A female focused design strategy for developing a self care information system

The study has developed a conceptual female-focused acceptance model FAM which empirically examine the derived research hypotheses concerning the perception and acceptance of female user

XUE LISHAN

(BA.ID (Hons.), NUS)

(Volume 1)

A THESIS SUBMITTED FOR THE DEGREE OF DOCTOR OF PHILOSOPHY

DEPARTMENT OF ARCHITECTURE NATIONAL UNIVERSITY OF SINGAPORE

2009

I have been extremely fortunate in grant support Institutions that provided valuable help in the form of research scholarship, funding and knowledge resource include the National University of Singapore (NUS), School of Design and Environment (SDE), Industrial Design (ID) Programme and the Department of Obstetrics and Gynaecology at NUHS In particular, I

am grateful for my supervisors’ guidance – Dr Yen Ching Chiuan, Assistant Professor and Course Director of the Industrial Design Programme, Department of Architecture and A/P Mahesh Choolani, Research Director at the Department of Obstetrics and Gynaecology at the Yong Loo Lin School of Medicine and Senior Consultant Obstetrician and Gynaecologist at High Risk Pregnancy Clinic, National University Hospital (NUH) for the many discussions and debates we have had Dr Yen, an excellent mentor and confidant over these years, remained firm that I needed to revise and update my material, and offered constructive comments all the way Dr Mahesh, thank you for your guidance which was shaped by a clear-cut firmness to achieve highest excellence in everything I do I appreciate your confidence in

me at moments it was needed most

In the course of time, many went the extra mile and read early parts and versions of the dissertation These include A/P Chan Hock Chuan from the School of Computer, Department

of Information Systems who advised on the validation of the conceptual model and A/P Tan Say Beng, director of theClinical Trials and Epidemiology Research Unit (CTERU), Duke-NUS Graduate Medical School, who supported me much on statistical issues and formalization of the survey data I am grateful to Dr Christian Bourcharenc from the Department of Architecture, Dr Leanne Chang from the Communications and New Media Programme, Faculty of Arts and Social Science, and Dr Henry Duh from the Department of Electrical and Computer Engineering/Interactive and Digital Media for reading portions of the dissertation draft I must also thank the thousand over survey participants, designers, and staff from the National University Healthcare System (NUHS) women’s clinics and National Healthcare Group (NHG) in participating polyclinics who have so kindly responded, cooperated and supported in my investigation Without them, survey research would not have been made possible Junior student researchers from our very own ID programme provided much support for research and design activities They provided extraordinarily able, cheerful, and willing help at every juncture, and made me reaffirmed my passion for design

Finally, there is also my wonderful family which I wish to thank them for contributing in their own special way to my writing, especially my beloved parents and maiden family who have always been very proud of me and cheered me on at difficult times I would also like to thank

my husband, Jackie, who was my sparring partner in technical and emotional issues surrounding my dissertation, design research, and practice He has relentlessly supported, encouraged, and inspired me on countless occasions Lastly, I am grateful for God’s grace and strength for allowing me to complete this dissertation over these years

Indeed, like reason, our research is-and ought to be- a slave of our passions

SUMMARY ii

ACKNOWLEDGMENT iii

TABLE OF CONTENTS iv

LIST OF TABLES vi

LIST OF FIGURES vii

ACRONYMS & ABBREVIATIONS ix

TERMINOLOGY xi

LIST OF PUBLICATIONS xiv

INTRODUCTION xv

Research Aims & Objectives xvi

Outine of the Thesis xix

References xxi

1 AN INTRODUCTION TO FEMALE-FOCUSED DESIGN AND ITS RELATION TO SELF-CARE OF WOMEN 1

1.1 Background 1

1.2 The Meaning of Female-focused 7

1.2.1 A Self-care Information System (SIS) 8

1.2.2 A Female-focused Design Strategy (FDS) 10

1.2.3 The Research Hypothesis 12

1.3 Method for Literature Review 14

1.3.1 Population 16

1.3.2 Technologies 18

1.3.3 Data Synthesis 19

1.4 Elements of a Conceptual Framework 20

1.4.1 Design for Self-care 21

1.4.2 Health IT and Content 25

1.4.3 Content Users: Women 27

1.4.4 Professionals: Designers and Healthcare Personnel 32

1.5 The Opportunities of the FDS 33

1.5.1 Design for Self-care as a Consequence of the FDS 33

1.5.2 Design by Means of the FDS 34

1.6 Areas of Enquiry & Discovery Contexts 35

1.7 Summary 37

References 37

2 RESEARCH METHODOLOGY: SYNCHRONISING EXISTING PERSPECTIVES & DESIGN ANALYZES 44

2.1 Ideological Marginalization 44

2.1.1 Triangulation and Complementarity 46

2.1.2 Normative Research Method 46

2.2 Existing Design Emphasis and Problems in Design for Health 48

2.3 Overview of Research Area Framework 49

2.4 Qualitative and Quantitative Studies 50

2.5 Realm of Theory: Research for Design 53

2.5.1 Discovery 54

2.5.2 Divergence 55

2.6 Realm of Practice: Research through Design 59

2.6.1 Application 61

References 66

3 COLLECTION AND ANALYSIS OF QUANTITATIVE AND QUALITATIVE DATA IN RESEARCH OF A SELF-CARE INFORMATION SYSTEM (SIS) 69

3.1 Towards Female Preferences in Design 72

3.2 Consideration for the Design of a SIS 80

3.2.1 Women’s Perception and Acceptance towards the SIS 81

3.2.2 Reasons of Women for Seeking Health Information Online 99

3.2.3 Women’s Health Concerns 102

3.2.4 Design Qualitities for a SIS 106

3.2.5 Latent Concerms for Using the SIS 109

3.3 Caregivers and Clinicians 117

3.4 Methodological Limitations 119

3.5 Implications of Findings 120

3.6 Summary 121

References 123

4 A FEMALE-FOCUSED DESIGN STRATEGY (FDS): THE FRIEND MODEL 130

4.1 Constructing the FDS 130

4.2 The FRIEND Model 133

4.3 First Level Impact of FRIEND 136

4.4 Tailoring Age Differences in the FRIEND Model 140

4.5 Implications of FDS 146

4.6 Summary 147

References 147

5 APPLICATION OF THE FEMALE-FOCUSED DESIGN STRATEGY (FDS) TO THE DESIGN PROCESS 151

5.1 Users of Strategy 152

5.2 Understanding F.R.I.E.N.D 154

5.3 Identifying Characters 155

5.4 User Scenario Design 158

5.5 Graphical Representation of FRIEND for SIS Design 161

5.6 Concept Generation 162

5.7 Users of Application 165

5.8 Opinion about the SIS 168

5.9 Summary 169

References 170

6 CONCLUSION AND FURTHER DIRECTIONS 172

6.1 Application of FDS to Design 172

6.2 Challenges for Female-focused Design 173

6.3 Conclusions drawn from the Findings 176

6.4 Opportunities and Future Development 178

References 182

This study is derived from the desire for designers and healthcare professionals to better create a self-care information system (SIS) for women, especially to benefit those who practise self-care where the development of home-care products usually was assigned with low priority although their benefits to lay-users and the community have been substantial Women are under-represented in the design of current information systems (IS) and female-focused design can help improve their self-care Acquiring user needs and acceptability levels from the female lay user about the system which they will handle is as one of the most important tools to better design , where the validity of female-focused design can be justified not only from a utilitarian perspective

The study has developed a conceptual female-focused acceptance model (FAM) which empirically examine the derived research hypotheses concerning the perception and acceptance of female users in the context of adopting the IS and introduce a female-focused design strategy (FDS) which addressed fundamental issues in designing and marketing IS for women’s health A tripartite theoretical framework, grounded on review of literature, followed by qualitative and quantitative surveying was structured The normative research approach was used which explored current models used for women healthcare; evidence of the potential barriers; views of target audience i.e female lay-users and their family members and healthcare professionals; describing the FAM that highlighted women’s pragmatic approach to technology in self-monitoring systems

Empirical data was described and analysed using frequency tables and multiple linear regression to access differences among the female population This study tested and confirmed that the FAM works well for detecting factors that influence women’s perception and acceptance of the self-care IS To date, this study is the only one that has examined the underlying motives for such self-care innovation adoption by women They would consider adopting it only if its use proved effortless and its technological value already demonstrated Women want flexibility and empathic designs, which is responsive for them to manage, intricate in its detailing, with natural dialogues used, and dependable in both physical and virtual interactivity Their preferences are illustrated through the FRIEND model The study also reveals that the social factor (intended in this work as the importance of others’ point of view in determining our choices and attitude) does not play a fundamental role in woman acceptance of the SIS Women believed that the SIS is useful and easy to use and going to have beneficiary outcomes has not only strong but significant direct contributions FRIEND can be represented in different graphical ways for women from different age groups to determine and aid in the future design of healthcare and self-care technologies across society

