Product Requirement Specification (PRS) ###################################### !! This Section is Work in Progress. !! This section gathers all product requirements which can also be interpreted as the design input for the ScanHub platform. Steakholder and User Roles ========================== +----------+--------------------------------------------+-----------------------------------------------------------------------------------+ | ID | Stakeholder | Description | +==========+============================================+===================================================================================+ | SH_010 | Medical Professional | Medical professionals who operate or interpret the MRI scans. Operators prepare | | | (MTRA, Radiologist) | patients, ensure optimal image quality, and provide feedback on the system's | | | | usability and functionality. Radiologists interpret the MRI scans to diagnose | | | | medical conditions. | +----------+--------------------------------------------+-----------------------------------------------------------------------------------+ | SH_020 | Scientist | Researchers who use MRI for advanced studies require access to experimental | | | | features, customized sequences (upload) and retrieval of raw data at distinct | | | | stages. | +----------+--------------------------------------------+-----------------------------------------------------------------------------------+ | SH_030 | System Administrator | IT professionals responsible for the setup, maintenance, and security of the | | | | system. They ensure the reliability and data integrity of the system. | +----------+--------------------------------------------+-----------------------------------------------------------------------------------+ | SH_040 | (Field/Service) Engineer | Technical experts responsible for the installation, maintenance, and repair of | | | | the system. They ensure that the hardware as well as software components | | | | are functioning. | +----------+--------------------------------------------+-----------------------------------------------------------------------------------+ | SH_050 | Patient | Individuals undergoing MRI scans. They are concerned with the comfort, safety, | | | | and privacy aspects of the MRI experience. | +----------+--------------------------------------------+-----------------------------------------------------------------------------------+ | SH_060 | Medical Device Manufacturer | Company that produces and distribute the MRI system. It is concerned with the | | | (Regulatory Affairs) | system’s marketability, quality, and regulatory compliance. | +----------+--------------------------------------------+-----------------------------------------------------------------------------------+ | SH_070 | Healthcare Facility / Clinic / Hospital / | Organizations that provide healthcare services and use the MRI system for | | | Research Institution / Customer | patient diagnosis. They are concerned with the system's reliability, efficiency, | | | (Interoperability Manager) | and integration with other healthcare systems IT and healthcare workflows. | +----------+--------------------------------------------+-----------------------------------------------------------------------------------+ User Needs ========== General ------- +----------+---------------------------------------------------------------------------+-----------------------------------------------------------------------------------+---------------------+----------------+----------+ | ID | Product Requirements (Stakeholder) | Design Input | Acceptance Criteria | Intended claim | Priority | +==========+===========================================================================+===================================================================================+=====================+================+==========+ | PRS_0010 | Execution of an MRI acquisition/job/experiment | Upload pulseq sequence, execution MRI job with withflows | | | | | | (Medical Professional, Scientist) | | | | | +----------+---------------------------------------------------------------------------+-----------------------------------------------------------------------------------+---------------------+----------------+----------+ | PRS_0020 | Planning of an MRI examination | Exam-Tree, workflows, processing modality worklist | | | | | | (Medical Professional, Scientist) | | | | | +----------+---------------------------------------------------------------------------+-----------------------------------------------------------------------------------+---------------------+----------------+----------+ | PRS_0030 | DICOM viewer | View DICOM image of a selected record, compare DICOM images, | | | | | | (Medical Professional, Scientist) | annotate DICOM image. | | | | +----------+---------------------------------------------------------------------------+-----------------------------------------------------------------------------------+---------------------+----------------+----------+ | PRS_0040 | User management | Assign different user roles, support of multi-tendency cloud environment | | | | | | (System Administrator) | | | | | +----------+---------------------------------------------------------------------------+-----------------------------------------------------------------------------------+---------------------+----------------+----------+ | PRS_0050 | Monitor device status | Current execution progress, detectable device malfunctiuons, | | | | | | (Medical Professional, Scientist) | device connection | | | | +----------+---------------------------------------------------------------------------+-----------------------------------------------------------------------------------+---------------------+----------------+----------+ | PRS_0060 | Monitor Patient safety | Specific absorption rate (SAR), temparatur, total scan time duration, | | | | | | (Medical Professional) | Optional: Video stream, patient communication system | | | | +----------+---------------------------------------------------------------------------+-----------------------------------------------------------------------------------+---------------------+----------------+----------+ | PRS_0070 | Integration of processing workflows | Assambling of workflow steps to be executed on MRI raw data or images. | | | | | | (Scientist) | Includes system calibration, image reconstruction and analysis. | | | | | | | | | | | +----------+---------------------------------------------------------------------------+-----------------------------------------------------------------------------------+---------------------+----------------+----------+ | PRS_0080 | System calibration | Adjust larmorfrequency, adjust gradients, adjust system flip angle, | | | | | | (Medical Professional, Scientist, Site Engineer) | B0-field shimming | | | | +----------+---------------------------------------------------------------------------+-----------------------------------------------------------------------------------+---------------------+----------------+----------+ | PRS_0090 | Clinical report | Structured form to create a clinical report which allows to fomulate a diagnosis, | | | | | | (Medical Professional) | viewer for clinical reports | | | | +----------+---------------------------------------------------------------------------+-----------------------------------------------------------------------------------+---------------------+----------------+----------+ | PRS_0100 | Device management | Organisation of different devices, device authentification, device selection, | | | | | | (System Administrator, Medical Professional, Medical Device Manufacturer) | device access management (who is trained on which device?) | | | | +----------+---------------------------------------------------------------------------+-----------------------------------------------------------------------------------+---------------------+----------------+----------+ Operational Needs ----------------- +----------+---------------------------------------------+----------------------------------------------+---------------------+------------------------------------------+-------------+ | ID | Product Requirements (Stakeholder) | Design Input | Acceptance Criteria | Intended claim | Priority | +==========+=============================================+==============================================+=====================+==========================================+=============+ | PRS_0010 | Real-time Monitoring (Medical Professional) | - Continuously monitor and display MRI scan | 99% uptime | Ensure real-time monitoring for accurate | Must Have | | | | data in real-time. | | diagnosis. | | | | | - Provide real-time feedback on scan quality | | | | | | | and progress. | | | | | | | - Instant notification for scan completion. | | | | +----------+---------------------------------------------+----------------------------------------------+---------------------+------------------------------------------+-------------+ | PRS_0020 | Alerting (Medical Professional) | Real-time alerts for scan anomalies or | <5 minutes | Rapid response to scan anomalies or | Should Have | | | | issues. | | issues. | | +----------+---------------------------------------------+----------------------------------------------+---------------------+------------------------------------------+-------------+ | PRS_0030 | On-Prem Setup (System Administrator) | Support for on-prem setups. | 100% Compatibility | Provide flexibility in deployment | Must Have | | | | | | options to cater to different | | | | | | | organizational needs. | | +----------+---------------------------------------------+----------------------------------------------+---------------------+------------------------------------------+-------------+ | PRS_0040 | Cloud Setup (System Administrator) | Support for cloud setups in environments | 100% Compatibility | Enable versatile deployment options | Must Have | | | | with no local compute workstations. | | to accommodate varying infrastructure. | | +----------+---------------------------------------------+----------------------------------------------+---------------------+------------------------------------------+-------------+ Regulatory Needs ---------------- +----------+--------------------------------------+--------------------------------------------+---------------------+------------------------------------+--------------+ | ID | User Need (Stakeholder) | Design Input | Acceptance Criteria | Intended claim | Priority | +==========+======================================+============================================+=====================+====================================+==============+ | PRS_0110 | Compliance (Regulatory Affairs) | - Compliance with HIPAA, GDPR, and FDA | 100% Compliance | Ensure compliance with industry | Must Have | | | | regulations. | | regulations for patient safety. | | | | | - Regular updates to adhere to evolving | | | | | | | regulations. | | | | | | | - Detailed logging and audit trails. | | | | +----------+--------------------------------------+--------------------------------------------+---------------------+------------------------------------+--------------+ | PRS_0120 | Data Security (System Administrator) | Strong data encryption and role-based | 100% Compliance | Secure patient data and adhere to | Nice to Have | | | | access control. | | compliance requirements. | | +----------+--------------------------------------+--------------------------------------------+---------------------+------------------------------------+--------------+ | PRS_0130 | Compliance with ISO 14971:2019 | Implementation of Risk Mitigation Measures | 100% Compliance | Minimize risks associated with the | Must Have | | | (Regulatory Affairs) | (RMM) in adherence to ISO 14971:2019. | | system operation. | | +----------+--------------------------------------+--------------------------------------------+---------------------+------------------------------------+--------------+ Reliability and Resilience Needs -------------------------------- +----------+-----------------------------+-----------------------------------------+---------------------+------------------------------------+-----------+ | ID | User