SlideShare a Scribd company logo

How User Experience Design and Human Factors Engineering can Accelerate Product Development

•
•
Greenlight Guru
Greenlight Guru

This document discusses how human factors engineering and user experience design can accelerate medical product development. It recommends implementing these practices early in development to avoid costly changes later. Following standards like IEC 62366 involves user research, usability testing, and risk analysis to identify and address usability issues. This helps ensure medical devices are safe, effective and easy to use as intended.

1 of 38
Download to read offline
How User Experience Design and Human Factors Engineering can Accelerate Product Development 1
Who is UserWise? 3 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.
To inspire usability engineering best practices within medical product companies and to facilitate the development of usable medical products. Company Mission 4
About ICS 5 ● Founded in 1987, 120 employees ● HQ in Boston, offices in the Bay Area and Ottawa ● We provide: ○ UX design ○ Full-stack 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
Boston UX ● Offer a full suite of user experience services: ○ Product vision and direction ○ UX design ○ Visual & motion design ○ Voice integration design ○ Usability research and testing ● IEC 62366 compliant process www.bostonux.com
What is Human Factors Engineering, and why is it important? 7
Human Factors Engineering 8 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.”
Why is Human Factors Engineering Important? 9 Conservatively estimated, there are 210,000 preventable hospital deaths annually in the United States. J Patient Saf & Volume 9, Number 3, September 2013
American Combat Deaths by War 10
Implement Human Factors Early in the Development Process 11 Cost WITH Human Factors Development phase (Time) Investment Cost WITHOUT Human Factors
Implement Human Factors Early in the Development Process 12 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
Implement Human Factors Early in the Development Process 13 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
Glucose Meter Recall 14 What error do you think people might make with this display?
NicoletOne vEEG System (Software) by CareFusion - 2010 Recall 15 ● 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
What are the Human Factors Guidance and Regulations? 16
Code of Federal Regulations (CFR) – Quality System Regulation 17
FDA Focus on Human Factors and Industry Response 18 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.
FDA Guidances 19
FDA Emergency Use Authorization (EUA) Guidance 20
Human Factors Standards Outside of the US 21
What is the Human Factors Process? 22
The Human Factors Process 23 User Research Risk Analysis Iterative Prototyping & Usability Testing Usability Validation Human Factors Submission
User Research 24 • Who will be the device Users? • What are their characteristics, capabilities, training and background? • How does the user profile impact the potential design? • What environmental conditions will the device be used in? Physicians EMTsSurgeons General Population Elderly Patients
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
Use-Related Risk Analysis (Use FMEA) 26 Use-Related Risk Analysis Analytical & Empirical Methods to Identify Use Errors User Profiles Use Environment
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
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
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
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
Human Factors Engineering to Accelerate Product Development Usability UX Software 31
Vignette – Safe vs. Easy (per FDA) Human Factors Applying knowledge of human abilities/limitations to device design Usability User Experience - Risk Mitigation - Safe & effective use - Learnable - Efficient - Delightful
● 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, and test that they’re effective Reasonableness of the HF/UX Rationale (IEC 62366) 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
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
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
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
Key Takeaways - How UX Design Streamlines Development High Fidelity Prototypes (pre-engineering) Fewer late stage changes UX Specifications (Conditional UI behaviors “shall alert until message acknowledged”) Software Engineers UI Definition (Every UI, All Navigation) Test Engineers Define and Prototype (IEC 62366 documentation) HFE/UE Report for 510K
Q&A info@ics.com miles@userwiseconsulting.com

Recommended

Risk Based Classification of Medical Devices and grouping
Risk Based Classification of Medical Devices and groupingRisk Based Classification of Medical Devices and grouping
Risk Based Classification of Medical Devices and grouping
Paulyne Wairimu
 
The European Medical Device Regulations - analysis of the final text
The European Medical Device Regulations - analysis of the final textThe European Medical Device Regulations - analysis of the final text
The European Medical Device Regulations - analysis of the final text
pi
 
Medical Devices Regulation (MDR) 2017/745 - Clinical investigations
Medical Devices Regulation (MDR) 2017/745 - Clinical investigationsMedical Devices Regulation (MDR) 2017/745 - Clinical investigations
Medical Devices Regulation (MDR) 2017/745 - Clinical investigations
Arete-Zoe, LLC
 
User Interface Design for Medical Devices - The Relationship Between Usabilit...
User Interface Design for Medical Devices - The Relationship Between Usabilit...User Interface Design for Medical Devices - The Relationship Between Usabilit...
User Interface Design for Medical Devices - The Relationship Between Usabilit...
UXPA Boston
 
FDA Regulation of Medical Devices
FDA Regulation of Medical DevicesFDA Regulation of Medical Devices
FDA Regulation of Medical Devices
Dr Dev Kambhampati
 
21 cfr, parts 210 211
21 cfr, parts 210 21121 cfr, parts 210 211
21 cfr, parts 210 211
Compliance Insight, Inc.
 
The New EU MDR and What You Need to Know
The New EU MDR and What You Need to KnowThe New EU MDR and What You Need to Know
The New EU MDR and What You Need to Know
EMMAIntl
 
medical device regulatory approval in USA
medical device regulatory approval in USAmedical device regulatory approval in USA
medical device regulatory approval in USA
Suraj Pamadi
 

Recommended

Risk Based Classification of Medical Devices and grouping
Risk Based Classification of Medical Devices and groupingRisk Based Classification of Medical Devices and grouping
Risk Based Classification of Medical Devices and grouping
Paulyne Wairimu
 
The European Medical Device Regulations - analysis of the final text
The European Medical Device Regulations - analysis of the final textThe European Medical Device Regulations - analysis of the final text
The European Medical Device Regulations - analysis of the final text
pi
 
Medical Devices Regulation (MDR) 2017/745 - Clinical investigations
Medical Devices Regulation (MDR) 2017/745 - Clinical investigationsMedical Devices Regulation (MDR) 2017/745 - Clinical investigations
Medical Devices Regulation (MDR) 2017/745 - Clinical investigations
Arete-Zoe, LLC
 
User Interface Design for Medical Devices - The Relationship Between Usabilit...
User Interface Design for Medical Devices - The Relationship Between Usabilit...User Interface Design for Medical Devices - The Relationship Between Usabilit...
User Interface Design for Medical Devices - The Relationship Between Usabilit...
UXPA Boston
 
FDA Regulation of Medical Devices
FDA Regulation of Medical DevicesFDA Regulation of Medical Devices
FDA Regulation of Medical Devices
Dr Dev Kambhampati
 
21 cfr, parts 210 211
21 cfr, parts 210 21121 cfr, parts 210 211
21 cfr, parts 210 211
Compliance Insight, Inc.
 
