Daiken Medical, a Japanese Medical Device Manufacturer, were seeking regulatory approval to launch one of their innovative patient-controlled analgesia (PCA) infusion pumps in Europe, with a particular focus on the UK market.
Following a competitive tender, we were selected to conduct an independent Formative Evaluation / Human Factors study of their PCA device, as well as undertake some market research and provide insight on potential European distributors of PCA devices.
In addition to providing a summary of potential European distributors, we carried out a Formative Usability study, complying with IEC 62366-1:2015 Application of Usability Engineering to Medical Devices.
We developed the Human Factors study protocol and recruited a selection of ICU Nurses and Consultant Anaesthetists from our NHS clinical network. We developed an interview script and cognitive walkthrough questions to assess the usability and safety of the PCA device in specific clinical tasks and scenarios. We conducted interviews with the clinical staff and reviewed their interactions with the PCA device, the digital user interface, as well as the device components and consumables.
The various interactions with the device in the clinical tasks and scenarios, including all instances of correct usage, use errors and close calls were analysed and collated in a Formative Evaluation Usability Report, together with additional feedback on functionality, safety and ease of use.
Feedback from the Formative Evaluation Usability Report has been reviewed and design modifications have been implemented following the report’s recommendations. Daiken Medical are now taking the next steps in the regulatory approval process for the device, which aims to give patients safer and easier postoperative pain management.