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Human Factors Considerations from an Expert Survey for Development of a Portable, Patient Driven Device to Administer Negative Pressure Wound Therapy
DescriptionPressure wounds, also known as ulcers, develop on the lower leg and foot often as the result of poor circulation and diabetic complications that can quickly become deep and chronic. Applying negative pressure wound therapy (NPWT) promotes healing of chronic ulcers by removing excess fluid and assisting in granulation tissue formation. The objective of this research is to develop and assess the efficacy of a non-occlusive device that is easily operably by the patient and successful at delivering low intensity NPWT to lower limb ulcers.
Current NPWT has two key requirements, (1) an occlusive membrane completely covers the wound and surrounding skin to maintain a pressurized environment, and (2) a vacuum pump remains tethered to a patient for the duration of treatment, sometimes lasting multiple weeks. Treatments can be cumbersome, expensive, painful, and require medical personnel to change the dressings every 48-72 hours.
Researchers assembled an advisory group as the first phase of device concept definition and development. The advisory group consisted of 3 field experts and 2 human factors consultants. Consultants participated in 30-minute interviews that covered topics in medical device usability, home-use considerations, existing NPWT benefits and issues, and pressure ulcer patient needs and struggles. These interviews provided both a breadth and depth of insights meant to help the researchers establish empathy and understanding of the abilities and experiences of the target population for the device. Insights from the advisory group became the first set of user needs that informed target product specifications and initial prototypes that were used in an exploratory usability assessment. This presentation will cover what researchers learned from the panel and how those learnings were systematically transformed into properties of a device concept.
From the interviews, researchers validated 8 initially hypothesized user needs covering self-operability, efficacy, adjustability, reusability, breathability, cost, unobtrusiveness, and gentleness. Interviews also uncovered an additional 6 needs that address status clarity and error resolution, ease of set-up, robustness, consistency of use, portability, and quietness. After determining 3 needs to be outside of the scope of current research, the team arrived at 11 user needs and 24 target requirements the device should achieve to deliver those needs.
Improvements in NPWT delivery have the potential to afford pressure injury patients a more comfortable healing process and reduce costs by transferring the burden of care to the home environment. This work provides the first step in quantifying the impacts of human factors engineering and specific design attributes on device use and effectiveness, and increases our knowledge of how to successfully deliver a novel application of non-occlusive NPWT.
Event Type
Poster Presentation
TimeMonday, March 234:45pm - 6:15pm EDT
LocationRhinelander Gallery
Tracks
Medical and Drug Delivery Devices