Presentation
A Novel HF User Characteristics Assessment Approach for a New Platform-Based, Breath-Triggered Nebulizer in Inhalation Therapy
SessionPoster Session 1
DescriptionThe development of a new platform-based nebulizer for inhalation therapy faces several challenges. One major issue is the broad and diverse respiratory patient population, which includes a large number of potential target indications. After the device development is completed, pharmaceutical companies often conduct additional comprehensive HF programs including early formative testing with the device, even though their primary focus is on the drug-related components of the combination product. As a result, redundant data is generated, processed, and reviewed repeatedly by regulatory bodies such as the FDA.
To address these challenges, the development needs to ensure that the device design meets the needs and characteristics of a diverse target population with varying respiratory conditions. That allows future pharmaceutical companies to leverage existing device usability test data in their drug-delivery development programs, thereby increasing the likelihood of success in their HF programs for combination products and minimizing the risk of regulatory complications and delays. Furthermore, the introduction of user characteristics provides a more systematic understanding of use errors and their root causes, enabling deeper insights of the test individual and user population. Ultimately, the aim is a more robust design by introducing effective mitigations early on, addressing the true root cause(s) by including detailed user capabilities.
The approach to achieving these goals involves prioritizing disease and user characteristics over a strictly disease-related diagnosis. This includes conducting literature reviews and early research with pulmonologists to explore similarities and differences in symptoms across various respiratory diseases, and translating these symptoms into user characteristics. Additionally, the assessment of user characteristics introduces a novel pillar to support and enhance traditional HF formative and summative testing approaches. This involves using a variety of validated tests and tools to document user characteristics within user studies and strengthen in-depth root cause analyses. User characteristics data collected during early and late prototype testing can provide insights that inform and guide design improvements more effectively.
To address these challenges, the development needs to ensure that the device design meets the needs and characteristics of a diverse target population with varying respiratory conditions. That allows future pharmaceutical companies to leverage existing device usability test data in their drug-delivery development programs, thereby increasing the likelihood of success in their HF programs for combination products and minimizing the risk of regulatory complications and delays. Furthermore, the introduction of user characteristics provides a more systematic understanding of use errors and their root causes, enabling deeper insights of the test individual and user population. Ultimately, the aim is a more robust design by introducing effective mitigations early on, addressing the true root cause(s) by including detailed user capabilities.
The approach to achieving these goals involves prioritizing disease and user characteristics over a strictly disease-related diagnosis. This includes conducting literature reviews and early research with pulmonologists to explore similarities and differences in symptoms across various respiratory diseases, and translating these symptoms into user characteristics. Additionally, the assessment of user characteristics introduces a novel pillar to support and enhance traditional HF formative and summative testing approaches. This involves using a variety of validated tests and tools to document user characteristics within user studies and strengthen in-depth root cause analyses. User characteristics data collected during early and late prototype testing can provide insights that inform and guide design improvements more effectively.
Event Type
Poster Presentation
TimeMonday, March 234:45pm - 6:15pm EDT
LocationRhinelander Gallery
Medical and Drug Delivery Devices