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How Beacon Biosignals Reduced Their Release Cycle to Two Weeks for AI/ML Products with PCCPs

Beacon Biosignals is a pioneer in the FDA’s latest guidance around machine learning and AI in medical devices. In 2024, Beacon received two of the FDA’s 44 total Predetermined Change Control Plan (PCCP) authorizations, ensuring both their hardware and software products remain cutting-edge. Their products combine wearable technology and AI-driven analytics to transform and enhance the treatment of neurologic, sleep, and psychiatric diseases. Their scalable solution combines FDA-cleared devices and software, machine learning algorithms, and extensive datasets to accelerate drug development by providing rapid and precise analysis of brain data.

Impact

50%

Reduction in release cycle time

75%

Reduction in documentation cycle time

Industry

Medical Device

Device Type

AI Platform, Wearables

Tech Stack

Jira, GitHub

Customer pain points

Manual traceability created inefficiencies

Before Ketryx, the Beacon Biosignals team spent many hours on highly manual documentation and traceability processes, leading to longer release cycles.

• Manual Documentation: Documentation process for updating requirements and specifications was extremely labor-intensive, significantly slowing down their development workflow.
• Traceability Breaks: Time consuming to keep traceability up-to-date with manual and error-prone methods such as Word documents and Excel spreadsheets.
• Redundant Efforts: Generation of test plans and reports for software testing that was already automated and documented in code was redundant and effortful.
• Microservice Complexity: Needed to manage a microservice architecture with varying regulatory requirements across components, but found traditional documentation approaches inflexible.

The Ketryx solution

A self-documenting SDLC

Beacon Biosignals sought a developer-centric solution to streamline SDLC management and selected Ketryx to achieve the following objectives:

• Establishing Traceability: Automated traceability in Ketryx significantly decreases manual effort and errors in maintaining documentation for both hardware and software, including the PCCP for their machine learning algorithm.
• Automated Tests: Integration with GitHub Actions automates test execution logging, streamlining the development process. ‍
• SBOM Support: With Ketryx, uploading an SPDX and maintaining an accurate Software Bill of Materials (SBOM) became effortless. This capability streamlines risk analysis of software dependencies, reducing errors and enhancing overall efficiency.
• Engineering Controls: Beacon uses Ketryx to enforce the strong technical and procedural controls in their PCCPs that prevent overfitting of the test dataset.

Business outcomes

Faster validated releases

With Ketryx, the Beacon Biosignals team quickly realized several key benefits:

• Faster Releases: Reduced release cycles from four weeks to two weeks while significantly enhancing documentation quality and keeping AI/ML software updates aligned with FDA expectations outlined in their PCCP.
• Reduced Documentation Time: Achieved a 75% reduction in documentation cycle time, with the generation of necessary documents now instantaneous.
• End-to-End Traceability: Ketryx automatically generated clear traceability and referencing within complex microservice architecture. ‍
• Automated Testing Efficiency: Ketryx increased agility by integrating automated testing into the developer workflow and made it easy to document the results of comprehensive testing for every release.

“Ketryx has allowed us to channel our hardware and software engineers’ existing set of development, testing, and documentation practices directly into the generation of compliant documentation with minimal additional burden. This has allowed us to remain agile while delivering high-quality products.”

Alexander Chan

VP of Analytics and Machine Learning

How Beacon Ships AI Updates Every Two Weeks with FDA-Authorized PCCPs

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Hear directly from Alex Chan, VP of Analytics and Machine Learning at Beacon Biosignals, on why his team pursued two PCCP authorizations and built an agile, FDA-compliant release process that ships every two weeks. He shares the processes and lessons that helped Beacon stay ahead of evolving AI/ML regulations while moving fast.