www.team-consulting.com Confidential © Team Consulting 2011: World PFS Summit 2012, slide 1
Presenter: Date:
Julian Dixon 20th September 2012
Appealing to Users Developing Usable & Desirable Devices
www.team-consulting.com Confidential © Team Consulting 2011: World PFS Summit 2012, slide 2
• What is human factors (HF)?
• Why so much current interest in HF?
• Best practice in patient-use, drug delivery device HF
– what is different about patient-use, drug delivery device usability?
• Practitioners’ experiences – tips and pitfalls
• Realistic usability targets for self-injection devices
• Looking beyond usability - safety and effectiveness – towards desirability
Overview
www.team-consulting.com Confidential © Team Consulting 2011: World PFS Summit 2012, slide 3
“Understanding and optimizing how people interact with technology
is the subject of
human factors engineering (HFE)
and
usability engineering (UE).”
What is Human Factors Engineering?
Ref: FDA Draft Guidance, June 2011: Applying Human Factors and Usability Engineering to Optimize Medical Device Design
www.team-consulting.com Confidential © Team Consulting 2011: World PFS Summit 2012, slide 4
• medical devices pose use-related risks
• risks need to be identified & addressed during device development …
• … to ensure devices can be used safely and effectively by their intended users
• why now?
• in the past, as an industry, we didn’t pay sufficient attention to use-related risk or to its management through the application of human factors engineering
• events have recently focused regulatory attention on the importance of the topic
Why current interest in HF?
www.team-consulting.com Confidential © Team Consulting 2011: World PFS Summit 2012, slide 5
www.team-consulting.com Confidential © Team Consulting 2011: World PFS Summit 2012, slide 6
• disposability = very low cost target
• patient use
– potentially untrained users
– used by anyone, anywhere
• limited functionality / limited number of distinct tasks
– all use-steps are ‘essential’ or core
• tasks go beyond the device
– task completion depends on some user behaviour the device cannot enforce
– dependence on user
– e.g. correct storage / pre-injection checks / disposal
• simple task structure / simple device interface
– perhaps their apparent simplicity/familiarity may promote guessing?
Patient-use, drug delivery devices pose a unique HF challenge
www.team-consulting.com Confidential © Team Consulting 2011: World PFS Summit 2012, slide 7
“… intended users of a medical device can safely and effectively perform critical tasks for the intended uses
in the expected use environments.”
“… no patterns of use failure or difficulties that could be eliminated or reduced
through further modification of the design of the user interface.”
“… residual risk is outweighed by the advantages offered by the device.”
Statements of HF Objective
Ref: FDA Draft Guidance, June 2011: Applying Human Factors and Usability Engineering to Optimize Medical Device Design
www.team-consulting.com Confidential © Team Consulting 2011: World PFS Summit 2012, slide 8
HFE Summary Report
User Interface Design (e.g. device + IFU + packaging)
Optimized User Interface
Use-Related Risk Assessment (e.g. uFMEA)
Residual Risk
Formative Studies
Device Concept
Drug/ Formulation
Hazards & Clinical Impact
Opportunities for Use Error Critical
Use Errors
mitigate
verify
HF Validation Study
www.team-consulting.com Confidential © Team Consulting 2011: World PFS Summit 2012, slide 9
HFE Summary Report
User Interface Design (e.g. device + IFU + packaging)
Optimized User Interface
Use-Related Risk Assessment (e.g. uFMEA)
Residual Risk
Formative Studies
Device Concept
Drug/ Formulation
Hazards & Clinical Impact
Opportunities for Use Error Critical
Use Errors
mitigate
verify
HF Validation Study
Intended Use (users, tasks, environments)
www.team-consulting.com Confidential © Team Consulting 2011: World PFS Summit 2012, slide 10
HFE Summary Report
User Interface Design (e.g. device + IFU + packaging)
