Presentation
From Continuity to Competitive Edge - How Long-Term Collaboration Drives Faster, Frictionless, HF Program Success
SessionPoster Session 2
DescriptionDrug-device combination products often rely on platform devices used across multiple pharmaceutical partnerships. This is particularly relevant for nebulizers and other delivery systems such as Pre-filled syringes (PFS’s), autoinjectors (AI’s), and dry powder inhalers (DPI’s). Due to both commercial interests and increasingly stringent regulatory requirements, human factors (HF) testing has become a critical and resource-intensive component for both pharmaceutical companies and regulatory bodies.
Although platform devices may have undergone extensive HF testing in previous combination product programs, proprietary data is typically locked within individual partnerships and cannot be shared or reused. However, beyond proprietary data, significant learnings from past programs can be leveraged to set up the design of new HF studies — helping to speed up the HF program, reduce the risk of regulatory rejections, and avoid costly rework. Submission processes will be more efficient for pharmaceutical companies, highly reducing the risk of unnecessarily extended timelines for the overall program.
In the long-standing collaboration between PDD (HF study vendor) and PARI (device manufacturer), it has become evident that a strong and efficient partnership can deliver consistent, streamlined HF services to pharmaceutical clients:
- Regulatory bodies such as the FDA acknowledge the continuous development of the platform across programs, which is reflected in fewer comments in the reviews regarding instructions for use, consistent feedback on the study protocol, and requested comparisons with existing platform devices.
- Learnings are embedded into risk management strategies, enabling the design of mitigations independent of past liabilities, reducing the need for redundant formative testing and avoiding re-testing from ineffective interventions.
- Transparency that all known possible improvements have been taken into account – despite the design limitations of a platform product - and that existing experience has been incorporated into a robust combination product, underlining the nature of an iterative human factors engineering process.
Key contributions include:
- Developing universally applicable labeling strategies
- Creating robust instructions for use that integrate seamlessly into combination product labeling
- Incorporating proven moderation techniques and smart test scenarios into draft study protocols
- Defining critical tasks for long-term treatment products. These elements support efficient study execution and smooth progression to summative testing. By minimizing device familiarization time for the team involved, setting realistic task acceptance criteria and optimizing test durations, the approach enhances usability demonstration while conserving resources.
This poster outlines how strategic collaboration and experience-based product design and study execution can improve HF testing outcomes in the development of combination products.
Although platform devices may have undergone extensive HF testing in previous combination product programs, proprietary data is typically locked within individual partnerships and cannot be shared or reused. However, beyond proprietary data, significant learnings from past programs can be leveraged to set up the design of new HF studies — helping to speed up the HF program, reduce the risk of regulatory rejections, and avoid costly rework. Submission processes will be more efficient for pharmaceutical companies, highly reducing the risk of unnecessarily extended timelines for the overall program.
In the long-standing collaboration between PDD (HF study vendor) and PARI (device manufacturer), it has become evident that a strong and efficient partnership can deliver consistent, streamlined HF services to pharmaceutical clients:
- Regulatory bodies such as the FDA acknowledge the continuous development of the platform across programs, which is reflected in fewer comments in the reviews regarding instructions for use, consistent feedback on the study protocol, and requested comparisons with existing platform devices.
- Learnings are embedded into risk management strategies, enabling the design of mitigations independent of past liabilities, reducing the need for redundant formative testing and avoiding re-testing from ineffective interventions.
- Transparency that all known possible improvements have been taken into account – despite the design limitations of a platform product - and that existing experience has been incorporated into a robust combination product, underlining the nature of an iterative human factors engineering process.
Key contributions include:
- Developing universally applicable labeling strategies
- Creating robust instructions for use that integrate seamlessly into combination product labeling
- Incorporating proven moderation techniques and smart test scenarios into draft study protocols
- Defining critical tasks for long-term treatment products. These elements support efficient study execution and smooth progression to summative testing. By minimizing device familiarization time for the team involved, setting realistic task acceptance criteria and optimizing test durations, the approach enhances usability demonstration while conserving resources.
This poster outlines how strategic collaboration and experience-based product design and study execution can improve HF testing outcomes in the development of combination products.
Authors
Event Type
Poster Presentation
TimeTuesday, March 244:45pm - 6:15pm EDT
LocationRhinelander Gallery
Medical and Drug Delivery Devices