Regulatory Open Forum

Dear colleagues

The topic of benefit-risk for medical devices is very important.

This is because the regulatory standard of safe and effective is directly related to the balance between benefits and risks.

Yet, clearly articulating the benefit-risk of a medical device is not an easy exercise.

Recently, I asked my LinkedIn colleagues a question on this topic to understand their perspectives on benefit-risk, and how they would evaluate 3 different options for a new medical device. It generated a lot of interest and good discussion!

In an effort to gather additional perspectives from a broader audience, I would like to ask your opinion on this question below. Please select the most preferred option and clarify your thinking in comments below.

Thank you!

Which of the following 3 options would you prefer the most for a new medical device?

My perspective:   First take into account the need for the 'new device' when one is considering a new or improved device.  Will this device be part of treatment for a serious health condition and provide significant treatment (benefit) which improves significantly the patient outcomes?  This immediately brings me to side with increased benefit as a priority.  If the benefit is critical to a large population, then one may be able to accept the additional risks.  At the same time, are these risks minimal (do not lead to serious harm or death) or are the risk major (may lead to serious injury or death).  The answer to what type of risks may change my answer. 

Of course, the ultimate goal would be to have increased benefit and the same or lower risks (but that was not an option given). 

Dear colleagues

The topic of benefit-risk for medical devices is very important.

This is because the regulatory standard of safe and effective is directly related to the balance between benefits and risks.

Yet, clearly articulating the benefit-risk of a medical device is not an easy exercise.

Recently, I asked my LinkedIn colleagues a question on this topic to understand their perspectives on benefit-risk, and how they would evaluate 3 different options for a new medical device. It generated a lot of interest and good discussion!

In an effort to gather additional perspectives from a broader audience, I would like to ask your opinion on this question below. Please select the most preferred option and clarify your thinking in comments below.

Thank you!

Which of the following 3 options would you prefer the most for a new medical device?

My perspective:   First take into account the need for the 'new device' when one is considering a new or improved device.  Will this device be part of treatment for a serious health condition and provide significant treatment (benefit) which improves significantly the patient outcomes?  This immediately brings me to side with increased benefit as a priority.  If the benefit is critical to a large population, then one may be able to accept the additional risks.  At the same time, are these risks minimal (do not lead to serious harm or death) or are the risk major (may lead to serious injury or death).  The answer to what type of risks may change my answer. 

Of course, the ultimate goal would be to have increased benefit and the same or lower risks (but that was not an option given). 

Dear colleagues

The topic of benefit-risk for medical devices is very important.

This is because the regulatory standard of safe and effective is directly related to the balance between benefits and risks.

Yet, clearly articulating the benefit-risk of a medical device is not an easy exercise.

Recently, I asked my LinkedIn colleagues a question on this topic to understand their perspectives on benefit-risk, and how they would evaluate 3 different options for a new medical device. It generated a lot of interest and good discussion!

In an effort to gather additional perspectives from a broader audience, I would like to ask your opinion on this question below. Please select the most preferred option and clarify your thinking in comments below.

Thank you!

Which of the following 3 options would you prefer the most for a new medical device?

You may need to factor in the level of risk of no treatment at all.

And it's important to note that the particular type of risk will be judged differently by different patients. If you ask "which symptoms would you especially want to alleviate" and "which side effects are you most afraid of", you'll hear an assortment of answers.

My perspective:   First take into account the need for the 'new device' when one is considering a new or improved device.  Will this device be part of treatment for a serious health condition and provide significant treatment (benefit) which improves significantly the patient outcomes?  This immediately brings me to side with increased benefit as a priority.  If the benefit is critical to a large population, then one may be able to accept the additional risks.  At the same time, are these risks minimal (do not lead to serious harm or death) or are the risk major (may lead to serious injury or death).  The answer to what type of risks may change my answer. 

Of course, the ultimate goal would be to have increased benefit and the same or lower risks (but that was not an option given). 

