Ketryx Company Profile

Background

Ketryx is a pioneering provider of connected application lifecycle management (ALM) software tailored for the life sciences industry. The company's mission is to enhance medical software safety and reliability, thereby reducing recalls and improving patient outcomes. Ketryx envisions a world where software performs as intended without unforeseen or negative outcomes, striving to eliminate human error through self-correcting development tools that push the limits of innovation safely.

Key Strategic Focus

Ketryx focuses on automating and aligning manual tasks and processes required in medical software development and quality assurance. By integrating automation and quality process enforcement into the software development lifecycle, Ketryx ensures teams follow best practices and proactively identify and mitigate risks before they affect performance. The company's platform overlays and transforms development tools into an FDA-compliant single source of truth for the total product lifecycle, including automated documentation.

Financials and Funding

In December 2023, Ketryx raised $14 million in a Series A funding round led by Lightspeed Venture Partners, with participation from existing investors including MIT's E14 Fund and Ubiquity Ventures. This round brought the total funding raised to over $18 million. The funds are intended to accelerate product development and commercial expansion.

Technological Platform and Innovation

Ketryx offers a Connected Lifecycle Management platform that automates and aligns many of the manual tasks and processes required in medical software development and quality assurance. Key features include:

Traceability: Automatically creates a real-time requirements traceability matrix by connecting items, risks, code, and tests from all systems.

Documentation: Compiles all requirements, design inputs, outputs, and tests into a configurable and submission-ready design history file (DHF).

Enforcement: Ensures teams follow standard operating procedures (SOPs) exactly as defined.

Software Bill of Materials (SBOM): Provides a consolidated view of the open-source supply chain directly from the source code.

Integrations: Seamlessly integrates with preferred development tools like Jira, GitHub, GitLab, and AWS, allowing developers to work within their existing environments while maintaining compliance and traceability.

Leadership Team

Erez Kaminski, CEO & Founder: Erez has a background in computational mathematics, biotech, and energy. Prior to founding Ketryx, he led AI/ML initiatives at Amgen and worked at Wolfram Research. He holds a Master of Science in Electrical Engineering and Computer Science and an MBA from MIT.

Jan Pöschko, CTO & Founder: Jan led cloud development for Wolfram Research, where he and Erez launched developer tools used by millions daily. He has over 15 years of experience as a software developer and infrastructure architect. Jan holds a Master of Science degree in Mathematical Computer Science from Graz University of Technology.

John Koontz, COO: With over 25 years in research, engineering, IT, and operations, John was previously VP of Engineering and CIO at Wolfram Research. He holds a Master of Science degree in Computer Technology from Eastern Illinois University.

Brian Katzman, Chief Marketing Officer: Brian has been at the forefront of digital marketing for the past 20 years, starting with Google in 2003. He was the original marketing leader at Tile and has led marketing teams across several B2B and B2C companies. Brian holds an MBA and MS from the University of Michigan and a BA/BS from Northwestern University.

Paul Jones, VP of Regulatory Strategy: Paul joined Ketryx after 25 years at the FDA, where he helped create the FDA’s approach to safety-critical software and medical devices. He holds a Master of Science degree in Computer Engineering from Loyola University, Maryland.

Jake Stowe, VP of Client Operations: Jake brings experience that fuses technology and quality systems. Prior to Ketryx, he was a manager in a GMP pharmaceutical plant at Amgen. Jake holds an MBA in Operations and Logistics and a Master's degree in Systems Engineering from MIT.

Leadership Changes

In 2024, Ketryx expanded its leadership team by welcoming:

Zack Jha as SVP of Worldwide Sales: Previously with PTC and AWS.

Randall Markham as Chief of Staff: Formerly with American Industrial Partners and Booz Allen.

Gabriel Pascualy as Director of Solutions: Formerly with MITRE and Amgen.

Competitor Profile

Market Insights and Dynamics

The healthcare industry is increasingly integrating software and AI/ML technologies to improve patient outcomes. This trend necessitates robust quality assurance and regulatory compliance mechanisms, creating a growing demand for solutions like Ketryx's Connected Lifecycle Management platform.

Competitor Analysis

Ketryx's primary competitors include internal teams within medical device companies that develop home-grown systems or augment general-purpose tools to accommodate regulated software development. Unlike these internal solutions, Ketryx offers:

Automated FDA-compliant documentation generation.

Enforcement of standard operating procedures.

Continuous updates to stay in sync with evolving FDA regulations and submission requirements.

Strategic Collaborations and Partnerships

Ketryx has established significant partnerships to enhance its market position and innovation capacity. Notably:

DeepHealth, Inc.: A global leader in AI-powered health informatics and a wholly-owned subsidiary of RadNet, Inc., selected Ketryx to accelerate the delivery of AI-powered health informatics solutions. This collaboration enables DeepHealth to scale innovation with quality through a streamlined software development lifecycle.

Operational Insights

Ketryx differentiates itself by integrating with modern development tools like Jira, GitHub, and AWS, allowing developers to work within their preferred environments while maintaining compliance and traceability. This approach reduces the complexity, time, and cost associated with building Software as a Medical Device (SaMD) applications.

Strategic Opportunities and Future Directions

Looking ahead, Ketryx anticipates the following trends shaping the MedTech landscape:

AI Integration as Standard Practice: By 2025, all major MedTech manufacturers are expected to have AI-enabled products in their portfolios. Ketryx's platform is designed to help manufacturers ensure these innovations are compliant and secure.

Accelerated Software Updates: Weekly or monthly software updates will become more common in MedTech, requiring companies to adopt tools that balance speed with reliability.