Appealing to Users: Designing Inhalers to Maximize Compliance and Minimize Misuse (RDD 2009)
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This document discusses how to design inhalers to maximize proper use and minimize misuse. It provides examples of use errors seen with different inhaler designs and suggests approaches to understand user behavior and accommodate it in device design. The goal is to eliminate errors by considering usability early in development and testing prototypes with users. Future inhalers should be designed to be inclusive of a wide range of user abilities and minimize the risk of errors in preparation and use of the medication.
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Appealing to Users: Designing Inhalers to Maximize Compliance and Minimize Misuse (RDD 2009)
- 1. Appealing to Users Designing Inhalers to Maximize Compliance and Minimize Misuse Julian Dixon, Iain Simpson Team Consulting Ltd www.team-consulting.com RDD 2009 – Team Presentation WIP01, slide 1 © Team Consulting 2009
- 2. Overview HOW? What processes can and should we follow? WHAT? What are realistic and achievable objectives? What should we be demand of ourselves now? What are the remaining challenges for further research and technological development? www.team-consulting.com RDD 2009, slide 2 © Team Consulting 2009
- 3. Device Developer Usability engineering and inclusive design skills application How to INFLUENCE USERS and ACCOMMODATE TO THEM OVER 3 HUNDRED IN THE AUDIENCE? 2009 1936 www.team-consulting.com RDD 2009, slide 3 © Team Consulting 2009
- 4. Types of Use Error (1/2) - Incompetence or Contrivance Dose Inhalation more challenging to influence users‟ behaviour focus on how the core technology can accommodate users‟ behaviour Dose Preparation design has great inherent potential to significantly influence users‟ behaviour – and to readily accommodate to the anticipated range of users‟ behaviour www.team-consulting.com RDD 2009, slide 4 © Team Consulting 2009
- 5. Types of Use Error (2/2) – Non-Adherence Failure to Use features can support remembering to take dose, but it is very hard for the inhaler to influence ‘refusal’ www.team-consulting.com RDD 2009, slide 5 © Team Consulting 2009
- 6. Case Study 1 – Eliminating a Dose Preparation Error (1/3) Example from findings of Wieshammer & Dreyhaupt, RDD 2009 Aerolizer and HandiHaler share a common interaction design, differing in interface and mechanical design. In both cases, failure to release the piercing button/s prior to inhalation is a significant use error. www.team-consulting.com RDD 2009, slide 6 © Team Consulting 2009
- 7. Case Study 1 – Eliminating a Dose Preparation Error (2/3) Findings: Failure to release piercing buttons occurred in: • 1/22 patients with Aerolizer • 6/32 patients with HandiHaler Discussion: • Would we find a statistically significant difference if we could test larger samples? • How much of the difference is due to difference in user group? – ~60% of Handihaler users were COPD patients vs. ~20% of Aerolizer users • Are the differences in interface and mechanical design influencing error rate? • Can we understand the drivers of this user behaviour? – what mental models do users have? Findings taken from Wieshammer & Dreyhaupt, RDD 2009 www.team-consulting.com RDD 2009, slide 7 © Team Consulting 2009
- 8. Case Study 1 – Eliminating a Dose Preparation Error (3/3) What if these insights had been gathered at the start of development? Purposefully test with the more challenging user group to … • … understand the likely range of behaviour on the basis of mental models – is this use error going to be a common „contrivance‟ or just an „incompetence‟? • … explore how the interface design could influence error rates – can the form and layout of the interface reliably cue correct behaviour? If necessary, modify interface and mechanical design to either … • eliminate the opportunity for the unwanted user input … or … • accommodate to the user input Test this with simple interact-like and POP models and eliminate the use error before sinking significant development costs. www.team-consulting.com RDD 2009, slide 8 © Team Consulting 2009
- 9. Principle – start by considering how the user and device will interact … Understand Understand your User Behaviour Interaction Core Technology Design (Design Intent) Interface Design (Design Intent) Mechanism Design (Design Reality) www.team-consulting.com RDD 2009, slide 9 © Team Consulting 2009
- 10. And in usability jargon … Interaction Cognitive Design (Design Intent) Usability Interface Design (Design Intent) Physical Usability Mechanism Design (Design Reality) The whole and the sum of the parts = Emotional Usability www.team-consulting.com RDD 2009, slide 10 © Team Consulting 2009
- 11. Case Study 2 – Minimising Dose Inhalation Errors (1/3) Example from conclusions of Chrystyn, RDD 2009 important to identify the minimum inhalation (rate & volume) required for drug delivery, not just the optimal flow www.team-consulting.com RDD 2009, slide 11 © Team Consulting 2009
- 12. Case Study 2 – Minimising Dose Inhalation Errors (2/3) Understand Understand User Behaviour Inclusive Core Technology Inhaler Design what factors influence the how does delivery range of variation in performance vary over a inspiratory behaviour? range of inspiratory –resistance, mouthpiece behaviour shape, auditory feedback … ?? –words used in training …? system performance user behaviour “inclusiveness” www.team-consulting.com RDD 2009, slide 12 © Team Consulting 2009
