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Towards a Health 4.0 Framework for the Design of Wearbles: Leveraging Human-Centred and Robust Design

DOI:10.1016/j.procir.2020.02.222
Authors:
Melania Bause at University of Liverpool
Melania Bause
Hannah Forbes at University of Liverpool
Hannah Forbes
Farnaz Nickpour at University of Liverpool
Farnaz Nickpour
Dirk Schaefer at University of Lincoln
Dirk Schaefer
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In today's business environment, the trend towards more product variety and customization is unbroken. Due to this development, the need of agile and reconfigurable production systems emerged to cope with various products and product families. To design and optimize production systems as well as to choose the optimal product matches, product analysis methods are needed. Indeed, most of the known methods aim to analyze a product or one product family on the physical level. Different product families, however, may differ largely in terms of the number and nature of components. This fact impedes an efficient comparison and choice of appropriate product family combinations for the production system. A new methodology is proposed to analyze existing products in view of their functional and physical architecture. The aim is to cluster these products in new assembly oriented product families for the optimization of existing assembly lines and the creation of future reconfigurable assembly systems. Based on Datum Flow Chain, the physical structure of the products is analyzed. Functional subassemblies are identified, and a functional analysis is performed. Moreover, a hybrid functional and physical architecture graph (HyFPAG) is the output which depicts the similarity between product families by providing design support to both, production system planners and product designers. An illustrative example of a nail-clipper is used to explain the proposed methodology. An industrial case study on two product families of steering columns of thyssenkrupp Presta France is then carried out to give a first industrial evaluation of the proposed approach.
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Procedia CIRP 00 (2017) 000–000
www.elsevier.com/locate/procedia
2212-8271 © 2017 The Authors. Published by Elsevier B.V.
Peer-review under responsibility of the scientific committee of the 28th C IRP Design Conference 2018.
28th CIRP Design Conference, May 2018, Nantes, France
A new methodology to analyze the functional and physical architecture of
existing products for an assembly oriented product family identification
Paul Stief *, Jean-Yves Dantan, Alain Etienne, Ali Siadat
École Nationale Supérieure d’Arts et Métiers, Arts et Métiers ParisTech, LCFC EA 4495, 4 Rue Augustin Fresnel, Metz 57078, France
* Corresponding author. Tel.: +33 3 87 37 54 30; E-mail address: paul.stief@ensam.eu
Abstract
In today’s business environment, the trend towards more product variety and customization is unbroken. Due to this development, the need of
agile and reconfigurable production systems emerged to cope with various products and product families. To design and optimize production
systems as well as to choose the optimal product matches, product analysis methods are needed. Indeed, most of the known methods aim to
analyze a product or one product family on the physical level. Different product families, however, may differ largely in terms of the number and
nature of components. This fact impedes an efficient comparison and choice of appropriate product family combinations for the production
system. A new methodology is proposed to analyze existing products in view of their functional and physical architecture. The aim is to cluster
these products in new assembly oriented product families for the optimization of existing assembly lines and the creation of future reconfigurable
assembly systems. Based on Datum Flow Chain, the physical structure of the products is analyzed. Functional subassemblies are identified, and
a functional analysis is performed. Moreover, a hybrid functional and physical architecture graph (HyFPAG) is the output which depicts the
similarity between product families by providing design support to both, production system planners and product designers. An illustrative
example of a nail-clipper is used to explain the proposed methodology. An industrial case study on two product families of steering columns of
thyssenkrupp Presta France is then carried out to give a first industrial evaluation of the proposed approach.
© 2017 The Authors. Published by Elsevier B.V.
Peer-review under responsibility of the scientific committee of the 28th CIRP Design Conference 2018.
Keywords: Assembly; Design method; Family identification
1. Introduction
Due to the fast development in the domain of
communication and an ongoing trend of digitization and
digitalization, manufacturing enterprises are facing important
challenges in today’s market environments: a continuing
tendency towards reduction of product development times and
shortened product lifecycles. In addition, there is an increasing
demand of customization, being at the same time in a global
competition with competitors all over the world. This trend,
which is inducing the development from macro to micro
markets, results in diminished lot sizes due to augmenting
product varieties (high-volume to low-volume production) [1].
To cope with this augmenting variety as well as to be able to
identify possible optimization potentials in the existing
production system, it is important to have a precise knowledge
of the product range and characteristics manufactured and/or
assembled in this system. In this context, the main challenge in
modelling and analysis is now not only to cope with single
products, a limited product range or existing product families,
but also to be able to analyze and to compare products to define
new product families. It can be observed that classical existing
product families are regrouped in function of clients or features.
However, assembly oriented product families are hardly to find.
On the product family level, products differ mainly in two
main characteristics: (i) the number of components and (ii) the
type of components (e.g. mechanical, electrical, electronical).
Classical methodologies considering mainly single products
or solitary, already existing product families analyze the
product structure on a physical level (components level) which
causes difficulties regarding an efficient definition and
comparison of different product families. Addressing this
Procedia CIRP 91 (2020) 639–645
2212-8271 © 2020 The Authors. Published by Elsevier B.V.
This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/)
Peer-review under responsibility of the scientific committee of the CIRP BioManufacturing Conference 2019
10.1016/j.procir.2020.02.222
© 2020 The Authors. Published by Elsevier B.V.
This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/)
Peer-review under responsibility of the scientic committee of the CIRP BioManufacturing Conference 2019.
2212-8271 © 2020 The Authors. Published by Elsevier B.V.
Peer-review under responsibility of the scientific committee of the CIRP Design Conference 2020.
