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Anaesthetic mouthpiece development through

QFD and customer interaction with functional


prototypes
G.J. Booysen, L.J. Barnard, M. Truscott and D.J. de Beer
Central University of Technology, Bloemfontein, South Africa

Abstract
Purpose The paper reflects on the development of a medical product using rapid prototyping technologies and customer interaction through a
quality function deployment (QFD) approach to speed up the process, and to result in customer satisfaction. The purpose of the specific medical product
was to develop a device for fixing an Endo-tracheal (ET) tube in a patient during anaesthesia, as it is common for an ET tube to move and/or become
dislodged due to various extraneous reasons. If the tube deviates from the correct position it can cause one or both lungs to collapse, which can be
fatal. The paper reviews how the anaesthetists idea, which was to develop a product that could hold an ET tube in place in a more secure manner than
is possible with current technologies, was brought to fruition through customer interaction.
Design/methodology/approach Using an action-research approach, the design evolved through series of design concepts, which through
customer interaction contributed to a total optimized design. Virtual and physical prototypes, together with silicone mouldings were used as part of the
customer interaction.
Findings As with any new product, some functional parts were needed to conduct tests, which in turn would help to prove the product, and hence,
the design. Traditionally this meant the manufacturing of a hard tool and proving of the design through trial and error. Hard tooling allows for some
small changes to be made, but if the changes are radical a new tool will have to be designed and manufactured.
Research limitations/implications Following a developmental approach through the application of various types/stages of prototyping (such as
virtual prototypes), revolutionised this process by simplifying and accelerating the development iteration process it also developed a new version/
paradigm of QFD.
Practical implications Opposed to traditional forms of QFD where customer inputs are gathered through questionnaires, this case study proved that
functional models provide an efficient client-feedback, through constant involvement in the development process, as well as evaluation of the
systematic progress.
Originality/value The case study shows that experts in other disciplines can become involved in the product development process through the
availability of functional prototypes, and builds on previous work to introduce a concept of customer interaction with functional prototypes.

Keywords Rapid prototypes, Quality function deployment, Design, Medical equipment

Paper type Research paper

1. Introduction quality function deployment (QFD) are aimed at propagating


the voice of the customer throughout the entire new
1.1 Management of the product development process product development (NPD) process and have been shown to
Product development can be of a high technical nature, and produce tangible benefits. At each stage of the process, the
has traditionally been executed in a time-consuming, customer requirements are re-interpreted into desirable
sequential approach. Most companies are not organised to design outcomes related to the specific tasks at hand.
make a meaningful reduction in the product development Effective use of such techniques eliminates aspects such as
cycle time. Last-mentioned is in general viewed as the heart of over the wall engineering and result in a streamlined
the information assembly line, and has tremendous potential product development process, which in turn increases R&D
for improvement. Concurrent engineering (CE), solid efficiency and thereby lower the cost and time for a certain
modelling, reverse engineering (RE), rapid prototyping (RP) amount of work. Better processes lead to reduced scrap and
and other related processes may streamline the product rework, earlier and fewer prototype design cycles, and
development process. However, all of these factors need good therefore shorter time to market. This in turn, influences
management practices to produce results. CE tools such as the volume of sales and production (De Beer, 2001).

The current issue and full text archive of this journal is available at 1.2 Determining the customers needs
www.emeraldinsight.com/1355-2546.htm The aim of the study was to develop and prove the new
product before committing to manufacturing within the

Rapid Prototyping Journal


12/4 (2006) 189 197 Received: 16 November 2005
q Emerald Group Publishing Limited [ISSN 1355-2546] Revised: 28 February 2006
[DOI 10.1108/13552540610682697] Accepted: 9 May 2006

