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Medical device
Quality and continuous manufacturing
improvement in medical
device manufacturing
541
Alan Brown
Northern Ireland Bioengineering Centre (NIBEC),
University of Ulster, Newtownabbey, UK
Julie Eatock
School of Information Systems,
Computing and Mathematics, Brunel University, Uxbridge, UK, and
Dorian Dixon, Brian J. Meenan and John Anderson
Northern Ireland Bioengineering Centre (NIBEC), University of Ulster,
Newtownabbey, UK

Abstract
Purpose – The purpose of this paper is to compare a range of quality and continuous improvement
strategies and to investigate whether there is a best choice of strategy for use within the medical
devices sector.
Design/methodology/approach – A brief literature-based review of a number of continuous
improvement strategies. Comparison of these strategies and a subsequent discussion of the rationale
that guides the choice of strategy based on the prevailing conditions. An overview of this process in
the context of the medical devices sector is provided.
Findings – Quality and continuous improvement strategies can be differentiated in terms of their
cultural or process focus. Moreover, the favoured leadership style of an organisation may play a part in
determining which strategies are likely to be most appropriate. From the medical device and
healthcare product perspective, regulatory and purchasing considerations will have a role in
determining the strategy adopted.
Practical implications – For managers seeking to implement a strategy for continuous
improvement, a review of organisational leadership styles may help the decision –making process.
For the medical devices sector, in particular, the need to align the strategy adopted with
regulatory requirements is perhaps self-evident. However, only by a detailed understanding of the
issues involved in continuous improvement, can all of the attendant benefits be gained.
Originality/value – The paper proposes a link between a given organisation’s favoured leadership
style and the applicability of a particular continuous improvement strategy. The implications for the
medical device and healthcare technologies sector are specifically addressed.
Keywords Total quality management, Six sigma, Lean production, Leadership, Medical appliances
Paper type Research paper

The TQM Magazine

The authors acknowledge Dr Michael Craven at the University of Nottingham who designed the Vol. 20 No. 6, 2008
in-depth interview instrument and all MATCH colleagues who conducted interviews. The pp. 541-555
q Emerald Group Publishing Limited
authors acknowledge support of this work through the UK MATCH Programme (EPSRC Grant 1754-2731
GR/S29874/01), although the views expressed are entirely their own. DOI 10.1108/17542730810909329
TQM Introduction
20,6 The medical device sector
This research has been carried out as part of the UK Multidisciplinary Assessment of
Technology Centre for Healthcare (MATCH). MATCH is an EPSRC innovative
manufacturing research centre (IMRC), which aims to improve the processes by which
healthcare technologies are brought to the market. Through this research, evidence has
542 emerged that suggests that the implementation of continuous improvement strategies
is not as widespread as expected within the sector. Through in-depth interviews with
medical device manufacturers, MATCH researchers have noted that larger medical
device companies tended to make more use of strategies like total quality management
(TQM), six sigma and lean manufacturing, while smaller or newer organisations
tended to have a much stronger focus on the appropriate regulatory approval process.
This focus on regulatory compliance, the associated medical device quality
management standards and the difficulty in making changes once a product is
approved (Brown et al., 2007), may limit the implementation of quality and continuous
improvement strategies in this sector, especially in smaller and newer organisations.
In addition, in a recent benchmarking survey of new product development in the
medical devices sector undertaken by the authors Brown et al. (2008), the use of
strategies and tools associated with quality and continuous improvement in the medical
devices sector are lower than those reported elsewhere. For example, 30.4 per cent of
respondents indicated that they used TQM, with a further 16.1 per cent indicating
limited use. This compares with reported levels in the automotive industry of 54 per cent
(Ahire et al., 1995) and in information services of 71.5 per cent. Figure 1 shows the level of
use of different strategies and tools as reported in this survey.
Within the medical device manufacturing environment, probably the most important
regulatory frameworks are those applied by the Food and Drug Administration (FDA) in

Figure 1.
Bar chart showing the
percentage of respondents
to the MATCH NPD
benchmarking survey who
used NPD and continuous
improvement tools
the USA and the European Commission via the Medical Device Directive (MDD) system. Medical device
The manufacture of medical devices is normally carried out under the associated quality manufacturing
systems, i.e. the FDA quality system regulation (QSR) or ISO13485. These standards
emphasise conformance to a given specification rather any form of continuous
improvement. For example, the continuous improvement section within ISO9001 is not
part of the medical device specific version, ISO13485. This paper considers how medical
device companies might best respond to the need for continuous improvement in the 543
light of the requirements of regulation and procurement.

