Development of an Automated Spectroscopy-Based Diagnostic Software for Early Cancer Detection

The client requires a robust, regulatory-compliant software platform that can transform raw spectroscopic data into accurate, binary diagnostic results without requiring specialist interpretation. Existing methods involve manual interpretation of scripts which are time-consuming, error-prone, and lack compliance with medical standards, impeding rapid deployment and regulatory approval.

A mid-sized healthcare technology company specializing in innovative diagnostic solutions aiming to improve early cancer detection through spectroscopy and machine learning integration.

• Develop a stable, automated software solution capable of processing raw spectral data from multiple spectrometer brands to deliver binary diagnostic outputs.
• Ensure full compliance with medical device regulations such as ISO 13485, IEC 62304, and IVDR risk class C, including comprehensive documentation.
• Translate existing MATLAB scripts into a Python-based application to enhance scalability, maintainability, and integration capabilities.
• Implement automated testing, quality assurance, and risk assessment processes aligned with medical standards.
• Create a user-friendly, reliable end-product that simplifies interpretation and accelerates clinical decision-making.

• Data ingestion module supporting multiple spectrometer data formats
• Automated preprocessing and spectral data normalization
• Conversion of legacy MATLAB scripts into optimized Python routines
• Implementation of machine learning models for classification tasks
• Automated validation and error handling mechanisms
• Comprehensive software documentation adhering to regulatory standards
• Reporting and audit trail features for regulatory audits
• Automated testing framework to ensure ongoing stability and performance

• Spectrometer device data input interfaces
• Laboratory information systems (LIS) or hospital data systems for seamless data exchange
• Regulatory submission systems for documentation management

• High system availability and stability, supporting continuous operation
• Compliance with ISO 13485, IEC 62304, IVDR, and other relevant regulatory standards
• Data security and patient privacy aligned with GDPR and healthcare data policies
• Scalability to support expansion to additional spectrometer models and increased data volume
• Performance benchmarks ensuring real-time or near-real-time processing of spectral data

The developed software aims to enable rapid, reliable, and accurate early cancer diagnostics, reducing manual interpretation errors and accelerating clinical decision-making. It will facilitate regulatory approval and market deployment, potentially increasing diagnostic throughput and improving patient outcomes while ensuring full compliance with medical standards.