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Anaesthetic mouthpiece development Rapid Prototyping Journal
G.J. Booysen, L.J. Barnard, M. Truscott and D.J. de Beer Volume 12 Number 4 2006 189 197

normal boundary conditions such as the shortest possible including resins, waxes and low melting point alloys. The
development time and lowest possible costs. In opposition main use for silicone or room temperature vulcanisation
with many new products that are developed and based on a (RTV) tooling is in the manufacture of cavities for two-part
perceived need, this idea started from the customer, focussing resin casting. However, irrespective of down-stream
on a specific need. It is common for an Endo-Tracheal (ET) application, manufacturing of silicone cavities rely on a
tube to move and/or become dislodged due to various master-pattern from which copies are replicated.
extraneous reasons, when a patient is intubated during Vacuum casting resins are currently available to mimic a wide
anaesthesia. If the tube deviates from the correct position it variety of production polymers including ABS, filled nylon, heat
can cause one or both lungs to collapse, which can be fatal. It resistant acetyl and a simulation of rubber. Tool life is
is therefore very important that the ET tube remains in the dependent on both the complexity of the cavity and the resin
correct place. The anaesthetists idea was to develop a used in the casting process. A typical cavity may last between 10
product that could hold an ET tube in place in a more secure and 20 replications before severe degradation of the silicone.
manner than is possible with current available technologies. This degradation is a result of a chemical reaction between the
The process started with discussions between the product casting resins and the silicone. After a few castings the surface of
development team and the customer, based on a rough wire the cavity inside the mould may be damaged to such an extent
and fibre-glass prototype, made by the customer. that the part cannot release, and the manufacturing of a new
mould is necessary (Anonymous, 1997).
1.3 Applying time compression technologies (TCT) Once the product design is evaluated and accepted, a single
Both in South Africa, as well as internationally, RP cavity injection mould is manufactured using the rapid mould
technologies are being used more and more with a very high manufacturing protocol. This mould needs to produce 30,000
success-rate in medical product development. Campbell and products/month. For this specific product, the total
De Beer (2005), Gibson et al. (2006) and De Beer et al. development consisted of a series of iterations entailing 10
(2005) discuss various applications of RP to aid in CAD designs, six prototypes (grown with the SLA process),
visualisation, the preparation of medical implants for and six different silicone moulds made to cast the different
reconstructive surgery, as well as patient-unique geometry products, using the vacuum casting process.
development.
For the development of the anaesthetic mouthpiece, the solid
modelling was done with Solid Edge, with stereolithography
2. Results
(SLA) and laser sintering (LS) as the available prototyping 2.1 Design evolutions
technologies. These were backed by conventional and high The design process followed an evolutionary approach with
speed CNC machining (HSM), together with vacuum casting many iterations involving the client. Throughout the process
and reaction injection moulding (RIM) technologies as limited the main aims of design improvements were:
production options. The RP phase would be used to facilitate .
patient comfort: the airway clamp rubbed on the patients
the bridge between design and the manufacturing of functional gums;
parts in limited quantities through a silicone mould (soft .
more secure clamping was needed on the ET tube; and
tooling). Rapid manufacturing (RM) options like vacuum .
design changes to make the manufacturing of an injection
casting or the RIM process were used to produce functional mould simpler and cheaper, and in parallel, to decrease
parts for testing and evaluation of the product in epoxy materials the cycle time to make the unit price more competitive.
that resemble the required (final) engineering material. Finally,
a hard tool was needed to deliver the demanded product Successive design iterations are now described in detail.
volumes. The manufacturing of the hard tool could only 2.1.1 Design evolution 1
commence once assurance could be given that no alterations to The client approached CRPM with a fibre-glass prototype,
the product, and hence, the hard tool would be necessary after attached to each other by wire. The wire was also meant to keep
completion, which furthermore implied that the customer had the pipe in position. The anaesthetists idea was that that the
to be satisfied with the product or that the product had to be patient be put onto the bed first, where after the mouthpiece is
proved. placed into the patients mouth and to then only install the pipe.
To enable physical testing of the mouthpiece, rubber Plate 1 shows the anaesthetists mock-up of the products first
prototypes were needed. The only option for the development concept. Interpreting the mock-up design, the first digital
team was through the process of vacuum casting, which concept, as shown in Plate 2, was developed for virtual
necessitates a high quality surface finish to ensure smooth inspection by the anaesthetist, taking his feedback into account.
surfaces of the cast products. Since, the SLA process offers a It was meant to attach a pipe in the centre, as well as a smaller
smooth surface finish, it was the preferred prototyping pipe on its side, by means of a loose bracket. Pipes with inner-
method for the development. The LS process does however, diameters of 7 to 15 mm would be used. Based on the
offer lower part production prices, but due to a rough surface observations made by having a virtual prototype (VP), the client
finish, the required sanding and polishing of the prototype could immediately suggest further changes. The space between
would be time-consuming and costly. Table I shows some of the front and back lips was decreased, and the wall of the back lip
the advantages and disadvantages of LS and SLA that were was raised to ensure that it pressed against the pallet. A process
considered in the selection of a process for the development of designing in CAD (Solid Edge), for inspection by the client,
under discussion (Anonymous, 1997). was followed.
1.4 RM process used in case study vacuum casting 2.1.2 Design evolutions 2 and 3
Silicone tooling is the most common technique for part Plate 3 shows the development of a second design,
replication, and can be used to supply a wide range of material incorporating observations made through evaluation of the VP.

