World Medical Device Summit 2022

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!