The Physics as a metric of certainty for patients awaiting bioartificial organ transplants

This study analyzes the ethical and regulatory dilemmas of 3D bioprinting and bioartificial organs within the fields of engineering, medical physics, and transplant surgery. Using a qualitative approach, 19 stakeholders (transplant candidates and donors) were interviewed at the Cà Foncello Hospital (Treviso, Italy). The thematic analysis revealed the "Knowledge versus Unconditional Trust" paradox: low technical literacy regarding stem cells combined with absolute therapeutic faith in biomanufacturing. To resolve uncertainty concerning long-term graft maturation, a "responsible innovation" framework incorporating medical physics criteria is required. In the face of international regulatory ambiguity, a model based on Mill's sovereignty is proposed to provide physical certainties. This construct is operationalized as "Elastic Consent": a dynamic architecture of iterative verification, real-time physical monitoring, and continuous tracking of the implant's lifecycle.