Available online at www.sciencedirect.com ScienceDirect
Procedia CIRP 00 (2020) 000–000
www.elsevier.com/locate/procedia
30th CIRP Design 2020 (CIRP Design 2020)
Towards a Health 4.0 Framework for the Design of Wearables: Leveraging
Human-Centered and Robust Design
Melania F. Bausea*, Hannah Forbesa, Farnaz Nickpoura, Dirk Schaefera
aUniveristy of Liverpool, Brodie Tower, Liverpool, L693GL, United Kingdom,
* Corresponding author. Tel.:+44(0)7435736278; E-mail address: melania.bause@liverpool.ac.uk
Abstract
With the introduction of Health 4.0 we face a new era in healthcare and notice the disruption of delivery, adoption and use through newly
introduced technology. Wearables have become increasingly important in the medical sector and their remote application and widespread use are
significant to the development of technology in healthcare today and the future. The implementation of wearables requires regulations and clinical
approval when intended to use for health tracking and monitoring. Within this process designers play a crucial role. Design methodologies are
the guideline to accomplish a successful path towards the creation of a new product. In this paper the authors explore and draw from established
design methodologies to support the creation of a framework for design of wearables in a health 4.0 context. Identifying the positions of design
practices and analyzing the correlations in the context of Health 4.0 is therefore presented within this paper.
© 2020 M.Bause, H. Forbes, F. Nickpour, D. Schaefer. Published by Elsevier B.V.
Peer-review under responsibility of the scientific committee of the CIRP Design Conference.
Keywords: Health 4.0, inclusive design, mental health, user-friendly, user-centred design, wearable technology
1. Introduction
Driven by networked Electronic Health Record systems,
Artificial Intelligence, real-time data from wearable devices
with an overlay of invisible user interfaces and improved
analytics, a revolution is afoot in the healthcare industry. Over
the next few years, it is likely to fundamentally change how
healthcare is delivered and how the outcomes are measured.
The focus on collaboration, coherence, and convergence will
make healthcare more predictive and personalised. This
revolution is called Health 4.0. Data portability allows patients
and their physicians to access it anytime anywhere and
enhanced analytics allows for differential diagnosis and
medical responses that can be predictive, timely, and
innovative. Health 4.0 allows the value of data more
consistently and effectively. It can pinpoint areas of
improvement and enable decisions that are more informed. It
also helps move the entire healthcare industry from a system
that is reactive and focused on fee-for-service to a system that
is value-based, which measures outcomes and ensures
proactive prevention [1].
In this context, the overarching research aim is to investigate
and understand how smart healthcare systems of the future
(products or product-service-systems) can be designed
effectively and efficiently. To be more specific, our focus is on
the design of digital wearables for monitoring and managing
health conditions remotely, and potentially for detecting
developing health conditions and thus preventing medical
emergencies. To achieve this aim, we intend to devise a design
framework to aid the design process of such products. In this
context, the research question addressed in this paper is “How
can existing design methodologies support the creation of such
a framework for the design of wearables for Health 4.0
applications”.
2212-8271 © 2020 The Authors. Published by Elsevier B.V.
Peer-review under responsibility of the scientific committee of the CIRP Design Conference 2020.
Available online at www.sciencedirect.com ScienceDirect
Procedia CIRP 00 (2020) 000–000
www.elsevier.com/locate/procedia
30th CIRP Design 2020 (CIRP Design 2020)
Towards a Health 4.0 Framework for the Design of Wearables: Leveraging
Human-Centered and Robust Design
Melania F. Bausea*, Hannah Forbesa, Farnaz Nickpoura, Dirk Schaefera
aUniveristy of Liverpool, Brodie Tower, Liverpool, L693GL, United Kingdom,
* Corresponding author. Tel.:+44(0)7435736278; E-mail address: melania.bause@liverpool.ac.uk
Abstract
With the introduction of Health 4.0 we face a new era in healthcare and notice the disruption of delivery, adoption and use through newly
introduced technology. Wearables have become increasingly important in the medical sector and their remote application and widespread use are
significant to the development of technology in healthcare today and the future. The implementation of wearables requires regulations and clinical
approval when intended to use for health tracking and monitoring. Within this process designers play a crucial role. Design methodologies are
the guideline to accomplish a successful path towards the creation of a new product. In this paper the authors explore and draw from established
design methodologies to support the creation of a framework for design of wearables in a health 4.0 context. Identifying the positions of design
practices and analyzing the correlations in the context of Health 4.0 is therefore presented within this paper.
© 2020 M.Bause, H. Forbes, F. Nickpour, D. Schaefer. Published by Elsevier B.V.
Peer-review under responsibility of the scientific committee of the CIRP Design Conference.
Keywords: Health 4.0, inclusive design, mental health, user-friendly, user-centred design, wearable technology
1. Introduction
Driven by networked Electronic Health Record systems,
Artificial Intelligence, real-time data from wearable devices
with an overlay of invisible user interfaces and improved
analytics, a revolution is afoot in the healthcare industry. Over
the next few years, it is likely to fundamentally change how
healthcare is delivered and how the outcomes are measured.
The focus on collaboration, coherence, and convergence will
make healthcare more predictive and personalised. This
revolution is called Health 4.0. Data portability allows patients
and their physicians to access it anytime anywhere and
enhanced analytics allows for differential diagnosis and
medical responses that can be predictive, timely, and
innovative. Health 4.0 allows the value of data more
consistently and effectively. It can pinpoint areas of
improvement and enable decisions that are more informed. It
also helps move the entire healthcare industry from a system
that is reactive and focused on fee-for-service to a system that
is value-based, which measures outcomes and ensures
proactive prevention [1].
