PREVIEW: Early Feasibility Studies Playbook
Gathering Community Feedback Before Final Release
Pre-Release Document – Not for Public Distribution
This document is a pre-release draft and is provided for review purposes only. It is not intended for public use, publication, or dissemination. MDIC welcomes and appreciates feedback on this pre-release document.
Overview
This 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.
Appendices
EFS Budgeting Template
Site Feasibility and Qualification Information
EFS-FDA Engagement Checklist
MDIC EFS Explorer is an interactive tool designed to increase transparency and operational insight across the U.S. Early Feasibility Study (EFS) landscape. The platform aggregates publicly available clinical trial data to visualize EFS activity by therapeutic area, sponsor, and clinical site.
The intent is to support more informed decision-making by identifying patterns in site participation, geographic concentration, and study volume — ultimately enabling more strategic site selection and broader adoption of EFS best practices.
We welcome your review and feedback on the current version. In particular, we would value input on:
- Usability and clarity of the interface
- Relevance and completeness of data fields and filters
- Additional features or metrics that would increase value
- Any gaps or inaccuracies identified
Access EFS Explorer here: https://efs-explorer.com/