“Applying modern engineering techniques to the development of SaMD is no easy feat. Orthogonal’s approach to blending these domains helped Tandem accelerate our product innovation cycle and outputs.”
Larkin Lowrey Senior Director of Software Engineering, Tandem Diabetes Care
We’ve developed medical device software for Class II and Class III connected medical devices, with functionality including remote patient monitoring, remote patient care delivery via smart therapeutics (insulin pumps, nerve stimulators) and point of care in vitro diagnostics (IVDRs).
Orthogonal has deep experience developing SaMD products that take the form of mobile apps, web apps, desktop apps cloud computing, AI algorithms and SDKs for integration to 3rd party platforms. Our past projects include Digital Therapeutics (DTx), digital diagnostics and digital biomarkers.
Our Agile processes are designed for efficiency so you can deliver software faster and with higher quality.
Phase 0: Inception: A series of workshops that lay the technical, design and quality foundations of the medical device software and get the team working together.
Phase 1a: Iterative Design and Human Factors: Brings the medical device software design from storyboard to high fidelity screens, with highly integrated user testing to add in the user’s voice, needs and preferences early in the process, as well as meet human factors compliance requirements.
Phase 1b: Technical Elaboration: Firms up key architectural aspects of the medical device software system and addresses key domains such as cybersecurity, risk analysis, quality and regulatory.
Phase 2: Development Under Design Controls: The Agile process for bringing medical device software to life. Sprints are typically two weeks and follow a cadence of baking, grooming, planning and execution.
Phase 3: Software Verification: Performs formal verification activities as outlined in the Software Verification Strategy. These activities are performed iteratively in the specification and development phases, resulting in a faster final verification for the medical device software.
Phase 4: Design Transfer and Support for System Testing: Provides support for the final User Acceptance Test (UAT) and transfer of medical device software source code, build files, quality documentation and any needed knowledge transfer.
Phase 5: Evolution: Incorporates real world feedback into rapid release cycles that propels medical device software further and faster than competitors.
“Orthogonal brought us the expertise we needed to ensure our technology platform met the high standards of the FDA. Through their involvement, we absolutely accelerated our pace through the regulatory process. ”
“We needed a SaMD partner equally versed in medical device software development and modern software engineering. Orthogonal clearly crosses that bar, and has been an invaluable asset for Boehringer Ingelheim Digital.”
“Applying modern engineering techniques to the development of SaMD is no easy feat. Orthogonal’s approach to blending these domains helped Tandem accelerate our product innovation cycle and outputs”