In this context, the overarching research aim is to investigate
and understand how smart healthcare systems of the future
(products or product-service-systems) can be designed
effectively and efficiently. To be more specific, our focus is on
the design of digital wearables for monitoring and managing
health conditions remotely, and potentially for detecting
developing health conditions and thus preventing medical
emergencies. To achieve this aim, we intend to devise a design
framework to aid the design process of such products. In this
context, the research question addressed in this paper is “How
can existing design methodologies support the creation of such
a framework for the design of wearables for Health 4.0
applications”.
2212-8271 © 2020 The Authors. Published by Elsevier B.V.
Peer-review under responsibility of the scientific committee of the CIRP Design Conference 2020.
Available online at www.sciencedirect.com ScienceDirect
Procedia CIRP 00 (2020) 000–000
www.elsevier.com/locate/procedia
30th CIRP Design 2020 (CIRP Design 2020)
Towards a Health 4.0 Framework for the Design of Wearables: Leveraging
Human-Centered and Robust Design
Melania F. Bausea*, Hannah Forbesa, Farnaz Nickpoura, Dirk Schaefera
aUniveristy of Liverpool, Brodie Tower, Liverpool, L693GL, United Kingdom,
* Corresponding author. Tel.:+44(0)7435736278; E-mail address: melania.bause@liverpool.ac.uk
Abstract
With the introduction of Health 4.0 we face a new era in healthcare and notice the disruption of delivery, adoption and use through newly
introduced technology. Wearables have become increasingly important in the medical sector and their remote application and widespread use are
significant to the development of technology in healthcare today and the future. The implementation of wearables requires regulations and clinical
approval when intended to use for health tracking and monitoring. Within this process designers play a crucial role. Design methodologies are
the guideline to accomplish a successful path towards the creation of a new product. In this paper the authors explore and draw from established
design methodologies to support the creation of a framework for design of wearables in a health 4.0 context. Identifying the positions of design
practices and analyzing the correlations in the context of Health 4.0 is therefore presented within this paper.
© 2020 M.Bause, H. Forbes, F. Nickpour, D. Schaefer. Published by Elsevier B.V.
Peer-review under responsibility of the scientific committee of the CIRP Design Conference.
Keywords: Health 4.0, inclusive design, mental health, user-friendly, user-centred design, wearable technology
1. Introduction
Driven by networked Electronic Health Record systems,
Artificial Intelligence, real-time data from wearable devices
with an overlay of invisible user interfaces and improved
analytics, a revolution is afoot in the healthcare industry. Over
the next few years, it is likely to fundamentally change how
healthcare is delivered and how the outcomes are measured.
The focus on collaboration, coherence, and convergence will
make healthcare more predictive and personalised. This
revolution is called Health 4.0. Data portability allows patients
and their physicians to access it anytime anywhere and
enhanced analytics allows for differential diagnosis and
medical responses that can be predictive, timely, and
innovative. Health 4.0 allows the value of data more
consistently and effectively. It can pinpoint areas of
improvement and enable decisions that are more informed. It
also helps move the entire healthcare industry from a system
that is reactive and focused on fee-for-service to a system that
is value-based, which measures outcomes and ensures
proactive prevention [1].
In this context, the overarching research aim is to investigate
and understand how smart healthcare systems of the future
(products or product-service-systems) can be designed
effectively and efficiently. To be more specific, our focus is on
the design of digital wearables for monitoring and managing
health conditions remotely, and potentially for detecting
developing health conditions and thus preventing medical
emergencies. To achieve this aim, we intend to devise a design
framework to aid the design process of such products. In this
context, the research question addressed in this paper is “How
can existing design methodologies support the creation of such
a framework for the design of wearables for Health 4.0
applications”.
640 Melania F. Bause et al. / Procedia CIRP 91 (2020) 639–645
2 Melania F. Bause et al. / Procedia CIRP 00 (2020) 000–000
Wearables have become increasingly important in the
medical sector and their remote application and widespread use
are significant to the changing healthcare landscape. Despite
their importance, there is limited guidance for designers
seeking to produce new wearable devices in the context of
Health 4.0. In this paper, existing design methodologies, and
their associated standards and practices, are reviewed for use in
a new design framework for wearable design in the context of
Health 4.0. In this section, tangible differences between Health
3.0 and Health 4.0 are considered in the wearable design
context, existing literature in this sector is discussed and the
research questions, to be addressed by this paper, is identified.
1.1. Designing for Health 3.0 vs. Health 4.0
Health 4.0 represents the ongoing results of a significant
technological revolution in healthcare. Technologies such as
MioT (medical Internet of Things), AI (Artificial Intelligence),
VR (Virtual Reality), ML (Machine Learning), Big Data, Deep
Learning and NLP (Natural Language Processing), are now
integrated within healthcare systems and have significantly
altered the way care is given and received.
Designers play a vital role in bridging the gap between
disciplines and in understanding the needs of stakeholders
within the healthcare system. As problem solvers they help to
design products, services and systems for and with people. The
changes resulting in the Health 4.0 era, however, have resulted
in tangible changes to the way designers must approach new
projects. Table 1 below gives an example of these tangible
changes and how they may influence the design of wearables.
Table 1: Designing for Health 4.0
Tangible changes from Implication on Wearable Design Health
3.0 to Health 4.0 Process
Shift from point of care to Quality expectations and requirements
point of need (shift away should be clearly defined as part of the
from hospitals/institutions) problem definition. [2]
Virtual delivery of care
outside of hospitals [2
]
-making process.
