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Developing & Verifying User Interface Requirements

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Developing & Verifying User Interface Requirements DEVELOPING & VERIFYING USER INTERFACE REQUIREMENTS Tara Feuerstein | Human Factors Engineer Kelly GordonVaughn | Program Manager / Principal Human Factors Engineer Farm Design, Inc. MassMEDIC Webinar 05.31.2017 Page 1 of 47 Kelly GordonVaughn | Program Manager / Principal Human Factors Engineer - Research and strategy professional with 20+ years of experience - Responsible for managing and executing all phases of research studies (generative, formative, summative) - Author and contribute to documentation and risk processes - MA in Psychology from Boston University, with a concentration in brain, behavior, and cognition, and a BA in psychology and English literature from the University of South Carolina Tara Feuerstein | Human Factors Engineer - Research and Engineering professional with 5+ years experience - Responsible for executing all phases of research studies (generative, formative, summative) - Author and contribute to documentation, requirements, and risk processes - MS in Industrial Engineering/Human Factors, a BS in Biomedical Engineering, and a BA in Cognitive Science with a concentration in neuroscience, all from the State University of New York at Buffalo Farm Design, Inc. MassMEDIC Webinar 05.31.2017 Page 2 of 47 FARM IS A HIGHLY CREATIVE DEVELOPMENT GROUP THAT IS PASSIONATE & DEDICATED TO IMPROVING PEOPLE’S LIVES. Exclusively healthcare 50+ employees 45+ years of experience Expertise: - Human Factors Engineering ISO 13485 certified - Industrial Design Locations in: - User Interface Design - Hollis, NH - Concept Development - Flex Boston - Advanced Development Innovation Center - Engineering Farm Design, Inc. MassMEDIC Webinar 05.31.2017 Page 3 of 47 INTRODUCTION Farm Design, Inc. MassMEDIC Webinar 05.31.2017 Page 4 of 47 OUTLINE 1. Introduction 2. Background - Requirements & Regulatory History 3. User Interface Requirements (UIRs) - What Are UIRs - Who Should Be Involved - Writing UIRS - UIR Examples - Tracing/Mapping UIRs - Verifying UIRs 4. Conclusion 5. Questions & Comments Farm Design, Inc. MassMEDIC Webinar 05.31.2017 Page 5 of 47 THE PURPOSE OF THIS WEBINAR IS TO DISCUSS HOW USER INTERFACE REQUIREMENTS ARE A SUBSET OF DESIGN REQUIREMENTS AND THUS, SHOULD BE TREATED THE SAME WAY. Farm Design, Inc. MassMEDIC Webinar 05.31.2017 Page 6 of 47 USABILITY REQUIREMENTS IN TERMS OF “THE USER SHALL BE ABLE TO” IS NOT THE BEST APPROACH. Farm Design, Inc. MassMEDIC Webinar 05.31.2017 Page 7 of 47 USER INTERFACE REQUIREMENTS SHOULD BE VERIFIED THE SAME WAYS AS DESIGN REQUIREMENTS (NOT USABILITY TESTING). Farm Design, Inc. MassMEDIC Webinar 05.31.2017 Page 8 of 47 BACKGROUND Farm Design, Inc. MassMEDIC Webinar 05.31.2017 Page 9 of 47 WHAT ARE REQUIREMENTS? REQUIREMENTS ARE CRITERIA FROM WHICH A DEVICE IS DEVELOPED Requirements are mandated by US regulations (21 CFR part 820.30) as well as international regulations (ISO 13485) when developing a medical device and must be part of the Design History File (DHF). Requirements (design inputs) provide: - A way to develop the intended device via design constraints, and - Criteria to test the design against (design verification) to ensure the design output meets the design input. Farm Design, Inc. MassMEDIC Webinar 05.31.2017 Page 10 of 47 REGULATORY HISTORY OF HUMAN FACTORS 2011 2016 FDA (CDRH) issued the Applying Human Factors and Human Factors Draft Usability Engineering to Medical Devices discussing Guidance was finalized. design and testing medical devices applying human factors best practices. 2007 2015 IEC 62366:2007 IEC 62366-1:2015 IEC/TR 62366-2:2016, BSI Medical devices – Medical devices – Standards Publication, Application of Part 1: Application of Medical devices; Part 2: usability engineering usability engineering Guidance on the application to medical devices. medical devices. of usability engineering to medical devices. Farm Design, Inc. MassMEDIC Webinar 05.31.2017 Page 11 of 47 USER INTERFACE REQUIREMENTS (UIRS) Farm Design, Inc. MassMEDIC Webinar 05.31.2017 Page 12 of 47 WHAT ARE UIRS? IEC 62336-1: USER INTERFACE REQUIREMENT: TESTABLE TECHNICAL DESIGN REQUIREMENT FOR A USER INTERFACE CHARACTERISTIC. UIRs ensure the user interface meets usability engineering principles (accommodating human capabilities and constraints, user workflows, and preferences) while mitigating potential risk. UIRs may be developed for: - Software - Hardware - Labeling UIRs can be used to mitigate or decrease high-risk situations by following human factors best practices. - UIRs can not eliminate risk but may reduce the probability of occurrence (e.g., making an alarm volume louder than ambient noise). Farm Design, Inc. MassMEDIC Webinar 05.31.2017 Page 13 of 47 WHAT ARE UIRS? IEC 62366-1 states: