The Challenge

A UK-based MedTech company was preparing to submit a next-generation surgical robot for FDA approval. A key requirement? A comprehensive Human Factors (HF) Validation study — conducted on U.S. soil, with U.S. based surgeons, under strict regulatory scrutiny.

The stakes were high. The study needed to show that trained users could safely and effectively use the robotic system under realistic conditions. But simulating "realistic" conditions for a complex surgical device meant more than just a checklist. It meant replicating actual use scenarios involving:

• Appropriately trained surgical teams

• Fully functional robotic surgery systems

• Cadaveric specimens in appropriate lab environments

• A multidisciplinary study team including Human Factors experts, engineers, and clinical support staff

And it had to be done in the U.S. – far from the base of operations.

Logistical Hurdles

Coordinating these elements was a puzzle with hundreds of moving parts. The challenges stacked up fast:

• Aligning multiple surgeons’ schedules for several rounds of procedure simulations, each requiring hours of prep and execution.

• Coordinating surgical teams meant organising the travel, accommodation, training and reimbursement for 68 participants, each attending for 3-4 days.

• Transporting and maintaining surgical robots in a certified cadaver lab in the U.S. – far away from home and the supply of spare parts.

• Sourcing and managing suitable cadaveric specimens in compliance with both ethical and regulatory requirements.

• Ensuring fidelity of the test environment, with operating room conditions, instrument setup, and real-time observation protocols.

• Sending a UK-based HF team to the U.S. for three months, dealing with visas, accommodations, work permits, and time zone coordination — all while staying productive and on schedule.

Everything had to be tightly choreographed. There was zero room for error or delay.

The Outcome

Despite the complexity, the team delivered — on time, and with data robust enough to support the FDA submission.

We handled:

• Full logistical planning and execution of the 3-month U.S. deployment

• On-site coordination of surgical teams, lab staff, and the robotic systems

• Real-time compliance checks to align every aspect with FDA Human Factors guidance

• Post-study analysis and reporting, tailored for regulatory review

The company cleared the HF validation hurdle with confidence — and ultimately, cleared the regulatory path for their breakthrough surgical robot.

Why It Matters

This wasn’t just about ticking regulatory boxes. It was about proving that surgeons could use cutting-edge robotic tools safely, even in the most demanding settings. And it was about bridging the gap between innovation and approval.

When success depends on orchestrating people, systems, and environments across continents, expertise and execution are everything.