Appealing to users: developing usable & desirable devices

Appealing to Users
Developing Usable & Desirable Devices

Presenter: Julian Dixon
Date: 20th September 2012

Confidential © Team Consulting 2011: World PFS Summit 2012, slide 1 www.team-consulting.com

Overview

• 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


What is Human Factors Engineering?

“Understanding and optimizing how people interact with
technology
is the subject of
human factors engineering (HFE)
and
usability engineering (UE).”

Ref: FDA Draft Guidance, June 2011: Applying Human Factors and Usability Engineering to Optimize Medical Device Design


Why current interest in HF?

• 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


Patient-use, drug delivery devices pose a unique HF challenge

• 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?


Statements of HF Objective

“… 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.”

Ref: FDA Draft Guidance, June 2011: Applying Human Factors and Usability Engineering to Optimize Medical Device Design


User Interface Design Optimized
(e.g. device + IFU + packaging) User Interface
mitigate

Device Opportunities
Concept for Use Error
Critical Formative HF Validation HFE Summary
Drug/ Hazards & Use Errors Studies Study Report
Formulation Clinical Impact
verify
Use-Related Risk Assessment 
Residual Risk
(e.g. uFMEA)


mitigate

verify
Use-Related Risk Assessment 
Residual Risk
(e.g. uFMEA)

Intended Use
(users, tasks, environments)


start early



Use-Related Risk Assessment
Residual Risk
(e.g. uFMEA)

Intended Use


our understanding on day 1 was/is good



Residual Risk
(e.g. uFMEA)

Intended Use


be clear about who are not intended users



Residual Risk
(e.g. uFMEA)

Intended Use


an important
instructions for use are part of the user interface



Residual Risk
(e.g. uFMEA)

Intended Use


analytical and empirical HF



Residual Risk
(e.g. uFMEA)

Intended Use


expect to iterate



Residual Risk
(e.g. uFMEA)

Intended Use


don’t leave root cause analysis until validation



Residual Risk
(e.g. uFMEA)

Intended Use


‘critical’ and ‘successful’ should be applied with care



Residual Risk
(e.g. uFMEA)

Intended Use


we should learn nothing important during validation



Residual Risk
(e.g. uFMEA)

Intended Use


don’t hope for zero



Residual Risk
(e.g. uFMEA)

Intended Use


usability acceptance criteria are risk acceptance criteria



Residual Risk
(e.g. uFMEA)

Intended Use


qualitative not quantitative



Residual Risk
(e.g. uFMEA)

Intended Use


demonstrate understanding



Residual Risk
(e.g. uFMEA)

Intended Use


What might be a realistic and sound target for self-injector usability?

• 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 …


design research – going beyond usability
Opportunity Certainty

Summative - validatory
Formative - confirmatory

Generative - exploratory

Projective - discovery


narrative – tell a coherent story



Residual Risk
(e.g. uFMEA)

Intended Use


For further information, please contact

Julian Dixon
Tel: +44 (0)1799 532 746
Email: jrd@team-consulting.com

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: info@team-consulting.com


Appealing to users: developing usable & desirable devices

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