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

Abstract

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, hardw