The New EU MDR and What You Need to Know
The New EU MDR and What You Need to KnowThe New EU MDR and What You Need to Know
The New EU MDR and What You Need to Know
EMMAIntl
 
medical device regulatory approval in USA
medical device regulatory approval in USAmedical device regulatory approval in USA
medical device regulatory approval in USA
Suraj Pamadi
 
Presentation: Manufacturing medical devices
Presentation: Manufacturing medical devicesPresentation: Manufacturing medical devices
Presentation: Manufacturing medical devices
TGA Australia
 
FDA regulation for medical devices
FDA regulation for medical devicesFDA regulation for medical devices
FDA regulation for medical devices
Simrana Fathima
 
8 Steps You Should Be Taking to Implement an EU-MDR Compliance Program
8 Steps You Should Be Taking to Implement an EU-MDR Compliance Program8 Steps You Should Be Taking to Implement an EU-MDR Compliance Program
8 Steps You Should Be Taking to Implement an EU-MDR Compliance Program
Greenlight Guru
 
GHTF
GHTFGHTF
GHTF
KDivya11
 
FDA Focus on Design Controls
FDA Focus on Design Controls FDA Focus on Design Controls
FDA Focus on Design Controls
April Bright
 
ISO: 14971 Quality risk management of medical devices
ISO: 14971 Quality risk management of medical devicesISO: 14971 Quality risk management of medical devices
ISO: 14971 Quality risk management of medical devices
Atul Bhombe
 
7 Steps - How to Get a CE Marking Certification for Medical Devices?
7 Steps - How to Get a CE Marking Certification for Medical Devices?7 Steps - How to Get a CE Marking Certification for Medical Devices?
7 Steps - How to Get a CE Marking Certification for Medical Devices?
Puneet sharma
 
Difference between fda 21 cfr part 820 and ISO 13485
Difference between fda 21 cfr part 820 and ISO 13485Difference between fda 21 cfr part 820 and ISO 13485
Difference between fda 21 cfr part 820 and ISO 13485
Anil Chaudhari
 
Product life cycle management
Product life cycle managementProduct life cycle management
Product life cycle management
Vikas Rathee
 
21 cfr part 210 and 211
21 cfr part 210 and 21121 cfr part 210 and 211
21 cfr part 210 and 211
Bhanu Chava
 
Process Validation for Beginners - FDA - EMA Approach
Process Validation for Beginners - FDA - EMA ApproachProcess Validation for Beginners - FDA - EMA Approach
Process Validation for Beginners - FDA - EMA Approach
GMP EDUCATION : Not for Profit Organization
 
Sampling in process validation
Sampling in process validationSampling in process validation
Sampling in process validation
Salum Mkata
 
Cfr code of federal regulations-1 (1)
Cfr code of federal regulations-1 (1)Cfr code of federal regulations-1 (1)
Cfr code of federal regulations-1 (1)
sai sree
 
PQS Presentation Final
PQS Presentation FinalPQS Presentation Final
PQS Presentation FinalSimba Mavhunga
 
Steps to Compliance with the European Medical Device Regulations
Steps to Compliance with the European Medical Device RegulationsSteps to Compliance with the European Medical Device Regulations
Steps to Compliance with the European Medical Device Regulations
April Bright
 
Gamp 5 overview by jaya prakash ra
Gamp 5 overview by jaya prakash raGamp 5 overview by jaya prakash ra
Gamp 5 overview by jaya prakash ra
JAYA PRAKASH VELUCHURI
 
New approach to Process Validation 4
New approach to Process Validation 4New approach to Process Validation 4
New approach to Process Validation 4Santosh Singh
 
Clinical investigation and evaluation of medical devices and ivd.pptx
Clinical investigation and evaluation of medical devices and ivd.pptxClinical investigation and evaluation of medical devices and ivd.pptx
Clinical investigation and evaluation of medical devices and ivd.pptx
reechashah2
 
Medical Device Exemption and Post Marketing Survelliance
Medical Device Exemption and Post Marketing SurvellianceMedical Device Exemption and Post Marketing Survelliance
Medical Device Exemption and Post Marketing Survelliance
CSIR-URDIP, NCL Campus, Pune
 
rahb module 5.pptx
rahb module 5.pptxrahb module 5.pptx
rahb module 5.pptx
PrachiSharma575050
 
Accelerating MedTech Product Development with UX and Human Factors Engineering
Accelerating MedTech Product Development with UX and Human Factors EngineeringAccelerating MedTech Product Development with UX and Human Factors Engineering
Accelerating MedTech Product Development with UX and Human Factors Engineering
ICS
 
Integrating Human Factors Engineering into the Product Development Lifecycle_...
Integrating Human Factors Engineering into the Product Development Lifecycle_...Integrating Human Factors Engineering into the Product Development Lifecycle_...
Integrating Human Factors Engineering into the Product Development Lifecycle_...
BasemAbdo4
 

More Related Content

What's hot

Presentation: Manufacturing medical devices
Presentation: Manufacturing medical devicesPresentation: Manufacturing medical devices
Presentation: Manufacturing medical devices
TGA Australia
 
FDA regulation for medical devices
FDA regulation for medical devicesFDA regulation for medical devices
FDA regulation for medical devices
Simrana Fathima
 
8 Steps You Should Be Taking to Implement an EU-MDR Compliance Program
8 Steps You Should Be Taking to Implement an EU-MDR Compliance Program8 Steps You Should Be Taking to Implement an EU-MDR Compliance Program
8 Steps You Should Be Taking to Implement an EU-MDR Compliance Program
Greenlight Guru
 
GHTF
GHTFGHTF
GHTF
KDivya11
 
FDA Focus on Design Controls
FDA Focus on Design Controls FDA Focus on Design Controls
FDA Focus on Design Controls
April Bright
 
ISO: 14971 Quality risk management of medical devices
ISO: 14971 Quality risk management of medical devicesISO: 14971 Quality risk management of medical devices
ISO: 14971 Quality risk management of medical devices
Atul Bhombe
 
7 Steps - How to Get a CE Marking Certification for Medical Devices?
7 Steps - How to Get a CE Marking Certification for Medical Devices?7 Steps - How to Get a CE Marking Certification for Medical Devices?
7 Steps - How to Get a CE Marking Certification for Medical Devices?
Puneet sharma
 
Difference between fda 21 cfr part 820 and ISO 13485
Difference between fda 21 cfr part 820 and ISO 13485Difference between fda 21 cfr part 820 and ISO 13485
Difference between fda 21 cfr part 820 and ISO 13485
Anil Chaudhari
 
Product life cycle management
Product life cycle managementProduct life cycle management
Product life cycle management
Vikas Rathee
 