The FAM with its constructs and possible extensions should give new insights to overcome age, user characteristics, and technology generation barriers, and provide a profile of how women from different backgrounds use new communication media to seek health information The FDS could be aligned with design in terms of advertising, marketing, packaging, and service Future research can include refining sampling procedures and measurement instrument, testing alternate conceptual models with other constructs, investigating new research contexts, and incorporating qualitative methods such as participatory design for the development of a potential SIS

Chapter 1

1.1 Common human factors activites that occur during product development 22

1.2 Five methods of learning 30

Chapter 2 2.1 Identifying three key approaches in design research 45

Chapter 3 3.1 Classification of concerns 70

3.2 Relationship between schemes and product properties 77

3.3 Summary of existing information and results from present study 78

3.4 Measures for predictors of FAM 84

3.5 Characteristics of respondents 90

3.6 Women’s expection of the SIS 91

3.7 Reliability of scale measures 92

3.8 Cross loadings 92

3.9 Linear regression analysis results 94

3.10 Correlation matrix of health topics 105

3.11 Choice of health concerns among pregnant and non-pregnant women 105

3.12 Design qualities for the SIS architecture and attributes 106

Chapter 5 5.1 Comparison of wording 151

5.2 Conceptual framework for women’s perceptions of iCare 167

5.3 Profile of respondents 167

5.4 Implications from findings 169

Introduction

A Design concept of ibloom xv

B Application of the female-focused design strategy within design processes xviii

C Outline of the thesis xx

Chapter 1 1.1 Health problems pertinent to women 3

1.2 From a doctor-centred model to a patient-centred model and to female-focused model of healthcare 7

1.3 Pictogram of a strategy 11

1.4 Literature review for female-focused design 15

1.5 Some of the questions review of literature can answer 19

1.6 Literature search tree 20

1.7 Elements contributing to the new strategy 21

1.8 Relationship between a user interface design process and the U.S FDA design controls 22

1.9 Brief evolution of medical design from early records to near future 23

1.10 A schematic representation of design characteristics for self-care in near future 24

1.11 Framework examining female user response to GUI for e-health information 31

1.12 A systems representation of human-technology interfaces 32

1.13 Sequence of medical procedures and design processes 34

1.14 Inter-linked agents in the design of the SIS 35

1.15 Design control and the waterfall model with feedback 36

Chapter 2 2.1 Normative study 47

2.2 Iterative design process 48

2.3 Areas of research for female-focused design study 51

2.4 Research for design 53

2.5 Lateral thinking 57

2.6 Research through design 59

2.7 Types of new product 62

2.8 Stages in concept development 64

Chapter 3 3.1 Final selection of mobile phones 74

3.2 Final selection of mp3 players 75

3.3 Final selection of fragrance bottles 75

3.4 Aesthetic key points between the genders 79

3.5 Functional key points between the genders 79

3.6 Social key points between the genders 79

3.7 Possible function and workflow of the SIS 81

3.8 Technology acceptance model (TAM) 82

3.9 Conceptual female-focused acceptance model (FAM) 83

3.10 Locations for the survey of the SIS 89

3.11 National University Healthcare System Women’s Clinics and National Healthcare Group polyclinics 89

3.12 Full dataset results of FAM 93

3.13 Future research model 99

3.14 Reasons for seeking health information online 101

3.17 Items to learn of the SIS 112

3.18 Product information to know about the SIS 114

3.19 Reference of a medical device which could possibly induce stress 114

3.20 Reasons that may induce stress 115

3.21 Reasons for stress among total sample 116

Chapter 4 4.1 Preliminary model 132

4.2 The FRIEND model 133

4.3 Steps in using the FDS 137

4.4 Preferences of women aged 24 and below 141

4.5 Preferences of women aged 25 to 34 142

4.6 Preferences of women aged 35 to 44 143

4.6 Preferences of women aged 45 to 54 144

Chapter 5 5.1 FDS within the waterfall model 152

5.2 Discussion and brainstorming among the young designers 153

5.3 Exploration of isses with the FRIENDmodel 154

5.4 Expansion of user concerns from the FRIEND model 155

5.5 Static personas to dynamic archetypes 156

5.6 Personas for the SIS design 157

5.7 A potential contextual scenario for SIS users 159

5.8 Illustration of a persona using the SIS 160

5.9 Illustration of a persona in her familiar environment 160

5.10 Mood collage illustrating the Empathy attribute 161

5.11 Graphical representation of FRIEND for SIS users 162

5.12 Interaction design during concept generation 163

5.13 Project interaction process 163

5.14 Projected SIS design 164

5.15 Screen shots of the animation 166

Chapter 6 6.1 Conceptual visualisation for a future FDS design blog 180

AAMI Association for the Advancement of Medical Instrumentation

BSS Breast Screen Singapore

BSRI Bem’s Sex Role Inventory

CGMP Current Good Manufacturing Practice

DIA Dynamic interactive aesthetics

DoH Department of Health

DSRB Domain Specific Review Board

EMR Electronic medical records

FDS Female-focused design strategy

FHAs Female-focused healthcare applications

FRIEND Flexibleness Responsiveness Intricateness Empathy Naturalness

Dependableness GMP Good manufacturing practice

GUI Graphical user interface

HPB Health Promotion Board

HSA Health Sciences Authority

ICT Information and communication technology

IEEE Institute of Electrical and Electronics Engineers

IRB Institutional Review Board

ISA Information system architecture

MDD Medical Device Directives

MeSH Medical Subject Headings

MHCU Mobile health communication unit

MDDI Medical Device and Diagnostic Industry

MOH Ministry of Health

NHG National Healthcare Group

NHS National Health Service

NUHS National University Health System

PACS Picture archiving and retrieval systems

PCC Patient-centred care

PDS Product design specifications

PEOU Perceived ease of use

PHR Personal health records

Concept: A design proposal for a product, through a selection of ideas Usually

a series of different design proposals will be suggested to facilitate a definite concept choice A proposal may exist out of drawings, additional text and design models

Detailing: To create a fair opinion of the design proposals, it is necessary to

detail them equally Detailing may concern: materials, standard parts, manufacturing techniques, cost calculations, form details, finishing, etc The final concept will be tailed in greater length

Female-focused: This term refers to a female user-centric focus, which has considered

women’s needs, preferences, and biology to enhance their user experiences and adherence to recommendations

Female-focused It refers to design with female user-centric focus in medical devices Design: for women’s health, which ultimately contributes to better quality to

their healthcare, self-care, and personal well-being

Female-focused Such applications refers to customizable and mobile wireless Healthcare healthcare interventions such as or network-based clinical Applications: information system transforming a general purpose computer into a

special-purpose monitoring device component which users can access to validated advice for effective self-care, manage, and share their personal health information, and that of others for whom they are authorised in a secure, confidential, and non-hospital environment

Female This term is understood that to achieve it, it needs to involve female user-friendliness: users in the design-process, possibly helping in redressing the

imbalance between male and female designers and users of information and communication technologies (ICT), hence the user-friendliness of the design would then received more attention, such that even computer-illiterates or women who are usually fearful of ICT could participate

Gender-specific: It refers to the socially constructed roles and responsibilities assigned

to women and men in a given culture

Healthcare design: The term ‘healthcare design’ is used throughout this dissertation to

refer to the design of responsible products such as monitoring devices and systems such as e-health applications which could directly impact the safety, operation, clinical outcomes, and self-care management of people now and into the future

Idea generation: A controlled grow process of the human mind with the objective to

gain insight in developing ideas

Medical adherence: It is defined as the extent to which a user’s behavior (in terms of

taking medications, following diets, or executing lifestyle changes)

Model: Models are used in the design process to communicate ideas and

visions Models, when 2-dimensional, refer to diagrams and schematic representations When they are 3-dimensional, one can relate them as display prototypes where they can be held up and tested In this way, a better understanding of the design can be achieved/ Models are useful tools in early as well as later stages of the design process

Professional: The term ‘professional’ can refer to a designer or a

healthcare/medical provider (i.e the clinician), who is the person providing the service to the healthcare consumer For healthcare-related professionals, it extends to other personnel involved in the healthcare system, including the minority of viewers involved in the process of visual consumption such as healthcare professionals (i.e nurses) and women’s health advocates

Prosumer: Prosumer is a portmanteau formed by contracting either the word

‘producer’ or ‘professional’ with the word ‘consumer’ However, it is also said that it refers to a “proactive” consumer Prosumers are of particular value to marketers looking to anticipate future trends because they act as an early detector about the consumer “next” Typically making up 20-30 percent of any group, they are not connected than others, so they function as human media, voicing out their points of views and exerting influence over their less