Continuous improvement
Continuous Improvement is used in organisations of all types and sizes worldwide,
from mass manufacturers to public sector organisations. As far back as the 1930s,
Shewhart (1986) suggested a repeated cycle of plan-do-see for continual improvement.
This approach has been well documented, and is called both the Deming wheel and the
Shewhart cycle and forms the basis of many continuous improvement activities that
are practiced currently.
During the Second World War, the training within industry service (TWI) in the
USA contributed greatly to the development of continuous improvement. The TWI
introduced “Job Methods” for process improvement, with a four-step cycle comprising:
break down the job – question every detail – develop the new method – apply the new
method. The TWI methods were exported to Japan in the post war period and the “job
method” of TWI has been described as the father of Kaizen (Huntzinger, 2002).
Two strands of continuous improvement are common, continuous productivity
improvement, including lean thinking and the theory of constraints, and continuous quality
improvement, including TQM and six sigma. A comparison of these well-established
approaches, including how they differ in terms of their implementation, is considered here.
Whether it is possible to choose a “best” strategy for a given situation is of key
consideration.

Continuous quality improvement

Quality improvement in operations and production has been one of the most significant
influences on worldwide manufacturing in the last 50 years. The most spectacular result
of its application can be seen in the rise of Japan as a powerful manufacturing economy.
In addition to quality benefits, other business benefits are noted as a direct result of quality
improvement strategies (Elshennawy et al., 1991) including improvements in work flow
and productivity (Feigenbaum, 1991; Pande et al., 2000).

Quality management standards

The development of a standardised methods of quality assurance led to the original
ISO9000 series of standards. In more recent versions of these standards, such as
ISO9001:2000, the specific reference to quality assurance has been removed and the
statement made that the goal of a quality management system must involve enhancing
customer satisfaction. (British Standards Institute, 2000). The ISO 9000 standards may
therefore now be the first exposure that a company gets to the principles of continuous
improvement.
The healthcare technologies sector has additional quality standards, which can be
required for regulatory approval. ISO13485:2003 and the FDA quality system regulation
TQM (21 CFR 820) being the most prevalent. These standards emphasise compliance with
20,6 customer requirements rather than satisfying the customer (British Standards Institute,
2003). Within this sector then, the use of quality standards does not necessarily point the
way to continuous improvement, as might be the case in other sectors.

Total quality management

544 While there is some debate on exactly what constitutes TQM (Hellsten and Klefsjo,
2000), most authors agree that it is a “people-focused, organisational-wide philosophy
aimed at improving customer satisfaction while reducing costs through a continuous
improvement regime” (Cua et al., 2001; Geraedts et al., 2001; Hashmi, 2003).
As well as the obvious emphasis on creating an empowered quality culture, TQM is
associated with a large array of tools and techniques that are used to reduce variation
and make improvements to a process. As such TQM can be defined as having both
mechanistic and cultural approaches (Spencer, 1994; Wilkinson et al., 1997). It is
possible to implement the mechanistic, or process focused aspects of TQM without
major changes in the organisational culture, but doing so may be missing the point.
In the case of medical device manufacturing, TQM is more often utilised by larger
companies. Effective TQM implementation may support the process of compliance
with regulatory quality standards, but will not be able to replace the externally
required systems, such as ISO13485:2003 of the FDA quality system regulation.

Six sigma
Six sigma started as a quality improvement programme in Motorola, who had an
existing TQM programme. The term “six sigma” refers to the goal of having a process
specification which is at least six standard deviations (sigma) from the target value
resulting in fewer than 3.4 defects per million (Bhote, 2002; Pande et al., 2000). The focus
on defects makes it more amenable to use in volume manufacturing, but there have
been successful implementations of six sigma outside this field.
As a process improvement method, six sigma is largely mechanistic or process
focused (McAdam and Lafferty, 2004). The tools used within six sigma have use in
many areas of manufacturing (Dixon et al., 2006), but it can also have a cultural
dimension in applying a system of business improvement (Ehie and Sheu, 2005). It has
its own system of maintaining expertise in the use of a martial arts grading system of
Yellow Belts, Green Belts, Black Belts and Master Black Belts. This system promotes
centralised knowledge, although not in a hierarchical arrangement, rather than having
the quality expertise distributed throughout the system.

