ISSUE: The rise of digital and health technologies is changing the landscape of decision-making in the health care system. Stakeholders are now faced with a dichotomy by which more information is readily available, but the systems in place for harnessing this information are decentralized and inefficient. To combat this, NESTcc is working to be the leading, go-to, organization within the medical device ecosystem for conducting efficient, timely, and high-quality Real-World Evidence (RWE) studies throughout the Total Product Life Cycle (TPLC) for the purpose of enhancing decision-making to improve patient health and outcomes. Rachael Fleurence will lead the discussion, providing an overview of NESTcc and its goal to establish functional and efficient pathways for key stakeholders to generate lower-cost, nearer real-time evidence of sufficient quality for regulatory, coverage, patient, and clinical decision-making. Kathleen Blake will address the need for increased clinician access to information in order to enhance quality of patient care. Naomi Aronson will provide a unique perspective on the importance of Real-World Evidence to coverage decision-making while Owen Faris will speak to the impacts of Real-World Evidence on premarket clearance and regulatory decision-making.
OVERVIEW: The changing landscape of decision-making in health care is catalyzing the need for high-quality Real-World Evidence. For patients, this means more transparent access to information regarding appropriate device use and potential health outcomes. Clinicians benefit from having access to nearer real-time and high-quality information about the quality of care they provide. From a regulatory standpoint, Real-World Evidence can enhance support for premarket clearances and enhancing device safety monitoring. This panel will explore how to ensure Real-World Evidence generation is useful for regulatory, coverage, and clinical decision-making.