September 11, 2020

Appropriate communication of benefits, risks, and uncertainty is essential at every stage of the medical device
life cycle. Products can be designed, and studies conducted, based on the risk, benefit, and uncertainty
preferences of the target patient population. During review, approval, and subsequent use of a device,
manufacturers and regulators have an obligation to ensure that benefits, risks, and uncertainty associated with
the device are communicated in an understandable way. Similarly, in the clinical setting, patient-centered care
requires effective communication of benefits, risks, and uncertainty between patients and providers. There
is increasing awareness surrounding the importance of patient engagement during the treatment decisionmaking
process, as well as across the medical technology product development cycle by industry
and regulators.

The intent of this report, developed by the Science of Patient Input Communication Working Group of
the Medical Device Innovation Consortium, is to familiarize all medical device stakeholders with evidence-based
practices for communicating the benefits, risks, and uncertainty of medical technology to patients
and providers.