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Anaesthetic mouthpiece development Rapid Prototyping Journal
G.J. Booysen, L.J. Barnard, M. Truscott and D.J. de Beer Volume 12 Number 4 2006 189 197

Table I Advantages and disadvantages of SLA and LS


SLA LS
Advantages Disadvantages Advantages Disadvantages
Good surface finish can be Models need support structures that No post-curing of the parts is needed, Surfaces of the parts are porous, and
sanded/polished to required must be removed as a finishing unless they are ceramic surface finish can be poor
surface finish operation
Complex geometry easily Parts can warp, especially with Parts can often be built without Process machines can take a long
obtained acrylate resins additional support structures time to heat up and cool down
Resins are hazardous and need
careful handling Investment casting requires the
Generally there is good accuracy Some types of resin parts are more Parts in a range of materials can be surface of master parts to be sealed
of the geometry brittle obtained directly Parts can warp significantly
Source: Rapid Prototyping Workshop (1997)

Plate 1 A mock-up of the products first concept, as done by the Plate 3 Development of a second design, incorporating observations
Anaesthetist made through evaluation of the VP

Plate 2 Digital interpretation of the mock-up design, to produce the


first concept
.
grow a SLA prototype;
. make a RTV mould; and
.
cast AXSON PX761 and PX 774 to get a rubber
prototype for testing.
For safer fitment, the centre clamp was moved to the side, to
facilitate easier clamping or removing of the pipe. Previously
fitting required a shifting motion through the centre clamp.
On the anaesthetists request/proposal, grooves were
introduced to facilitate teeth rings for better fitting in
different sizes. Plate 4 shows the further development.
Following an SLA prototype, a silicone mould and castings
were made with AXSON 761. AXSON 761 has a Shore A
hardness of 60, and proved a little soft for tests. Castings were
also made with AXSON 774, which has a Shore A hardness of
70, and resulted in better parts for testing/rigidity. Tests
revealed that the clamping action was insufficient, as the pipe
still moved or slipped out. In bending the middle piece, the
clamp ring opened up. Also, the teeth-rings did not work, as
The design was followed by the creation of an LS prototype.
teeth do not follow a set curve.
Testing showed that the space between the front and back lips
was too large, as the mouthpiece moved freely in the patients 2.1.3 Design evolutions 4 and 5
mouth. When trying to bend the two halves to test the LS For the next concept, the thickness of the centre clamp was
prototype, it broke. It was decided for future changes to this increased, to improve the clamping action. The front lip was
product, to: also adapted to closer represent the mouths form.

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Anaesthetic mouthpiece development Rapid Prototyping Journal
G.J. Booysen, L.J. Barnard, M. Truscott and D.J. de Beer Volume 12 Number 4 2006 189 197

Plate 4 Introduction of grooves to facilitate teeth rings for better fitting Plate 6 Introduction of biting blocks and rope knobs upon suggestions
in different sizes on the anaesthetists request/proposal by the client

