Early Feasibility Study Design
Early human data determines the path to pivotal studies
Key Outcomes
Clear feasibility and early safety data to inform future studies
Early evidence aligned with pivotal requirements
Defined transition plan to pivotal execution
A clinically credible foundation for commercialization planning
Early Feasibility Studies and First-in-Human trials set the technical, procedural, and safety foundation for U.S. market entry. FDA evaluates early human data for feasibility, preliminary safety, device performance, and alignment with the intended use. Sites require clear protocols, defined feasibility endpoints, experienced operators, and predictable operational workflows. When early-stage studies lack structure, enrollment slows, amendments increase, and pivotal planning is delayed.
Our team designs EFS and FIH programs that meet FDA expectations, support downstream pivotal strategy, and establish the evidence required for PMA or De Novo success.
CHALLENGES
When Early Human Trials Lack Structure and Direction
Across early-stage and international MedTech companies, several issues consistently limit progress in early human use
Protocols without clear early feasibility endpoints or safety measures
Site selection that does not reflect FIH capability or procedural experience
Insufficient operational planning for early feasibility studies
Endpoints that do not support subsequent pivotal study design
Investigators without alignment on procedural workflow or device handling
Evidence plans that fail to support PMA or De Novo requirements
These gaps create delays in IRB approval, enrollment, and FDA interaction
OUR PROCESS
How We Structure EFS and FIH Trial Design
UnifiMed designs early-phase studies to generate clean, high-value data that accelerate pivotal readiness
Protocol and Endpoint Development
We develop EFS and FIH protocols that meet FDA expectations by defining feasibility criteria, early safety and technical performance endpoints, procedural workflow requirements, and the evidence elements needed to inform pivotal trial design
Investigator and Site Strategy
We identify first-in-human sites based on prior FIH experience, procedural expertise, throughput capacity, workflow capability, and investigator alignment with early-stage device evaluation to ensure credible and efficient early enrollment
Operational Feasibility Planning
We structure the operational resources required for predictable early execution, including case support expectations, enrollment forecasting, monitoring and safety reporting workflows, and early-phase staffing models that support consistent performance
Regulatory and Pivotal Pathway Integration
We align early-phase design with FDA Pre-Sub feedback, pivotal trial structure, PMA and De Novo evidence requirements, and downstream workflow considerations so early human data directly accelerates regulatory progress and future adoption
Ready to Learn More?
Contact our team to discuss how we can support your EFS and FIH trial needs