The document discusses challenges with inhaler devices and patient use. It advocates for applying human factors engineering principles and design thinking to address issues of patient competence in using the devices properly and adherence to treatment regimens. The document recommends realistic targets for improving competence and adherence through early focus on human factors, clear instructions, effective communication design, and harnessing the patient experience.

1. OIP Device Design:
Approaches to Creating Successful Products
for Patient Use
Benjamin Cox, Julian Dixon
Senior Human Factors Consultant – Team Consulting
06 April 2013

2. 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
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3. familiar challenges

4. Familiar challenges
Aerolizer Autohaler Diskus pMDI Turbuhaler
(n = 769), % (n = 728), % (n = 894), % (n = 552), % (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
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5. 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 competence poor adherence
at drug delivery to dose regimen
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6. 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
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7. Realistic targets today
• Embrace practical HFE in device development
• Address the addressable elements of COMPETENCE
• Start to think about enhancing ADHERENCE through design
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8. ... 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
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9. Human factors engineering
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10. Human factors engineering
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11. Human factors engineering
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12. Human factors engineering
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13. 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
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14. Confidential © Team Consulting 2013
information design

15. before after
Dickinson et al. 2010
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16. 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
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17. use steps
uninstructed instructed
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18. 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
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19. harnessing the patient experience

20. 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
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21. Device Core
Form factor
Features
Aesthetics
IFU / PIL
Carton
Accessories
Apps
user experience
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22. Confidential © Team Consulting 2013

23. QSG
Inhaler
PIL
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24. Confidential © Team Consulting 2013

26. 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