21 cfr part 210 and 211
21 cfr part 210 and 21121 cfr part 210 and 211
21 cfr part 210 and 211
Bhanu Chava
 
Process Validation for Beginners - FDA - EMA Approach
Process Validation for Beginners - FDA - EMA ApproachProcess Validation for Beginners - FDA - EMA Approach
Process Validation for Beginners - FDA - EMA Approach
GMP EDUCATION : Not for Profit Organization
 
Sampling in process validation
Sampling in process validationSampling in process validation
Sampling in process validation
Salum Mkata
 
Cfr code of federal regulations-1 (1)
Cfr code of federal regulations-1 (1)Cfr code of federal regulations-1 (1)
Cfr code of federal regulations-1 (1)
sai sree
 
PQS Presentation Final
PQS Presentation FinalPQS Presentation Final
PQS Presentation FinalSimba Mavhunga
 
Steps to Compliance with the European Medical Device Regulations
Steps to Compliance with the European Medical Device RegulationsSteps to Compliance with the European Medical Device Regulations
Steps to Compliance with the European Medical Device Regulations
April Bright
 
Gamp 5 overview by jaya prakash ra
Gamp 5 overview by jaya prakash raGamp 5 overview by jaya prakash ra
Gamp 5 overview by jaya prakash ra
JAYA PRAKASH VELUCHURI
 
New approach to Process Validation 4
New approach to Process Validation 4New approach to Process Validation 4
New approach to Process Validation 4Santosh Singh
 
Clinical investigation and evaluation of medical devices and ivd.pptx
Clinical investigation and evaluation of medical devices and ivd.pptxClinical investigation and evaluation of medical devices and ivd.pptx
Clinical investigation and evaluation of medical devices and ivd.pptx
reechashah2
 
Medical Device Exemption and Post Marketing Survelliance
Medical Device Exemption and Post Marketing SurvellianceMedical Device Exemption and Post Marketing Survelliance
Medical Device Exemption and Post Marketing Survelliance
CSIR-URDIP, NCL Campus, Pune
 
rahb module 5.pptx
rahb module 5.pptxrahb module 5.pptx
rahb module 5.pptx
PrachiSharma575050
 

What's hot (20)

Presentation: Manufacturing medical devices
Presentation: Manufacturing medical devicesPresentation: Manufacturing medical devices
Presentation: Manufacturing medical devices
 
FDA regulation for medical devices
FDA regulation for medical devicesFDA regulation for medical devices
FDA regulation for medical devices
 
8 Steps You Should Be Taking to Implement an EU-MDR Compliance Program
8 Steps You Should Be Taking to Implement an EU-MDR Compliance Program8 Steps You Should Be Taking to Implement an EU-MDR Compliance Program
8 Steps You Should Be Taking to Implement an EU-MDR Compliance Program
 
GHTF
GHTFGHTF
GHTF
 
FDA Focus on Design Controls
FDA Focus on Design Controls FDA Focus on Design Controls
FDA Focus on Design Controls
 
ISO: 14971 Quality risk management of medical devices
ISO: 14971 Quality risk management of medical devicesISO: 14971 Quality risk management of medical devices
ISO: 14971 Quality risk management of medical devices
 
7 Steps - How to Get a CE Marking Certification for Medical Devices?
7 Steps - How to Get a CE Marking Certification for Medical Devices?7 Steps - How to Get a CE Marking Certification for Medical Devices?
7 Steps - How to Get a CE Marking Certification for Medical Devices?
 
Difference between fda 21 cfr part 820 and ISO 13485
Difference between fda 21 cfr part 820 and ISO 13485Difference between fda 21 cfr part 820 and ISO 13485
Difference between fda 21 cfr part 820 and ISO 13485
 
Product life cycle management
Product life cycle managementProduct life cycle management
Product life cycle management
 
21 cfr part 210 and 211
21 cfr part 210 and 21121 cfr part 210 and 211
21 cfr part 210 and 211
 
Process Validation for Beginners - FDA - EMA Approach
Process Validation for Beginners - FDA - EMA ApproachProcess Validation for Beginners - FDA - EMA Approach
Process Validation for Beginners - FDA - EMA Approach
 
Sampling in process validation
Sampling in process validationSampling in process validation
Sampling in process validation
 
Cfr code of federal regulations-1 (1)
Cfr code of federal regulations-1 (1)Cfr code of federal regulations-1 (1)
Cfr code of federal regulations-1 (1)
 
PQS Presentation Final
PQS Presentation FinalPQS Presentation Final
PQS Presentation Final
 
Steps to Compliance with the European Medical Device Regulations
Steps to Compliance with the European Medical Device RegulationsSteps to Compliance with the European Medical Device Regulations
Steps to Compliance with the European Medical Device Regulations
 
Gamp 5 overview by jaya prakash ra
Gamp 5 overview by jaya prakash raGamp 5 overview by jaya prakash ra
Gamp 5 overview by jaya prakash ra
 
New approach to Process Validation 4
New approach to Process Validation 4New approach to Process Validation 4
New approach to Process Validation 4
 
Clinical investigation and evaluation of medical devices and ivd.pptx
Clinical investigation and evaluation of medical devices and ivd.pptxClinical investigation and evaluation of medical devices and ivd.pptx
Clinical investigation and evaluation of medical devices and ivd.pptx
 
Medical Device Exemption and Post Marketing Survelliance
Medical Device Exemption and Post Marketing SurvellianceMedical Device Exemption and Post Marketing Survelliance
Medical Device Exemption and Post Marketing Survelliance
 
rahb module 5.pptx
rahb module 5.pptxrahb module 5.pptx
rahb module 5.pptx
 

Similar to How User Experience Design and Human Factors Engineering can Accelerate Product Development

Accelerating MedTech Product Development with UX and Human Factors Engineering
Accelerating MedTech Product Development with UX and Human Factors EngineeringAccelerating MedTech Product Development with UX and Human Factors Engineering
Accelerating MedTech Product Development with UX and Human Factors Engineering
ICS
 
Integrating Human Factors Engineering into the Product Development Lifecycle_...
Integrating Human Factors Engineering into the Product Development Lifecycle_...Integrating Human Factors Engineering into the Product Development Lifecycle_...
Integrating Human Factors Engineering into the Product Development Lifecycle_...
BasemAbdo4
 
WCIT 2014 Peter Elkin - Human computer interaction, evaluation, usability tes...
WCIT 2014 Peter Elkin - Human computer interaction, evaluation, usability tes...WCIT 2014 Peter Elkin - Human computer interaction, evaluation, usability tes...
WCIT 2014 Peter Elkin - Human computer interaction, evaluation, usability tes...
WCIT 2014
 
