model was employed fully in the third step, allowing the comparison
between the methods. The results enabled to identify a discrepancy between the
critical costumers in the use of mentioned methods. Customers were limited to the
direct and indirect users in the QFD application: the patient, physician and
physical therapist. This list got a considerable increase when CVCA was
applied: the clinical engineering, product engineering, process and reliability
engineering, project and product managers, financial sector, quality system and
regulatory issues. These results show the importance of analyzing the supply
chain systemically in order to consider all stakeholders to the CPM device development.
Thus, needs and relationships delineation of all process customers can be done.
Keywords: quality management; QFD; CVCA; product development;
continuous passive motion.
1.
INTRODUCTION
New
technologies are revolutionizing services delivery since the last half century.
The health sciences seek to resolve research problems integrating
multidisciplinary teams involving engineering skills and other physical
sciences into life sciences (SHINE, 2004). This integration is visible in the
health products development, such as devices for the application of continuous
passive motion (CPM) in the human body’s joints, such as the elbow and forearm.
These devices are used in post-operative, post-trauma of joint injuries and
cartilage avascular healing (MAVROIDIS et al., 2005) and (CALLEGARO, 2010).
According
to Gadelha (2006), developed countries that compete in better conditions with
advanced countries have associated endogenous basis of knowledge, learning and
innovation with a strong industry. Zago (2004) states the acquisition of itself
experience is essential to the planning of scientific development in health. As
a result, Brazil needs to develop national technology to be able to compete or
replace the imported technology.
Shine
(2004) emphasizes the development of new devices for health, requires, besides
multidisciplinary teams, and the costumer involvement in the value chain of the
product. Martin et al. (2006) point out the identification of needs is
important to the development of new products, when they are performed early in
the process. These needs can ensure the incorporation of new features to
prototypes with greater facility and lower cost. According to Rozenfeld et al.
(2006), needs become functional requirements of a new product and, in
accordance with Silva (2004), they contribute for the development of products
with higher quality, safety and reliability.
Andrietta
and Miguel (2002) believe the understanding the Voice of Customer (VOC), in
others words, their needs, expectations, requirements and desires is a step of
fundamental importance. It is in this stage that the VOC are translated on
technical requirements, specifications, products, processes and services. Its
understanding and exact translation can be obtained by using the Quality
Function Deployment Method (QFD Method). Cheng (2003) asserts the QFD method
seeks to coordinate the control and quality improvement, integrating them with
the market. This method is widely known and applied in the development of
several products in the world and it aims at the consensus attainment of agreed
actions in development projects to facilitate participants’ learning and
understanding.
The
involvement of customers of the product value chain in product development for
health can be understood by the systemic approach of the value chain. This
approach allows the viewing of the group of actors that integrates their
knowledge and skills to develop products focused on individuals and
organizations (KRUCKEN, 2009). Thus, the association of Customer Value Chain
Analysis tool (CVCA) to QFD can assist in innovation and consequent
creation of value to the health products. The CVCA tool helps in understanding
the business unit, product value chain and identification of critical customers
(DONALDSON et al., 2006), while the QFD method assists the requirements
management, one of the fundamental activities in the product development
process (ROZENFELD et al., 2006).
Based
in this context, the need to identify the differences between the QFD method application in relation to its
association with the CVCA tool is justified when they are used in the
development of CPM device for elbow and forearm rehabilitation. Emphasizing
differences in the identification of critical costumers of the device value
chain and business units of this product as well the demanded quality and
results of deployment of QFD matrices.
Thus,
this paper aims to present differences between the use of QFD and its association with CVCA tool in the
development of CPM device for elbow and forearm rehabilitation. The structure
comprises the following sections: (i) the literature review on the research
topic; (ii) procedures used to reach the proposed objective, (iii) results and
discussion, and (iv) study conclusions.
2.
LITERATURE REVIEW
This
section presents definitions and theoretical foundations on the development of
products in health, CVCA and QFD, which support
this study.
