Design and characterization of innovative medical devices

Chronic skin conditions such as non-healing ulcers and pathological scars represent a major unmet clinical challenge due to their prevalence, limited therapies, and impact on quality of life. Current treatments rarely modulate aberrant scarring or support regeneration effectively, while pharmacological options show limited efficacy and systemic risks. Biomaterials therefore offer unique opportunities to design therapeutic systems combining structural, mechanical, and bioactive functions. This PhD project aimed to develop innovative biomaterials for medical devices targeting wound healing and scar management, articulated across seven chapters. The research spans bioinspired graded scaffolds, protein-chitosan complexes, and drug-free microneedles modulating mechanotransduction, to inorganic-organic nanocomposites, like chitosan-nanoclay composites, improving mechanics, adhesion, and hydration. Advanced microneedle systems incorporating carvacrol-loaded sepiolite demonstrated antifibrotic potential in keloid models. Finally, a regulatory review contextualized substance-based medical devices under MDR 2017/745. Collectively, the thesis bridges material innovation, biological validation, and regulatory translation.