THE IMPLEMENTATION POWER GRID

First, the discretionary stakeholders. Which include the research institutes ZiNL, Nivel, and ZonMw, as well as the universities and hospitals. These stakeholders can have legitimate concerns with the implementation process of the solution. However unlikely that they will become involved in the implementation, it could occur that an investigation is started on the justification and outcome of the process. When something inappropriate is found, then these stakeholders will move to the dependent category and demand the powerful stakeholders to act, adding urgency to their claim. However, for now it is assumed that neither of these organisations will be bothered to research the implementation.

Second, the dominant stakeholders which include the same group as can be seen in the development power grid (figure 10). For similar reasons, these stakeholders have the legitimacy and the capability to claim and impose regulations and mandates that will influence the implementation process. Similarly, however, it is unlikely that such actions will have the urgency to be acted upon immediately. Additionally, also with this process, it is more likely that these organisations will employ other organizations to act on their behalf (which are all located in the definitive category). The only new entry, is the ZiNL. This organization is responsible to decide on the contents of the basic care package in cooperation with

Figure 10. Development power grid.

What not is included are ‘common’ business related stakeholders (e.g., the tax authority and the Chamber of Commerce). As these stakeholders do not have relevant influence on the development of either the solution or the implementation.

the NZa. Therefore, in the implementation phase, this organisation has significant influence when the company wants the solution included in insured care. Third, the dangerous stakeholder: the insurer. Also in this case, the insurer might disregard or reject a technology that has proven its validity and effectiveness due to an unwillingness to include the tech in the insurance packages or because no care professional is willing to represent the tech and indirectly the company. It can be argued that the role of the insurer in the medical device industry is questionable, as they act like for-profit companies while running on governmental funds (.i.e., tax). The behaviour of the insurer can best be described as an unwillingness to become involved in the development and implementation of new tech, unless a significant portion of care professionals support the technology, it has proven its scientific validity and clinical effectiveness, it does not need more investments then three years of use can repay, and not too much risk is involved. In other words, an insurer will never support unproven, high risk tech, which is usually the output of a start-up company, while demanding the most. Therefore, also in this case, the insurer should be involved in the project as soon as clinical data (data from the smaller studies of the validation process could suffice) is present and relationships with care professionals have been established. Fourth, in this process multiple dependent stakeholders are present: the Health Council, the NHG and LHV, and the patient and care professional associations. During the implementation, these parties might alert their powerful allies of any wrongdoings of either the product, its use, or the process. Although these organizations are dependent on others to act upon any issues, their relationships with these organisations is close and strong. Fifth, the definitive stakeholders during this process are the familiar NZa, the IGJ, the NB, and the ACM, as well as the GP and the specialist. For similar reasons as with the establishment of the development power grid, these stakeholders have a powerful and legitimate influence on the process that is urgent and should be addressed immediately. Additionally, the general practitioner turned to a definitive stakeholder in this process as the power attribute establishes in accepting the use of the system or not. If a patient turns up with the test results in a report constructed by the solution, then the GP must be convinced of their use and the scientific and diagnostic validity. Otherwise, the patient will experience a rude awakening when the GP does not take the report seriously and does not act on the patients concerns. This situation must be prevented at all cost as the value of the system will be obsolete without GP approval and acceptance. Additionally, the specialist is also in this process important due to their advising and defining role of what devices have been validated properly. Sixth, the insurer association is a demanding type of stakeholder as this organization has no power or influence over the process and has no legitimate claim to do so, but can pressure the insurer to act upon their demands. Last, some organizations are not a stakeholder in this process. They might have opinions on the system and its use and effectiveness, but they have no influence, no legitimacy, and no urgency.

The relevant stakeholders of the industry have been described and analysed and the implementation challenges have been identified. Therefore, it is now time to define possible entry points for new technology to enter the Dutch medical (device) market. These entry points are often described as routes, as they signify a certain order and amount of steps that must be taken to complete the route and enter the market. Four routes have been identified: the consumer route, the care professional route, the insurer route, and the governmental route. Each of these routes demand a certain preparation, specific investments in time, money, and resources, as well as an involvement of stakeholders. Which are all discussed in this chapter. Additionally, a short summary is provided detailing the preparations necessary before attempting one of these routes. In Part IV, the routes are incorporated in the implementation design of this research project. Using them to achieve different results with the same technology.