Fortune 500 Diagnostics - Ketryx
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From quarterly to weekly: How a Fortune 500 diagnostics company transformed its release cycle
One of the world's largest in vitro diagnostics companies, a Fortune 500 organization, develops software-driven diagnostic systems used in clinics and laboratories worldwide. At that scale, the ability to release fast without compromising regulatory standards is critical. Every delay has downstream consequences on patient workflows.
After implementing Ketryx, the company reduced its end-to-end release cycle from three months to one week, shortened documentation time by 70%, and eliminated more than half of its existing tooling costs. Engineering and quality teams that once spent release cycles catching up on compliance now reinvest that capacity toward advancing the product.
Impact
Three months to one week
End-to-end release cycles
70%
Reduction in documentation time
50%+
Savings in tooling costs
Industry
IVD
Device Type
Diagnostics + SaMD
Tech Stack
Jira, GitHub
Pain Point: Engineering was not the bottleneck. Compliance was.
Code was routinely wrapped and ready to push well before the release window opened. The delay lived in compliance, but the problem wasn't processes or standards. It was the tooling meant to manage it:
- Tool sprawl created hidden compliance gaps: Teams worked across separate systems with inconsistent adoption and processes. Work duplicated, records were misaligned, and compliance risk quietly accumulated in the gaps between platforms.
- Documentation trailed every release: Every development cycle ended in a documentation sprint, with QA and R&D cleaning up old releases instead of preparing for the next ones.
- Compliance issues surfaced when they were most expensive to fix: Gaps stayed invisible until teams were already deep in the release process, when resolving them was slow, costly, and disruptive to future release timelines
Solution: Quality built into existing workflows. No migration required.
Jira, GitHub, and the rest of the engineering toolchain remained intact. Ketryx overlaid the environment around those tools, embedding compliance infrastructure without requiring a platform migration.
- Compliance at the point of work: Quality controls and traceability embedded into engineering workflows, with no new platform for engineers to learn or maintain
- Real-time traceability across the full development stack: Requirements, risks, tests, and designs linked end-to-end across connected tools and ALMs
- Automated evidence generation: Compliance documentation populated automatically as a byproduct of engineering activity
Business Outcome: 90% Faster Release Cycle
- 3 months to 1 week: Embedding compliance into existing workflows stopped rework from accumulating at the end of every cycle and unlocked 90% faster releases
- 70% reduction in documentation time: Continuous traceability standardizes a baseline of regulatory readiness, so documentation no longer piles up between releases
- >50% savings in tooling costs: Staying in existing tools let the team consolidate their compliance stack without replacing what already worked
“I almost can't believe it, but as your website says, we did reduce our documentation time by over 90%.”
Senior Product Lead
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