Best Practices for Communicating Benefit, Risk, and Uncertainty for Medical Devices Report

Sep 20, 2020Clinical, Communicating Benefit, Risk and Uncertainty, Post-Market Monitoring, Product Launch, Regulatory Decision, SPI Guiding Principles

Patient Introduction

MDIC designed this report to be a practical resource to help professionals across the medical device community discuss medical device benefits, risks, and uncertainty in easy-to-understand language. While investigators, physicians, regulators, and others involved in healthcare delivery may be comfortable with the concepts and terms used by product developers and regulators in describing benefits and risks, patients are often less familiar with the medical terms. The best practices included in the report can support and guide patient engagement throughout the medical device product life cycle. Patients may find this report useful in understanding how medical device sponsors work to support this important communication, and may be especially interested in reviewing the case studies that are incorporated into the report to see how principles for this communication are applied in ‘real life.’


Efforts dedicated to understanding patient preferences and approaches to risk-benefit trade-offs have grown, as have the use of shared decision-making (SDM) efforts between providers and patients and peer-to-peer mentorship within patient and caregiver communities. The combined impact of these trends has created a need to identify and promote best practices resources for medical device developers as they communicate with providers and patients about the benefits, risks, and uncertainty associated with the use of medical devices. This report intends to familiarize all medical device stakeholders with evidence-based practices for communicating the benefits, risks, and uncertainty of medical technology to patients and providers.