From my experience there is not necessarily a risk/benefit ratio, but rather the company performs an analysis where they weigh all the risks and compare them to the benefits and make a decision whether or not to proceed with the project. Often they get a clinician's input when making this determination as well. However, an output of this analysis could be that the risks are too high, which means either the project will be stopped or will not resume until there is a plan in place that will reduce the risk to an acceptable level.

I think Risk/Benefit ratio is something only used to decide at the beginning when the company has to decide whether or not to go ahead with the project. Whether the benefit is worth the risk or is Risk to high for the benefit the company will make. It is something really important for a business to survive.
Other Risk we talk about is what risk does the medical device manufactured poses and this are risk which needs to be tackled if not removed. This risk needs to identified from time to time through out the project management phase.And this are the only one which can be reduced.

I think that the risk/ benefit ratio is used throughout the product life cycle but not in cooperation with the risk management process. The risk management process is for aspects that are going to happen like coatings and packaging. They will be used but they may be altered to lower any present risk if the risk is high. I think that the risk/benefit ratio is used to decide if something is going to occur or not. As someone stated before deciding whether or not a project is going to be worth it for the company. It is also used when determining if clinical studies are worth the physical risk to patients.

This topic brings to mind the end of any commercial and how there is a long list of things that may happen based on their statistical analysis. For devices, their risks seem to incorporate an entire warning’s page (or something of the sort). I can think that the only reason why the product is on the market is because the warnings, or risks, scarcely happen and worth the benefit they bring over the potential danger. I think companies should always have this risk to benefit ratio. In the beginning, they can use it to determine the fate of their product (to continue with it or drop it). Then it can be used throughout their research to meet guidelines and regulations. I think this falls on both the risk management and project management responsibilities.

I think this raises an interesting point. As many people mentioned, risk is an essential part of the planning process and deciding if its worthwhile to pursue the project. Yet how exactly is the risk/benefit ratio determined? Is seems partly mathematical and partly human/instinct based. For anyone who has been involved in risk management and the FMECA/PMECA, how are these decisions made? Is an actuary involved to help calculate risk? Who ultimately decides how much risk is acceptable?

Risk analysis is crucial for medical device companies. Medical device companies has to be safe and service efficiently. I do not think there is a specific ratio, because the less risk companies have or more awareness the companies know about the risk, the more beneficial. I think medical device companies that have class III devices have to be more complaint, because remember companies do not want to lose millions in recalls or lawsuits. The more money they have to give up less beneficial the product will be.

I think that the risk/benefit ratio is something that is looked at throughout the entire project and it is something that is consistently changing as the project moves along. As every action will carry a risk/benefit ratio it is important to look at how one ratio can affect a ratio later on. It is also means that different risk and benefits are weighed differently. You have to combine all the risks and benefits together to get an accurate ratio and can not just analyze one or two aspects of the project. Ideally you want the ratio to be as close to zero as possible so that your benefits will greatly outweigh the risks. By constantly analyzing the risk/benefit ratio you can see how the project is changing over time and you can possibly identify trends as to how the ratio will continue to change based on how the project is going and what is next to be done.

To me, risk/benefit ratio for a company mainly comes down to money. For any company that wants to create a high quality product, cutting corners should be kept to a minimum. However, there are certain specifications that can be made that will have the benefit of keeping costs down. One example would be designing a device that is only meant to last for 10 years instead of going with a more expensive material that can last 20 years. Choosing a material a cheaper material may come with the risk of breaking more easily or even degrading into toxic microparticles if it is an implantable device. Choosing a longer lasting material also involves some risks. If the device lasts so long that there is never a need to replace it, this may limit potential profits as opposed to a device that needs to be replaced multiple times. Therefore, I think comparing the risks to benefits of how the design will affect the customer should be the priority but comparing the risks to benefits as applied to the company should be a close second.

Risk–benefit analysis is analysis that seeks to quantify the risk and benefits and hence their ratio. Analyzing a risk can be heavily dependent on the human factor. A certain level of risk in our lives is accepted as necessary to achieve certain benefits.
To date, manufacturers haven’t addressed risk very well as part of product design quality. Handling design control as a document-centric process introduces a high risk of failure over the product lifecycle. That’s because documents are very limited representations of complex products. They typically represent only a subset of product design information at a specific point in time. Even worse, they lack resilience to change.
Medical device manufacturers must also account for the Internet of Things (IoT). IoT technology enables smart, connected products to send manufacturers information about their products and processes while in operation. In turn, manufacturers can offer innovative services for medical devices, including restarting devices remotely in order to significantly reduce service costs while boosting customer satisfaction.

