How Cytovale Transformed Change Impact Assessment with Ketryx AI

Cytovale's breakthrough AI-enabled diagnostic system analyzes a patient’s risk of sepsis in under 10 minutes, a critical capability for emergency departments to triage patient care. Cytovale faced a common challenge for cleared medical device companies: how to continuously improve their product while managing the rigorous traceability and documentation required by FDA regulations. With requirements in Polarion, test protocols in separate systems, and hardware specifications across multiple tools, their engineering team spends considerable effort gathering the materials to perform the impact analysis of proposed design changes.

In a case study evaluation of Ketryx AI and where it could help expedite the impact analysis and planning phase of a design change, the Cytovale team recognized the potential for a strong ROI eliminating bottlenecks, achieving 70% reduction in time spent, and with 90% accuracy in analysis when compared to an engineer drafted plan.

Impact

70%

Faster documentation

Eliminated

SME bottlenecks

90%

AI accuracy

Industry

Life Science / In Vitro Diagnostics

Device Type

AI-enabled, Class II Diagnostic System

Tech Stack

Polarion

Customer Pain Points: Manual Change Assessment Created Multi-Week Bottlenecks

• Change Assessment: Understanding what requirements, risks, and tests would be impacted by a proposed change currently requires up to weeks of analysis, depending on the complexity of the change.
• Subject Matter Expert Bottlenecks: Complex systems require consulting multiple SMEs to assess impacts, creating scheduling bottlenecks and delays.
• High Overhead, Low Value Work: Engineers spend significant time on information gathering and synthesis of a plan. This delays the execution of the design and extended timelines delaying design implementation to advance business goals and ultimately improve patient outcomes.

Ketryx Solution: AI-Powered Engineering Thought Partnership

Cytovale is in the process of piloting Ketryx as an engineering tool that combines AI agents with unified traceability to accelerate the drafting of change impact assessments across its hardware and software platform.

• Unified Traceability Across Tools: Ketryx connects requirements from Polarian with test protocols, code, and other artifacts in a single interface, reducing manual information gathering across disparate systems.
• Agentic AI for Impact Assessment: Ketryx AI reads hardware description documents, software specifications, requirements, and risk documentation to generate comprehensive impact assessments that identify affected requirements, propose testing strategies, and draft supporting rationale.
• Reduced SME Bottlenecks: Ketryx AI outputs may be used by the team to bounce off ideas and challenge their thinking, even when subject matter experts aren't immediately available, accelerating initial scoping and planning.
• Guardrails: Establishing human-in-the-loop workflows to review all AI-generated outputs, alongside defined procedural guidelines to verify preliminary drafts.

Deep Dive: AI-Powered Multi-Step Engineering Reasoning

Ketryx AI has the capability to perform system analysis across Cytovale's complex hardware-software system:

• Systematic Impact Analysis: Ketryx AI reads hardware description documents to understand how systems connect and interact, tracing multi-step logic across mechanical assemblies, pneumatic systems, and software components to aide in identification of downstream impacts that require engineering judgment.
• Multiple Perspectives in Parallel: Engineers work with Ketryx to generate multiple perspectives on how changes can be viewed. Ketryx generates multiple strategies with a clear rationale for each requirement's impact status, enabling teams to evaluate tradeoffs and select the optimal approach.
• Novel Engineering Insights: Ketryx AI identifies simplified assessment strategies and alternative interpretations the team hadn't initially considered, improving both the quality and efficiency of change decisions.

Business Outcomes: Dramatically Accelerated Change Planning

Through the case study Ketryx was shown to deliver measurable improvements to Cytovale's engineering workflows:

• 70% Faster Documentation: Ketryx accelerates change impact assessments by linking disconnected tools and AI-augmented reviews.
• 90% AI Accuracy: Ketryx AI correctly identifies the majority of impacted requirements, while flagging additional impacts for additional consideration.
• Engineers Focus on Decisions: The AI tool has the potential to allow teams to shift from information gathering to decision-making, focusing on safety-critical technical decisions rather than administrative overhead. ‍
• Faster Response to Critical Issues: Cytovale believes this may now allow them to scope change impacts in minutes instead of days, enabling same-day leadership communication, immediate resource planning, and reduced reactivity.

Ketryx was shown to have the potential to replace chasing documents with connected traceability. Critical engineering information that used to take hours to connect across multiple tools may now be done in minutes in one place with the help of Ketryx.

Cedar Farwell

Staff Product Development Engineer