Fimea develops agile procurement and expertise – adverse drug reactions database was the pilot

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Fimea celebrated the first introduction of a system procured and developed directly for the public cloud when the new national human and veterinary medicines adverse drug reaction database was published for production on 7 December 2023. The project was a “laboratory” of the new procurement model and practices, testing new ways of carrying out an IT development project.

The testing can be considered successful with the project going into production.  
The new system speeds up the processing time of adverse reaction reports and replaces manual steps of the previous process with various interface solutions. In addition, the new online service for human and veterinary medicines has clearly improved the quality of the information in the adverse reaction reports, which for its part contributes to the faster processing of the reports.  

The project also developed operational processes

The procurement of the new system began at the end of 2021 with a comprehensive market dialogue. A market dialogue informs the market about future procurements and enables dialogue between the procurement unit and tenderers. Based on these discussions, Fimea’s first real agile procurement was carried out, in which the system was developed directly for a cloud environment as an hourly-priced implementation. 

The procurement consisted of two phases: the scoring of written outputs and the interview phase. After the first phase, Fimea interviewed the two tenderers with the highest scores, on the basis of which a final selection was made. The future Fimea product owners and the information management unit participated in the interviews and thus were able to influence the selection of future colleagues. 

The commitment of experts to the upcoming reform project already in the procurement phase is in line with Fimea’s IT policies, according to which there are no development projects only related to IT. IT development projects must always develop the process and practice. As the operating method in the project was very different from that of previous development projects, new roles, such as Scrum Master and Agile coach, were added to the team to support the team in the best possible way.  

The implementation project itself began in spring 2022 with a service design phase of approximately one month, in which the scope of the project was determined together with the application provider and a shared understanding of the project goals was formed. The service design phase was found to be a good method and a soft landing for the members of the supplier team to familiarise themselves with Fimea and the sector. After the service design phase, the actual implementation phase of the system began, and the application developers joined the team. 

The agile development model made it possible to focus on the essential

From the outset, the aim of the project was to create good cooperation between the application provider and the client and to follow the principles of agile development. Fimea also invested in its own agile development expertise, and the product owners took part in product owner training before the project began. The team met at regular intervals, and a good team spirit formed in the project, remaining throughout the project and reflected in shared responsibility and good quality of implementation. 

In practice, the project succeeded in creating a highly functional way of cooperating with system providers and following the principles of agile development. After each sprint, an open demo was held to show what had been achieved during the sprint. Open demos brought transparency to the process and served as training sessions for future end users. 

The test environment was developed on a fast schedule, and continuous testing and consideration of end users during the development worked very well. The start of end-user testing at an early stage of the project brought clear benefits at the end of the project, as the quality of the system entering production was very good due to continuous testing, and approval testing could be carried out in a lighter manner.  

The product owners of the project took on their roles in a great way and stated in the project’s retrospective that other projects should also be carried out in the same way. It would not have been possible to know in advance all the details that came up during the specification work, and agile procurement made it possible to mutually agree on everything and always assess that the most valuable thing would be worked on next.

The project’s methods were utilised to form a constantly evolving operating model which systematically brings good practices to Fimea’s development projects and which should also be repeated in a supplier-independent manner in the future.

Read more:

Fimea online news 07 December 2023: Online reporting of adverse drug reactions to be renewed