2.1 Product Development for Health
The
growing technification procedures for health makes this area one of the most
dynamic in relation to the absorption of new technologies produced and consumed
according to the market logic. Technological advances are related to the
introduction of information technology, modern and sophisticated devices that
benefited and allowed speed in the fight against diseases (BARRA et al., 2006).
The
device industry related to the health field is characterized by a strong
interdisciplinary content, in which the involvement of health specialists is
crucial to the making of innovations. They give a support to identify needs and
possibility of new devices, creating the first prototype and decisive
improvement in the development of the devices (ALBUQUERQUE and CASSIOLATO,
2002). Furthermore, Back et al. (2008) assert that differentiated products of high
quality are achieved primarily with the high quality of the product design,
which is only achieved with teams that integrate different and relevant
knowledge’s to product design development.
The
use of different technologies has increased in Physical Therapy as
well as the interest increasing of professionals in this
field. Physical Therapists use devices from simple to complex to
assist in the kinetic-functional diagnostics, in the
prescription, the planning, the managing, the analyzing, the monitoring and the
evaluation of treatment (WALDROP, 2003). According to Cooper et al.
(2008), the technology used to assist the physical therapeutic treatment
qualifies the therapy received by the subject and it improves his engagement
with the treatment. The computerized technology assists the patient in
performing movements that require assistance of the Physical Therapist.
Continuous Passive Motion devices (CPM) are used in the rehabilitation of
patient’s limb joints (LENSSEN et al., 2008). The use of these devices assists
the performing of passive joint movements continuously during the initial phase
of rehabilitation (HEBERT et al., 2003). A prototype of CPM device for elbow
and forearm rehabilitation can be viewed in the Figure 1 (1); Figure 1 (2)
shows how the patient positions his arm at the device.
|
Figure 1: (1) Prototype of
Computerized CPM Device for Elbow and Forearm Rehabilitation; (2) Arm
positioned on CPM. Source:
Callegaro (2010). |
Studies
about CPM devices are more advanced for lower limb joints, especially the knee
(SPERB, 2006) and (MAVROIDIS et al., 2005). But there is a demand by
professionals work in elbow and forearm rehabilitation for CPM devices to help
these joints treatment, indicating the need for researches focused on the upper
limbs (MAVROIDIS et al., 2005) and (CALLEGARO et al., 2011).
2.2 Customer Value Chain Analysis – CVCA
Value
is a concept created by the own value chain that guides each organization or
tool management, it is crucial to the survival of a business model (PETETIN et
al., 2010). Economy, intellectual capital and intangible assets are included in
the values networks of the business model knowledge (ALLEE, 2000). Miccoli
(2004) adds there are two types of influencers interfering in the life and values
of organizations: external - owners, associates (suppliers, customers, partners
and competitors), the employees' associations, trade unions and the various
audiences that surround them all; and internal – members of the organization
themselves.
When it
comes to an innovative product, values that will be created or destroyed by
it are key factors in deciding upon its release. It is, therefore, essential
the design team early in the process of product development define precisely
what types of values a business model has (PETETIN et al., 2010), as well as
parties involved in the product’s life cycle - stakeholders - and their
relationship with the product. That’s because interested parties often have
different perceptions, including when it concerns about understanding the value
assigned by project management (DONALDSON et al., 2006). The CVCA is a tool
allows, in the product definition phase, the identification in a comprehensive
manner of relevant stakeholders, relationships with each other and their role
in the product life cycle. This increases the team’s ability to recognize the
diverse requirements of the product and priorities to define the product.
CVCA
is a strategic and tactical tool, implemented from the organization’s business
model which has seven stages: i) to define the initial business model and its
assumptions; ii) to delineate the parties involved with the product; iii) to
determine how the parts relate; iv) to identify the relationships between the
parties defining flows between them; v) to analyze the resulting CVC (customer
value chain) to determine the critical customers and their propositions; vi) to
include the information in PDA (Product Definition Assessment); and vii) to use
the results of CVCA in the product project process (DONALDSON et al., 2006).
