MDIC releases a Discussion Guide for patients considering a medical procedure during COVID-19

It is important for patients to feel empowered to make healthcare decisions, understand the benefits and risks associated with medical procedures, and feel comfortable about receiving healthcare, especially during the COVID-19 pandemic (also known as Coronavirus). After realizing that much of the current guidance was focused on helping healthcare professionals safely return to healthcare facilities, […]

MDIC announces Case for Quality Collaborative Community with FDA participation

MDIC announced today that the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) will participate in its Case for Quality Collaborative Community (CfQcc) initiative. The mission of the CfQcc is to convene a collaborative community of diverse stakeholders representing and serving the medical device industry with the goal of transitioning […]

MDIC Seeks Proposals for MedTech Industry Benchmarking via MedTech Joint Security Plan

MDIC is seeking proposals for assistance with collecting, synthesizing and reporting on healthcare industry maturity data and learnings submitted from medical device companies that leverage the MedTech Joint Security Plan (JSP). The goal of this project is to provide a common method and rubric for the medical technology industry to measure cybersecurity maturity and benchmark […]

MDIC Welcomes Jo Carol Hiatt, MD, MBA as its Vice President of Health Economics and Patient Value

The Medical Device Innovation Consortium (MDIC) today announced that Jo Carol Hiatt, MD, MBA has joined the organization as Vice President of Health Economics and Patient Value (HEPV). As VP of HEPV, Dr. Hiatt will facilitate efforts among the MDIC, CMS, private payers and patient advocacy groups to empower medical device companies to better understand the […]

Johnson & Johnson Medical Devices Chief Medical Officer Jijo James named Chair-Elect of the MDIC Board of Directors

The Medical Device Innovation Consortium (MDIC) today announced that its board of directors has elected Jijo James, Chief Medical Officer of Johnson & Johnson Medical Devices Companies, as the new chair-elect of the MDIC board. James has been on the MDIC Board of Directors since 2017 and a member of the MDIC Executive Committee since […]

MDIC releases Best Practices for Communicating Benefit, Risk, and Uncertainty for Medical Devices report

The Medical Device Innovation Consortium (MDIC) has announced the release of Best Practices for Communicating Benefit, Risk, and Uncertainty for Medical Devices. The intent of this report, developed by MDIC’s Science of Patient Input Communication Working Group, is to familiarize all medical device stakeholders with evidence-based practices for communicating the benefits, risks, and uncertainty of medical technology […]

MDIC recognized with RAPS 2020 Patient-Centered Health Award

The Regulatory Affairs Professional Society (RAPS) recently announced the recipients of its 2020 Founder’s Award, Community Leadership Award and Patient-Centered Health Award which are bestowed annually in conjunction with RAPS Convergence, the largest annual conference for the global healthcare regulatory community. The Medical Device Innovation Consortium (MDIC) is honored to be recognized with the 2020 Patient-Centered Health […]

MDIC releases final framework on Real-World Evidence generation for In Vitro Diagnostics

MDIC’s Clinical Diagnostics program today released the final version of its framework Real-World Clinical Evidence Generation: Advancing Regulatory Science and Patient Access for In Vitro Diagnostics (IVDs). Created through a collaborative process between MDIC, FDA CDRH, and industry partners, the framework aims to help industry and FDA consider when and how real-world data might be […]

MDIC seeks applicants for Accelerate Sustainable Capability Pilot Study

The Medical Device Innovation Consortium (MDIC) is seeking medical device manufacturers to participate in the Accelerate Sustainable Capability (ASC) pilot study, which was developed in collaboration with the medical device industry, Information Systems Audit and Control Association (ISACA), and FDA. The ASC pilot study is designed to serve as a way to help manufacturers improve […]

NESTcc Announces First International Research Network Collaborator

NESTcc has announced NorthWest EHealth (NWEH) and Discover-NOW, the Health Data Research Hub for Real World Evidence, as its newest Network Collaborator partnership and first international addition to its Research Network. The Manchester, UK-based NorthWest EHealth, funded by UK Research and Innovation, are world leaders in the innovative and trustworthy use of routinely collected healthcare […]