“passionate” friends Euro RSCG’s proprietary research shows that what prosumers think now, consumers will think next, typically over

a period of 6 to 18 months

P-value: In statistical hypothesis testing, the p-value is the probability of

obtaining a result at least as extreme as a given data point, under the null hypothesis The fact that p-values are based on this assumption is crucial to their correct interpretation Generally, one rejects the null hypothesis if the p-value is smaller than or equal to the significance level, often represented by the Greek letter α (alpha) If the level is 0.05, then the results are only 5% likely to be as extraordinary as just seen, given that the null hypothesis is true In the above example, the calculated p-value exceeds 0.05, and thus the null hypothesis - that the observed result of 14 heads out of 20 flips can be ascribed to

chance alone - is not rejected Such a finding is often stated as being

"not statistically significant at the 5% level" However, had a single extra head been obtained, the resulting p-value would be 0.041 This time the null hypothesis - that the observed result of 15 heads out of

20 flips can be ascribed to chance alone - is rejected Such a finding would be described as being "statistically significant at the 5% level" Critics of p-values point out that the criterion used to decide

"statistical significance" is based on the somewhat arbitrary choice of level (often set at 0.05) (Kallenberg 2002)

Regression analysis: There is a null hypothesis (β = 0) and an alternative hypothesis (β≠0)

When β is 0, there is no relationship between the response and its predictors The reason for checking for p-values lesser than 0.05 is

the research to accept the null hypothesis when the p-value is less than 0.05, which in turn means that there is a relationship between the predictors and the responses

Self-care information It modularises software architecture, assigning specific functionality system: for use in the prevention, awareness, monitoring and well-being of

the female user in self-care environments The specific functionality within the SIS would be executed by different technologies; some components are proposed for the future design of the SIS but are still not fully determined For example, a partial component of the SIS comes with sensors to detect the temperature, breath moisture and even volume and dynamics of her voice are detected by voice capturing systems (VCS) and analyzed for mood, microscopic drops

of saliva are captured and examined for bacteria, salinity, and other health indicators Besides capturing sound, the speed of her heartbeat (i.e heart rate, ECG), the firmness of her grip could probably be measured and recorded Ideally, summarization tools that would identify important observations obtained from users and present the information via carefully crafted visual representations could be implemented in the SIS to assist health providers in caring for their patients The SIS with its significant advantages can effectively treat patients as well as cost efficiently provides advice to users who do not have any chronic condition at hand The confidentiality of healthcare information for both types of users would be maintained

User: When a person turns to an object, inviting it to be a part of her world,

decides to start using it for some purpose; and as she begins to use the object, she becomes a ‘user’ This concept of a ‘user’ is based on

an object-centric perspective, the person defined in relation to the object (Grudin 1990) The term ‘user’ is used throughout this dissertation mainly to refer to women who may gain access self-care devices for personal use and better well-being It is used throughout this research to refer also to clients, consumers, lay users, prosumers, participants, or respondents (who are female) and all these terms could mean the same interchangeably It is preferred to use the term

‘user’ to emphasize that such applications refer to tools that may be helpful in monitoring health and wellness as well as a support to help with illnesses that the term ‘patient’ would imply

Xue, L., Yen, CC and Choolani, M (2006) Framework Examining Female User Response to

GUI for E-Health Information Design Thinking and Innovation Conference, “Towards a

Global/Asian Perspective”, collaboration with Cumulus, the European Association of Universities & Colleges of Art, Design and Media, Singapore, March 29-31 Singapore

Xue, L., Yen, CC and Choolani, M (2006) Framework Examining Female User Response to Graphical User Interface for E-Health Information WonderGround Proceeding Book, ed Ken Friedman, Terence Love, Eduardo Côrte Real and Chris Rust (2006) Lisbon: CEIADE _ Centro Editorial do IADE (WonderGround: 2006 Design Research Society Conference, 1-5 Nov 2006, IADE Instituto de Artes Visuais, Lisbon, Portugal)

Xue, L and Yen, CC (2006) Towards Pleasure-Based Approach in Design Proceedings of International Design Research Symposium, ed Yong Se Kim, pp 19-31 Seoul: KSME (Invited paper) (International Design Research Symposium, 10-11 Nov 2006, Expo, Seoul, Republic of Korea)

Xue, L and Yen, CC (2007) Towards Female Preferences in Design – a pilot study

International Journal of Design 1(3): 11-27

Xue, L., Boucharenc, CG., Yen, CC., and Choolani, M (2007) A Review of Healthcare Devices: Moving Design from Object to User Proceedings of the International Association of

Societies of Design Research (IASDR) Conference “Emerging Trends in Design Research”,

Hong Kong

Xue, L., Yen, CC., Choolani, M and Chan, HC (2009) The Perception and Intention To

Adopt Female-Focused Healthcare Applications (FHA): A Comparison between Healthcare

Workers and Non-Healthcare Workers International Journal of Medical Informatics 78:

248-258

Xue, L and Yen, CC (2008) Introducing a Female-Focused Design Strategy (FDS) for

Future Healthcare Design Proceedings of the 6 th Conference on Design & Emotion “Dare to

Desire”, Oct 6-9, Hong Kong

Xue, L., Yen, CC., Boucharenc, CG and Choolani, M (2008) The Design Evolution of

Medical Devices: moving from object to user The Journal of Design Research 7(4): 411-438

Xue, L and Yen, CC (2009) Thinking Design for Women’s Health Design Connexity

Proceedings of the Eighth Conference of the European Academy of Design, ed Julian Malins,

pp 508-512 (Design Connexity: 2009, 1-3 Apr 2009, Gray School of Art, The Robert Gordon University, Aberdeen, Scotland.)

Xue, L., Duh, HBL., Yen, CC., Chan, HC., Tan, SB., Tang, WE and Choolani, M (2010) Health informatics for elderly women – an exploratory study CHI2010 workshop - Senior-Friendly Technologies: Interaction Design for the Elderly held in conjunction with CHI2010, Atlanta, GA, USA, 10 April 2010

The objective of this thesis is to investigate and introduce a female-focused design strategy (FDS) to better approach the design of medical devices for women It offers a dimension to understand the relationship between female users and a self-care information system (SIS) and their acceptance levels that may result from their initial perception The SIS found its

beginnings from a concept design named as the Ibloom (Figure A), conceived as a mobile

health communication unit (MHCU)1 targeted at women who may need to refer to a based healthcare information system (IS) that functions as a monitor, educator, and support (Xue 2005).It was anticipated that certain groups of women, such as the pregnant users who required prenatal and postnatal care; the non-pregnant who may be suffering from chronic illnesses or those experiencing an unexpected health event would be particularly interested in managing their health routine (Roudsari 2006; Millard & Fintak 2002)

The home and self-care equipment has been identified by the FDA in 1998 as one of six future major trends in medical device technology development (Lewis 2001) Many a times, the use of patient-controlled medical devices has been proven to be significant in improving their treatment and healing process (Orel 1995) In a study of pregnancy scanning, Yen (1995) reported that women facing the monitor felt less nervous than those who did not do so Pregnant women may not understand the images displayed on the monitor screen but by doing so it can bring them psychological assurance to allow them to participate in something

so close to them It is also a fact that the female gender experiences a great deal of health

time than men do, and probably seek more self-care than their counterparts (Miles 1991) Surveys have also indicated that most patients would like to be able to access their health records (Keeler & Newman 2001; Martin 2003; Coulter 2006) A potential lies within the fact that more design research could be carried out for products of such nature so that the quality

of women’s health through self-care can be improved

The review of current literature reveals little of design for female users in self-care A new term needs to be defined for the purpose of this research, entitled as female-focused design A simple and direct understanding of it would relate to design that considers the healthcare needs, emotions, and experiences of female users and to what extent the technology through self-monitoring systems and devices can benefit them It then depends on the field of design

to explore the right attributes in defining a design strategy for this purpose In the design of most medical devices, the focus tends to be on the technologies and clinical engineering for interface platforms (Lewis 2001, Protti 2007) Little research attempts to define the user experience in a way that is theoretically informed, not to say – female-focused user experience towards medical adherence This thesis proposes that to study about female-focused design, and the reaction and justification for the SIS It would create new knowledge which should benefit in the field of gender design, and in the real social and marketing, policy making, and physical contexts of future healthcare and female users’ lives By surveying the qualities that are valued after and how female users across different levels in society interpret and respond to medical devices designed for their perspectives, researchers, designers, and practitioners can develop a holistic understanding of the elements that are relevant for female users

Research Aims & Objectives

What was the gap identified before this study?

