Advancing Trusted Evidence for Better MedTech Decisions
MDIC Center for Real-World Evidence
MDIC catalyzes the adoption of Real-World Evidence (RWE) to revolutionize medical device innovation and enhance the predictability of regulatory decision-making, ultimately advancing patient care and outcomes. Through its flagship initiative, the National Evaluation System for health Technology (NEST), serving as the central convener for stakeholders across the MedTech ecosystem, MDIC advances the trusted tools, methodologies, and partnerships needed to generate and apply high-quality evidence, enabling more informed healthcare and regulatory determinations.
From Real-World Data to Better Decisions
A study question agnostic, expert-developed, and FDA‑guidance aligned evaluation of a real-world data source’s foundational capabilities to determine whether a data source can reliably generate high‑quality RWD that may support RWE for medical device regulatory submissions.
NEST Mark™ Real-World Data Source: One Evaluation, Distinct Ecosystem Value
FDA Reviewers
Baseline assurance on foundational data source capabilities reduces redundant evaluation across submissions. Reviewers can focus fit-for-purpose assessment on study-specific questions rather than re-establishing basic data source quality.
Industry Sponsors
Faster data source shortlisting eliminates months of wasted diligence and resources on sources lacking basic requirements. More predictable submission packages reduce regulatory uncertainty and support efficient evidence generation timelines.
RWD Partners
Clear, standardized expectations replace ambiguous requirements and source-specific assessments. Reusable evidence packages provide credibility to sponsors and regulators, and a quality goal to improve, differentiating capabilities in a competitive marketplace.
Featured Resource: NEST Data Quality and Research Methods Frameworks for RWE
Turn real-world data into trusted evidence. The NEST Data Quality and Research Methods Frameworks provide practical guidance for evaluating real-world data (RWD), designing rigorous real-world evidence (RWE) studies, and generating reliable evidence to support medical device regulatory decision-making.
From Data to Decisions Across the Device Lifecycle
MDIC catalyzes the adoption of real-world evidence (RWE) to revolutionize medical device innovation and enhance the predictability of regulatory decision-making, ultimately advancing patient care and outcomes. Through its flagship initiative, the National Evaluation System for health Technology (NEST), serving as the central convener for stakeholders across the medtech ecosystem, MDIC partners with collaborators to develop and refine the trusted tools and methodologies, and nurture partnerships needed to generate and apply high-quality evidence, enabling more informed healthcare and regulatory determinations. MDIC’s leadership in real-world data quality, evidence generation frameworks for pre-market evaluation, and translation of regulatory expectations into practical, trusted approaches, drives stakeholder collaboration, accelerates innovation, and strengthens decision-making across the medical technology lifecycle.
Advances Trusted Evidence for More Predictable Pathways
Works alongside manufacturers and regulators to generate real-world evidence that reduces uncertainty, increases confidence, and supports evolving regulatory and payer needs.
Strengthens Confidence in Evidence-Based Decisions
Advances high-quality data, trusted methodologies, and fit-for-purpose evidence approaches that support informed and consistent regulatory decision-making.
Fosters Collaboration to Accelerate Innovation
Convenes stakeholders across the MedTech ecosystem to improve evidence generation, enhance data quality, and drive better outcomes for patients.
Real-World Evidence Resources
NEST Research Methods Framework: A Practical Guide to Real-World Evidence (RWE) for Medical Devices
NEST Data Quality Framework: A Practical Guide to Real-World Evidence (RWE) for Medical Devices
Elevating Your RWE Strategy With Direct Patient Input
Integrating Real-World Evidence Into Evidence Generation Strategies To Expand Payer Coverage and Improve Patient Care
Real-World Clinical Evidence Generation: Advancing Regulatory Science and Patient Access for In Vitro Diagnostics (IVDs)
Join MDIC Innovators Circles
Innovators Circles are MDIC member communities of practice that convene around topics spanning the medical technology ecosystem. These quarterly member-only forums are designed to unite stakeholders across the MedTech ecosystem. Sign up to join Clinical Diagnostics or Clinical Studies/Evidence Generation Innovators Circles.