Management and processing
of data: services tailored to
individuals rather than
des
igned by statistical
averages [2
]
patients.
Interactive pharmaceuticals:
A more reactive
pharmaceutical industry [2
]
Wearable devices allow
pharmaceuticals and other health
stakeholders to be more reactive but
only if there is adequate feedback from
individuals to stakeholders. Design
ers
must consider how their device
supports other stakeholders and
provides the right information in a
timely manner.
1.2. Existing Literature on Wearable Design in Health 4.0 era
For wearable design in a Health 4.0 era, existing literature
exclusively includes design approaches for the use and
application of wearables. Literature can therefore be
categorised according to the application domain. Existing
literature, set in the context of Health 4.0, addresses either the
use of wearables for specific medical conditions, use of
wearables for a specific user group or use of wearables for a
specific medical unit, such as cardiology. Use of the term
“Health 4.0” is still emerging, so search terms such as “smart
healthcare” and “digital healthcare” were also considered and
yielded the same results.
The first sector of literature considers the use of wearables,
in the context of Health 4.0, for specific medical conditions
such as multiple sclerosis. Golab et al. [3] present an approach
to design for a “wearable headset for monitoring
electromyography responses within spinal surgery”. They find
that the design process must place emphasis on “improving
efficiency of the device” with regards to ease of use.
Grigoriadis et al. [4] present a Health 4.0 approach for the
design of wearables for the “management of multiple
sclerosis”. They find that as a consequence of the “chronic and
variable” nature of the disease, designers must recognise the
need for “flexibility” in the final design.
The second sector of literature considers the use of
wearables in the context of Health 4.0, for specific user groups.
Terroso et al. [5] present a wearable for active fall detection for
the elderly, Dong et al. [6] evaluate consumer attitudes towards
wearable in China and Petrie et al. [7] discuss lifecycle design
in the context of wearables for those with disabilities. These
and other authors, offer some insight for an approach to design
but all insights are very specific to the user group. Furthermore,
this literature is predominantly in the field of health, as opposed
to design, and therefore does not leverage existing design
research or methodologies.
The final sector is the design of wearables, in a Health 4.0
context, for specific medical units. Park et al. [8] discuss the
“design and control of a bio-inspired soft wearable robotic
device for ankle–foot rehabilitation”. They find that bioinspired
design methodologies can support the design of wearables for
healthcare applications. This is a concept echoed by Pevnick et
al. [9] who considers wearable technology for cardiology. They
“also offer several frameworks to classify and better understand
wearable devices” in the context of digital health. These
frameworks can be described as micro-abstract design methods
Melania F. Bause et al. / Procedia CIRP 91 (2020) 639–645 641
Author name / Procedia CIRP 00 (2020) 000–000 3
and are therefore “not appropriate for guiding the full design
process” [10]. As a consequence, there is still a need for holistic
design framework for guiding wearable design in the context of
Health 4.0.
Existing literature offers many insights into design
approaches for a Health 4.0 context but since these insights are
founded on specific application domains, they are not clearly
applicable for general use.
1.3. Literature Gap and Research Aim
Tangible differences in Health 3.0 and Health 4.0, and the
implications on the design process (Table 1), results in a need
to devise new approaches to design in the Health 4.0 era. In the
context of wearable design, existing literature is yet to present
a holistic framework to guide the design of wearables. To begin
to address this literature gap and devise a design framework,
the authors consider what existing design methodologies can
provide. The research question to be addressed in this paper is
therefore:
How can existing design methodologies support the creation
of a framework for the design of wearables in a Health 4.0
context?
The following section first includes a discussion on which
existing design methodologies to consider. Inclusive design,
emotional design, robust design and participatory design are
then reviewed for their use in the context of wearable design in
the Health 4.0 era. Following this section, a consolidation of the
findings is presented, followed by future research directions
and conclusions.
2. Design Methodologies
In this section, four design methodologies, and how they can
support wearable design in a Health 4.0 context, are presented.
Distilling the design requirements in Table 1, demonstrates the
need for patient understanding and stakeholder management in
the Health 4.0 era. By shifting from point of care to point of
need, further emphasis is placed on the requirement of the
individual and, as a consequence, stakeholder requirements are
more numerous and diverse to fulfil customisation. With
regards to delivery of virtual care and the consideration of
access, emphasis on individuals as stakeholders means
consideration of a range of levels of accessibility and a range
of types of accessibility (such as technical savviness, access to
the internet, motor skills and other physical access).
Management of data and information flow requires significant
collaboration of stakeholders, and further emphasises the need
to consider stakeholder management in the design process.
Inclusive and emotional design are chosen to reflect both the
needs and feelings of patients, while robust and participatory
design have been considered due to the significance of
stakeholder management for designers in the context of Health
4.0.
2.1. Inclusive Design
“The British Standards Institute (2005) definition of
inclusive design is: “The design of mainstream products and/or
services that are accessible to, and usable by, as many people
as reasonably possible ... without the need for special
adaptation or specialized design.” [11].
Organizations such as SCOPE focus on the independence of
disabled people and argue that medical interventions focus on
what is “wrong” rather than on what is “needed” (SCOPE,
2019). Designers in this case, and this should be applied
broadly in healthcare, are the middle man or better said the
mediator between the “medical model of disability” and
aforementioned charitable organization. Functioning in a pool
of cross-disciplinary interaction [12]. The “BS 7000-6:2005
Guide to managing inclusive design”, released by the bsi in
2005, is out there but progress is stagnating. The guidelines
address the need of inclusive design and “disabled people’s
needs are considered throughout the lifecycle of a product or
service.”
