A Model Based Systems Engineering Framework for Digital Twins in Medical Device Innovation

ABSTRACT Medical device development remains constrained by development processes centered largely in the physical domain. These methods limited early understanding of system behavior and prolonged timelines relative to other innovation pathways. Such limitations increase prototype cycle duration and the number of iterations required to resolve design challenges. They also extend verification and validation activities. Consequently, this slows the generation of technical evidence required for regulatory submission, particularly for Class II and higher medical devices. This study presents a Model‐Based Systems Engineering (MBSE) framework, which integrates digital twin capabilities, to support the development of capsule‐based biomedical delivery systems as a specific use case. The framework captures system functions, requirements and behavior from empirical data. These elements are cross linked with a multi‐layered digital twin model that incorporates analytical and numerical computation for higher fidelity system evaluation. Application of the framework demonstrated substantially improved traceability from high level stakeholder needs to granular Measures of Effectiveness (Moe). The framework also improved system performance, specifically the structural performance of the capsule‐based biomedical delivery system increasing by 70% compared to the baseline design. Additional benefits were observed in prototype cycle efficiency, with the 30 h versus 19‐week comparison suggesting an indicative acceleration of approximately two orders of magnitude. At broader development scale, the framework shows how traceable MBSE‐digital twin workflows may shorten development timelines for regulated Class II medical devices. This is achieved through a reduced dependence on serial physical prototyping, faster design iteration and stronger evidence generation for verification, validation and regulatory decision making.