for in a company is good pay and experience that will help me further my career. I think that even larger companies can sometimes offer less because they have a larger pool of qualified candidates to choose from. This wouldn’t be a deal breaker if I believe that the quality of…[Read more]

As others have stated, the quality department must work with other departments in order to complete its main function. As such, it is important to make sure that positive interdepartmental relations are maintained. That means that each department should understand and respect the quality department and vice versa. Once that is established, the…[Read more]

The traditional method that QA usually does is to develop tests after the requirements have been finalized. However this means that if any issues are found the requirements must be reviewed which can lead to significant changes especially if some requirements depend on each other. An improved method would be to develop test cases during the…[Read more]

At present, Form 438 seems to be ineffective in assuring that companies to comply with the rules and regulations set by the FDA. For both cases that are stated above, inexperienced companies are companies that may be too large to keep organized, a separate third party regulator may be the proper solution. Often times a company’s own regulation…[Read more]

Recalls can be delayed to due to insufficient evidence to pull a product off of the shelves. The company itself can often be biased and try to prolong the time it has on the market to increase sales. Often, they are not reprimanded for this practice to the point that they would actively try to avoid putting out products prematurely. There is too…[Read more]

The FDA’s main priority is to make sure all regulated products are safe and effective. A device that is both precise and accurate is necessary for both of these requirements.

Often, when a device is first conceptualized, it worth pursuing if it is at least one or the other. Maybe the device only works correctly half of the time so the precision…[Read more]

I have actually been meaning to watch that documentary. I think the same question applies to the pharmaceutical industry. There have been many recalls of drugs as well, even though it takes years for them to get on the market. I think the problem lies in trying to create a universal path for getting medical devices on the market. Even with the…[Read more]

I would want to do research that benefits society sooner rather than later. However I think the research the lays the groundwork is more important. In academia, the research conducted often has similarities with research that had already been conducted. The small differences are in the approach, comparisons, duration etc. This kind of research is…[Read more]

Apart from FDA regulations and ISO 10993, it is equally important to test the material understand the different conditions it will undergo. For example, if an implant is meant to bear load (orthopedic implant), it would be beneficial to know the tolerances and the maximum limit it can handle, as well as extreme cases such as a such twisting motion…[Read more]

The key difference lies in the purpose of conducting research. In academia researchers start with a question and try to answer it. Even if they can’t answer their original question, meaningful and repeatable data make the research valuable. Whereas in industry the scientists are take to come up with solutions or innovative alternatives that…[Read more]

As many have mentioned, a missed milestone is a failure. It is important to figure out how the milestone was missed what could could have been done to avoid it. Once a plan is put in place for the next time things may go wrong, the milestone may be achieved without losing any time. After careful analysis, it is equally important to understand that…[Read more]

While working on my senior project we took care to avoid and setbacks. We were careful to order our materials ahead of time. We actually ordered 6 weeks early, which was three times the estimated delivery time. Still, our key material, a film former, was cancelled last minute. Luckily we were able to receive a very generously sized sample from a…[Read more]

I’ve had similar experiences when working on my research project. I had a mentor who had years of research experience. While some of my issues were unique in that we both didn’t know how to solve them, his experiences allowed us to quickly find relevant papers and figure out which option would work best with our situation. He also started as an…[Read more]

As many have mentioned (jr377 in particular went into detail), I believe that students should be given the chance to tailor their degree to the ratio they believe will help the reach their end goal. Of course, students will have the help of experienced advisors to navigate through which classes makes sense to complete their degree. This way a…[Read more]

As I mentioned earlier, it is helpful to take courses that introduce students to the BME field. Even for people who think they know what they want to do, they may find something else that interests them. But in the long run, it is important for students to demonstrate the ability to apply their knowledge to real life problems. These problem…[Read more]

So far people have mentioned that the BME curriculum requires the student to learn a bit of everything, making them a jack of all trades. In the short run this can be helpful. As Dkonara921 states a student can try different areas before settling on one that matches their interest the most. However, some people figure it out sooner then others,…[Read more]