Usability Validation Testing of Medical Devices and Software
Usability Validation Testing of Medical Devices and SoftwareUsability Validation Testing of Medical Devices and Software
Usability Validation Testing of Medical Devices and Software
UXPA Boston
 
Connected devices
Connected devicesConnected devices
Connected devices
Andrea Shteynberg
 
Medical Device Overview Greg Browne 2014
Medical Device Overview Greg Browne 2014Medical Device Overview Greg Browne 2014
Medical Device Overview Greg Browne 2014
gregvb
 
mHealth Israel_Human Factors for MedTech Ergonomics and Usability_Rebecca Moses
mHealth Israel_Human Factors for MedTech Ergonomics and Usability_Rebecca MosesmHealth Israel_Human Factors for MedTech Ergonomics and Usability_Rebecca Moses
mHealth Israel_Human Factors for MedTech Ergonomics and Usability_Rebecca Moses
Levi Shapiro
 
Carolien Creemers & Maarten Bressinck Talk at UX Antwerp Meetup
Carolien Creemers & Maarten Bressinck Talk at UX Antwerp MeetupCarolien Creemers & Maarten Bressinck Talk at UX Antwerp Meetup
Carolien Creemers & Maarten Bressinck Talk at UX Antwerp Meetup
UX Antwerp Meetup
 
Medical Device Development - Concept to Commercialization | Jahnavi Lokre | L...
Medical Device Development - Concept to Commercialization | Jahnavi Lokre | L...Medical Device Development - Concept to Commercialization | Jahnavi Lokre | L...
Medical Device Development - Concept to Commercialization | Jahnavi Lokre | L...
UCICove
 
5 Key Considerations at the Start of SaMD Development
5 Key Considerations at the Start of SaMD Development5 Key Considerations at the Start of SaMD Development
5 Key Considerations at the Start of SaMD Development
ICS
 
Agile in Medical Software Development
Agile in Medical Software DevelopmentAgile in Medical Software Development
Agile in Medical Software Development
Bernhard Kappe
 
Human factor standards and usability (by Ed Israelski)
Human factor standards and usability (by Ed Israelski)Human factor standards and usability (by Ed Israelski)
Human factor standards and usability (by Ed Israelski)
Stella Tsank
 
Human factors and ergonomics society 20120311
Human factors and ergonomics society 20120311Human factors and ergonomics society 20120311
Human factors and ergonomics society 20120311
Jones Wu
 
Concept for Testing a New Medical Product for World-wide Launch
Concept for Testing a New Medical Product for World-wide LaunchConcept for Testing a New Medical Product for World-wide Launch
Concept for Testing a New Medical Product for World-wide Launch
Christian Graf
 
User Centred Design
User Centred DesignUser Centred Design
User Centred Design
Ayo Apampa
 
Critical Steps in Software Development: Enhance Your Chances for a Successful...
Critical Steps in Software Development: Enhance Your Chances for a Successful...Critical Steps in Software Development: Enhance Your Chances for a Successful...
Critical Steps in Software Development: Enhance Your Chances for a Successful...
Sterling Medical Devices
 
PLATFORM COMBINATION PRODUCT STRATEGIES FOR HUMAN FACTORS
PLATFORM COMBINATION PRODUCT STRATEGIES FOR HUMAN FACTORSPLATFORM COMBINATION PRODUCT STRATEGIES FOR HUMAN FACTORS
PLATFORM COMBINATION PRODUCT STRATEGIES FOR HUMAN FACTORS
iQHub
 
Software as a Medical Device (SaMD) Challenges and Opportunities for 2021 and...
Software as a Medical Device (SaMD) Challenges and Opportunities for 2021 and...Software as a Medical Device (SaMD) Challenges and Opportunities for 2021 and...
Software as a Medical Device (SaMD) Challenges and Opportunities for 2021 and...
Greenlight Guru
 
Quality Function Deployment (QFD) for Design Controls
Quality Function Deployment (QFD) for Design ControlsQuality Function Deployment (QFD) for Design Controls
Quality Function Deployment (QFD) for Design Controls
EMMAIntl
 
Usability Challenges in Cutting-edge Medical Devices and Exoskeleton Robotics
Usability Challenges in Cutting-edge Medical Devices and Exoskeleton RoboticsUsability Challenges in Cutting-edge Medical Devices and Exoskeleton Robotics
Usability Challenges in Cutting-edge Medical Devices and Exoskeleton Robotics
ICS
 

Similar to How User Experience Design and Human Factors Engineering can Accelerate Product Development (20)

Accelerating MedTech Product Development with UX and Human Factors Engineering
Accelerating MedTech Product Development with UX and Human Factors EngineeringAccelerating MedTech Product Development with UX and Human Factors Engineering
Accelerating MedTech Product Development with UX and Human Factors Engineering
 
Integrating Human Factors Engineering into the Product Development Lifecycle_...
Integrating Human Factors Engineering into the Product Development Lifecycle_...Integrating Human Factors Engineering into the Product Development Lifecycle_...
Integrating Human Factors Engineering into the Product Development Lifecycle_...
 
WCIT 2014 Peter Elkin - Human computer interaction, evaluation, usability tes...
WCIT 2014 Peter Elkin - Human computer interaction, evaluation, usability tes...WCIT 2014 Peter Elkin - Human computer interaction, evaluation, usability tes...
WCIT 2014 Peter Elkin - Human computer interaction, evaluation, usability tes...
 
Usability Validation Testing of Medical Devices and Software
Usability Validation Testing of Medical Devices and SoftwareUsability Validation Testing of Medical Devices and Software
Usability Validation Testing of Medical Devices and Software
 
Connected devices
Connected devicesConnected devices
Connected devices
 
Medical Device Overview Greg Browne 2014
Medical Device Overview Greg Browne 2014Medical Device Overview Greg Browne 2014
Medical Device Overview Greg Browne 2014
 
mHealth Israel_Human Factors for MedTech Ergonomics and Usability_Rebecca Moses
mHealth Israel_Human Factors for MedTech Ergonomics and Usability_Rebecca MosesmHealth Israel_Human Factors for MedTech Ergonomics and Usability_Rebecca Moses
mHealth Israel_Human Factors for MedTech Ergonomics and Usability_Rebecca Moses
 
Carolien Creemers & Maarten Bressinck Talk at UX Antwerp Meetup
Carolien Creemers & Maarten Bressinck Talk at UX Antwerp MeetupCarolien Creemers & Maarten Bressinck Talk at UX Antwerp Meetup
Carolien Creemers & Maarten Bressinck Talk at UX Antwerp Meetup
 
Medical Device Development - Concept to Commercialization | Jahnavi Lokre | L...
Medical Device Development - Concept to Commercialization | Jahnavi Lokre | L...Medical Device Development - Concept to Commercialization | Jahnavi Lokre | L...
Medical Device Development - Concept to Commercialization | Jahnavi Lokre | L...
 
