Elevating Your RWE Strategy With Direct Patient Input
A Framework for Direct Patient Input (DPI) in Real World Data and Evidence Generation
The Medical Device Innovation Consortium (MDIC) has released a new framework to help the medical device community strengthen the role of patients in real-world data (RWD) and real-world evidence (RWE) generation. The Direct Patient Input in Real World Data Framework is designed to guide manufacturers in collecting, using, and standardizing patient input across the medical device lifecycle. This work supports innovation in medical device development and regulatory submissions by making the patient voice central to evidence generation—improving clinical trial design, post-market surveillance, and patient outcomes.
The Critical Role Direct Patient Input has in RWE Generation
Understanding the patient perspective is imperative for the generation of RWE to guide clinical decision making, patient satisfaction, and product efficacy. Capturing these insights through tools like wearables, digital health platforms, and patient-reported outcomes can help manufacturers and regulators better understand device impact in real-world use. This framework also outlines strategies for gathering and integrating diverse patient voices and highlights how DPI can enhance the quality, relevance, and reliability of RWE used for regulatory decision-making.
How this Framework Can Enhance Your RWE Strategy
- Learn how to use registries and unstructured data sources to gather patient feedback
- Explore best practices for capturing diverse, culturally informed patient input
- Gain new methods to improve data quality, completeness, and usability
- Insight into how Artificial Intelligence and Machine Learning can transform raw data into actionable evidence
Who Should Use This Resource?
This framework is valuable for:
- Medical device manufacturers
- Clinical trial designers
- Regulatory affairs professionals
- Health data scientists
- Patient engagement leaders