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How Heartflow Reduced Complexity by 90% in 10 Weeks with a System of Systems

HeartFlow is a pioneering SaMD company transforming the diagnosis and treatment of cardiovascular disease with its non-invasive, AI-enabled cardiac test used in conjunction with standard CT scans. HeartFlow leverages deep learning and computational fluid dynamics to establish a new standard in cardiovascular care, servicing over 250,000 patients at more than 1000 hospitals worldwide to date. With Ketryx, HeartFlow achieved a system of systems architecture, end-to-end traceability, and automated documentation, all within the tools they were already using (Jira, GitHub), all in just 10 weeks.

Impact

90%

Reduction in complexity

10

Weeks to fully implement system of systems architecture

250,000

Patients served

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Industry
SaMD
Device Type
AI-Enabled, Cardiovascular
Tech Stack
Jira, GitHub

Customer pain points

Documentation and approvals delayed releases

As an AI-first company, HeartFlow uses modern development tools, but like most companies in the industry, faced challenges creating compliance documents efficiently, managing approval workflows, and ensuring accurate traceability.

• DevTool-Associated Documentation Burden: Integration issues between existing DevTools required costly custom-built solutions, like custom scripts, to ensure traceability. These scripts were time-consuming to maintain and validate and used valuable developer resources.
• Complex Monolithic Architecture: The monolithic structure of over 100,000 items created a high level of complexity and made the release and documentation processes inefficient.
• Burdensome Traceability Matrix: To establish traceability, teams relied on manual processes and scripts to compile data from multiple sources. This workflow was cumbersome and error-prone, and consumed significant time and resources.
• Lack of Usability: Their existing eQMS lacked adequate integration with essential tools like Jira, impacting workflows and productivity.
• Isolation of Quality from Development Processes: After the introduction of a new eQMS, the team recognized the growing distance between their quality management system processes and the agile medical device software development workflows.

The Ketryx solution

Real-time traceability and automated processes

HeartFlow sought a solution to streamline SDLC management and selected Ketryx to achieve the following objectives:

• Reduced Documentation Burden and Maintenance: Ketryx automates the generation and management of documentation from within their preferred DevTools like Jira and GitHub, eliminating the need for custom scripts and allowing developers to focus on product development.
• Streamlined and Integrated Approval Workflow: Ketryx integrates approval processes within tools like Jira and GitHub, eliminating system-switching and enhancing efficiency.
• Enhanced Visibility and Traceability: Ketryx provides real-time visibility into quality control and traceability matrices, simplifying oversight and ensuring comprehensive coverage of requirements and tests.
• Enforcement: Workflow-driven compliance guardrails invisibly guide developers to perform the right actions and prevent process deviation in their DevTools while providing peace of mind to the Quality team.
• Intuitive for R&D and Quality: Ketryx offered an intuitive solution that is invisible to developers with workflow-driven enforcement, automated documentation, and guided workflows for the Quality team.

Business outcomes

Agile workflows for a more productive future

With Ketryx, the HeartFlow team quickly realized several key benefits in just 10 weeks:

• Streamlined System of Systems and Component Reuse: Ketryx broke down HeartFlow’s complex monolithic architecture of over 100,000 items into a modular system of systems, deprecating 90,000 items and allowing the team to reuse and revise various components across different products.
• End-to-End Traceability: The native Jira integration and automated workflows provided by Ketryx enhance traceability, readability, and compilation of content, improving overall quality management and regulatory compliance.
• Aligned R&D and Quality: Ketryx improved the workflow between R&D and Quality teams and processes, resulting in enhanced collaboration and efficiency.

“Ketryx supports our system of systems architecture really easily out of the box. We were able to migrate our monolithic ecosystem into a single project and break it down into a desired state just within a couple of days. Ketryx delivered that because it was designed to scale. That was a huge plus.”

Emre Gültürk
VP of Regulatory Affairs and Quality Systems

“The fewer tools that my developers have to worry about, the better, because they should be worrying about saving people's lives with AI through our products. They don't need to be worrying about yet another tool to make sure that they can get our technology out there.”

Allan Snippen
VP of Engineering

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