Ultrasmall materials have the potential to revolutionize various medical fields, but navigating regulatory approval and market access can be a challenge. To aid businesses in this sector, a dedicated open access innovation platform has been developed. By manipulating materials on a near-atomic level, unique properties are created, opening up exciting opportunities in cancer research, regenerative medicine, neurology, dentistry, and more.
However, the novel properties of nanomaterials also pose challenges in terms of characterization, preclinical testing, safety profiles, regulatory evaluation, and market access. The usual standards often do not fully apply to these materials, making careful scrutiny of nano-enabled medical technologies (MedTech) essential.
To accelerate innovation, regulation, and market access in this promising sector, the EU-funded project SAFE-N-MEDTECH (Safety testing in the life cycle of nanotechnology-enabled medical technologies for health) has developed an open access innovation platform. This platform serves as a one-stop shop for assessing the qualification, regulation, biocompatibility, and specific properties of nanomaterials for medical applications.
The platform offers a wide range of services, including feasibility discussions with key stakeholders, regulatory expertise, market access support, and reimbursement information. It also includes a decision support system to guide clients in finding the right services tailored to their needs and technical requirements. Additionally, the platform provides regulatory support, health technology assessment advice, laboratory testing, proof of concept in clinical settings, and, when possible, clinical validation and support in clinical trials.
One of the project’s major achievements is the cooperative framework established among its 28 partners over more than four years. The consortium has also created a business entity that aims to be the single entry point for future commercial development of nano-enabled MedTech in Europe.
To date, SAFE-N-MEDTECH has supported eight products on their path to commercialization, with seven being developed by various types of companies, including academic spin-offs, SMEs, and large multinational industries.
Date: 1 April 2019