Applying Soft Systems Methodology and Analysis to a Real World Product Design Problem.

Executive Summary
This paper focuses on Research for Design, more centrally it focuses Soft Systems Methodology as a problem solving tool for a product design brief. The basis of the paper is allowing a company to better understand the users and stakeholders within a project and how is best to meet their needs. Soft Systems Methodology is a handy tool in reflecting on a problem like this and is the focus of the literature review, giving an understanding of the results of a real analysis that follows. The problem focussed on for this report is The Design of a Neuroendoscope Holder/Manipulator for Surgical Use, which gives a great insight into the stakeholders involved in within the design of surgical devices and also the NHS. Having explained the Soft Systems approach it is then implemented into this real world problem. The results of this are two conceptual models and a better understanding of the problem at hand. The study gives more clarity to the situation and allows you to see where the main conflicts are between stakeholders, in this case between the NHS/MHRA and practicing surgeons. The main conclusive piece is that you must consider the needs of all stakeholders, and not just those immediately in front of you as it could be the other stakeholders that have the most say come to the end of a project.

Introduction
Imagine that you are working as a designer in a company that produces and sells the kinds of products you are designing in your team project. The Board has decided that it wishes to get a better understanding of the following questions. Who are the people who will interact with the results of your project? What are typical needs and wants of target users and other people who will interact with your results? What are key design issues that need to be considered in the design and development of new products?

The premise of, and motivation for this report is the concept of Research for Design. This can be interpreted as a thorough and methodical analysis of the problem, reference materials, the users and stakeholders to inform the process of design and arrive at a final visual artefact; research in its most simplistic form (Frayling 1993 p5). The soft systems thinking and analysis approach, detailed in the report, is a tool that allows you to model and develop systems using the viewpoint of the stakeholders to inform the direction of development, and this is used to answer the research questions listed above. An informed set of conclusions can then be made giving the board a better understanding of the product interactions and the implications of these. The team project being analysed for this report is titled, The Design of a Neuroendoscope Holder/Manipulator for Surgical Use. The project entails developing a device that holds a nueroendoscope in a fixed still position, but allowing for quick and easy removal of the endoscope for cleaning and also a degree of easy movement and adjustment when positioned. The purpose of this is to reduce the effect of fatigue on the Primary and Secondary surgeons and make surgery more manageable for the surgeons, thus reducing errors in surgery. The report is structured in a simple progressive manner beginning with a literature review. This is the primary process in Research for Design, gathering knowledge on the problem and any current solutions, and involves an extensive look at literature related to both the Neuroendoscope project and Soft Systems Methodology. This gives a good scope of reference to refer to in the following sections. Following this there is a description of the method by which soft systems is used to analyse the team project leading to the results of this analysis. Here a rich picture and two conceptual models are included and used for evaluation. This gives the viewpoints of two stakeholders which allows for a wider scope of study. These results are then discussed and evaluated with the key findings outlined and any new learning relating to the team project reviewed. This is all then concluded by addressing the questions set in this introduction and giving the board the answers they seek.

Literature Review Soft Systems Methodology

The principle of Soft Systems Methodology, or Thinking, was first developed by at the Lancaster University in the late 60s and early 70s. The original premise to the research and the eventual SSM tool was to find a new way for people in managerial

