Usability Works

Usability Works blends human factors, cognitive science, biomechanics, and advanced simulation to help make medical devices safer, smarter, and more effective. Our usability services align with international standards and regulatory requirements—turning concepts into validated, ready-to-use so...

Usability Services

Whether you’re an early-stage innovator or an established manufacturer navigating global regulatory demands, Usability Works delivers end-to-end usability engineering that drives competitive advantage and de-risks development. We pair tailored strategies with objective, verifiable test data—empowering teams to make confident design decisions that accelerate timelines and reduce use-related risk.

Grounded in decades of behavioral and cognitive science, our methods combine rigorous experimental protocols with advanced analysis to remove subjectivity from the design process. We don’t just summarize raw data—we translate it into clear, actionable insights that leave no ambiguity, enabling the design of safer, more intuitive, and more effective medical devices.

Our core services span comprehensive risk management support, formative and summative usability testing, structured task and use-related risk analyses, and the development of clear, audit-ready human factors documentation. By leveraging Carilion’s state-of-the-art Center for Simulation, Research, and Patient Safety and its deep clinical expertise, we deliver unmatched realism and clinical insight throughout the design and evaluation process.

Clinical context

As part of Carilion—a nationally recognized, nonprofit health system—we tap directly into frontline expertise from nurses, physicians, technicians, and EMS providers. Your design decisions are informed by the people who will actually use your product.

Usability Works is housed inside a state-of-the-art, nationally accredited healthcare simulation center, giving you:

  • Realistic clinical environments
  • Full team simulations and workflows
  • High-fidelity clinical scenarios

Whether you’re refining a digital platform, a surgical instrument, or a patient monitoring system, we provide the context you need to see how your product actually performs—before it reaches users.

Regulatory expertise

We align every usability engineering activity with internationally recognized standards and regulatory guidance, including:

  • IEC 62366-1:2015/AMD1:2020
  • EN ISO 14971:2019
  • ANSI/AAMI HE75:2009/(R)2018
  • FDA Guidance (2016)
  • EU MDR 2017/745

By combining scientific rigor with regulatory insight, Usability Works helps clients de-risk innovation, accelerate regulatory approvals, and design products clinicians and patients can trust.

Contact us

Robert Turner, PhD
Managing Director, Usability Works
Center for Simulation, Research and Patient Safety
Roanoke, VA 24016

usability@carilionclinic.org

 

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