EXISTING SOLUTIONS

The goal of the benchmarking analysis is to define the most common haemodialysis machines, to find a representative case study to analyse in detail (Table 8). The comparison started from identifying the most important manufacturers and the related machines. For each machine, treatments). It was also reported which ancillary products are produced by the manufacturer, to understand which machines are designed together with the disposable products to perform the treatment, and which ones are designed to be compatible with the existing products.

The benchmarking analysis highlighted that most machines are designed for in-centre haemodialysis (14 out of 18 are full-system equipment) and can perform a broad range of dialysis treatments (Table 9). Regarding shape, all machines are large-sized and have a narrow and elongated shape, including a wide touchscreen monitor for managing the treatment parameters.

From an operational point of view, in most cases, the priming process is automatized, and all machines are compatible with products from different brands. Compact-system machines (4 out of 18) are small-sized and have no monitor so that they take up the least amount of space in a home environment. They only perform haemodialysis or, in some cases, hemofiltration, and are designed to be easily set up by non-expert people.

Table 7 – Product requirements

Table 8 - Benchmarking analysis of the existing haemodialysis machines

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In all cases, companies manufacture filters and tubing systems for their machines, while different suppliers produce the other ancillary products.

Overall, the benchmarking identified 7 global manufacturers and only 8 machines that are able to perform the three most important type of dialysis treatment (haemodialysis, hemofiltration, and haemodiafiltration).

Among these, Fresenius Medical Care agreed to make an equipment available for the disassembly analysis, while also providing technical support during the entire study. Therefore, the research focused on the case study of Fresenius 5008, that has been analysed in detail through a disassembly analysis.

3.2.2 Equipment assessment through a disassembly analysis

The chosen method to analyse the haemodialysis equipment is based on a well-defined methodology, which has already been applied to several projects concerning the home environment and household appliances (Fiore et al., 2016). The method combines the approaches of Design By Components (Bistagnino, Virano, & Marino,

2008) and Design for Disassembly (Bogue, 2007): the disassembly deeply affects the end of life of a product, by increasing or hampering the possibilities of reusing or recycling the product and its components.

From a system thinking perspective, this approach can go further the end of life, focusing on the whole life cycle. The exploration of the components (materials, connections, operation, layout) and the interaction of the user(s) with the product (needs and procedures), allows improving usability, maintenance, and disassembly. Systemic Design shapes the product starting from the relationship between the components and the users, taking into account the material flows that occur within a specific context (inputs and outputs). So the application of a methodology based on Systemic Design enables to understand the main environmental and functional issues of a complex product, so as to identify its actual requirements and define possible solutions to solve them.

The complex nature of a biomedical equipment exceeds many other products, from a technical, regulatory and ethical point of view. The analysis of this kind of machine must face many challenges:

first, it is a product that is not commonly used in the daily life, so designers need to acquire specific

Table 9 - Results of the benchmarking analysis

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functioning. Secondly, biomedical companies spent many years developing, testing and patenting the components of the medical equipment, which are therefore not easily replaceable with other solutions. Thirdly, every modification of the equipment affects the complex system of ancillary products that are needed within the treatment. Lastly, a medical device takes from 3 to 7 years before being placed on the market (Fargen et al, 2013; Christin, 2012), this is not only due to its design complexity but also because every change requires new medical testing and approvals. The more it will change, the longer it will take to fulfil all the conditions and get on the market. For these reasons, the equipment analysis, unlike other sectors, aimed at reaching a better understanding of components and material flows to identify layout and functioning requirements, while leaving the current components unchanged.

When dealing with other products, the analysis takes into account the product as a whole. The complexity of medical equipment requires a first step to divide the product into several macro-components according to their function. Then each macro-component is individually analysed.

Fresenius 5008 has been divided into nine

macro-components (Figure 9), according to their function and position.

Electrical macro-components:

1. Monitor. It includes the touchscreen monitor, the movable arm which allows to move it, the alarm system, and the card reader to identify patients and staff.

2. Computer. It contains the main electronic system which controls the operation of the equipment.

Blood circuit macro-components:

3. Extra-Corporeal Blood Circuit Module (EBM). It is responsible for the blood circulation within the tubing system; it includes blood pumps, heparin pump, bloodline clamps, blood flow monitors, and pressure monitors.

Hydraulics macro-components:

4. Hydraulics Back + Front. It represents the biggest hydraulics macro-component and it contains several components aimed at creating the dialysate bath and managing the blood-filtering procedure.

5. Hydraulics Left Door. It manages the supply of bicarbonate.

6. Hydraulics Bottom left. It contains the ultrafiltration pump, and it is responsible

Fig. 9 - Macro-components of Fresenius 5008

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for pumping the concentrates in the mixing chamber.

7. Hydraulics Right Door. It manages the supply of acid concentrate.

8. Hydraulics Bottom right. It includes the dosing and the mixing chamber, which are aimed at mixing the concentrates and the purified water.

Protective macro-components:

9. Shell. It includes all the components aimed at containing the other macro-components and providing structural rigidity and strength to the equipment.

The detailed analyses of the macro-components are included in Annex I.