The aim of the strategydesign proposal is to make clear to the Manager what the product is, what itsintended use is and how would be best to market it, all whilst taking into accountthe existing legislation related to medical devices. As well, it needs to ‘specifythe clinical and technical performance it is looking for and to identify whichrequirements must be met in full and which ones are desirable’ (Willson, Ison andTabakov (2014).
In this case, the product is a pill dispenser that hasincorporated certain unique features, such as biometric identification, wirelesscontrol between the dispenser and the carers computer and a new feature for reminding the user aboutthe time to take their medication. The different methods that are used whencreating a product design specification will be discussed and the most suitablewill be applied to the final product design specification. To generate asuitable product design specification, the predicted number of sales and thetarget market should be considered. The customers themselves will fall into twocategories, the client and the user and both of their requirements will betaken into account when coming up with the best design. Before theproduct can be sold, there must first be a process involving the productdevelopment and concept development of the idea, to ensure that the product isof good design and is in demand. The design team should be sure to check otherpatented ideas to make sure that there isn’t already a similar design on themarket, as this would mean that they were not allowed to sell the device.
Adesign specification is needed to make sure that the developed product doeseverything that it set out to do. Productdesign specification: Pills dispenserFunction: Manyolder people have to take many tablets a day and they aren’t always able toremember for themselves and so need a nurse to administer these tablets forthem. This pill dispenser will remove the need for a nurse to come every day asit can be preloaded to automatically dispense the tablets as and when is neededwhilst reminding the user to take said tablets.CustomerRequirements:1. Client· Device should be easy to set up· Device should have the same orbetter functionality as those already on the market· Device should be priced well· Device should have the abilityto dispense multiple different pills at different times of the day· Device should be able to remindthe user to take their pills· Device should only allow theintended user to access it· Device should be wireless· Device should be batterypowered2. User· Device should be easy to use· Device should be aestheticallypleasing · Device should be very safe touseCharacteristics:a. Performance Requirements The device needsto be able to dispense multiple different pills throughout the day without theneed for manual use.
The pills need to be released into a pot that can only beaccessed by the intended user through the use of biometric identification and onlyat specific times. The device should have a wireless connection to the carer’scomputer 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 theirtablets. The device should be wireless and run on a battery that would needrecharging once a week. b. SafetyThe deviceshould be free of sharp edges to make sure that nobody accidentally cutsthemselves and should not be so heavy that it could cause damage if it were tofall. The different sections should be completely isolated so as not to get amix of pills.
The device needs to be protected from overheating via anautomated shut off feature for high temperatures.c. AccuracyThe deviceshould have complete accuracy when it comes to which pill is dispensed and beable to dispense it within 5 minutes of the allotted time.
d. Physical characteristics anddesignThe outer device should bea neutral colour so as to fit in with many surroundings, with the internalsections being different colours so that the pills can easily be differentiated.The internal sections should be removable so as not to accidentally mix thetablets.e. Production characteristics600 need to be manufacturedand packaged.Other: i. LegislationThe device willneed to meet all the set legislations and standards.
ii. DisposalThe pill container shouldbe disposed of via a recycling centre, ensuring the battery inside is disposedof properly. iii. Client concernsThe device is easy to useand easy to set up for an untrained individual. For the product to fulfil all of theserequirements, the team behind it would need to come up with many differentideas after agreeing on a specific objective (a very short statement on thedevice and what it needs to do) (Stefanov, 2017b). ‘Thereare 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 workwith so that you can get as many ideas as possible with which to work with (Stefanov, 2017b). Once the brainstorming has produced asufficient amount of ideas, constraints can be set. This means that there areset parameters that the product design is limited to and if the suggesteddesign doesn’t and cannot have it then it is disregarded.
This reduces theamount of ideas that there are to work with and so the team can move on toevaluating the ideas using different criteria that customers want. The peoplein the team give each criterion a code and then rank them on importance.Following this, the weighting coefficient is calculated by comparing thecriterion against each other. When one criterion is more important, it isawarded 2 points and when it is of lesser importance, it is given 1 point. Thesolutions are then compared with each other by comparing them to the setcriterion.
The needs and wants of the customerare of the upmost important. Quality function deployment (QFD) is a ‘systematicapproach to design based on a loose awareness of customer desires’ (Stefanov, 2017b)It involves making sure that the often ‘subjective quality criteria are turnedinto objective ones’ (Stefanov, 2017b) in order to make the design right forthe customers. It was first developed by Yoji Akao in Japan in 1966 and fromthen there have been many advances in the system, with a common model being theKano model that was developed in the 1980s. QFD is used so that the preferred customerrequirements are the ones that are included in the final design and it is madeclear what the design goals should be. It gives the opportunity for thecustomer to be involved from the early stages of the design. In the case of thepills dispenser, the customers want an easy to use device that looks good andcan be used wirelessly.
