Risk management is an integral part of the medical device product development lifecycle. It helps medical device developers ensure that the product is reliable, works as expected and causes no harm to the patients, operators or the environment. There are several ways to mitigate the risk management: 1- Changing the design of the product to a level where the risk is mitigated. 2- Integrate protective measure in accordance with a particular risk to decrease the occurrence of harm. 3- labeling or adding instructions in the device manual regarding the risks involved in a particular device.
For a low severity risk, we can accept the risk depending on its occurrence or try to mitigate the risk.
While or the high severity of the risk should be either avoided but it will be a huge loss as it is difficult to do in the final stages of the project, also we can try to mitigate the risk which would be ideal or else the last option can be transference to avoid any loss to the company and let the third party handle the issue.
I would choose acceptance for low severity of risk as this is a good strategy to use for very small risks that won’t have much of an impact on your project if they happen and could be easily dealt with if or when they arise. I would not choose anything for a high severity risk because if the severity is high then there needs to be action taken to reduce the severity and get it within acceptable range in order for the device to be safely used. In my opinion and as mentioned in the lecture the option that do not reduce the risk level out of these four is transference and tends to be mostly used in projects where there are several parties involved.
For the low severity you can try to choose avoidance but if the design of the product is changed to the point where making anymore changes will contradict with the initial function of device then I will choose mitigation or acceptance.
For the high severity of risk I would do the same thing as low severity risk, however if severity is high and probability is also high then I would consider dismissing the project unless it really helps user.
Acceptance does not reduce the risk level as you are accepting that there will be risk of using the device. However, you can try to give training to professionals or provide instructions or use labels so user knows how to use it. For the implanted device tell the user what the risks are associated with the device and how to avoid them. For example the device won't work in hot environment then you should let the user know that they have to avoid hot environment.
When selecting the method of risk management, I would take into account both the level of severity and occurrence. For high severity and high occurrence risks, I would definitely choose avoidance since that kind of risk is impossible to justify. In cases where the risk has high severity, but low occurrence, I would either implement mitigation, acceptance, and/or transference(if the project has a high enough budget). For low severity and high occurrence risks, I would use mitigation and acceptance if the minor side effect of the medical device is unavoidable. For example, minor skin irritation lasting 5 minutes after using a deep brain stimulation device can occur for many users. I would work on reducing the duration and occurrence of that symptom, or even accept it after informing users of that possible side effect. It would be difficult to use avoidance and unnecessary to turn to transference for this case. As for low severity and low occurrence risks, I would use mitigation and/or acceptance.
For high severity risks, I would choose avoidance since that kind of severity of the risk is high any way to completely eliminate these risks would be necessary. For low severity risks, I would use mitigation or acceptance if the side effect of the medical device is unavoidable. For example, there is some skin irritation after using surface electrodes. The way you can mitigate it is reducing the time and frequency of occurrence of the skin irritation or you can accept it after informing users of the possible side effect.
There are four ways to manage risk: avoidance, mitigation, acceptance, and transference. Transference is basically transferring the risk elsewhere and not commonly used in medical device development. However, one of the remaining three tactics must be considered in order to do an effective risk management process. Avoidance is the most favorable as it avoids the risk all together. This would be the preferred way of managing a risk and may be accomplished through some design change considerations. Next, mitigation can be explained as decreasing either the probability or severity of the risk. In the case where the risk cannot be avoided or designed out, the next best option would be to mitigate. This may also be accomplished through a design change, but one that may include putting up safeguards. Lastly is acceptance, and this means to basically accept the risk for what it is. Professor Simon gave a good example of this in his lecture with the scalpel. The risk of a scalpel accidentally cutting someone is an accepted risk because that is the function of the scalpel. If the scalpel couldn't cut, it would not preform its intended use. I believe that acceptance of a risk should only be done if avoiding or mitigating would compromise the devices intended function, such as the scalpel example, or if the probability or severity is so low it would not pose harm to the end user. In all other cases of more serious risk, either avoidance or mitigation should be done as best as possible. And of course, all risks should be reconsidered and measured to evaluate the effectiveness of the risk management process. If the risk is still too great, consider the risk verses the reward.
