Key Tips for Communicating Benefit-Risk for Device Approval and Market Adoption

There are many stakeholder groups that ultimately define the benefit-risk assessment of a medical device. These include payers, patient groups, providers, policy-makers, regulators, and many more.  Benefit-risk messages touch on multiple points in the product life cycle and sponsors must constantly assess if the benefits outweigh the risks.  The framework below, based upon guidance set forth by the FDA, can be used to help identify key benefit-risk messages and the variables to be measured through the clinical development.


There are four major benefits.

  • Type of benefit
    • Impact on patient clinical management, patient health, and patient satisfaction in the target population
  • Magnitude of benefit
    • The extent to which a patient population experiences a treatment benefit and can be assessed along a scale or with pre-defined endpoints
  • Probability of the patient experiencing one or more benefits
    • This may not always be possible to predict, but if it is, it should be considered in the benefit-risk assessment
  • Duration of effect
    • Does the device cure disease or require repeated treatments, and is the duration of value to patients?

There are four major risks.

  • Extent of probably risks/harm
    • Severity, types, number, and rates of harmful events associated with the use of the device
  • Probability of a harmful event
    • Percentage of patients in the intended population or in subpopulations who are expected to experience an adverse event, and whether patients are willing to accept the risk
  • Duration of harmful events
    • Length of time adverse consequences last, reversibility of event, and intervention requirement
  • Risk from false-positive or false-negative results
    • Potential issue for diagnostic devices

There are additional factors that could be considered benefits or risks.

  • Uncertainty
    • Various factors can lead to uncertainty of device safety and effectiveness
  • Patient-Centric assessments and patient-reported outcomes
    • Valuable to incorporate into benefit-risk assessment because they have recently become a main area of focus by the FDA
  • Characterization of the disease
    • Addresses how the condition is treated or diagnosed, how it progresses, and how the disease manifests itself
  • Patient perspective
    • A qualitative or quantitative assessment on what benefits or risks patients are willing to accept in relation to other available treatments; includes healthcare giver or caregiver’s preference
  • Availability of alternative treatments or diagnostics
    • Consider their effectiveness, associated risk and benefit-risk profile, how they are used in practice, and how they meet the needs of the patients and providers

The framework above will help create benefit-risk messaging that will guide development and evolve throughout the product life cycle.

Key Tips for Benefit-Risk Assessments