Regulatory Open Forum

Dear colleagues - I would love to hear your opinion on this question. 

In practical terms, should we treat both Severity (S) and Probability (POH) to have the same impact on risk or is one more impactful than the other?

Recently, I did a quick poll on LinkedIn which prompted a good discussion. Here is a summary of results:

I think severity has more impact on risk than probability. If the severity of the risk is high - i.e. could lead to death - then the probability could be low and the product would still carry high risk. If the probability is high but the severity is very low, then there is likely little concern. That would look something like: 

S=5, P=1 > S=1, P=5

Interested to hear what others think as well! I am new to medical devices so thank you for this discussion as I am learning this new field of regulatory affairs. 

Dear colleagues - I would love to hear your opinion on this question. 

In practical terms, should we treat both Severity (S) and Probability (POH) to have the same impact on risk or is one more impactful than the other?

Recently, I did a quick poll on LinkedIn which prompted a good discussion. Here is a summary of results:

Dear colleagues - I would love to hear your opinion on this question. 

In practical terms, should we treat both Severity (S) and Probability (POH) to have the same impact on risk or is one more impactful than the other?

Recently, I did a quick poll on LinkedIn which prompted a good discussion. Here is a summary of results:

Hi Narveen.

This is a great topic.  Lots of potential differences in opinion on this point.  I tend to generally agree with Stephanie when you have any "significant" severity (I usually consider anything 4 or 5 "significant").  I tend to look at these sorts of things with reason so the higher the severity the lower the probability needs to be.  So anytime I am looking at a 4 I want the probability at 1 if at all possible.  For "5"s I generally want to work at getting the severity of the rise decreased because anything that is likely to lead to death or significant impairment is never something to be looked at flippantly even when probability of the harm is extremely low.

That said, and being realistic, I recognize that in some instances there is no way to make the severity less or the probability "0".  In those instances I tend to error on the side of caution and build as many of the guardrails as I can think of in the process to mitigate or minimize the severity.  At the mid-level points, I think that 2,3 and 3,2 are essentially the same "risk" in reality.  I think that a moderate risk (maybe ER visit or office visit) is really not nearly as significant as hospital stays even.  I also tend to look at this from a "liability" perspective when I am trying to make decisions in how to manage this sort of severity x probability scenario.  Living and working in the US where there are such things as "class action lawsuits" my goal in part during the mitigation of the dangers is to ensure that we as a company have the best information and program to show due diligence in mitigating risks for patients.

Dear colleagues - I would love to hear your opinion on this question. 

In practical terms, should we treat both Severity (S) and Probability (POH) to have the same impact on risk or is one more impactful than the other?

Recently, I did a quick poll on LinkedIn which prompted a good discussion. Here is a summary of results:

Thank you @Victor Mencarelli for your thoughtful comment.

I agree, that for S=5 risks, we should expect the lowest probability level, such as P=1.

The question is, would you be willing to accept a risk with S=1 and P=5? At what point do you say that even S=1 risks need to be below a certain level of occurrence?

Best regards

Hi Narveen.

This is a great topic.  Lots of potential differences in opinion on this point.  I tend to generally agree with Stephanie when you have any "significant" severity (I usually consider anything 4 or 5 "significant").  I tend to look at these sorts of things with reason so the higher the severity the lower the probability needs to be.  So anytime I am looking at a 4 I want the probability at 1 if at all possible.  For "5"s I generally want to work at getting the severity of the rise decreased because anything that is likely to lead to death or significant impairment is never something to be looked at flippantly even when probability of the harm is extremely low.

That said, and being realistic, I recognize that in some instances there is no way to make the severity less or the probability "0".  In those instances I tend to error on the side of caution and build as many of the guardrails as I can think of in the process to mitigate or minimize the severity.  At the mid-level points, I think that 2,3 and 3,2 are essentially the same "risk" in reality.  I think that a moderate risk (maybe ER visit or office visit) is really not nearly as significant as hospital stays even.  I also tend to look at this from a "liability" perspective when I am trying to make decisions in how to manage this sort of severity x probability scenario.  Living and working in the US where there are such things as "class action lawsuits" my goal in part during the mitigation of the dangers is to ensure that we as a company have the best information and program to show due diligence in mitigating risks for patients.

Dear colleagues - I would love to hear your opinion on this question. 

In practical terms, should we treat both Severity (S) and Probability (POH) to have the same impact on risk or is one more impactful than the other?

Recently, I did a quick poll on LinkedIn which prompted a good discussion. Here is a summary of results: