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Presentation

BD Evolve Human Factors development and testing
Event Type
Poster Presentation
TimeThursday, April 152:00pm - 3:00pm EDT
LocationMedical and Drug Delivery Devices
DescriptionIn the current environment pressures are intensifying to reduce healthcare costs, improve patient convenience leading to potentially better adherence and outcomes, and increase access to effective remote care and treatment. One effect is that health care providers – hospitals, clinicians, payors, and pharmaceutical companies – are focusing on identifying simple solutions to enable patient care delivery in the home setting. On-body injectors that provide a degree of patient autonomy and mobility are being considered for use by biotech and pharmaceutical companies to deliver injectable drug therapies to patients outside of the clinic.

This poster will highlight usability considerations for on-body injectors to promote effective, safe, and wearable drug delivery in non-clinical settings.

We intend to present the body of Human Factors (HF) engineering and testing work conducted on the BD Evolve™ on-body injector. We will demonstrate the evolution of device design in response to feedback from regulators and users. We will also review objective usability data that was gathered via research with over 100 healthcare professionals, lay-users representing patients, lay-users representing caregivers, and patients experienced in undergoing treatment using similar products.
Usability considerations contributed to device development in three phases:
i. Capture user needs via extensive interviewing and prototype demonstrations
ii. Review anthropological and ergonomic data to determine technical specifications relating to usability
iii. Conduct iterative HF formative testing to
a. Assess usability performance,
b. Inform the use risk file,
c. Assess Instructions for Use (IFU) comprehension
Iterative testing and development were performed on the device-user interface (DUI) including:
- Components requiring end-user manipulation
- Electronic user-notifications
- Users’ mental model of the intended use of the product
- IFU comprehension
The poster will provide an overview of each of the phases of development, describe how subjective and objective data was collected to address each aspect of the DUI, and how the DUI evolved over time to reach its current state.
The methods used in this program of HF engineering and testing will also be discussed. Methods include:
- Voice of customer (VOC) research
- Literature reviews
- Usability Risk management
- Human Factors formative testing and study design
- Instructions for Use design and testing
Author
Clinical and Human Factors Program Leader