- 13. Case Study 2 – Minimising Dose Inhalation Errors (3/3) What if these insights had been gathered at the start of development? Select and optimise aerosolisation technology and inhaler geometry for greatest robustness to real patient behaviour … • … understanding the likely range of behaviour • … understanding the factors that increase the variation in behaviour • … including recognition of which inhalation system/behaviour combination is easiest to reliably train Test with simple profile-logging models before sinking significant development costs. www.team-consulting.com RDD 2009, slide 13 © Team Consulting 2009
- 14. Case Study 3 – Prohaler - integrating an understanding of users in development User input Concept generation Task analysis Ergonomic research Visual Observational user Targeted user Confirmatory (with block models & requirements research research on observational Interaction design workshop („looks like‟ semi mouthpiece user studies mouthpiece shapes) functional models) design and dose counter Concept generation POP testing Inhalation profile Development of Consideration Detailed Design, of Mechanical and filtering of investigation internal of DFMA design for Process principles concepts mechanisms manufacture FMEA including dose Technical input counter DFMA www.team-consulting.com RDD 2009, slide 14 © Team Consulting 2009
- 15. What should we expect of our future inhalers? effective use proportion of patients (illustrative) 1 dose preparation errors 2 dose inhalation errors 3 failure to use today’s DPI readily achievable achievable our long term goal www.team-consulting.com RDD 2009, slide 15 © Team Consulting 2009
- 16. The details I have purposefully omitted … • pro‟s and con‟s of “automatic” vs. “manual” devices • the „legacy‟ challenge – so many different inhalers and what this means for common mental models • tidal-breathing DPI‟s • additional feedback to generate greater confidence • reminder features to support adherence • potential of enhanced functionality? – e.g. reward systems, on-board diagnostics, wireless communications www.team-consulting.com RDD 2009, slide 16 © Team Consulting 2009
- 17. Our users are a key design input Device Developer Usability engineering and inclusive design skills application How to Usability Engineering INFLUENCE USERS and ACCOMMODATE Inclusive Design TO THEM OVER 3 HUNDRED IN THE AUDIENCE? We can and should work with them www.team-consulting.com RDD 2009, slide 17 © Team Consulting 2009
Editor's Notes
- I’m here to REPRESENT DEVICE DEVELOPERS in responding to the kind of challenges that Doctors Wieshammer and Chrystyn have outlined – looking to the future, by learning from the past. Put simplistically - the solution lies in APPEALING to users – in both senses of the word.
- What CAN and SHOULD we be DOING to develop inhalers that minimise misuse in the hands of our users and support maximum adherence to the prescribed dosing regime? What PROCESSES should we follow? And what are REALISTIC AND ACHIEVABLE goals for us to set ourselves? What should we DEMAND of ourselves? What should we ACCEPT as the REMAINING CHALLENGES that further research and technological development are needed to address?
- I want to keep to time and not confuse myself by getting into too many interesting sub-topics – so will try to outline BASIC PRINCIPLES as clearly as possible and avoid getting into too many details. And when I was trying to think of a MEMORABLE way to state these basic PRINCIPLES I found myself making a play on the title of the grandfather of self-help books – Dale Carnegie’s “How to Win Friends and Influence People” – which I was interested to see was written soon after the last great financial crash. Anyway … I came up with … “How to INFLUENCE USERS …… and ACCOMMODATE TO THEM”. In a nutshell that’s what we can and should be doing as device developers.
- Before going on … it is going to be useful to distinguish between two kinds of use error with inhalers … because of the very different challenges they pose and therefore the different kind of development response we can expect. The illustration shows the patient instructions for Accuhaler – I could have picked any inhaler. FIRST we have errors that are associated with the handling of the device – i.e. with … DOSE PREPARATION In these cases correct use is entirely connected with actions WITH and direct feedback from the inhaler … and therefore the form, design/styling and various mechanisms – however simple or complex – of the inhaler have great INHERENT potential to INFLUENCE user behaviour. The mechanisms will provide direct mechanical feedback – possibly visible, certainly haptic or feelable. And where we find the limits of the ability of the design to influence or guide users’ behaviour – in practice it is more than likely to be possible to design the user interface and mechanisms in such a way as to ACCOMMODATE to the range of anticipatable user behaviour. SECOND we have errors that are associated with correct INHALATION technique … Here correct use is only loosely connected with actions and direct feedback from the inhaler … it is to be expected that we will struggle more to INFLUENCE user behaviour Dose Inhalation core aerosolization & formulation technology correct use is not entirely connected with actions with the inhaler
- So … let’s return to the first type of use error – a dose preparation error … and let’s draw on one of the findings of Wieshammer & Dreyhaupt as an illustrative case study. Aerolizer and HandiHaler same interaction design uncover, open, insert capsule, close, pierce capsule, inhale … mostly transparent to user – except the question of whether to hold the button down during inhalation … (the most common use error!) different interfaces and mechanical design hinged vs. pulled-off cover hinged vs. twist capsule insertion single vs. double piercing buttons
- Interface … is there something about a single button that miscues??? Mechanical design … is there something about the spring forces that discourage holding???
