MDIC Patient Engagement Forum: Communicating Benefit, Risk & Uncertainty – Lessons Learned Report

Mar 8, 2021Communicating Benefit, Risk and Uncertainty, Post-Market Monitoring, SPI Guiding Principles

Patient Introduction

As a follow up to its 2020 Patient Engagement Forum, MDIC published a “Lessons Learned Report” to highlight key takeaways from the day-long virtual meeting. This report highlights opportunities to support and enhance communication with patients about medical device benefits, risks, and uncertainty by working closely with healthcare providers, recognizing and supporting patient empowerment and transparency, and designing communications in a variety of formats. Patients may be interested in reviewing this report to enhance their understanding of various approaches to achieving successful communication of information relating to benefit, risk and uncertainty.


This report summarizes the lessons learned and themes emerging from MDIC’s 2020 Patient Engagement Forum. Key topics discussed in this report include:

  • The FDA is committed to patient-centricity and, specifically, the importance of supporting effective communications with patients about the benefits, risks, and uncertainty associated with use of medical devices.
  • It is important to consider the total product lifecycle of an implanted medical device in context of the “cycle of a patient’s life”.
  • Providers play a crucial role in ensuring that information about benefit, risk, and uncertainty is effectively communicated with patients.
  • It is important to test how information is communicated to be sure that it is being understood, especially given distinctions in how people gather and interpret information.
  • Patient decision aids are key in supporting effective shared decision-making between patients and their health care providers.
  • Consider the context when probability information is used to present information about benefits, risks, and uncertainty.
  • Patients should be empowered to evaluate information about benefit, risk, and uncertainty and there should be transparency about where this information comes from and how it is presented.
  • Communications work best when they are delivered in multiple different ways and formats.