positions to resolve problems. These problems are the day to day situations that arise in a professional environment, named wicked problems, which are not always straightforward to understand and clear up. The research was carried out in real life action research conditions, as the problems cannot be simulated realistically and real life outcomes are hard to follow up when under test conditions (Lancaster University 2013). The research requires that the problem situation is the point of study and that the observations made throughout the experience are used as a point of evaluation by conscious reflection (Checkland and Scholes 1999). Soft Systems Methodology itself is designed to improve a system, where systems engineering has failed (Checkland and Scholes 1999). It is different to a hard systems approach in how it views a system. It uses an epistemological view, meaning it creates a mental construct of knowledge to assist in human understanding, over a bounded entity like a computer system. The system can be viewed from many different points by different stakeholders and this is where the problems tend to arise. Not everyone involved in a problem will have the same view on it or expectations on a solution. Having the other stakeholders included in the model makes for an easier understanding of the problem system, and makes for the development of a more effective resolution (Wikipedia 2013). The classic Soft Systems Methodology examination analysis comprises of seven set stages. The first two stages concern defining the situation to be looked at. A definition is sought on the real world problem situation area that is being explored, but not of the problem itself. This can only really be explained by example and this report has two examples in the Method and Results section that follows. The problem area is used as a simple starting point but is not the confines of the analysis, and it can be opened out to include more facets of the situation, and is therefore arbitrary. The idea is to collect as much data as is possible, be it qualitative or quantitative, to study and evaluate (Williams 2005). Having defined the area the problem is then expressed pictorially as a rich picture, describing the problem at hand in all its richness. This stage has some guidelines as to what to include in this picture, which is essentially a rough cartoon, showing as many of the aspects of the problem and its area as can be found. These guidelines say that you should look to include: Structures, Processes, Climate, People, the Issues expressed by people and any conflicts within the problem. This again is shown in the following section with a rich picture of the problem area regarding the Team Project mentioned in the introduction, which does illustrate this stage well showing how different stakeholders can conflict (Williams 2005). The third stage is likely the most difficult and moves away from the real world and into systems. At this stage you must formalise a root definition from which to build a model, hence it is the root from which everything else grows. Each problem will have a number of perspectives, shown in the rich picture, which are conceivable, related and purposeful. These, when isolated, are called holons, and each provides a differing value base by which to evaluate and analyse the problem. The purpose of this is to get every viewpoint as there will be some discovered that senior management personnel may not recognise, but do affect the people within the system and therefore affect the success of the outcome. These viewpoints are best assessed separately as together it is too big a task, and this is the role of Soft Systems Methodology. You gain a clear insight into each key perspective and each interaction with the system of product and can use this in evaluating a solution for future action (Williams 2005). Having gathered these holons, the next step is to create a model of them. Before this is possible the holons have to be structured for development, and this is done using the mnemonic CATWOE. Customers - who (or what) benefits from this transformation Actors - who facilitates the transformation to these customers Transformation - from start to finish Weltanschauung - what gives the transformation some meaning? Owner - to whom the system is answerable and/or could cause it not to exist Environment - that influences but does not control the system Figure 1. CATWOE (Soft Systems Methodology, Williams 2005, p6.) The order of development is important. The idea is that everything must flow from the Transformation, which is logical as that is the action being sought. Figure 1, above, describes the meanings being the letters of the mnemonic. Having defined the transformation is most logical to then define the Weltanschauung, and then the rest. From this CATWOE breakdown it becomes much easier to construct a good root definition. There are two example CATWOE breakdowns in the results section of this report for reference. The root definition is a carefully structured statement that summarises the problem domain and is usually structured as, A system to do X, by Y in order to do Z. For example, A system to assist a brain surgeon, by holding a neuroendoscope in order to improve results for patients would be a broad root definition for the problem encountered in the Team Project mentioned previously (Williams 2005). With this root definition complete you progress to stage four, developing the conceptual model. This is another visual stage, again with two full examples in the results section. The purpose of the model is to structure debate with a mental construct of

