How a Medical Device Leader Reduced Change Impact Assessment from Days to Minutes with Ketryx AI

Customer pain points

Time-Consuming Manual Change Management Processes

The company faced challenges related to time-consuming manual change impact analysis work, partly due to disconnected tooling.

• Manual Change Management: Finding requirements impacted by a change took up to 15 days per change, depending on change scope. 
• Slower Bug Fixes: Manual change impact assessment processes made change planning challenging, slowing patches, bug fixes, and new features. 
• Process Bottlenecks: The team had to wait on subject matter experts to review change impacts, slowing release time. 

‍

Ketryx solution

Agentic AI and Visual Traceability

Ketryx provided a solution to centralize data from Polarion, key documents, and other tooling and automate complex tasks like change impact analysis. 

• Agentic AI: Ketryx utilizes agentic AI that acts directly on the company's product data to build a semantic and relational understanding of the company’s systems, documents, requirements, and risks. 
• Visual Traceability Across Tools: Ketryx links and syncs requirements, risks, tickets, and other items across tools like Polarion, GitHub, and Jira with visual traceability and editability.
• Automatic Document Generation: Ketryx automatically generates procedural documents at the end of each software change, summarizing open risks and anomalies, explaining mitigations or deferrals, and pulling in other required reports to save significant time and effort. 

‍

Business outcomes

Accelerated Change Management 

Ketryx demonstrated significant and immediate benefits:

• Time Savings: Ketryx delivered a draft impact assessment in minutes. For critical software bugs, this capability reduces initial planning from up to 15 days per change to just minutes. Because scope changes quickly, this enables immediate change planning that’s critical for quick turn patches or bug fixes and new feature timeline acceleration. 
• High-Accuracy AI Impact Assessment: Ketryx correctly identified the requirements in the original change plan, aligning them with the team’s impact assessment in minutes and providing clear rationale for excluded requirements.
• Proactive Requirement and Risk Generation: Ketryx drafted 20+ new suggested software and module requirements for review, along with an updated risk assessment and a list of requirements that would need retesting. 

‍

Future use cases

Faster Bug Fixes and Document Generation

The company plans to use Ketryx AI Agents for additional use cases: 

• Utilizing AI to scope fixes for critical software bugs would reduce initial planning from days to minutes, enabling immediate leadership communication, same-day resource planning, faster customer updates, and shorter release timelines. 
• Autogenerating procedural change documents after software changes with Ketryx would reduce document generation time from 5 FTE days to minutes. 
• Ketryx finds and drafts changes needed between requirements and tracking documents, a process that is currently manual, time-consuming, and error-prone. Ketryx automatically flags changes to keep documents in sync with requirements for up-to-date traceability. 
• Instead of manually drafting and routing validation documents, teams generate, execute, and approve changes in one place with Ketryx. Ketryx keeps traceability and compliance up to date automatically, reducing validation cycles from days to hours, and maintaining alignment between software, tests, and quality records.
• Ketryx Agents check for redundant requirements and overlap, suggest requirement edits based on requirements best practices, and find test case coverage gaps.