Product Requirement Specification (PRS)#

Note

This section is a work in progress.

This section gathers the product requirements for the ScanHub platform, derived from stakeholder and user needs. It forms the design input from which the Software Requirements Specification and, ultimately, the Software Architecture Design Description are derived.

Stakeholders and User Roles#

The table below lists the stakeholder groups considered when deriving the product requirements. Each stakeholder ID is referenced from the requirement tables below to indicate who a given need originates from.

ID

Stakeholder

Description

SH_010

Medical Professional (MTRA, Radiologist)

Medical professionals who operate or interpret the MRI scans. Operators prepare 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 and 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 and software components are functioning correctly.

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 (Regulatory Affairs)

Company that produces and distributes the MRI system. It is concerned with the system’s marketability, quality, and regulatory compliance.

SH_070

Healthcare Facility / Clinic / Hospital / Research Institution / Customer (Interoperability Manager)

Organizations that provide healthcare services and use the MRI system for patient diagnosis. They are concerned with the system’s reliability, efficiency, and integration with other healthcare IT systems and workflows.

User Needs#

The following tables translate the stakeholder concerns above into concrete, prioritized product needs. Each need is assigned a unique PRS_xxxx ID that is referenced from the corresponding software requirement in the SWRS.

General#

Needs that apply broadly to everyday use of the platform, covering the core acquisition, planning, viewing, and administrative capabilities.

ID

Product Requirement (Stakeholder)

Design Input

Acceptance Criteria

Intended Claim

Priority

PRS_0010

Execution of an MRI acquisition/job/experiment (Medical Professional, Scientist)

Upload Pulseq sequence, execute MRI job with workflows

PRS_0020

Planning of an MRI examination (Medical Professional, Scientist)

Protocol tree, workflows, processing modality worklist

PRS_0030

DICOM viewer (Medical Professional, Scientist)

View DICOM image of a selected record, compare DICOM images, annotate DICOM image

PRS_0040

User management (System Administrator)

Assign different user roles, support multi-tenancy cloud environment

PRS_0050

Monitor device status (Medical Professional, Scientist)

Current execution progress, detectable device malfunctions, device connection

PRS_0060

Monitor patient safety (Medical Professional)

Specific absorption rate (SAR), temperature, total scan time duration; optional video stream and patient communication system

PRS_0070

Integration of processing workflows (Scientist)

Assembling of workflow steps to be executed on MRI raw data or images, including system calibration, image reconstruction, and analysis

PRS_0080

System calibration (Medical Professional, Scientist, Site Engineer)

Adjust Larmor frequency, adjust gradients, adjust system flip angle, B0-field shimming

PRS_0090

Clinical report (Medical Professional)

Structured form to create a clinical report allowing formulation of a diagnosis, viewer for clinical reports

PRS_0100

Device management (System Administrator, Medical Professional, Medical Device Manufacturer)

Organization of different devices, device authentication, device selection, device access management (who is trained on which device?)

Operational Needs#

Needs related to how reliably and flexibly the system runs once deployed, independent of a specific clinical workflow.

ID

Product Requirement (Stakeholder)

Design Input

Acceptance Criteria

Intended Claim

Priority

PRS_0710

Real-time monitoring (Medical Professional)

  • Continuously monitor and display MRI scan data in real time.

  • Provide real-time feedback on scan quality and progress.

  • Instant notification for scan completion.

99% uptime

Ensure real-time monitoring for accurate diagnosis.

Must Have

PRS_0720

Alerting (Medical Professional)

Real-time alerts for scan anomalies or issues.

< 5 minutes

Rapid response to scan anomalies or issues.

Should Have

PRS_0730

On-prem setup (System Administrator)

Support for on-prem setups.

100% compatibility

Provide flexibility in deployment options to cater to different organizational needs.

Must Have

PRS_0740

Cloud setup (System Administrator)

Support for cloud setups in environments with no local compute workstations.

100% compatibility

Enable versatile deployment options to accommodate varying infrastructure.

Must Have

Regulatory Needs#

Needs driven by applicable healthcare, data-protection, and medical-device regulations that the platform must comply with.

ID

Product Requirement (Stakeholder)

Design Input

Acceptance Criteria

Intended Claim

Priority

PRS_0110

Compliance (Regulatory Affairs)

  • Compliance with HIPAA, GDPR, and FDA regulations.

  • Regular updates to adhere to evolving regulations.

  • Detailed logging and audit trails.

100% compliance

Ensure compliance with industry regulations for patient safety.

Must Have

PRS_0120

Data security (System Administrator)

Strong data encryption and role-based access control.

100% compliance

Secure patient data and adhere to compliance requirements.

Nice to Have

PRS_0130

Compliance with ISO 14971:2019 (Regulatory Affairs)

Implementation of Risk Mitigation Measures (RMM) in adherence to ISO 14971:2019.

100% compliance

Minimize risks associated with system operation.

Must Have

Reliability and Resilience Needs#

Needs concerning system uptime and the ability to keep operating dependably over time.

ID

Product Requirement (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 acquisition system.

Must Have

Usability Needs#

Needs concerning ease of learning and day-to-day efficiency for platform users.

ID

Product Requirement (Stakeholder)

Design Input

Acceptance Criteria

Intended Claim

Priority

PRS_0310

User-friendly (Medical Professional)

  • Intuitive UI for scan setup and patient management.

  • Comprehensive user manuals and guides.

  • Quick access to frequently used features.

< 30 minutes onboarding

Streamline user interaction for increased productivity.

Should Have

PRS_0320

Advanced features (Scientist)

Access to raw MRI data and experimental sequence options.

N/A

Facilitate sequence development and research.

Nice to Have

Interoperability Needs#

Needs concerning the exchange of data with third-party systems and standard medical imaging formats.

ID

Product Requirement (Stakeholder)

Design Input

Acceptance Criteria

Intended Claim

Priority

PRS_0410

Interoperability (Medical Device Manufacturer)

Compatibility with various DICOM systems.

N/A

Seamless integration with existing healthcare systems.

Should Have

PRS_0420

Data storage (Medical Professional)

Support for XNAT storage.

N/A

Ensure compatibility with widely used medical imaging data storage formats.

Must Have

PRS_0430

File format (Medical Professional)

Support for NIfTI file format.

N/A

Facilitate diverse data representation and interoperability.

Must Have

PRS_0440

File format (Scientist)

Support for ISMRMRD file format.

N/A

Facilitate diverse data representation and interoperability.

Must Have

PRS_0450

File format (Scientist)

Support for raw MR file format.

N/A

Facilitate diverse data representation and interoperability.

Must Have

Maintainability Needs#

Needs concerning the ability to evolve, scale, and update the platform over its lifetime without degrading performance.

ID

Product Requirement (Stakeholder)

Design Input

Acceptance Criteria

Intended Claim

Priority

PRS_0510

Scalability (System Administrator)

  • Scalable architecture to accommodate increasing data and users.

  • Modular design for easy updates and enhancements.

  • Efficient data management and storage solutions.

< 10% degradation at 2x data

Ensure system performance as data and users grow.

Should Have

System Interfaces to Third-Party Solution Needs#

Needs concerning integration with external systems that are not part of ScanHub itself, such as patient monitoring equipment.

ID

Product Requirement (Stakeholder)

Design Input

Acceptance Criteria

Intended Claim

Priority

PRS_0610

Patient monitoring systems (Medical Device Manufacturer)

Seamless interaction with patient monitoring systems.

Real-time data exchange

Ensure real-time data exchange and patient safety.

Must Have