Presentation
Validate Smarter, Not Harder: Exploring the Scope of Critical Tasks in an HF Validation Test
SessionValidation/Testing (MDD8)
DescriptionThis presentation will examine the potential for medical product manufacturers to refine the scope of their HF validation test by considering the exclusion of some critical tasks.
For an HF validation test of a medical product, the evaluation activities are crafted to include all tasks that are associated with risks above a certain severity threshold and/or that could result in compromised medical care (i.e., critical tasks). However, there might be opportunities in certain cases to streamline the scope of critical tasks to include only those which are related to a product’s most unique interactions. In doing so, manufacturers could consider excluding critical tasks for which there exists a compelling rationale that they do not require further validation. For example, a manufacturer could consider excluding validation of common contraindications for their product if they are widely accepted contraindications known by clinicians in the field and they have validated such contraindications in the past.
To conduct more efficient (yet still comprehensive) HF validation tests, these sorts of tasks could be considered “out of scope” despite being associated with high-severity risks. In doing so, manufacturers could collect data, run HF validation tests, and analyze the results more efficiently while still maintaining the integrity of the key data. In our work as consultants, this novel approach of limiting the scope of critical tasks has proven effective and acceptable when reviewed by FDA in at least one case, and we have taken a similar approach with other clients more recently when appropriate.
In this presentation, we plan to explore the idea of deeming some critical tasks “out of scope” in an HF validation test. We will first briefly set the stage for the typical approach to developing HF validation test evaluation activities based on critical tasks, and then introduce situations where this traditional approach could be streamlined. We will present the suggested approach of “in scope” and “out of scope” critical tasks and discuss the merits and drawbacks of utilizing such an approach. We will then illustrate through case studies situations for which this approach would be most applicable and effective. Lastly, we will discuss some practical tips for implementing this approach. We will base our guidance on our extensive experience planning for, conducting, and analyzing the results of HF validation tests for a variety of manufacturers.
For an HF validation test of a medical product, the evaluation activities are crafted to include all tasks that are associated with risks above a certain severity threshold and/or that could result in compromised medical care (i.e., critical tasks). However, there might be opportunities in certain cases to streamline the scope of critical tasks to include only those which are related to a product’s most unique interactions. In doing so, manufacturers could consider excluding critical tasks for which there exists a compelling rationale that they do not require further validation. For example, a manufacturer could consider excluding validation of common contraindications for their product if they are widely accepted contraindications known by clinicians in the field and they have validated such contraindications in the past.
To conduct more efficient (yet still comprehensive) HF validation tests, these sorts of tasks could be considered “out of scope” despite being associated with high-severity risks. In doing so, manufacturers could collect data, run HF validation tests, and analyze the results more efficiently while still maintaining the integrity of the key data. In our work as consultants, this novel approach of limiting the scope of critical tasks has proven effective and acceptable when reviewed by FDA in at least one case, and we have taken a similar approach with other clients more recently when appropriate.
In this presentation, we plan to explore the idea of deeming some critical tasks “out of scope” in an HF validation test. We will first briefly set the stage for the typical approach to developing HF validation test evaluation activities based on critical tasks, and then introduce situations where this traditional approach could be streamlined. We will present the suggested approach of “in scope” and “out of scope” critical tasks and discuss the merits and drawbacks of utilizing such an approach. We will then illustrate through case studies situations for which this approach would be most applicable and effective. Lastly, we will discuss some practical tips for implementing this approach. We will base our guidance on our extensive experience planning for, conducting, and analyzing the results of HF validation tests for a variety of manufacturers.
Event Type
Oral Presentations
TimeWednesday, March 278:52am - 9:15am CDT
LocationContinental Ballroom, Lobby Level
Medical and Drug Delivery Devices