CIDETEC Nanomedicine lays the foundations to take innovation by SMEs in the medical sector to the market

CIDETEC Nanomedicine participates in the European MDOT project, whose main objective is to facilitate the verification of developments by SMEs in the health sector. The project is adapted to the new regulations on clinical products, which, due to the new safety requirements and the high costs of the tests required, could jeopardise the competitiveness of these companies and their benefits for the population.

Approximately 95% of Europe's 26,000 medical technology companies are small and medium-sized enterprises that provide more than 650,000 jobs in Europe, generate a positive trade balance of € 14 billion and are number one in patent applications (EPO). However, the new European medical devices regulation, which introduces a new level of patient safety, may jeopardise their continuity due to high clinical testing requirements.

MDOT’s goal is to establish a platform that allows these players to share information and optimise efforts, preserving technological innovation and economic viability, reducing animal testing and increasing patient safety benefits thanks to the new regulations.

The new platform will facilitate the understanding of regulatory requirements for the safety assessment of medical devices developed and will establish a database of commonly used materials and components. In addition, the new networking will enable joint assessments to be carried out and data to be exchanged in a secure and transparent manner. This will reduce costs while increasing the quality and safety of medical device innovations.

In addition to leading the orthopaedic node within the project, CIDETEC Nanomedicine will lead one of the case studies that will be used to validate the platform: a hydrogel-based coating to control wear on prostheses.

MDOT, coordinated by Fraunhofer ITEM and with a budget of more than € 8 million, consists of a consortium covering the entire value chain: from basic research and testing (ITEM, CIDETEC Nanomedicine, University of Bayreuth, University of Linz, University of Leeds, University of Southampton), to industry (DEMCON, ACMIT, MATHYS), regularisation experts (MT-Consult, Nanoconsult) and clinical applications (University of Poznan, Hannover Medical School).