These authors state that the CVCA’s seventh stage consists in using the results
of the value network analysis for the application of other tools such as
Failure Mode and Effect Analysis (FMEA); Design for X (DfX); Quality Function Deployment
(QFD) and others.
2.3 Quality Function Deployment – QFD
Quality
Function Deployment (QFD) can be
defined, according to Akao (1996), as a method aims to establish the quality of
the project and also to obtain customer satisfaction. The complete conceptual
model, originally developed in Japan, consisted of a total of 22 matrices in 27
implementation steps, covering the deployment of four dimensions: quality,
technology, cost and reliability. Since its construction depends entirely on
the project objectives and the product nature, among other characteristics, has
the possibility to adapt it (CHENG and MELO FILHO, 2007). An example of
adaptation is the model of 7 matrices proposed by Ribeiro et al. (2001).
Particularly,
in the medical field, subject of the present study, some applications were
found as follows: i) application of the method in an approach to improving the
service offered by a podiatry clinic to relocate operations to provide services
more comprehensive and satisfactory for both physicians and patients (MAZUR et
al., 1995); ii) understanding of customer requirements and their inclusion to
continuous improvement of the quality of the services provided by the health
care system (Radharamanan and Godoy, 1996); iii) QFD employed in developing a computational network
service support for occupational therapists (HALLBERG et al., 1999); iv) method
used in the design and development of a range of simple medical diagnosis with
a high degree of precision (LIU et al., 2009); v) verification of the ability
to plan for quality in family health units, through the use of QFD (VOLPATO et
al., 2010); vi) application of QFD in order to improve outpatient services for
elderly patients (KUO et al., 2011).
Thus,
all the applications listed relate to the services sector in the medical field.
A similar situation occurs in the studies developed in Brazil, and not just in
this particular area, but in general. Sassi and Miguel (2002) have shown that
the use of QFD in Brazilian territory is more frequent in the
service sector with the goal of improving the provision of services and,
consequently, increase customer satisfaction.
3.
METHODOLOGY
This
research is characterized as a qualitative study. Based on its overall objectives,
it is classified as exploratory as it aims to provide greater familiarity with
the problem and thus make it more explicit (GIL, 2002). The definition of
methods and techniques involves the methodology used to achieve each specific
goal and, consequently, the overall goal of the research. To achieve this goal,
the study was divided into three steps. The first step consisted of applying
the proposed model, referring to the QFD method using eight matrices: quality, product,
parts characteristics, process, process parameters, human resources,
infrastructure and costs. The development of a conceptual model that integrates
the proposed CVCA + QFD tool for application in the development of health
device occurred in the second step. The proposed conceptual model was employed
fully in the third step, allowing the comparison between the methods.
3.1 First Step - Application of Adapted QFD
The
first step consisted of using a adapted conceptual QFD model from Ribeiro et al. (2001), which
employs the use of seven matrices, as follows: quality, product, parts
characteristics, process, process parameters, human resources, infrastructure
and costs (Figure 2). Instead of seven matrices, eight were applied in this
research, because the human resources and infrastructure matrix was deployed
into two, i.e. human resources matrix and infrastructure matrix. The
identification of the target population to be studied occurred prior to the
application of the matrices, and relied on the criteria of prior knowledge of
device or possible relationship to the value chain of the device in question,
according to the perception of researchers.
|
Figure 2: QFD conceptual model adapted from Ribeiro et al. (2001). Source: primary. |
3.2 Second Step - CVCA+QFD: The Proposed Conceptual Model of the CVCA Associated with QFD
A
model that integrates CVCA and QFD tools is proposed in this step (Figure 3). The
CVCA tool facilitates the identification of critical customers and carries out
analysis of the value chain.
