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.  

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SPI Guiding Principles

MDIC Video Series: How to Maximize Patient Input in the Design and Development of Medical Device Clinical Trials

MDIC Video Series: How to Maximize Patient Input in the Design and Development of Medical Device Clinical Trials

MDIC created a “How-To” video series 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...

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

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

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...

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)

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...

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

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...