Warwick Consulting

01/23/2026

A device’s Instructions for Use (IFU) should not only be easy to read, but also easy to scan. Clinicians rely on clear headings, visuals, and logical flow to find information quickly when it matters.

A well-designed IFU can make a meaningful difference in safe operation.

01/20/2026

Reasonably foreseeable misuse is about predicting what users will realistically do under pressure, even if it’s not how designers intended for them to use the device. If a behavior is predictable, the design must accommodate it and not blame the user.

It’s one of the most common and preventable sources of device-related risk.

01/19/2026

01/07/2026

Regulatory challenges rarely appear overnight. They’re usually the result of early trade-offs catching up later.
Early alignment creates clarity. Late fixes create pressure.

01/05/2026

The core design challenge shifts from "how precise is the robot?" to "how intuitive is the teamwork?"

This means designing for:

→ Strategic Task Allocation: Assigning judgment calls and adaptation to the surgeon, and precise, repetitive actions to the robot.

→ Shared Mental Models: Does the surgeon know what the robot is "thinking"?

→ Clear Communication: How does the robot signal its status and intentions?

The goal is calibrated trust, not blind faith.

What's the biggest hurdle in creating true human-robot teaming in the OR?

01/01/2026

As we step into a new year, clarity and preparation matter more than ever. Warwick wishes you a focused and fulfilling New Year.

12/30/2025

Not every moment worth acknowledging needs a metric attached to it. Grateful for the people and conversations that made this year meaningful.
Thank you for being part of the journey.

12/25/2025

Behind every smooth delivery is thoughtful preparation. Warwick wishes you a Merry Christmas and a joyful holiday season.

12/23/2025

Real clinical environments are loud, busy, and cognitively demanding. Hence, testing should reflect that. Quiet-room studies often hide the errors that only appear under pressure.

Simulating noise, multitasking, and time stress reveals true usability risks.

12/18/2025

Our Boston team got together for a lovely evening.
It was a chance to unwind, connect, and enjoy time outside the usual workday.
Appreciative of the people who make this team what it is.

12/17/2025

This isn't an arbitrary number.

The FDA's "15 users per group" benchmark for summative human factors testing comes from an evidence-based model. The goal is problem-discovery saturation, which is testing enough people to uncover the vast majority of critical use errors.

Key nuance: The 15 must be truly representative of the actual user group. Diversity in skill and experience is non-negotiable.

What's the biggest hurdle in recruiting a representative sample of 15?