Furthermore, the back lip was raised, and the angle inclined mouth. Too little mouth-clamping force resulted in dislodging
to adapt to the pallets shape. Pyramid blocks were introduced of the mouth-piece.
to let it hook into the molars for better stability. The client
verified the VP, which led to immediate suggestions for 2.1.4 Design evolutions 6 and 7
further changes/iterations. Amongst others, the bridge As a further iteration, a centre-piece with grooves around it
between the top and bottom mouth-piece was made thicker was developed. Owing to problems identified in the previous
to give more stability for the clamp. Plate 5 shows the result of
iteration, a feature was included to tie a rope around the
these suggestions in the design.
clamp after the pipe is installed, to ensure that the pipe does
Plate 6 shows the next concept evolution, where biting
not come out. The middle part was also made thicker to
blocks were introduced to ensure that the teeth would not
enlarge the contact area with the pipe. Plate 7 shows the
obstruct airflow in the pipe when the mouthpiece is folded.
enlarged centre-piece, as well as pipe-securing device. Patient
Rope knobs were suggested to tie the mouthpiece around the
feedback was that it hurts when pressing against the pallet,
patients head, as to stay in the patients mouth. An even
and the anaesthetist found the product to be unstable.
thicker centre-piece and clamp-ring was introduced to
As a result of numerous tests with the previous iteration, it
increase stiffness and clamp-force. Difficulty was
was decided to resort to the making of dental imprints, to
experienced; because of a thick middle part that caused
attempt to create a generic design/fit. Plate 8 shows dental
deformation of the front-lip when the mouthpiece was folded
imprints, which were made in an attempt to develop a generic
into the patients mouth. An SLA prototype was grown,
shape for a mouth-form. Four different peoples mouth
followed by castings in AXSON 774. This concept was also
imprints were used to design a one-size-fit-all for adults. The
tested on patients, but did not fit well into the patients

Plate 7 Introduction of a centre-piece with grooves around it to aid in


Plate 5 Further changes/iterations upon verification of the VP by the
securing the pipe again upon suggestions by the client
client to give more stability for the clamp

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Anaesthetic mouthpiece development Rapid Prototyping Journal
G.J. Booysen, L.J. Barnard, M. Truscott and D.J. de Beer Volume 12 Number 4 2006 189 197

Plate 8 Dental imprints, which were made in an attempt to develop a Plate 10 Introduction of lips (winged-handles) to make it easier to
generic shape for a mouth-form install the pipe, on the anaesthetists request/proposal

width/profile of the teeth was measured to make an optimal


design. The idea was to develop a kids profile at a later stage. Plate 11 Introduction of longer bite-blocks to ensure that no
Through customer feed-back, it was decided to make the obstruction of airflow occurs when the pipe is folded/bitten
back-lip a bit higher to give it a better grip/hold in the
patients pallet. An SLA prototype was grown, RTV mould
was made and AXSON 774 castings were made. The centre-
piece with grooves could be taken out because the thickness of
the clamp gave the stability needed. Plate 9 shows the next
concept, indicating the higher side-walls.

2.1.5 Design evolution 8, 9 and 10


Plate 10 shows the next concept, where lips (winged-handles)
were installed to make it easier to install the pipe, by opening
it. This feature made it easier to install the pipe. An SLA
prototype was grown, RTV mould was made and AXSON
774 castings were made.
As can be seen from Plate 11, the bite-blocks were made a bit
longer to ensure that no obstruction of airflow occurs when the
pipe is folded/bitten. This was only a design and the client made
some more changes. The bite-blocks design was changed to a
more solid bite block on the side of the mouthpiece. stays in the mouth. An SLA prototype was grown, an RTV
A new concept was tried in this iteration. Another bite- mould was made and AXSON 774 castings were made.
block was installed in the middle, to act as a spring Plate 12 shows an image of the new concept, and illustrates
mechanism. If the two smaller halves are folded over the the extended middle-piece.
bite-block, it will result in a perpendicular force, ensuring it

Plate 9 Introduction of a higher back-lip to give it a better grip/hold in 2.1.6 Design evolutions 11 and 12
the patients pallet through customer feed-back Plate 13 shows further developments of the concept, where a
tongue protector was included, as the patient sometimes pushed
the mouth-piece out with the tongue. The lips were also made
longer to ensure that all the teeth (up to the back of the mouth)
would press against the mouth-piece. The bite-block was made
longer, at angle to make the spring action larger. Side bite-blocks
were included as displayed on the image. An SLA prototype was
grown, RTV mould was made and also some AXSON 774
castings were made. The concept was very successful with
physical tests. It satisfied the client, to result in final changes.
A final shape that met all of the design criteria was modelled
(Plate 14). The iterations lead to a more suitable configuration
and a rubber prototype was moulded (Plate 15), which was
accepted and used in patient trials (Andrews, 2003).

