Society and clinical practice pose a growing demand on novel biomaterials, ICT, micro and nanotechnologies for innovative medical devices and in vitro diagnostics (Medical Technologies-MTs). In addition to the challenge of time, the new technologies are subjected to other pressing factors such as qualification, regulation, cost, biocompatibility and the need to be applicable worldwide. In the most recent years it is obvious that nano-enabled MTs can be applied in nearly every medical area, with a major presence and increased importance in cancer, regenerative medicine, advanced therapies, neurology, cardiology, orthopaedics, and dentistry. On the other hand, any innovation in the Health sector has to be carefully assessed in terms of risk/benefit ratio. Nano-enabled MTs particularly require careful assessment, since they are complex products group and their technological assessments are still under development. This assessment will be a key pillar for the here proposed Open Innovation Test Bed (OITB) To address all the aforementioned challenges, the SAFE-N-MEDTECH consortium aims to bring a strong and competitive cooperation to compete in the market for a coordinated OITB for nano-enabled MTs. SAFE-N-MEDTECH will build an innovative open access platform to offer to 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. This across the whole Life Cycle. This OITB will offer a multidisciplinary and market oriented innovation approach to SME´s, Healthcare providers and Industries for the translation to the market of MTs, based on a deep understanding and knowledge of the material-nanoproperties, their advance use and applications in MTs and other aspects involved in MTs safety (electric compatibility, electromagnetic properties, etc).

An increasing number of nanomaterials (NMs) are entering the market in every day products spanning from health care and leisure to electronics, cosmetics and foodstuff. Nanotechnology is a truly enabling technology, with unlimited potential for innovation. However, the novelty in properties and forms of NMs makes the development of a well-founded and robust legislative framework to ensure safe development of nano-enabled products particularly challenging. At the heart of the challenge lies the difficulty in the reliable and reproducible characterisation of NMs given their extreme diversity and dynamic nature, particularly in complex environments, such as within different biological, environmental and technological compartments. Two key steps can resolve this: 1) the development of a holistic framework for reproducible NM characterisation, spanning from initial needs assessment through method selection to data interpretation and storage; and 2) the embedding of this framework in an operational, linked-up ontological regime to allow identification of causal relationships between NMs properties, be they intrinsic, extrinsic or calculated, and biological, (eco)toxicological and health impacts fully embedded in a mechanistic risk assessment framework. ACEnano was conceived in response to the NMBP 26 call with the aim to comprehensively address these two steps. More specifically ACEnano will introduce confidence, adaptability and clarity into NM risk assessment by developing a widely implementable and robust tiered approach to NM physico-chemical characterisation that will simplify and facilitate contextual (hazard or exposure) description and its transcription into a reliable NMs grouping framework. This will be achieved by the creation of a conceptual “toolbox” that will facilitate decision-making in choice of techniques and SOPs, linked to a characterisation ontology framework for grouping and risk assessment and a supporting data management system.

The main goal of SUNSHINE is to develop and implement S&SbD strategies for products enabled by multi-component (advanced) nanomaterials (MCNM), including high aspect-ratio nanomaterials (HARNs). To this end, the project will generate essential knowledge, tools and data on the exposure, hazard and functionality characteristics of these materials, especially those arising from their unique properties and interactions (e.g. mixture effects due to the multi-component nature of the materials). To facilitate the uptake and utilisation of the S&SbD strategies by industry, especially SMEs, we will deliver them as part of a user-friendly e-infrastructure designed to: (1) facilitate collaboration and information exchange between actors along nanotechnology supply chains (developers, producers, downstream users) to promote the development and implementation of S&SbD strategies for MCNM-based materials, products and processes; (2) support SMEs and large industries in the selection and application of simple, robust and cost-effective experimental, modelling and grouping/read-across approaches to acquire/generate the data needed to test the effectiveness of the S&SbD strategies; (3) enable risk-benefit analysis of the S&SbD-modified materials and products at each stage of the innovation process to ensure that they are safe for the human health and the environment without compromising their technical and/or commercial probability of success The S&SbD strategies that are effective in reducing the risks from MCNMs, while retaining product performance and economic viability, will be proposed for full scale industrial implementation. In addition, the project will contribute to Regulatory Preparedness by providing recommendations on improvement and adaptation of the current regulatory hazard, exposure and risk assessment guidance (e.g. REACH, Biocides, Consumer Products, Food and Feed, Medical Technologies) and standard guidelines (OECD, ISO, CEN) for MCNMs.

NanoInformaTIX aims to create a comprehensive, sustainable, multi-scale modelling framework for exposure and (eco)-toxicity of Engineered Nanomaterials (ENM) to facilitate cost-effective risk assessment, less reliant on animal testing, and to support the design of safer materials and products. Our approach integrates several relevant EU/US databases with validated nanoinformatics models covering: Materials, Exposure, Physiologically-Based Pharmacokinetics (PBPK), Quantitative-Structure-Activity Relations (QSAR) and Systems Biology modelling and in vitro/in vivo extrapolation to support the prediction of biological effects and exposure of ENM at various stages of their life cycle and product development. NanoInformaTIX will address grouping and read-across for risk assessment and safer product design. NanoInformaTIX will use existing curated data from several completed EU/US projects and from peer-reviewed literature to develop, extend the models and will also consider emerging data from ongoing projects for model validation following the OECD validation principles. This will take the NanoInformaTIX models from TLR4 to TLR6. The NanoInformaTIX modelling framework will be a web-based platform with a user-friendly interface tailored to the needs of different stakeholders (industry, regulators, academia and the civil society). To obtain optimal confidence in the use of the NanoInformaTIX modelling and database framework, all models will be described clearly using agreed standards terminology and implemented on harmonized standard operating protocols based on Good Modelling/Software Design practices. Their applicability domain will be clearly documented and referenced for full transparency and detailed user guidance for each will be provided. NanoInformaTIX will achieve considerable impact by providing the much -needed validated accessible data management modelling framework to predict human and environmental risks, to support the design of sustainable ENM and products.