Need (Stakeholder) | Design Input | Acceptance Criteria | Intended claim | Priority | +==========+=============================+=========================================+=====================+====================================+===========+ | PRS_0210 | Reliability (Field Engineer)| System stability with minimum downtime. | 99.99% uptime | Maintain a reliable and stable MRI | Must Have | | | | | | acquisition system. | | +----------+-----------------------------+-----------------------------------------+---------------------+------------------------------------+-----------+ Usability Needs --------------- +----------+--------------------------------------+---------------------------------------------+---------------------+-------------------------------------+--------------+ | ID | User Need (Stakeholder) | Design Input | Acceptance Criteria | Intended claim | Priority | +==========+======================================+=============================================+=====================+=====================================+==============+ | PRS_0310 | User-Friendly (Medical Professional) | - Intuitive UI for scan setup and patient | <30 minutes | Streamline user interaction for | Should Have | | | | management. | onboarding | increased productivity. | | | | | - Comprehensive user manuals and guides. | | | | | | | - Quick access to frequently used features. | | | | +----------+--------------------------------------+---------------------------------------------+---------------------+-------------------------------------+--------------+ | PRS_0320 | Advanced Features (Scientist) | Access to raw MRI data and experimental | N/A | Facilitate sequence development and | Nice to Have | | | | sequence options. | | research. | | +----------+--------------------------------------+---------------------------------------------+---------------------+-------------------------------------+--------------+ Interoperability Needs ---------------------- +----------+--------------------------------------+-------------------------------------------+---------------------+----------------------------------------+-------------+-----+ | ID | User Need (Stakeholder) | Design Input | Acceptance Criteria | Intended claim | Priority | | +==========+======================================+===========================================+=====================+========================================+=============+=====+ | PRS_0410 | Interoperability | Compatibility with various DICOM systems. | N/A | Seamless integration with existing | Should Have | | | | (Medical Device Manufacturer) | | | healthcare systems. | | | +----------+--------------------------------------+-------------------------------------------+---------------------+----------------------------------------+-------------+-----+ | PRS_0420 | Data Storage (Medical Professional) | Support for XNAT storage. | N/A | Ensure compatibility with widely used | Must Have | | | | | | | medical imaging data storage formats. | | | +----------+--------------------------------------+-------------------------------------------+---------------------+----------------------------------------+-------------+-----+ | PRS_0430 | File Format (Medical Professional) | Support for NIFTI file format. | N/A | Facilitate diverse data representation | Must Have | | | | | | | and interoperability. | | | +----------+--------------------------------------+-------------------------------------------+---------------------+----------------------------------------+-------------+-----+ | PRS_0440 | File Format (Scientist) | Support for ISMRMRD file format. | N/A | Facilitate diverse data representation | Must Have | | | | | | | and interoperability. | | | +----------+--------------------------------------+-------------------------------------------+---------------------+----------------------------------------+-------------+-----+ | PRS_0450 | File Format (Scientist) | Support for RAW MR file format. | N/A | Facilitate diverse data representation | Must Have | | | | | | | and interoperability. | | | +----------+--------------------------------------+-------------------------------------------+---------------------+----------------------------------------+-------------+-----+ Maintainability Needs --------------------- +----------+------------------------------------+-----------------------------------------+---------------------+---------------------------------------+-------------+ | ID | User Need (Stakeholder) | Design Input | Acceptance Criteria | Intended claim | Priority | +==========+====================================+=========================================+=====================+=======================================+=============+ | PRS_0510 | Scalability (System Administrator) | - Scalable architecture to accommodate | <10% degradation | Ensure system performance as data and | Should Have | | | | increasing data and users. | at 2x data | users grow. | | | | | - Modular design for easy updates and | | | | | | | enhancements. | | | | | | | - Efficient data management and storage | | | | | | | solutions. | | | | +----------+------------------------------------+-----------------------------------------+---------------------+---------------------------------------+-------------+ System Interfaces to Third Party Solution Needs ----------------------------------------------- +----------+-------------------------------+-----------------------------------+---------------------+------------------------------------+-----------+ | ID | User Need (Stakeholder) | Design Input | Acceptance Criteria | Intended claim | Priority | +==========+===============================+===================================+=====================+====================================+===========+ | PRS_0610 | Patient Monitoring Systems | Seamless interaction with patient | Real-time data | Ensure real-time data exchange and | Must Have | | | (Medical Device Manufacturer) | monitoring systems. | exchange | patient safety. | | +----------+-------------------------------+-----------------------------------+---------------------+------------------------------------+-----------+