Dear colleagues

The topic of benefit-risk for medical devices is very important.

This is because the regulatory standard of safe and effective is directly related to the balance between benefits and risks.

Yet, clearly articulating the benefit-risk of a medical device is not an easy exercise.

Recently, I asked my LinkedIn colleagues a question on this topic to understand their perspectives on benefit-risk, and how they would evaluate 3 different options for a new medical device. It generated a lot of interest and good discussion!

In an effort to gather additional perspectives from a broader audience, I would like to ask your opinion on this question below. Please select the most preferred option and clarify your thinking in comments below.

Thank you!

Which of the following 3 options would you prefer the most for a new medical device?

You may need to factor in the level of risk of no treatment at all.

And it's important to note that the particular type of risk will be judged differently by different patients. If you ask "which symptoms would you especially want to alleviate" and "which side effects are you most afraid of", you'll hear an assortment of answers.

My perspective:   First take into account the need for the 'new device' when one is considering a new or improved device.  Will this device be part of treatment for a serious health condition and provide significant treatment (benefit) which improves significantly the patient outcomes?  This immediately brings me to side with increased benefit as a priority.  If the benefit is critical to a large population, then one may be able to accept the additional risks.  At the same time, are these risks minimal (do not lead to serious harm or death) or are the risk major (may lead to serious injury or death).  The answer to what type of risks may change my answer. 

Of course, the ultimate goal would be to have increased benefit and the same or lower risks (but that was not an option given). 

Dear colleagues

The topic of benefit-risk for medical devices is very important.

This is because the regulatory standard of safe and effective is directly related to the balance between benefits and risks.

Yet, clearly articulating the benefit-risk of a medical device is not an easy exercise.

Recently, I asked my LinkedIn colleagues a question on this topic to understand their perspectives on benefit-risk, and how they would evaluate 3 different options for a new medical device. It generated a lot of interest and good discussion!

In an effort to gather additional perspectives from a broader audience, I would like to ask your opinion on this question below. Please select the most preferred option and clarify your thinking in comments below.

Thank you!

Which of the following 3 options would you prefer the most for a new medical device?

Dear colleagues

The topic of benefit-risk for medical devices is very important.

This is because the regulatory standard of safe and effective is directly related to the balance between benefits and risks.

Yet, clearly articulating the benefit-risk of a medical device is not an easy exercise.

Recently, I asked my LinkedIn colleagues a question on this topic to understand their perspectives on benefit-risk, and how they would evaluate 3 different options for a new medical device. It generated a lot of interest and good discussion!

In an effort to gather additional perspectives from a broader audience, I would like to ask your opinion on this question below. Please select the most preferred option and clarify your thinking in comments below.

Thank you!

Which of the following 3 options would you prefer the most for a new medical device?

------------------------------
Naveen Agarwal, Ph.D.
Problem Solver | Knowledge Sharer.
Let's Talk Risk!
@https://naveenagarwalphd.substack.com/
------------------------------

Dear colleagues

The topic of benefit-risk for medical devices is very important.

This is because the regulatory standard of safe and effective is directly related to the balance between benefits and risks.

Yet, clearly articulating the benefit-risk of a medical device is not an easy exercise.

Recently, I asked my LinkedIn colleagues a question on this topic to understand their perspectives on benefit-risk, and how they would evaluate 3 different options for a new medical device. It generated a lot of interest and good discussion!

In an effort to gather additional perspectives from a broader audience, I would like to ask your opinion on this question below. Please select the most preferred option and clarify your thinking in comments below.

Thank you!

Which of the following 3 options would you prefer the most for a new medical device?

