Failure analysis of subcutaneous sensor: Ascensia Diabetes Care

Our client asked:

A multifactorial complex issue was encountered on a development program which involved a complex technology that was also new to Ascensia. Given the time urgency and the need for a multi-disciplinary approach, Sagentia Medical was engaged to augment the internal team’s effort.

The project story:

Analysis was done utilising a very pragmatic approach, balancing theoretical modelling and experimental approaches to hone-in on both the root cause and the solution space. Work undertaken involved:

• High quality optical microscopy
• Analysis of the device logging data from the clinical trials
• Development of a simple FEA model
• Development of a model of a failure mechanism which explained the fault detected by considering underlying materials properties under mechanical and chemical actions
• In a second phase, development of a FEA model simulating the whole device and including realistic materials properties

Results: deliverables and outcomes

We identified the cause of the failure our client was experiencing with a subcutaneous sensor in human clinical trials. As a result, our client engaged us in a further piece of work to develop a sophisticated FEA model which could be used as a design tool for further development.

• Identification of root-cause before further, expensive, clinical studies
• Model-based design decisions for further development of the product

“Our experience with Sagentia Medical was very positive. They brought a sense of urgency and a comprehensive technical team to approach a complex issue. The urgency and expertise they applied to the program, while executing in close partnership with our internal team and in a cost-effective manner, was highly effective and appreciated. Given this experience, Sagentia Medical is on my short list for R&D activities where external expertise is necessary to augment our internal team.” Martin Gerber, Global Head of Innovation