Accelerating MedTech Product Development with UX and Human Factors Engineering
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This document provides an introduction to human factors and user experience (UX) for medical devices. It discusses Integrated Computer Solutions Inc. and UserWise Inc., two companies that provide UX and human factors engineering services for medical products. The document outlines the human factors process, which includes user research, risk analysis, iterative prototyping and usability testing to develop usable and safe medical devices that are compliant with regulations. It emphasizes applying human factors early in the design process to reduce costs and facilitate regulatory approval.
Accelerating MedTech Product Development with UX and Human Factors Engineering
- 1. Integrated Computer Solutions Inc. UserWise Inc. www.ics.com www.userwiseconsulting.com Introduction to Human Factors and UX Lana Sneath, Human Factors Engineer at UserWise, Inc. Milton Yarberry, Director of Medical Programs, ICS 1
- 2. Integrated Computer Solutions Inc. UserWise Inc. www.ics.com www.userwiseconsulting.com Who is UserWise? 2 UserWise works with medical product companies to: • Fulfill all steps of the Usability Engineering Process • Maintain compliance to applicable standards and regulations: • 2016 FDA/CDRH Human Factors Guidance for Medical Devices • IEC 62366:2007 and/or IEC 62366-1:2015 • IEC 60601-1-6 • ISO 14971.
- 3. Integrated Computer Solutions Inc. UserWise Inc. www.ics.com www.userwiseconsulting.com To inspire usability engineering best practices within medical product companies and to facilitate the development of usable medical products. Company Mission 3
- 4. Integrated Computer Solutions Inc. UserWise Inc. www.ics.com www.userwiseconsulting.com About ICS 4 ● Founded in 1987, 120 employees ● HQ in Boston, offices in the Bay Area and Ottawa ● We provide: ○ UX design services ○ UI development ○ Custom software development services ○ IS0 13485-compliant development process ○ Linux and QNX platform and board support ○ Full end-to-end product realization ○ Qt training ● Our UX First approach means products we design are developed on time and on budget ● We deliver 70+ projects annually for global brands
- 5. Integrated Computer Solutions Inc. UserWise Inc. www.ics.com www.userwiseconsulting.com Boston UX ● User experience (UX) design to help you with your IEC 62366 compliant process ● Offering a full suite of user experience services: ○ Product vision and direction ○ UX design ○ Visual & motion design ○ Voice integration design ○ Usability research and testing
- 6. Integrated Computer Solutions Inc. UserWise Inc. www.ics.com www.userwiseconsulting.com What is Human Factors Engineering, and why is it important? 6
- 7. Integrated Computer Solutions Inc. UserWise Inc. www.ics.com www.userwiseconsulting.com Human Factors Engineering 7 The FDA defines Human Factors as “the application of knowledge about human behavior, abilities, limitations…to the design of medical devices including… • mechanical and software driven interfaces, • user documentation, and • user training …to enhance and demonstrate safe and effective use.”
- 8. Integrated Computer Solutions Inc. UserWise Inc. www.ics.com www.userwiseconsulting.com Why is Human Factors Engineering Important? 8 Conservatively estimated, there are 210,000 preventable hospital deaths annually in the United States. J Patient Saf & Volume 9, Number 3, September 2013
- 9. Integrated Computer Solutions Inc. UserWise Inc. www.ics.com www.userwiseconsulting.com American Combat Deaths by War 9
- 10. Integrated Computer Solutions Inc. UserWise Inc. www.ics.com www.userwiseconsulting.com Implement Human Factors Early in the Development Process 10 Cost WITH Human Factors Development phase (Time) Investment Cost WITHOUT Human Factors
- 11. Integrated Computer Solutions Inc. UserWise Inc. www.ics.com www.userwiseconsulting.com Implement Human Factors Early in the Development Process 11 Cost WITH Human Factors Pass validation testing at first attempt Iterative design - make mistakes early and often Apply correct user requirements, design standards and assumptions Development phase (Time) Investment Cost WITHOUT Human Factors
- 12. Integrated Computer Solutions Inc. UserWise Inc. www.ics.com www.userwiseconsulting.com Implement Human Factors Early in the Development Process 12 Late realization of mismatch between user expectations and product design Applying last-minute design changes Expensive training and support due to ease-of-use issues Apply long-term support costs Development phase (Time) Investment Unexpected validation results – features need to be modified & re-validated Cost WITHOUT Human Factors Cost WITH Human Factors
- 13. Integrated Computer Solutions Inc. UserWise Inc. www.ics.com www.userwiseconsulting.com Glucose Meter Recall 13 What error do you think people might make with this display?