Continuous productivity improvement

As with the quality improvement strategies, continuous productivity improvement
aims to enhance business practices, but starts from a position of improving the
productivity of the operations. Secondary benefits of these strategies include improved
quality and customer satisfaction (Hobbs, 2004; Nave, 2002).

Just-in-time and lean thinking

Lean thinking is an extension of the ideas of just-in-time (JIT). JIT is a method of
production control that aims to deliver the output of an operation at the precise time
that it is required by a customer or a subsequent process. The result of this is that
buffer stocks are eliminated and the production process runs with the minimum of Medical device
waste (Cua et al., 2001; Vuppalalati et al., 1995; Womack and Jones, 2003). manufacturing
The goal of lean thinking is to optimise a process by eliminating waste. This
approach includes looking beyond the production plant to suppliers and customers
(Womack and Jones, 2003). In lean thinking the value of an item is explicitly based on
the customer’s perception of value, and therefore anything that does not add value to
the customer is seen as waste (Phillips, 2000). The involvement of all staff distributes 545
knowledge and helps to empower employees to change the processes at source. Lean
thinking takes a system wide view and tries to create a culture that enables a move
towards an optimised system of production.
Overall, while lean thinking focuses on productivity and the flow of the process, it also
has secondary effects including improved quality and reduced costs. Given the focus that
lean thinking has on the production process and on streamlining these, it is clearly directly
applicable to Medical Device companies. While, there are obvious constraints associated
with the sector, for example the need to engage with appropriate routes to regulatory
compliance, these can be accommodated within a Lean organisation.

Theory of constraints
The Theory of Constraints (TOC) aims to optimise production by maximising
throughput. It is based on the principle that a chain is only as strong as the weakest
link. As a consequence, TOC aims to identify the weak link, or constraint, and to then
elevate and manage the constraint as necessary. It uses a five-step focusing process
(Ehie and Sheu, 2005; Goldratt and Cox, 1993; Keller, 2001; Simatupang et al., 1997)
as follows:
.
identify the constraint;
.
decide how to exploit the constraint;
.
subordinate everything else to the above decision;
.
elevate the constraint; and
.
repeat the cycle.

This repetition of the process on the next constraint in turn means that TOC is a
strategy of targeted continuous improvement. This strategy is methodological in
nature and focuses on the process rather than on creating a specific organisational
wide culture (Nave, 2002).
TOC can, therefore, be readily adopted by medical device manufacturers. Indeed
TOC may add significant value to companies within the healthcare technologies sector.
For example, the need to ensure regulatory compliance can be seen as a constraint
within the process and dealt with such that it becomes a stronger link without affecting
other parts of the overall product development cycle.

Direct comparison of strategies for effective continuous improvement

Table I provides a summary of the aspects of the major strategies that have been
discussed above. The ISO9001:2000 (Gotzamani and Tsiotras, 2001) and JIT strategies
can be considered as starting points in implementing continuous improvement
strategies. The more comprehensive strategies of TQM, six sigma, lean thinking and
the Theory of Constraints are then the focus of much of the following discussion.
 20,6

546
TQM

Table I.

strategies
Comparison of
continuous improvement
TQM Six-sigma Lean thinking Theory of constraints

Goal Improve organisational Maximise business success Maximise productivity Continuous profit improvement
performance and quality (Hunt, (Pande et al., 2000)
1993)
Primary focus Quality culture Systematic reduction in variation Minimise waste Minimise constraints
Secondary Customer satisfaction Cost reduction Reduced variation Less inventory/waste
effects Cost reduction Productivity improvement Improved quality (Nave, 2002) Improved quality (Nave, 2002)
Employee empowerment Cycle time reduction Reduced cycle time Continuous improvement
Reduction in bottlenecks Culture change (Pande et al., Increased flexibility
(Feigenbaum, 1991) 2000) Productivity improvements
(Hobbs, 2004)
Knowledge All employees contribute, leading Yellow belts through to master Knowledge is distributed as Knowledge is centralised and
distribution to distributed knowledge black belts. Knowledge is reduction in waste is the focused on constraints
Broadly focused training centralised with experts responsibility of all employees
Training is narrowly focused

