MDIC releases report to help sponsors improve device clinical trials by engaging patients

Patient engagement in medical device clinical trials can lead to faster completion of studies, higher retention and compliance, and more streamlined and relevant data. Maximizing Patient Input in the Design and Development of Medical Device Clinical Trials, developed by the Science of Patient Input Participation in Clinical Trials Working Group, highlights benefits of using patient […]

MDIC seeks participants to join Medical Extended Reality Devices working group

MDIC is launching a working group on the evaluation of Medical Extended Reality Devices (MDIC MXR WG). Extended Reality (XR) encompasses augmented and virtual reality and is being explored for a wide range of medical applications including rehabilitation, mental health therapies, pain management, diagnostics, surgery, and image-guided interventions. While these applications present exciting possibilities for […]

MDIC releases report on lessons learned from the Patient Engagement Forum

Last year, MDIC hosted its Patient Engagement Forum 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. MDIC has compiled a report on lessons learned from the forum which is now available for […]

MDIC releases draft blueprint for fingerstick specimens for point of care in Vitro diagnostic medical devices

MDIC is seeking public comment on its Study Design Blueprint for Evaluating Analytical Performance Characteristics of Point of Care In Vitro Diagnostic Devices with Capillary Whole Blood (Fingerstick) Specimens. This document is intended to serve as a study design blueprint for using capillary whole blood (fingerstick) data for analytical validation of IVD tests. This document […]

Project Focused on Using RWE to Convert IVD EUAs to 510(k) Underway

In 2020, MDIC’s Clinical Diagnostics program launched the ‘Open Hand’ project, a process to pave a path for using IVD Real-World Evidence in regulatory submissions. The goals of this project are to provide a transparent process to evaluate new technology and methods; capture “the how” to share with broader community while staying in the pre-competitive space […]

MDIC releases playbook of best practices for shifting organizations to a Culture Of Quality

MDIC has released its Leadership Engagement Playbook of best practices and tools to help leaders move their companies from a culture of compliance to a culture of quality. Created through the Case for Quality Collaborative Community (CfQcc), the playbook aims to help organizations tailor their approach to quality by providing resources to determine which concepts, […]

MDIC seeks candidates to provide feedback on COVID-19 Patient Discussion Tool

MDIC is developing an updated COVID-19 Patient Discussion Tool to help patients better understand the implications of delaying or forgoing medical treatment during the ongoing pandemic. The aim of the tool is not to guide the patient towards a specific conclusion, but to assist them in gathering information potentially important to making a final decision. In […]

MDIC releases draft framework on External Evidence Methods for public comment

MDIC is seeking public comment on its framework External Evidence Methods: Statistical Methods for Leveraging External Data in Regulatory Decision-Making.  This framework intended to help stakeholders navigate their way through the nuts and bolts of leveraging external data. It catalogs different sources of external data and traditional and novel statistical methods applicable to the design and […]

NESTcc welcomes Regenstrief Institute to Research Network

In a partnership to advance the generation of high-quality evidence in medical device evaluation, NESTcc has announced the Regenstrief Institute as the newest Network Collaborator to join the NESTcc Research Network. Based in Indianapolis, Regenstrief Institute is a global leader dedicated to improving health and healthcare through innovations and research in biomedical informatics, health services […]

FDA Participates in MDIC’s New Collaborative Community Enabling Innovations in Pathology

The Medical Device Innovation Consortium (MDIC) announced today that the organization will serve as the convener of the new Pathology Innovation Collaborative Community (PIcc), and that the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) will be a participant. MDIC is convening the collaborative community as a regulatory science initiative […]