Professional Documents
Culture Documents
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.
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
189
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.
190
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 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
191
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
192
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
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).
193
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
194
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 16 Design of final product for injection moulding Plate 18 One half of the injection moulding tool
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
195
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
196
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
Aggenbacht, C.F. (2004), Development and evaluation of a
vacuum casting process, unpublished MTech thesis,
Central University of Technology, Free State.
Andrews, S. (2003), SABS Design Awards Entry.
Anonymous (1997), Rapid prototyping workshop notes,
Innovative Manufacturing Centre, University of
and as a communication medium amongst designers and Nottingham.
between the design team and the customer. However, Burns, A.D. and Evans, S. (2000), Insights into customer
sketches can only be used to evaluate aesthetics whereas delight, in Scrivener, S.A.R., Ball, L.J. and Woodcock, A.
functional models can be used to evaluate aesthetics, (Eds), Collaborative Design, Springer, London.
ergonomics, performance, manufacturability, etc. In Campbell, R. and De Beer, D.J. (2005), Rapid prototyping
addition, when RP is used in combination with other in South Africa: past, present and future, Rapid Prototyping
technologies, it enables customers to be brought more Journal, Vol. 11 No. 4, pp. 260-5.
directly into the NPD process, even to the extent of De Beer, D.J. (2001), The role of rapid prototyping to
geometry creation. Current technologies cannot fully support concurrent engineering in South Africa,
support the customer as designer paradigm as they are unpublished DTech thesis, Central University of
often too complex to use. However, future CAD, RE and Technology, Free State.
design analysis systems may indeed become accessible to the De Beer, D.J. and Campbell, R.I. (2005), Concept
customer/user. development through functional RP, Rapid Prototyping
The case study furthermore iterates the fact that customers Quarterly, Vol. 11 No. 4.
(represented here by both the anaesthetist and patients that De Beer, D.J., Truscott, M., Booysen, G.J., Barnard, L.J. and
participated in this development) are becoming much more Van Der Walt, G. (2005), Rapid manufacturing of patient-
discerning and selective, so for any product to be successful, it
specific shielding masks, using RP in parallel with metal
must be highly attractive to the customer fulfilling both
spraying, Rapid Prototyping Journal, Vol. 11 No. 5,
aesthetical and functional needs Therefore, designers are
pp. 298-303.
required that have specific skills to analyse customer wishes,
Gibson, I., Cheung, L.K., Chow, S.P., Cheung, S.L., Beh,
needs and requirements and understand how these can be
M., Savalani, M. and Lee, S.H. (2006), The use of rapid
translated to an end experience for the customer. Designers
prototyping to assist medical applications, Rapid
need to get inside the heads of customers by observing
Prototyping Journal, Vol. 12 No. 1, pp. 53-8.
them using the product in the real-world. They need to
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
197
Reproduced with permission of the copyright owner. Further reproduction prohibited without permission.