The importance of these would be ranked and the designteam would do its best to incorporate them. There are four phases in regards tothe QFD. The first phase relates to the product planning stage, where the houseof quality is ‘built’. It is also known as the QFD diagram and includes therelationship matrix which is used to determine the relationship between thecustomer’s needs and the company’s ability to meet those needs. The design teammust also priorities compliance with any legal and safety requirements beforeconsidering aesthetic features. Phase 2 is the product design, during which theactual product is designed.
Phase 3 is the process planning stage that involveslaying out how the manufacturing processes will work. Phase 4 is the processand quality control phase and this is the phase where controls are put in placeto prevent failures and ensure that the production process and maintenanceschedules are kept on track (Stefanov, (2017b)In order tosuccessfully sell the product, market research must be done to ensure that theproduct is wanted and needed with there being people interested in buying theproduct. The market research is thefirst step in the marketing process (Stefanov 2017a) and is used to understandwhat is wanted from the device in both function and aesthetics and if theproposed design is satisfactory. Oftentimes, the product has to be altered inorder to fit the requirements discovered when doing market research.
In thecase of the pill dispenser, the device is a needed piece of equipment that willhave a long product lifecycle as medication and assisted living have been inhigh demand for some time, with no sign on that declining any time soon.Theproduct also goes through a PESTEL analysis, which is used by ‘marketersto 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 productitself not being a new idea and only being a new design, the pill dispenser hasentered the lifecycle of medical devices in the growth phase, being one of theproducts offering competitive prices and services (Stefanov, 2017c) which ismostly influenced by the device using a novel design with the new prototypecoming out much cheaper than other similar products in the market. Because ofthis, the devices will be cheaper to manufacture than others that are alreadyon the market and so the overall cost will be less, meaning that the productcan be sold at a lower price than competitors, making it a more desirableproduct. Oncethe price and product have been decided, it is important to think about how theproduct will be distributed. This refers to ‘place’, and there are differencemethods of the distribution. One way is to sell via a wholesaler who will thensell your product on, with the possibility of rebranding the product (Stefanov,2017c) alongside it becoming the wholesaler’s complete responsibility.
There isalso the possibility of selling directly to the retailer who would then proceedto 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 ofdistribution that would work best for this product is the direct supply/directsale approach. This involves selling straight to the customers and being theone to deliver the product, meaning you are always working directly with thecustomer and on a more personal level. ‘The delivery process requires liaison(with) … end users and clinical engineering services’ (Willson, Ison andTabakov (2014) in order to ensure that the needs of all involved are met and asthere is a fairly small number of expected sales, this is feasible (as thereare only 600 devices predicted to be sold and they are more than likely to bebought in batches). Asthe device is a medical device, there are a few legislations and standards thatthe device must satisfy before it can go on the market. It is compulsory tofollow these and so it is necessary that medical products be designed inaccordance with current legal requirements before being introduced to themarket. (GOV.
UK, 2014). The most important standard is the risk managementstandard ISO 14971 (Speer, 2015). This standard has to be adhered to worldwideas it is an international standard.
This standard involves there being a risk evaluationthat compares an estimated risk against its likelihood it is to occur. Thisparticular part of the risk management is similar to an Failure mode and Effectanalysis (FMEA).There are multipledifferent kinds of FMEAs: system, design and process. They each have their ownfocuses but the ultimate goal is for them all to minimise the cost andmaintenance (Stefanov, 2017d) An FMEA uses a risk rating scale to analyse thepotential failures of the device. This includes the severity which is the ‘severityof the potential failure’ on a scale of 1 to 10 (10 being maximum severity), theprobability of occurrence which is the ‘likelihood of failure’ on a scale of 1to 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 beingimpossible to detect) (Stefanov, 2017d). All this is put together under therisk priority number (RPN) which is the severity, probability of occurrence anddetection all multiplied together. When the RPN is high, it indicates a highrisk 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, FMEAsneed to be updated as and when changes have been made in the design (Stefanov, 2017d). Itis important that these FMEAs are carried out properly and that the riskassessments in regards to user and client usage are of a good standard toensure that everyone is safe when using the equipment so that any unnecessaryaccidents are avoided. The pill dispenser was determined in the risk assessmentto be of low risk, due to it having a low risk coefficient. However, it doesstill contain some batteries and electronics, so extra care must be used when handlingwater 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 (whichshould not happen anyway). If this does happen then the issue must be reportedto find out if there is a fault with the system or if there is user error.
Thepill dispenser is an innovative redesign of an existing product that can bemanufactured at a lower price than that which is already on the market as wellas being of a higher quality. At this stage, the best way to manufacture anddistribute the product is by selling directly to the target market and keepingexcess stock in storage, as there are only 600 pill dispensers to be held at amaximum. The item is considered relatively risk free and there should be littleroom for user error.