5 Key Considerations at the Start of SaMD Development
5 Key Considerations at the Start of SaMD Development5 Key Considerations at the Start of SaMD Development
5 Key Considerations at the Start of SaMD Development
 
Agile in Medical Software Development
Agile in Medical Software DevelopmentAgile in Medical Software Development
Agile in Medical Software Development
 
Human factor standards and usability (by Ed Israelski)
Human factor standards and usability (by Ed Israelski)Human factor standards and usability (by Ed Israelski)
Human factor standards and usability (by Ed Israelski)
 
Human factors and ergonomics society 20120311
Human factors and ergonomics society 20120311Human factors and ergonomics society 20120311
Human factors and ergonomics society 20120311
 
Concept for Testing a New Medical Product for World-wide Launch
Concept for Testing a New Medical Product for World-wide LaunchConcept for Testing a New Medical Product for World-wide Launch
Concept for Testing a New Medical Product for World-wide Launch
 
User Centred Design
User Centred DesignUser Centred Design
User Centred Design
 
Critical Steps in Software Development: Enhance Your Chances for a Successful...
Critical Steps in Software Development: Enhance Your Chances for a Successful...Critical Steps in Software Development: Enhance Your Chances for a Successful...
Critical Steps in Software Development: Enhance Your Chances for a Successful...
 
PLATFORM COMBINATION PRODUCT STRATEGIES FOR HUMAN FACTORS
PLATFORM COMBINATION PRODUCT STRATEGIES FOR HUMAN FACTORSPLATFORM COMBINATION PRODUCT STRATEGIES FOR HUMAN FACTORS
PLATFORM COMBINATION PRODUCT STRATEGIES FOR HUMAN FACTORS
 
Software as a Medical Device (SaMD) Challenges and Opportunities for 2021 and...
Software as a Medical Device (SaMD) Challenges and Opportunities for 2021 and...Software as a Medical Device (SaMD) Challenges and Opportunities for 2021 and...
Software as a Medical Device (SaMD) Challenges and Opportunities for 2021 and...
 
Quality Function Deployment (QFD) for Design Controls
Quality Function Deployment (QFD) for Design ControlsQuality Function Deployment (QFD) for Design Controls
Quality Function Deployment (QFD) for Design Controls
 
Usability Challenges in Cutting-edge Medical Devices and Exoskeleton Robotics
Usability Challenges in Cutting-edge Medical Devices and Exoskeleton RoboticsUsability Challenges in Cutting-edge Medical Devices and Exoskeleton Robotics
Usability Challenges in Cutting-edge Medical Devices and Exoskeleton Robotics
 

More from Greenlight Guru

The Compliance Concern: Challenges and Roadblocks for Ensuring Compliance in ...
The Compliance Concern: Challenges and Roadblocks for Ensuring Compliance in ...The Compliance Concern: Challenges and Roadblocks for Ensuring Compliance in ...
The Compliance Concern: Challenges and Roadblocks for Ensuring Compliance in ...
Greenlight Guru
 
How Electronic Data Capture Is Transforming the MedTech Industry
How Electronic Data Capture Is Transforming the MedTech IndustryHow Electronic Data Capture Is Transforming the MedTech Industry
How Electronic Data Capture Is Transforming the MedTech Industry
Greenlight Guru
 
The ROI of Shifting Mindset From Compliance to Quality
The ROI of Shifting Mindset From Compliance to QualityThe ROI of Shifting Mindset From Compliance to Quality
The ROI of Shifting Mindset From Compliance to Quality
Greenlight Guru
 
Leveraging Modern Software Technologies: MedTech’s Best Kept Secret
Leveraging Modern Software Technologies: MedTech’s Best Kept SecretLeveraging Modern Software Technologies: MedTech’s Best Kept Secret
Leveraging Modern Software Technologies: MedTech’s Best Kept Secret
Greenlight Guru
 
Behind the Stats: Expectations vs. Reality of Bringing a Device to Market
Behind the Stats: Expectations vs. Reality of Bringing a Device to MarketBehind the Stats: Expectations vs. Reality of Bringing a Device to Market
Behind the Stats: Expectations vs. Reality of Bringing a Device to Market
Greenlight Guru
 
Common Misconceptions on Medical Device Risk & Design Controls
Common Misconceptions on Medical Device Risk & Design ControlsCommon Misconceptions on Medical Device Risk & Design Controls
Common Misconceptions on Medical Device Risk & Design Controls
Greenlight Guru
 
QMSR Harmonization: The Future of FDA's Quality Management System Regulation
QMSR Harmonization: The Future of FDA's Quality Management System RegulationQMSR Harmonization: The Future of FDA's Quality Management System Regulation
QMSR Harmonization: The Future of FDA's Quality Management System Regulation
Greenlight Guru
 
QMS from a Regulatory Perspective
QMS from a Regulatory PerspectiveQMS from a Regulatory Perspective
QMS from a Regulatory Perspective
Greenlight Guru
 
Modernizing your QMS to keep up with the Modern Age of Requirements
Modernizing your QMS to keep up with the Modern Age of RequirementsModernizing your QMS to keep up with the Modern Age of Requirements
Modernizing your QMS to keep up with the Modern Age of Requirements
Greenlight Guru
 
eMDR Program and Process
eMDR Program and ProcesseMDR Program and Process
eMDR Program and Process
Greenlight Guru
 
Moving up to the State of the Art in Risk Management
Moving up to the State of the Art in Risk ManagementMoving up to the State of the Art in Risk Management
Moving up to the State of the Art in Risk Management
Greenlight Guru
 
ISO 13485: What's Next?
ISO 13485: What's Next?ISO 13485: What's Next?
ISO 13485: What's Next?
Greenlight Guru
 
Computer Software Assurance (CSA): Understanding the FDA’s New Draft Guidance
Computer Software Assurance (CSA): Understanding the FDA’s New Draft GuidanceComputer Software Assurance (CSA): Understanding the FDA’s New Draft Guidance
Computer Software Assurance (CSA): Understanding the FDA’s New Draft Guidance
Greenlight Guru
 
Making Headway Despite the Turbulence: Regulatory Requirements, Quality, and ...
Making Headway Despite the Turbulence: Regulatory Requirements, Quality, and ...Making Headway Despite the Turbulence: Regulatory Requirements, Quality, and ...
Making Headway Despite the Turbulence: Regulatory Requirements, Quality, and ...
Greenlight Guru
 
