MDIC 2019 ANNUAL REPORT
DATA SCIENCE AND TECHNOLOGY The Data Science and Technology initiative works to fulfill the promise of advances in data analysis by creating tools and methods to use advanced data analysis techniques and new technology to accelerate the collection of clinical data, remove barriers to patient access, and monitor product safety, quality, and effectiveness.
Programs: • Case for Quality • Computational Modeling & Simulation • Cybersecurity • External Evidence Methods
2019 Data Science and Technology Year in Review: The Data Science and Technology Advisory Committee was formed in November 2019 to gather input from government, industry, and non-profit stakeholders to identify high-value data science and technology initiatives and recommend strategic priorities and future directions for MDIC. The committee will focus on modeling and simulation, external evidence methods, cybersecurity, interoperability, artificial intelligence and machine learning, and other technology-based initiatives for devices and diagnostics. In 2020, the committee will develop a multi-year roadmap with recommended areas of focus required to advance regulatory science for patient benefit. The current committee will serve a two-year term.
CASE FOR QUALITY MDIC’s Case for Quality (CfQ) is setting a cultural shift in motion to focus the medical device ecosystem on sustained product quality that enhances patient safety and outcomes and adds value to stakeholder organizations. Through the collaboration of ongoing working groups, representatives from FDA and medical device manufacturers of every size are developing practices, tools, and metrics to enhance product design and manufacturing processes and inform regulatory practices.
Case for Quality Voluntary Improvement Program Governance and Charter Established A governing committee, charter, and initial membership were established. The number of active participants increased to 59 active sites across 27 companies. Of the active sites, 39 percent are located internationally (outside of the United States) and 7 percent are recognized by FDA as small businesses.
CfQ Governance by the Numbers
59 Sites 27 Companies 39% International 7% Small Business PAGE 9