Process Large toolkit available Dominant aspects Uses JIT workflow Dominant aspects
aspects Statistical tools similar to six Specific statistical tools management Specific accounting metrics
sigma Technical terminology Process optimisation Systematic focus on constraints
Specific structure of experts
Culture Dominant aspects Cultural aspects of six sigma Dominant aspects Requires a change in approach
aspects Employees empowered come from the process aspects Culture of minimum waste Extends into all parts of
Change philosophy Similar philosophy to TQM Emphasis on continuous business
Focus on customers improvement
(continued)
 TQM Six-sigma Lean thinking Theory of constraints

Criticisms Difficult to implement in SMEs Creates elite employees Does not value statistical Minimal employee input (Nave,
(Aspinwall and Yusof, 2000) analysis (Nave, 2002) 2002)
A “Fuzzy” concept Stifles creativity (McAdam and Narrow focus on waste Can ignore parts of the
Lack of clear goals (Pande et al., Lafferty, 2004) organisation
2000) Difficult in non-manufacturing
operations
Leadership Empowering Directing Empowering Directing
style
Targets Entire organisation Specific projects All waste throughout system Constraint (one at a time)
Assumptions Figures and numbers are valued Waste removal improves Speed and volume are
Output improves if all variation business performance (Nave, important
is removed (Nave, 2002) 2002) Existing systems are OK
Processes are interdependent
(Nave, 2002)
manufacturing
Medical device

547

Table I.
TQM In terms of benefit to a Medical Device company, whether one strategy is better than another
20,6 is not easy to determine. With lean thinking, TQM, six sigma and TOC, there have been
reports of successful implementations of these strategies that have improved organisations
competitiveness (Aspinwall and Yusof, 2000; Bhote, 2002; Pande et al., 2000; Stein, 1997).
Similarly, each has its own supporters within the business and academic world.
One of the means by which the strategies can be differentiated is to consider
548 whether they focus on mechanistic, process issues or in establishing a specific
organisational culture (Spencer, 1994). All of the strategies considered here have both
process and cultural elements, but TQM and lean thinking start from the premise that
cultural change is requirement for their successful implementation, while six sigma
and TOC start from the perspective of getting the right processes in place at the outset.
On the basis of details presented above, differences between these continuous
improvement strategies can be viewed in terms of where they fit on planes described
between focus (culture or process) and productivity versus quality as shown in Figure 2.

Combining strategies
Combinations of strategies have been reported in the published literature. Lean
thinking with six sigma (Arnheiter and Maleyeff, 2005; Keller, 2001; Kubiak, 2003;
Snee, 2005), six sigma with TOC (Ehie and Sheu, 2005; Keller, 2001) and TQM with
TOC (Simatupang et al., 1997; Stein, 1997) have all been discussed.
The combination of lean thinking and TQM may be problematic because both of
these strategies emphasise cultural change. Attempting to implement two cultures will
often be difficult. The same is not true of process-based strategies, as it is possible to
use multiple tools, strategies and processes within the same organisational culture and
value set.
As an example from the authors’ experience, a medium sized medical device
manufacturer was engaged with both lean thinking and six sigma, however, the
dominant system in the day-to-day running of the organisation was the FDA Quality
System Regulation. The application of six sigma was less thorough than in other
organisations that the authors have observed, and highlights both the difficulty in
effectively applying more than one strategy at the same time, and the additional
regulatory restrictions that apply to medical device manufacturers.

Figure 2.
A graphical representation
of continuous
improvement strategies by
focus and primary effect
Is there a best option? Medical device
The difference between a cultural and a process perspective in these continuous manufacturing
improvement strategies and a difference between a quality focus and a productivity
focus can be seen in Figure 2. It is likely that these differences will influence the choice
of strategy for a particular organisation.

Quality versus productivity 549

The decision to embark on either a quality improvement programme or a productivity
improvement programme is not a straightforward one. It is clear that for any
organisation to be successful it must be actively improving both quality and
productivity, and so elements of both need to be included. All of the strategies outlined
report benefits to both quality and productivity, see Table I, so perhaps it is the focus
of the strategies that will be a better starting point for deciding on a best strategy.

