About the project

Canostix is a group of scientists working on a revolutionary method of cancer diagnosis using photonics and machine learning. The technique will enable doctors to detect various cancer types at an early stage, allowing patients to benefit from less invasive and more effective treatments. 

The client invented a new way of blood testing using spectroscopy to differentiate bet­ween patients with and without cancer with excellent accuracy. 

The end product - CancerScan - doesn’t need a specialist to interpret the outcomes, as the device produces a reliable result with high accuracy. 

What did our client need? 

Canostix came to us with very thought-through, innovative project ideas in the field of diagnostics / laboratory software. The client needed a healthcare-experienced software development partner to make their idea a ready product.

There was a need for an external company to redevelop the MatLab script to a ready-to-use solution. The whole process had to be compliant with ISO 13485, IEC 62304 and IVDR risk class C, that includes software documentation.

How did we help to approach it? 

We provided a service of Managed Project with a team of two developers, Michał and Przemek, and Marta, a Project Leader with a PhD and academic background in the field of BioTech.

Our work was focused on: 

• setting business goals 

• review of client’s materials - Matlab scripts and documentation 

• setting technical goals for project including translating Matlab scripts into Python

• translation of Matlab scripts to Python console application according to technical and medical requirements

• code review - a standard procedure of our ISO process

• software documentation - quality assurance and risk assessment needed for regulatory reasons

Responding to our client's needs, we organised the development process in accordance with ISO/IEC 62304 within the client's Quality Management System (QMS). We created a simplified lean process tailored to the size of the project. It followed the requirements of our client and medical regulations/standards. 

We coordinated the software development process in a Kanban project management framework. Together with the client, we chose Jira, Slack and emails as communication channels on which we were available daily. 

We also regularly uploaded and reviewed MDR & ISO 13485 implementation documentation in the Confluence documentation system (by Atlassian).

What have we delivered? 

We developed a Python-based SiMD, including automated testing and documentation, that could receive data from multiple types of input devices and process raw data to provide a binary diagnostic result.

• ISO 13485 certified process of Software Development

• Fully automated and stable end-product

• Solution applicable for diverse brands of spectrometers

• Ready-to-use software documentation compliant with ISO & MDR requirements