Patient Introduction

The goal of the Forum was to familiarize a diverse group of medical device stakeholders with key concepts and considerations for successful communication with patients about benefits, risks, and uncertainty associated with the use of medical devices. Additionally, participants had the opportunity to learn directly from individual patients with diabetes, arthritis, chronic pain, and cardiovascular disease about their experiences with medical devices and the quest for information about how these products would impact their health and their overall lives. This input helped participants work together to design sample communications to illustrate the various best practice recommendations from MDIC’s Best Practices for Communicating Benefit, Risk, and Uncertainty Report (Communication Report). Patients may find this material useful to understand how various stakeholders approach and communicate the important concepts of benefit, risk, and uncertainty relating to use of medical devices.


MDIC’s November 18, 2020 Patient Engagement Forum engaged approximately 100 participants, including patients, patient advocates, medical device leaders, regulators, healthcare providers, payers, and experts in communication and shared decision-making. Participants joined in a day-long, interactive meeting focused on communicating benefit, risk, and uncertainty for medical devices. Content for the Forum included presentations, panel discussions, and interactive activities inspired by the best practices and examples contained within the recently released MDIC Best Practices for Communicating Benefit, Risk, and Uncertainty Report.

Overall, this event offered the medical device community a platform from which to evaluate current communications efforts, identify gaps, and prioritize additional needs for advancing progress on this topic. Key lessons learned and themes emerging from the Forum provide the foundation for this report.

Session recordings are available below.

Opening Session

Opening Session
MDIC President and CEO Pamela Goldberg provided an overview of MDIC and its Science of Patient Input (SPI) Program, Jeff Shuren, Director of CDRH at FDA described the Agency’s commitment to patient centricity and support for efforts to enhance communication with patients. David Walton, a fpatient representative, described his first-hand experience in regard to communicating benefits, risks, and uncertainties with medical devices. Scott Goates, Chair of the SPI Communications Working Group, reviewed the forum objectives and agenda.


  • Pamela Goldberg, MBA | President and CEO, Medical Device Innovation Consortium (MDIC)
  • Jeff Shuren, MD, JD | Director of the Center for Devices and Radiological Health (CDRH), FDA
  • David Walton | Patient and Patient Advocate, CEO of T1D Exchange
  • Scott Goates, PhD | SPI Communications Working Group Chair, Senior Advisor, HEOR, Abbott Laboratories

Patient Panel #1: Challenges in Communicating Uncertainty and Benefit/Risk

During this session, a panel of patient experts discussed challenges in communications. Patient advocacy group representatives provided a summary of specific communications challenges experienced by their patient communities.


  • Jijo James, MD (Moderator) | Chief Medical Officer, Johnson & Johnson Medical Devices
  • Anna Legassie | Patient Advocate, Joint replacement patient
  • Jay MacIntosh | Patient Advocate, Spinal cord stimulator patient
  • Julie Eller | Arthritis Foundation Representative
  • Mariann Farrell | American Chronic Pain Association Representative

Key Findings from MDIC Report & Understanding Medical Device Information

Forum attendees learned about the key findings of challenges and best practices of patient communication from MDIC’s Communications Report with a focused introduction of key topics to be used during interactive activities.

Speaker: Wendy Selig | Founder & CEO, WSCollaborative LLC

Forum attendees were presented with some of the key issues identified in the science of communicating medical information followed by an opportunity to ask questions of leading expert in field of communication and comprehension.

Speaker: Ruth Day, PhD | Director, Medical Cognition Lab, Duke University

Interactive Activity #1: Challenges in Communicating Uncertainty and Benefit/Risk

Medtronic’s Innovation Lab facilitated a highly interactive brainstorming session to help identify the different ways in which communication can be challenging. Participants provided perspectives and learned from first-hand experiences with communicating difficult topics about medical devices.

Keynote on Shared Decision Making

During this Keynote Session, attendees heard from Dr. J. Matthew Brennan on shared decision-making and about one approach to effectively communicate medical information to patients. This keynote was followed by commentary from Barry Liden, of Edwards LifeSciences, who provided information on a case study that serves as an example of how patient preferences can be incorporated into shared decision-making.

  • J. Matthew Brennan, MD, MPH | Associate Professor of Medicine, Duke University School of Medicine
  • Barry Liden, JD | Vice President Patient Engagement, Edwards Lifesciences
Patient Panel 2: Best Practices in Communicating Uncertainty, Benefit or Risk

During this panel session, forum attendees learned about success stories in communications from patient experts. Attendees also heard specific patient stories and examples of communications success from patient advocacy group representatives.


  • Sue Peschin, MHS (Moderator) | President & CEO, Alliance for Aging Research
  • Marianne Sherman | Patient Advocate, Pacemaker patient
  • Pat Gray | Patient Advocate, Insulin pump patient
  • Paul Madden, M.Ed. | American Diabetes Association Representative
  • Mellanie True Hills, CSP | Representative

Interactive Activity #2: Learn by Doing: Best Practices in Communication

Medtronic’s Innovation Lab facilitated a communication development exercise among participants during which they conducted a pilot-test of the principles and techniques identified in MDIC’s Communications Report.

Patient Engagement Forum Closing Sessions: Reflection Panel and FDA Next Steps

Stakeholders summarized key findings from the event and provided additional observations from the day. The panel discussed challenges and best practices in communicating benefit, risk, and uncertainty and ways to increase understanding among patients.


  • Barry Liden, JD (Moderator) | Vice President Patient Engagement, Edwards Lifesciences
  • Brett Hauber, PhD | Senior Economist and Vice President of Health Preference Assessment, RTI
  • Jodi Duckhorn, MS | Acting Deputy Director for the Office of Communication and Education, CDRH, FDA
  • Heidi Dohse | Patient Advocate and Professional Heart Patient, Founder & CEO, Tour de Heart

FDA Next Steps: Dr. Michelle Tarver and Alicia Witters from CDRH identify key areas of opportunity for FDA and the medical device community to incorporate some of the lessons learned from the Patient Engagement Forum.


  • Michelle Tarver, MD, PhD |Director of Patient Science and Engagement, CDRH, FDA
  • Alicia Witters | Director, Division of Communication, CDRH, FDA