June 27, 2023

The importance of integrating real-world evidence (RWE) into the evidence gathering process for determining the placement of new medical technologies on the market cannot be underestimated. RWE derived from real-world data (RWD) can offer more reliable evidence than traditional evidence generation models, leading to improved patient outcomes, greater access, and faster delivery.

MedTech companies often will generate evidence for one specific purpose at a time, such as waiting for regulatory approval before initiating an outcomes-based study.  While this has served the industry well to satisfy regulatory requirements, it has had the unintended consequence of delaying evidence planning for reimbursement.

Instead, adopting an early and integrated approach across all departments can help optimize evidence generation.  A successful comprehensive strategy will provide decision makers with evidence that is delivered earlier, through more efficient and representative studies, and is better tailored to the payer, provider, and patient.

To facilitate this process, the Medical Device Innovation Consortium has created a comprehensive guide for MedTech companies. It assists in embedding RWE throughout their organization and establishing an enterprise-wide RWE strategy. This strategy drives innovation, expands payer coverage, and increases patient access.


This resource guide includes the following topics and more:

  • The role of RWE in technology innovation
  • The value of real-world evidence in medical innovation
  • Assessing long-term outcomes and expanded indications
  • Increasing the development and use of RWE for medical devices
  • Best practices for developing and assessing the quality of RWD and RWE
  • Incorporating RWE in future strategies