• Patient-centred care (PCC)2

and self care, explored in areas such as medical informatics, nursing informatics, telemedicine, telehealth, telecare, and ehealth, have underlying differences but are overlapping expanding fields of interest

2

There are three definitions which place close meanings on what is considered to be Patient-centred care (PCC) (1) It can refer to the redesign of patient care so that hospital resources and personnel are organised around patients rather than around various specialised departments (Sherer 1993, p.14) (2) PCC is that of patient autonomy whereby patients are involved as participants in their own treatment (HFN01 1993, p.7) (3) PCC is healthcare that

is closely congruent with and responsive to patients’ wants, needs and preferences (Laine & Davidoff 1996, p.152).

What are the objectives of this study that potentially adds to new knowledge?

• To understand female users’ perceptions and experiences of using medical devices and to integrate such information in identifying designs which are female-focused, enabling women to effectively enhance their health management and well-being

• To suggest a Female-focused Design Strategy (FDS) for health information system design

• To publish in the design field investigating about female-focused designs as well as in the medical field dealing with women’s health, well-being, and self-care

This study aims to introduce the concept of a FDS into the design of medical devices, especially self-care devices since there is an increasing number of self-care products made easily available over the counter The method for this developing the FDS would consist of both linear (i.e a typical design process) and non-linear (i.e PCC principles) design (see Figure B) There are various non-linear PCC principles that provide a range of design alternatives The aim of PCC principles adopted within design practice is to enhance the relationship between industrial designers, patients, clinicians and manufacturers Such principles also provide a useful framework to identify the patients’ and doctor’s needs, to prioritise such needs and to measure outcome performance, in order to design an appropriate product for the patient The methodology is a continuous process within which information is continuously being updated through practice Consequently, it will grow, adapt and continue

to evolve according to individual needs and experience To provide a clear picture of the use

of the methodology in design practice, developed by Roy and Bruce (1984) was applied, in order to demonstrate how the PCC methodology can be integrated within it

Consequently the FDS would not erode away existing design procedures and product development protocols, but rather suggests an alternative option for the designers and marketers involved in this field to consider in future design work What could be observed from this design strategy is that emerging products would have included user characteristics and primary considerations from the major disciplines involved This is central to the research study whilst it hopes to provide conceptual aids for other disciplines such as psychology and sociology in the future It is hoped that the FDS can help enable future medical device designs

to cater more specifically to female users’ illness-prevention and treatment, subsequently improving on their well-being

1

The feedback based on the clinical assessment according to statutory regulations

2

The feedback may include the response of operators, clinicians, and patients, etc., and the

performance of the equipment itself

3

The report is based on the health authorities’ policies and regulations

Figure B Positioning of the female-focused design strategy (FDS) within design

processes (Source: Adapted from Roy & Bruce 1984, EC MDD, and Yen 1998)

Project background research

Design brief

Concept design

Detail design

Design Engineering, Manufacturing &

Marketing

Industrial Design &

Design Development

Female-focused Design Strategy

Design for manufacturing

Production, marketing and sales

Post-marketing surveillance

Mock-up development & testing

Final design concept

& design engineering

Investigation and identification of female user needs, perspectives, for self-care devices and systems

New knowledge update

on Female-focused design

the collaboration of multi-disciplines (the reconciliation, generation, and sharing of new knowledge between self-care and design) It examines specifically what future designers need

to consider in the design of these highly challenging devices which may concern much user safety, involvement, experience, and identity For sub-areas of research it could enhance the current knowledge of female gender analysis, which is a highly controversial topic in design theory as debates concerning its validity have been central to discussions of modernism in design (Benton 1990) The parameters, flexibility, and benefits would be further elaborated through the outline of the thesis that follows

Outline of the Thesis

This thesis is organised around the objectives introduced in this chapter Broadly speaking, each chapter takes into account and consideration at least one objective The main structure is depicted in Figure C

Chapter 1 explores, reviews, and analyses current literature within gender, health, and design disciplines Attention is paid to describing the terms such as design strategies and healthcare information systems, establishing a conceptual framework, areas of enquiry, and its discovery context Furthermore different terms will be explained to its underlying context and the implications of this research topic discussed This chapter will be often referred to in the following chapters

Chapter 2 describes available knowledge within design research that links design methodology, theory, and practice It will be explained that the overall research setting (e.g research population, ethical considerations, etc.) has been designed to ensure that the results are of strong interest and good quality Second, the chapter describes the proposed research methodology and data analysis methods for this topic area and options for answering research questions and objectives previously generated

Chapter 3 investigates the research topic extensively through a number of quantitative and qualitative studies The rationale, methods, findings, and data analysis from the surveying will

be discussed and, based on the previous chapters, what is needed to further the design research will be represented for analysis later on The research objectives and questions are examined again in detail

Figure C Outline of the thesis

Chapter 4 proposes a way to represent the FDS through a model known as FRIEND and uses age as a differentiator within the model to enhance its usefulness to designing specifically for the needs of women from different age groups The data collection material provided in Chapter 3 will generate most of the materials for this chapter

Research Methodology - Synchronising Existing Perspectives and Design Analyses

Chapter 3

Collection and Analysis of Quantitative and Qualititative Data

in Research of a Self-care Information System (SIS)

Chapter 4

A Female-focused Design Strategy (FDS):

the FRIEND model

System Architecture

Existing Design Protocols and Processes Relationships, Strengths and Weaknesses

documented The chapter comprises sections such as Identifying Characters, Concept

Generation, and Evaluation and Refinement of Final Designs which they are to be described

in detail Secondly, the final proposed concept design of the SIS will be presented to a group

of potential users for a series of deep and open-ended interviews The explication of subjective-meaning structures of women’s view on the system and their relation to the more readily observable outcomes - both strengths and weakness will then be presented

Chapter 6 concludes the research It should comprise comprehensive vision documentation where female user values, systems, and technology enablers are considered The conclusion and directions for further research are suggested

Council Directive 90/385/EEC (1990), “On the Approximation of the Laws of the Member States

Relating to Active Implantable Medical Devices”, Official Journal of the European

Communities, No L 189: 17-35

HFN01 (Health Facilities Note 01) (1993) Design for Patient Focused Care London: HMSO

Kalbfleisch PJ and Bonnell KH (2006) “Menarche, Menstruation, and Menopause: The

Communication of Information and Social Support”, in R Parrott and C Condit (eds.),

Evaluating Women's Health Messages London: SAGE Publications, pp 265-278

Keeler, J and Newman, J (2001) Paperless Success: The Value of E-Medical Records Healthcare

Information and Management Systems Society (HIMSS) Proceedings 2(45): 1-7

Laine, C and Davidoff, F (1996) The Patient-Physician Relationship, Patient-Centered Medicine: A

Professional Evolution Journal of the American Medical Association 275(2): 152-6

Lewis, C (2001) Emerging Trends in Medical Device Technology: Home Is Where the Heart Monitor

Is U.S Food and Drug Administration, FDA Consumer Magazine 35(3)

Martin, JB (2003) Effectiveness, Efficiency, and the Value of IT Journal of Healthcare Information

Management 17(2)

Miles, A (1991) Women, Health and Medicine Buckingham: Open University Press

Millard, RW and Fintak, PA (2002) Use of the Internet by patients with chronic illness, Disease

Management & Health Outcomes 10(3):187–194

Orel, T (1998) The Technologies of Self-Fashioning: Beyond University and Variance of the

Industrial Product Design Issues 4 (1) & (2), special issue: 38-51

Protti, DJ (2007) Informing the Future with Emerging Clinical Information Technologies

Sherer, JL (1993) Putting Patients First: Hospitals Work to Define Patient Centered Care Hospital

67(3): 14-18

Roudsari, A (2006) Patient Relationship Management in response to fragmented healthcare: A

vision realized through technology NHS Connecting for Health Website Available at:

www.connectingforhealth.nhs.uk/worldview/comment11/ [11 Nov 2008]

Roy, R and Bruce, M (1984) Product design, Innovation and Competition in British

Manufacturing - Background, Aims and Methods, Working Paper, WP-02, Milton Keynes:

Open University

Xue, L (2005) Mobile Health Communication Unit, Unpublished Bachelor of Arts (Industrial

of Central England in Birmingham

Yen, CC (1998) The Application of Patient-Centred Principles to Medical Equipment through

Industrial Design Practice (unpublished), Birmingham: The University of Central England in

