I believe that written contracts are favorable to verbal contracts because of how much easier it is to enforce and defend that contract. With everything written out, anytime a potential issues regarding the contract arises it is far easier to go to a written agreement than it is a verbal agreement. Documentation is highly stressed in the…[Read more]

These restrictions do seem very harsh, but I believe that they are necessary to maintain an ethical business environment. In the case of not being able to pay for dinner for the physician’s wife I think it is important to keep the relationship with the physician strictly professional and paying for his wife’s dinner may not seem like a big deal…[Read more]

I think completion between teams can often be beneficial as long as that completion is healthy and friendly. The key I believe in staying away from negative completion is strong communication and collaboration between departments. A closer knit work environment is less likely to develop unhealthy negative completion than when departments have…[Read more]

My current position is in a functional organization where each department team has a functional manager to whom other team members report to. I think this style work well for us as each department needs to concentrate their focus on certain activities and having functional managers to report to makes it easier for a team to work together and…[Read more]

I think I would be more suited for choosing upper management, but I also think I would be able to work in middle management as well. I also agree with the assertion that upper managers should spend time in middle manager roles because that role could be a real eye opener for an upper manager to understand more about the company. I think that an…[Read more]

Risk-benefit analysis is an important consideration for a product. Part of the risk management framework is to decide what risks that you are willing to take with a product. It is important to identify what kind of risks that you are willing to take and which risks, if any you will take. This is when risk-benefit analysis likely comes into play…[Read more]

Risk factors depend on variables such as the severity of the risk, likelihood a particular risk occurs and the types of risks that they are willing to take. The severity of a risk can be severe, critical, significant, or minor and the frequency can be frequent, infrequent, or occasional. The combination of these two variables can show the level…[Read more]

I agree that the phrase “as far as possible” is broad and difficult to quantify. Because there is no way of knowing how many risks that may exist but haven’t been identified. Because of this it isn’t possible to reduce risky 100% or by any percentage. Without being able to quantify the reduction in risk I think that the phrase as far as…[Read more]

All parts are very critical so it is difficult to say which is most important but I’d like to highlight the team member list/responsibilities section. For the project to move slowly assigning the right team members to the right role is an important way for the project to move along successfully. This makes it clear which team members you need to…[Read more]

The only medical devices used outside the body that likely wouldn’t need clinical trials are probably low risk devices where there are already substantially equivalent devices on the market such as gauze, stretchers, walkers, surgical masks, stethoscope, or a gait analyzer.

In my experience with design reviews during my undergrad capstone we had weekly meetings with an advisor and a customer to discuss progress made in the past week and any new concerns. The meetings themselves typically started out by going through a status report that as prepared before the meeting that addresses any milestones meet or missed in…[Read more]

In most cases I believe validation and verification may be necessary especially in medical devices. Verification and validation together prove that a product is safe and that it meets its requirements, specifications, and is used as intended. The purpose of validation is to make sure the product meets its business needs from which the…[Read more]

I think design input can come from many sources including customer/client requests or observations, team members raising their own observation. Design inputs are defined allowing development to proceed after ensuring that all the requirements have been met and that the product has its desired function, and is safe to use in its intended function,…[Read more]

I took BME capstone during my undergrad at NJIT and the requirements document and test plan documents are both things that I’ve seen and worked with since I started working. When I worked in a test analist role I was required to read and understand all requirements pertaining to my module. The requirements came from different findings from…[Read more]

When I worked o nay undergraduate capstone project in order to get approval to do testing on human subjects we needed to fill out IRB application and present the project and test cases involving the use of human subjects to NJIT’s IRB and it was up to them whether or not to allow someone to go further with human testing. Given the risks of human…[Read more]

I think that placebo controlled studies are ethical and also very important in clinical trials. Placebo studies are important to the study because they can be compared to the results of the drug and without any other factors differing besides the drug show the true difference that the drug makes, if it makes any at all. From an ethical…[Read more]

There are positives and negatives about clinical trials, but I think that clinical research is important and needed in medicine and treatments. The biggest negative on clinical trials is the possibility that something goes wrong and one of the subjects experience serious adverse effects. There have been cases were people have been greatly…[Read more]

I think social media has become the most common way of using participation. Participation is an important consideration along with the 4 P’s because a company needs to be able to quickly engage a customer in wanting more information on their products or services. It has become more difficult for companies to do this through advertisements…[Read more]

Emotional intelligence is the ability of a person to identify their emotions and then manage and regulate their emotions. EI also includes being able to identify the emotions of others and manage interactions with them based on the emotions they identified. You can know if you have EI when you are able to pick up on your emotions and realize how…[Read more]

I think that this company with $10 million in revenue would fare best as as INC as opposed to and LLC. For this company being able to issue shares of stocks to investors is an advantage that an LLC doesn’t offer. Lowering taxes by splitting income is another advantage this company can gain by becoming an “INC”.