Reducing Friction Between Companies and Regulatory Bodies
Reducing Friction Between Companies and Regulatory BodiesReducing Friction Between Companies and Regulatory Bodies
Reducing Friction Between Companies and Regulatory Bodies
Greenlight Guru
 
Latin American Regulations - What you Don't Know
Latin American Regulations - What you Don't KnowLatin American Regulations - What you Don't Know
Latin American Regulations - What you Don't Know
Greenlight Guru
 
Insights on the MedTech Regulatory and Clinical Environment in Israel
Insights on the MedTech Regulatory and Clinical Environment in IsraelInsights on the MedTech Regulatory and Clinical Environment in Israel
Insights on the MedTech Regulatory and Clinical Environment in Israel
Greenlight Guru
 
The Global Guide to Human Factors and Usability Engineering Regulations
The Global Guide to Human Factors and Usability Engineering RegulationsThe Global Guide to Human Factors and Usability Engineering Regulations
The Global Guide to Human Factors and Usability Engineering Regulations
Greenlight Guru
 
MDSAP Certification: Success and Failures
MDSAP Certification: Success and FailuresMDSAP Certification: Success and Failures
MDSAP Certification: Success and Failures
Greenlight Guru
 
QMSR Harmonization - The Good the Bad and the Ugly
QMSR Harmonization - The Good the Bad and the UglyQMSR Harmonization - The Good the Bad and the Ugly
QMSR Harmonization - The Good the Bad and the Ugly
Greenlight Guru
 

More from Greenlight Guru (20)

The Compliance Concern: Challenges and Roadblocks for Ensuring Compliance in ...
The Compliance Concern: Challenges and Roadblocks for Ensuring Compliance in ...The Compliance Concern: Challenges and Roadblocks for Ensuring Compliance in ...
The Compliance Concern: Challenges and Roadblocks for Ensuring Compliance in ...
 
How Electronic Data Capture Is Transforming the MedTech Industry
How Electronic Data Capture Is Transforming the MedTech IndustryHow Electronic Data Capture Is Transforming the MedTech Industry
How Electronic Data Capture Is Transforming the MedTech Industry
 
The ROI of Shifting Mindset From Compliance to Quality
The ROI of Shifting Mindset From Compliance to QualityThe ROI of Shifting Mindset From Compliance to Quality
The ROI of Shifting Mindset From Compliance to Quality
 
Leveraging Modern Software Technologies: MedTech’s Best Kept Secret
Leveraging Modern Software Technologies: MedTech’s Best Kept SecretLeveraging Modern Software Technologies: MedTech’s Best Kept Secret
Leveraging Modern Software Technologies: MedTech’s Best Kept Secret
 
Behind the Stats: Expectations vs. Reality of Bringing a Device to Market
Behind the Stats: Expectations vs. Reality of Bringing a Device to MarketBehind the Stats: Expectations vs. Reality of Bringing a Device to Market
Behind the Stats: Expectations vs. Reality of Bringing a Device to Market
 
Common Misconceptions on Medical Device Risk & Design Controls
Common Misconceptions on Medical Device Risk & Design ControlsCommon Misconceptions on Medical Device Risk & Design Controls
Common Misconceptions on Medical Device Risk & Design Controls
 
QMSR Harmonization: The Future of FDA's Quality Management System Regulation
QMSR Harmonization: The Future of FDA's Quality Management System RegulationQMSR Harmonization: The Future of FDA's Quality Management System Regulation
QMSR Harmonization: The Future of FDA's Quality Management System Regulation
 
QMS from a Regulatory Perspective
QMS from a Regulatory PerspectiveQMS from a Regulatory Perspective
QMS from a Regulatory Perspective
 
Modernizing your QMS to keep up with the Modern Age of Requirements
Modernizing your QMS to keep up with the Modern Age of RequirementsModernizing your QMS to keep up with the Modern Age of Requirements
Modernizing your QMS to keep up with the Modern Age of Requirements
 
eMDR Program and Process
eMDR Program and ProcesseMDR Program and Process
eMDR Program and Process
 
Moving up to the State of the Art in Risk Management
Moving up to the State of the Art in Risk ManagementMoving up to the State of the Art in Risk Management
Moving up to the State of the Art in Risk Management
 
ISO 13485: What's Next?
ISO 13485: What's Next?ISO 13485: What's Next?
ISO 13485: What's Next?
 
Computer Software Assurance (CSA): Understanding the FDA’s New Draft Guidance
Computer Software Assurance (CSA): Understanding the FDA’s New Draft GuidanceComputer Software Assurance (CSA): Understanding the FDA’s New Draft Guidance
Computer Software Assurance (CSA): Understanding the FDA’s New Draft Guidance
 
Making Headway Despite the Turbulence: Regulatory Requirements, Quality, and ...
Making Headway Despite the Turbulence: Regulatory Requirements, Quality, and ...Making Headway Despite the Turbulence: Regulatory Requirements, Quality, and ...
Making Headway Despite the Turbulence: Regulatory Requirements, Quality, and ...
 
Reducing Friction Between Companies and Regulatory Bodies
Reducing Friction Between Companies and Regulatory BodiesReducing Friction Between Companies and Regulatory Bodies
Reducing Friction Between Companies and Regulatory Bodies
 
Latin American Regulations - What you Don't Know
Latin American Regulations - What you Don't KnowLatin American Regulations - What you Don't Know
Latin American Regulations - What you Don't Know
 
Insights on the MedTech Regulatory and Clinical Environment in Israel
Insights on the MedTech Regulatory and Clinical Environment in IsraelInsights on the MedTech Regulatory and Clinical Environment in Israel
Insights on the MedTech Regulatory and Clinical Environment in Israel
 
The Global Guide to Human Factors and Usability Engineering Regulations
The Global Guide to Human Factors and Usability Engineering RegulationsThe Global Guide to Human Factors and Usability Engineering Regulations
The Global Guide to Human Factors and Usability Engineering Regulations
 
MDSAP Certification: Success and Failures
MDSAP Certification: Success and FailuresMDSAP Certification: Success and Failures
MDSAP Certification: Success and Failures
 
QMSR Harmonization - The Good the Bad and the Ugly
QMSR Harmonization - The Good the Bad and the UglyQMSR Harmonization - The Good the Bad and the Ugly
QMSR Harmonization - The Good the Bad and the Ugly
 

Recently uploaded

The Parable of the Pipeline a book every new businessman or business student ...
The Parable of the Pipeline a book every new businessman or business student ...The Parable of the Pipeline a book every new businessman or business student ...
The Parable of the Pipeline a book every new businessman or business student ...
awaisafdar
 