- 14. Integrated Computer Solutions Inc. UserWise Inc. www.ics.com www.userwiseconsulting.com NicoletOne vEEG System (Software) by CareFusion - 2010 Recall 14 ● Software led users to confuse the left and right sides of patient’s brain ● This depiction of brain hemispheres is inherently confusing. The person’s right side is labelled ‘left’ and vice-versa
- 15. Integrated Computer Solutions Inc. UserWise Inc. www.ics.com www.userwiseconsulting.com What are the Human Factors Guidance and Regulations? 15
- 16. Integrated Computer Solutions Inc. UserWise Inc. www.ics.com www.userwiseconsulting.com Code of Federal Regulations (CFR) – Quality System Regulation 16
- 17. Integrated Computer Solutions Inc. UserWise Inc. www.ics.com www.userwiseconsulting.com FDA Focus on Human Factors and Industry Response 17 Quality System Regulations (1996) 1st FDA Guidance, Human Factors (2000) Human Factors Team formed at FDA’s Office of Device Evaluation (2007) FDA boosts organization’s Human Factors Staff (2015) ImprovedapplicationofHF Time and Events Human Factors/Usability for Medical Devices: An Historical Perspective, Ron Kaye Office of Device Evaluation, CDRH, Food and Drug Administration, NIST Workshop on Usability and EHR Technology, June 7, 2011.
- 18. Integrated Computer Solutions Inc. UserWise Inc. www.ics.com www.userwiseconsulting.com FDA Guidances 18
- 19. Integrated Computer Solutions Inc. UserWise Inc. www.ics.com www.userwiseconsulting.com FDA Emergency Use Authorization (EUA) Guidance 19
- 20. Integrated Computer Solutions Inc. UserWise Inc. www.ics.com www.userwiseconsulting.com Human Factors Standards Outside of the US 20
- 21. Integrated Computer Solutions Inc. UserWise Inc. www.ics.com www.userwiseconsulting.com What is the Human Factors Process? 21
- 22. Integrated Computer Solutions Inc. UserWise Inc. www.ics.com www.userwiseconsulting.com The Human Factors Process 22 User Research Risk Analysis Iterative Prototyping & Usability Testing Usability Validation Human Factors Submission
- 23. Integrated Computer Solutions Inc. UserWise Inc. www.ics.com www.userwiseconsulting.com User Research 23 • Who will be the device Users? • What are their characteristics, capabilities, training and background? • How does the user profile impact the potential design? Physicians EMTsSurgeons General Population Elderly Patients
- 24. Integrated Computer Solutions Inc. UserWise Inc. www.ics.com www.userwiseconsulting.com User Research 24 • How is the device intended to be used? • Who would be using the device? • Where would the device be used (intended or not)? • What conditions is the device intended to be used in? Document in the: • Use Specification, • Risk Analysis, and/or • Usability Study Protocol
- 25. Integrated Computer Solutions Inc. UserWise Inc. www.ics.com www.userwiseconsulting.com Known Use Problem Summary 25 Identifying Known Use Problems: Use Problems • 1st Generation Products • Competitive Products • Similar Products Complaints MDRs Literature Internet Data Use-Related Risk Analysis User Interviews Customer Service RecallsSales Representatives For FDA and CE Submissions
- 26. Integrated Computer Solutions Inc. UserWise Inc. www.ics.com www.userwiseconsulting.com Use-Related Risk Analysis (Use FMEA) 26 Use-Related Risk Analysis Analytical & Empirical Methods to Identify Use Errors User Profiles Use Environment
- 27. Integrated Computer Solutions Inc. UserWise Inc. www.ics.com www.userwiseconsulting.com Use Error Definitions 27 Use Error (IEC 62366-1): User action or lack of USER action while using the MEDICAL DEVICE that leads to a different result than that intended by the MANUFACTURER or expected by the USER. Use Error (FDA): User action or lack of action that was different from that expected by the manufacturer and caused a result that (1) was different from the result expected by the user and (2) was not caused solely by device failure and (3) did or could result in harm
- 28. Integrated Computer Solutions Inc. UserWise Inc. www.ics.com www.userwiseconsulting.com Usability Testing 28 • Early-Stage Formative Studies on mock-ups and prototypes • Later-Stage End-to-End Formative Studies to confirm readiness for Validation • Final Summative Usability/Human Factors Validation Testing for regulatory submissions
