Even after granting marketing authorization for a medical device, the FDA continues to monitor how it performs once it is commercially available. Although pre-market clinical trials provide important information on a device’s safety and effectiveness, it is possible that new safety concerns will emerge once the device is widely used by people. FDA has several programs that allow manufacturers, health professionals, and consumers to report problems associated with approved medical devices to make sure that any safety issues are identified and can be addressed. This ongoing, post-marketing surveillance is critically important to ensuring patient safety. Read about the Total Product Life Cycle here »
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...
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...
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,...
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...
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...
The Patient Centered Benefit-Risk (PCBR) Framework introduces the concept of the total product development lifecycle and discusses how patient preference information might be useful at each stage of this lifecycle. The report provides background on the concepts of...