Oli Gould, Design Team Manager at Owen Mumford, says, “We have developed a risk management process that helps us take a smarter approach to potential hazards for healthcare providers and their patients using medical devices like our drug delivery products. We believe this approach will build greater confidence in using our devices, lead to better outcomes, and help patients stick to their treatments more effectively.
Gould believes this new system lets companies look deeper into what’s behind each risk and why it could be a problem.
He says, “While we still use FMEA severity scoring to organize possible failures into categories of harm and no harm, our advanced risk management process goes beyond just assigning risk scores.
“The improved process looks at not only how to lower risk to an acceptable level but also how to eliminate it entirely by factoring user needs into how we design and manufacture our devices.”
Risks are identified by analyzing each step of how users interact with the device, and at every stage, potential hazards are reviewed. In addition to removing risks for all users—including healthcare workers, caregivers, or patients—Owen Mumford uses human factors engineering to make it as easy as possible for end users to follow their treatment plans.
The new process has been tried and tested within the company and is now being rolled out across our existing products.
Gould sums up, “We think it’s vital to focus on delivering healthcare safely and to make sure this is built into the way we design and develop products. Owen Mumford takes this responsibility very seriously, and we’re in the process of bringing the new system to all of our products in development.”