I think the consequences of risking the project with poor experimental data are much greater than any time delays. If poor experimentation fails to uncover a particular design issue or if it is not accepted by appropriate regulatory agencies, then the delay to the project would be much greater than the alternative.

In a situation where the team is in turmoil and arguing about how to reach a proper solution I believe it is best to form a platform on which everyone is able to communicate with each other. This process should not be rushed as members will be angered by decisions that they do not all agree on. It is best to take more time so that all members can voice their opinions and if a decision can not be reached after the extended period of time then a majority decision should be used as it is not practical to waste time on a discussion that will remain in a deadlock. When looking at whether to shorten the time for an experiment I do not think it outweighs the results that can be obtained from a correctly run experiment. When a experiment is rushed more mistakes are likely to happen, which can then cause the project to take even longer to conduct. Also, if poor results are produced than they can not be used to verify your product. I believe that a couple weeks added onto a project is worth it to make sure that the product will pass all of the necessary specs set out. If too much time, such as an extra month is added than a lot of money and resources will be used that can be allocated to other aspects of the project. Also, a medical product can cause serious injury to the user if not designed correctly. This can cause major problems down the road if users are unhappy or are getting hurt using your product. It is better to take the time and make sure your product will be perfect to ensure commercial success.

I think those were very good points mentioned by cs22 and msc52njit-edu. Although I do agree that it can be more beneficial in the long run to delay the project in order to fully resolve an issue, I do think that in some scenarios where the company is developing a new technology and speed to market is critical to the success of the project, a significant delay may render the project useless, and in cases like these it may be appropriate to increase the project risk in order to keep the project on track. However, when this is the case, it is very important that the team understands exactly what the risk is to the project, and not only that, they need to be have a plan in place to handle the additional risk.

I agree with everyone stated above that the project team should be open to communicating on a consistent basis. Communication is key because any issues that arise or may arise can be solved or addressed during meeting times instead of having it come up later towards the due date. I also agree with my colleagues that the project schedule should be pushed back even though upper management might disagree however a good case for that would be a better end result instead of having butchered results. However, sometimes that isn't the case and the project will still need to get done without extensions. Communication, in this case, would help to allocate best the most priority tasks and resources to those tasks in order to complete the project. Projects may need to be rushed if let's say an equipment/process is running at risk which would definitely need to get done immediately as it is a potential violation.

Increasing project risk should be avoided as much as possible. In the mini-sim example, decreasing the animal experiment time would be very bad. From these studies we will see how well the product performs and observe any negative reactions that the product can potentially cause. If we decrease the time we may miss something important that could derail the project and I agree with cs22 that poor experimental data are much greater risks than any time delays. If we have to increase risk in a project it should be limited to something less important than experimental data, like manufacturing volume or something.

Also if a calm and productive discussion doesn’t provide a solution then it will be up to you to decide what to do next. Gather all the data you can and make the best possible call on what to do. Sometimes you have to take charge and put your thoughts before others and make them adapt to your decision whether they like it or not. You have a project to run so decide on the best course of action and go with it.

I don't think there are many cases where it would be acceptable to increase project risk to shorten the time duration of the project. Depending on the project adding more risk to an already moderate to high risk device could be the tipping point for the harsh consequences of a risk potentially going wrong. Adding the extra risk just to shorten the time frame of the project could be a moot point if the increased risk adds time to the project in a different way which is a real possibility.

I don't believe that shortening the time span is worth increasing risk. I understand that in some cases the time span must be decreased for emergency reasons, but at the same time, if the project fails, then the project will be prolonged all over again. The team will have to compensate for their rushed and insufficient work which would overall defeat the purpose of shortening the time and more money and resources would be wasted.

I think shortening the time frame will ultimately increase the project risk which is not a good idea. Risk management is an integral part of the medical device product development life cycle. It helps medical device developer ensuring that the product is reliable works as expected and causes no harm to the end users. If the end product that is the medical device is not meeting the expectation of the standards then there no use of decreasing the animal testing it will cause product recall ultimately. The efficiency and the output of the product will not be known. I think adding more time for testing and experiment will achieve the expectation of the product performance. The time should not be too long for the animal testing as it will be waste of the resources.

I think that mitigating risks is more important than reducing the time needed for a project. As Dr. Simon mentioned in the lecture when reviewing the project proposal, a coated hip stem may take 10 years before it hits the market, and he also mentioned that a risk plan where 2% of the product fail, would never be approved. Imagine having a product that you spend 10 years of research on and then it gets shut down because of the risk management plan. It is better to take your time and prepare and administer the appropriate tests to mitigate as much risk as possible.

I think a cost-benefit analysis is important to answer your question. Will the risk cost the company more than it will benefit it? Or vise-versa? If the benefit is greater than the cost than the risk should be taken due to the higher expected benefit.

Delays in a project can be a major factor for the failure of it. There are multiple solutions around this however. The solutions are specific to what the time delays are caused by. But in general, most unexpected delays can be solved by getting inputs from team members and collaboratively thinking of a solution. If that doesn't work for whatever reason (maybe the team doesn't have enough experience, etc), the team should reach out to different teams within a company or seek outside help.

Pertaining to the second question, the time for a project experiment should never be shortened for the purpose of efficiency. It is better to extend the timeline of the project and have more accurate data than to shorten it. This will ensure the success of your project in the long run. Sometimes it is better to shorten the experiment if its a repeating experiment. But the experiment should be repeated enough times to ensure that its shortening will not have an effect on the outcome.

Time is an important factor in any project because extending a project not only makes it more expensive but could also lead to a competitor putting out a similar product before you could. To shorten it in order get it done faster can lead to problems down the line. If all the risks of a product is not fully understood before it reaches the market it can be the difference between costing the company a couple extra thousand to people getting hurt and potentially dying

I think both time and risk are important, but if I had to choose losing a project or getting law suits from harming the public, I would choose increasing testing time because safety is number 1. I could not be able to reduce the time because quantity is not everything, but quality is. The product needs to be done the right way because someone can get hurt and even the company can be shutdown due to the incident. I would honestly extend the time because comparing the cost of a law suite due to death vs extension, extension would be less. The company will benefit from extending time because they can make it up in selling a good product that won't harm anyone rather being shutdown from a bad product.

If the discussion doesn't produce a solution, then it should be tried again and again until it does because the project team is responsible for everything about the project. It's important for them to have efficient communication with each other. If there are arguments and tensions between members, then it must be resolved by reminding people that they are on the same side and if they can't work together, the team will suffer, which is why one person must suffer by being asked to leave. Risks should be minimized to very low numbers. I disagree that shortening the time frame is worth the increase in risk because, in this case, without sufficient time for the animal trials, the validity of the results will be questioned even though you may have yielded great results. Minimizing risks is always a must, which is why there is such a thing as the Quality Department. Shortening animal trials is not worth it, because even though you may have saved time, your findings could get rejected later on, and that will be much worse. Therefore, it's better for you to put in the time and work early on so that the risk will be kept minimal. It's not worth increasing risk because you will be worrying about it throughout the project if it's so high that it will set your project back.