PRISMA

PRISMA is a revolutionary thin-film micropump realised with novel ceria-based oxides actuating materials in the frame of the FET-OPEN BioWings project, which can be used as an innovative pumping system in wearable insulin delivery devices for the treatment of diabetes. The integration of the PRISMA micropump in insulin patch pumps addresses the 3 most important pain points that still keep the vast majority of diabetic patients away from this life-saving treatment:

1) Size, which is more than two orders of magnitude smaller than state-of-the-art.

2) Higher drug delivery accuracy within the 5% range ensures the highest therapeutic efficacy.

3) drastic reduction in energy consumption.

Besides the short-term vision to realise extremely compact and accurate patch pumps, the long-term goal is to allow the realisation of multi-drug delivery systems, making real the much-lauded multi-hormone treatment. The main objective of this project is to validate the pump and its manufacturing process in a real operating environment, proving to system integrators that all specifications are consistently met to pave the way for post-project system integration and clinical validation.

Reason for applying to HSbooster.eu services

Most insulin pumps use syringe pumps, and the current standards perfectly fit that technology. Our technology though will be significantly different, and we need to understand whether those standards can be applied to thin film pumps, too or if we will need to consider additional/different standards. Besides this, we would like to deepen why there seems to be no threshold for accuracy in such delicate devices and how standards influence the regulation of insulin pumps in Europe. Our new technology could improve reliability and safety of insulin pumps and could possibly open new opportunities for standards that allow for greater diffusion of insulin pumps thanks to accuracy and reliability standards. We believe that the standardisation booster would speed up our project in the direction of a safe and marketable product.

Main Standardisation Interests

PRISMA aims to build a prototype of an insulin pump, so we will need to work on many standardisation topics (electronics, connectivity, materials and so on). The project started in July 2022. At this early stage, we are focusing our attention on standards related to pumping capabilities since our main innovation is new pumping technology. The standard IEC 60601-2-24:2012 defines accuracy and reliability for insulin pumps. To have success, PRISMA and its new technology will need to meet European standards requirements.