Open Design and Medical Products
Total Page：16
File Type：pdf, Size：1020Kb
Open design and medical products DEXTER, Matt Available from the Sheffield Hallam University Research Archive (SHURA) at: http://shura.shu.ac.uk/12190/ A Sheffield Hallam University thesis This thesis is protected by copyright which belongs to the author. The content must not be changed in any way or sold commercially in any format or medium without the formal permission of the author. When referring to this work, full bibliographic details including the author, title, awarding institution and date of the thesis must be given. Please visit http://shura.shu.ac.uk/12190/ and http://shura.shu.ac.uk/information.html for further details about copyright and re-use permissions. Open Design and Medical Products an Open Medical Products Methodology Dr. Matt Dexter CAD 1 Open Design and Medical Products Open Design and Medical Products A thesis submitted in partial fulfilment of the requirements of: Sheffield Hallam University For the degree of Doctor of Philosophy Submitted: June 2014 PhD awarded: August 2014 Thesis examination team consisted of: SHU Internal Examiner: Professor Paul Chamberlain. Design Director Lab4living and Head of Art and Design Research Centre External Examiner: Professor Mike Press Chair of Design Policy at DJCAD Supervisory Team: Director of Studies: Professor Paul Atkinson Professor of Design & Design History Second Supervisor: Professor Andy Dearden Professor of Interactive Systems Design Suggested Reference: DEXTER, Matthew HL (2014). Open Design and Medical Products: An Open Medical Products Methodology. PhD, Sheffield Hallam University Contact Details Matt Dexter PhD +44 (0) 770 880 4341 [email protected] Except where otherwise noted, this work is licensed under the Creative Commons Attribution-ShareAlike 4.0 International License. http://creativecommons.org/licenses/by-sa/4.0/ 2 Abstract Abstract Open Design and Medical Products—an Open Medical Products Methodology This research details the use of Open Design to enable participation in the conceptualisation, design and development of medical products for those who are excluded by their chronic health condition. The research was directed according to the Action Research methodology outlined by Checkland & Holwell (1998); Action Research being highlighted by Archer (1995) as a method compatible for practice-led design research. Open design directed the design practice, which consisted of a long case study spanning 18 months from February 2012, through to July 2013. This case study, dubbed AIR involved the creation of a bespoke online social network, recruitment of people living with cystic fibrosis, and the facilitation of collaborative design work resulting in prototype medical devices based on the lived experience of the participants. The work involves research into design within health as the context for this research. In order to place design in this wider context, it has been tempting to adopt the mantle Evidence Based Design Evans, 2010) – however in this research the position of design as phronesis, in a similar manner to health practice (Montgomery, 2005) is adopted. This allows for an alignment of the work done in both fields, without the problematic associations with an evidence hierarchy (Gaver & Bowers, 2012; Holmes, Murray, Perron, & Rail, 2006). The contribution to knowledge is an Open Medical Products Methodology, consisting of the artefacts supporting the evidence of the methodology’s ability to foster genuine participation amongst those who are excluded from traditional participatory design. The artefacts constituting this submission are this thesis, the reflective log kept during the research (Appendix A on page 135), the prototypes from the collaborative research (Appendix B on page 212), and the online social network that contained the work (AIR1 ). TheOpen Medical Products Methodology is expected to be of interest primarily to designers of medical products, design management and policymakers- although Open Design as a product methodology has appeal to other sectors and the future work into standardisation, regulation, distributed manufacture and recruitment detailed at the conclusion of this thesis has application broader than the medical field. 