the viewpoint of a stakeholder. The models are therefore notional and do not depict what really exists, just the stakeholders viewpoint. The models are formed of 72 bubbles, and each bubble contains an activity which can be performed and then discussed. An arrow between two bubbles indicates a logical dependency, meaning that the second bubble is dependent on the outcome of the first bubble. There are two examples of this in the results that illustrate this. The model must focus on one area and one viewpoint to work. It should also have a monitoring and control aspect to it. These elements are the evaluative points where discussion has to take place and problems can be worked over. Checkland believes that models should not be slaved over as the comparison stage where there are discussions and observations are made allows you to change and improve the model as knowledge is gained. This is why the process is often described as cycles of discussion. The perfect solution is not found first time around, but over a period of iteration and evaluation (Williams 2005). In the final three steps you leave the systems centric activities and move back to the real world problem. The idea here is to compare the model to the real world situation to gain insights into the problem and any potential improvements. Checkland outlined four different ways of doing this. The first is simple unstructured discussions between stakeholders and people involved. The second is structured questioning. The model is looked over and questioned using a matrix approach. The other two methods are scenario or dynamic modelling, and modelling the real world and comparing, but it is the second method that is most commonly used. Question and comparison using a matrix is the most efficient evaluative method and therefore is preferred by many. The idea is to find out how effective each component is. The matrix generally asks these four questions: Does it exist in the real world? How does it behave? How is its performance identified and measured? Is this process any good? (Williams 2005) Having evaluated the model the sixth stage is to gain more insight. This means looking at all of the other viewpoints or holons that have been gathered from the rich picture. The first way of doing this is simply to create a conceptual model for each of the holons and study and discuss these. Having done this Checkland suggests that the Owner, Social and Political sides are analysed. This gives the analysis more reality and is where the feasibility of many ideas it truly tested. Owner refers to who has the authority to take action. If this is a stakeholder that has a conflicting viewpoint then many ideas will not pass. The social aspect, Social system analysis, looks at how the varying roles, norms and also values that people bare in the real world share with the conceptual model. This again can be a stumbling block if say peoples values are not in line with the suggested ideas for change. Political analysis looks at power and how it is expressed within the problem and by whom (Williams 2005). All of this considered, the seventh and final stage uses the output and ideas from the study to create actions to improve the situation. The methodology is seen as a cyclical analysis and therefore this stage may not constitute the final solution and the end of evaluation, and may in fact ignite another cycle of Soft Systems Methodology in order to create a better more suitable solution, with new information gained from the original cycle used to better the models and further expand the study and eventual actions. The use of a process like this in a product design context is exactly the same as a business, just on a smaller scale and probably with less stakeholders, although not always. (Williams 2005).

The Team Project

Neuroendoscopy is a relatively new type of procedure, building upon the technologies used in other types of endoscopy, but within a very complex area of the body. The surgery uses a small telescope with a high resolution camera link which is used to look inside the skill and brain, and these images are used to help guide the surgeon to the problem area. This means that the surgery can be performed in a minimally invasive manner as only a small section of skull needs to be removed to gain access to the brain, whereas in other procedures an entire large section is removed to gain visible access to the brain. This minimal invasive approach leaves fewer traumas for the patient and in some instances the surgery is significantly shorter in length, all meaning that the patient is likely to be released for hospital sooner and able to carry on with normal activities again (UCLA 2013). The problem area in the team project is with the endoscope and the demands it puts on the surgeons. At present the endoscope is supported by hand and held in position normally by the secondary surgeon whilst the primary surgeon holds the surgical tools which are used for things like tumour removal. This means that the two surgeons are often going between each others arms, restricting movement and causing discomfort. The operations can last for anything in excess of 5-6 hours and holding an endoscope for this period of time causes fatigue and tremor in the surgeons arms and back.

The procurement of medical equipment and devices on the NHS, such as the eventual final design to the team project, is dictated by the Medicines and Healthcare products Regulatory Agency or MHRA. This body is in place to regulate and assess new devices and determine their value to the NHS. There is a procedure undertaken before a device can be implemented on the NHS and this begins with a case of need. There needs to be an immediate justification for looking at new devices, be it a problem or just something that could be improved. There is then a shortlist of equipment drawn up and these are evaluated to see which should be taken forwards to trials and testing. The financial side is important and the MHRA has a duty to abide by the Standing Financial Instructions and Standing Orders and budget manual. This means that a business plan is then drawn up before any testing takes place. This is another stage of justification. The business plan will weed out any devices that are not financially viable and narrows down the options. It considers all sides of the device from maintenance to any staff and training issues and also installation issues. The devices are then tested and evaluated and one is chosen to be put forward as the business case submission. This is the device that is most suitable and most cost effective. The business case is then reviewed and the Executive board reach a conclusive decision on whether or not to implement the new device. If it is approved then next there is an extensive planning stage making sure that all training needs and operational and maintenance areas are covered. (South Tyneside NHS Foundation Trust 2012) There are also a variety of standards that have to be met in medical devices before they can be implemented as well as areas evaluated. Figure 2, below, shows an overview of the evaluative process and also the planning that must be shown to be done by the manufacturer, before a product will be considered for implementation in the NHS. Decontamination equipment life cycle procurement records adverse incident reporting actions required on MHRA's Medical Device Alerts and manufacturers' corrective notices training technical specifications regulatory compliance and related issues rationalisation to single models, where possible risk management equipment inventory manufacturer's instructions Disposal

Figure 2. Medical Device Management Policies (John Sandham 2009) The NHS and the MHRA are potentially the biggest barrier and area of conflict, but this will become clearer in the following sections where the models are built and evaluated.

