SaMD are both consumer products and medical devices at the same time – and the underlying technologies that patients use as consumers, as well as patient expectations and behaviors, are always changing. Even the ecosystem of medical products and data that can be used to improve patient outcomes continuously evolves. Orthogonal understands that our patients are people. We rely on user research to guide our iterative design and feedback process, applying product analytics and real-world data to continue to evolve the product in the face of change.
Agile development methodologies are the gold standard in most industries, allowing developers to adapt to change and uncertainty on the fly without wasting time and effort. Orthogonal’s Agile approach is compliant with FDA and EU quality systems regulations as well as IEC 62304 and AAMI TIR45, incorporating design controls into a streamlined process that accelerates the delivery and continued evolution of SaMD and connected medical device systems.
Unlike traditional waterfall development, where verification and validation often happen at the end, Orthogonal’s Agile approach weaves in V and V activities throughout the development process. By testing user stories as soon as they are implemented and automating integration testing, we uncover defects and discrepancies early in the process – when they are easier to fix and have the least overall impact – leading to fewer errors, fewer delays and faster releases.
Risk management is baked into our ISO 14971 and IEC 62304 compliant Agile approach. By addressing risk early and often, we enable our product teams to focus on the highest-risk areas throughout the process, thereby saving time and money. Whether we’re evaluating use error inputs from human factors, drawing from cybersecurity risk analysis, analyzing hardware and firmware components, or applying software segregation techniques, we’re ensuring clarity, regulatory compliance and – most important of all – patient safety.
For software-enabled medical devices, the road to regulatory approval from the FDA, EU and other bodies is littered with potholes. Orthogonal’s proven approach is based on our deep knowledge of standards, regulatory guidance and commitment to safety. We can help ensure that SaMD and connected device systems are built and documented with compliance in mind at the onset of development. And all of that sets us up for long-term agility and flexibility in enhancement.
If your connected medical device is ailing from malfunctioning software, lack of effective testing or incomplete documentation for regulatory compliance, it could be time to get a second opinion. Our breadth and depth of experience allows us to identify root causes of symptoms exhibited by your project, assess the project’s current state and where it needs to go, and set your device on the road to rapid recovery.