Presentation
MDD33 - Which Differences Make a Difference? An Analysis of How Design Differences in a CUHF Study Correspond With IFU Use
SessionPoster Session 1
DescriptionComparative Analyses are conducted in order to examine the proposed user interface (UI) of a generic drug-device combination product (the generic product) and the UI of the reference listed drug (RLD). Differences between the RLD UI and the generic product UI that may be more than minor, categorized as “other” differences, should be minimized during development. The objective of a Comparative Use Human Factors (CUHF) study is to assess the acceptability of “other” differences; to ultimately demonstrate that “the UI of the proposed generic product is non-inferior to that of the RLD so that it may be substituted for the RLD without the intervention of a healthcare provider and/or without additional training prior to use of the generic combination product.”*
Proposed generic products have varying degrees of “other” external design differences from their corresponding RLDs which may impact the critical tasks associated with use of the generic product. These differences often require data from a CUHF study to evaluate whether they introduce new risks when the generic product is substituted for the RLD*. Even if a CUHF study ultimately demonstrates that the use success rate associated with the generic product is similar to the corresponding use success rate for the RLD, the overall user experience can still be impacted by these differences.
This project focused on combination product injection devices where the delivery device constituent part and the drug constituent part were a single entity, such as a pre-filled pen or autoinjector. The objective of this project was to observe how and when participants in CUHF studies interacted with the Instructions for Use (IFU) included with these combination products. In a CUHF study, participants represent existing RLD users, and therefore their experience may allow them to transfer knowledge of injecting with the RLD to their first use of the generic product. However, negative transfer could also occur and lead to use errors. As a result, manufacturers should minimize the “other” differences to maximize the amount of positive transfer. On the other hand, if a generic product is different enough, will the users be more likely to refer to the product’s labeling? Data was collected retrospectively from CUHF studies previously conducted by Core Human Factors, Inc. (Core) to observe how “other” external design differences impacted IFU use.
Five recent CUHF studies were re-analyzed to find instances where participants referenced the IFU of the RLD or generic product. A total of 258 participant sessions were observed for the purposes of this project. All five studies involved devices intended for patients to self-inject at home, but the data analyzed here was otherwise fully blinded. The degree of “other” external design differences for each study was represented quantitatively by the number of critical tasks assessed.
IFU use was first measured in a binary fashion (Did not refer at all and Did refer). If the IFU was referenced, when it was used was recorded (Referred to IFU at start of product use, Referred to IFU at a later point during use of the product). Other data including use events experienced and counterbalancing sequences– whether the participant started the session with the RLD or the generic product first– were analyzed to detect additional trends and patterns.
*Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA: Draft Guidance for Industry (January 2017)
Proposed generic products have varying degrees of “other” external design differences from their corresponding RLDs which may impact the critical tasks associated with use of the generic product. These differences often require data from a CUHF study to evaluate whether they introduce new risks when the generic product is substituted for the RLD*. Even if a CUHF study ultimately demonstrates that the use success rate associated with the generic product is similar to the corresponding use success rate for the RLD, the overall user experience can still be impacted by these differences.
This project focused on combination product injection devices where the delivery device constituent part and the drug constituent part were a single entity, such as a pre-filled pen or autoinjector. The objective of this project was to observe how and when participants in CUHF studies interacted with the Instructions for Use (IFU) included with these combination products. In a CUHF study, participants represent existing RLD users, and therefore their experience may allow them to transfer knowledge of injecting with the RLD to their first use of the generic product. However, negative transfer could also occur and lead to use errors. As a result, manufacturers should minimize the “other” differences to maximize the amount of positive transfer. On the other hand, if a generic product is different enough, will the users be more likely to refer to the product’s labeling? Data was collected retrospectively from CUHF studies previously conducted by Core Human Factors, Inc. (Core) to observe how “other” external design differences impacted IFU use.
Five recent CUHF studies were re-analyzed to find instances where participants referenced the IFU of the RLD or generic product. A total of 258 participant sessions were observed for the purposes of this project. All five studies involved devices intended for patients to self-inject at home, but the data analyzed here was otherwise fully blinded. The degree of “other” external design differences for each study was represented quantitatively by the number of critical tasks assessed.
IFU use was first measured in a binary fashion (Did not refer at all and Did refer). If the IFU was referenced, when it was used was recorded (Referred to IFU at start of product use, Referred to IFU at a later point during use of the product). Other data including use events experienced and counterbalancing sequences– whether the participant started the session with the RLD or the generic product first– were analyzed to detect additional trends and patterns.
*Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA: Draft Guidance for Industry (January 2017)
Event Type
Poster Presentation
TimeMonday, March 314:45pm - 6:15pm EDT
LocationFrontenac Foyer
Digital Health (DH)
Simulation and Education (SE)
Hospital Environments (HE)
Medical and Drug Delivery Devices (MDD)
Patient Safety and Research Initiatives (PS)