We can agree upon one fairly in common sense
understandable fact that is that we are all different from each
other, this is expressed in size, shape and form. And the aim of
inclusive design is to take down the barriers of separation and
move towards empowerment of an equal, independent and
confident lifestyle without limitations in the built environment.
This is where the design of wearables for healthcare ‘in its
infancy’ should focus on, the benefits in designing universally
creates the aforementioned viewpoint (equality). Following up
on the empowerment of inclusive design in context with
wearables for the use of monitoring, gathering data and
evaluation. The main stakeholders involved are the user/patient
and the clinician/ practitioner. But as researchers from the
Berkeley University of California have accurately illustrated,
these are not the only parties involved in the process of
accumulating big data (Fig. 1). Although primarily information
on vital signals is send to the practitioner for evaluation and
diagnosis. In later stages it surpasses the payer (insurance
companies) and pharma companies.
Figure 1: Source ELPP 2016. [13]
Inclusivity plays a role here too by bridging the gap between
stakeholders it can create services, systems and products that
642 Melania F. Bause et al. / Procedia CIRP 91 (2020) 639–645
4 Melania F. Bause et al. / Procedia CIRP 00 (2020) 000–000
operate on an interconnected level. An example would be the
Remote Care Monitoring (Preparation) Scheme introduced by
the NHS in 2013/14 for GP’s to remotely follow up on patients
with long-term conditions that do not need hospitalisation. This
scheme is designed to support GP’s with identifying “… the
ongoing tests or bodily measurements required to support the
stable management of the chosen condition and how those tests
and measurements will be accessed or fed in by patients with
the condition.” (p.2/10b) [12]. Further it allows patients to
participate in “the monitoring of results from such tests or
measurements other than by face to face consultation (e.g.
video call, telephone, text, email or letter) and the governance
arrangements to support these including safe and confidential
exchange of information.” [14]. This is happening today and
will be accessible for the wider mass rather than ‘just’ to
patients with long-term conditions. Which draws us back to
inclusive design that is engraved in the aforementioned
examples and analysis. Thus far we have understood that the
method of inclusive design is to be able to widen the focal area
with a design approach aiming at including people and to attain
information from multiple perspectives. Other than ‘User
centred Design’ and ‘Participatory Design’ as well as similar
design approaches that are rather mainstream focused,
Inclusive Design aims at including the generality; “Universal
Design”, “Inclusive Design” and “Design for All” movements
have encouraged designers to extend their design briefs to
include older and disabled people.”[15].
To include the different stakeholders displayed in Berkeley’s
research example, designers need to consider the significance
of the solid system and provide inclusivity for all parties
involved in the circle. In the context of Health 4.0 it can
establish an opportune stage for universal applicable devices,
systems and services.
2.2. Emotional Design
Design is key in shaping the lifes of individuals. This part of
the paper deals with the emotional aspect in designing wearable
technology in Health 4.0. D. Norman in his book Emotional
Design states: “The problem is that we still let logic make
decisions for us, even though our emotions are
telling us otherwise. Business has come to be ruled by logical,
rational decision makers, by business models and
accountants, with no room for emotion. Pity!” [16]. To his
understanding rational thinking rules out emotional response.
The design of wearables within the context of emotional design
faces challenges since these products are attached to the body
or embedded. An online database search on ‘emotional design
and wearables’ lacks of in depth research and design methods.
Most articles are concerned with studying how to detect
emotions with sensors and computing systems. In emotional
design we analyze the responds of individuals to the form,
shape, surface and look of products in order to consider
reactions for the design process and create a positive experience
for the consumer. D. Norman’s Three Level of Design concept
is displayed in Figure 2 which consists of three different parts
that are interconnected and form a method to the practice of
emotional design.
Visceral Design – "Concerns itself with appearances".
Behavioural Design – "...has to do with the pleasure and
effectiveness of use."
Reflective Design – "...considers the rationalization and
intellectualization of a product. Can I tell a story about it?
Does it appeal to my self-image, to my pride?" [16].
Figure 2: Norman’s Three Levels of Design [15]
What we see is translated into our senses and Norman’s
emotional system describes the three different areas in our
minds that are responsible for it, as mentioned above. All
dimensions are separated into three areas of design that together
are the sum of emotional design. In regard to designing
wearables for healthcare it is vital to understand the difference
of these levels, as their methods are applicable in different
areas, i.e. commercial use, business interest or to suite
companies’ objectives (visceral design) [17]. Especially
designing for healthcare requires to set new rules for quantitate,
content focused environment. Though designers will face
limitations in ethical concerns, healthcare norms and
regulations. This part of the paper gave a brief example of a
method to apply when designing wearables provided by Donald
Norman. Reference aimed specifically at designing wearables
for Health 4.0 have been mentioned earlier in this paper and
appear to be a gap when exploring online. Designers are
challenged to apply these methods to a field of product design
and engineering where the primary focus is held on form,
function and performance. Clearly defining how emotional
design contributes to the process in the context of Health 4.0.
2.3. Robust Design
Having established the importance of stakeholder management
for design in the context of Health 4.0, robust design is the first
design methodology considered. Robust design is a group of
methods implemented to limit deviations from original function
[18]. This methodology may provide insight for wearable
design by ensuring multiple stakeholder inputs are a
consideration but not a distraction from fulfilling the design
problem. Unlike other design methodologies included in this
paper, robust design is centred in increasing performance. In
robust design, associated with each quality characteristic, the
design objective often involves multiple aspects such as
“bringing the mean of performance on target” and “minimizing
Melania F. Bause et al. / Procedia CIRP 91 (2020) 639–645 643
Author name / Procedia CIRP 00 (2020) 000–000 5
the variations” [19]. In this section, the authors specifically
consider the Taguchi method and identify theories transferrable
to the creation of a framework for wearable design in a Health
4.0 context.
