Framework to Support SMEs Transition from Traditional to Connected Smart Medical Devices: Value Creation Through Data and Enhanced User Experience

The medical device industry is undergoing a transformative shift, driven by the integration of connectivity, data analytics, and user-centered design. While large corporations are increasingly adopting smart and embedded medical systems, small and medium-sized enterprises (SMEs) often face significant barriers in this transition due to limited resources, limited hardware-software co-design expertise, fragmented knowledge, and regulatory complexity. This paper presents the design of a new comprehensive framework adapted to support SMEs in evolving from traditional standalone medical devices to connected Internet of Things (IoT)-enabled medical device systems. The proposed framework integrates technological, organizational, and human-centered dimensions to guide SMEs through critical stages of transformation, including digital capability assessment, data strategy and interoperability across ecosystems, and stakeholder experience optimization. By enabling SMEs to harness the full value of data generated by connected devices, the framework supports evidence-based decision-making, predictive maintenance, personalized healthcare solutions, and enhanced collaboration across the medical ecosystem. Further, emphasizing the co-creation value among diverse stakeholders including patients, clinicians, manufacturers, and regulators through improved user experience and data-driven insights. An iterative design approach combines literature analysis, consultations, and case study validation within the medical device industry. Results demonstrated potential to accelerate digital transformation, reduce innovation risks with systems, and foster sustainable competitiveness among SMEs in the emerging smart healthcare landscape.