Early Feasibility Studies Playbook

The Early Feasibility Studies Playbook summarizes key considerations related to EFS regulatory and operational planning, site selection, site reimbursement structures and contracting, and broader ecosystem factors influencing early-stage device evaluation. Developed for sponsors, investigators, research institutions, and clinical partners and informed by insights from the past decade of EFS clinical trials, this resource aims to support the consistent, high quality conduct of EFS programs across diverse organizational settings while ensuring that studies are executed in a manner that is both efficient and resource-conscious.

This playbook is intended to serve as both a practical resource and a strategic guide for organizations seeking to build or strengthen their EFS capabilities in an evolving global landscape. The chapters provided below present a systematic and detailed framework for advancing early-stage medical device innovation while upholding the highest standards of safety, ethics, and scientific quality.