Hamilton Medical Expands ALM-PLM Integration Strategy

Medical device manufacturers are under increasing pressure to manage software complexity, maintain regulatory traceability, and coordinate development across hardware, software, quality, and risk management teams. Integrated ALM-PLM environments are becoming a central part of this process, particularly in sectors where verification and audit readiness directly affect product approval and patient safety.

In this context, PTC announced that Hamilton Medical has adopted the Codebeamer^® application lifecycle management (ALM) platform to replace its previous ALM infrastructure and paper-based workflows.

Linking development and compliance workflows
Hamilton Medical, which develops mechanical ventilation systems for clinical and intensive care applications, already uses PTC’s Windchill^® product lifecycle management (PLM) platform. The addition of Codebeamer^® is intended to create a unified development environment connecting requirements management, testing, validation, release decisions, and quality processes within a single product data framework.

The combined ALM-PLM setup is designed to improve collaboration between engineering, risk management, quality assurance, and verification teams. Automated traceability functions are integrated across the product development lifecycle, enabling relationships between requirements, test results, design changes, and approvals to be tracked continuously. This type of end-to-end traceability is increasingly relevant for compliance with medical device regulations and standards that require documented verification and audit readiness.

The transition also removes paper-based process steps that can complicate version control and validation activities during regulated product development.

Multi-year development agreement targets medical device workflows
Alongside the deployment, PTC and Hamilton Medical entered a multi-year collaboration agreement focused on extending industry-specific ALM and PLM capabilities for medical device engineering.

Under the agreement, Hamilton Medical will contribute operational knowledge from its development methodologies, engineering workflows, and tool usage practices. The input is expected to support PTC’s work on standardized, out-of-the-box capabilities tailored for regulated medical technology environments.

The collaboration also includes further integration work between Codebeamer^® and Windchill^®, with the aim of supporting Integrated Product Engineering (IPE) processes. In practice, this approach connects software engineering, hardware development, quality management, and lifecycle documentation within a shared digital supply chain framework.

Managing software complexity in regulated product development
Medical ventilation systems increasingly combine embedded software, electronics, sensors, and connected device functions, creating higher demands for lifecycle traceability and change management. In these environments, ALM platforms are used not only for software development tracking, but also for linking regulatory documentation, risk assessments, verification records, and release validation.

Hamilton Medical indicated that maintaining both rigorous risk-focused development practices and adaptability to evolving regulatory requirements was a key factor behind the migration. The integrated environment is intended to support scalable product development while maintaining compliance visibility across the company’s portfolio.

PTC positioned the deployment within its broader Intelligent Product Lifecycle strategy, which focuses on building connected engineering data environments capable of supporting enterprise-wide product data management and AI-enabled development processes.

Edited by Aishwarya Mambet, Induportals Editor, with AI assistance.

www.ptc.com