Client: Global Pharmaceutical (Fortune 500)
Challenge
BlueBridge Technologies (BBT) were asked to deliver a Software as a Medical Device (SaMD) iOS app for use in Phase III of a Clinical Trial (CT). The app assessed the visual acuity of the participants as performance outcomes (PerfO), and collected questionnaire responses as electronic patient-reported outcomes (ePROs).
The SaMD App interfaced with a cloud backend from a different vendor. Needs & Requirements came from a wide set of client stakeholders (Clinical, BioStatistics, Regulatory, Program, DevOps etc.). And the app needed to be fully verified on the latest iOS version, which Apple was due to release towards the latter end of the project.
The app had to perform accurate distance measurement (between the eyes and the handset) during the visual acuity assessment. The Apple handset that the client chose had a single front-facing camera, and so BBT had to design and implement a mono-scopic distance measurement solution.
Approach
BBT developed the SaMD app and full Design History File (DHF) under BBT’s own Quality Management System (which is certified to ISO 13485:2016, IEC 62304:2006+A1:2015, and ISO 14971:2019).
An elegant custom AI/ML algorithm solution was designed, implemented, and rigorously tested under various environmental conditions.
The UI/UX was designed through iterative formative human factors evaluations, and the summative human factors evaluation confirmed the adequacy of the design for the intended users. BBT undertook the design and development of UI/UX in compliance with IEC 62366.
BBT placed a significant focus on test automation – building a large suite of automated tests leveraging real devices accessed via a device cloud (where the stack included BrowserStack | Appium etc.). This allowed a large portion of the Verification to be automated, and greatly assisted in being able to quickly verify the SaMD on the latest version of iOS.
The team prioritised regular client engagements, including Architecture Review Board meetings, backlog grooming sessions, design reviews, and demos. We strongly leveraged the project Risk Register to help manage project risks and inform project decisions.
Outcome
The SaMD app met the client’s needs and was delivered on time and on budget.