Birmingham

Design and its Relation to care of Women

Self-1.1 Background

Medical devices, products and information systems (IS) are increasingly made available in many countries, to encourage home and self-care, thus changing the façade of how people view and approach health systems People are able to play a greater part in maintaining their own health The potential benefits of self-care are substantial and a large research agenda surrounds it Self-care is defined as “the actions individuals take to lead a healthy lifestyle; to meet their social, emotional and psychological needs; to care for their long-term condition; and to prevent further illness or accidents” (Barlow et al 2002) The process of self-care is facilitated by the use of devices, such as home glucose monitors, customised wearable devices, mobile electronic patient records, wireless network-linked systems and potentially

"smart devices" that can think by themselves (Lewis 2001; Noury et al 2003)

Mobile information technologies (IT), information communication technologies (ICT) and IS applications in healthcare can be recognised as both emerging and enabling technologies (Ammenwerth et al 2003; Haux 2006) The promotion and maintenance of health is now a critical consideration in the design of medical devices and healthcare portals Such personalised tailored tools are intelligent and effective enough to help people manage illnesses and improve health management (Schneider et al 1993; Bental & Cawsey 2002) Interest in creating a personalised health portal extends internationally Many healthcare organisations in the United States (US) have already offered portals that “enable patients to schedule appointments, request prescription renewals, receive laboratory and test results, review their medical records, and obtain an ‘online consultation’ directly with one’s physician” (Weingart et al.2006) In Singapore, the current status of IT use in the health sector

is partly driven by governmental efforts (Teo et al 1997; eCitizen 2004) The latest blueprint consists of a ten year plan to implement the use of infocomm over the next ten years, known

as the Intelligent Nation 2015 (iN2015) (IDA 2008) According to IDA (2008), “Infocomm will link hospitals, clinics, nursing homes and laboratories with patients’ homes, enabling healthcare professionals to access comprehensive patient information instantly An integrated healthcare delivery system will give individuals the ability to better manage their health and 1

access high quality clinical care, providing cost-effective healthcare and supporting strong clinical research” Singapore’s National Healthcare Group (NHG) is offering a NetCare portal that enables patients to view their online personal medical and health dossier and to make appointment changes and electronic payments (NHG 2000; Weingart et al.2006)

Other public organisations, such as SingHealth, the Breast Cancer Foundation, Health Promotion Board (HPB), and the Ministry of Health (MOH) are increasingly exploring methods by means of IT to promote self-care for long term costing reasons and raise awareness for women’s health (Health Feedback Group 2004) Besides mammography, there

is health screening for conditions, such as HIV and Hepatitis for women at appropriate times According to Leong and his colleagues (2007), “in the year 2002, the HPB embarked on Breast Screen Singapore (BSS) which is a national screening programme for breast cancer and the NHG polyclinics which started its first mammographic screening service within one

of its polyclinics in year 2000 gradually established mammographic screening in all nine polyclinics by year 2004, leveraging on the BSS” SingHealth has also compiled a list of screening options for conditions ranging from eye diseases to stomach ailments which is to allow the person to gain intimate knowledge of his/her body and help one make informed decisions should the time come for his/her to treat any conditions (SingHealth 2006)

Although the design and services provided by health portals were promised to be improved greatly, evidence suggests that the people who would access to such systems tend to be younger, more affluent, and healthier than the average patient (Fox 2003; Fox 2004; U.S Department of Commerce 2000; Weingart et al.2006) There is a need to better understand what lay people expect of health advice and care and their essential needs, the appropriate ways of helping them to deal with their health concerns themselves, and of methods to enable them to maximise services effectively as the systems mentioned before begin to be introduced into their homes According to Jones (2000), “research into the efficacy of self help information about minor illness and common symptoms needs to be extended to examine the value of better targeted and more sophisticated sources of information, including interactive communication”

By introducing personalisable self-care applications along with such a national vision, it could well become one of the mechanisms towards improving the quality of life for the citizens In fact, creativity may well provide resolution to new technical hurdles and the challenges of new market and user needs Sadly, the determination of the design and the allocation of

requirements of self-monitoring devices do not include factors, such as the perception and efficacy of the genders, especially the females (Fries & Bloesch 2004)

Women, however, are catching up with men in most measures of online life, so much so that they have consistently engaged more in health-related online activities; interestingly, according to Miles (1991), “…women are significantly more likely than men to look for health and medical information”, in particular, over the Internet (Fisk & Stevens 1993; Hawisher & Sullivan 1998; Fallows 2005; Burst Media 2007) 80% of women accessed the internet and 62% accessed health related information from the Internet while 70% of women expressed a perceived need to obtain more information from the Internet if they were diagnosed with a condition, e.g breast cancer This study supports using the Internet as a viable way of communicating health information to women in all age groups (Dey et al 2006)

Figure 1.1 Health problems pertinent to women (Source: Adapted from Kunz & Finkel 1987)

The planning and implementation of design in healthcare care should be tailored to address the differences demonstrated by age and psychosocial life stage, and to enhance quality of life issues, for both young and old

Dutta and Feng (2007) reported that women are “…more likely to look for support groups to communicate with for diseases or conditions” Women were more likely than men to engage

in a search for health information for themselves and they continue to be the most likely audience for health-related online activities (Atkinson 2009) Most women do not, initially, regard the natural functioning of their bodies as an illness For example, women, who become pregnant, do not immediately think of themselves as patients Neither menstruation nor the menopause is, by definition, an illness (Kalbfleisch & Bonnell 1996) Yet in all these cases, women may well find themselves the recipients of medical treatment (see Figure 1.1)

In recent years, women’s clinical needs are changing, mainly because so many of them are deferring childbirth in order to pursue higher education or a better career and large numbers

of women face problems with infertility as they have their families later in life (Waldron 1997) The concept of women’s health as its own entity, in terms of specific medical treatment and care, is relatively new, however, demographics of the 21st century will affect healthcare for women (Walvrood, no date) The elderly population is predicted to increase during the next two decades; women will make-up the majority of this population (Magnus 2009) This will result in a significant increase in the demand for healthcare and health maintenance programs for women Women now have more economic power, they demand that any new treatment options demonstrate cost-effectiveness and there is a true demand of minimally invasive, cost-effective products to address the clinical needs of women (Waldron 1997).The convergence of these factors has resulted in making self-care for women a viable design opportunity today A number of the women health problems, such as yeast infections are preventable and treatable right from the home setting (Smith 2008) Evidence from Huff (2002) who evaluated work from other disciplines, such as psychology and marketing, suggests that “women process information and solve problems in different ways than men do” To include gender concerns in such design developments can make health messages more effective and enhance the current knowledge of health behaviours (Zaman & Underwood 2003)

There had been research on relationships between gender differences with computer display hardware (Tan et al 2003), gender-oriented marketing strategies for Web-based shopping (Van Slyke et al 2002), and computer game software content (Cassell & Jenkins 1998) Recognition of the possibility that software dealing with health IT could erect barriers to females has only recently emerged (Beckwith & Burnett 2004) Among the studies

addressing the issues of usefulness and usability3 for interactive health IT for lay users, few studies had analysed individuals’ reactions and their reasons behind their adoption or rejection (Kaplan 2001; Kaplan & Brennan 2001) None compared the usability between different genders within a single study in the self-care context

The problem is that computers and the computer culture are generally regarded as created, defined and controlled by men, and that most women are often made to feel “as welcome as a system crash” (Kramer & Lehman 1990; Perry & Greber 1990; Kantrowitz 1994; Grundy 1996) Researchers indicate that for most women their initial experiences of working with a computer or technical devices have not been that favourable (Benyon & Mackay 1993; Turkle 1995; Lander & Adam 1997) Women also report lower levels of computer-related self-efficacy and a higher computer anxiety (Busch 1995; Durndell et al 2000; Sam et al 2005) Karna (1994) claimed that “women have the ability to be computer people, but due to less access and social pressures they tend to stay away from the computer world” In this paradigm, a woman’s psychological and social health needs in addition to her physical health should become a major priority in planning healthcare activities and the design of self-care devices

According to Akrich (1995), designers represent their users and incorporate them “into a technological artefact which becomes part of the ‘script’ of the technology Scripts attribute and delegate competencies, actions and responsibilities to the users of the technology”, dictating strong influence upon “who the users of the technology will and can be” (Rommes

et al 1999) When these scripts reveal a gendered pattern, they are known as gender scripts (Oudshoorn et al 2004) Previously Schalken and Pieter (1994) wrote, “the lack of female users of ICT may be explained by gendered user-representations created during the design-process; designers of ICT use explicit user-representation techniques, such as surveys or testing software on users to make user-representations; however, studies of the design of ICT indicate that user-representations are often made unconsciously; the resulting implicit representation is known as the ‘I-methodology’ where designers see themselves as representative of the users” In fact, some research has shown that some software is unintentionally designed for men (Beckwith & Burnett 2004) As most designers and software

