HUMAN CENTERED DESIGN

Transcription

1 HUMAN CENTERED DESIGN Ed Israelski PhD CHFP, Convener of Usability and Ergonomics Working Groups IEC/ISO Retired Director Human Factors, AbbVie Past Co-Chair HFE Committee, AAMI HFE Consultant Roundtable on Health Literacy The National Academies of Sciences, Engineering, and Medicine Communicating Clearly about Medicine: A Workshop November 17,

2 What is Human Factors/Human Centered Design Definition Applying data on human capabilities and characteristics to the design and evaluation of systems and devices Relies heavily on methods of the behavioral sciences and engineering Goal is to make products efficient, safe, easy to learn and use Synonyms: ergonomics, usability engineering, user experience design, user centered design, cognitive ergonomics, macro ergonomics, cognitive engineering, human engineering, etc. 2

3 Ease of Use Awards Abbott

4 Human Factors Core Methods Contextual Inquiry User Profiles: Who? Use Environment: Where? Task Analysis: What? Risk Analysis Estimate Hazards & Risks 4 User Interface Specification Acceptance Criteria Quantified Usability Objectives Iterative Design Rapid Prototyping Simulations Usability Testing Formative (Early Designs) Summative at the End

5 Critical HF Process Steps Contextual Inquiry (Tasks, Users, Environment) Risk Analysis (Use Error Focused) Prototyping and Iterative Design Usability Testing Always Simulated Use Testing Sometimes as part of a Clinical Trial Post Market Analysis 5

6 Types of Usability Testing Formative Done early with simulations and first prototypes Explore user interface concepts Detect obstacles and design defects Explore if usability goals are attainable, but does not necessarily have strict acceptance criteria Summative Done in the final stage of design Need to have acceptance criteria (usability goals for human performance and satisfaction ratings) 6

7 Usability Testing Best Practices Representative users Sample from user population, e.g.: MedTechs, Lab Supervisor, Pathologists, Nurses, Physicians, Patients, etc. Small, but sufficient sample size 5 to 8 for early formative testing 15 to 25 for later summative testing against objectives Real tasks User scenarios based on previous task analysis and risk analysis Realistic use environment (lighting, noise, workflow, etc.) Using real product or reasonable simulation If using simulation for validation, must show equivalency to actual Record what users do and say (usually one-on-one) Think aloud for formative tests 7

8 Summary: HFE Process for Medical Products Systematic and Scientific process is required Contextual Inquiry Usability Objectives Usability Testing with iterative design Design controls are specified by the FDA and recommended by international regulators. A Design History File must be maintained. It is auditable. Formal Risk Management is required to identify use errors that might lead to high levels of risk for patients and end users. Verification is required to show that design outputs meet design inputs. Validation of the user interfaces is required via usability testing against formal acceptance testing, which must reflect customer requirements. Post market surveillance is required to track adverse events and customer complaints via CAPA corrective action preventative action plan. 8

9 Human Factors Standards ANSI/AAMI US Domestic HF Standards [Design Principles Standard] ANSI/AAMI HE 75:2009 Human factors engineering Design of medical devices IEC :2015 Medical devices Part 1: Application of usability engineering to medical devices [Process Standard] IEC TR :2016 Medical devices Guidance on the application of usability engineering to medical devices [Process Tutorial Technical Report] 9

10 Implications of external standards and FDA guidances Bar is being raised for quality of Human Factors Engineering Work US FDA expects more FDA Recognizes major HFE/UE Standards ( ANSI/AAMI HE- 75:2009, IEC :2015 and IEC TR :2016) CDRH New Final Guidance on Medical Devices CDER New Final Guidance on Minimizing Med Errors CDER Draft Guidances for all Medical Products Packaging/Labeling Drug Naming Combination Product HF DRAFT Guidance issued Feb,