Medical Device Manufacturer: Human Factors Validation

Challenge

A major manufacturer of infusion pumps asked User Centric to conduct human factors validation testing on a new pump.  The client had conducted formative research but did not have the capacity to scale their research to accommodate the logistics of a human factors validation study.  All research was to be used to apply for pre-market FDA approval.

The client was confident that User Centric would design a successful validation study and author the human factors component of a 510(k) submission, had the capacity to simulate various hospital environments, and could accommodate large scale research.

User Centric Approach

The human factors validation protocol was created based on what was known about the formative human factors research. There were a number of user groups who would be expected to interact with the device differently, including sub-acute and intensive care unit (ICU) nurses. There were also a number of training conditions simulated within each user group with various amounts of training decay imposed. This included simulated group training in a classroom format, as well as simulated self-training and reliance on user manuals and documentation.

The protocol called for a number of tasks to be completed in simulated use environments where representative distractions were present. These distractions included those commonly experienced by nurses in either a sub-acute or ICU environment. Moderators administered tasks to participants in simulated dual patient scenarios in each of these environments. The sub-acute environment was simulated in User Centric’s purpose built usability studio. User Centric’s unique partnership with Northwestern University was leveraged to utilize their SIM lab to create a high-fidelity simulation of a functional ICU.

Moderators followed the human factors validation protocol by administering tasks in each of these environments, recording performance metrics, and later probing on any failures or close calls to understand the root cause of any observed use errors.

Results

The simulated environments and representative tasks in this study allowed observations of realistic nurse behavior and realistic interaction with the pump. In fact, the simulation was sufficiently realistic that some nurses were observed checking vitals on the manikins before interacting with the pump.

By leveraging our experience creating and executing human factors validation protocols, our knowledge of FDA guidelines for simulated use and human factors validation, and our experience simulating user environments, User Centric was able to guide the manufacturer through the human factors aspects of pre-market approval, and provide them with a complete human factors component of their 510(k) submission for this pump.