Method
The method used to create the models for this report was simply the method described in the literature review. The key difference is that it is a product design problem being reviewed, not the original intended area of study for the Soft Systems Methodology is to be implemented. It is in essence the same concept though, just on what appears to be a smaller scale to a company and professional environment. The actual models do show that the scale is in fact larger than a small design problem and that there are actually various stakeholders involved who are all looking for something different. The two models built were chosen from the development of the rich picture. The rick picture shows that there are various stakeholders present in the problem, the student designers, the surgeons, the University of Leeds, the patients and the NHS. All of these stakeholders have a slightly different aspiration and this is made evident within the models themselves and also the discussion of the results to follow. The two viewpoints chosen for evaluation for this report are that of the neurosurgeon looking for a new design to aid their work, and that of an NHS MHRA advisor evaluating the benefit of spending money on a new assistive device for neurosurgery. These were chosen as they give a slightly intertwined viewpoint but from very different backgrounds. The surgeon is there first hand day to day and is informed on the demands of the surgery, whereas the NHS advisor has little or no firsthand experience and makes judgements based on evaluation and financial constraint. These two viewpoints therefore are conflicting.

As stated the same process as described in the Literature Review was used to develop these models. This began with the rich picture where the wider scale of the problem has been illustrated showing the stakeholders outside of the university and outside of our regular contact. The root definitions were then developed for each viewpoint using CATWOE as is recommended by Checkland. These allow for the models to be developed to the correct specifications as outlined, meaning they will be of more use. The models are then created and finalised ready to be analysed. The analysis, titled the Discussion of Results, involves structured questioning moving towards a look at the Owner, Social and Political aspects. Having considered these, the Conclusions section offers actions to improve the situation as well as answers to the research questions posed in the introduction.

Results A Rich Picture of the Problem Domain:

The Point of View of our Surgical Contact Root Definition - A system designed by students and operated by a surgeon that holds a neuroendoscope during surgery to make surgery less demanding and improve results for patients. CATWOE
C The patient A The surgeon T Ideas and problems into a visual product (neuroendoscope holder) W To aid the surgeon in Neurosurgery O The University of Leeds E The operating room

Conceptual Model

Supply a brief on project to the students

Provide supporting information to students

Allow students to design a solution for application in theatre Apply a system that reduces surgical demands when using an endoscope

Invite students to view surgery first hand

Ask surgical peers to speak about problems to students

Evaluate and give feedback on designs

Improve results for patients

The Point of View of the NHS and MHRA Root Definition A system that improves neurosurgery patient outcomes, by assisting the surgeon within reasonable financial
constraints and cost benefit analyses.

CATWOE

C The surgeons A NHS supply chain approval team T Non approved to tested and approved for use W To help surgeons get better results and suffer less fatigue O The University of Leeds (at present) E Financial constraints

Conceptual Model

Ask surgeons to recommend assistive devices Assess the financial constraints on implementing new devices Monitor financial elements and surgical results

Evaluate the costs of testing vs. the possible outcome

Ask surgeons to test assistive devices

Perform a cost benefit analysis of implementing vs. results

Approve and fund the device for use in theatre

Improve patient outcomes

Discussion of Results
The first major finding here is from the rich picture and is that there are five key stakeholders in this problem, all with a different viewpoint. Put simplistically, these are those viewpoints: Student designers primarily looking to achieve a good grade Surgeons looking for innovation to assist with surgery The University of Leeds looking to develop ideas to real commercially viable product Patients looking for surgical help NHS looking for better results under financial constraints