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Anaesthetic mouthpiece development Rapid Prototyping Journal
G.J. Booysen, L.J. Barnard, M. Truscott and D.J. de Beer Volume 12 Number 4 2006 189 197

Plate 12 Introduction of another bite-block installed in the middle, to Plate 15 Moulded functional prototype
act as a spring mechanism

2.2 Injection moulding phase


Plate 13 Introduction of a tongue protector to stop the patient from An injection mould was designed and manufactured for mass
pushing the mouth-piece out with the tongue production of the product. This was necessary because large
quantities of the product were needed and latex-free moulding
material was essential for an approved medical product.
The following design changes to suit the injection mould
were made on the product:
1 Draft angles were added to faces for easier ejection of the
product.
2 Thick parts of the product were replaced with ribbed
structures. This was done for the following reasons:
.
To avoid the characteristic heat sinks commonly
occurring when a large concentrated volume of
material cools down.
.
Reduce the material to produce the product, because
the cost of a product is largely based on material cost.
. The mouthpiece had to angle upwards to avoid
unnecessary undercuts in the injection mould. This
feature made the moulding process simpler. It did not
only reduce the manufacturing costs but also
simplified the manufacturing of the mould. This
Plate 14 The final shape, which met all of the design criteria feature furthermore turned out to be a design
improvement adding extra spring force to the
product. Having been able to identify all possible
manufacturing problems during the design evolution,
it enabled the completion of the mould within two
weeks. Plate 16 shows the final DFM product. The
CAD design of the tool layout is shown in Plate 17.

The mould making process included the following:


1 A single cavity mould was produced within two
weeks (from designing to completion of the injection
mould).
2 This was largely made possible by the following:
.
HSM: reduced machining time because of high feed
rates; and mirror like surface finish, not necessary for
time consuming hand polishing.

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Anaesthetic mouthpiece development Rapid Prototyping Journal
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Plate 16 Design of final product for injection moulding Plate 18 One half of the injection moulding tool

Plate 17 Tool layout to accommodate the final design

Table II Composition of Bohler grade M201

Composition per cent of


Bohler grade M201 C Cr Ni Mo V Mn Co Si S
0.40 2.00 0 0.20 0 1.50 0 0.30 0

Plate 19 Moulded part in the top half of the injection moulding tool
.
Advanced CAM software-Delcams Power Mill
variety of tool path strategies to choose from for
optimal machining; and optimised tool path
generation, reducing machine time (e.g. avoid
unnecessary lifts of the cutter during machining).
3 Beryllium copper inserts were used for maximum cooling
of the injection mould. This did not only improve the
cycle time, but also reduced the costs of the product.
4 Injection mould was nitrided.
Plate 18 shows one half of the injection mould tool.
The tool steel used for the injection mould is the Bohler
grade M201, the composition of which is given in Table II.
During the injection moulding process various materials
were tested in different shore hardness and a suitable material
was found. The product is made from latex-free EVA type
thermo rubber. The final product as used during operations is
shown in Plate 19.

3. Discussion
The total cost for the RP development phase amounted to hard tool has been made and it is evident that the cost and
R46,220, consisting of 10 CAD designs at R2,500 per design timeframe of development would have been much higher if a
with two alterations allowed, six SLA prototypes at R2,500 decision was made to start directly with hard tooling. The cost
each, six silicone moulds at R820 each and 26 cast of the injection-moulded product was estimated to be
components at R50 each of the different designs between R20 to 25, depending on the volume of the product.
(Aggenbacht, 2004). Table III shows the various cost- Furthermore, it must be realised that the product was the
components. result of an idea generated by anaesthetists, not familiar with
The conventional method of manufacturing an injection- manufacturing processes, or the advantages offered by rapid
moulding tool would have amounted to R45,000. The price product development technologies over conventional
to manufacture the product decreases dramatically once a practices. Table IV shows the advantages of the rapid