I think that risk/benefit ratio is something that comes up throughout the entire lifecycle of the project. Risk is a major concern regarding medical devices because an issue could lead to serious injury or death if the device malfunctions. The greater the risk that comes up is the more difficult the decision becomes to make for the company. With a greater risk the company would need to foresee a significant benefit to even consider the risk. At the same time risks may exist that are too risky to take, no matter what the perceived benefit may be.

Risk is the function of seriousness of the harm and probability that will occur . The risk can be physical,social,physiocologlcal, Economic. The risk-benefit ratio is a comparison between the risks of a situation and its benefits. The goal is to figure out whether the risk or benefit is most significant. Every medical procedure has risks associated with it, and some procedures that could be cause more harm than good. That's how medical researchers figure out whether certain procedures are worth doing and what types of people will benefit. The risk-benefit ratio is useful for everyone. By actually thinking about the risks and benefits, we can make better decisions about our lives. To complete a risk-benefit ratio we need to know what are the risk how likely they are going to happen and the benefits associated with them. Increased risk should be accompanied by the probability of appropriately increased benefits. Everything should be-done to minimize the risks and to maximize the potential benefits, and to determine that the potential benefits to individuals and society are proportionate to, or outweigh, the risks.

The concept of a risk/benefit ratio is to acknowledge that the most promising rewards come at a price. Immunotherapy for example, extracts, amplifies, and expands a patient's own white blood cells (WBCs) so that they can be infused back into the patient to treat diseases/conditions such as cancer, HIV, hepatitis, etc. The risk present in this field of study is the possibility of the WBCs becoming overly-aggressive, resulting in them attacking the patient rather than treating them. Another risk in immunotherapy is that something could go wrong during manufacturing/processing that can result in the infusion getting scrapped. This results in time lost that the time-sensitive patient could have spent reaching out to alternate treatments. Although there is significant risk present in immunotherapy, the benefit yields enhanced treatment capabilities for the most debilitating diseases, which therefore allows it to undergo further research in clinical trials. One similar immunotherapy technique (the KYMRIAH) has actually been commercialized in 2017 by Novartis, demonstrating how the benefit outweighs the risk (1).

One effective method for optimizing the risk-benefit ratio over a product's life cycle is to take future risk into consideration as early as possible (2). Future risk includes subcategories such as statistical risk, which is risk based on statistical analysis that a company may present to an insurance company when determining its premiums. Projected risk makes estimations based on previous models/studies that are considered relevant. Perceived risk is risk based on the intuition of the team members involved in the project. Are there any other ways to evaluate future risk to prevent potential complications? Is there such a thing as being too cautious when it comes to presenting risk during the planning phase of a project? Who is responsible for determining whether a risk outweighs the benefit or vice versa?

References:
(1) Alex Philippidis.Human Gene Therapy.Jan 2014.ahead of print http://doi.org/10.1089/hum.2013.2526
(2) Yokata, Fumie "Value of Information Analysis in Environmental Health Risk Management Decisions: Past, Present, and Future" (June 2004) https://doi.org/10.1111/j.0272-4332.2004.00464.x

Risk/benefit ratio for a medical device manufacturers will be all the possible benefits of the device which would come along with a number of possible associated risks. These risks and benefits have to be reviewed and discussed at the starting of the project proposal and during clinical trials. A negative result during these clinical trials will have to be considered and trials should be continued to reduce the associated risks after looking at the benefits post success of the project. As the efforts are taken to reduce the risks, the product in itself gets better thereby increasing the product life cycle will increase. However, as time progresses new products with better benefits and lower risks would be replacing the products as time goes by.

Risk/ Benefit Ratio is an assessment of the risks against their benefit. Ideally the benefit has to outweigh risks in order for the company to accept the risk. Typically, risk analysis has a qualitative component and the result feeds into the assessment. According to PMBOK, there are several ways to approach how risks are assessed. Probabilistic analysis of the project are made of the potential project schedule and cost outcomes listing the possible completion dates and cost with their confidence levels. Probabilistic of achieving cost and timeline objectives with the risk facing the project, the probability of achieving the project objectives under the current plan using estimated qualitative risk analysis. Prioritized list of qualified risks includes those risks that may have the greatest effect on cost contingency and those that are most likely to influence the critical path (these risks may be evaluated in some cases through a tornado diagram). Trends in qualitative risk analysis results may become apparent that leads to conclusions affecting risk responses. The organization historical information on a project schedule, cost, quality, and performance should reflect new insights gained through qualitative risk analysis.