Dr. Simon,

I did go into this class thinking it would be like the rest, but I do believe your consistency is putting up lectures and keeping them interesting was why your course was different and little bit more to my taste. As a pre-med student, hoping to enter medical school next year, I believe this course has given me a bit more…[Read more]

I do believe that this is too restricted, to go as not paying for the physician’s wife to a dinner. I believe that these companies should have some type of budget that they know they are willing to spend regardless of who is involved, even if that person was not part of the actual project. Companies can also make it clear that they should not…[Read more]

Verbal agreements can be enforced, and are constantly used in the medical field. When a patient cannot make their own decision and their life is in an emergency life-threatening situation that requires certain medical procedures, the guardian of the patient can make a quick verbal agreement in order to save the patient’s life as long as the…[Read more]

I also believe that I could do both. I believe that I have the leadership qualities to set a vision and to make sure that it gets done to completion. However, I would be more comfortable in middle management. Setting daily tasks and being organized are my strengths and I feel that each day another goal needs to be accomplished in order to get…[Read more]

I think a little bit of both would be the best in terms of creating a team. If you know who you want to work with, you already have an idea of that person’s skill set and their capabilities of getting things done when prompted to do so. However, sometimes there may be another individual that you may not know well, but who is more knowledgeable in…[Read more]

I believe when two companies team up, there needs to be some type of organization that occurs so that effective communication occurs and that the product is being developed well enough to be put on to the market. As said previously, I believe that the matrix organization is the best way to keep that good management and keep a good communication…[Read more]

As the professor says, plainly putting something on the label does not help manage risk for the user. He describes that the instructions on the packages of equipment never get read, which is true for the most part. A lot of companies can help by maybe holding seminars about the equipment and teach surgeons and technicians how to use the equipment…[Read more]

I believe that the Task Analysis and the Use Error analysis is a good way to asses product design risks. Older models tend to neglect the psychological aspects of the individual user. Also, traditional human factors methods only detect errors that just happen to occur during testing with no real systematic way of identifying or assessing use…[Read more]

Other factors should also contribute to the risk value. The EDP audit staffs usually look for both threat and vulnerability in the corporate information systems. Usually, this can take some time to evaluate. Other factors to consider would be the environment that the risk analysis is being conducted. As mentioned above by others, it is quite…[Read more]

Each manufacturer is responsible for establishing and maintained a procedure to ensure that design requirements relating to device are appropriate and address the intended use of the device. The design input requirements should be documented and approved by a designated individual. The input should require the functional and safety requirements,…[Read more]

Although I have no been involved in any industry jobs, I had the pleasure of having design meetings with my capstone group in order to create a product for an outside company. I plan to continue to work with this company and recently we had our design review meeting in order to create a specific structure and design for an implant in the body.…[Read more]

The FDA has very strict guidelines that have to be followed in order to have a device reach the market. These protocols are just standard for FDA. The device may also need to be classified in terms of a Class I, II, III device. The FDA wants to make sure that the device does not malfunction and it is used appropriately and with essentially no harm…[Read more]

I have yet to work in industry, but I do have experience in creating gantt charts in my capstone class in high school and during my undergraduate years in BME. I feel that sometimes the timelines are always off or not effectively predicted. For the next time, I have learned to meet with others to discuss how much time is needed for each event that…[Read more]

I also am taking capstone, where the requirements are the same. I am working with another orthopedics company in hopes of finding a way to create a product that fits their requirements and works well with the body. Along with customer needs, they also have specific design requirements that need to be met and created. As a result, my group and I…[Read more]

I am currently also in the BME Capstone class, as I am in my senior year. I also had to make an extensive list for the design requirements and customer needs. We met with our customer and they told us exactly what they wanted and we worked towards building the device in a specific way. We also had to meet with their design requirements, and they…[Read more]

I have also yet to work in industry, but I do have experience in creating a gantt chart in high school, for my capstone class, and again at NJIT in my current capstone class. Both times, I believe the easiest way is to color code and bold words I deem are necessary to meet as a deadline. It is also helpful to have the months on the x-axis and on…[Read more]

There have been countless amount of times where minutes served its actual purpose of re-capping what was said at the meeting and what new deadlines were established that needed to get done. Even for people that were not at the meeting, they can easily follow what was going on and what they missed and any responsibilities that they may have or need…[Read more]