- use the words INSENSITIVE, ROBUST make the distinction between CONTRIVANCE and INCOMPETENCE what to do about it? test with the more challenging group – INCLUSIVE DESIGN seek to understand the mental processes (mental model) behind patients behaviour – COGNITIVE USABILITY identify which errors can be addressed through changing the interface / mechanical design (e.g. recognising some WILL hold the button – “to get the full dose” – design a mechanism that is insensitive to this) DO ALL THIS WITH SIMPLE INTERACTS LIKE MODELS EARLY IN DEVELOPMENT … get usability right before it costs a lot! this illustrates the principles … not intended as a direct call to capsule inhaler manufacturers/marketers …
- optimise the match between technology and user behaviour THIS IS ‘USABILITY ENGINEERING’ not complicated … it is about getting the basics right! understand what interaction design is going to work best implement that interaction design without mechanical compromise only then start to look at how to add EXTRA functionality to support correct use “ what do people want out of their boiler??” that it works, that it doesn’t breakdown, that when they set the timer it …
- much like manufacturing … we ALWAYS need to understand our operating window … our tolerances are as important as the nominal value principle … understand what users’ think and do … and how much they can be influenced don’t just focus in on how to get them to do WHAT WE WANT” technology selection for inclusive design - minimise the sensitivity of the technology to variation in inhalation technique – select technologies for their ‘robustness’, not for the peak performance robust to potential contrivance! minimise the training burden what can’t we achieve through device design? eliminate ALL requirement on the patient to inhale! least demanding possible is only to require tidal breathing can’t eliminate potential exhalation into the device can’t eliminate potential failure to exhale before inhaling
- No one would accept and progress an inhaler development that shows no promise regarding achieving an acceptable fine particle dose … a similar rejection should be made of an inhaler development that cannot demonstrate that avoidable and important use errors have been eliminated / minimised. 1. eliminate dose prep errors 2. usability engineering to reduce inhalation technique errors 2. tuning aerodynamic design to best optimise performance with real users behaviour … working in consort with training aids … (e.g. inhaler isn’t going to tell you to exhale or hold … ) 3. select new technologies to radically reduce the demands of inhalation technique And beyond … we can talk about enhanced functionality … assess the incremental value of monitoring / reminders / etc. BUT LET’S GET THE BASICS RIGHT. Referring back to the table of factors affecting compliance shown by Dr Chrystyn – we should be ensuring we meet requirements around ACCEPTANCE of and CONFIDENCE with the device, FIT … and the most basic … eliminate as many BARRIERS that future inhalers may represent for patients. “ What do you want out of your inhaler?” is still the same kind of question as “What do you want out of your boiler?” … the answer is that basic reliability and fitness for purpose are still the critical requirements
- I hope I’ve delivered on my intention to avoid getting into too many sub-topics, but instead keeping up at the level of the basic principles. Certainly I have left out quite of lot of relevant and important detailed debates … for example … Listen to users … and potentially segment users by their needs … do they differ by trade-off between speed and sense of being in control? speed – go for an open-breathe-close interaction … control – a next-generation unit-dose interaction (a really easy to use capsule inhaler) is the simple device NECESSARILY going to have higher error rates … how much $ is it appropriate to invest to eliminate the opportunity for error … … depends on how often the opportunity is acted on! Think commercially
- So … to return to the beginning and summarise this summary … … the key principle is one of TIMING . The issues that the previous two presentations have highlighted on MARKETED inhalers should be investigated at the START of development. USERS are a key DESIGN INPUT. Armed with this understanding of the kind of DOSE PREPARATION ERRORS that our users will make – given the opportunity – we are more than likely able to design to eliminate them. Our interaction design will acknowledge We can also expect to make significant improvements to the rate of DOSE INHALATION ERRORS through a greater degree of understanding and acceptance that the patient is part of the system we are seeking to optimise. The processes of usability engineering and inclusive design are easy to understand – we can and should employ them! I WOULD LIKE TO THANK MY COLLEAGUE IAIN SIMPSON FOR TAKING THE LION’S SHARE OF THE BURDEN OF PUTTING THIS PAPER TOGETHER – AND TO THANK JOANNE PEART FOR HER GREAT SUPPORT THROUGHOUT. And, obviously, we’d be delighted to talk more about this topic with any of you in the breaks. You can find us at our table-top stand just round the corner. Thank you