A quick poll - evaluating benefit-risk of medical devices
Please share your opinion in this quick poll and clarify your thinking in comments
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?
A - same as predicate device; 10% uncertainty
B - 20% less Benefits (B), 20% less Risks(R); 10% uncertainty
C - 20% more Benefits(B), 20% more Risks(R); 10% uncertainty
Notes:
➡ B => clinical benefit; R => overall residual risk
➡ Dotted circles around each option indicate the level of uncertainty in B-R levels
➡ Assume you have perfect data to quantitatively estimate both B and R
Please select the most preferred option below:
Please clarify your thinking in a comment below.
My answer is C. You clearly want more benefit with a new device. But all depends on the magnitude of the benefit and of the risk. You would like to ensure your overall benefits outweigh the overall (residual) risks, and depending on the medical field and the type of innovation, one would accept a higher risk if the benefit is clearly above those of current existing devices. With the EU MDR, manufacturers are now required to quantitatively analyse the benefit/risk ratio of their medical device, and to compare this to the benchmark of the standard of care/state of the art, providing a clinical evaluation report with all information and supporting clinical data. In the end, you want to be able to help the patient.
Same to equivalent could be considered as no innovation but if you have a novel device that compares in BR ratio to a well standing comparator then great. Other two options show direct proportion of movement of both R and B so question becomes do you want more of one or less than one and since they move together I’ll take more benefit and same amount of risk increase. We all strive to have these two variables move in different direction (more benefit and less risk) - but that’s not an option since it would be a no brainer answer