Transforming Lifecycle Management

Ketryx Briefing Note

Axendia was recently briefed by Erez Kaminski, founder and CEO of Ketryx.  After leading AI initiatives at Amgen, Kaminski saw firsthand how legacy systems hindered innovation. He founded Ketryx in 2021 to bridge the gap between modern software development practices and the stringent requirements of regulated environments.

Ketryx positions itself as a “connected lifecycle management platform,” an overlay that integrates seamlessly with existing tools like Jira, GitHub, and AWS. The company’s mission is to reduce complexity, automate compliance evidence generation, and accelerate product release cycles without sacrificing quality or safety.

Regulated industries are at a crossroads, with increasing product complexity, tighter compliance requirements, and a growing need for rapid innovation. Whether it’s software-enabled medical devices or AI-driven diagnostics, companies face challenges such as duplicate documentation, inefficient traceability, and prolonged release cycles.

“The systems built for simpler products like insulin pumps cannot handle today’s interconnected devices spanning sensors, cloud systems, and machine learning models,” said Kaminski.

Image Source: Courtesy of Ketryx

Ketryx addresses these challenges by creating a unified framework.

Adapts to diverse requirements across multiple projects, devices, or regulatory standards.

Automates evidence generation for FDA and global regulators.

Supports traceability across tools without duplicating work.

Supporting Compliance and Innovation in Life Sciences

“Unlike traditional Application Lifecycle Management (ALM) or Product Lifecycle Management (PLM) tools, Ketryx operates as an interoperable overlay that works across existing systems. Instead of forcing companies to adopt a single monolithic platform, it enhances tools already in use,” explained Kaminski.

The big challenge with so many different applications is managing them all—especially for CIOs and digital transformation leaders who have to juggle licenses from multiple vendors. “Fit-for-purpose tools are great, but connecting and streamlining them is where the real value lies. It’s about finding a balance: reducing the number of tools you use without losing functionality, which is especially important in industries where mergers and acquisitions often leave you with overlapping systems,” added Kaminski.

Image Source: Courtesy of Ketryx

Kaminski also offered how Ketryx differentiates itself in the market and added, “For some companies, we’re taking them 50 years into the future compared to where they are now.”

  1. Fit-for-Purpose Integration: Ketryx connects with widely used development tools, avoiding the pitfalls of niche systems that require specialized knowledge. “With Ketryx, you can hire any developer in the world without training them on outdated systems,” explained Kaminski.
  2. Automation of Compliance: By enforcing processes and generating real-time compliance evidence, Ketryx reduces manual work and speeds up approvals. This includes supporting ISO 62304 compliance, a notable achievement for a non-medical device IT system.
  3. Generative AI for Lifecycle Tasks: From creating test cases to summarizing release notes, Ketryx leverages generative AI to streamline lifecycle activities, offering suggestions while keeping the human in the loop for validation.
  4. Alignment with Computer Software Assurance (CSA):  Ketryx’s approach to integrating Quality Management Systems (QMS) with existing development tools aligns with the FDA’s evolving stance on CSA. The draft guidance emphasizes a risk-based approach to establish confidence in automation used for production or quality systems, moving away from traditional validation methods. This shift aims to reduce the burden of compliance and encourage the adoption of advanced technologies in regulated industries.

By automating compliance evidence generation and ensuring traceability across tools, Ketryx supports the FDA’s objectives of enhancing product quality and patient safety through modernized manufacturing operations. Its alignment with CSA principles positions Ketryx as a forward-thinking solution for life sciences companies seeking to streamline compliance processes and accelerate innovation.

For a deeper understanding of CSA, we invite our subscribers to read more here.

A Vision for the Future

As regulatory requirements evolve, Ketryx is seeking to push the boundaries of what’s possible in regulated industries. The platform is built to grow, with a roadmap that includes advanced AI for reverse-engineering legacy systems and further automating compliance.

Kaminski pointed out leading companies in medical devices and biotech, like HeartFlow and Foresight Diagnostics, have reported dramatic reductions in documentation time (up to 90%) and moved to faster release cycles with Ketryx. And its flexibility in managing complex systems makes it a viable solution for biotech firms balancing rapid innovation with stringent compliance.

“Our approach isn’t just about solving today’s problems; it’s about preparing life sciences for the next generation of innovation. We’re building the future of regulated software and product development, making it as simple as creating regular software—without compromising compliance,” said Kaminski.

In Brief

Ketryx is a connected lifecycle management system designed to bridge the gap between modern software development practices and the rigorous compliance requirements of life science companies.  Life Science companies are seeking to achieve faster product releases and improved traceability, and Ketryx offers capabilities that can help them transition from outdated systems to a connected and more efficient framework. 

This approach would allow companies to retain their fit-for-purpose tools while connecting them into a unified framework, eliminating duplicate work and automating compliance evidence generation. This approach also provides a scalable solution for organizations dealing with overlapping systems from mergers and acquisitions.

We will continue to provide updates on Ketryx as they become available.

To discuss how this initiative impacts your organization.  Click on this link to schedule an Analyst Inquiry on this topic.

The opinions and analysis expressed in this post reflect the judgment of Axendia at the time of publication and are subject to change without notice. Information contained in this post is current as of publication date. Information cited is not warranted by Axendia but has been obtained through a valid research methodology. This post is not intended to endorse any company or product and should not be attributed as such.

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