Image courtesy of "The Silver Sheet"
Human Factors Engineering
HFE applies what is known about human limitations and capabilities to the design of products or systems. By incorporating HFE into the development process, the resulting product should be more intuitive and easier to use, resulting in improved compliance and minimizing use related hazards.
More and more medicines are intended for administration without the intermediation of a healthcare professional. The FDA has expressed alarm at the number of reports of medical device errors outside the clinical setting (more than 19,000 from 1997 to 2009). As Ron Kaye, the FDA lead on Human Factors and Devices said, “The reality is dawning on everyone that this stuff is important and it needs a lot of work.”
HFE has been central to Intelliject’s development approach from the very beginning. Intelliject is represented on national and international expert groups on this topic – including Human Factors & Ergonomics Society (HFES) and the Medical Devices for Injection and Human Factors Committees for the Association of the Advancement of Medical Instrumentation (AAMI) – our goal is to set the standard on incorporating HFE into product development. Our development process involves multiple iterations with patients and other users ensuring that every aspect of the final product has been evaluated through the lens of the user.