World Medical Device Summit 2022

The place where thought leaders come to get inspired

The “Why”

a) Situation

Public healthcare systems are under increasing pressure. The pandemic makes these problems even more evident.  

Medical and digital technologies are important elements to stabilize healthcare systems. Medical device regulations and burdensome approval processes impact not only the availability of these products but also threaten the innovative power and competitiveness of US and European medtech companies.

While the FDA has identified these problems and reacts by overhauling its regulatory system, Europe has not yet communicated similar activities. As regulations diverge, the regulatory burdens increase.

b) Questions

The World Medical Device Summit wants to contribute to effective and efficient regulatory and healthcare systems, by providing answers to essential questions such as:

  • What are the objective functions that regulatory and healthcare systems must optimize? How shall objectives be balanced such as patient safety, availability, affordability and effectiveness of patient care?
  • What are the levers and what is the process to shape regulatory and healthcare systems to deliver the specified outcomes?
  • Which products and innovations are needed to support healthcare? How to identify the blank areas on the product map?
  • How can we accelerate the process from invention to application of knowledge in routine care? 
  • How to accelerate the digital transformation of regulatory systems and regulatory affairs?

The “Who”

a) The participants

At the World Medical Device Summit a small inner circle (by invitation only) meets in person and/or virtually. 

These leading experts represent the different stakeholder groups:

  • Politics
  • Industry
  • Authorities and Notified Bodies
  • Healthcare providers
  • Science
  • Society

b) The opening address

Countess Bettina Bernadotte af Wisborg opens the first World Medical Device Summit and inaugurates the new conference area. She is Managing Director of Mainau Island and serves as president of the Council for the Lindau Nobel Laureate Meetings and member of the Board of the Foundation Lindau Nobel Laureate Meetings. 

c) The host

The World Medical Device Summit is hosted by the new university that is in the course for formation. The aim of the university is to support the mentioned stakeholder by contributing evidence to answer the above questions. The university also wants to serve as neutral platform.

Thereby it follows its mission: Leveraging science and technology for a better life – for everyone

The “How”

The World Medical Device Summit is not just another event. It is a continuous and iterative process of 

  • identifying problems
  • asking the relevant questions
  • providing input for the scientists
  • evaluating research results
  • translating these results into real world applications such as new devices, new blueprints for healthcare delivery, proposing improved regulations etc.

The World Medical Device Summit is like the entire university a non for profit initiative.

The “Where”

The events take place in Konstanz, Germany, directly at the Swiss border. Direct trains connect Konstanz very well with Zurich airport. Konstanz is also connected to the German and Swiss motorway. 

The venue is provided by the Johner Institute. Its modern building and conference rooms have spectacular views on the lake of Constance, the river Rhein and the entire panorama of Swiss alps. It provides a calm, protected and inspiring environment for productive and enjoyable work.

The first WMDS

The first World Medical Device Summit took place on May 12, 2022.

Opening address

In her opening address, Baden-Württemberg's Minister of Economic Affairs, Hoffmeister-Kraut, wished the participants of the World Medical Device Summit every success. She emphasized how important the healthcare industry is for the region and how indispensable good regulation is.

The problem to solve

Regulatory scientists from the Johner Institute and Harvard University then showed latest research data that revealed the extent of MDR's impact on the approval of medical devices and that Europe is falling far behind the US in this respect.

In this context, several ministries were dismayed to hear during further conversations how many companies want to give up because of MDR.

Lack of clear goals, metrics and scientific evidence

Regulation only can be effectively designed based on scientific evidence and based on a consensus on the goals it intends to achieve. Both is currently lacking. There are also no metrics to determine if the goals are being met, and feedback to which the regulation must respond.

Bakul Patel, the former director of the FDA Center for Digital Health, reported that the FDA systematically invests in research and employs between 200 and 300 regulatory scientists to arrive at good regulation. The EU Commission, in comparison, has between 20 and 30 people working on MDR and IVDR, including not a single regulatory scientist.

Contribution of the WMDS

The participants found it crucial that for the first time, all parties sat together and talked to each other. They value the World Medical Device Summit as a process and neutral platform to contribute to better health care and a competitive standard.

For this purpose, short-term measures were derived, and a list of questions for the regulatory scientists of the Johner Institute and the Harvard University was developed. The EU Commission pointed out that the MDR's degrees of freedom could be better used.

All in all, the first World Medical Device Summit gave great hope and, at the same time, represented a moving experience for all participants.

Dr. Helmut Scherer from Erbe Medizintechnik wrote:

"I found the meeting with all players (authorities, EU, manufacturers, scientists, and physicians) very good and important to create a common understanding of the situation - especially the preparation and scientific support presents the situation neutrally and fact-based. This reduces the emotional discussion and ideally complements the previous activities which are mostly based on examples."

In this context, Professor Minssen of Kopenhagen University hopes that the World Medical Device Summit will continue to be the platform where all stakeholders come together to create better regulation.

This wish will be fulfilled: The next meeting is already being planned!



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