In the assessment of risks of devices section (4.2) the standard lists duration of the risk as a parameter. This is an important distinguisher because it dictates how much damage a risk can do under worst case scenario. Oftentimes business decisions are guided by worst case scenario simulations. This metric tells you that, at worst case, a very severe and very frequent risk can only do damage for X amount of time. If this risk is a paralysis of the device but lasts for 0.1 seconds, it does not warrant much attention. By the time you diagnose and try to fix it its already over.

A risk-benefit analysis is a comparison between the risks of a situation and its benefits. Risk Benefit Analysis is important to determine the benefits and risks which are considered for the product. The main aim is to find out if the risk or benefits is significant. It is often used in medicines since every medical procedure has risks associated with it and some procedures that could be beneficial turn out to statistically cause more harm than good. That is why it is figured out if certain procedures are worth doing and what types of people will be benefitted. Risk benefit analysis could improve the effectiveness of the product.

Risk-benefit assessment is the foundation for FDA's decision making process in terms of its medical device regulations. This assessment helps to determine whether the advantages a medical device brings to the public outweighs the risks that it might have associated with it. FDA not only focuses on the benefit, but also pays close attention to the extent of that benefit in determining whether the device should be cleared or not. It takes into account factors such as whether the quality of life is increased, how it is increased and for how long these effects will last. Another factor FDA looks at is the medical necessity of the product. They want to make sure that the product being proposed addresses an unmet need in the market. Also, they want to make sure that there are no other cleared products on the market that can be used in treatment of whatever disease the new proposed product is aiming to treat.

Risk-benefit factors for assessment of medical device risk includes:
1) Severity of harm
2) Likelihood of risk
3) distribution of nonconforming devices
4) duration of exposure to population
5) False-positive or false-negative results
6) tolerance of risk
7) risk factors for healthcare professionals and caregivers

One of the factors is Assessment of the Benefits of Devices. In this assessment, the FDA takes into account the types of benefits that the device has on patient health as well as their satisfaction. The types of benefits can be assessed by evaluating the impact the device has had among the population, and its ability to help prevent a disease, identify if certain patients are more likely to respond, predict a disease or help to provide an early diagnosis. All this information is helpful to assess the extent of probable benefits.

Risk Benefite analysis is important determining the benefits and risks that need to be considered for 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 as companies will have to consider the risk-reward ratio for all factors that they are considering. Moreover, if a device already exists that is able to treat the same symptoms with lower possible health risks, the FDA will not sign off on the proposed new project idea. The proposed device would fill a major need in the market with little to no other comparable competition in both the financial and benefit sectors.

One risk-benefit factor to consider is how false-positive or false-negative results would affect the patient. In the case of a diagnostic device that produces a false-positive result, the patient would be incorrectly diagnosed with a disease. The patient would then be subject to all of the risks associated with the treatment while receiving none of the benefits. In addition, a healthy patient might actually have an increased risk depending on the nature of treatment. A false-negative result would meant that the patient would miss out on the possible benefits of treatment. Each of these risks carry varying severities therefore a proper analysis would incorporate the level of harm and the possibility of it occurring.

A risk benefit analysis 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. Risk benefit analyses are useful for everyone . To make a good risk benefit analysis you should know some information that you need like: What are the risks? How likely are the risks to happen? What are the benefits? How likely are the benefits to happen? 

A risk benefit analysis must be considered carefully in developing devices and improving existing devices/products. It is the comparison between risks of a situation along with its benefits. Analyzing risk is considered a human factor. A certain level of risk in our lives is accepted to achieve certain benefits. Risk benefit factors for medical devices include risk tolerance, likelihood of risk, false negative or false positive results.

Risk-Benefit analysis is one of the central features of Risk Management. It is one of the most important principle in the ISO 14971. In September 11, 2019, the FDA release some factors to consider when making Risk-Benefit determination in Medical Device premarket approval. This served as a tool to address whether a Medical Device risk is acceptable when compared against its benefits. It provides another level of analyses whether the suitability of a Medical device to be marketed. These factors include:

• clinical Judgement
• Patient / End-user perception
• Available information
• Market experience

For example high risk device such as radiation diagnostics and implants have high benefits. Also if there is no other alternative treatment for a life threatening condition - Risk Benefit analysis is vital in helping to decide whether certain risk are acceptable.  

Reference:

• https://incompliancemag.com/fda-releases-guidances-on-benefit-risk-determinations-for-medical-devices/
• risk-management/

Your comment about product availability reminds me of a potential risk that I have experienced. Many medical devices have components that are outsourced from a supplier. They could be a "simple" as a plastic tube or more complicated as a computer chip. In any case, the point I am making is that a company may decide to outsource without really understanding the risk vs benefits. Initially, the risk may seem to be low or they provide a very competitive price but if the supplier has quality issues or can bring in variability of the component which will make the device difficult to use, it can have major impact on product availability. The supply chain of medical devices needs to be clearly investigated and evaluate the risk/benefits.  

Another factor to consider is the Duration of harmful events. For example, cancer therapies and surgeries often cause adverse symptoms in patients that can last for the entirety of their treatment and even sometimes after.  If the cancer was going to kill an individual but the treatment was going to result in disability, it may be beneficial to treat the patient. If a non-malignant cancer treatment resulted in permanent disability, it may not be beneficial to treat cancer since the treatment creates an event that is riskier than the benefits of treating the cancer.

Medicine and medical treatments often injure patients in the process of treating them (ex. getting an IV in requires your skin to be punctured). It is thus important to take into account if this injury and the consequences of this injury outweigh the benefits of the treatment the injury requires. 

I think one of the most interesting risk factors is the probability of a harmful event. The FDA factors the proportion of the intended population that would experience that event and how many times it would occur. It is important because some risks might be unavoidable. I this case the mitigation efforts should focus on minimizing the occurrence of these events.

Risk benefit analysis is basically a comparison between the risks and the benefits of the situation.  It is used to figure out if the course of action to be implemented is worth the risk or if the risk is too high.  There are 3 steps to completion a risk/benefit analysis:

1. Summarizing all potential risks after the review of all risk analysis documents

2. Summarizing risk mitigation actions

3. Then you want to arrange a follow up review the results with the project team and management, also include the QA team and regulatory team if you have one.

In my opinion, covering all of these steps is a way to ensure that the risk analysis process of identifying and analyzing potential issues will help to ensure that key business initiatives and processes are not negatively impacted.

The risk benefit analysis is important for medical devices that are developed. The benefits need to outweigh the risks to have a safe and effective medical device. The risk benefit analysis will determine the availability of a product. If the product is effective and safe with limited risk then the product will be a hit and used a lot. Therefore it will have limited availability. However if the device pose many risk then the product will most likely not sale, and be readily available because it is not selling.