A cost/benefit analysis is the process of comparing the projected or estimated costs and benefits associated with a project decision to determine whether it makes sense/worth pursuing from a business standpoint. As mentioned in the lecture this week, we shouldn’t really look into the benefit from a medical device from a price standpoint but looking at it this way helps determine whether the device is safe enough to make. Risk management needs to be carried throughout the entire process of device development but I believe that noticing the risks early and reducing the risks by changing the design would be the most efficient for the analysis. This could be because instead of allowing the risk to continue through the design and end up becoming a large issue, it is taken care of toward the beginning and allows for prevention. Taking care of the issue toward the beginning also allows the cost to be controlled because there is still time to investigate what is wrong and how to deal with it in the best way possible. If the issue was left to continue through the design, it could bring up costs because there would be the production changes and potentially wasted parts which would decrease the benefit overall. Beginning the project with the least amount of risk would create a more efficient cost/benefit analysis.

I always believe that catching the risks early is more beneficial to creating a safer and more effective product for the intended patients and customers. Finding these possible risks early could lead to a more efficient cost/benefit analysis and allow for you fix the design before it even reaches production. There could obviously been unseen risks that can be noticed later on due to a part design or a material issue, but if you try to reduce a lot of the risks early, the team would have enough budget to help mitigate the issues that arise. For the medical field, the devices that are made so that it is as safe as possible for the patient and to accept that there are some potential risks that cannot be avoided. I definitely agree it would be more beneficial to catch some design risks earlier on in the process but not every issue will be very obvious at first. 

I believe modifying the risk part is the most efficient method for cost down. However, it is impossible to create a device without any risk. Some functions of the device always accompany the risk. Moreover, some parts which seem to have no risk become risky as the project goes on happens sometimes. Therefore, I think modifying the risk, instruction, and training safeguard will exist at the same time. Since every project has a deadline for marketing, the project has to find out the risk part as much as possible in the planning stage. If the risk cost of the project exceeds the reward, the company needs to consider about close the project or restarting the project carefully.

I had mentioned this is another thread, but as others have said, catching risks early is the best way to save money. It is also the most efficient at preventing harm. Creating an inherently safer design is always safer than adding a warning label when you know there will be a risk present. That being said, if you have a product ready to be released but you notice a hazard, there is a HUGE amount of money to be saved by slapping on a sticker for warning or creating a safety training instead of throwing the product that has been made into the garbage and starting the whole entire process from square one.

I believe that noticing the risks early would be beneficial in the cost/benefit analysis. Adding a warning/label would save the company in legal battles but could backfire on them when the damage is too high. That's why project managers would hire those that have a keen eye in overlooking process just for these scenarios. 

It is quite dangerous to mix cost/benefit analysis in with risk analysis and it is not advised to do so. Here's an example of why: Changing the design is often the best way to mitigate risk, but it is often the most expensive. Adding warnings/trainings is often the least effective way of mitigating risk, but it is often the cheapest. Risk analysis should be kept separate from cost/benefit analysis as much as possible because of this. Medical devices should be made with as little risk as possible, regardless of cost. This is not always plausible but it is the standard we should strive for. Cost/benefit analysis can be done to decide whether a device should be produced but it should not be part of the risk management process once the device is being designed.