Medical Device Innovation Consortium | Regulatory Science Advancement

New Approach to Clinical Trial Design Helps Medical Devices Better Meet Patient Needs and Priorities
Science of Patient Input Provides a Systematic Approach to Collect, Analyze, and Apply Patient Preferences into the Medical Device Development and Regulatory Process

Read the Press Release Download the Framework
MDIC Publishes First MedTech Cybersecurity Maturity Benchmarking Report
The MDIC Medical Device Cybersecurity Maturity- Industry Benchmarking Online Tool and Report aims to help Medical Device Manufacturers (MDMs) identify the strengths and weaknesses of their cybersecurity and positively impacts public health.

Read the Report
MDIC Announces New Threat Modeling Bootcamp Dates
MDIC Will Host a 5-day Bootcamp in Collaboration with Shostack and Associates; December 12-16
Ready to Volunteer for a Case for Quality Workgroup?
Join one our CfQ Work Groups and get involved in projects that help promote the culture of quality.
EFS Working Groups Update 2 Key Resources
The Master Clinical Trial Agreement (MCTA) working group and Informed Consent and Institutional Review Board (ICF) working group within the Early Feasibility Studies (EFS) program have completed updates to two key EFS resources.

MDIC is the only public-private partnership (PPP) developed to work with government and industry stakeholders in an effort to advance solutions that promote patient access to innovative medical technologies.

Upcoming Events:

Threat Modeling Bootcamp

December 12-16

Latest Headlines:

New Approach to Clinical Trial Design Helps Medical Devices Better Meet Patient Needs and Priorities

November 4, 2022/by MDIC Communications

ARLINGTON, Va.–(BUSINESS WIRE)–A Medical Device Innovation Consortium (MDIC) program today released a new framework that provides U.S. medical device companies a systematic approach for patient-focused clinical trial design to better meet patient needs and priorities. The Science of Patient Input (SPI), with representatives from the U.S. Food and Drug Administration (FDA), patient advocacy groups, and the medical […]

Medical Device Innovation Consortium (MDIC) Partners with PerkinElmer’s Horizon Discovery to Improve Accuracy of Next Generation Sequencing-Based Cancer Diagnostics

October 19, 2022/by MDIC Communications

ARLINGTON, Va.–(BUSINESS WIRE)–The Medical Device Innovation Consortium (MDIC) has partnered with PerkinElmer’s Horizon Discovery to develop and manufacture somatic reference samples (SRSs) to simplify and support validation of next generation sequencing (NGS)-based cancer diagnostics. The SRSs are expected to be commercially available by early 2024, following a rigorous characterization and validation process in collaboration with […]

Medical Device Innovation Consortium Launches Initiative to Improve Accuracy of Next Generation Sequencing-Based Cancer Diagnostics

August 23, 2022/by MDIC Communications

Initiative to develop, manufacture, and validate publicly available somatic reference samples and create public genomic datasets with the potential to be used by sponsors and regulators ARLINGTON, Va.–(BUSINESS WIRE)–The Medical Device Innovation Consortium (MDIC) formally launched its Somatic Reference Samples (SRS) Initiative with a pilot project to improve the validation and regulatory review process for […]