MDIC’s Maximizing Patient Input in the Design and Development of Medical Device Clinical Trials Report

Apr 5, 2021Clinical, Discovery & Ideation, Patient Participation in Clinical Trials, Post-Market Monitoring, Regulatory Decision, SPI Guiding Principles

Patient Introduction

This report provides a series of resources to help sponsors maximize patient input in their design and development of clinical trials. In particular, the report offers a series of best practices for device sponsors to identify and engage the “patient voice.”  By encouraging sponsors to take the time and make the effort to build relationships with patient groups and individual patients that are based on a shared commitment to the effort, clear expectations, regular communications, and common terminology, this report offers a practical resource to improve the patient-centricity of medical device trials. Patients may be interested in reviewing this report to better understand the steps and approaches that are recommended for sponsors.


There are key distinctions between device trials and drug trials that present unique opportunities, challenges, and resource needs for engaging patient insights in the device field. In developing this report, MDIC evaluated a series of device trial characteristics (level of invasiveness; outcomes assessment; trial enrollment; and trial design) and prioritized them based upon their relevance for patient engagement. Drawing on existing resources and information identified through a comprehensive literature review and a series of surveys within the device ecosystem, the report provides information, resources, and best practice recommendations that can be used by device sponsors to assist their efforts to gather patient insights for clinical development programs.

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