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New MDIC Education Series Helps Sponsors Design IVD RWD Studies
MDIC’s Clinical Diagnostics Program has launched a new educational series to help sponsors and regulators who want to use real-world data (RWD) and real-world evidence (RWE) in in vitro diagnostic (IVD) regulatory submissions. Module 1 of the MDIC IVD RWE Education Series the series focuses on study design considerations for an IVD clinical performance study […]
MDIC Celebrates Manufacturing Day with Release of Advanced Manufacturing White Paper
The Medical Device Innovation Consortium (MDIC) joins manufacturers and organizations across the country in celebrating Manufacturing Day 2021. MDIC today released its white paper The Road to Advanced Manufacturing in the Medical Device Industry. The white paper illustrates how a digitalization roadmap can guide a medical device company in its journey to digitally transform its […]
Medical Extended Reality Devices Working Group Seeks Subgroup Participants
The MDIC Medical Extended Reality (MXR) working group will be working to develop a framework to support the safety and effectiveness of 3D-capable MXR devices for surgical planning and procedures, including open and minimally-invasive surgery. The working group currently has four subgroups started to work on the project deliverables which includes: Terminology Subgroup Image Quality […]
MDIC Launches Digital Health Initiative
MDIC announced today the launch of its Digital Health initiative. The range of digital health-related efforts crosses over several existing programs at MDIC, including Data Science and Technology, Clinical Science, and NESTcc. This launch of this new Digital Health initiative recognizes the convergence of connectivity, information, and software in these active programs and provides an […]
MDIC Adds New Board Chair and New Board Members
The Medical Device Innovation Consortium (MDIC) today announced that Dr. Jijo James, Chief Medical Officer, Medical Devices and Global External Innovation at Johnson & Johnson, has begun his role as chair of the MDIC Board of Directors. Additionally, MDIC has added three new members to their Board of Directors: Kevin Sayer, Chairman, President and CEO […]
New MDIC Blueprint Helps Sponsors Develop Fingerstick Point of Care IVDs
Point of care testing (POCT) is performed at or near the site of a patient and provides test results in real time, enabling faster decision-making. Collection of capillary whole blood by fingerstick is one method of sample collection for POCT devices. As the demand for POCT devices that use fingerstick specimens increases, so does the […]
MDIC releases 2020 Annual Report
MDIC is excited to announce the release of our third annual report and share the impact of our work during the 2020 year. This report quantifies and demonstrates the organization’s impact and identifies opportunities for growth and improvement. Highlights of 2020 include MDIC’s response to COVID-19, release of the Early Feasibility Studies Tool Kit for sites and sponsors, recognition […]
MDIC Selects Booz Allen Hamilton to Support its Medical Device Cybersecurity Benchmarking Initiative
The Medical Device Innovation Consortium (MDIC) today announced a partnership with Booz Allen Hamilton to establish a benchmark of the medical device industry’s cybersecurity maturity and create resources to measure maturity over time. The benchmark will serve as a critical source of information and further enable the industry to continue to improve product security. Read the […]
MDIC announces transition of Case for Quality Voluntary Improvement Program from a pilot to a full program
MDIC’s Case for Quality collaborative community (CfQcc) is announcing the transition of the Case for Quality Voluntary Improvement Program (CfQ VIP) from a pilot to a full program. This transition is separate from FDA efforts to develop a program that engages with CfQ VIP. In 2018, MDIC supported the FDA/CDRH’s Voluntary Medical Device Manufacturing and Product Quality Pilot […]
NESTcc Welcomes MedStar Health to Research Network
The National Evaluation System for health Technology Coordinating Center (NESTcc) today announced MedStar Health as the newest network collaborator to join its research network, partnering with the largest health provider in the D.C. region to expand its research expertise and data capabilities for medical device evaluation. Leveraging access to electronic health records, claims, and other relevant […]