First,
one analyzes the value chain using the steps of the CVCA. To that end, there
was an adaptation of the steps proposed by Donaldson et al. (2006), i.e. used
the first five steps that actually related to the customer's value chain. The
last two refer to the use of information obtained in the definition of product
evaluation and design process. Therefore, the steps were followed:
·
Define
the initial business model and assumptions;
·
Delineate
the pertinent parties involved with the product;
·
Determine
how the parties are related to each other;
·
Identify
the relationships among the parties by defining flows between them;
·
Analyze
the resulting Customer Value Chain to determine critical customers and their
value propositions (DONALDSON, 2006).
|
Figure 3: CVCA+QFD model
for health product development. Source: primary. |
After
identifying critical customers, the remaining steps which coincide with the
conceptual model of QFD adapted from Ribeiro et al. (2001) were
applied normally until the construction of the quality matrix.
3.3 Third Step – Application of CVCA+QFD
The
application of the proposed model CVCA+QFD in the development of a CPM machine for elbow
and forearm rehabilitation was in a medical, physical therapy, and hospital
products company of a city in the State of Rio Grande do Sul, Brazil. The
company was selected because of the developed products technologies and the
market areas provided synergies with those of the above-mentioned device.
Discourse on the results in the following section.
4.
RESULTS & DISCUSSION
This section presents and discusses the main
differences identified in the QFD application
related to its association with CVCA in the following steps: critical costumer’s
definition; demanded quality survey; demanded quality deployment, deployment of
product and its parts, deployment of process and its parameter. The
human resources deployment, infrastructure deployment and costs deployment are
not discussed because there were no differences when compared with the first
application. In other words, in the human resources matrix deployment, it was
noted in both applications the production supervisor and the process and
quality engineers play crucial roles to ensure compliance with the process
specifications. In the infrastructure matrix, cutting machines were identified
as the most important resources, because its excellence will provide quality in
the essential parts of the final product. In the costs matrix, the molding
process and the cuts finishing, assembly, polymers and fabrics cuts and
finishing had the highest monthly costs.
4.1 Critical costumers definition
The present study revealed a discrepancy between the
costumers considered critical, the association between the QFD and the CVCA
tools had an effect on the customer’s definition. The
QFD application showed the costumers were limited to what was considered direct
and indirect costumers: patient, physician and physical therapist. The
costumers list of the association between the QFD and the CVCA tools had a
considerable increase: product and process engineers, clinical and reliability
engineering department; product managers; project control department; financial
sector; product manager and regulatory affairs (Figure 4). Customers not
mentioned during the application of the QFD method were incorporated in this
second application, increasing the capacity of the project team of recognizing
diversified product requirements and new priorities. These discrepancies
allowed noticing that the QFD method refers to the meeting of the product
functionalities, while the CVCA considers the system functionalities to which
the product belongs. Thus the CVCA helps the research team in determining the
critical customers for the application of the market research that aims at
gathering data needed to define the demanded quality, the starting point for
the QFD.
|
Figure 4: Results of CVCA application to product
development in the health area. Source: primary |
4.2 Demanded Quality Survey
The primary attributes ‘aesthetics’, ‘material’,
‘components/elements’, ‘handling’, ‘ergonomics’ and ‘functions’ identified in
the QFD application were
the same in the CVCA+QFD application. Secondary attributes
differ in both applications
The QFD application shows
the attribute ‘functions’ has the greatest product’s relative importance
(22,90%), and it is deployed in ‘possible physiological range’ (5,93%),
‘assistive, active and resistive programs’ (5,67%), ‘programmable functions’
(5,42%) and ‘simple interface’ (7,17%). The attribute
‘ergonomics’ (21,50%) is deployed in ‘harmonic movements’ (7,62 %), ‘lateral
supports for alignment’ (6,03%), ‘not pose a risk to the user’ (5,72%),
‘anthropometric adjust’ (5,44%), and,
(see Table
1).
