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The aim of the strategy
design proposal is to make clear to the Manager what the product is, what its
intended use is and how would be best to market it, all whilst taking into account
the existing legislation related to medical devices. As well, it needs to ‘specify
the clinical and technical performance it is looking for and to identify which
requirements must be met in full and which ones are desirable’ (Willson, Ison and
Tabakov (2014). In this case, the product is a pill dispenser that has
incorporated certain unique features, such as biometric identification, wireless
control between the dispenser and the carers computer and

a new feature for reminding the user about
the time to take their medication. The different methods that are used when
creating a product design specification will be discussed and the most suitable
will be applied to the final product design specification. To generate a
suitable product design specification, the predicted number of sales and the
target market should be considered. The customers themselves will fall into two
categories, the client and the user and both of their requirements will be
taken into account when coming up with the best design.

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Before the
product can be sold, there must first be a process involving the product
development and concept development of the idea, to ensure that the product is
of good design and is in demand. The design team should be sure to check other
patented ideas to make sure that there isn’t already a similar design on the
market, as this would mean that they were not allowed to sell the device. A
design specification is needed to make sure that the developed product does
everything that it set out to do.

 

Product
design specification: Pills dispenser

Function:

            Many
older people have to take many tablets a day and they aren’t always able to
remember for themselves and so need a nurse to administer these tablets for
them. This pill dispenser will remove the need for a nurse to come every day as
it can be preloaded to automatically dispense the tablets as and when is needed
whilst reminding the user to take said tablets.

Customer
Requirements:

1.    
Client

·     
Device should be easy to set up

·     
Device should have the same or
better functionality as those already on the market

·     
Device should be priced well

·     
Device should have the ability
to dispense multiple different pills at different times of the day

·     
Device should be able to remind
the user to take their pills

·     
Device should only allow the
intended user to access it

·     
Device should be wireless

·     
Device should be battery
powered

2.    
User

·     
Device should be easy to use

·     
Device should be aesthetically
pleasing

·     
Device should be very safe to
use

Characteristics:

a.    
Performance Requirements

The device needs
to be able to dispense multiple different pills throughout the day without the
need for manual use. The pills need to be released into a pot that can only be
accessed by the intended user through the use of biometric identification and only
at specific times. The device should have a wireless connection to the carer’s
computer so they can manage tablet dosage and intervals remotely. As well,
there needs to be alert system put in place to remind the user to take their
tablets. The device should be wireless and run on a battery that would need
recharging once a week.

b.    
Safety

The device
should be free of sharp edges to make sure that nobody accidentally cuts
themselves and should not be so heavy that it could cause damage if it were to
fall. The different sections should be completely isolated so as not to get a
mix of pills. The device needs to be protected from overheating via an
automated shut off feature for high temperatures.

c.    
Accuracy

The device
should have complete accuracy when it comes to which pill is dispensed and be
able to dispense it within 5 minutes of the allotted time.

d.    
Physical characteristics and
design

The outer device should be
a neutral colour so as to fit in with many surroundings, with the internal
sections being different colours so that the pills can easily be differentiated.
The internal sections should be removable so as not to accidentally mix the
tablets.

e.    
Production characteristics

600 need to be manufactured
and packaged.

Other:

     
i.        
Legislation

The device will
need to meet all the set legislations and standards.

    
ii.        
Disposal

The pill container should
be disposed of via a recycling centre, ensuring the battery inside is disposed
of properly.

  
iii.        
Client concerns

The device is easy to use
and easy to set up for an untrained individual.

 

For the product to fulfil all of these
requirements, the team behind it would need to come up with many different
ideas after agreeing on a specific objective (a very short statement on the
device and what it needs to do) (Stefanov, 2017b). ‘There
are many creativity and brainstorming techniques for enriching the idea stream’
(Bhuiyan, 2011) and the way to utilize these is to choose a good team to work
with so that you can get as many ideas as possible with which to work with (Stefanov, 2017b). Once the brainstorming has produced a
sufficient amount of ideas, constraints can be set. This means that there are
set parameters that the product design is limited to and if the suggested
design doesn’t and cannot have it then it is disregarded. This reduces the
amount of ideas that there are to work with and so the team can move on to
evaluating the ideas using different criteria that customers want. The people
in the team give each criterion a code and then rank them on importance.
Following this, the weighting coefficient is calculated by comparing the
criterion against each other. When one criterion is more important, it is
awarded 2 points and when it is of lesser importance, it is given 1 point. The
solutions are then compared with each other by comparing them to the set
criterion.

 The needs and wants of the customer
are of the upmost important. Quality function deployment (QFD) is a ‘systematic
approach to design based on a loose awareness of customer desires’ (Stefanov, 2017b)
It involves making sure that the often ‘subjective quality criteria are turned
into objective ones’ (Stefanov, 2017b) in order to make the design right for
the customers. It was first developed by Yoji Akao in Japan in 1966 and from
then there have been many advances in the system, with a common model being the
Kano model that was developed in the 1980s. QFD is used so that the preferred customer
requirements are the ones that are included in the final design and it is made
clear what the design goals should be. It gives the opportunity for the
customer to be involved from the early stages of the design. In the case of the
pills dispenser, the customers want an easy to use device that looks good and
can be used wirelessly. The importance of these would be ranked and the design
team would do its best to incorporate them. There are four phases in regards to
the QFD. The first phase relates to the product planning stage, where the house
of quality is ‘built’. It is also known as the QFD diagram and includes the
relationship matrix which is used to determine the relationship between the
customer’s needs and the company’s ability to meet those needs. The design team
must also priorities compliance with any legal and safety requirements before
considering aesthetic features. Phase 2 is the product design, during which the
actual product is designed. Phase 3 is the process planning stage that involves
laying out how the manufacturing processes will work. Phase 4 is the process
and quality control phase and this is the phase where controls are put in place
to prevent failures and ensure that the production process and maintenance
schedules are kept on track (Stefanov, (2017b)

