March CÚRAM Partner in EU Research Project to Accelerate Patient Access to Innovative Solutions

CÚRAM is part of a new EU research project TBMED (Test bed for high-risk medical devices), which aims to support European Medtech companies in global competition by reducing the time-to-market of high-risk medical devices. An Open Innovation test bed for the development of devices of risk classification IIb and higher will provide expert support from an early development stage to the optimised transformation of prototypes into valuable and innovative products. The project has received €8.5 million in funding from the European Union’s Horizon 2020 Framework Programme and will run for a period of over four years.

CÚRAM, the Science Foundation Ireland Centre for Research in Medical Devices based at NUI Galway is one of 13 European partners in the TBMED project, which sets out to tackle two of the most pressing issues in the EU healthcare system - the large variation in patient diagnosis and continually increasing costs which result in an urgent need to create and incorporate value in healthcare. However, new EU regulations regarding medical devices classified as high-risk impose great challenges especially on smaller European production companies which are the core target group of TBMED. In order to help Small to Medium Enterprises (SMEs) to deliver better care at more reasonable costs and enable them to face global competition by large suppliers, the consortium aims to develop an Open Innovation test bed focusing on the most challenging devices of high-risk classification IIb upwards.

Commenting on the new project, Professor Abhay Pandit, Scientific Director at CÚRAM in NUI Galway, said: “The TBMED research project will produce a real and lasting impact on patient access to emerging medical device solutions. Partnering in this project provides a valuable opportunity for CÚRAM to assist in strengthening the growth and development of SMEs in Ireland through the Open Innovation test bed’s unique approach.”

Professor Thomas Ritter a Principal Investigator at CÚRAM and Partner in the TBMED, added: “This project is an exciting opportunity of delivering medical devices to patients suffering from serious diseases faster and more safely.”

In a quality-by-design approach, the test bed will help companies to accelerate the development of medical devices, reduce their time to market and offer additional business management services. Counselling and advisory sessions with experts on clinical investigations and an advisory health technology assessment team, EUnetHTA*, who will make sure that important evidence on the safety and efficacy of the new devices and adequate comparators is generated during preclinical development.

TBMED will use three case studies to build the test bed: GlycoBone®, keratoprosthesis and new magnetic nanoparticle devices to improve cancer treatments based on hyperthermia. The deliberate choice of three very different cases will facilitate the development of an Open Innovation test bed suitable for a broad range of applications in the field and turning TBMED into a one-stop-shop providing Medtech companies with open access at fair conditions.

Iraida Loinaz from Fundación CIDETEC Nanomedicine, who coordinates the TBMED project, said: “We want to make our approach sustainable through the strategic involvement of existing European clusters and the use of collaboration opportunities. Our aim is to strengthen the growth and development of SMEs in many different regions and increase their chances of success by bringing them in contact with potential investors interested in new products.”

The TBMED consortium comprises of 13 European partners from Spain, France, Ireland and Germany and is coordinated by the Spanish Research Institute CIDETEC. On 21-22 February 2019, the TBMED partners came together for the official project kick-off in Donostia-San Sebastian, Spain. The meeting was preceded by an open session on Wednesday, 20 February 2019 with participation from representatives of the local Basque government and the Basque Health Cluster. In addition to TBMED, the Horizon 2020 projects MDOT (coordinated by Fraunhofer Gesellschaft, Germany) and SAFE-N-MEDTECH (coordinated by Biopraxis, Spain), which pursue similar approaches in the development of test beds, will be presented.

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