3 In the review of these studies, usability was considered to be “the degree to which the system and services could

be used effectively, efficiently and with satisfaction by the users.” (Clemensen et al 2005) Researchers studying the usability of health IT most often referred to using the framework described by Nielsen (1993) In his framework, usability is considered to be a component of user acceptance, which refers to the willingness of users

to use a system in a particular setting over a period of time It also comprises social and practical acceptability

Nielsen’s Model of System Acceptability includes the concepts of attractiveness, controllability, efficiency,

helpfulness, and “learnability.”

engineers are male, often using the so called I-methodology, testing products in environments familiar to themselves, thus creating a gender bias toward representations which are more male-dominated (Berg 1994a; Rommes et al 1999; Oudshoorn et al 2004) This may explain for the few numbers of female users truly enjoying and experiencing what they are using

According to Rommes and colleagues (1999), “the I-methodology results in technological end products reflecting the ideas and interests of the designer instead of the end user” In such cases, the user representation that designers generate is one-sided, emphasising the characteristics of the designers themselves and neglecting the diversity of the envisioned user group The personal and subjective accounts from designers themselves when implemented as guidelines in design may not actually work well for the needs required by other users in reality Although, in product development there are clearly tactics aimed at increasing sales and can be seen, in the light, as a manipulative and exploitative means of offering women what they thought they wanted in their lifestyles It is till recent that projects are beginning to design for the lacked consideration for female users An example can be seen from Cook, Inc, which has started a new company division in designing therapies specifically for female patients According to Fontanazza (2006), “the idea of launching a women’s health business unit basically came from the fact that there are gender-specific treatments that are targeting the female patient”, hence the next step to move on to address the specific needs of patients based on gender and devote to devices just for women becomes logical Another example which can be cited is the Femme Den is an internal movement at Smart Design (2007), where four designers4 tired to explain the true understanding of the psychology of complex and diverse female users by drawing connections between social, cultural, and economic changes

in design

There are indeed many more evidences for design research to take action towards establishing new design thinking and approaches for healthcare IS for the female user: the pursuit of a healthy lifestyle through self-care towards better well-being due to the development of an ageing population, the advances in medical and informatics, and the growing considerations

of gender-specific concepts In the belief that it is only till now that when attention given to female users of technology and ICT for women’s health are still lacking, developing interventions which are specifically designed for them entitled as a Self-care Information System (SIS) should lead to better consumer satisfaction The SIS supports for pathways to be made available in self-care for women Expanding the preliminary concept of the SIS, a FDS

4 The designers are Erica Eden (American), Agnete Enga (Norwegian), Yvonne Lin (Chinese-American), and Gina Reimann (British)

would be developed to aid in all future design of self-care technologies and devices for women

1.2 The Meaning of Female-focused

This section attempts to clarify some of the terms used and explore into the elements that may contribute to the formation of a FDS There may be different applications which mean differently according to their context and therefore, it is necessary to develop a common language for both understanding and applying the FDS

According to the Oxford Study Dictionary & Thesaurus (2nd Ed.) (2004), the following

definitions of the terms female and women are:

Female: adjective of the sex that can bear off-spring or produce eggs or fruit

Women: a grown-up female human being

Figure 1.2 From a doctor-centred model to a patient-centred model and to female-focused model of healthcare (Source: Adapted from Fulford et al 1996, p.10; Yen 1998)

The FDS aims to examine how female gender factors needs to be considered one step beyond the patient-provider relationship in the design of devices meant for women’s self-care

It was considered that in using the term ‘women-focused’, it might give the impression that this research would be more attuned to socially-inclined and value-oriented discussions However, the interest of this research hopes to establish a strategy and relevant applications in which the needs, wants, and limitations of any female end-user regardless of their social obligations, is given extensive user-centric design attention Hence it is suggested to use the term ‘female-focused’ to refer to health situations in which a female face problems directly

related to her biology To use the term female would refer to health issues specific to the

human female anatomy; which includes menstruation, child birth, menopause, and breast cancer, etc Hence, ‘female-focuseddesign’ represents a potential up and coming model in the

design of the healthcare IS resulting directly as a consequence of women’s increasing needs

of devices specifically designed for their health, self-care, and personal well-being (see Figure 1.2)

1.2.1 A Self-care Information System (SIS)

Current medical devices may be composed entirely of hardware, entirely of software, or a combination of the two, and many kinds of self-care devices are rapidly becoming software-intensive and such software controls their operation, collects and analyses information to help make treatment decisions (Fries & Bloesch 2004) In many self-monitoring devices, the software transforms a general purpose computer into a special-purpose medical device component As in hardware design, specifying the software requirements, creating a sound software design and correctly implementing it poses difficult technical challenges

Based on multiple studies and reports on the need for patient-centred care (Campbell et al 1999; Borzekowski & Rickert 2000; Gustafson et al 2001; Baker et al 2003; Mendelson 2003; Pandey et al 2003), some tools and resources through software seem to have growing importance to the role of female lay-users in managing their own health, in partnership with healthcare providers, for example as summarised by the U.S Department of Health and Human Services, Office of Disease Prevention and Health Promotion (2006):

• Health information—either a spectrum of searchable information or more narrowly defined content;

• Health self-management—tools for achieving and maintaining healthy behavior in lifestyle areas, such as diet and exercise;

• Online communities—Internet-based communities for interaction among consumers, patients, or informal caregivers about shared health concerns;

• Decision support—structured support for making treatment decisions, choosing and evaluating insurance programs or healthcare providers, or managing healthcare benefits;

• Disease management—monitoring, recordkeeping, and communication devices for managing a chronic disease, usually in conjunction with healthcare providers;

• Healthcare tools—means of maintaining or accessing health records and interacting with healthcare providers This category includes personal health records

Hence, the SIS refers to healthcare ICT for women that allows for interactivity through a software for providing, processing and accessing healthcare information through a secured network and stored on a secured server, primarily functioning in self-care contexts Somehow, the SIS can relate itself to a medical device as the medical device area is expanding to include items, such as medical information-based supports, IS, diagnostic tools, picture archiving and retrieval systems (PACS), and electronic patient records The trend certainly is to include more information processing capability in all medical devices (Sloane 2004; Subramanian

2004; Rosow & Adam 2004; Cohen 2004) The term ‘medical device’ is being understood to mean different things in different contexts Traditionally speaking, a medical device is an object which is useful for diagnostic or therapeutic purposes Examples of medical devices include medical thermometers, blood sugar meters, and X-ray machines However, confusion can occur as a result of relating to other terms, such as ‘medical products’, ‘medical aids’, medical appliances’ and ‘medical equipment’ (Department of Health (DoH) 1991; Nobel 1994) Some of these definitions are looked at as to better clarify the definition and scope of the SIS for the purpose of this research

The US Food and Drug Administration (FDA) provided the definition of a medical device as (2000a):

“An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:

• recognised in the official National Formulary, or the United States Parmacopoeia, or

any supplement to them,

• intended for use in the diagnosis of disease or other conditions, or in the cure,

mitigation, treatment, or prevention of disease, in man or other animals or

• intended to affect the structure or any function of the body of man or other animals,

and which does not achieve any of its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolised for the achievement of any of its primary intended purposes”

A complete definition of a medical device can be found in the Food Drug and Cosmetic Act section 201(h) The term covers all products, except medicines, used in healthcare diagnosis, prevention, monitoring or treatment of illness or handicap Medical devices are a diverse group of products that ranges from simple items, such as sticking plasters to complex devices, such as heart by-pass machines Directive 2007/47/EC of the European Parliament and of the council of 5 September, 2007, which amended the Council Directive 93/42/EEC of 14 June,

1993 concerning medical devices, defines a medical device as:

“Any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper

application, intended by the manufacturer to be used for human beings for the purpose of:

• diagnosis, prevention, monitoring, treatment or alleviation of disease,

• diagnosis, monitoring, treatment, alleviation for or compensation for an injury or

handicap,

• investigation, replacement or modification of the anatomy or of a physiological

process

• control of conception

and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.”