The Taguchi method is classified as a significant aspect of
robust design methodology [20]. The Taguchi method is a
concept that has produced a unique and powerful quality
improvement discipline that differs from traditional practises
[21]. It is considered a powerful tool for design optimization
for quality [22]. The Taguchi method is defined by three
principles which each have implications on the product
development process, as shown in Table 2 below.
Table 2. The Three Taguchi Principles and their Implication on the Design
Process
Three Principles for the
Taguchi method
Implication on Design Process
Quality should be designed
into the product and not
inspected into it [21].
Quality expectations and requirements
should be clearly defined as part of the
problem definition.
Quality is best achieved by
minimizing the deviation
from a target. The product
should be so designed that it
is immune to uncontrollable
environmental factors [21].
In any decision-making stage,
implications on quality should be
considered and heavily weighted as part
o
f the decision-making process.
The cost of quality should be
measured as a function of
deviation from the standard,
and the losses should be
measured system wide. [21]
Quality should be defined
quantitatively in problem definition and
in the context of
the problem. For
example, in the Health 4.0 context,
deviations from ergonomic standards,
should be recognised as the number of
excluded patients.
To obey the principles of the Taguchi method, designers,
most fundamentally, need to place significant consideration on
quality throughout the product development process. This
means incorporating feedback loops and stage-gates throughout
the process to consider how decisions influence the quality of
the wearable. Furthermore, this means placing importance on
clearly defining what quality means, in the context of the
product and Health 4.0, in the problem definition phase.
Taguchi also proposes a prescriptive approach to applying
robust design as shown in Figure 3. These stages are not defined
according to product development phases and are therefore
phase agnostic. They also may be repeated within product
development phases or considered on a macro level.
Fig. 3. Three-stages of Robust Design
In Table 3 below these stages are considered in the context of
wearable design and Health 4.0
Table 3. The Three Taguchi Stages and an example in the context of Health 4.0
Three Stages for the Taguchi
method
Example in Context of Health 4.0
System Design
Consider dimension range for optimal
ergonomics suitable for patients.
Parameter Design
Assign range within which the device
dimensions can differ.
Tolerance Design
Consider how movement with this
ranged can be recognised
quantitatively. For example, deviations
from ergonomic standards, should be
recognised as the number of excluded
patie
nts.
In summary, robust design has been developed to improve
product quality and reliability in industrial engineering [18].
This is applied through methods such as the Taguchi method
which is defined by three principles and a three-stage
prescriptive approach. In this section, this methodology has
been considered in the context of wearable design for Health
4.0. Findings show that the following could be included in a
framework for wearable design in the context of Health 4.0:
• Clearly defined requirements of quality
• Consideration of these quality requirements and how they
are impacted, with all key decisions
• Assignment of quantitative measure of quality such as
patients impacted
The purpose of robust design is to limit the design process
to deviation due to external factors [23]. In the context of
Health 4.0, this means fulfilling functional requirements
despite demands from several and multiple stakeholders. Using
the Taguchi method could allow incorporation of stakeholder
input while ensuring performance. Furthermore, by assigning a
quantitative consideration of quality, such as patient impact, the
robust design methodology centres the design process on the
needs of the patient, mirroring the existing shift in healthcare
as a consequence of Health 4.0 technologies.
2.4. Participatory Design
In robust design, the risk of distraction from stakeholder
involvement is mediated. In participatory design, involvement
of stakeholders is expanded to create a collaborative
relationship between designers and stakeholders. While robust
design views stakeholder involvement as a challenge,
participatory design views stakeholder involvement as an
opportunity. Considering both of these perspectives is valuable
for yielding balanced insights for future work.
Participatory design is “not defined by the type of work
supported, nor by the technologies developed, but instead by a
commitment to worker participation in design” [25]. It is an
“attitude from designing for users to one of designing with
users” [27] and an attempt to “rebalance the power relations”
between designers and users [25]. Participatory design attempts
to steer a course "between tradition and transcendence" that is,
between participants' tacit knowledge and researchers' more
abstract, analytical knowledge [26, 28, 30]. In the context of
Heath 4.0, participatory design means recognising the vital
Syst em Desig n
Determine suitable working levels of design facto rs
Parameter
Design
Determine the factor levels that produce the best performance
Tolerance
Design
Fine tune the results
of parameter design by tightening the tolerance of factor s
644 Melania F. Bause et al. / Procedia CIRP 91 (2020) 639–645
6 Melania F. Bause et al. / Procedia CIRP 00 (2020) 000–000
involvement of patients, health professionals and health
institutions in the design process.
This attitude is realised in the form of several techniques and
activities to ensure collaboration with users. Activities for
applying participatory design include workshops, stories,
creation of shared languages, descriptive artefacts and working
prototypes [24]. Table 4 considers the prescriptive design
process [29] in the context of wearable design for Health 4.0,
how users can contribute and through which participatory
design activities they could be involved.
Table 4. Participatory Design Activities for wearable design in Health 4.0
context
Product
Development
Process
Value of User Input
Participatory Design
Activity
Problem
Definition:
What problem
is this wearable
device
addressing?