Optimized User Interface
Use-Related Risk Assessment (e.g. uFMEA)
Residual Risk
Formative Studies
Device Concept
Drug/ Formulation
Hazards & Clinical Impact
Opportunities for Use Error Critical
Use Errors HF Validation
Study
Intended Use (users, tasks, environments)
start early
www.team-consulting.com Confidential © Team Consulting 2011: World PFS Summit 2012, slide 11
HFE Summary Report
User Interface Design (e.g. device + IFU + packaging)
Optimized User Interface
Use-Related Risk Assessment (e.g. uFMEA)
Residual Risk
Formative Studies
Device Concept
Drug/ Formulation
Hazards & Clinical Impact
Opportunities for Use Error Critical
Use Errors HF Validation
Study
Intended Use (users, tasks, environments)
our understanding on day 1 was/is good
www.team-consulting.com Confidential © Team Consulting 2011: World PFS Summit 2012, slide 12
HFE Summary Report
User Interface Design (e.g. device + IFU + packaging)
Optimized User Interface
Use-Related Risk Assessment (e.g. uFMEA)
Residual Risk
Formative Studies
Device Concept
Drug/ Formulation
Hazards & Clinical Impact
Opportunities for Use Error Critical
Use Errors HF Validation
Study
Intended Use (users, tasks, environments)
be clear about who are not intended users
www.team-consulting.com Confidential © Team Consulting 2011: World PFS Summit 2012, slide 13
HFE Summary Report
User Interface Design (e.g. device + IFU + packaging)
Optimized User Interface
Use-Related Risk Assessment (e.g. uFMEA)
Residual Risk
Formative Studies
Device Concept
Drug/ Formulation
Hazards & Clinical Impact
Opportunities for Use Error Critical
Use Errors HF Validation
Study
Intended Use (users, tasks, environments)
instructions for use are part of the user interface
an important
www.team-consulting.com Confidential © Team Consulting 2011: World PFS Summit 2012, slide 14
HFE Summary Report
User Interface Design (e.g. device + IFU + packaging)
Optimized User Interface
Use-Related Risk Assessment (e.g. uFMEA)
Residual Risk
Formative Studies
Device Concept
Drug/ Formulation
Hazards & Clinical Impact
Opportunities for Use Error Critical
Use Errors HF Validation
Study
Intended Use (users, tasks, environments)
analytical and empirical HF
www.team-consulting.com Confidential © Team Consulting 2011: World PFS Summit 2012, slide 15
HFE Summary Report
User Interface Design (e.g. device + IFU + packaging)
Optimized User Interface
Use-Related Risk Assessment (e.g. uFMEA)
Residual Risk
Formative Studies
Device Concept
Drug/ Formulation
Hazards & Clinical Impact
Opportunities for Use Error Critical
Use Errors HF Validation
Study
Intended Use (users, tasks, environments)
expect to iterate
www.team-consulting.com Confidential © Team Consulting 2011: World PFS Summit 2012, slide 16
HFE Summary Report
User Interface Design (e.g. device + IFU + packaging)
Optimized User Interface
Use-Related Risk Assessment (e.g. uFMEA)
Residual Risk
Formative Studies
Device Concept
Drug/ Formulation
Hazards & Clinical Impact
Opportunities for Use Error Critical
Use Errors HF Validation
Study
Intended Use (users, tasks, environments)
don’t leave root cause analysis until validation
www.team-consulting.com Confidential © Team Consulting 2011: World PFS Summit 2012, slide 17
HFE Summary Report
User Interface Design (e.g. device + IFU + packaging)
Optimized User Interface
Use-Related Risk Assessment (e.g. uFMEA)
Residual Risk
Formative Studies
Device Concept
Drug/ Formulation
Hazards & Clinical Impact
Opportunities for Use Error Critical
Use Errors HF Validation
Study
Intended Use (users, tasks, environments)
‘critical’ and ‘successful’ should be applied with care
www.team-consulting.com Confidential © Team Consulting 2011: World PFS Summit 2012, slide 18
HFE Summary Report
User Interface Design (e.g. device + IFU + packaging)
Optimized User Interface
Use-Related Risk Assessment (e.g. uFMEA)
Residual Risk
Formative Studies
Device Concept
Drug/ Formulation
Hazards & Clinical Impact
Opportunities for Use Error Critical
Use Errors HF Validation
Study
Intended Use (users, tasks, environments)