Having then evaluated two of these viewpoints, it is easy to see where the main conflicts are. The NHS is under financial constraint and cannot always meet the needs or even demands of the surgeons. Any assistive device created for use in this situation must be cost effective, and fit the criteria that the NHS looks for. From the viewpoint of the surgeon it is easy to see that they are where the ideas come from. They are the people with the genuine need, and are the people whom should be listened to and questioned in order to come to an effective solution. You could not create a product for use in a surgical theatre without learning about the people in the theatre and how they will be using the product. The first hand experience of observing a surgical procedure brings the student designers closer to the surgeons as stakeholders, having seen the problem situation in action. From the viewpoint of the NHS and the MHRA you can see that they are the power here politically. They are the only people with the ability to put an action in place as they are the stakeholder with the money. The surgeons have some say and can influence these bodies but it is ultimately the decision of the NHS and MHRA. The patient is rendered almost powerless to influence anything, but that can be considered normal as they do not have any experience in the situation and are just unfortunate enough to be on the receiving end of the surgical procedures. The most influential new learning from this analysis is seeing the situation from the viewpoint of the NHS and the MHRA. They have to operate in a socially challenging environment where norms and values may have to be put aside due to financial constraints. An unlimited source of money would likely see these bodies investing in the very best, most innovative devices, equipment and drugs, but that is not a reality and they have a budget to abide by. This means that a new device has to be deemed as more beneficial to surgeons than the affects of its cost are on budgetary constraints. This means it must be cost effective as well as baring all of the traits found in Figure 2 in the literature review. The learning here is that more emphasis needs to be put on things like the disposal of the product or any one time use parts, to better meet the policies and guidelines for medical devices as well as the regulations and laws that were already being considered. There must be evidential proof that the new device is easy to train on and easy to install, easy to clean and so on. These factors may not have been as carefully reviewed were it not for the use of Soft Systems Methodology.

Conclusions
To conclude this report, the responses to the research questions posed at the beginning of this paper are given, summarising and reflecting on the overall report. Who are the people who will interact with the results of your project? With the rich picture and conceptual models as reference it is clear to see that it is not just the surgeon and the patient that will interact with the results of the team project. Firstly the University of Leeds has a key role in protecting the project and also developing it further after the project has finished, as a final working NHS approved product will not be the outcome of the project. The NHS and MHRA are therefore a key interaction with the results of the project, not now, but further into the future if the project becomes a viable product looking to be implemented within the NHS. The main interactions though, immediately clear when you look at the situation are between the product, the surgical team and the patient. These interactions had been critically evaluated, but the interactions between the other stakeholders had not been too prominently thought of and this is something that can now be taken into the team project and improved upon. What are typical needs and wants of target users and other people who will interact with your results? From the surgical point of view the needs and wants are for an assistive device for use in neurosurgery. They want a device that will hold an endoscope and reduce the demands of operating for long periods of time. This will allow them to better concentrate

and fatigue less, meaning that there are fewer mistakes in what is a very demanding and also quite underdeveloped surgical procedure. There is a lot of room for errors and a device that can reduce these errors and give a constant stable picture of the area being operated on could improve this situation. The patient interacting with the device is also looking for better results and therefore in a sense has the same needs and wants as the surgeon, but indirectly. The needs and wants of the NHS and the MHRA are where there is a point of conflict. They are looking for a cost effective solution to the problem. There is a financial constraint on the spending they can allow and as a fairly specialist area of treatment, there is not as much budget as there is for something more common. They want a device to pass a cost/benefit analysis so as to improve the service on the NHS, but they need it to be well within financial constraints too. What are key design issues that need to be considered in the design and development of new products? The major design issues found that affect the design and development of new products revolve solely around the NHS and the MHRA. Any design must meet the regulations, policies and criteria set by these bodies before it will be implemented within the NHS. These stringent controls are there firstly to ensure the safety of patients, secondly to ensure the budgetary demands are met and thirdly so as not to waste time and money testing and evaluating something that will end up being an unfeasible solution. The points listed in Figure 2 have to be met along with the many regulations and laws that are in place. It is a difficult industry to design for due to the nature of use of the products and the liability that then surrounds them. Liability has to be established and that is probably one of the biggest stepping stones, as accepting liability means that you are confident that the product will work and are happy to take any repercussions that may arise. The point here is that it is not just the immediate user, the surgeon, you are designing for, and that you must design for the NHS and MHRA as a key stakeholder too. Without doing this, the product will never pass evaluation and will not sell. References
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