From laboratory to pre-market prototyping: lessons learned from a noninvasive blood glucose level measurement device

The transition from laboratory prototype to marketable medical device presents significant challenges in biomedical engineering. This paper describes the methodological approach and practical experiences in evolving the Glucube® system, a noninvasive blood glucose monitoring device based on near-infrared spectroscopy (NIRS), from laboratory prototype to pre-industrial product. The process encompassed multiple aspects including user-centered design methodology, risk analysis and management, hardware and firmware adaptations, housing redesign, calibration procedures, and development of supporting software infrastructure. Key challenges addressed include optimization of measurement repeatability, signal quality evaluation, and compliance with medical device regulations. The resulting Class IIb medical device features a modular architecture comprising the measuring device, smartphone application interface, and web services for glucose estimation and data management. The methodology and lessons learned provide valuable insights for accelerating the development cycle of medical devices while maintaining compliance with regulatory requirements.Clinical Relevance- This work addresses the critical need for noninvasive blood glucose monitoring solutions, offering practical insights into developing medical devices that can potentially improve diabetes management adherence by eliminating the pain and inconvenience of traditional finger-prick methods. The described methodology can serve as a reference for developing other medical devices intended for clinical practice.