Usability Engineer CPUX Medical Devices IEC 62366

01. human-centred design process according to ISO 9241-210:2010

• Understanding the basic elements of human-centred design
• 6 principles of human-centred design
• Involving users
• Iteration based on frequent usability evaluation
• Addressing the whole user experience
• Understand the activities of human-centred design and their interdependency
• Understand the purpose of each deliverable of the HCD activities
• Understanding the similarities and differences between IEC 62366-1 / -2 & ISO 9241-210
• Human-centred quality

08. human-centred design maturity

• Determine maturity model & maturity level
• Measures to improve maturity level
• Other maturity models, UX maturity, UX Maturity & UX Strategy

02. usability & user experience according to ISO 9241-11:2018

• Usability & User Experience 
• Difference between usability and user experience
• Effectiveness, efficiency, satisfaction
• Usability metrics of ISO 9241-11:2018 as acceptance criteria for medical devices
• Interactive system, user-system interaction, user interface and user interface element
• Accessibility & assistive technologies
• Avoidance of harm from use

03. planning activities for human-centred design in a project

• Planning activities for a human-centred design project
• Human-centred quality objectives

Practical exercises: 

• Simple examples of user interfaces that illustrate essential features of usability
• Introduction to CPUX-F certification

04. Understand and specify the context of use

elements of context of use

• user, primary, secondary and indirect users and stakeholder, user group profile
• goal, task, environment, resource
• context of use analysis and how to conduct it
• focus group, observation, contextual interview
• as-is scenario
• persona
• task model
• user journey map
• touchpoints

Practical exercises:

Brainstorming - participants think about users, tasks, resources and environment and write them down on post-it notes

07 Evaluate the designs against user requirements

• Usability evaluation in human-centred design
• key differences between usability tests, usability inspections and user surveys for usability evaluation
• understand why interviews and focus groups are unsuitable for usability evaluation

Usability Test

• the main activities in a usability test
• unmoderated usability test
• how to prepare a usability test
• usability test guide
• usability test task
• recruiting of test participants
• activities in a usability test session
• Briefing, pre-test interview, moderation and post-test interview
• usability test report
• usability problem & positive finding
• ratings used for usability findings
• responsibilities in a usability test
• Moderator, note-taker, observer and usability test participant

Usability inspections and user surveys

• usability inspection
• how and why a user survey is used for usability evaluation

Practical exercises:

• Getting to know a tool for unmoderated / crowd usability tests with video recording (e.g. Rapidusertests)
• Formulating test items for a usability test with video recording

05. Specify the user requirements

• User Need / User Requirement
• Relationship between User Need / User Requirement
• Difference between market, organisational and user requirements
• Qualitative and quantitative user requirements
• Acceptance criteria

Practical exercises:

• Identifying User Needs - What does the user really need?

06. Design solutions that meet user requirements

06.1 Design process and deliverables

• Iterative design process
• task models for design 
• use scenario & storyboard
• user system interaction
• information architecture and navigation structure
• card sorting
• prototypes and wireframes
• low-fidelity prototype and high-fidelity prototype
• user assistance
• user interface specification
• ethical design & sustainable design

06.2 Guidance for user interface design

• Interaction principles ISO 9241-110:2020
• Nielsen Heuristics
• Mental Model & Affordance
• User Interface Guideline and Style Guide
• Design Patterns & Stylguides

Practical exercises:

• Formulating usage scenarios using a mobile app / tablet app as an example

01. Usability Inspection

• Overview Usability Testing & Evaluation - Evaluation Methods
• Most important usability evaluation methods
• Selection criteria for Inspection methods
• Inspection methods - Expert Review, Heuristic Evaluation, Usability Inspection, Cognitive Walkthrough
• Classification of the evaluation methods in usability engineering

Practical exercises:

• Carrying out usability inspections at expert level with interaction principles, design rules and sytleguides.

02. Prepare Usability Test

• Select Method - Determine the test method
• Develop a usability test plan
• Create Usability Test Script
• Formulate Usability test tasks
• Formulate Pre- / Post Conditions
• Formulate Success Criteria
• Typical problems in usability test tasks
• Conduct pilot test session
• Recruit test participants

03. Conduct usability test sessions 

• Prepare usability test session
• Formalities for conducting the test
• Briefing 
• Pre-session interview
• Moderation
• Post-Session Interview
• Moderation guidelines
• Typical problems in moderation

Practical exercises:

• Creating a test plan
• Recruiting test participants
• Preparing a usability test
• Conducting a pilot test session and iteratively improving the test script
• Conducting and moderating a usability test sessions

04. Cluster and rate findings

• Evaluate usability test sessions
• Categorise and prioritise findings
• Conduct a KJ workshop

05. Documents findings

• Describe and document findings

Practical exercises:

• Extract and describe findings
• Conducting a KJ workshop
• Writing a usability test report

The usability file according to IEC 62366 

• Structuring the usability file
• Specify requirements for the usability of the device
• Processes for formative and summative evaluation
• Relationship to former terms Verification and validation
• Developing test plan and carrying out and documenting usability tests
• Classify contents; in which file (usability file, risk management file, quality management manual, etc.)
• Which results should be documented and how to link the files

Differences in IEC 62366 / FDA conformity / interaction with ISO 14971

• IEC 62366 and the Human Centered Design Process
• Interaction of IEC 62366 / HCD and risk management according to ISO 14971
• Structure of a usability file, documentation structure
• Evaluation methods like usability testing, Including inspection methods (e.g. evaluations against style and design guidelines, ISO 9241, heuristics)
• Method selection - Participant observation (usability testing) as well as quantitative and qualitative usability evaluations and user surveys
• Documentation of test specifications and test results
• FDA compliance aspects

Analyse and define context of use

• Plan and conduct context of use analysis
• Collect and document context of use information
• Plan, prepare and conduct interview, observation, focus group

Practical exercises:

• Conduct interviews
• Develop and describe persona

Interviews
Develop and describe persona
Analyse and document task models
Define usage requirements

Identify user needs in context of use information
Derive and structure user requirements from user needs
Consolidate user requirements
Work products and roles
Design Thinking & Human Centered Design
Practical exercises:

Derive user needs from context of use information

Analyse and define the context of use

• Plan and carry out context of use analysis
• Collect and document context of use information
• Plan, prepare and conduct interview, observation, focus group

Practical exercises:

• Conduct interviews
• Develop and describe persona
• Analyse and document task models
• Identify and describe Information models
• Identify and describe task objects and their attributes
• Identify and describe scenarios as is 

Define User Requirements

• Identify user needs in context of use information
• Derive User Requirements from needs and structure them
• Consolidate User Requirements
• Work products and roles
• Design Thinking & Human Centered Design

Practical exercises:

• Derive user needs from context of use information
• Formulate User Needs & User Requirements
• Prioritize User Requirements