Appealing to users: developing usable & desirable devices

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


• 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


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Ref: FDA Draft Guidance, June 2011: Applying Human Factors and Usability Engineering to Optimize Medical Device Design


• 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?


• 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


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Ref: FDA Draft Guidance, June 2011: Applying Human Factors and Usability Engineering to Optimize Medical Device Design


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


HFE Summary Report




Residual Risk

Formative Studies

Device Concept

Drug/ Formulation



Use Errors

mitigate

verify

HF Validation Study

Intended Use (users, tasks, environments)


HFE Summary Report




Residual Risk

Formative Studies

Device Concept

Drug/ Formulation



Use Errors HF Validation

Study


start early


HFE Summary Report




Residual Risk

Formative Studies

Device Concept

Drug/ Formulation




Study


our understanding on day 1 was/is good


HFE Summary Report




Residual Risk

Formative Studies

Device Concept

Drug/ Formulation




Study


be clear about who are not intended users


HFE Summary Report




Residual Risk

Formative Studies

Device Concept

Drug/ Formulation




Study


instructions for use are part of the user interface

an important


HFE Summary Report




Residual Risk

Formative Studies

Device Concept

Drug/ Formulation




Study


analytical and empirical HF


HFE Summary Report




Residual Risk

Formative Studies

Device Concept

Drug/ Formulation




Study


expect to iterate


HFE Summary Report




Residual Risk

Formative Studies

Device Concept

Drug/ Formulation




Study


don’t leave root cause analysis until validation


HFE Summary Report




Residual Risk

Formative Studies

Device Concept

Drug/ Formulation




Study


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


HFE Summary Report




Residual Risk

Formative Studies

Device Concept

Drug/ Formulation




Study


we should learn nothing important during validation


HFE Summary Report




Residual Risk

Formative Studies

Device Concept

Drug/ Formulation




Study


don’t hope for zero


HFE Summary Report




Residual Risk

Formative Studies

Device Concept

Drug/ Formulation




Study


usability acceptance criteria are risk acceptance criteria


HFE Summary Report




Residual Risk

Formative Studies

Device Concept

Drug/ Formulation




Study


qualitative not quantitative


HFE Summary Report




Residual Risk

Formative Studies

Device Concept

Drug/ Formulation




Study


demonstrate understanding


• 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?


Summative - validatory

Formative - confirmatory

Generative - exploratory

Projective - discovery

Certainty Opportunity

design research – going beyond usability


HFE Summary Report




Residual Risk

Formative Studies

Device Concept

Drug/ Formulation




Study


narrative – tell a coherent story


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]

mailto:[email protected]



Appealing to users: developing usable & desirable devices

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