I think reducing the discussion of benefit-risk to a quantitative analysis or trying to shoe horn it into being expressed as a ratio runs the risk of misrepresenting the information.  Note that ISO 14971:2019 makes provision for a benefit-risk analysis to be performed in the event that a residual risk does not meet the acceptability criteria in the risk management plan order "to determine if the benefits of the intended use outweigh this residual risk" (clause 7.4).   This provision is only applicable if a residual risk fails to meet the criteria set out for the medical device and is not required for each product.  Likewise, ISO/TR 24971:2020 has additional guidance in clause 7.4 in which the estimation of benefit is discussed as varying in "nature and degree" depending on the patient population and provides example analyses that mention the types and magnitude of benefits in contrast with the potential risks, but do not provide a composite value. 

Likewise, the issue of benefit-risk analysis is clouded by the mention of a benefit-risk "ratio" in the EU MDR, despite the fact that there is no meaningful numerical statement to be made regarding these two things.  

I suspect that attempting to quantify risks vs benefits in order to meet an arbitrary metric will have some inevitable affect on those responsible for risk management activities.  For example, it may result in the exaggeration of the number/value of benefits or conversely incentivize reducing the granularity/scrutiny placed on risk analysis in order to keep the denominator as small as possible. Such a ratio, including those presented in the poll may lead to incorrect assumptions regarding the safety of the device, not to mention it does not address the magnitude of the benefit(s) given the device's intended use. 

Dear colleagues

The topic of benefit-risk for medical devices is very important.

This is because the regulatory standard of safe and effective is directly related to the balance between benefits and risks.

Yet, clearly articulating the benefit-risk of a medical device is not an easy exercise.

Recently, I asked my LinkedIn colleagues a question on this topic to understand their perspectives on benefit-risk, and how they would evaluate 3 different options for a new medical device. It generated a lot of interest and good discussion!

In an effort to gather additional perspectives from a broader audience, I would like to ask your opinion on this question below. Please select the most preferred option and clarify your thinking in comments below.

Thank you!

Which of the following 3 options would you prefer the most for a new medical device?

Hi  Christopher

Thank you for articulating the real-life challenge we face as practitioners of risk management in the medical device industry. Benefit-risk analysis is definitely not easy.

Having said that, I wanted to clarify a few points:

1. Clause 7.4 is provides a way to accept an otherwise unacceptable individual residual risk after all practicable risk control measures have been effectively implemented. At this stage, we are looking at only a specific residual risk, not the overall residual risk. In practice, this exercise is very difficult because evaluating the specific benefit in the context of a specific risk is not easy. I use a few examples in my risk management training course to clarify this point.
2. The requirement of overall residual risk evaluation in Clause 8 refers to the final benefit-risk evaluation after all individual risks have been appropriately mitigated. This is where I think the notion of "benefit-risk- ratio" becomes relevant in the context of EU-MDR

Although I understand your point about the challenge in applying a more quantitative approach, I feel this should not stop us from thinking about potential options. 

The question is not about an absolute level of benefit-risk; rather a relative measure compared to alternate options. 

That is why I posed this poll question in relation to a predicate device.

Thanks for sharing your thoughts!

I think reducing the discussion of benefit-risk to a quantitative analysis or trying to shoe horn it into being expressed as a ratio runs the risk of misrepresenting the information.  Note that ISO 14971:2019 makes provision for a benefit-risk analysis to be performed in the event that a residual risk does not meet the acceptability criteria in the risk management plan order "to determine if the benefits of the intended use outweigh this residual risk" (clause 7.4).   This provision is only applicable if a residual risk fails to meet the criteria set out for the medical device and is not required for each product.  Likewise, ISO/TR 24971:2020 has additional guidance in clause 7.4 in which the estimation of benefit is discussed as varying in "nature and degree" depending on the patient population and provides example analyses that mention the types and magnitude of benefits in contrast with the potential risks, but do not provide a composite value. 

Likewise, the issue of benefit-risk analysis is clouded by the mention of a benefit-risk "ratio" in the EU MDR, despite the fact that there is no meaningful numerical statement to be made regarding these two things.  

