MDIC created a “How-To” video to accompany its report on Maximizing Patient Input in the Design and Development of Medical Device Clinical Trials. The goal of this video series is to help medical device sponsors understand how to implement key recommendations from the...
SPI Guiding Principles
The SPI Guiding Principles are defined as information that does not fall into a specific Medical Device TPLC phase. This is information that is applicable across all TPLC phases. The themes referenced in the SPI Guiding Principles include topics on patient engagement, communicating risk, benefit, and uncertainty, and maximizing Patient input in medical device design.
SPI Guiding Principles
Video Release of MDIC’s Maximizing Patient Input in the Design and Development of Medical Device Clinical Trials
In conjunction with its release of the Maximizing Patient Input in the Design and Development of Medical Device Clinical Trials, MDIC issued a short video in which several experts involved in writing the report, including a patient who uses a medical device patient,...
MDIC’s Maximizing Patient Input in the Design and Development of Medical Device Clinical Trials Report
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...
MDIC Patient Engagement Forum: Communicating Benefit, Risk & Uncertainty – Lessons Learned Report
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...
Parkinson’s Patients’ Tolerance for Risk and Willingness to Wait for Potential Benefits of Novel Neurostimulation Devices: A Patient-Centered Threshold Technique Study (PCOR Project Aim 2 paper)
A growing literature has developed identifying outcomes that matter to patients. The study that these published articles (Aims 1, 2 & 3 of MDIC’s PCOR project) are based on demonstrates an approach to identifying outcomes of medical devices for Parkinson’s disease...
MDIC’S 2020 Patient Engagement Forum
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,...
MDICx SPI: Science of Patient Input Report: Communicating Benefit/Risk for Medical Devices Presentation
This slide deck is presented in the webinar video “MDICx: Science of Patient Input Report: Communicating Benefit/Risk for Medical Devices.” Patients that are planning to watch the video may find it useful to review the presentation slides as they provide an overview...
Best Practices for Communicating Benefit, Risk, and Uncertainty for Medical Devices Report
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...
Patient Centered Outcomes Research (PCOR) Project Workshop
In May 2018, MDIC convened a public workshop to review and discuss the outcomes from MDIC’s Patient Centered Outcomes Research (PCOR) project. The workshop featured presentations and panel discussions involving experts from across the medical device ecosystem,...