- 29. Integrated Computer Solutions Inc. UserWise Inc. www.ics.com www.userwiseconsulting.com FDA Guidelines for Design of a Human Factors Validation Study 29 The human factors validation testing should be designed as follows: • Sample size of at least n=15 per user profile. • Participants must be US Residents • Participants must have representative training (or lack of training), and appropriate training decay • Participants must have no prior exposure to the product • Participants must use the device independently and naturally, without interference or influence from the facilitator or moderator. We typically recruit 18 participants per user profile to account for no shows/disqualified participants
- 30. Integrated Computer Solutions Inc. UserWise Inc. www.ics.com www.userwiseconsulting.com Usability Testing Considerations During the COVID-19 Pandemic 30 Special modifications should be made to usability tests to minimize the risk of transmission of the novel coronavirus: ● All participants and the study team should be equipped with necessary PPE, including gloves and face masks ● The study articles, equipment, and surfaces in the study room should be wiped down with disinfectant between study sessions ● The study team should require participants to inform the study team if they show symptoms prior to or within 2 weeks after the study session ● Remote moderation and observation is encouraged ● Government rules and regulations supersede the study protocol
- 31. Integrated Computer Solutions Inc. UserWise Inc. www.ics.com www.userwiseconsulting.com HFE to Accelerate Product Development UX Software 31
- 32. Integrated Computer Solutions Inc. UserWise Inc. www.ics.com www.userwiseconsulting.com Vignette – Safe vs. Easy (per FDA) Human Factors Applying knowledge of human abilities/limitations to device design Usability User Experience - Risk Mitigation - Safe to use - Learnable - Efficient - Delightful
- 33. Integrated Computer Solutions Inc. UserWise Inc. www.ics.com www.userwiseconsulting.com ● USERS AND ENVIRONMENTS Identify and analyze intended users and expected use scenarios and use environments ● HAZARDS AND CONSEQUENCES Identify and explore potential device use‐ related hazards and risks, and their potential clinical consequences ● IMPLEMENT CONTROLS Explore different design alternatives The Reasonableness of the HF/UX Rationale Define intended use, users, environment Identify use related hazards Estimate & prioritize use error risk Implement risk controls Validate safety of use Risk Acceptable? New risks Introduced? Document Process Monitor unanticipated risks in post market Yes YesNo No
- 34. Integrated Computer Solutions Inc. UserWise Inc. www.ics.com www.userwiseconsulting.com Using UX to Feed Regulatory Development DEFINE & ANALYZE RAPID SOFTWARE PROTOTYPING FORMATIVE STUDIES CONVERT PROTOTYPES TO APPLICATION DEVELOP BACK END SOFTWARE Begin Design Controls 21 CFR 820, ISO 13485 - Design Control and QMSIEC 62366 - Human Factors and Usability Standard
- 35. Integrated Computer Solutions Inc. UserWise Inc. www.ics.com www.userwiseconsulting.com Using UX to Feed Development 21 CFR 820, ISO 13485 - Design Control and QMS DEFINE & ANALYZE RAPID SOFTWARE PROTOTYPING IEC 62366 - Human Factors and Usability Standard FORMATIVE STUDIES CONVERT TO FRONT END APPLICATION FRAMEWORK DEVELOP BACK END SOFTWARE ● User research ● Functional analysis ● Task analysis ● Hazard analysis ● Design specifications ● User interface design with Industry leading tools ● Quick, efficient product realization ● UX Specifications ● High Fidelity Prototyping ● Early, inexpensive, design modification ● GUI Navigation, GUI Definition, Summative Criteria ● Documented support for FDA’s HFE/UE report ● Application Framework ● Built in software architecture ● Framework Unit Tests Product Requirements Software and System Specifications Verification and Validation FDA Submission
- 36. Integrated Computer Solutions Inc. UserWise Inc. www.ics.com www.userwiseconsulting.com Vignette: UOUP for Legacy UI SOUP = Software Of Unknown Provenance UOUP = SOUP on a UI = UI without IEC 62366 1) Perform full usability processes on all parts of the UI (5.1-5.9), or 2) Post-market analysis and report , or 3) Rationale to not apply usability procedures to legacy UI
- 37. Integrated Computer Solutions Inc. UserWise Inc. www.ics.com www.userwiseconsulting.com Key Takeaways - How UX Design Streamlines Development High Fidelity Prototypes (pre-engineering) Fewer late stage changes UX Specifications (Conditional UI behaviors “shall show alerts until message received”) Software Engineers UI Definition (Every UI, All Navigation) Test Engineers Define and Prototype (IEC 62366 documentation) HFE/UE Report for 510K
- 38. Integrated Computer Solutions Inc. UserWise Inc. www.ics.com www.userwiseconsulting.com Q&A