Planning your project Overview: Module 1Introducing the design and development processSetting out your product storyDesign development planningPlanning around dependencies and assumptionsGetting teams working togetherCreating prototypesDocumenting design decisionsWrap up: Module 1QuizModule 1TaskDesign Development PlanningTaskRoles and ResponsibilitiesTaskDocumenting design decisions User research: understanding users Overview: Module 2Introducing user researchUnderstanding users in contextUser recruitment, consent and ethicsResearch methodsAnalysis of qualitative insightRepresenting insight back to decision makersWrap up: Module 2Quizmodule 2TaskFraming questions and research designTaskUsing stimulus materials to drive designTaskCoding qualitative responses Design for healthcare Overview: Module 3What is design?Design process in detailDesign controlsDesigning personalised medicineWrap up: Module 3QuizModule 3TaskGenerating design proposalsTaskTesting your proposalTaskBeing inclusive, engaging and adaptive User research: validating your design Overview: Module 4Using research throughout the product development cycleResearch and human factorsGood clinical practicesAdverse event reportingUsability evaluationLongitudinal evaluationClinical evaluationResearch in the real worldWrap up: Module 4QuizModule 4TaskChecklist of the relevance of GCP for your projectTaskOutline usability issues to assessTaskBenefits and challenges of longitudinal research
Question 1 of 4 Why do you need to create a design and development plan? Select one answer below, then click submit. So it can be used as part of a project pitch to potential investors. It is a legal requirement for all medical products So you have a record of all the design decisions made throughout a project. It provides a checklist to make sure you’ve considered and planned all aspects of product development. Question 2 of 4 Which one of these would not apply to a design history file? Select one answer below, then click submit. It contains a record of all the design decisions made in a project and why you made them. It is a requirement for any submission for approval to the FDA. It must be contained within a single spreadsheet. It is recommended to build it into your workflow rather than try to complete it at the end. Question 3 of 4 Which of these categories appears in our risk register format? Select one answer below, then click submit. Failure mode. Individual responsible for causing risk. Failure impact. Date risk occurred. Question 4 of 4 Which of these is not a feature of our design process? Select one answer below, then click submit. User research. Weekly client reviews Iterative sprints. Design verification. Submit answer Next Question Congratulations on completing the quiz. You are now ready to move onto the tasks which will put what you have learnt so far into action. Skip this question