Understanding the when, why, and how - Eurofins Human Factors MD helps clients develop safe and effective therapies, one human factors study at a time

Christina Mendat, President, Eurofins Human Factors MD

If you read our last newsletter issue, you know that Human Factors MD is a proud new member of the Eurofins family. If you aren’t familiar with human factors (HF) testing, the goal is to ensure products can be used as intended. The objective of a clinical trial is to demonstrate that a medicine or therapy is safe and effective, by administering it to patients and seeing how they respond. The purpose of human factors testing, however, is to ensure that the intended users of these medicines or therapies CAN give them safely and effectively. After all, the medicine can’t work if not delivered correctly.

Our most important and effective tool is called a simulated-use test, where the participants attempt to learn and use the products just as they would in real life, usually without help or training. These can occur at any point in the product development process. As a general rule, HF testing should be happening throughout your development process - and the sooner it starts, the better. However, the scale of what you do and how will depend on the functional complexity of your product and the risk it poses to your users. If you are developing a novel combination product, you might scale your HF testing to include early user research, requirements definition, use-related risk analyses, formative tests, and a final HF validation test. If you are using an off-the-shelf delivery vehicle, you might scale this program significantly down. Let us help you figure it out at: www.humanfactorsmd.com/