Safety & Usability Testing

Commercialization Process: Safety & Usability Testing


Safety and Usability Testing involves assessing the safety of the technology in the “hands” of the user, and whether the user utilizes the technology properly based on the labeling and/or instruction.  This may be in a laboratory or non-clinical setting, ensuring the technology as a whole is safe.

How this Milestone Reduces Project Risk

Clearing this hurdle ensures that the technology works as intended, as interpreted by the user. Problem identification at this stage can save extensive resources by allowing changes to the design before production.

What to consider at this time

What are the uses, labeling and instructions, and do they fit the intended use and audiences?

Ready to get started?

In this module, you will:

  • Develop the research questions that must be answered for regulatory requirements and marketing needs.
  • Develop questions to ask test participants in order to answer research questions.
Safety and Usability Testing Guide

Use TREAT’s Safety and Usability Testing Guide to inform any necessary changes to prototype before finalizing. Consider revisiting the Concept Evaluation and Regulatory Strategy modules at this stage for a refresher on how to evaluate the design as it is today and the importance of regulatory requirements.

Introduction to Safety and Usability Testing

This presentation will give you an introduction and resources for Safety and Usability testing.