Cultural versus process focus

The difference in focus of a strategy may be the most significant factor in deciding
which strategy to employ. A strategy with a cultural focus will require a more
empowering form of leadership and an ability and willingness to distribute knowledge.
A strategy that has a process focus will generally be easier with a more directive form
of leadership, in that this approach has to communicate and initiate new procedures
and processes, and to ensure that these are implemented effectively. The result will be
more centralised knowledge that requires staff to be trained so that they are competent
in the methods that are to be used.

Leadership
The commitment of management is vital to the success of all continuous improvement
strategies (Henderson and Evans, 2000; Klefsjo et al., 2001). How the programme is
implemented, managed and led is one of the most critical factors in success (Samson
and Terziovski, 1999) or failure (Tatikonda and Tatikonda, 1996). The requirements for
leadership differ between these strategies as summarised in Table I.
There are several models of effective leadership. One of the more well known is the
Situational Leadershipw model. Blanchard and Hersey (Blanchard, 1991; Hersey et al.,
1996) characterised leadership style as points on axes of supportive behaviour and
directive behaviour, as shown in Figure 3.
Generally leaders will use all of these styles in different situations, but most tend to
have a favoured leadership style. Blanchard extended the model to suggest that the
most appropriate leadership style will depend on the person being led (Blanchard,
1991), suggesting four levels of development (D1 to D4) for the follower, as shown in
Table II.
Development levels are also situational. One person may be D1 in one area of work,
but D3 in another. The model suggests that the leadership style should be adjusted
depending on the development level, i.e. S1 with D1, S2 with D2, etc. In this model, the
follower, when faced with a new task, is likely to be at development level D1. As the
task becomes more familiar and an individual becomes more motivated, they progress
through the stages D2-D4, and the leader should adopt a different style of leadership to
reflect the development level attained.
TQM
20,6

550

Figure 3.
Situational leadership
styles

D4 High competence Experienced at the job, and comfortable with their own ability to do it well.
High commitment May even be more skilled than the leader
D3 High competence Experienced and capable, but may lack the confidence to go it alone, or the
Variable commitment motivation to do it well/quickly
D2 Some competence May have some relevant skills, but won’t be able to do the job without
Table II. Low commitment help. The task or the situation may be new to them
Situational leadership D1 Low competence Generally lacking the specific skills required for the job in hand, and lacks
development levels Low commitment any confidence and/or motivation to tackle it

When applied to the implementation of a continuous improvement strategy, the major

issues that affect organisational development level will be the balance of distributed
versus centralised expertise and the level of empowerment of the staff. Organisations
where expertise is centralised will be more comfortable with leadership that is more
directing, while an empowered workforce will respond better to supportive leadership
styles. A modified version of the development levels is shown in Table III.
Again these development levels are situational, an organisation may have distributed
expertise in quality, but centralised expertise in maintenance or human resources.
Likewise, managers in different parts of the organisation will have different preferred
leadership styles. In these circumstances, managers with preferred leadership styles
that are directive in nature will probably favour a continuous improvement strategy that
is process focused, while those who favour more supportive management styles might

D4 Distributed expertise
High empowerment
D3 Distributed expertise
Table III. Variable empowerment
Organisational D2 Mainly centralised expertise
development levels in the Low empowerment
context of continuous D1 Centralised expertise
improvement Low empowerment
Common understanding, values and motivation. Less likely within
larger organisations
Common values and experience. Leadership maintains focus and
continues change
Some common knowledge and values. Leaders set direction with
some employee involvement
Demarcated responsibilities, limited shared values. Specific
direction and control needed
prefer a culturally focused strategy. Spencer (1994), in an analysis of TQM suggested Medical device
that managers more comfortable with mechanistic concepts prefer the mechanistic manufacturing
approaches, while managers who are “systems thinkers” are more comfortable with the
cultural aspects.
As an example, we consider here six sigma and TQM. Six sigma, with a process focus
and centralised expertise, fits more comfortably with a directive leadership style, i.e. the
bottom right region in Figure 4. Black belts might be in the “delegating” region, as 551
knowledge and motivation are high with these staff. Other parts of the organisation will
require different styles of leadership. As the organisation becomes more familiar with six
sigma, the range of development levels will extend towards the top left, with knowledge
then becoming more distributed and the six sigma programme becomes more “cultural”.
TQM on the other hand, fits with a more supportive leadership style, due to its
emphasis on culture and distributed expertise, i.e. the top left region in Figure 4. Again,
there will be areas within any organisation which reflect different levels of motivation
and knowledge, but the emphasis for management will be on supporting employees
and leading cultural change. As the culture is established, relevant techniques and
systems will develop, requiring some more directive leadership and an extension
towards the bottom right region of Figure 4.

