"Swissmedic 4.0" digital initiative concludes

The "Swissmedic 4.0" initiative concluded at the end of May 2025. During the five years of the initiative, the six-person team followed up innovative approaches to digital transformation, tools and agile working methods. Now the focus will shift to integrating the findings into the core sectors and to continuing certain projects.

The Management Board launched "Swissmedic 4.0" five years ago to promote competencies in digitalisation, artificial intelligence, data science and innovative technologies. As an innovation laboratory for change, the team of scientists, data processing experts and sociologists adopted an agile "trial and error" approach. Work focused on people and culture, organisation and processes, and technology.

The mandate was to question everything – even things that made good sense, if necessary – undermine, experiment and take liberties. This took place against the background of a medtech and pharmaceutical industry in the throes of change and which Swissmedic wants to have a hand in shaping. "Swissmedic 4.0" was the embodiment of the prototype mentality. If a prototype was developed and found to work, it was pursued further. If it did not, it was dropped in accordance with the "trial and error" principle.

"Swissmedic 4.0" drove forward the digitalisation and modernisation of the Agency. Working with the specialist organisation and IT, the team facilitated progress that included the implementation of digitalised processes, new tools and internal procedures that had been optimised using agile methods. Solutions to alleviate repetitive tasks were rolled out to employees. These included a risk assessment of medical devices that determined probability, severity of consequences and frequency. Since then, reviewers have been able to implement the decision process faster.

"Swissmedic 4.0" focused on delivering technological and methodological competencies. During the initiative, the team designed and conducted a large number of internal training events in various formats, including workshops, eLearning content and short learning units, as well as seminars and live updates on various specific subjects. Key to all these was the promotion of data literacy and an understanding of agile methods, as well as the safe use of AI-based tools. Events were held to discuss developments in artificial intelligence, machine learning, digital transformation and process automation using real-life cases. As a result of dialogue with international specialist organisations (e.g. EMA, FDA and the Access Consortium), the team was able to transfer the latest findings and established practices to the organisation. These were supplemented within Swissmedic by digital games and apps that provided a fun way of encouraging willingness to innovate, cost awareness and acceptance of new technologies.

The Management Board has decided to integrate the pending tasks of "Swissmedic 4.0" into the core sectors. IT will take responsibility for operating some of the apps and tools in order to safeguard their long-term benefits. The insights obtained from the digital initiative are being used within the Agency. The team was dissolved at the end of May. Of its six members, four will remain at Swissmedic, while the remaining two will continue their careers elsewhere. The Management Board views "Swissmedic 4.0" as a successful experiment and thanks the entire team for their inspiring dedication. Their outstanding expertise ensured the success of the digital initiative.