Oli Gould, design team manager at Owen Mumford said: “We have developed a risk management process that allows us to think more intelligently about hazards to healthcare providers and their patients using medical devices, such as our drug delivery products. We believe that this approach will create more confidence in using the devices, as well as a better outcome and increased compliance among patients.”
The company hopes that the system will allow businesses to consider what is behind the risk and why it’s likely to be an issue.
Gould continued: “While we continue to use the FMEA (failure mode and effects analysis) severity scoring to categorise possible failures into harm and non-harm, our enhanced risk management process allows us to go beyond simply scoring the risk.
“The improved process considers not just how to reduce risk to an acceptable level but how to remove it altogether by addressing user factors within the design and manufacturing of our devices.”
Risks are identified by analysing the user interaction with the device step-by-step with the potential hazards being considered at every step.
As well as eliminating risks to the user, Owen Mumford applies human factors engineering to make it as easy as possible for the end-user to adhere to a treatment regime.
The new process has been tested within the business and is now being rolled out across current products.
Gould added: “We believe that it is essential to focus on safe delivery of healthcare and to ensure that this is factored into the design and development of products. Owen Mumford takes its responsibility in this area very seriously and we are in the process of introducing the new system to all products in development.”