Pressures to get to market quicker haven’t eased up any over the past year. Everyone’s looking for an advantage to press home. Developing medical devices that really meet users’ needs will give you that competitive advantage.
And, given how many people die in hospitals each year due to human error (98,000 in the US and nearly 12,000 in England alone), there is an ethical imperative to get it right.
Against this backdrop, the Medical Device School is held in London twice a year, attracting regulators and development organisations from across the EU, and further afield.
Medical device human factors
Following a very successful maiden seminar at the school last November, I recently had the pleasure of returning to present and lead sessions covering the theory and regulatory expectations of Human Factors and, very importantly, its practical application.
Across several “full-on” hours, delegates to the School learned how to deliver a more effective process for product development, incorporating ISO 62366:2015 alongside US and EU regulatory requirements. Delegates took away a tool-kit that enabled them to understand their product’s target user group(s), identify and mitigate risks effectively.
Experiencing User Needs first hand – human factors in action
As you may have come to expect from us, students experienced three full immersion workshops during our all-too brief time together. These workshops are an integral feature of our training events. Delegates experienced first hand some of the key steps in satisfying Human Factors requirements, from identifying User Needs through to identifying and evaluating use related risks!
“A great way to get inside the heads of our users and understand things from their point of view”
The conversation over lunch was full of enthusiasm and eagerness to implement what they’d learned.
Pick up the phone or email us right now about your training needs, because it is never too early.