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 […]

MDIC seeks input on 5-year Computational Modeling & Simulation roadmap

MDIC is in the process of drafting a revised 5-year strategic roadmap for its Computational Modeling and Simulation (CM&S) Program, which is built on a foundation of validation requirements demonstrating regulatory grade simulation results. This roadmap will chart the course of milestones to realize the MDIC CM&S vision of quick and predictable access for patients […]

NESTcc Expands Governing Committee into Digital Health

The National Evaluation System for health Technology Coordinating Center (NESTcc), an initiative of the Medical Device Innovation Consortium (MDIC), today announced the addition of two new members to its Governing Committee: David Feygin, Ph.D., MBA, chief digital health officer and vice president of IT digital health at Boston Scientific, and David Rhew, M.D., chief medical […]

MDIC launches new 5G working group with FDA and industry experts to ensure patient safety

Today, MDIC announced the formation of a working group focused on 5G-enabled healthcare technologies. The goal of this group, championed by FDA, is to bring key stakeholders and ideas from different sectors to improve the process for development and assessment of novel medical devices enabled by 5G wireless communication, while ensuring patient safety. The working […]