How Connected Lifecycle Management Is Revolutionizing MedTech Software Development

Application Lifecycle Management (ALM) tools were originally designed to manage the development and maintenance of simple software components that existed as part of hardware systems. But today’s software is much more complex than it was 20 years ago when those ALM platforms reached the market. 

Now, R&D teams must consider AI, the cloud, open-source software, new developer tooling, and modern cybersecurity risks, among other changes. MedTech has undergone a significant shift, with software becoming the primary driver of innovation and value. Even in hardware-based systems, embedded software has become the key differentiator. In fact, studies show that the SaMD (Software as a Medical Device) market is expected to reach $6.1 billion by the end of 2034, up from $1.8 billion in 2024. SaMD solutions offer new levels of flexibility, scalability, and potential for continuous improvement, creating significant value for both manufacturers and patients.

Yet many companies still rely on traditional ALM tools — and the fragmented, manual workflows they offer — to facilitate critical processes. These outdated systems prevent medical device software development teams from innovating and rapidly releasing updates at the speed of modern software.  

What is Connected Lifecycle Management? 

Savvy and innovative MedTech companies are moving away from waterfall methodologies and adopting agile development practices and tools. These companies are embracing Connected Lifecycle Management (CLM) solutions — platforms that integrate and streamline software development and delivery while eliminating the need to duplicate work across multiple tools. A CLM breaks down silos between different teams, tools, and processes involved in the software lifecycle. It also automates the manual tasks of MedTech software development, including traceability, process enforcement, and the creation of documentation. 

A CLM solution can connect to, and synthesize the operations of, multiple software development tools. Using a CLM solution, quality and engineering leaders can streamline their development efforts and deliver thoroughly tested and validated software while adhering to regulatory standards. 

Let’s examine the difference between ALMs and CLMs in more detail.

ALM Tools

Traditional ALMs cater to a legacy MedTech software development model, as their focus is on hardware-specific design. Most of these legacy ALM platforms were built for standalone operation. 

Hardware-specific design

ALMs were designed for software that was closely tied to hardware devices, such as embedded systems or firmware. These ALMs targeted small software components that supported specific hardware devices. This encouraged the development of software meant to be coupled with hardware and PLM (product lifecycle management) processes, including the design, manufacturing, distribution, and retirement of physical products. Many traditional ALM tools fall into this category. Some examples are Siemens Polarion ALM, Perforce Helix ALM, and Jama Connect.  

These legacy MedTech solutions cannot accommodate rapid software development because they don’t support modern development methodologies (i.e., DevOps and CI/CD) that incorporate open-source packages, run in the cloud, and use machine learning and AI features. Modern MedTech software requires agile development practices — including quick versioning, automated testing, frequent release cycles, and adherence to new regulatory requirements. 

Built for standalone operation, not integration

ALMs were designed to meet the compliance needs of regulated industries, allowing teams to manage the software development cycle from initial planning and requirements gathering to final deployment and maintenance. They accomplished this through a system that allowed everything to happen within one controlled environment. This worked well when software was simpler — these tools were previously considered adequate for MedTech developers building hardware that contained small bits of software, but they now fail to meet the needs of MedTech development due to their inherent limitations and disconnected nature.

Faced with the realities of open-source software, cybersecurity concerns, cloud development, distributed teams, and changes in development methodologies, these ALMs have attempted to add on integrations and syncs with other tools. However, ALMs were ultimately designed to function as singular systems, not as tools that connect with other systems. They typically include the following limitations, which don’t allow for integration with other tools across the development process:  

• Walled garden: With ALMs, developers are forced to leave their preferred tools and constantly switch between their primary work environments and the ALM. This leads to context switching and duplicate work, such as the need to manually update the ALM system with information that was already captured elsewhere (e.g., a Git repository). Relying on human intervention to duplicate work across disconnected tools increases the likelihood of errors and inconsistencies, as well as the demand placed on teams.
• Static system: ALMs typically operate as isolated systems, providing only a static snapshot of a project rather than offering a real-time, dynamic view. This lack of real-time visibility can cause delays in identifying and addressing potential issues, such as critical requirement changes not being immediately reflected in the ALM system.
• Waterfall methodology: With ALM tools, the necessary documentation for compliance and auditing purposes is generated as a separate, manual step after the software development itself is complete. ALM tools were not designed to create documentation as development happens; rather, they create documentation at the end of the process, when development is complete. This means that compliance and quality checks are out of sync with development, which is not in line with modern best practices of shifting left.

Connected Lifecycle Management (CLM) Tools

CLMs are designed with a developer-first approach and aligned with modern regulated software development.

