In order to guarantee performance and safety, medical devices have to pass numerous tests before being released on the market. With the new European Medical Device Regulation (EU-MDR), manufacturers are required to document not only the safety and efficacy of their medical products but also their clinical performance. In order to do so, additional clinical data has to be collected continuously. This poses an enormous challenge to many companies as the procurement, analysis and evaluation of the required clinical data is extremely costly. The low interoperability of existing IT systems further complicates the process.

To ensure the continued availability of vital medical products, the project “KIKS – Artificial Intelligence for Clinical Studies” was launched at the beginning of the year. KIKS is part of the innovation competition “Artificial Intelligence (AI) as a driver for economically-relevant ecosystems” and funded by the German Federal Ministry for Economic Affairs and Energy (BMWi).

With over 40 funded and associated partners, who are managed by BioRegio STERN Management GmbH, the project is developing innovative solutions that utilize AI to collect and store clinical data in a fast, structured, secure and compliant manner. “The project will develop a digital ecosystem with the name AIQNET that integrates the analysis of treatment processes utilizing AI into everyday clinical practice,” explained Frank Trautwein, Managing Director of RAYLYTIC GmbH and consortium leader of the project.

AIQNET – The basis for success in international markets

In order to further expand the AIQNET ecosystem, which will be made available to medical professionals worldwide by 2023, medical technology experts were invited to take part in the international forum “AI for Medical Technology: Mastering the EU-MDR – Increasing Competitiveness”.

“During the event, we were able to present the goals and advantages of the project to a broad audience. We look forward to welcoming further partners from around the world, who will use AIQNET for their companies’ further development and the benefit of patients everywhere,” Frank Trautwein continued.

While the event highlighted the hurdles that have to be overcome owing to the new EU-MDR, it also demonstrated how a modern ecosystem can be utilized to ensure patient safety and the continued success of medical device manufacturers.

According to Dr. Ina Wüstefeld, Director Medical Scientific Affairs at Aesculap AG, a founding partner in the KIKS project, and one of the presenters at the event: “The digital transformation does not stop at medical technology and it improves diagnosis and treatment. With AIQNET, clinical, paraclinical and radiographic data will be analyzed fully automatically utilizing AI. This will increase the performance and safety of modern medical technology and thus directly benefit the patient.”

Owing to the fact that AIQNET is being developed with the needs of all stakeholders – healthcare providers, the medical device and pharmaceutical industry, research institutions and patients – in mind, not only manufacturers of medical technology but also healthcare professionals will be able to benefit considerably, making the project truly unique. Going forward, new strategies and business models will be developed to further advance the digitalization of the healthcare system.