Software as a medical device (SaMD) is increasingly central to cancer care, yet current regulatory frameworks from the International Medical Device Regulators, the US Food and Drug Administration and the European Medical Device Regulation lack clear premarket standards for evaluating usability, accessibility and emotional/cultural appropriateness for intended users. This gap is particularly problematic in oncology, where patients, caregivers and clinicians navigate high cognitive load, emotional stress and complex care coordination that can make poorly designed tools ineffective or even harmful.
This paper introduces a structured, feature-based benchmark grounded in human-centred design and user-centred design principles to address this critical gap and enable integration into early regulatory review. The benchmark defines measurable design criteria for premarket review, with a focus on usability, accessibility, emotional safety and clinical applicability, providing both developers and regulators with a practical checklist. By embedding these standards early in the product lifecycle, the framework supports regulatory consistency, reduces postmarket usability failures and improves patient trust, engagement and clinical outcomes.
While developed for oncology care, the benchmark principles are adaptable across diseases, offering a replicable pathway to align SaMD design with both clinical requirements and the real-world needs of patients and healthcare systems.