Implications for medical device manufacture

Within medical device manufacturing, the influence of the regulatory and procurement
environments mean that quality assurance and ensuring that processes do not
change will be critical. The tools and strategies that are applicable in these
circumstances will be those, such as statistical process control (SPC) and failure modes
and effects analysis (FMEA), which aim to reduce variability and risk. This would
suggest more of a “process approach” rather than a “cultural approach” to continuous
improvement.
Within other areas of the medical device organisation, such as in R&D, marketing or
clinical assessment, regulatory requirements do not result in the same restrictions on
the ability to make process changes. In these other areas medical device manufacturers
can therefore make use of the more cultural approaches to continuous improvement,
with strategies such as TQM and lean thinking facilitating greater empowerment

Figure 4.
Mapping a strategy’s
focus to the situational
leadershipw model
TQM and knowledge distribution. An organisation that can continuously improve the
20,6 quality and effectiveness of its research, product development, clinical assessment and
marketing processes will make better products more quickly and more cost effectively.
Smaller companies find it more difficult to implement different cultures in different
parts of the organisation than large multinationals. As a result they may be more
limited in their ability to implement culture focused continuous improvement
552 strategies, but should be able to implement the more process focused strategies, such
as six sigma and TOC in the first instance.
Despite the issues surrounding continuous improvement strategies in the
manufacture of medical devices, it remains essential that manufacturers persist with
continuous improvement in all areas of the business. In particular, it may be in the
areas that surround the development of new products where these strategies might be
most effectively utilised, enabling manufacturers to effectively compete globally
within the constraints that they face. Moreover, such an approach will ultimately
benefit patients, in that improved devices will result in better clinical outcomes.

Conclusions
This paper has considered both quality improvement and productivity improvement as
being related but distinct approaches to continuous improvement. TQM and six sigma
have been considered as typical quality improvement strategies and lean thinking and
the TOC as productivity improvement strategies. Within the area of medical devices, it is
noted that the quality standards, such as ISO13485:2003 de-emphasise continuous
improvement when compared with the general ISO9001 standards, suggesting that
continuous improvement can be problematic in the context of regulatory processes.
In comparing the applications of the strategies discussed, two distinct emphases are
observed. One focuses on a discrete process approach using structured programmes.
The other focuses on creating an organisational culture that directs the efforts of
employees. In this regard, six sigma and the TOC are largely process focused, while
TQM and lean thinking are largely culturally focused. While it is noted that this
categorisation is a somewhat simplified view of how these strategies are implemented
in real world situations, the ethos of the strategies can be clearly seen.
When choosing to implement a strategy for continuous improvement, leadership is
critical to success. The situational leadershipw model has been adapted and can be
used to indicate whether a cultural or process focused approach might be more
appropriate in different situations. This approach considers how “empowered”
a workforce is and how the expertise is distributed within an organisation in order to
determine what style of leadership is most appropriate and therefore which continuous
improvement strategies might work better.
It is suggested that organisations where the expertise is centralised and where
a more directive leadership is used will find process focused strategies easier to
implement, while organisations where expertise is distributed and leadership is
more supportive will find cultural strategies more appropriate. A review of the
organisation’s development level and the preferred leadership style of management
will help the organisation to choose a strategy that requires a minimum jump from the
current state of the organisation onto the path of continuous improvement.
Research indicates that, whereas larger companies within the medical devices sector
do apply continuous improvement methods, many of the small and medium size
(SME) companies do not. It is suggested that this is because the focus of engaging with Medical device
the regulatory and procurement processes provide a perspective that is more aligned manufacturing
with meeting specific requirements rather than making changes associated with
continuous improvement. The information provided in this paper suggests that that a
company can engage with continuous improvement in the right areas of its
organisation, the effects on new product development could be significant.
553
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Corresponding author
Alan Brown can be contacted at: a.brown@ulster.ac.uk

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