Client: Global Pharmaceutical (Fortune 500)
Challenge
BlueBridge Technologies (BBT) were asked to deliver several aspects of a program to provide a HCP Portal, Patient App and custom algorithm – to provide companion diagnostics for an established drug, to help provide an early-warning for specific harmful drug side-effects. The Patient App interfaced with a wireless sensor accessory – a medical grade Bluetooth pulse oximeter. The algorithm needed to accommodate highly variable physiological differences that may exist in the real world and needed to be cloud hosted. The Patient App and HCP Portal were both designated Software as a Medical Device (SaMD). The Patient App was due to be deployed to both iOS and Android handsets. There were multiple vendors involved on this large project.
Approach
BBT provided a pivotal role in ensuring the system was developed under design controls. BBT developed the HCP Portal and associated backend algorithm services, and autored the Design History File (DHF) documentation for the device functions. Safety risks were managed in complaince with ISO 14971:2019, and the software components were developed in compliance with IEC 62304:2006+A1:2015.
A high-level overview of the system is provided in Fig 1.
Fig 1: System Overview
In tandem with early algorithm development, BBT developed an advanced model of the overall system in SysML (Systems Modelling Language) and leveraged this to simulate algorithm usage. This work surfaced several new insights that informed algorithm evolution and helped expedite overall progress.
Outcome
The system was delivered to the client for use in their clinical trials. The client praised the high standard of the technical and DHF deliveries from BBT, as well as the overall collaborative approach taken by the BBT team.