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Anaesthetic mouthpiece development Rapid Prototyping Journal
G.J. Booysen, L.J. Barnard, M. Truscott and D.J. de Beer Volume 12 Number 4 2006 189 197

Table III Cost comparison between the RP development and conventional injection moulding
Rapid product development phase Conventional injection moulding manufacturing
10 CAD designs R2,500/design R25,000 Design and manufacturing of injection moulding tool R45,000
6 SLA prototypes R2,500/prototype R15,000
6 vacuum casting moulds R820/mould R4,920
26 cast components R50/rubber prototype R 1300
Total R46,220 Total R45,000

Table IV Advantages and disadvantages of rapid product development and conventional injection moulding
Rapid prototype development phase Conventional injection moulding manufacturing
Advantages Disadvantages Advantages Disadvantages
Inexpensive product alterations Unit price of moulded part is high Unit price of moulded part is low Expensive product alterations
The more alterations the better Small quantities of the product can Large quantities of the product can Because of the cost implication many
the end product be produced be produced alterations arent possible
Physical testing can be done The end product must be produced
before the end product for physical testing

product development process followed, over a conventional on the national and export markets. This product has the
practice, which would have lead directly to the manufacturing ability to save lives and this will be paramount to the products
of an injection- moulding tool. success.
The final product, shown in use in Plate 20, was used
during patient trials, and had a 100 per cent success rate, with
the ET tube staying exactly in place, for perfect ventilation of
4. Conclusions
the patient. If the tube is grossly displaced (e.g. by somebody This research has demonstrated how the utilisation of
standing on a ventilator tube) the Secure Airway Clamp will functional prototypes can enable complete design iterations
be pulled out of the mouth and is easily noticed, which is not (involving analysis of all design criteria) to be repeatedly
true for current methods of fixation. Even when one patient undertaken until an optimised design is reached. This is
had a seizure on the operating table, the airway remained possible as RP prototypes are sufficiently similar to the final
secure. This is not normally the case during such an episode product for all functional testing and customer evaluation to
using the old method of securing the tube. be completed with a high degree of confidence. In addition,
The product is now being commercialised. Millions of the provision of fully functional prototypes can also act as the
operations are performed annually worldwide and if only a catalyst for stimulation of further ideas and development.
small percentage of market shares can be secured, the A particular benefit of RP functional prototypes is that they
development has the possibility of substantial earnings both are readily understood by industrial designers, engineering
designers, manufacturing engineers and even the target
Plate 20 Injection moulded functional part in use customer. They can perform an analogous role to VPs
within the domain of PDM (product data management), as
defined by De Beer and Campbell (2005). In PDM, members
of the product development team have remote access to the
VP as shown in Figure 1(a) and can perform their own
specific analysis upon it. The PDM network can also act as a
medium for communication between team members. As such,
PDM/virtual prototyping has been promoted as a means of
breaking down the barrier between engineering design and
manufacturing. De Beer and Campbell (2005) furthermore
suggests that the functional RP/RM prototype can act in a
similar way (Figure 1(b)) with the advantages of being
portable, more widely understood and easily accessible to
several people at the same time and place (rarely the case with
VPs). This is indicated by the cluster members in
Figure 1(b) being shown as more numerous, in actual
contact with the prototype and with each other and inclusive
of customers.
The mouthpiece development once again shows that the
role of the RP functional prototypes can be similar to that for
which sketches and mock-up models are used within
industrial design, i.e. for rapid and copious design iterations

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Anaesthetic mouthpiece development Rapid Prototyping Journal
G.J. Booysen, L.J. Barnard, M. Truscott and D.J. de Beer Volume 12 Number 4 2006 189 197

Figure 1 Relationship between PDM network and functional prototype organised companies (Burns and Evans, 2000). The common
cluster practice of designers receiving customer preferences via a
separate marketing or market research department is no
longer sufficient. Designers must be encouraged to
communicate directly with customers and customer
interaction with functional prototypes (CIFP) has a vital
role to play in this.

References
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increase their insight into the lives of potential customers.
This will help expose them to the often unspoken needs and
Corresponding author
attitudes of users. This already happens in many smaller,
innovation-led companies but is quite rare in larger, more G.J. Booysen can be contacted at: gbooysen@tfs.ac.za

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