2. Describe the benefit of a conceptual systems architecture and Systems of Systems approach for innovations in mobile healthcare delivery systems development, analysis, integration, and deployment.
3. Evaluate the ability of DSE tools to support clinicians, vehicle designers and medical information system technologists in defining stakeholder systems requirements that satisfy competing needs across a variety of clinical services.
Access to hospital-level care in rural America is persistently challenged by a limited number of clinicians to support a population of over 60 million individuals, a decreasing number of “brick-and-mortar” healthcare facilities, and the distance patients need to travel to secure primary and specialty care (e.g., cancer therapies, OB/GYN, wound care) To address this need, the Advanced Research Projects Agency for Health (ARPA-H) is developing a vehicle-based Platform Accelerating Rural Access to Distributed & Integrated Medical care (PARADIGM), which will deliver hospital-level care via a multi-purpose Care Delivery Platform (CDP). The CDP will pioneer new developments in point-of-care diagnostics, ensure seamless data exchange between medical devices and electronic health records (EHRs), and offer real-time guidance for medical tasks. The CDP is designed for large-scale deployment by healthcare systems, particularly in rural and resource-limited settings. Achieving this goal will involve multiple parallel work streams including the development of a miniaturized self-shielded CT scanner that achieves >80% reduction in size, weight, and power from standard scanners; software that connects remote medical devices with EHRs; and intelligent task guidance systems to provide real-time, interactive decision support for healthcare workers to perform functions beyond their usual training. These innovations will be integrated into a rugged electric vehicle (EV) platform to create a seamless and efficient environment for advanced and customized care delivery. Health systems will deploy CDPs across the country to evaluate CDP-based care in a broad range of use cases for clinical effectiveness and financial sustainability. The PARADIGM program leverages a complex system-of-systems (SoS) development strategy, enabling system requirement traceability from clinical needs to CDP physical and functional design elements. This strategy is crucial to support verification and validation of a unique innovation in rural healthcare and clinical service delivery. To ensure accelerated CDP design, implementation, and deployment, the CDP evaluation process employed a highly proactive stakeholder engagement approach incorporating both traditional and non-traditional verification and validation (V&V) methods. Utilizing industry standard Model-Based Systems Engineering (MBSE) software tools, a Digital Systems Engineering (DSE) methodology establishes a digital thread, connecting healthcare technologies, clinical workflows, and provider activities to verifiable CDP requirements. By capturing these requirements with traceability to stakeholder needs and V&V activities, DSE aids designers, clinicians and program managers to monitor SoS requirement evolution, mitigate integration challenges, and rapidly prototype and evaluate the CDP’s ability to meet clinical use case needs. Application of modern DSE methods enabled design and evaluation of 3 CDP variants supporting 6 clinical use cases, across 3 separate healthcare systems in 18 months.