https://orcid.org/0000-0001-5625-4518
Figures & data
Table 1. List of the analysed theses. In the second column, a short description of the thesis is given. The third column describes whether this was a MSc or a PhD thesis. In the fourth column, the type of client is given. We divided these into 3 main categories: medical device manufacturers, universities or university hospitals, and care institutions. The fifth column shows the academic year in which the thesis was submitted. In the sixth column, the anonymised code of the promotor is given. In the seventh column, the reference to the university website is given to find more details on the thesis.
Table 2. Overview of general methodology in our IDE programme. Our curriculum and research combine three typical methodologies: research-through-design, co-design and systems thinking. In the third column, we linked each of these general methodologies to the main themes that were identified in this analysis: 1) regulatory aspects, 2) testing methods, 3) patient-centricity and 4) systemic design. This can also be found in .
Figure 1. Overview of methodologies and tools used in MDD at the Industrial Design Engineering specialisation at our university. The first row shows a simplified version of Pahl and Beitz’ Systematic Approach. This is our design workflow of choice at Ghent University, but as shown by Ocampo (Ocampo & Kaminski, Citation2019) different general design workflows are applicable in MDD. The second row shows the general approaches we actively teach that also may show added value to MDD. The 3rd row shows the 4 main aspects we focused on. Next to these aspects, the initials of the general approaches from the 2nd row are placed, showing which approach is typically used in the given aspect. In the 4th row, we placed the different tools and guidelines that were found in the analysis, sorted underneath the proper main aspect.
Table 3. Summary of the methods and tools. Each of these appeared at least once in the analysed theses. Column 1 shows the main theme to which the tool or method can be linked. This allocation was discussed amongst the researchers and is not exhaustive. Column 2 shows the specific tool, method (or guideline) that was analysed. A structured overview of the themes and their tools can be found in Figure 1. Column 3 offers a short description. Column 4 refers to related methods and tools, that were not found in the student theses but are also relevant to MDD. This non-exhaustive list was composed by researchers with experience in MDD.
Table 4. Count of the different methods and tools. We divided both the MSc and the PhD theses in 3 subgroups, differentiated by the client type. For the methodologies, tools and guidelines, we used the same structure as found in Figure 1.
Table 5. Thesis examples of different methods and tools for MDD. In this table, we highlighted some good examples of tools used in the analysed MDD theses. In the 4th column we explain the added value of this method or tool for the end result of this specific thesis, addressed by the student (in the thesis) or the reviewers. In the 5th column we explain the potential pitfalls of these tools, addressed by the reviewers. The examples are visualised in .
Figure 2. Validation & Verification (Design Control) as a template for designerly tools in MDD (adapted from (Privitera et al., Citation2015).The work of professor Privitera shows the possibility of using the classical Design Control figure as a template to map different design techniques upon. It is noteworthy that next to the clinical and technical requirements, participatory techniques can play a useful role in uncovering user needs. This may lead to a usable and desirable product, as checked by the Validation process. Furthermore, the active testing of prototypes is an important step to valorise the overall functioning of the product, as checked by the Verification process. For this process, we have described the benefits of using a Research through Design approach in a co-design trajectory.
Figure 3. Testing methods in MDD (adapted from (Yock et al., Citation2015)). The first row shows the simplified “Levels of evidence in healthcare design”, which give students notice of the ways healthcare professionals determine evidence. The second row shows the “Testing continuum”, a schematic overview of the different testing procedures in MDD and their respective order. The “Testing continuum” is not limited to medical devices, whereas the “Key R&D” milestones (3rd row) provides a chronological order of important testing milestones that relate to medical devices.
Figure 4. Visual examples of tools used in the examined theses. The letters (A-F) 406 correspond with the detailed explanation given in .
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