In its simplest form, the SIS described in this research refer to customisable and mobile wireless health interventions which female users can access to validated advice for effective self-care, manage, and share their personal health information, and that of others for whom they are authorised in a secure, confidential, and non-hospital environment Subsequently, it is envisioned that the future of the SIS could link up as communication channels and supplement their visits to a physician in the long run However, by adding the word “home” may be too limiting and “home use” is an inaccurate characterisation, because there are other non-clinical venues besides the home where the SIS may be used (e.g., car or other transport); some monitoring devices are used on the person wherever she might go, indoor or outdoor (U.S FDA 2002b) To deal with this, it was decided that the definition be extended to describe devices and systems outside of institutional environments (or outside of “traditional health care settings”), where the concept of institutional environments is understood to mean those venues under relevant regulatory and professional control

In all previous examples, research has focused on the medical needs of people in decline or a focus on detecting that decline is taking place There may be similar applications aligned with the concept of a SIS in the Asia-Oceania market (Lovell et al 2002; Celler et al 2003; TeleMedCare, no date; Australian Government, no date) Therefore, it is envisioned that the SIS with its significant advantages can effectively advise patients and cost efficiently provides advice to users who do not have any chronic condition at hand The confidentiality of healthcare information for both types of users would be maintained To date, no empirical studies have been conducted to explore interventions which can help women in good health to track their medical history and health status and no results of effective methods of design for the female gender

1.2.2 A Female-focused Design Strategy (FDS)

To understanding fully the nature of design, it is necessary not only to seek out the similarities between different designs situations, but also to recognise the very real differences Inevitably, anyone would approach this general understanding of design from their own particular background

“Design is the optimum solution to the sum of the true needs of a particular set of

circumstances.”

In fact Matchett (1968) who defined design as stated above comes from an engineering background This definition suggests at least two ways in which design situations can vary Matchett’s use of ‘optimum’ indicates that the results of design as he knows it can be measured against established criteria of success This may well be the case for the design of a machine where output can be quantified on one or more scales of measurement

It is nevertheless possible to arrive at a definition of design which allows for both the disparate and the common features Jones (1970) regarded the ‘ultimate definition’ of design

as something to initiate change in man-made things Such a definition is probably too general

and abstract to be useful in the understanding of what is design The answer is people shall never really find a single satisfactory definition but that the searching is probably much more important than the finding He had already recognised just how difficult this search is in his earlier description of design: “the performing of a very complicated act of faith” The early years of the design methodology movement were characterised by a tendency to look for common features in the design process or at least to classify a design strategy A design strategy can be defined as a proposal of ways of approaching design problems or investigating contexts within which to work (see Figure 1.3)

Figure 1.3 Pictogram of a strategy (Source: Von der Weth, 1999, p.458)

Strategies define sub-goals, distinctive features of proceeding be it offensive or defensive, and in that way limit the possible operations

Strategies have these three characteristics (Von der Weth & Frankenberger 1995; Von der Weth 1999): they are oriented towards an ultimate goal of an action process In attaining sub-goals or intermediary goals we cannot use the term strategy; e.g strategies in chess playing do not aim at taking a chess piece but at placing the other player into checkmate Strategies have

a methodological character—they contain information about how to proceed in order to reach

the final goal under certain conditions, whilst suitable strategies structure and simplify the

Final goal

Subgoals and intermediary goals

Features of procedure (e.g careful, thoughtful)

Sequence of action is planned later in the process

Situation

profile

action However by following a strategy, not every single step of the continuation of action has to be planned It is rather the preconditions of the strategy which allow control of the problem-solving process based on a limited number of alternatives Thus one cannot speak of

a strategy if action is controlled by routine or automatically and/or a complete plan has been made up for the further course of action (Person et al 2008)

Strategic thinking stresses a systematic perspective of interrelations and interdependence The route to establish the FDS embraces a range of disciplines, research inquiries and methodologies and is interdisciplinary which ultimately produces tangible artefacts The investigation of women’s acceptance of the SIS would contribute to the formation of the FDS The definition of the FDS is to gain a greater design understanding of a future SIS for female users, ultimately to better support it and speak up for the needs and preferences of the users themselves; decide what to create with a perspective beyond the current situation (e.g 3 to 5 years) It aims to participate in the redefinition of the design process away from any stand-alone design and into the integrated system of intent to usage and even to product attachment The process of achieving the FDS is a combination of analysis and synthesis Analysis relates

to the methods of investigation, enquiry and understanding central to the research of a project brief, concept or a particular context Existing theoretical knowledge is used to generate proposals or hypotheses that are tested to build knowledge “…at the nexus of science and technology, education, healthcare and corporate policies, it is known that the public should be aware of the distinctive and underrepresented role women presently play in the creation of IT” (Fountain 2000) Synthesis, on the other hand, is the means by which a researcher is able to draw upon his or her initial analytical work and investigation to produce meaningful solutions

to interventions New knowledge for design can be demonstrated by an overall process with regards to the combination of theoretical and practical knowledge

1.2.3 The Research Hypothesis

Due to an increasing number of technologies for self-care, such as Internet-based technology,

it leads us to ponder on the new expression of ‘electronic health’ which underlines a new process of thinking and starts new relationships between different stakeholders (Tjora et al 2005; Umefjord et al 2006; Kerr et al 2006; Nijland et al 2008) More so in developed countries, female users can now expect better access to affordable healthcare, and they are better treated as autonomous partners in the healthcare decisions process; “they are more aware of possible adverse events and expect these to be avoided or compensated for; and increasingly seek alternative healthcare” (Niselle 1999; Lewith 2000; Komesaroff 1998)

Although quality improvement now receives far more priority in women healthcare organisations, the consumer still plays a secondary role If healthcare is going to be responsive to end user needs, as users perceive them, then they will have to play a major role

in assessments of healthcare quality

By drawing terminology from theory and previous empirical work about gender differences from other domains, such as technological confidence, perceived usefulness and benefit, information processing, and technology adoption models, the notion of female-focused design

is hypothesized based upon gender issues and their causes that could arise from gender-based differences in the use of both software and hardware The FDS has to be conceived with the assumption being made that improved design processes (for better well-being in the direction

of self-care for female users) leads to improved outcome (health for herself and probable other individuals) Subsequently, the potential benefits should remain in many respects By considering the role of industrial design in medical devices, it covers the most important decision parameters to deciding whether to invest in a given application for the design of future medical devices for female usage

The hypothesis of the FDS is defined as such:

“Female-focused design can help enhance their self-care. They would actively accept and use female-focused intended self-care information systems to improve their well-being.”

Healthcare models relevant to the next generation of female consumers have been developed from exploring issues, such as the quality of continuous care, sufficient medical decision-making involvement, and providing informed choices Subsequently, by developing a FDS based on these models and by conducting primary user research through surveys, it is sufficient to analyse and evaluate a wide range of interested parties, in resolving the current lack of female-focused design when actualised by an application which proposes solutions for female well-being

A number of key questions in conceiving the FDS will be further examined later in this study:

• How can findings from women’s attitudes towards self-care and their intention to adopt the SIS be translated to attributes for constructing the FDS?

• What are the foreseeable implications from this research approach?

• What are the challenges for proposing the FDS in self-care, in terms of, design, usability, trend forecasting, and healthcare innovations?

On the back of this hypothesis, it attempts to adopt ideas from the existing models of Centred Care (WCC) to the study, whilst attempting to include the patients’ quality of life

Women-(QoL) and try to reduce potential conflict with other associated clinical terms According to Yen (1998) and a review of the recent publications (Fulford et al 1996, Stewart et al 1995; Hopkins 1994), they support the balanced model of understanding between doctors and patients Some clinicians are already employing a model which combines patient needs and

medical requirements Changing Childbirth (DoH 1993) for example, shares this concept and

is decisively in favour of patient-centred maternity services The above questions and objectives indicate that the research has an explorative character This is not surprising given the limited design literature available about this topic at the present moment Hence, the research starts with a thorough exploration and analysis of the available literature

1.3 Method for Literature Review

“Exactly whose priorities and values are at the core of the debate”

(Noble & Bestley 2005)

The research, at whatever level of maturity, is expected to undertake a review of the literature

in its field, as well as cross-related topics of discussion (Hart 1998) A number of WCC discussions in healthcare policy that have been developed and used as the basis for some clinical practice, such as maternity care Not surprisingly, the abundance of data and opinion from both medical and social research fields tends to confusion To consider the true needs for

a FDS and their relationship, there is a need to systematically organise the large and diverse amount of material available, in a way that is compact and comprehensible, to determine the core relationship of women to health and industrial design opportunities for their healthcare Some elements PCC methods are also considered within this research to construct a meaningful background revolving around the FDS

The research revolves around four main aspects, namely: design, self-care, female users, and content providers Literature review can provide for an initial understanding of concepts related to female health, current healthcare IS and the future possibilities of self-care for female users Since the knowledge about women’s preferences may not have been applied to the design development of medical device software (especially towards female patient user-ship), the primary aim in literature review is to retrieve relevant published scientific literature

to transfer to both theoretical and practical foundations for the new strategy Existing and prior knowledge essential to the FDS has been reviewed to identify gaps for further research and development

