The Board

Prof. Dr. Christian Johner

Christian Johner is the founder and first share­holder of the Johner Institute. Christian is an enthusiastic mountain biker and runner. The professional life of the physicist, who holds a doctorate, revolves around regulation, medi­cine, and digitalization. 

During his studies and parallel to his corporate career, he built up compa­nies and was commit­ted to improving adult education. While holding a professorship in Konstanz, he also taught at the universities of Würzburg, St. Gallen, and Stanford.

His tasks at the Johner Institute include 

• promoting the professional excellence of the Johner Institute with the entire team and other research teams,
• providing significant impetus for innovation in the Johner Institute's products and services, and
• communicating the findings, future visions, and strategies to internal and external audiences

to support manufacturers, notified bodies, authorities, politics, and the Johner Institute in contributing to safe, effective, and affordable medical devices. 

Stefan Gössel

Stefan Gössel is the second shareholder of the Johner Institute. Stefan discovered triathlon in his 40s and is now a proud ironman.

Since he started researching evolutionary algorithms in the late 1990s, he has been very interested in using artificial intelligence to optimize compa­nies. In addition to pure value creation, he is also concerned about creating livable workplaces. 

As an entrepreneur, Stefan has led global corporations to success in their digital trans­for­mation.

His tasks at the Johner Institute include  

• providing enterprise software solutions in the form of a vertical SaaS platform for a regulatory system that protects patients, promotes innovation, and makes medical devices available globally, as well as
• transferring best practices, particularly from other industries, to medical techno­logy and achieving more innovation, shorter time-to-market, and global compe­ti­tive­ness through ambitious change ​​​​​​​projects.

1. The disruption of regulatory pro­cesses is overdue and imminent. The current problems are unacceptable.

The Johner Institute finds the situation of the regulatory system unaccep­table:   

• Poor (excessive, incompre­hen­sible, contra­dictory, not risk-based, and counter­productive) regulatory requirements,
• incoherent implementation in the imple­men­tation and monitoring ​​​​​​​(of notified bodies and manufacturers), and
• a non-document-based and, therefore, non-automated approach  

have led to

• the time required for placing medical devices on the market increasing drama­ti­cally,
• the associated efforts and costs exploding,
• the innovative strength, competitiveness, and profitability of European manu­fac­turers collapsing, and
• the supply of effective and affordable medical devices no longer being guaranteed to the necessary extent. 

These problems can be solved. 

The digital transformation of notified bodies and manufac­turers makes these problems solvable: 

• Around 80% of regulatory work can be saved.
• Approval times can be reduced from years to a few weeks.
• The shortage of skilled workers, especially regulatory affairs experts, can be overcome. 

The Johner Institute has a concrete vision. Its real-time compliance system has been success­fully tested and used by the first manufacturers and notified bodies. 

2. The regulatory system can and must be taken to the next level.

The Johner Institute is convinced that a regulatory system should be understood as a system and treated as such. That means that 

• legislation must pursue measurable objectives and align the laws with them comprehensibly. The EU Medical Device Regulations do neither of these things.
• Legislation should use models and “experiments” to assess the effects, continuously monitor them with the help of sensors in the regulatory system, and respond in an evidence-based manner.
• That requires not only models but also the use of regulatory experts (regulatory scientists). The FDA employs several hundred of these scientists, while the EU has none.
• Regulation must be able to react quickly to technological changes and market demands.

The Johner Institute supports legislators (e.g., EU Commission, federal ministries, state ministries) in creating better regulation as part of the World Medical Device Summit.