The term “clinical research” refers to studies, or trials, in which the device is tested in humans. Once a sponsor has sufficient pre-clinical data, the next step is to plan for clinical studies to establish the safety and effectiveness of the product. The Federal Food, Drug, and Cosmetic Act established a risk-based device classification system for medical devices. Each device is assigned to one of three regulatory classes Class I, Class II or Class III, based on the level of control necessary to provide reasonable assurance of its safety and effectiveness and the level of regulatory control. Read about the Total Product Life Cycle here »
A growing body of 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...
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...
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,...
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 created a video to accompany its release of the Combined Survey Report. The goal of this video is to help all stakeholders learn about the three surveys MDIC conducted among medical device industry professionals, patients, and clinical study investigators. The...
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...
Recognizing that the field of patient engagement in medical device clinical trials is evolving, MDIC conducted three surveys about patient engagement activities to better understand the current landscape. Survey participants included medical device and diagnostic...
As the field of patient engagement in medical product development continues to expand, it can be difficult to find useful resources and materials in this area. MDIC undertook a comprehensive literature review in 2019 and 2020 to compile the most relevant information...
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...
Through this project, MDIC brought together six heart failure device companies to work in collaboration to develop an understanding of what matters to patients living with heart failure, especially how those patients might be willing to accept potential risks from...