Description: At the heart of every medical device marketing submission is a robust benefit risk assessment. This requirement begs the question: what is meant by benefit and how is it measured? The EU MDR definition of clinical benefit, and the definition of benefit given in ISO 14971 and FDA guidances describe general concepts like improvements in patient health, patient management, or public health. These are intuitive ideas for directly therapeutic devices like mechanical heart valves, but they are more difficult to conceptualize for devices with indirect benefits. The benefit of a guidewire must still be identified and assessed alongside risk for regulatory approval. This discussion will focus on describing a harmonized concept of benefit and applying it to identify both direct and indirect benefits to the patient, user, and general public. In addition to smoothing the regulatory pathway, identifying and communicating a clear benefit will lead to better defined claims, aiding manufacturers with market access supporting sales and marketing efforts.
Learning Objectives:
Understand the definition of what is meant by ‘benefit’ and/or ‘clinical benefit.’
Explore the difference between direct and indirect benefits, and understand expectations for both types.
Write an appropriate benefit statement for a medical device of their choice.
