Nanomedicine, a convergence of nanotechnology and medical sciences, has unleashed transformative potential in healthcare. However, harnessing the benefits of nanomedicine requires a thorough understanding of its regulatory landscape. An in-depth discussion of regulatory considerations, including molecular safety assessment, harmonization of the regulatory landscape, and shaping the future of innovation, is presented in this discourse. The molecular safety assessment entails evaluating interactions between nanoparticles and biomolecules, ensuring compatibility at the molecular level. Harmonization involves developing international standards and guidelines for a consistent regulatory approach, while shaping innovations emphasizes integrating molecular safety assessments into early stages of development. Challenges encompass the need for standardized assessment methods, balancing innovation with safety, and addressing unique features of novel molecular designs. As the nanomedicine landscape evolves, effective regulatory strategies must navigate the intricate interplay of molecules and technologies, ensuring both patient access and product safety.

Translating biomaterials research into clinical products is a multidisciplinary yet rewarding journey. It should primarily aim to improve patient treatment and clinical outcomes by addressing unmet clinical needs. Four examples of commercial development of biomaterial implants illustrate the diversity of paths, starting from academic research work (AlchiMedics, TISSIUM, Cousin Surgery) or corporate initiatives to develop new products (Medtronic-Sofradim Production). They have been selected from the Translational Research session of the 2022 Conference of the European Society for Biomaterials (ESB) in Bordeaux (France). Commitment, agility, and perseverance were among the key common skills to successfully meet challenges, especially the most unexpected ones. All dimensions of translation projects must be integrated from the start, including the regulatory strategy.