Validation that problem
is the right problem
Understanding of how
the problem impacts the
user
Interviews with users
Focus groups with users
Brainstorming workshop
to encourage suggested
problems from users
Requirements
Elicitation and
Analysis: What
do users require
from this
device?
Feature suggestions
Understanding of
physical constraints
Understanding of
nonphysical constraints
User scenario mapping
Interviews with users
Focus groups with users
Brainstorming on feature
list
Observational studies for
understanding of lived
experience
Concept
Generation
Diverse ideas from new
and user perspective
More numerous ideas
Crowdsourcing activity
seeking idea submissions
Brainstorming session
with users
Concept
Evaluation
Early testing of ideas
Refinement of features
within boundary of
existing ideas Weighted
input from users in
selection process
Group interviews gaging
interest on individual
concepts
Individual interviews for
each concept
Collaborative creation of
weighted selection tool
Embodiment
Design
Regular feedback from
users
Open design tools to
allow read access for
group of users
Detailed Design
Regular feedback from
users
Open design tools to
allow read access for
group of users
Testing and
Validation: Has
this design
addressed the
problem?
Understanding of use in
real environment
Understanding of use in
reality
Observational studies
with use of prototypes
A framework for the design of wearables in a Health 4.0 context
can use participatory design techniques, to ensure stakeholder
input is placed at the centre of the design process. Designers
essentially must engage and involve users in each design phase
and in important design decisions. This can be done by using
several of the participatory design techniques listed above, and
by adopting the participatory design mindset. In the context of
Health 4.0, the participatory design mindset means
understanding that patients, health professionals and health
institutions should have as much, if not more, ownership of the
device than researchers and designers, and their input must be
treated with upmost importance in design decision making.
3. Conclusions
This paper addresses the research question: how can existing
design methodologies support the creation of a framework for
the design of wearables in a Health 4.0 context?
Four design methodologies were considered inclusive
design, emotional design, robust design and, participatory
design, to yield insight for framework development. From
robust design, the authors recognize a need for clearly defined
quality requirements, consideration of quality as part of all
design decision making and a quantitative assessment of quality
to leverage as part of design decisions. From participatory
design, authors recognize a need to adopt a mind-set that places
user input as highest in a hierarchy of decision influencers.
From inclusive design, the authors recognize a need to, not only
include users, but make user involving activities accessible to
all user groups, especially vulnerable users such as those with
disabilities or the elderly. Finally, emotional design highlights
the need to assess the visceral, behavioural and reflective
impact on users, throughout the design process.
In summary, the authors will incorporate the following into
a framework for wearable design in the context of Health 4.0:
• Varying techniques of user involvement to ensure inclusivity
• Recognition of different user needs and adoption of new
approaches to include all users
• Identification of user responses to design on the three
emotional levels
• Robust design methods to ensure user involvement does not
distract designers from performance and quality
requirements.
Future research directions, suggested by the authors,
include consideration of software, as well as hardware, design
methodologies, ethnographic studies to assess user
involvement in the design of wearables, and extensive
consideration of the ethics associated with the involvement of
vulnerable people in design.
4. Discussion of Future Research Directions
To leverage these findings and continue towards a
framework for the design of wearables in a Health 4.0 context,
several future research directions have been identified.
Firstly, additional design methodologies must be considered.
Methodologies such as interface design, interactive design and
functional design may provide further insights to support
framework development. Furthermore, analysis in this paper
has been biased towards hardware design but software design
methods must also be incorporated into a future design
framework. Methodologies derived from software such as user
interface design, user experience design and agile, should be
considered as part of framework development.
In addition, further consideration of the design of wearables,
outside of the context of Health 4.0 should be included in
framework development. The authors consider the implications
of the context of wearable design and the context of Health 4.0,
as equally important. This paper considers Health 4.0 in more
Melania F. Bause et al. / Procedia CIRP 91 (2020) 639–645 645
Author name / Procedia CIRP 00 (2020) 000–000 7
detail, and therefore the wearable design sector should feature
more significantly in future research.
User involvement has been shown to be key in the
development of a future design framework. Further research in
this area is a vital research direction. Researchers should seek
insight from user involvement in previous wearable projects
and should also seek to understand how vulnerable users have
been previously involved in product development.
Furthermore, the ethics associated with vulnerable user
involvement will significantly impact this work and should be
extensively considered by future researchers.
Finally, the authors suggest future work includes
observational studies. Existing literature includes limited use of
ethnographical studies and, based on the importance of
addressing user needs, observational studies could be a method
to extract new findings in this field.
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Conference Paper
  • Sep 1998
In robust design, associated with each quality characteristic, the design objective often involves multiple aspects such as “bringing the mean of performance on target” and “minimizing the variations”. Current ways of handling these multiple aspects using either the Taguchi’s signal-to-noise ratio or the weighted-sum method are not adequate. In this paper, we solve bi-objective robust design problems from a utility perspective by following upon the recent developments on relating utility function optimization to a Compromise Programming (CP) method. A robust design procedure is developed to allow a designer express his/her preference structure of multiple aspects of robust design. The CP approach, i.e., the Tchebycheff method, is then used to determine the robust design solution which is guaranteed to belong to the set of efficient solutions (Pareto points). The quality utility at the candidate solution is represented by means of a quadratic function in a certain sense equivalent to the weighted Tchebycheff metric. The obtained utility function can be used to explore the efficient solutions in the neighborhood of the candidate solution. The iterative nature of our proposed procedure will assist decision making in quality engineering and the applications of robust design.
