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CAPÍTULO II: MARCO TEÓRICO

2.3 MARCO LEGAL

2.3.2 Ley de Régimen Tributario Interno y Reglamento

After beginning the project at either of two terminals, a working proposal is created based on the formulated preliminary need and a SotA analysis. The fit of this working proposal and the project within RaM is directly assessed via a set of Qualitative Design Questions (QDQ).

By directly assessing the project, even at such an early stage, an as high as possible fit between the project and the R&D-team can be created. If such a fit is not possible, or when the SotA analysis points out no new MT is necessary, the project can be tweaked or terminated. Again, as soon as possible to safe time, money and effort.

Either the project is started by aneed expressed by a medical specialist orstarted as an in-

ternal project within RaM. Now apreliminary need has to be formulated. Even though the

medical specialist has expressed a need already, this is more than often already formulated as a proposed solution for a still underlying problem [26]. With a SotA analysis a quick overview of the currently available technology that tries to/possible solves the expressed need is given. With these pieces of information, a working proposal can be created. This overview is the direct input for the QDQ.

Such a set of qualitative questions can be used to determine the viability of the project and its eventual product(s) within RaM and the market before quantitative analyses are needed. These questions are stated in the list below and are partly familiar to any product designer. If one of these questions cannot be answered or has a negative outcome, it is likely that the project holds little relevance and viability within the group/company or even the market.

It is natural that each member of the project has his or her own skill set. This means that the introduced questions could be weighted according to this expertise to achieve optimal effectiveness. A first step towards this can be found in Future work found in phase 8.

QDQ category Project

1. What is the expressed need/formulated problem? 2. What is the output of the project?

3. Will it be a(n) (assistive) diagnostic or (assistive) therapeutic type product? 4. Will it fulfil a specific function, a global function or a set of functions? 5. Will this product fulfil the expressed need?

QDQ category Costumer

1. To whom will the product be sold? 2. Why do these ... need this product? 3. How big is this expressed need?

4. How big is the group of costumers expressing this need? 5. Does this create a large enough sales market?

QDQ category User

1. Who will be the user of the product? 2. Why do ... need this product?

3. How big is this expressed need?

4. How big is the group of users expressing this need? 5. Does this create a large enough sales market?

QDQ category Patient

1. For what patient groups will the product be beneficial? 2. Why do ... need this product?

3. How big is this expressed need?

4. How big is the group of patients expressing this need? 5. Does this create a large enough sales market?

QDQ category Management

1. Does this project fits in with our skills [15, 43, 44]?

2. Do we expect to have the necessary skills for this project [15, 43, 44]? 3. Does this project fits within our current business model [15]?

4. Is the deadline set achievable?

QDQ category Future project questions

1. Do we have partners with the necessary/complementary skills for this project? 2. What are their interests?

3. What are our shared interests? 4. Who are our competitors [15]? 5. What are their interests? 6. What are our shared interests?

7. How will our decision influence competitor behaviour [15]? 8. What changes to the regulations are in the pipeline [15]? 9. Are similar/competing technologies about to be launched [15]?

These questions will again give a good indication of the real world need, and thus the needed application, of the project, specifying what is expressed by the medical specialist.

4.2. The Decision Making Model

4.2.2. ”Classic“ stakeholder analysis

A final project description needs to be defined [23, 26]. This is done by creating a problem statement following the indexation of the stakeholders relevant to the project and their requirements (and wishes).

To know what research needs to be conducted, a clear set of research questions is needed. These can be found within the problem statement. This process is common practice within many design projects and has already been mentioned in Figure 2.2.

Bycharting the stakeholders involved with the project a clearer indication of the shape of

the final product can be made [23, 26]. Via the charting of the requirements (and wishes) of the stakeholders a so called design brief can be created. The design brief is a check list used to determine if the (finished) product meets the set requirements. With all this information a problem statement can be defined as a definite project description and to indicate, on a more detailed level than a SotA analysis, what the knowledge gaps are that need to be filled. Before continuing to the next stage within the model, the problem state- ment is redefined for educational research.

A possible option to fill these knowledge gaps is the integration of BSc, MSc and PhD- students and their assignments carried out within RaM into the projects. For this the problem statement has to be altered to such an extent that the information to be ex- tracted via these assignments is on par with the level of the respective student. This distribution will be made via a Technology Readiness Assessment.

TRA 2 TRA 1 Technology concept formulated Experimental proof of concept

Technology validated in lab

Technology validated in relevant environment*** MSc-student Yes Yes PhD-student or Post doc Technology demonstrated in relevant environment

System prototype demonstrated in operational environment

Actual system proven in operational enviornment System complete and qualified Yes TRL9 TRL 1 No BB DD MM NN PP QQ Bsc-student EE CC FPM-analysis Successful proposal predicted Unsuccessful proposal predicted

Proposal success indication

Create research proposal FF FPM** TRL 2 No TRL 3 No Yes Yes Yes Yes Yes No TRL 5 No TRL 4 No TRL 6 No TRL 7 No TRL 8 QQ

4.2. The Decision Making Model

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