The CVCA+QFD application
shows in the secondary levels the attribute ‘ergonomics’ had the greatest
product relative importance (19,10%), deployed in ‘patient and operator safety’
(4,88%), ’effective performance’ (4,88%), ‘anthropometric adjust’ (4,78%), and
‘patient’s comfort’ (4,58%). This attribute is followed by
‘functions’ and ‘aesthetics’, both with product is relative importance of
17,90%. The attribute ‘functions’ is deployed in ‘simple and intuitive
interface’ (5,72%), ‘possible physiological amplitude’ (4,67%), ‘multiple
functions’ (4,35%), ‘applicable to various joints’ (3,67%), while the attribute
‘aesthetics’ is deployed in ‘compact and portable’ (6,62%), ‘organic design’
(4,37%), ‘innovative’ (3,88%), and ‘discrete’ (1,84%) (see Table
1).
The comparison of attributes identified in the
demanded quality in both QFD and CVCA+QFD showed in Table 1 highlights the demanded-quality importance index is
adjusted using two different factors. The first factor is
used to consider the relevance of each item, considering its importance to the
company strategy and the second factor is used to consider the company
competition position in the market in comparison to a benchmarking
organization. The result is the Demanded-quality Importance Index Adjusted
(IDi*).
Table
1 - Comparison of attributes identified in the demanded quality in both
QFD and CVCA+QFD
Source: primary
4.3 Demanded Quality Deployment
The QFD application
analysis demonstrates the main demanded qualities are ‘harmonic movements’ and
‘simple interface’, associated to ‘ergonomics’ and ‘functions’, respectively. The
least valued qualities demanded by the costumer are related to the
‘aesthetics’, and they are ‘discrete’ and ‘neutral color’. Thus, according to
the results, it’s not necessary to make great efforts towards the appearance of
the product, since this is little appreciated by the customer and will not
contribute to its further acceptance in the market.
Main demanded qualities in the CVCA+QFD application
are ‘compact and portable’ (‘aesthetic’) and ‘simple and intuitive interface’
(‘functions’). The least valued qualities demanded by
the critical customers are ‘discrete’ (‘aesthetic’), ‘easy to store’
(‘handling’), and ‘replacement parts guaranteed’ (‘components/elements’). This
application differs from the first one especially because of the fact that the
demanded quality ‘aesthetic’ was not valued (see Table
2).
The
Table
2
shows the Importance of Quality Characteristics (IQj). The intensity of the
relationship between the items of the demanded quality, the quality
characteristics and the relative importance of the demanded quality were
considered. The Index Importance of Quality Characteristics (IQj*) was adjusted
using a correction factor by assessing the difficulty of acting on the Quality
Characteristics (Dj) and a competitive assessment with respect to Technical
Characteristics (Bj).
Table
2 - Quality Matrix
Source: primary
4.4 Deployment of Product and its Parts
In the product matrix at the QFD application, it
was observed the necessity to prioritize the following parts of the product:
‘support shaft’, ‘joystick’, ‘arm support’, ‘forearm support, ‘base support’,
‘electronic system’, ‘mechanic system’ and ‘software’ (see Table 3). After the deployment and the
prioritization or the parts, characteristics of parts matrix were filled and
the greatest parts were crossed with their quality characteristics. Thus, it
was possible to identify which characteristics must be controlled in the
critical parts to provide the product quality. Through characteristics of the
parts matrix, it was observed the need to prioritize the following
characteristics of the parts of the product: ‘support shaft angle’, ‘height
adjustment’, ‘shaft thickness’, and ‘Joystick dimensions’ (see Table
4).
Differently of previous tables, the Table 3 shows the Level of Importance of the Quality
Characteristics (IPi*). It was adjusted using a correction
factor by evaluating the difficulty of making modifications and the time
required for modifications.