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Wearable Technology for Cardiology: An Update and Framework for the Future
Article
The field of cardiology has long used wearable medical devices to monitor heart rate and rhythm. The past decade has seen the emergence of many new wearable devices, including several that have been widely adopted by both physicians and consumers. In this review, we discuss existing and forthcoming devices designed to measure activity, heart rate, heart rhythm and thoracic fluid. We also offer several frameworks to classify and better understand wearable devices, such that we may weigh their potential benefit in improving healthcare with the many challenges that must be addressed to reap these benefits.
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Consumers’ perceived attitudes to wearable devices in health monitoring in China: A survey study
Article
  • Mar 2017
Background and objective: Capital market and consumer market interest in wearable devices has surged in recent years, however, their actual acceptance in the field of health monitoring is somewhat not as expected. This study aims to understand the perceptions of wearable devices of general consumers, analyze the review of the devices by users, and find existing problems associated with current wearable devices. Methods: Sojump.com, an on-line questionnaire tool, was used to generate the questionnaire, which focused on four aspects. The snowball sampling method was employed to collect questionnaires by making use of the author's social network. Results: (1) A total of 2058 valid questionnaires were received from the respondents from every province in China; of the respondents, 52.4% have used a wearable device. (2) The respondents had a low level of knowledge about wearable devices (2.79/5) but were optimistic with regard to the devices' future (3.86/5), and 84% recognized an acceptable price of less than 2000 RMB. Nearly half of the respondents were unwilling to continuously wear the device (47.1%) and share their health data (44.7%). (3) The functions of wearable devices that the respondents expected were mainly health management (63.5%), mobile phone accessories (61.9%), and location tracking (61.2%), and the promising hot future functions were mainly data analysis (74.2%), exercise coaching (60.5%), and child tracking (58.8%). Regarding the health monitoring functions, the respondents were most interested in heart health monitoring. (4) The respondents had different levels of emphasis regarding the existing problems of wearable devices at different use stages. Being easily damaged or lost (49.7%), being incapable of providing health recommendations based on data analysis (46.7%), and being uncomfortable to wear (45.8%) likely lead consumers to abandon the use of wearable devices. Conclusions: Consumers are optimistic about the prospects of wearable devices; however, there is a large gap between the reliability of the measurement data, the ease of use, and the interpretation of measurement data of current wearable products and consumer expectations. Consumer demand for health management functions is higher than that for daily auxiliary-type functions, which is an issue that should be properly addressed and resolved by manufacturers.
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A Health 4.0 Based Approach Towards the Management of Multiple Sclerosis
Chapter
  • Jan 2017
Multiple sclerosis is a chronic and variable disease in matters of symptoms, clinical course and outcome. The ultimate goal of currently used drugs and therapeutic strategies is the control of disease activity and the delay of the ongoing disability. During the last decades, a number of disease-modifying drugs (DMDs), all products of advanced biotechnology are being used. However, these DMDs are yet partially effective since the ongoing disability progression may hardly be prevented. There is growing evidence that these DMDs might be more effective if more accurate monitoring of the disease itself throughout a period of time might be available. In the new era of MS treatment and on the basis of our current knowledge about MS management, it became pretty clear that the overall therapeutic strategy should always be scheduled on strictly individualized basis. To this, MS patients should be encouraged to take control over their own disease and collaborate more effectively with their doctors. The advent of the IoT (Internet of Things) and 5G mobile technologies can support patients in this direction. Since a snapshot of the overall patient’s condition during a regular follow-up visit may not represent the every day reality of the patient, the advice given under these conditions may not be that effective. However, if hard data on the patient’s motoric and cognitive performance were available “theragnostics ” might be much more effective and efficient and a typical flare-up of the condition might be recognized much earlier—or even anticipated. Health 4.0 is the translation of Industry 4.0 design principles into the health domain. Health 4.0 is based on the utilization of the Internet of Things (IoT) and the use of cyber-physical systems to connect the physical and the virtual world. The use of smart pharmaceuticals biosensors and cyber-physical systems in the management of MS could optimize the accuracy and allow for a precise mapping of symptoms over time which is an inevitable prerequisite for personalization of care. Ideally captured data would be processed in real time in order to flag problems up to the care team and on an individual basis anticipate motoric and/or cognitive deficits in an attempt to compensate for neurological deficits. 5G networks are expected to provide the infrastructure and ease in supporting various parameters recording on a real-time basis. Relevant clinical studies may further highlight the need of information communication technology in MS management, thus contributing to the overall improvement of patent’s quality of life (QoL). This is an absolute necessity for a variable, fluctuating and largely unpredictable disease such as MS.
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Quality Utility – A Compromise Programming Approach To Robust Design
Article
In robust design, associated with each quality characteristic, the design objective often involves multiple aspects such as ''bringing the mean of performance on target" and "minimizing the variations." Current ways of handling these multiple aspects using either the Taguchi's signal-to-noise ratio or the weighted-slim method pre not adequate. In this paper we solve bi-objective robust design problems from a utility perspective by following upon the recent developments on relating utility function optimization to a Compromise Programming (CP) method. A robust design procedure is developed to allow a designer to express his/her preference structure of multiple aspects of robust design. The CP approach, i.e., the Tchebycheff method, is then used to determine the robust design solution which is guaranteed to belong to the set of efficient solutions (Pareto points). The quality utility at the candidate solution is represented by means of a quadratic function in a certain sense equivalent to the weighted Tchebycheff metric. The obtained utility function can be used to explore the set of efficient solutions in a neighborhood of the candidate solution. The iterative nature of our proposed procedure will assist decision making in quality engineering and the applications of robust design.
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