1 http://airdesignspace.ning.com 3 Acknowledgements Acknowledgements This PhD thesis presents independent research by the Collaborations for Leadership in Applied Health Research and Care for South Yorkshire (CLAHRC SY). CLAHRC SY acknowledges funding from the National Institute for Health Research (NIHR). The views and opinions expressed are those of the authors, and not necessarily those of the NHS, the NIHR or the Department of Health. CLAHRC SY would also like to acknowledge the participation and resources of our partner organisations. Further details can be found at www.clahrc-sy.nihr.ac.uk. As author, I would like to personally thank those who have helped me to complete this work, through the discussion of ideas & concepts, as well as introducing me to other fields and disciplines. Particular thanks go to the User-centred Healthcare Design team; Prof Andy Dearden, Rev Mark Cobb, Prof Peter Wright, Dr Simon Bowen, Dan Wolstenholme, Dr Helena Sustar, Dr Rémi Bec, Mark Fisher and Jackie Leaver. Working at UCHD was the best preparation and support for this PhD. The academic and support staff at Sheffield Hallam University have also been key in facilitating the making of prototypes, organising ethics and governance, and even helping to sort the finances. Of course, a PhD is not just about the research that’s conducted by me as author- the guidance and support of my supervisor Prof Andy Dearden and Director of Studies Prof Paul Atkinson has been key to the success of this work. Thank you both. AIR would not have been the success that it was, were it not for the participation of Holly, Amber, and Ronnie, as well as all who participated in AIR- I am indebted to all of you for your input and support. Thank you. On a personal note, there is no way that this PhD could have happened without the support and love of my children Isaac and Samuel, along with my wife Rachel- sorry for bringing papers, writing and the stress on holiday with us all! Finally, I am humbled and thankful for the talent, skill, support and love of design that the Lord God has blessed me with. Soli Deo Gloria! 4 Table of Contents Table of Contents 1. Background 11 1. 1 Introduction 11 1. 1. 1 Back Story 11 1. 1. 2 Research Question 13 1. 2 Theory - Open Source Hardware 13 1. 3 Study 15 1. 3. 1 This work 16 1. 4 Summary 16 2. Design in Health 17 2. 1 Background 18 2. 2 The Limits of Design in Health? 19 2. 2. 1 Wicked Problems in Health 19 2. 3 Health... and Design Therein 20 2. 3. 1 Design and the Scientific Method 20 2. 4 Evidence Based Medicine 21 2. 4. 1 Evidence Based Medicine and Design 22 2. 5 Evidence Based Medicine - a Critical View 23 2. 6 Experience Based (co) Design 23 2. 6. 1 Case Study - Better Outpatient Services for Older People (BOSOP) 25 2. 7 Chapter Summary 28 3. Research Methodology 29 3. 1 Design as Research 30 3. 1. 1 Rigour 30 3. 1. 2 Design Practice in Design Research 33 3. 1. 3 Production Values 33 3. 2 Action Research and Design 34 3. 3 Methodologies of Research, and Practice 36 3. 4 Participation in Design 36 3. 4. 1 Participatory Design 36 3. 5 Participatory Design in Medical Product Development 38 3. 5. 1 Barriers to Participation - a Manufacturer’s Perspective 40 3. 5. 2 Barriers to Participation - a Participant’s Perspective 40 5 Table of Contents 3. 6 Design Thinging 41 3. 7 Chapter Summary 42 4. Open Design 43 4. 1 Open Source Design 43 4. 1. 1 Manifestos and Definitions 43 4. 2 Open Innovation 46 4. 2. 1 Definition 46 4. 2. 2 Openness 47 4. 2. 3 Models and Organisation 48 4. 2. 4 Open Innovation in Medical Product Design 48 4. 3 Historical Context for Open Design 49 4. 3. 1 The Requirements of Technology 50 4. 4 Spaces 51 4. 4. 1 Fab Labs 52 4. 4. 2 Hackerspaces 53 4. 4. 3 Production / Infrastructure 54 4. 4. 4 Sharing Platforms 54 4. 4. 5 Free / Libre Open Source Software 55 4. 4. 6 The problem of continuous peer-review 56 4. 5 Hierarchies, and organization of open source development 58 4. 5. 1 The Revolutionary Internet? 58 4. 6 Open Design Controversies 60 4. 6. 1 Intellectual Property 60 4. 6. 2 CopyLeft 60 4. 6. 3 Creative Commons 61 4. 6. 4 Professional Identity 61 4. 6. 5 Cloning ain’t cool 62 4. 6. 6 Thingiverse.com, and the MakerBot Replicator 2 debate 64 4. 6. 7 Open Source Almost Everything 65 4. 7 Medical Products, and open source 67 4. 7. 1 Software 67 4. 7. 2 Hardware 67 4. 8 Chapter Summary 68 6 Table of Contents 5. Study 69 5. 1 Overcoming the barriers to participation 69 5. 2 Scoping Work 70 5. 2. 1 Online collaboration in a design project – ‘Phase Zero’ 71 5. 2. 2 Collaborative Design | PhD Research – Transition from MPhil to PhD 73 5. 2. 3 Cystic Fibrosis 73 5. 3 Open Design case study - AIR 74 5. 3. 1 Action Research 75 5. 3. 2 Ethics 75 5. 3. 3 Researcher Assumptions, and Personal Standpoint 76 5. 3. 4 Structure 77 5. 3. 5 α - Alpha Development Phase–first Action Cycle 78 5. 4 β - Beta Development Phase–second Action Cycle 84 5. 4. 1 Online Future Workshop 87 5. 5 Open AIR 90 5. 5. 1 Pharmaceutical Presentation | Pharmaceutical Conference Call 97 5. 6 After opening… Summary of AIR 99 5. 6. 1 Assumptions & Learning 101 5. 7 Chapter Summary 103 6. Discussion & Conclusion 104 6. 1 Reflections from Chapter 7 104 6. 1.