we should learn nothing important during validation
www.team-consulting.com Confidential © Team Consulting 2011: World PFS Summit 2012, slide 19
HFE Summary Report
User Interface Design (e.g. device + IFU + packaging)
Optimized User Interface
Use-Related Risk Assessment (e.g. uFMEA)
Residual Risk
Formative Studies
Device Concept
Drug/ Formulation
Hazards & Clinical Impact
Opportunities for Use Error Critical
Use Errors HF Validation
Study
Intended Use (users, tasks, environments)
don’t hope for zero
www.team-consulting.com Confidential © Team Consulting 2011: World PFS Summit 2012, slide 20
HFE Summary Report
User Interface Design (e.g. device + IFU + packaging)
Optimized User Interface
Use-Related Risk Assessment (e.g. uFMEA)
Residual Risk
Formative Studies
Device Concept
Drug/ Formulation
Hazards & Clinical Impact
Opportunities for Use Error Critical
Use Errors HF Validation
Study
Intended Use (users, tasks, environments)
usability acceptance criteria are risk acceptance criteria
www.team-consulting.com Confidential © Team Consulting 2011: World PFS Summit 2012, slide 21
HFE Summary Report
User Interface Design (e.g. device + IFU + packaging)
Optimized User Interface
Use-Related Risk Assessment (e.g. uFMEA)
Residual Risk
Formative Studies
Device Concept
Drug/ Formulation
Hazards & Clinical Impact
Opportunities for Use Error Critical
Use Errors HF Validation
Study
Intended Use (users, tasks, environments)
qualitative not quantitative
www.team-consulting.com Confidential © Team Consulting 2011: World PFS Summit 2012, slide 22
HFE Summary Report
User Interface Design (e.g. device + IFU + packaging)
Optimized User Interface
Use-Related Risk Assessment (e.g. uFMEA)
Residual Risk
Formative Studies
Device Concept
Drug/ Formulation
Hazards & Clinical Impact
Opportunities for Use Error Critical
Use Errors HF Validation
Study
Intended Use (users, tasks, environments)
demonstrate understanding
www.team-consulting.com Confidential © Team Consulting 2011: World PFS Summit 2012, slide 23
• What might we agree we should be committed to designing out?
– too easy to repeatedly overdose/no-dose inadvertently
– too easy to damage device through ‘reasonable misuse’
– procedure of use too complicated
• hard to learn/hard to train
• easy to get wrong even if paying attention
– too easy to misinterpret instructions for use (IFU)
– too difficult to follow instructions for use (IFU)
– poor physical usability - some tasks too difficult for intended users
– opportunities for critical harm to result from predictable negative transfer of prior experience with other injectors
– …
• What usability issues might we recognise have justifiable residual risks associated with them?
– requirement for user to attend to simple-to-follow IFU in order to acquire adequate technique …
What might be a realistic and sound target for self-injector usability?
www.team-consulting.com Confidential © Team Consulting 2011: World PFS Summit 2012, slide 24
Summative - validatory
Formative - confirmatory
Generative - exploratory
Projective - discovery
Certainty Opportunity
design research – going beyond usability
www.team-consulting.com Confidential © Team Consulting 2011: World PFS Summit 2012, slide 25
HFE Summary Report
User Interface Design (e.g. device + IFU + packaging)
Optimized User Interface
Use-Related Risk Assessment (e.g. uFMEA)
Residual Risk
Formative Studies
Device Concept
Drug/ Formulation
Hazards & Clinical Impact
Opportunities for Use Error Critical
Use Errors HF Validation
Study
Intended Use (users, tasks, environments)
narrative – tell a coherent story
www.team-consulting.com Confidential © Team Consulting 2011: World PFS Summit 2012, slide 26
www.team-consulting.com Confidential © Team Consulting 2011: World PFS Summit 2012, slide 27
For further information, please contact
Julian Dixon
Tel: +44 (0)1799 532 746
Email: [email protected]
Team Consulting Ltd. Abbey Barns, Duxford Road
Ickleton, Cambridge CB10 1SX, UK
Tel:+44 (0)1799 532 700 Fax:+44 (0)1799 532 701
Email: [email protected]