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.
Jun 8, 2023·edited Jun 8, 2023Liked by Naveen Agarwal, Ph.D.
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
@Juan Daccach - thank you for sharing your perspective. Indeed, if we could wave a magic wand and create a product with higher benefits and less risk, that would be awesome. But, we do have to make trade-offs in the real world, right? What can be more worrisome is when we believe we are aiming for higher benefits but we end up having less in the real world while the risk continues to remain high. As I come across warning letters and recalls, I can't help but wonder if we are really monitoring the real world performance of our innovative devices against expectations.
This is very accurate - but what is even a more unclear area is a true way of measuring benefit as accurately as we measure risk … is benefit the absence of risk? Or how do we come about creating the same unit to compare them both and really come up with a side by side, same denominator, comparison to determine, with data, that benefits truly outweigh the risks
Indeed Juan - I have recently started wondering about this as well. You can monitor adverse events through FDA's MAUDE or TPLC databases, but there is no public information about benefits. In the context of regulatory standard of "safe and effective", my understanding is that we need to look at only clinical benefits. If you open a 510k summary, generally speaking, you don't find any details about clinical benefit(s). In PMA summaries of safety and effectiveness data, you can find information about primary and secondary end points. But what happens in the real world? There is no way for the public to learn about how well a medical device is performing against expectations. The only thing we have is warning letters and recalls.
Depends on the condition being treated and the quality of other treatment options. Are there few other options, none truly good, and the condition is devastating? Then C all the way. Is the condition just a time-limited nuisance? Then B all the way. If the condition is medium serious with a few good options already available for treating it, probably A.
I go back to what my first quality manager out of university and into the automotive industry told me: "My job is about achieving the appropriate level of quality for whatever product, not about perfection". So I answered A, but feel this is kind of a trick question if, like me, you aren't wedded to working with a single type of device. In reality, I don't think this question can ever be generalised like this. I'd want to judge product-by-product, dependent upon understanding the market and patient needs. Broadly, I suppose the three options respectively reflect market diversification, democratisation and pushing the envelope for high-risk patients, any of which is a legitimate and useful aim under appropriate circumstances.
I did not make a selection because stakeholders may have very different perspectives on benefits and risks, i.e. there is no one size fits all. Like Roger, my perception is that generalization is not appropriate.
This is very hard using an abstract situation. If we are talking about the benefit of a new life saving procedure to a fatal situation for the patient, where they were cured or died, I would be more likely to lean to higher benefit higher risk. I guess I am saying that I cant generalize, and would want to see the exact situation.
Hi Roger - this question is framed in the context of a predicate device. You can look at each option relative to the other within the context of the same intended use and/or indication. It is not as open ended or general as it may appear at first.
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
@Juan Daccach - thank you for sharing your perspective. Indeed, if we could wave a magic wand and create a product with higher benefits and less risk, that would be awesome. But, we do have to make trade-offs in the real world, right? What can be more worrisome is when we believe we are aiming for higher benefits but we end up having less in the real world while the risk continues to remain high. As I come across warning letters and recalls, I can't help but wonder if we are really monitoring the real world performance of our innovative devices against expectations.
This is very accurate - but what is even a more unclear area is a true way of measuring benefit as accurately as we measure risk … is benefit the absence of risk? Or how do we come about creating the same unit to compare them both and really come up with a side by side, same denominator, comparison to determine, with data, that benefits truly outweigh the risks
Indeed Juan - I have recently started wondering about this as well. You can monitor adverse events through FDA's MAUDE or TPLC databases, but there is no public information about benefits. In the context of regulatory standard of "safe and effective", my understanding is that we need to look at only clinical benefits. If you open a 510k summary, generally speaking, you don't find any details about clinical benefit(s). In PMA summaries of safety and effectiveness data, you can find information about primary and secondary end points. But what happens in the real world? There is no way for the public to learn about how well a medical device is performing against expectations. The only thing we have is warning letters and recalls.
Enter the patients perspective and definition of benefit
Depends on the condition being treated and the quality of other treatment options. Are there few other options, none truly good, and the condition is devastating? Then C all the way. Is the condition just a time-limited nuisance? Then B all the way. If the condition is medium serious with a few good options already available for treating it, probably A.
This is an excellent insight Stephanie. Indeed, the base level of benefit/risk also matters.
I go back to what my first quality manager out of university and into the automotive industry told me: "My job is about achieving the appropriate level of quality for whatever product, not about perfection". So I answered A, but feel this is kind of a trick question if, like me, you aren't wedded to working with a single type of device. In reality, I don't think this question can ever be generalised like this. I'd want to judge product-by-product, dependent upon understanding the market and patient needs. Broadly, I suppose the three options respectively reflect market diversification, democratisation and pushing the envelope for high-risk patients, any of which is a legitimate and useful aim under appropriate circumstances.
I did not make a selection because stakeholders may have very different perspectives on benefits and risks, i.e. there is no one size fits all. Like Roger, my perception is that generalization is not appropriate.
This is very hard using an abstract situation. If we are talking about the benefit of a new life saving procedure to a fatal situation for the patient, where they were cured or died, I would be more likely to lean to higher benefit higher risk. I guess I am saying that I cant generalize, and would want to see the exact situation.
Hi Roger - this question is framed in the context of a predicate device. You can look at each option relative to the other within the context of the same intended use and/or indication. It is not as open ended or general as it may appear at first.