I think all posted comments have mentioned that with high severity risks the avoidance is the right choice, and I totally agree with that. Therefore, the level of severity gives us a clue to which choice we can consider. I just can accept the acceptance way to manage risk with low high severity. rather than these two severities, mitigation and transference methods can be chosen.
I can't decide which one I would go with over the other, mitigation or acceptance. While mitigation could be the most effective way to save money and to mitigate around risks, in certain examples you could get away with just acceptance for example if the product you are developing doesn't need to be mitigated such as a scale then acceptance would be the best risk management option to go with.
I agree with others in that the best risk management option depends on a variety of factors ranging from severity, frequency, and cost. In general, all risks should try to be avoided if possible. This is not always possible which is why the other options of risk management are necessary. For low severity, theoretically the logical option would be acceptance. This would typically save the most money as well. On the other hand, if the risk is low severity, but has a high frequency, then it may be worth mitigating the risk to reduce consumer disapproval. Similarly, high severity risks should be dealt with using the mitigation option. Regardless of if the frequency is high or low, high severity risks could cause major consequences down the line so it would be better to mitigate the risks. There is one more risk management option which was mentioned in the original post and in the lecture, which is transference. As professor had mentioned in his lecture, transference is not typically used within the medical device industry. Thus, the best option in terms of risk management should be decided based on a variety of factors.
I would choose acceptance for low severity risks and mitigation for high severity risks. Low severity has a slight or marginal impact on their occurrence. This can be manageable with acceptance as it does not cause much loss to the company or damage to the users. High severity risks would be devastating upon occurrence. The best option to manage this would be mitigation which involves taking action to reduce the exposure of an organization to potential risks and reduce the likelihood that those risks will happen again.
Proper risk management implies control of possible future events and is proactive rather than reactive. For low severity risks, acceptance or mitigation needs to be done. If the benefit is worth the severity of risk then one can accept the risk and go on with the product. If the benefit is not significant enough for the risk then mitigation of the severity is required and determining if the cost it takes to mitigate the product is worth not just avoiding it is something that has to be considered too. For high severity, avoidance or transference could be done. Avoidance is the most expensive option but most effective because it completely absolves the company's exposure to any risk. If money is an issue, then transference will help a company transfer any risk they may have to a third party to deal with.
Creating a list of risk is a good starting point, however, it is not enough on itself. You also need an action plan for each risk in order to be able to manage them effectively.
We learned about the standard way to manage risk in this weeks lecture:
Avoidance
Mitigation
Acceptance
Transference
Which option would you choose for low severity and for high severity of risk?
Which option do you think do not reduce the risk level out of these four and when would you use it?
The first option I would select for the purpose of managing risk with low severity would be acceptance of risk. For high severity risk I think that the mitigation of risk would be the most appropriate way of managing risk in that situation. I also think that acceptance and transference of risk are two methods that don't alleviate any risk from the situation and the only times when these options are probably acceptable are for low risk situations and scenarios where high severity risks are inevitable.
Creating a list of risk is a good starting point, however, it is not enough on itself. You also need an action plan for each risk in order to be able to manage them effectively.
We learned about the standard way to manage risk in this weeks lecture:
Avoidance
Mitigation
Acceptance
Transference
Which option would you choose for low severity and for high severity of risk?
Which option do you think do not reduce the risk level out of these four and when would you use it?
For low severity I would choose: Acceptance - I may have very little to lose with this option.
For high severity I would choose: Avoidance - I would likely stand to lose on this one.
Avoidance does not reduce risk. Instead it is a method to bypass the risk. I would use it if I felt like it would do more harm that good. I do tend to err on the side of caution and I do not tend to be a big risk-taker. Those things considered, I would use avoidance if I felt the risk was far too great.
No matter the level of risk, I would always first attempt to use the avoidance method in order to get rid of the risk in general for that product. For low severity risks, though, I would use the acceptance method of risk management. Since it is low, it would be okay to accept them without much harm being done to users. For high severity risks, I would specifically use the avoidance method because I would not want the product to have the chance to harm users. If avoidance is not possible, which it sometimes isn’t, I would use the mitigation method in order to decrease the amount of risk that comes with product use. The method that I believe is absolutely useless and does not reduce any risk level is transference. I don’t think this method should be used in risk management unless there is definitely not other choice possible.