Attending a job Interview for B1 and B2 Englsih learners
Attending a job Interview for B1 and B2 Englsih learnersAttending a job Interview for B1 and B2 Englsih learners
Attending a job Interview for B1 and B2 Englsih learners
Erika906060
 
Exploring Patterns of Connection with Social Dreaming
Exploring Patterns of Connection with Social DreamingExploring Patterns of Connection with Social Dreaming
Exploring Patterns of Connection with Social Dreaming
Nicola Wreford-Howard
 
一比一原版加拿大渥太华大学毕业证（uottawa毕业证书）如何办理
一比一原版加拿大渥太华大学毕业证（uottawa毕业证书）如何办理一比一原版加拿大渥太华大学毕业证（uottawa毕业证书）如何办理
一比一原版加拿大渥太华大学毕业证（uottawa毕业证书）如何办理
taqyed
 
falcon-invoice-discounting-a-premier-platform-for-investors-in-india
falcon-invoice-discounting-a-premier-platform-for-investors-in-indiafalcon-invoice-discounting-a-premier-platform-for-investors-in-india
falcon-invoice-discounting-a-premier-platform-for-investors-in-india
Falcon Invoice Discounting
 
BeMetals Presentation_May_22_2024 .pdf
BeMetals Presentation_May_22_2024 .pdfBeMetals Presentation_May_22_2024 .pdf
BeMetals Presentation_May_22_2024 .pdf
DerekIwanaka1
 
Improving profitability for small business
Improving profitability for small businessImproving profitability for small business
Improving profitability for small business
Ben Wann
 
Filing Your Delaware Franchise Tax A Detailed Guide
Filing Your Delaware Franchise Tax A Detailed GuideFiling Your Delaware Franchise Tax A Detailed Guide
Filing Your Delaware Franchise Tax A Detailed Guide
YourLegal Accounting
 
What are the main advantages of using HR recruiter services.pdf
What are the main advantages of using HR recruiter services.pdfWhat are the main advantages of using HR recruiter services.pdf
What are the main advantages of using HR recruiter services.pdf
HumanResourceDimensi1
 
Accpac to QuickBooks Conversion Navigating the Transition with Online Account...
Accpac to QuickBooks Conversion Navigating the Transition with Online Account...Accpac to QuickBooks Conversion Navigating the Transition with Online Account...
Accpac to QuickBooks Conversion Navigating the Transition with Online Account...
PaulBryant58
 
Unveiling the Secrets How Does Generative AI Work.pdf
Unveiling the Secrets How Does Generative AI Work.pdfUnveiling the Secrets How Does Generative AI Work.pdf
Unveiling the Secrets How Does Generative AI Work.pdf
Sam H
 
Putting the SPARK into Virtual Training.pptx
Putting the SPARK into Virtual Training.pptxPutting the SPARK into Virtual Training.pptx
Putting the SPARK into Virtual Training.pptx
Cynthia Clay
 
Skye Residences | Extended Stay Residences Near Toronto Airport
Skye Residences | Extended Stay Residences Near Toronto AirportSkye Residences | Extended Stay Residences Near Toronto Airport
Skye Residences | Extended Stay Residences Near Toronto Airport
marketingjdass
 
Role of Remote Sensing and Monitoring in Mining
Role of Remote Sensing and Monitoring in MiningRole of Remote Sensing and Monitoring in Mining
Role of Remote Sensing and Monitoring in Mining
Naaraayani Minerals Pvt.Ltd
 
Set off and carry forward of losses and assessment of individuals.pptx
Set off and carry forward of losses and assessment of individuals.pptxSet off and carry forward of losses and assessment of individuals.pptx
Set off and carry forward of losses and assessment of individuals.pptx
HARSHITHV26
 
Cree_Rey_BrandIdentityKit.PDF_PersonalBd
Cree_Rey_BrandIdentityKit.PDF_PersonalBdCree_Rey_BrandIdentityKit.PDF_PersonalBd
Cree_Rey_BrandIdentityKit.PDF_PersonalBd
creerey
 
CADAVER AS OUR FIRST TEACHER anatomt in your.pptx
CADAVER AS OUR FIRST TEACHER anatomt in your.pptxCADAVER AS OUR FIRST TEACHER anatomt in your.pptx
CADAVER AS OUR FIRST TEACHER anatomt in your.pptx
fakeloginn69
 
Discover the innovative and creative projects that highlight my journey throu...
Discover the innovative and creative projects that highlight my journey throu...Discover the innovative and creative projects that highlight my journey throu...
Discover the innovative and creative projects that highlight my journey throu...
dylandmeas
 
Global Interconnection Group Joint Venture[960] (1).pdf
Global Interconnection Group Joint Venture[960] (1).pdfGlobal Interconnection Group Joint Venture[960] (1).pdf
Global Interconnection Group Joint Venture[960] (1).pdf
Henry Tapper
 
Pitch Deck Teardown: RAW Dating App's $3M Angel deck
Pitch Deck Teardown: RAW Dating App's $3M Angel deckPitch Deck Teardown: RAW Dating App's $3M Angel deck
Pitch Deck Teardown: RAW Dating App's $3M Angel deck
HajeJanKamps
 

Recently uploaded (20)

The Parable of the Pipeline a book every new businessman or business student ...
The Parable of the Pipeline a book every new businessman or business student ...The Parable of the Pipeline a book every new businessman or business student ...
The Parable of the Pipeline a book every new businessman or business student ...
 
Attending a job Interview for B1 and B2 Englsih learners
Attending a job Interview for B1 and B2 Englsih learnersAttending a job Interview for B1 and B2 Englsih learners
Attending a job Interview for B1 and B2 Englsih learners
 
Exploring Patterns of Connection with Social Dreaming
Exploring Patterns of Connection with Social DreamingExploring Patterns of Connection with Social Dreaming
Exploring Patterns of Connection with Social Dreaming
 
一比一原版加拿大渥太华大学毕业证（uottawa毕业证书）如何办理
一比一原版加拿大渥太华大学毕业证（uottawa毕业证书）如何办理一比一原版加拿大渥太华大学毕业证（uottawa毕业证书）如何办理
一比一原版加拿大渥太华大学毕业证（uottawa毕业证书）如何办理
 
falcon-invoice-discounting-a-premier-platform-for-investors-in-india
falcon-invoice-discounting-a-premier-platform-for-investors-in-indiafalcon-invoice-discounting-a-premier-platform-for-investors-in-india
falcon-invoice-discounting-a-premier-platform-for-investors-in-india
 
BeMetals Presentation_May_22_2024 .pdf
BeMetals Presentation_May_22_2024 .pdfBeMetals Presentation_May_22_2024 .pdf
BeMetals Presentation_May_22_2024 .pdf
 
Improving profitability for small business
Improving profitability for small businessImproving profitability for small business
Improving profitability for small business
 
Filing Your Delaware Franchise Tax A Detailed Guide
Filing Your Delaware Franchise Tax A Detailed GuideFiling Your Delaware Franchise Tax A Detailed Guide
Filing Your Delaware Franchise Tax A Detailed Guide
 
What are the main advantages of using HR recruiter services.pdf
What are the main advantages of using HR recruiter services.pdfWhat are the main advantages of using HR recruiter services.pdf
What are the main advantages of using HR recruiter services.pdf
 
Accpac to QuickBooks Conversion Navigating the Transition with Online Account...
Accpac to QuickBooks Conversion Navigating the Transition with Online Account...Accpac to QuickBooks Conversion Navigating the Transition with Online Account...
Accpac to QuickBooks Conversion Navigating the Transition with Online Account...
 