Software-specific design 

Unlike hardware-oriented ALM tools, CLMs are built to provide visibility into the lifecycle of all software components, ensuring that product development is coordinated, synchronized, and traceable. This approach is critical for MedTech companies developing medical device software and SaMD products, where software is the primary driver of value.

With a CLM, every requirement, test case, and code change is linked and traceable in real time, providing a clear audit trail from initial concept to final release. QMS gates and checks are enforced automatically through workflows and configurations, ensuring that critical quality controls are consistently applied. For example, QMS checks can mandate that unit tests are run as part of the build process to verify that individual units or components of the software are working as expected. If any unit tests fail, the build process will be automatically stopped, preventing development from progressing until any issues are resolved. 

CLMs also address the need for change management across the software development cycle. By maintaining continuous traceability, CLMs ensure that all changes are properly documented, assessed, and propagated, reducing the risk of compliance issues.

Capturing and analyzing historical data across multiple projects and development cycles allows teams to:

• Continuously improve their software development processes.
• Identify best practices specific to medical device software development.
• Optimize resource allocation for software-centric projects.
• Refine development methodologies over time to meet evolving requirements. 

This data-driven approach helps MedTech companies measure the effectiveness of their software development processes and ensure that their products evolve as planned.

Built to integrate with multiple developer tools 

CLMs integrate with multiple popular developer tools, automatically capturing and synchronizing relevant information while allowing developers to focus on their core tasks and maximize efficiency. They provide a unified, real-time view of the entire software development lifecycle. CLMs offer the following key features:

• Open, connected ecosystem: With a CLM, developers can stay in their preferred tools, including Jira, GitHub, and other best-of-breed tools, without having to switch contexts or duplicate efforts. This integration eliminates the need for context switching and duplicate work. For example, updates made in a Git repository are automatically reflected in the CLM system, reducing manual intervention and the likelihood of errors. This interconnected approach increases efficiency and allows QA teams to focus on higher-value tasks instead of manual data entry and verification.
• Real-time, dynamic system: CLMs operate as interconnected systems, providing a real-time view of the entire project. Having this single source of truth ensures that all stakeholders have access to accurate, updated information, and continuous visibility allows teams to identify and address potential issues immediately. For example, critical requirement changes are instantly reflected across all connected tools and dashboards, ensuring that all team members are working with the most up-to-date information at all times. Furthermore, risk management and testing (e.g., automated testing that occurs directly in Git repos) are incorporated directly into the tools where work is being done, enabling teams to proactively identify and mitigate potential risks.
• Agile methodology support: CLMs are designed to create documentation and ensure compliance as part of the development process. Documentation is generated automatically as development progresses, so compliance and quality checks are always in sync with the latest code changes. Real-time generation of documentation and compliance checks support agile development methods that allow teams to iterate quickly.

By embracing these features, MedTech companies can develop software-centric medical devices more efficiently, with better quality control, and in full compliance with regulatory requirements. This approach is particularly valuable in the evolving SaMD market, where agility, quality, and compliance are essential.

How Ketryx is taking the lead in Connected Lifecycle Management

Ketryx is the pioneering CLM platform with the most advanced software in this category. Its seamless integrations allow developers to continue working within their preferred tools while providing an intelligent connective layer that links and synchronizes data across disparate systems.

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Ketryx offers real-time feedback on compliance status, identifies potential issues, and automatically generates the necessary documentation during the development process. Unlike ALM solutions that require expensive custom integrations, Ketryx takes a configuration-based approach to connectivity, allowing companies to easily set up and manage their processes through intuitive configurations.

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Out-of-the-box dashboards for requirements, risk, QA, releases, and compliance provide MedTech leaders with the insights needed to make informed decisions and keep projects on track. With Ketryx, teams can focus on their core responsibilities, assured that their lifecycle management system ensures traceability, compliance, and quality behind the scenes.

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Ketryx places developers at the heart of tooling and process workflows, empowering MedTech engineering and QA teams with enhanced efficiency and control.

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Modernizing MedTech with Connected Lifecycle Management 

CLM platforms are essential for developing MedTech software today. By connecting siloed tools, automating processes, and providing real-time visibility, CLMs allow MedTech companies to innovate faster without compromising quality or compliance.

As the pioneer of the CLM, Ketryx is setting the standard for the future of MedTech software development. Using Ketryx, MedTech companies can focus on what they do best — bringing life-saving technologies to market — while reducing the complexity of compliance.

Learn more about how you can enhance the SDLC with tools that bridge R&D and quality.