To shorten the time from development to certification, the BMBF-funded KIMEDS project aims to enable digital submission of risk management files (RMF).
KIMEDS
AI for Medical Device Risk Management Files
Mission
KIMEDS’ mission is to make the certification process of medical devices more efficient. The KIMEDS project partners aim to develop a safety solution that improves risk management file consistency and accelerates the submission, and approval of risk management files.
Funding
The German Federal Ministry of Education and Research (BMBF) is funding new digital medical technology solutions that sustainably improve healthcare through the “Medical Technology Solutions for Digital Healthcare” program. The KIMEDS project will receive €1.46 million euros of funding over 36 months. This will enable research with the aim of reducing the time to market for new medical devices and increasing the safety of medical devices.
Enabling Safe and Innovative Medical Devices
KIMEDS envisions a future in which science, industry and regulators work closely together to bring safe, innovative medical devices to the clinic so that patients can receive the best medical care. Transforming the area of digital submission of RMFs will help reduce the time to market for innovative medical devices while enabling RMF that are detailed and consistent.
We are aiming for an integrated, AI-based product safety risk monitoring approach that operates across the entire lifecycle of medical devices – from development to certification to product monitoring. Stephen Gilbert – Professor for Medical Device Regulatory Science
Relieving Pain Points in the submission of Risk Management files
Medical devices are increasing in complexity and the regulations that ensure safe medical devices are brought to the market are also becoming more complex. Increased regulatory requirements place a burden on both manufacturers and notified bodies, that has resulted in a drastic increase in the resources (both time and financial) required to place a medical device on the market. The current submission process for technical documentation is slow, and negatively impacts all stakeholders, from the overworked notified bodies to society, who would benefit from safe, innovative medical devices.
The KIMEDS research consortium is developing a solution to digitalize the Risk Management File (RMF) to help reduce time to market for manufacturers. Additionally, KIMEDS incorporates key aspects of Assurance Cases, enabling domain knowledge and modular aspects of the RMF to be reused and publicly available, thus increasing transparency and producing safer medical devices. The KIMEDS tool will first focus on defining a digital submission format for RMFs. Then the KIMEDS consortium will build a proof-of-concept tool that will addresses stake holder needs. This will include things like logic and continuity checks, filtering and sorting functions, integrated term recognitions/suggestions (IMDF terms), and different views to better analyze data (table, tree, html).
The potential benefits of the KIMEDS project are clear: safer devices in the clinics, reduced time to market for manufacturers, and reduced workload for notified bodies. In a digital world, its time to use some academic ambition to reduce hurdles for AI enabled, digital risk management files.