In order to
successfully sell the product, market research must be done to ensure that the
product is wanted and needed with there being people interested in buying the
product.  The market research is the
first step in the marketing process (Stefanov 2017a) and is used to understand
what is wanted from the device in both function and aesthetics and if the
proposed design is satisfactory. Oftentimes, the product has to be altered in
order to fit the requirements discovered when doing market research. In the
case of the pill dispenser, the device is a needed piece of equipment that will
have a long product lifecycle as medication and assisted living have been in
high demand for some time, with no sign on that declining any time soon.

The
product also goes through a PESTEL analysis, which is used by ‘marketers
to analyze and monitor the macro-environmental (external marketing environment)
factors that have an impact on an organisation’ (Professional academy,
2017). This stands for Political, Economic, Socio-cultural, Technological,
Environmental and Legal and is used to identify threats and weaknesses.

Due to the product
itself not being a new idea and only being a new design, the pill dispenser has
entered the lifecycle of medical devices in the growth phase, being one of the
products offering competitive prices and services (Stefanov, 2017c) which is
mostly influenced by the device using a novel design with the new prototype
coming out much cheaper than other similar products in the market. Because of
this, the devices will be cheaper to manufacture than others that are already
on the market and so the overall cost will be less, meaning that the product
can be sold at a lower price than competitors, making it a more desirable
product.

            Once
the price and product have been decided, it is important to think about how the
product will be distributed. This refers to ‘place’, and there are difference
methods of the distribution. One way is to sell via a wholesaler who will then
sell your product on, with the possibility of rebranding the product (Stefanov,
2017c) alongside it becoming the wholesaler’s complete responsibility. There is
also the possibility of selling directly to the retailer who would then proceed
to sell to the customers. This often comes with a lot of administration (Stefanov,
2017c)and so can take a long while to negotiate a good deal. The method of
distribution that would work best for this product is the direct supply/direct
sale approach. This involves selling straight to the customers and being the
one to deliver the product, meaning you are always working directly with the
customer and on a more personal level. ‘The delivery process requires liaison
(with) … end users and clinical engineering services’ (Willson, Ison and
Tabakov (2014) in order to ensure that the needs of all involved are met and as
there is a fairly small number of expected sales, this is feasible (as there
are only 600 devices predicted to be sold and they are more than likely to be
bought in batches). 

            As
the device is a medical device, there are a few legislations and standards that
the device must satisfy before it can go on the market. It is compulsory to
follow these and so it is necessary that medical products be designed in
accordance with current legal requirements before being introduced to the
market. (GOV.UK, 2014). The most important standard is the risk management
standard ISO 14971 (Speer, 2015). This standard has to be adhered to worldwide
as it is an international standard. This standard involves there being a risk evaluation
that compares an estimated risk against its likelihood it is to occur. This
particular part of the risk management is similar to an Failure mode and Effect
analysis (FMEA).

There are multiple
different kinds of FMEAs: system, design and process. They each have their own
focuses but the ultimate goal is for them all to minimise the cost and
maintenance (Stefanov, 2017d) An FMEA uses a risk rating scale to analyse the
potential failures of the device. This includes the severity which is the ‘severity
of the potential failure’ on a scale of 1 to 10 (10 being maximum severity), the
probability of occurrence which is the ‘likelihood of failure’ on a scale of 1
to 10 (10 being certain to occur) and the probability of detection which is
‘how likely it is to detect the failure’ on a scale of 1 to 10 (10 being
impossible to detect) (Stefanov, 2017d). All this is put together under the
risk priority number (RPN) which is the severity, probability of occurrence and
detection all multiplied together. When the RPN is high, it indicates a high
risk and so the design would have to be looked at again. When the RPN is low,
there is less risk and so the product could move into the next stage. However, FMEAs
need to be updated as and when changes have been made in the design (Stefanov, 2017d).

            It
is important that these FMEAs are carried out properly and that the risk
assessments in regards to user and client usage are of a good standard to
ensure that everyone is safe when using the equipment so that any unnecessary
accidents are avoided. The pill dispenser was determined in the risk assessment
to be of low risk, due to it having a low risk coefficient. However, it does
still contain some batteries and electronics, so extra care must be used when handling
water around it so that none gets in. As well, as it is an electronic device,
it is a fire risk and so care must be taken not to let it overheat (which
should not happen anyway). If this does happen then the issue must be reported
to find out if there is a fault with the system or if there is user error.

            The
pill dispenser is an innovative redesign of an existing product that can be
manufactured at a lower price than that which is already on the market as well
as being of a higher quality. At this stage, the best way to manufacture and
distribute the product is by selling directly to the target market and keeping
excess stock in storage, as there are only 600 pill dispensers to be held at a
maximum. The item is considered relatively risk free and there should be little
room for user error. 

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