Presentation
User Interface Design Taxonomy: A Systemic and Repeatable Method for Identifying and Categorizing Design Differences in Combination Products
DescriptionProposed generic drug-device combination products (DDCPs) submitted for FDA approval through the Abbreviated New Drug Application (ANDA) pathway require a comparison to the reference listed drug (RLD). An important part of this process is the identification of differences between the user interfaces of the two products, specifically an assessment of whether the design differences qualify as “minor” or “other”. When “other” design differences are present, additional supportive data or information are needed to establish if the proposed generic will be substitutable for the RLD.
As outlined in the FDA draft guidance, Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA (January 2017), comparative analyses provide an important framework for identifying and evaluating user interface differences between the proposed generic and RLD. “Other” design differences can be defined as user interface changes that may impact an external critical design attribute involved with administration of the drug product. However, industry continues to face challenges in understanding the impact of a change and, therefore, how to categorize design differences as “minor” or “other”.
Through an FDA-funded research initiative, we developed of a visual taxonomy of DDCP user interface (UI) design attributes. The purpose of the taxonomy is to provide a repeatable process to add structure and standardize the identification and classification of differences in design attributes between DDCP UIs. The process to develop the taxonomy involved generating a content library of DDCP types by creating a comprehensive list of combination products, developing a visual classification system based on design attributes, referencing design standards (e.g., ANSI/AAMI HE 75), creating a visualization of each category including written descriptions, and validating the taxonomy.
The current taxonomy is a hierarchical structure that can be used to classify UI features associated with either (1) labeling or (2) device UI interaction points. Whether assessing labeling or interaction points, the taxonomy breaks each component into applicable categories and subcategories/descriptors used to distinguish the UI design feature. A prototype visual taxonomy was developed for the purposes of using the card sorting technique to identify differences between design attributes. For each UI design feature a “card” was developed to visually display the design feature. The card includes the title (name) of the design feature, a colored border corresponding with the top-level category the design feature falls within, a descriptive image, and a brief definition of the feature. Physical cards were initially created to further the development of the taxonomy ensuring each category/subcategory was inclusive of all design features.
Through iterations of classifying UI design features using specific DDCPs, the hierarchy of the taxonomy was structured to facilitate use. A hierarchy of categories, sub-categories, and descriptors was finalized. After selecting the group type (Labeling or Interaction Point) for assessment, every design feature can be identified by “Category”. Categories related to labeling include (1) training materials, (2) patient labeling, (3) on-device labeling, (3) other labeling. For UI interaction points, features can be identified as falling within one of the following categories: (1) software GUI, (2) software input, (3) physical output to user, (4) informational output to user, (5) fundamental elements, (6) physical integrated controls, (7) safety related features, or (8) other interaction points. Each category has associated subcategories and descriptors to further define the design attribute.
To further facilitate use, a Microsoft Excel spreadsheet was created to enable users to easily use the taxonomy to classify design features by linking them to specific tasks and user groups. The process for utilizing the Excel spreadsheet begins by the human factors expert creating a detailed task analysis of the product. For each subtask, the expert identifies associated UI design attributes and categorizes the attribute by selecting the group, category and subcategory on the line(s) associated with the task or subtask. Finally, appropriateness to the intended user group can be specified by selecting the physical or sensory constraints required to complete the task.
A detailed set of instructions has been created along with an electronic copy of the taxonomy cards. The instructions include a detailed slide deck outlining the objective and underlying theory of the taxonomy. The instructions provide a detailed definition for each category, subcategory, and descriptor and ends with an example of how the taxonomy was used to classify design features for a common inhaler design. It specifically walks the user through the process of using the taxonomy Excel spreadsheet for classifying the task of loading the medication.
As outlined in the FDA draft guidance, Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA (January 2017), comparative analyses provide an important framework for identifying and evaluating user interface differences between the proposed generic and RLD. “Other” design differences can be defined as user interface changes that may impact an external critical design attribute involved with administration of the drug product. However, industry continues to face challenges in understanding the impact of a change and, therefore, how to categorize design differences as “minor” or “other”.
Through an FDA-funded research initiative, we developed of a visual taxonomy of DDCP user interface (UI) design attributes. The purpose of the taxonomy is to provide a repeatable process to add structure and standardize the identification and classification of differences in design attributes between DDCP UIs. The process to develop the taxonomy involved generating a content library of DDCP types by creating a comprehensive list of combination products, developing a visual classification system based on design attributes, referencing design standards (e.g., ANSI/AAMI HE 75), creating a visualization of each category including written descriptions, and validating the taxonomy.
The current taxonomy is a hierarchical structure that can be used to classify UI features associated with either (1) labeling or (2) device UI interaction points. Whether assessing labeling or interaction points, the taxonomy breaks each component into applicable categories and subcategories/descriptors used to distinguish the UI design feature. A prototype visual taxonomy was developed for the purposes of using the card sorting technique to identify differences between design attributes. For each UI design feature a “card” was developed to visually display the design feature. The card includes the title (name) of the design feature, a colored border corresponding with the top-level category the design feature falls within, a descriptive image, and a brief definition of the feature. Physical cards were initially created to further the development of the taxonomy ensuring each category/subcategory was inclusive of all design features.
Through iterations of classifying UI design features using specific DDCPs, the hierarchy of the taxonomy was structured to facilitate use. A hierarchy of categories, sub-categories, and descriptors was finalized. After selecting the group type (Labeling or Interaction Point) for assessment, every design feature can be identified by “Category”. Categories related to labeling include (1) training materials, (2) patient labeling, (3) on-device labeling, (3) other labeling. For UI interaction points, features can be identified as falling within one of the following categories: (1) software GUI, (2) software input, (3) physical output to user, (4) informational output to user, (5) fundamental elements, (6) physical integrated controls, (7) safety related features, or (8) other interaction points. Each category has associated subcategories and descriptors to further define the design attribute.
To further facilitate use, a Microsoft Excel spreadsheet was created to enable users to easily use the taxonomy to classify design features by linking them to specific tasks and user groups. The process for utilizing the Excel spreadsheet begins by the human factors expert creating a detailed task analysis of the product. For each subtask, the expert identifies associated UI design attributes and categorizes the attribute by selecting the group, category and subcategory on the line(s) associated with the task or subtask. Finally, appropriateness to the intended user group can be specified by selecting the physical or sensory constraints required to complete the task.
A detailed set of instructions has been created along with an electronic copy of the taxonomy cards. The instructions include a detailed slide deck outlining the objective and underlying theory of the taxonomy. The instructions provide a detailed definition for each category, subcategory, and descriptor and ends with an example of how the taxonomy was used to classify design features for a common inhaler design. It specifically walks the user through the process of using the taxonomy Excel spreadsheet for classifying the task of loading the medication.
Event Type
Oral Presentations
TimeTuesday, March 2611:00am - 11:30am CDT
LocationContinental Ballroom, Lobby Level
Medical and Drug Delivery Devices