Unveiling the Secrets How Does Generative AI Work.pdf
Unveiling the Secrets How Does Generative AI Work.pdfUnveiling the Secrets How Does Generative AI Work.pdf
Unveiling the Secrets How Does Generative AI Work.pdf
 
Putting the SPARK into Virtual Training.pptx
Putting the SPARK into Virtual Training.pptxPutting the SPARK into Virtual Training.pptx
Putting the SPARK into Virtual Training.pptx
 
Skye Residences | Extended Stay Residences Near Toronto Airport
Skye Residences | Extended Stay Residences Near Toronto AirportSkye Residences | Extended Stay Residences Near Toronto Airport
Skye Residences | Extended Stay Residences Near Toronto Airport
 
Role of Remote Sensing and Monitoring in Mining
Role of Remote Sensing and Monitoring in MiningRole of Remote Sensing and Monitoring in Mining
Role of Remote Sensing and Monitoring in Mining
 
Set off and carry forward of losses and assessment of individuals.pptx
Set off and carry forward of losses and assessment of individuals.pptxSet off and carry forward of losses and assessment of individuals.pptx
Set off and carry forward of losses and assessment of individuals.pptx
 
Cree_Rey_BrandIdentityKit.PDF_PersonalBd
Cree_Rey_BrandIdentityKit.PDF_PersonalBdCree_Rey_BrandIdentityKit.PDF_PersonalBd
Cree_Rey_BrandIdentityKit.PDF_PersonalBd
 
CADAVER AS OUR FIRST TEACHER anatomt in your.pptx
CADAVER AS OUR FIRST TEACHER anatomt in your.pptxCADAVER AS OUR FIRST TEACHER anatomt in your.pptx
CADAVER AS OUR FIRST TEACHER anatomt in your.pptx
 
Discover the innovative and creative projects that highlight my journey throu...
Discover the innovative and creative projects that highlight my journey throu...Discover the innovative and creative projects that highlight my journey throu...
Discover the innovative and creative projects that highlight my journey throu...
 
Global Interconnection Group Joint Venture[960] (1).pdf
Global Interconnection Group Joint Venture[960] (1).pdfGlobal Interconnection Group Joint Venture[960] (1).pdf
Global Interconnection Group Joint Venture[960] (1).pdf
 
Pitch Deck Teardown: RAW Dating App's $3M Angel deck
Pitch Deck Teardown: RAW Dating App's $3M Angel deckPitch Deck Teardown: RAW Dating App's $3M Angel deck
Pitch Deck Teardown: RAW Dating App's $3M Angel deck
 

How User Experience Design and Human Factors Engineering can Accelerate Product Development

  • 1. How User Experience Design and Human Factors Engineering can Accelerate Product Development 1
  • 2.
  • 3. Who is UserWise? 3 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.
  • 4. To inspire usability engineering best practices within medical product companies and to facilitate the development of usable medical products. Company Mission 4
  • 5. About ICS 5 ● Founded in 1987, 120 employees ● HQ in Boston, offices in the Bay Area and Ottawa ● We provide: ○ UX design ○ Full-stack 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
  • 6. Boston UX ● Offer a full suite of user experience services: ○ Product vision and direction ○ UX design ○ Visual & motion design ○ Voice integration design ○ Usability research and testing ● IEC 62366 compliant process www.bostonux.com
  • 7. What is Human Factors Engineering, and why is it important? 7
  • 8. Human Factors Engineering 8 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.”
  • 9. Why is Human Factors Engineering Important? 9 Conservatively estimated, there are 210,000 preventable hospital deaths annually in the United States. J Patient Saf & Volume 9, Number 3, September 2013
  • 11. Implement Human Factors Early in the Development Process 11 Cost WITH Human Factors Development phase (Time) Investment Cost WITHOUT Human Factors
  • 12. Implement Human Factors Early in the Development Process 12 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
  • 13. Implement Human Factors Early in the Development Process 13 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
  • 14. Glucose Meter Recall 14 What error do you think people might make with this display?
  • 15. NicoletOne vEEG System (Software) by CareFusion - 2010 Recall 15 ● 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
  • 16. What are the Human Factors Guidance and Regulations? 16
  • 17. Code of Federal Regulations (CFR) – Quality System Regulation 17
  • 18. FDA Focus on Human Factors and Industry Response 18 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.
  • 20. FDA Emergency Use Authorization (EUA) Guidance 20
  • 21. Human Factors Standards Outside of the US 21
  • 22. What is the Human Factors Process? 22
  • 23. The Human Factors Process 23 User Research Risk Analysis Iterative Prototyping & Usability Testing Usability Validation Human Factors Submission
  • 24. User Research 24 • Who will be the device Users? • What are their characteristics, capabilities, training and background? • How does the user profile impact the potential design? • What environmental conditions will the device be used in? Physicians EMTsSurgeons General Population Elderly Patients
  • 25. 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. Use-Related Risk Analysis (Use FMEA) 26 Use-Related Risk Analysis Analytical & Empirical Methods to Identify Use Errors User Profiles Use Environment
  • 27. 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. 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. 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. 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. Human Factors Engineering to Accelerate Product Development Usability UX Software 31
  • 32. Vignette – Safe vs. Easy (per FDA) Human Factors Applying knowledge of human abilities/limitations to device design Usability User Experience - Risk Mitigation - Safe & effective use - Learnable - Efficient - Delightful
  • 33. ● 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, and test that they’re effective Reasonableness of the HF/UX Rationale (IEC 62366) 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. 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. 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. 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. Key Takeaways - How UX Design Streamlines Development High Fidelity Prototypes (pre-engineering) Fewer late stage changes UX Specifications (Conditional UI behaviors “shall alert until message acknowledged”) Software Engineers UI Definition (Every UI, All Navigation) Test Engineers Define and Prototype (IEC 62366 documentation) HFE/UE Report for 510K