Human Factors Considerations in Inhaler Innovation
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1 Human Factors Considerations in Inhaler Innovation Julian Dixon Director of Human Factors, Team Consulting DDL December 2016 Team Consulting Ltd. 2016
2 Terminology HF: human factors the field ergonomics another name for a similar field HFE: human factors engineering the activity usability engineering another name for the same activity IFU: instructions for use
3 Just for today I m going to try to not mention regulatory agencies, their expectations or their issued guidance
4 How can a human factors (HF) perspective contribute to inhaler innovation?
5 Disclaimer I do not wish to claim that HF has exclusive ownership of any topic. HFE in inhaler development works at the interface of many disciplines. One perspective amongst many.
6 by designing easy to use inhalers. Innovating to support the inhaler user by supporting competence. by supporting disease management. Drug Delivery System formulations primary packaging devices reduce cognitive & emotional demands on users reduce physical demands on users reduce use-related risk improve fit with lifestyle Technique Training instructional materials training devices competence monitoring tools support competence Behaviour Change Interventions reminders self monitoring tools educational interventions gamification support adherence to dosing regimen enable and support disease management
7 by designing easy to use inhalers. Drug Delivery System Innovating to support the inhaler user Various porous particles Alviol (active primary pack) AZ Turbuhaler Aptar (high dose density DPI) Prohaler (open, breathe, close) Teva/MicroDose Electronic DPI (active aerosolisation) formulations primary packaging devices Boehringer Ingelheim Handihaler (step change in design) GSK Diskus (open, load, inhale, close) DirectHaler (single dose DPI) Elpen Elpenhaler (blister DPI) 3M ICI (flow regulator) reduce cognitive & emotional demands on users reduce physical demands on users GSK Haleraid (assistive tech) EasiBreathe (BA pmdi) Respirics MD Turbo (smart pmdi) Boehringer Ingelheim Respimat (low velocity aerosol) pmdi dose counters reduce use-related risk improve fit with lifestyle
8 by supporting competence. Technique Training instructional materials training devices competence monitoring tools Innovating to support the inhaler user Trainhaler Trainer with Flo-Tone (mechanical trainer) Noble Trainer (electronic trainer) 3M ICI (on-board technique training) (technique logging and app support) support competence
9 by supporting disease management. Behaviour Change Interventions reminders self monitoring tools educational interventions gamification support adherence enable and support disease management Innovating to support the inhaler user Various SMS interventions Clickhealth Packy and Marlon (educational video game) Various Apps Funhaler (fun spacer) Propeller, Adherium, Gecko, Cohero, etc. Inhaler Usage Monitors 3M ICI (adherence monitoring) Cohero Connected Spacer
10 A lot of great innovation in the inhaler field preceded any focused engagement with HFE
11 What is human factors (HF)?
12 Ergonomics (or human factors) is the scientific discipline concerned with the understanding of interactions among humans and other elements of a system International Ergonomics Association
13 HF is a marriage of psychology and engineering: the application of a scientific body of knowledge about human strengths and weaknesses to the design of technology. Human Factors MD Inc.
14 Understanding the interaction between humans and technology Understanding both the human and the engineering Understanding user interfaces
15 What characterises the HF perspective?
16 Warning! Due to a shortage of robots, some of our staff are human and therefore react unpredictably when abused or under pressure. Team Consulting Ltd
17 Warning! Due to a shortage of robots, our users are human and will make predictable errors and not always behave perfectly rationally. Team Consulting Ltd
18 human biology in vitro in vivo in reality rerus praxi feras human behaviour
19 engaging with what is really going to happen when our users use the inhalers we develop
20 focused on the usability of user interfaces focused primarily on how the user administers doses
21 The HF Perspective? evidence-based inclusion of the human factor in inhaler development concerned with real world performance: technical and therapeutic
22 The HF Perspective? evidence-based, scientific HF methods focus on real world performance HF objectives: different trade offs
23 HF objectives: different trade offs
24
25 An HF perspective on inhaler instructions for use (IFUs) Boy: Stick it in your mouth and push down. Right? Nurse: Well, then the medicine would end up in your mouth and not in your lungs. It needs to go to your lungs. It s very important to breathe in and squeeze your inhaler at the same time, so that it gets all the way into your body. Team Consulting Ltd
26 An HF perspective on choice of primary packaging Team Consulting Ltd
27 HF methods
28 HF methods analytical e.g. task analysis, state space analysis, PCA analysis empirical e.g. simulated-use studies, HF challenge on the bench
29 democracy is the worst form of government except for all those other forms that have been tried from time to time Winston Churchill
30 a small-scale, qualitative, simulated-use, observational study is the worst research method we have, except for all those others that have been tried from time to time.
31 Participant An Inhaler Prototype or Model
32 Participant An Inhaler A Task
33 One-way observation mirror Moderator Participant
34 formative work should be formative
35 How can a human factors (HF) perspective contribute to inhaler innovation?
36 Yes, HF will contribute as one perspective illuminating the potential promise of inhaler innovations
37 But, HF contributes primarily by providing a mindset and a toolkit that supports delivery of the promise of that innovation
38 HFE will help the development of inhalers meant for humans. Not least, by testing during development.
39 Acknowledgements My colleagues at Team, in particular: HFE: Claire Young, Martin Bontoft, Rob Fernall, Diane Aston-James ID: Alex Driver Engineering: Stuart Abercrombie
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