The USER INTERFACE SPECIFICATION, in particular, includes design requirements for those elements of the USER INTERFACE that are related to safe use including those that are RISK CONTROLS. IEC 62366-2 states: USER INTERFACE REQUIREMENTS are a principal means to ensure that a USER INTERFACE design ascribes to good USABILITY ENGINEERING principles as well as meets specific needs identified during earlier USER research activities and preferences expressed by the intended USERS. Farm Design, Inc. MassMEDIC Webinar 05.31.2017 Page 14 of 47 WHAT ARE UIRS? Our interpretation of the standard is that it takes a “design with HF in mind first” approach. - The design should have best practice principles built in and verified to confirm. - For example: When developing hardware that has to meet certain temperature or chemical requirements, engineers select materials based on their properties, which can likely meet the requirements. They then verify that the materials were able to withstand a certain temperature/chemical. - Design based on human capabilities and constraints is the same thing. Farm Design, Inc. MassMEDIC Webinar 05.31.2017 Page 15 of 47 HUMAN CAPABILITY AND CONSTRAINTS EXAMPLES: GRIP STRENGTH, VIEWING ANGLE, SHORT-TERM MEMORY Preferred Viewing area Extended Viewing area Farm Design, Inc. MassMEDIC Webinar 05.31.2017 Page 16 of 47 EARLY USER RESEARCH CAN UNCOVER USER PREFERENCES RELATED TO IMPORTANT USER INTERFACE ELEMENTS AND THESE CAN BE DEVELOPED INTO UIRS. Farm Design, Inc. MassMEDIC Webinar 05.31.2017 Page 17 of 47 EARLY USER RESEARCH CAN UNCOVER FINDINGS RELATED TO IMPORTANT USER INTERFACE ELEMENTS AND THESE CAN BE DEVELOPED INTO UIRS. These UIRs may relate to: - Most efficient/effective workflow (and design attributes that provide affordances for workflow). - Preferred size/shape/form factor. - Environmental attributes (lighting, ambient volume, etc.). Farm Design, Inc. MassMEDIC Webinar 05.31.2017 Page 18 of 47 WHO SHOULD DEVELOP UIRS? UIR DEVELOPMENT IS AN INTERDISCIPLINARY ACTIVITY INVOLVING MULTIPLE TEAM MEMBERS AND IS AN ITERATIVE PROCESS. At a minimum, we recommend including team members from the following functional areas: - Human Factors - Design - Marketing - Engineering Farm Design, Inc. MassMEDIC Webinar 05.31.2017 Page 19 of 47 WRITING UIRS Farm Design, Inc. MassMEDIC Webinar 05.31.2017 Page 20 of 47 UIRS SHOULD BE WRITTEN IN A WAY THAT TAKES INTO ACCOUNT THE EXPRESSED USER NEED AND DESCRIBES HOW IT CAN BE MET BASED ON HUMAN CAPABILITY CONSTRAINTS. Farm Design, Inc. MassMEDIC Webinar 05.31.2017 Page 21 of 47 UIRS SHOULD BE WRITTEN IN A WAY THAT TAKES INTO ACCOUNT THE EXPRESSED USER NEED AND DESCRIBES HOW IT CAN BE MET BASED ON HUMAN CAPABILITY CONSTRAINTS. Sources to generate user interface requirements and help you understand human capabilities and constraints: - HE75, Human Factors Textbooks, Anthropometric Standards. Manufacturers might develop just a few or many user interface requirements, depending on the extent to which users interact with the given medical device. – IEC 62366-2 - The right number of requirements depends on the important preferences, safety concerns, and usability issues (e.g. infusion pump vs syringe). Recommendation that manufacturers create a library of requirements to draw from. - Font size at certain distances, brightness level, reading level, actuation force. Farm Design, Inc. MassMEDIC Webinar 05.31.2017 Page 22 of 47 USABILITY REQUIREMENTS IN TERMS OF “THE USER SHALL BE ABLE TO” IS NOT THE BEST APPROACH. UIRs written in “the user shall be able to“ language can lead to: - UIRs that are difficult to verify as they are only able to be verified by usability testing. - Findings that are difficult to report out and can result in more rounds of revision possibly requiring additional testing. We propose that UIRs written in terms of device attributes that take into consideration human capabilities and constraints will lead to: - UIRs that are straight-forward to verify. - More usable and safe products. - Fewer design changes in the development cycle and potentially less testing (no promises!). Farm Design, Inc. MassMEDIC Webinar 05.31.2017 Page 23 of 47 UIR EXAMPLES Farm Design, Inc. MassMEDIC Webinar 05.31.2017 Page 24 of 47 UIR EXAMPLES User Interface Element Expressed User Need User Interface Requirement Control Panel Buttons “Buttons should be large enough so that you do Control panel buttons should be at least 1.5 cm tall and wide. Control panel buttons should be not hit the wrong one accidentally.” spaced at least 2 cm apart (measured center-to-center). Display “I would like the most important parameters to Primary treatment parameter shall be legible from a distance of 6 m (i.e. across the room). stand out so I can read them from a distance.” Handle “I would like the surgical instrument’s handle to fit The handle shall accommodate users with
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