Presentation
MDD23 - Service personnel are human too - From transparent users to usable tools. Applying human factors to servicing and maintenance of medical devices.
DescriptionInstalling and servicing is an often-overlooked aspect of medical devices, which can cause safety issues, corrective field actions, reduced clinical performance, and affect cost. Human Factors can have an indispensable role in addressing these shortcomings, and such considerations should be integrated throughout the entire product development process from the outset, a new approach applied in Medtronic's recent projects.
Human Factors is commonly underutilized when it comes to the planning for the installation and maintenance of medical devices. Usually, the development of the installation process occurs towards the project's end, when the deadline is approaching, resources are short, and may not have been included in usability evaluations, formative and/or summative. Moreover, the tools utilized for medical device installation are not always categorized as medical devices themselves, which influences the company process requirements and the definition of the user group relevant to these tasks. These challenges can be addressed successfully by incorporating Human Factors process and work in the service side of the project.
In recent Medtronic projects, the approach of applying the Human factors process in creating service tools, ensured safe and effective use while maintaining regulatory compliance and improving business results. The successful redesign of the installation workflow resulted in field issue prevention, higher satisfaction, and improved utilization. For example, calibration and qualification tasks, which take meaningful time and can take up to 12 hours, can be reduced meaningfully by providing a guided workflow, simplifying tasks, and adding automation to cognitively demanding tasks. The key takeaway includes the methods, advocacy, and execution applied to approach and succeed in this effort and will allow practitioners to use them as well.
The significance of this topic is underscored by regulatory requirements that directly refer to service and the growing complexity of medical devices, where Human Factors can take a more comprehensive role in the entire lifecycle of medical devices beyond the clinical setting. This approach fosters improved device usability, compliance, and business outcomes.
Human Factors is commonly underutilized when it comes to the planning for the installation and maintenance of medical devices. Usually, the development of the installation process occurs towards the project's end, when the deadline is approaching, resources are short, and may not have been included in usability evaluations, formative and/or summative. Moreover, the tools utilized for medical device installation are not always categorized as medical devices themselves, which influences the company process requirements and the definition of the user group relevant to these tasks. These challenges can be addressed successfully by incorporating Human Factors process and work in the service side of the project.
In recent Medtronic projects, the approach of applying the Human factors process in creating service tools, ensured safe and effective use while maintaining regulatory compliance and improving business results. The successful redesign of the installation workflow resulted in field issue prevention, higher satisfaction, and improved utilization. For example, calibration and qualification tasks, which take meaningful time and can take up to 12 hours, can be reduced meaningfully by providing a guided workflow, simplifying tasks, and adding automation to cognitively demanding tasks. The key takeaway includes the methods, advocacy, and execution applied to approach and succeed in this effort and will allow practitioners to use them as well.
The significance of this topic is underscored by regulatory requirements that directly refer to service and the growing complexity of medical devices, where Human Factors can take a more comprehensive role in the entire lifecycle of medical devices beyond the clinical setting. This approach fosters improved device usability, compliance, and business outcomes.
Event Type
Poster Presentation
TimeTuesday, March 264:45pm - 6:15pm CDT
LocationSalon C
Digital Health
Simulation and Education
Hospital Environments
Medical and Drug Delivery Devices
Patient Safety Research and Initiatives