Giving nanotechnology-enabled medical devices a boost to market
Manipulating materials on a near-atomic level gives them new properties, creating unique opportunities in medical applications. In this way, nanotechnology holds the potential for advances in cancer research , regenerative medicine, neurology, dentistry and more. However, these novel properties and behaviours also present fresh challenges regarding their characterisation, preclinical testing, safety profiles, regulatory evaluation and market access. In many cases, the usual standards are not fully applicable to nanomaterials. Nano-enabled medical technologies (MedTech) must be carefully scrutinised, as they are complex products with technologies often still under development. The EU-funded project SAFE-N-MEDTECH (Safety testing in the life cycle of nanotechnology-enabled medical technologies for health) aims to speed up innovation, regulation and market access/reimbursement in this promising sector. The project developed an open access innovation platform to provide a one-stop shop to assess the qualification, regulation, biocompatibility and specific properties of nanomaterials and validation in medical settings. “The main aim of SAFE-N-MEDTECH was to develop an Open Innovation Test Bed in order to support developers of nanotechnology-enabled medical technologies in their transition from clinics to the market,” says Iñaki Gutiérrez-Ibarluzea, director of innovation at the Basque Foundation for Health Innovation and Research (website in Spanish and Basque) and SAFE-N-MEDTECH project coordinator.
Open access platform for nanotech
The SAFE-N-MEDTECH project built an Open Innovation Test Bed combining the capabilities, knowledge and services necessary to develop nano-enabled medical devices. This includes applications and know-how specific to nanomaterials, including electromagnetic properties and electrical compatibility. “In our case we aim to cluster, test and offer all these capabilities through a single entry point, together with a coherent, regulatory and technology assessment-driven development strategy,” adds Gutiérrez-Ibarluzea. The platform offers a range of services, including discussions on the feasibility of an idea with key stakeholders, expertise in regulation, market access, and information on reimbursement specialists. It also includes a ‘decision support system’ that assists clients in finding the right services tailored to their needs and the technical characteristics of their technology. “Apart from the aforementioned services we include regulatory support, health technology assessment advice, laboratory testing including cytotoxicity, proof of concept in clinical settings – and depending on the demand and availability, clinical validation and support in clinical trials,” notes Gutiérrez-Ibarluzea.
A combined effort to produce a cooperative framework
The most important result from the project was the overall cooperative framework created over more than four years between the 28 project partners. The SAFE-N-MEDTECH consortium also created a business entity aiming to be the single entry point (SEP) for future commercial development of nano-enabled MedTech in Europe, which is currently entering a pilot test phase. “Moreover, we have contributed to a better implementation of regulatory science, early advice and early dialogue processes that, together with specific clinical evaluation tools, allow for guiding the developers towards the optimal indication for their products and the right development pathway,” notes Gutiérrez-Ibarluzea. So far, SAFE-N-MEDTECH has supported eight products in their pathway towards commercialisation, seven of which are being developed by different types of companies – from academy spin-offs and SMEs to large multinational industries. “The main objective was to create a sustainable organisation with a credible business plan that can first of all provide services to innovators considering the design and production of nano-enabled MedTech,” says Gutiérrez-Ibarluzea. “Without the EU funding this would not have been doable.”
Keywords
SAFE-N-MEDTECH, cooperative, framework, medical, technology, nanotechnology, devices, clinics, market