oip device design: approaches to creating successful products for patient use

Benjamin Cox, Julian Dixon

Senior Human Factors Consultant – Team Consulting

06 April 2013

OIP Device Design:

Approaches to Creating Successful Products

for Patient Use

Overview

• Familiar OIP challenges

• Realistic targets for improving patient competence and adherence

• The human factors engineering (HFE) process

• Information design and harnessing the patient experience

Confidential © Team Consulting 2013

familiar challenges

Familiar challenges

Aerolizer

(n = 769), %

Autohaler

(n = 728), %

Diskus

(n = 894), %

pMDI

(n = 552), %

Turbuhaler

(n = 868), %

At least one error 54 55 49 76 54

At least one device-dependent error 12 41 16 69 32

At least one critical error 12 11 11 28 32

Molimard et al. 2003


Familiar challenges

• Inhalers are reliant on patient technique and prone to human error

• Pharmaceutical products all face adherence challenges

• Instructions for use are often inadequate and training provision is patchy

poor competenceat drug delivery

poor adherenceto dose regimen


Familiar blockers

Commercial

• OIPs face significant cost pressures which limit uptake

of new technologies

• Established inhaler technologies are known to be

imperfect from a human factors perspective

• Long product life cycles restrict opportunities for change

Regulatory

• Significant increase in focus by regulators on human

factors engineering (HFE)

Healthcare system


Realistic targets today

• Embrace practical HFE in device development

• Address the addressable elements of COMPETENCE

• Start to think about enhancing ADHERENCE through design


... and in the future

• Clarity of HFE guidance and FDA review

• Select core technologies with fewest vulnerabilities to misuse

• Design out opportunities for error by adopting the HFE process from the outset

• Move beyond patient experience to real patient choice


Human factors engineering


Some key messages

• Acknowledge the unique challenge of patient-use device HF

• Start early and recognise how much is known on day 1

• Define who are not intended users and what is not intended use

• Understand the opportunities for error and the drivers of behaviour

• Include the instructions for use (IFU) as a key part of the user interface

• Develop a coherent HFE narrative for the FDA – drawing on analytical and empirical work


information designConfidential © Team Consulting 2013

before after

Dickinson et al. 2010


The power of communication

• Iterative process involving observation of real users is a critical step in developing effective

instructions

• Success rate of subjects administering a dose from breath-actuated MDI increased from 70 % to 96 %

Chang et al. 2011

• People

• rarely read two sentences of a manual consecutively

• start use before completing manual

• do not read introduction first

• do not read all of introduction or other sections

Sullivan and Flower 1987

• The more familiar people are with a product, the less likely they are to read instructions


instructeduninstructed

use s

teps


Inhaler IFU approach

• Identify areas of high risk or potential confusion to the user

• Clearly communicate key steps through the use of focused illustrations and simple language

• Use layout and formatting to reinforce core messages

• Test and iterate with users in realistic scenarios

• As part of user interface, instructions for use can provide effective mitigation but cannot in

themselves remove the opportunity for error

• Users may make assumptions or have preconceptions based on prior device experience

• Apparent simplicity or familiarity with inhalers can promote inappropriately relaxed attitude from users

• Users will engage with the IFU to varying degrees


harnessing the patient experience

Harnessing the patient experience

• Harness the potential of the IFU to enhance competence and reduce risk

• Consider how all aspects of a product offering affect patient experience

• Embrace design to strengthen the relationship between user and inhaler

• Seek opportunities to ‘nudge’ adherence


Apps

Accessories

Carton

IFU / PIL

Aesthetics

Features

Form factor

Device Core

user experienceConfidential © Team Consulting 2013

QSG

PIL

Inhaler


Summary

• Inhaler devices face a challenging intended use and intended user combination

• HFE and design can deliver real benefits despite known challenges and the limitations of existing

inhaler technology

• Great opportunities exist for improving competence and adherence through design

• Small practical steps tied together by a coherent HFE process can deliver more successful

products for patient use

oip device design: approaches to creating successful products for patient use

Health & Medicine

patient competence

patient technique

oip device design

patient use benjamin

hfe process information

use ifu

unique challenge of

device development