Usability Works

Whether you’re a startup seeking to disrupt the market or an established manufacturer navigating the complexities of global regulatory compliance, Carilion Usability Works provide end-to-end usability engineering expertise that delivers both competitive advantage and peace of mind. Our consulting services combine tailored strategies with objective, verifiable test data—empowering our clients to make confident design decisions that accelerate development and reduce risk.

Our methods are grounded in nearly a century of behavioral and cognitive science research, applied through rigorous experimental protocols and advanced statistical analysis. This evidence-driven approach removes subjectivity and ambiguity from the design process, ensuring safer, more effective, and more user-friendly medical devices.

Our core service offerings include comprehensive risk management support, formative and summative usability testing, structured use-related risk and task analyses, and the creation of clear, audit-ready human factors documentation. Leveraging Carilion’s state-of-the-art Center for Simulation, Research and Patient Safety as a dedicated testing hub and drawing on Carilion’s exceptional clinical practitioner depth and expertise, we provide unmatched realism and clinical insight throughout the design and evaluation process.

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

• IEC 62366-1:2015/AMD1:2020 – Application of usability engineering to medical devices
• EN ISO 14971:2019 – Application of risk management to medical devices
• ANSI/AAMI HE75:2009/(R)2018 – Human factors engineering design guidance
• FDA Guidance (2016) – Applying Human Factors and Usability Engineering to Medical Devices
• EU MDR 2017/745 – Guidance on Human Factors and Usability Engineering

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.