Table 3 - Product Matrix
Source: primary
Table
4 - Parts Characteristics Matrix
Source: primary
The CVCA+QFD application
considers the descending order of priority of the parts is as follows: ‘arm
support’ and ‘forearm support’, ‘shaft support’, ‘joystick’ and ‘base support’,
‘mechanic system’, ‘electronic system’ and ‘software’ (see Table 3). The main characteristics of parts must
be prioritized in the device development are: ‘arm support dimensions’,
‘shoulder angle adjustment’, ‘forearm support anthropometric adjust’ and ‘arm
and forearm support congruence’ (see Table
4).
4.5 Deployment of Process and its Parameters
The process matrix deploys the product manufacture
process, aiming to highlight the process associated with quality characteristics.
The following descending order of priority of the
manufacture process was identified in QFD application: ‘aluminum profile cuts’,
‘assembly’, ‘receiving components’, ‘polymers and textile cuts’, ‘steel
materials cuts’, ‘software programming’, ‘molding and finishing cuts’, ‘finishing’, ‘certification
processes’ and ‘expedition’ (see Table
5).
Table 5 - Process Matrix
Source: primary
The same processes was observed in the CVCA+QFD application,
but in the following descending prioritization order: ‘aluminum profile cuts’,
‘assembly’, ‘polymers and textile cuts’, ‘receiving components’, ‘steel
materials cuts’, ‘molding and finishing cuts’, ‘finishing’, ‘software programming’,
‘certification processes’ and ‘expedition’ (see Table 5).
The results of the process parameters matrix, which
are directly related to the process’ parameters and the stages of the
manufacturing process of the CPM device under study, differed especially in the
order of importance of four parameters when both QFD and CVCA+QFD
applications are compared. In other words, after the matrix
deployment it was observed, in the first application, the following descending
order of importance of process parameters: ‘cut dimensions’, ‘components
positioning’, ‘cutting angle’, ‘number of failures/lack of compliance’,
‘quality of the received components’, ‘possibility and time of programming’,
‘molding angle’, ‘percentage of on-time deliveries’, ‘ANVISA’s evaluation
result’, ‘programs storage capacity’, ‘shipping time (logistics)’ and
‘percentage of well packaged device’, respectively (see Table
6).
The second application had an exchange of order between ‘cutting angle’ and
‘number of failures/lack of compliance’, and between ‘possibility and time of
programming’ and ‘molding angle’ (see Table
6).
Table
6 - Process Parameters
Matrix
Source: primary
Table 6 - Process Parameters Matrix – cont.
Source: primary
5.
CONCLUSION
This study aimed to present the differences between
the use of an adapted method of QFD (compound of
eight matrices) and its association with CVCA tool in the development of a CPM
device for elbow and forearm rehabilitation.
Results allowed the identification of a discrepancy
between the critical costumers and differences in the demanded quality attributes,
as well as its prioritization. The importance of the product value
chain analysis in a systematic way can be highlighted, considering all the
involved parts in the development of a CPM device, besides the ones determined
by the researchers themselves.
The differences of the applications allowed noticing
that the QFD method refers to the meeting of the product functionalities, while
the CVCA considers the system functionalities to which the product belongs. Thus
the CVCA helps the research team in determining the critical customers for the
application of the market research that aims at gathering data needed to define
the demanded quality, the starting point for the QFD. Thus, the proposed
association between the CVCA+QFD methods was effective to identify needs of all
process costumers, incorporating them in the product design and production
process.
Such association can modify even the subsequent steps,
such as the matrices of quality, parties and characteristics of the parts, for
the prioritization of requirements can be differentiated, as observed in this
study. The impacts are felt in the subsequent process and QFD
resource matrices, equally. That is in reason of the distinct perceptions of
the interested parties, including the understanding of the value assigned to
the project. Although an exploratory study, the CVCA not only allowed this
joint project but also reduced the complexity by highlighting the elements that
represent value for stakeholders from the business model of a given organization.
This comparison was done in the product development
process of one device specifically. The integration of
the two methods and this same methods comparison are suggested for future
studies, especially to those that aim the product development for health area,
in order to confirm these results and detail more its impacts on the product
project and its value network for different products.
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