Insights on risk management topics and tips and techniques for implementation.

Evaluating Benefit-Risk of Medical Devices

benefit-risk fda medical device risk management Sep 15, 2021

Evaluating benefit-risk of a medical device is no easy task because it involves making a decision about their safety and effectiveness with very limited information. 

There is no doubt that medical devices have contributed to increasing our average lifespan and overall quality of life in a significant way. There are so many different types of devices available for use throughout our lifetime. Whether it is a simple rapid test for Covid-19 or a pacemaker, medical devices provide a lot of benefits to individual health, patient management and public health.

But they are not without risk

That is why regulatory authorities such as the US FDA look at the balance between the potential benefits of a medical device, and weigh them against the potential risks to make a decision about its safety and effectiveness. This is a very important decision because it is directly linked to regulatory approval before it can be marketed for use. 

Benefit-risk analysis involves a significant amount of judgment. That is why most people in the medical device industry struggle with this exercise. 

In this video below, you can learn about different factors that can be used for analyzing benefit-risk. This is illustrated by using an example of a case study published by the FDA where they analyzed the benefit-risk of a weight-loss device. 

In conclusion, analyzing benefit-risk involves a lot of judgment. But a systematic analysis of different factors related to benefits, risks and uncertainty can be helpful.

Contact us if you have questions or if you would like to learn more. 



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