SNV Story No. 7: A life full of standards

Medical law opens the door
It all began in the fifth semester – when the topic of medical law and thus standardization came up on the timetable. The lecturer was a lawyer with a vast range of knowledge and infectious enthusiasm. The student was someone with an appreciation of rules and an ability to see the bigger picture. There were up to three medical law lessons per week on the timetable, which is how Peter Bodika first came into contact with standards and the creative process behind them. By way of introduction, the class looked at the Electronic Patient Dossier (EPD) before moving onto Zivilgesetzbuch (ZGB; Swiss Civil Code) and Obligationenrecht (OR; Swiss Code of Obligations) standards and orders of precedence as well as the Conformity Agreement between Switzerland and the EU. A number of always topical scenarios were presented to get the students thinking and learning. The question regarding possible consequences for the Swiss medtech industry following developments in the bilateral negotiations was always on the table. This made the classes more exciting and their content more tangible.

More than just technology
Although the word «technology» is in the job description, the imparted knowledge is not just limited to this. After all, a medical technician can’t go on to do a good job if they have no knowledge of standardization. Standards play the decisive role in daily dealings with medical instruments. The course content focussed on the following three areas:

• SN EN 62353 (maintenance): This standard covers safety testing on medical devices – prior to commissioning, during maintenance, inspection or servicing, as well as following repairs or during recurrent testing.
• SN EN 60601-1 (manufacturer standard): This standard – aimed at manufacturers in the development and production phase – defines safety and ergonomics requirements for medical devices.
• SN EN ISO 14971 (risk management): This standard covers risk analysis, risk evaluation and risk control in relation to medical devices.

Various standards play a central role throughout the life cycle of a medical device in the context of the Swiss Therapeutic Products Act (TPA) and the Swiss Medical Devices Ordinance (MedDO), too. From the moment a medical technician holds a medical device in their hands to the moment this device is disposed of or reprocessed, medical professionals have to comply with standards at every turn. Concluding his recollection of time spent in the classroom, Peter Bodika says this: «Higher education has brought me a long way. It enabled me to acquire highly technical knowledge in the two worlds of medicine and technology. I was able to deepen my understanding of a highly dynamic and innovative industry.»

A thesis on the topic of quality management
Everyone studying at this level has to write a thesis at the end of their course. Peter Bodika was adamant that he would write his thesis on the topic of quality management – and in a practical environment. His conviction that quality management would become even more relevant in Zurich was strengthened not only by the standardization lessons he attended, but also by discussions with fellow students on campus. He started scrutinizing the SN EN ISO 9001 and SN EN 62353 standards. Prior to this research, he thought that a standards expert was simply someone who plotted processes in an administrative department. Only after gaining hands-on experience did he realize that this person gets a deep insight into all processes and thus has a major influence on the design and optimization of these processes. «For me, ISO 9001 is of crucial importance to any company that wants to remain competitive on the strength of quality products and quality work,» stresses Peter Bodika.

An insight with a surprise effect
Peter Bodika became aware of the SNV during his research work. Displaying the carefree attitude of a student, he simply contacted them and received an answer almost straightaway. The SNV offered him the opportunity to write his thesis «on the ground» – on two days. Peter Bodika was surprised by the transparent and open way in which standardization work was presented to him. «I had imagined being stuck in a meeting room doing desk research,» he remembers. «That couldn’t have been further from the truth. I was allowed to look over the employees’ shoulders, whatever they were working on, and even address my questions to the management team in person. I was immensely impressed with the work, the team and the warm welcome.»

The thesis was finished after two months, but not the collaboration. On the contrary – Peter Bodika is now a permanent member of the SNV team in his role as Committee Manager. He is responsible for managing the experts, organizing document sharing, and ensuring that coordination in the committees assigned to him is as it should be. The work is very international and not just limited to medical standardization.

Negotiations determine company locations
Even political negotiations harbour potential for the introduction and implementation of standards. One current example of this is the free movement of medical devices between Switzerland and the EU. This had been clearly regulated by the Mutual Recognition Agreement (MRA) for 19 years; however, following the breakdown in negotiations on the 2021 Framework Agreement, the updating of the MRA chapter on medical devices was postponed. This update is needed in order to maintain the ongoing equivalence of the two legal systems and thus ensure Switzerland’s continued access to the EU’s single market in this sector.

The facilitations of the MRA have now fallen away. Among other things, a new agent needs to be appointed in the EU for these devices, and the device labelling needs to be appropriately adapted. Swiss devices exported to the EU must now satisfy the MDR requirements for devices from third countries – unless a branch or subsidiary in the EU area assumes responsibility for the CE label and the marketing of the devices. Conversely, EU products exported to Switzerland must fully meet the Swiss statutory requirements for devices from third countries.

Such contexts are central in practice but, unfortunately, there is not enough time to include them in the curriculum. «In the classroom, students are not aware enough of just how severely decisions can impact a company’s daily business and viability,» states Peter Bodika.

Ideally prepared for the working world
Peter Bodika is convinced that the knowledge he acquired at the College of Higher Education gave him the ideal tools for his future career. And although his first job isn’t in his area of study, his knowledge of legal matters and standards helps him enormously. From discussions with other graduates, he also knows that what they have learned makes them ideally prepared for the working world. Peter Bodika can’t identify any topics that weren’t covered in the theory he was taught. It takes many years of professional experience to truly internalize the theory and put it into practice effectively, of course. Nonetheless, he sees potential in how classes can be made even more animated and practical.

And one last thing
«I see great potential in the collaboration between higher education, companies, the SNV and Swissmedic. Realistic casework in a project team adds great value for the students, gives companies a valuable second opinion, and helps to ensure better understanding of problems and opportunities in the industry. I view it as a kind of booster for companies. Quality management is a future-oriented topic that is relevant to success. If students learn just how much of a role strategic thinking and pragmatism play in a quality manager’s job before they graduate, I’m sure many more of them would choose this career path.» Peter Bodika has already made himself this promise: «Once I have acquired extensive practical knowledge, one day I will stand before a class of medical technicians and explain to them the fascinating opportunities that standards open up.»

Peter Bodika is a medical technician who has been working as a Committee Manager at the SNV since June 2022. His thesis was entitled «Quality Management System QMS. Introducing SN EN ISO 9001 in a company and maintenance in accordance with SN EN 62353.»