I suspect that attempting to quantify risks vs benefits in order to meet an arbitrary metric will have some inevitable affect on those responsible for risk management activities.  For example, it may result in the exaggeration of the number/value of benefits or conversely incentivize reducing the granularity/scrutiny placed on risk analysis in order to keep the denominator as small as possible. Such a ratio, including those presented in the poll may lead to incorrect assumptions regarding the safety of the device, not to mention it does not address the magnitude of the benefit(s) given the device's intended use. 

Dear colleagues

The topic of benefit-risk for medical devices is very important.

This is because the regulatory standard of safe and effective is directly related to the balance between benefits and risks.

Yet, clearly articulating the benefit-risk of a medical device is not an easy exercise.

Recently, I asked my LinkedIn colleagues a question on this topic to understand their perspectives on benefit-risk, and how they would evaluate 3 different options for a new medical device. It generated a lot of interest and good discussion!

In an effort to gather additional perspectives from a broader audience, I would like to ask your opinion on this question below. Please select the most preferred option and clarify your thinking in comments below.

Thank you!

Which of the following 3 options would you prefer the most for a new medical device?

Dear colleagues

The topic of benefit-risk for medical devices is very important.

This is because the regulatory standard of safe and effective is directly related to the balance between benefits and risks.

Yet, clearly articulating the benefit-risk of a medical device is not an easy exercise.

Recently, I asked my LinkedIn colleagues a question on this topic to understand their perspectives on benefit-risk, and how they would evaluate 3 different options for a new medical device. It generated a lot of interest and good discussion!

In an effort to gather additional perspectives from a broader audience, I would like to ask your opinion on this question below. Please select the most preferred option and clarify your thinking in comments below.

Thank you!

Which of the following 3 options would you prefer the most for a new medical device?

------------------------------
Naveen Agarwal, Ph.D.
Problem Solver | Knowledge Sharer.
Let's Talk Risk!
@https://naveenagarwalphd.substack.com/
------------------------------

Hi Naveen,

This is not an easy answer and as you see in the comments you've gotten now requires a lot of discussion. I will give a perspective on C because that's what I found interesting and what I've known some patients have chosen on some products I've worked on.

When looking at our QOL or when a condition is life threatening, increase in risk becomes more acceptable to us when there's a good chance of increased benefits. This is why we have many research centers that offer this option to patients and I even know of patients and patient advocate groups asking for anything, anything at all, that is different from the current treatment practice, which in some cases fits B. Patients pushing for other treatment options, as we know, is one of the motivations for invention or innovation of new procedures or medical products. It makes sense as one-size-fits-all isn't always the best answer.

To me, personally, it's really between the patient and their HCP as to what product or procedure would work best for them. This is also why we should be clear in our labeling about risks and benefits of our medical products. I have been surprised by how much patients are willing to tolerate for a better QOL even if the condition is non-life threatening. For me, let the patient make that decision for themselves together with their HCP.

------------------------------
ClarisaTate
Medical Devices, Regulatory/Quality/Engineering
CA, United States

Original Message:
Sent: 13-Jun-2023 15:00
From: Naveen Agarwal
Subject: Quick Poll - Evaluating benefit-risk of medical devices

Dear colleagues

The topic of benefit-risk for medical devices is very important.

This is because the regulatory standard of safe and effective is directly related to the balance between benefits and risks.

Yet, clearly articulating the benefit-risk of a medical device is not an easy exercise.

Recently, I asked my LinkedIn colleagues a question on this topic to understand their perspectives on benefit-risk, and how they would evaluate 3 different options for a new medical device. It generated a lot of interest and good discussion!

In an effort to gather additional perspectives from a broader audience, I would like to ask your opinion on this question below. Please select the most preferred option and clarify your thinking in comments below.

Thank you!

Which of the following 3 options would you prefer the most for a new medical device?

------------------------------
Naveen Agarwal, Ph.D.
Problem Solver | Knowledge Sharer.
Let's Talk Risk!
@https://naveenagarwalphd.substack.com/
------------------------------