There is relatively little practical evidence available regarding any specific design directives

of female-focused design to the development of existing medical or self-care devices, hence literature review extends to relevant content providers which refer to clinicians and that of medical systems and device manufacturers in order to encompass a better understanding of the relationship between female-focused design, healthcare IS and industrial design Figure 1.4 illustrates a listing of the selected criteria for the literature review The analysis of female-focused design strategies and frameworks can then proceed by comparing models to each other and identifying similarities and differences It is envisaged that the groupings be revised overtime as the research work progresses on and concepts would have become clearer and better defined in the process

Figure 1.4 Literature review for female-focused design

From the source material on female-focused ideology, frameworks and theories, this thesis relies heavily on the review and study of published design and research work Literature regarding this topic is widely spread across fields, such as self-care, sociology, ICT for healthcare and medical device design The search was limited to studies published in the English language, which is the preferred language for international reporting of work and a source language that is probably the least limiting one both culturally and regionally Journal articles and conference proceedings came from three relevant search databases, such as Science Direct, Medline5, POPLINE (POPulation information online)6, Intute (Social

5

Medline (Medlical Literature Analysis and Retrieval System online): This database is supplied by the National

Library of Medicine and is the most comprehensive, premier bibliographic database/on-line resource for national and international medical literature, covering the fields of medicine, nursing, dentistry, veterinary medicine, the health care system and the preclinical sciences

6 POPLINE (POPulation information online) is provided and maintained by the Information and Knowledge for

Optimal Health (INFO) Project at Johns Hopkins Bloomberg School of Public Health Subjects covered within the

Literature Review for Female- focused Design

Female Patients

Patient needs Patient experience Patient involvement Patient participation

Industrial Designers

Medical equipment design

Ergonomics Aesthetics Design methods

Market trends Health IT ICT for healthcare Design strategies

Sciences)7, and ISI Web of Knowledge8 As there is currently no validated search strategies suggested for these databases with the exception of Medline, neither do they incorporate any indexing method, some keywords and key phrases, other than those listed in Figure 1.4 were

of more interest and were used along with a flexible yet iterative search process They are WCC, ‘women’s health’, ‘health information technologies’, ‘patient-provider relationship’,

‘medical informatics’, ‘medical device design’ World Wide Web searches were also undertaken by using two main search engines, such as Yahoo and Google From the search, a variety of articles and publications9 were selected from the US Food and Drug Administration (FDA), King’s Fund, the UK Design Council, Singapore Statistics, the Singapore Health Sciences Authority (HSA), and the Medical Device and Diagnostic Industry (MDDI) In additional, several other specific areas were searched upon with regards to design and technology (the development of medical devices) from videos available online, for example, the TED Conferences and the content from the archive of relevant talks and performances was added to the review throughout the research study

1.3.1 Population

The design and use of healthcare IS can involve many different groups of people whose experiences and knowledge provides valuable data for research Thus, the population represented the various key individuals who play a significant role in both the use and design

of medical equipment Access to the extant research base within self-care and new product development is very restricted due to considerations of medical ethics and confidentiality The samples chosen were therefore based on available information and accessibility Populations examined in this review and the research would include female users, patients, database include family planning technology, family planning programs, fertility, population law and policy, demography, and population and the environment Information is sourced from family planning organisations, governments, and a variety of international agencies

7 Intute: Social Sciences is the subject group of Intute that provides the very best Web resources for education and

research for the social sciences, including law, business, hospitality, sport and tourism It has been created by bringing together two of the Hubs of the Resource Discovery Network (RDN): Altis and SOSIG

8 ISI Web of Knowledge has data from high quality and relevant journals, patents, proceedings and evaluated web

content in the sciences, social sciences, arts and humanities Its coverage dates back to 1945, and includes broad, multidisciplinary content such as Web of Science and targeted specialty resources

9 In addition to the challenges of working collaboratively across these disciplines, there are significant obstacles in the task itself, i.e language complexity In scientific literature, as in most other areas, findings are reported in writing and the concepts are embodied in words Yet words are often difficult to define, requiring a context to determine their meaning (Wright 1992) Fortunately for this project, scientific words are often, although not always, highly specialised and specific Moreover, in medicine, there are well-established specialist vocabularies and these vocabularies are organised in a structured conceptual system called the Unified Medical Language System (UMLS 1999) This system includes 135 semantic types and 54 semantic relations that organise medical knowledge in a hierarchy of parent/child relationships In addition, PubMed uses a vocabulary known as MeSH (Medical Subject Headings) to classify and categorise the content of papers This is an open vocabulary designed

to adapt whilst retaining control over the database of indexing terms used Another related technology available is Natural Language Processing (NLP) software, which is able to parse electronic texts and correctly identify key

words, such as UMLS terms

and other personnel involved in healthcare IS design development Among the group of female users, it comprised those who may be or may not be pregnant at the moment of any particular survey conducted by the study, or those who may or may not have a chronic condition at hand Pregnant subjects are to be included as it is increasingly common throughout the Asian, European, and American continents for home monitoring to be facilitated for preterm labour (Smith 2003) Research demonstrated that home monitoring does improve perinatal results (Torok et al 1999) Another study revealed that home monitoring for preterm labour does improve outcomes and helped in saving cost (Morrison et

al 2001)

In many parts of the world today, women undergoing through high-risk pregnancy are expected to exercise monitoring as part of the routine protocol, while other programmes have even introduced remote active monitoring of the fetus in these high-risk mothers Research had been conducted on the efficacy of these monitoring methods (Kitagawa et al 2000; Hod

& Kerner 2003; Ippoloto et al 2003) For example, pregnant mothers from China were able to use normal phone lines to transfer their non-stress tests of remote fetal evaluation (Su & Guo 2002), hence this further enhances their ability to experience fetal well-being at their familiar environments Indeed, telecare can provide some solutions in areas of women’s health, such

as pregnancy and prenatal care The design and development of a future SIS is expected to incorporate for these opportunities

In considering populations with chronic illnesses, female patients had conditions for more than one year and that would benefit from ongoing monitoring or treatment was included Conditions referred to diabetes, asthma, heart failure and auto-immune disease, such as lupus Patients receive benefits but also occasionally experience adverse effects associated with the use of healthcare portals As different treatments can result in different experiences, patients’ views through previous patient surveys and other relevant information were gathered through data from literature review and addressed accordingly for the purpose of this study The personnel involved in the healthcare IS and medical device development refers to a diverse range of people, such as healthcare professionals, designers, researchers, marketing executives and other engineers, who can be associated with the design planning Nurses are

in particular very important because they have long been advocates for better care of patients and for public health (Lee et al 2007) It is probable that such a subgroup of users would be very different adopters of healthcare technology because of their profession Secondly, medical regulatory bodies, such as the U.S FDA are usually very interested in the comments from nurses on the “user-friendliness” of the form and the new mechanisms of the product to

ensure that such over-the-counter health applications are as safe as possible before they are adopted by lay-users for home-use (Couig & Merkatz 1993) The majority of these healthcare workers are women (U.S Bureau of the Census 1987; Mahowald 1993)

1.3.2 Technologies

The review focused on highly interactive health IT, intended primarily for use by patients or female users which incorporated both patient interaction and patient-specific feedback Examples of included technologies are self-management and monitoring systems with tailored health advice; personal medical records or access to personal data in a provider electronic medical records (EMR); health games that adapt to patient conditions; interactive online support or chat groups; and sites with storage, indexing, retrieval, display, or advanced features (summarisation and decision support) Technology interventions were excluded if they had limited or no patient-driven involvement, if the interactions were without computer information support, or if they did not provide certain information to the user (e.g., Web browsing of general health information databases) Systems primarily or entirely for health professionals or caregivers were also excluded Examples of excluded technologies include: passive monitoring without interactive feedback, information Web sites, such as WebMD and MedlinePlus®, frequently asked question Websites, simple video or phone conferencing, non-tailored education information only programs, or electronic surveys without feedback

Some health IT interventions fit the inclusion criteria, but either had minimal tailoring of information, or minimal patient interaction with the system Minimal tailoring included educational systems that primarily tailored the interaction based on the user’s knowledge or interest, and minimal interaction included high-technology tailored reminding systems with patient-specific information but where patients had not entered or requested information Health IT systems, such as general health Websites and practice guidelines were excluded as they did not both assess and produce patient-specific information Monitoring only systems were also excluded as these systems transmit information to providers but do not require patient interaction or provide the patient with information The most relevant systems in this aspect include self management systems where patients input information about themselves and receive tailored feedback in response Studies examining these systems received full abstraction and review Other types of interventions, such as high-technology reminding, education with minimal tailoring, one-time-use decision aids, and online forums were summarised qualitatively Studies that reported of a broad spectrum of outcome measures, including technology use, health related behaviors, health service utilisation, disease status, quality of life and functional outcomes were included