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MDIC Announces Three New Board Members
The Medical Device Innovation Consortium (MDIC) is pleased to announce the addition of three new members to the Board of Directors: Jim Hollingshead, Kevin Sayer, and Randall L. Rutta. The Board provides leadership for carrying out the Consortium’s mission to promote patient access to safe and effective medical technologies. Jim Hollingshead was appointed president […]
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 […]
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 […]