Telekommunikationssystem und -management

Blockchain for MedTech Manufacturing

Abstract

Roberto Magnani

A project just terminated and reported back to the FDA in the US. In IBM, Watson Health aims to build a smarter health in several areas, government health and human services, payer and providers, enterprise imaging,  ¬oncology. Here we illustrate a specific solution in the area of Life Science where our blockchain expertise has been fused with expertise in the sector. IBM utilizes an open source technology with Linux, called Hyperledger Fabric. On top of it we are building several solutions and use cases. This pilot with other major companies creates a blockchain solution to respond to the FDA request of traceability of drugs and/or medical devices. Blockchain was specifically geared to create a system that would test a rapid alert system among business partners alongside  supply chain in case of medication recall. The results of the pilot can be summarized in 4 main points, Provenance and data privacy are guaranted, so only specific partners are notified in case of provenance enquiries,. Reports of recalls is generated and competent autorithies are notified properly. Patient safety is guaranteed by elimintating only the specific lot impacted by the reason of the recall and therefore no hijacking of falsified products or sumministration of bad drugs would be done. This process, which would usually takes 3 days, took only 10 seconds.. In Europe a similar regulation will be released middle 2021. Unique Device Identification (UDI) System under the EU Medical Device Regulations 2017/745 and 2017/746 will facilitathe to an easy traceability to enhance post market analysis and overall better monitoring by audit agencies and competent authorities. This will

prevent falsified and malfunctioning and reduce medical wast, guaranteeing higher standards of safety and we can take advantage of the experience already made in USA.