Presentation
Integrating Live Support Resources Into an HF Validation Test: Practical Considerations and Case Studies
DescriptionIn an HF validation test, it’s important to ensure all available resources intended for real-world use are available to participants to provide a representative user experience and to increase the likelihood of a successful test. For some medical products, these available resources might go beyond more “passive” reference materials like instructions for use or online videos, to include resources such as a customer support line or an on-site manufacturer representative. If a product is expected to have live support resources available in actual use, it is acceptable to include this type of support in the HF validation test. However, determining when and how to use these resources in a representative manner in an HF validation test can be a challenge.
This presentation will address the types of live support resources that might be available as a part of a product’s expected use and consider how best to simulate them in an appropriate and representative manner during an HF validation test. Specifically, we plan to discuss simulating the following types of support that might be available:
• A manufacturer representative, sometimes referred to as a clinical specialist or clinical support, who is expected to be present for initial or all cases involving the medical device being evaluated. This type of role is most often seen with medical devices intended for use in surgical settings, especially those involving particularly complex products.
• A dedicated helpline that users can contact when seeking guidance or answers to specific questions related to product use. This type of helpline might be most commonly available for home-use products.
• Other on-call support, such as dedicated nursing staff, who may or may not be present during device use but are available to provide in-person support as needed. This support might be available for more complex home-use products.
We will supplement this discussion with case studies that consider various approaches and how they might be implemented during an HF validation test. Furthermore, we will discuss practical considerations such as how to consider the appropriate balance between effectively using this live support while avoiding biasing test participants, what constitutes a moderator assist versus simulating live support, and how to report such events in an HF validation test report.
This presentation will address the types of live support resources that might be available as a part of a product’s expected use and consider how best to simulate them in an appropriate and representative manner during an HF validation test. Specifically, we plan to discuss simulating the following types of support that might be available:
• A manufacturer representative, sometimes referred to as a clinical specialist or clinical support, who is expected to be present for initial or all cases involving the medical device being evaluated. This type of role is most often seen with medical devices intended for use in surgical settings, especially those involving particularly complex products.
• A dedicated helpline that users can contact when seeking guidance or answers to specific questions related to product use. This type of helpline might be most commonly available for home-use products.
• Other on-call support, such as dedicated nursing staff, who may or may not be present during device use but are available to provide in-person support as needed. This support might be available for more complex home-use products.
We will supplement this discussion with case studies that consider various approaches and how they might be implemented during an HF validation test. Furthermore, we will discuss practical considerations such as how to consider the appropriate balance between effectively using this live support while avoiding biasing test participants, what constitutes a moderator assist versus simulating live support, and how to report such events in an HF validation test report.
Event Type
Oral Presentations
TimeWednesday, April 211:00am - 11:30am EDT
LocationHarbour A/B
Medical and Drug Delivery Devices (MDD)