Overview

Developing medical devices that are 100% safe is virtually impossible. A statement that will remain true as long as humans are part of the equation. Human error is one of the predominant factors in adverse events experienced in healthcare and it is an established fact that ‘human error is inevitable’. You cannot prevent users from making mistakes due to fatigue, ignorance, training decay or over-tasking. What you can do is be aware of human capabilities and constraints and integrate that knowledge into a design that can help users identify their mistake and prevent that such a mistake leads to harm to the patient. The Standards and Guidelines for applying Human Factors Engineering (also ‘Usability Engineering,’) to medical device development processes, are clear. Medical Device manufacturers are expected to identify use error as part of the overall device risks and eliminate or reduce, by design, flaws that allow a likely use error to result in possible harm to the patient. Pre-market submission reviewers expect you to apply good Human Factors Engineering principles and evidence of a focus on known-, expected-, or unanticipated use problems. HFE can be applied to enhance the safety and usability of your product, rregardless of whether you are a start-up company, redesigning an existing product or in the early, middle or late stage of your product development. Enable your team to detect and correct the BIG OOPSES early by embedding a few simple, good Human Factors Engineering principles. It will protect you from having to deal with late design changes, delayed market introductions or, even worse, product recalls Weaver Human Factors Engineering provides professional human factors engineering services and expertise for Medical Device manufacturers. Services provided include User Interface Analysis and Design, User Interface Testing and Evaluation, Product reviews, R&D process analysis&optimization, and Training.