SAFETY TESTING IN THE LIFE CYCLE OF NANOTECHNOLOGY-ENABLED MEDICAL TECHNOLOGIES FOR HEALTH.

Project Information

SAFE-N-MEDTECH

Grant agreement ID: 814607

DOI

10.3030/814607

Project closed

EC signature date 5 March 2019

Start date 1 April 2019

End date 30 September 2023

Funded under

• INDUSTRIAL LEADERSHIP - Leadership in enabling and industrial technologies - Advanced materials

Total cost

€ 18 387 395,36

EU contribution

€ 14 534 365,88

Coordinated by

FUNDACION VASCA DE INNOVACION E INVESTIGACION SANITARIAS
Spain

Periodic Reporting for period 3 - SAFE-N-MEDTECH (SAFETY TESTING IN THE LIFE CYCLE OF NANOTECHNOLOGY-ENABLED MEDICAL TECHNOLOGIES FOR HEALTH.)

Reporting period: 2022-04-01 to 2023-09-30

Summary of the context and overall objectives of the project

Society and clinical practice pose a growing demand on novel biomaterials, micro and nanotechnologies for innovative medical devices (MDs) and in vitro diagnostics (IVDR) (altogether, Medical Technologies-MTs). In addition to the challenge of time to market, the new technologies are subjected to other pressing factors such as qualification, regulation, cost, biocompatibility and the need to be applicable worldwide, according to strict standards and legislation, including the new EU Medical Device and IVD Regulation was published in May of 2017, addressing, among other issues, patient safety and the use of nanomaterials in MTs. The use of nanotechnology in medical devices, as there are interesting properties due to the nano-size (in the frame of 100 nanometers) but there are also safety and characterization challenges already not solved. Society will benefit from the adoption of “nano-enabled medical technologies”, as can be applied in nearly every medical area, with a major presence and increased importance in diagnostics, cancer, regenerative medicine, advanced therapies, neurology, cardiology, orthopedics, and dentistry. Nano-enabled medical technologies can be also applied in fighting pandemics like COVID-19

The main aim of SafeNMedtech project is to build an innovative open access platform to offer companies and reference laboratories, the capabilities, knowhow, networks and services required for the development, testing, assessment, upscaling and market exploitation of nanotechnology-based Medical and Diagnosis Devices, for the benefit of patients and the sustainability of Healthcare systems.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

We have completed the first project period. During this period, we have set up the basis for the interaction with future clients, based on the experience gained in relation to the real test cases that are being developed in Safe-N-Medtech (related to cancer, bone implants, advanced diagnostics and antibacterial/antifouling surfaces). This interaction includes early assessment of the proposed technology, regulatory and further development program (intelligent testing strategies). We have also assessed, compiled and homogenized our capabilities in nanomaterials characterization and preclinical evaluation, with a first practical application to the test cases. Regarding production needs, we have set up risk assessment tools and stablished the basis to work on sustainability and safety for the nano-enabled medical technologies. The needs for clinical research have been also addressed, a regulatory roadmap is defined and tools for early assessment of nano-enabled medical technologies have been set up. The overall workflow, legal structure and business models have been preliminary defined, supported by a dissemination strategy focused in stakeholder’s engagement and understanding of their needs. As a response to the pandemic, an emergency open call was open to include additional technologies which could benefit from our services, focused in COVID-19 diagnostics/treatment

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

The overall concept underpinning the Safe-N-Medtech OITB is beyond state of the art, as we will build a new, integrated framework to anticipate and connect needs from innovator with the right tools, people and equipment to solve them. Once the project is fully developed, we will have supported up to 10 real cases, based on the project initial test cases and two open calls for new proposals. Besides that direct support, the Safe-N-Medtech OITB will be a one stop shop for innovator in health technology, contributing to reduce costs and time to market, and helping them in overcoming the “valley of death”, the moment in a development when innovators need to move from laboratories to reality. This could have an unvaluable impact on society, as we would contribute to speed up the adoption of more effective medical technologies (meaning better health and healthcare sustainability), while contributing to the growth of this sector, creating better jobs and opportunities for European citizens.

Kick-off meeting