The service provided by TEF-Health partner LNE consisted of an assessment of the process used by the SME to develop and evaluate their AI data-based systems. This assessment is based on the study of the documentation describing the process, such as conception documents, risk analysis matrix or the evaluation plan. This first review allowed LNE to identify parts of the process where information is lacking and to better prepare the questions and specific topics to be discussed during meetings with the team developing the AI system. The duration of the meetings are scheduled depending of the amount of questions and topics that need to be discussed. These meetings are similar to auditing a company for a certification: the questions and topics are based on the certification of processes for AI published by LNE in 2021 and adapted to the SME to which the service is provided. Once the meetings are concluded, a report is redacted by LNE which aims to synthesize the strong points and the weakness of the process used by the SME/startup to develop their AI system. Given that this service is based on requirements that will be part of the regulation of AI system, the identification of the weak points should help the company to move toward a future certification.
About Median Technologies
Median Technologies is a French medium-sized SME founded in 2002 and based in Sophia Antipolis, France, with a subsidiary in the United States and another one in Shanghai. The company has around 230 employees worldwide as of end of 2022. Median Technologies is a Medtech that combines medical images and AI to provide innovative solutions with the goal of increasing the accuracy of diagnosis and treatment of cancers, while also contributing to the emergence of new therapies for patients. Historically Median Technologies is an imaging CRO specialized in oncology. Based on this solid experience, Median created a second Business Unit (BU) dedicated to the development of AI/ML-based medical device software solutions. The new BU is called ‘eyonis’ (formerly iBiopsy) and counts around 50 employees. Its main goal is to manufacture and bring to the European market safe and performant CE-Marked medical device software (class IIb) containing AI addressing different types of cancers.
The Challenge
Median Technologies were looking to test out the quality of their AI/ML-based eyonis solutions and improve the robustness of their processes in compliance with the increasing level of requirements of the incoming european regulation on AI systems. After the beginning of the TEF-Health project, contact was made again between Median Technologies and LNE: since Median were eligible to the discount provided by the project and wanted to improve their AI solutions regarding the certification process, talks began to define which LNE services would be provided to Median Technologies.