MDOT

MDOT is a 5 years collaborative project in the framework of DT-NMBP-02-2018 Open Innovation Test Beds for Safety Testing of Medical Technologies for Health (IA). The goal of MDOT is to implement a platform as a meta-network to preserve Med Tech innovation and economic strength, reduce animal testing, and support MDR´s new level of patient safety.

The project:

The new Medical Device Regulation (MDR) introduces a new level of (i) patient safety, (ii) product reliability in relation to its intended clinical use, and (iii) enhanced performance criteria within the conformity assessment process. However, this places a heavy burden on medical device innovation in Europe, since the requirements during obligatory conformity assessment have greatly increased. About 95% of Europe’s 26,000 medical technology companies are small and medium-sized enterprises (SMEs). They provide over 650,000 jobs in Europe, deliver a positive trade balance of €14 billion and are number one in patent applications (EPO). On the other hand, SMEs are particularly affected by MDR’s extensive documentation and report obligations and new clinical testing requirements. With the increased demands and their associated complexity, a significant number of SMEs in the MedTech field are now economically and resource wise at risk, which threatens value chains and thus has the potential to affect the sustainability of the entire European medical device sector. There is potential for a massive loss of innovation, jobs, economic strength and product diversity.

The goal of MDOT is to establish a ‘one-stop-shop’ platform that enables MedTech SMEs to:

1) better know the regulatory requirements for safety assessment of their medical devices
2) establish a database of detailed testing data of commonly used materials and components
3) gain access to advanced testing and fabrication methods
4) perform evaluations of commonly used parts together, and
5) safely and transparently exchange testing data using state-of-the-art technology to decrease cost while increasing quality and safety of medical device innovations.

Operability of MDOT will be demonstrated using three demonstrators:

1) A test bed for the unmet medical need of aerosol delivery through inhalers specifically designed and adopted for infants, term and preterm neonates to allow tests under standardised conditions, which does not yet exist.
2) A test bed for the long term accelerated testing of polymeric active medical devices inaccessible with current technologies due to the temperature sensitivity of polymers that will be also transformed into prediction software modules.
3) A test bed for increasing the safety and lifetime of total joint arthroplasty that involves state of the art testing protocols on wear measurement and computational modelling.

Partnership:

The MDOT platform design and development, profits greatly from the specialised expertise present within the MDOT consortium. Together, the partners cover the value chain from basic and applied research and testing (ITEM, CIDETEC Nanomedicine, University of Bayreuth, University of Linz, University of Leeds, University of Southampton), to MedTech industry (DEMCON, ACMIT, MATHYS), regulatory affairs experts (MT-Consult, Nanoconsult), and clinical application (University of Poznan, Hannover Medical School).

Our role:

– Developer of one of the demonstrators: Hydrophilic coating to control wear of the prosthesis.
– Head of the Orthopaedic Node inside the testing bed: Communication and MDR.