--- title: "IDC Spotlight - Connected Life-Cycle Management (sponsored by Ketryx)" type: white-paper publisher: Ketryx source: "https://www.ketryx.com/assets/idc-clm-spotlight-paper" content: text extracted from PDF (layout/tables/figures not preserved) --- # IDC Spotlight - Connected Life-Cycle Management (sponsored by Ketryx) *Source: [https://www.ketryx.com/assets/idc-clm-spotlight-paper](https://www.ketryx.com/assets/idc-clm-spotlight-paper)* --- SPOTLIGHT Sponsored by: Ketryx Connected Life-Cycle Management Streamlines Software Development for Medical Devices January 2025 Written by: Michael Townsend, Research Director, Life Sciences Commercial Strategies Introduction As software becomes a key differentiator in medicine, medtech companies are increasingly under pressure to release new software and new versions more frequently to stay competitive. With the rise of AI-driven products and the demand for faster innovation, medtech companies can be hamstrung by relying on existing technology and processes that were not designed to meet the compliance requirements of modern products or support the ability to release frequent updates. Traditional product life-cycle management (PLM) and application life-cycle management (ALM), which are used in a wide variety of industries, may not provide the regulatory compliance features needed for modern software development in the medical device field. PLM was originally designed more than 25 years ago for hardware rather than software and has since been retrofitted by vendors with functionalities to handle software. However, these additions fall short of supporting true agile methodologies. As a result, achieving compliance with the FDA's Predetermined Change Control Plan (PCCP) and standards such as IEC 62304, ISO 13485, and ISO 14971 are major hurdles for teams that want to use modern development environments. Connected life-cycle management (CLM) is a new platform category that helps medical device companies streamline quality assurance, documentation, change management, and traceability to meet the requirements of such regulatory bodies as the FDA, EU MDR, and Health Canada. While built to support modern cloud, mobile, and embedded software development, CLM is particularly well suited to the unique complexities of AI/ML-powered applications. Connected life-cycle management offers tremendous value to medtech companies and developers by automating regulatory compliance tasks, which frees developers to concentrate on innovation. KEY STAT 60% of life sciences companies plan to increase hiring for software developers, data scientists, and prompt engineers in 2025, according to IDC. WHAT'S IMPORTANT CLM provides medtech companies with a path to automate regulatory compliance, streamline change control, and capitalize on the FDA's Predetermined Change Control Plan guidance. AT A GLANCE Page 2 #US52953524 SPOTLIGHT Connected Life-Cycle Management Streamlines Software Development for Medical Devices A CLM Platform Can Integrate Regulatory Compliance into Modern Development Workflows Without Disrupting Agile Practices A CLM platform streamlines software development by connecting disparate best-of-breed development tools and automating manual tasks like traceability, enforcement of quality standard operating procedures (SOPs), and documentation across these tools. It breaks down silos between teams and tools, eliminating the need to duplicate work across multiple systems. Using CLM empowers quality and engineering leaders to deliver thoroughly tested, compliant software at scale and makes change control much simpler, even for complex systems of systems. The FDA's Predetermined Change Control Plan The FDA's Predetermined Change Control Plan is new guidance designed to allow for more flexible, continuous improvements and updates in medical devices without requiring resubmissions to the agency. This initiative allows medtech companies to release new product versions, AI or otherwise, as long as they are within the scope of their approved PCCP, simplifying change management. This approach accelerates the release of software updates while maintaining compliance. By leveraging modern DevOps practices and CI/CD methodologies, medtech companies can deliver software updates more quickly and efficiently, ensuring safer and more reliable product releases. PLM Versus ALM Versus CLM There are several ways in which each of these life-cycle management systems differ. While they share some common goals — such as improving efficiency, ensuring quality, and maintaining oversight — their focus areas and functionalities set them apart. PLM PLM is widely used in many industries and was originally developed for hardware-centric industries such as healthcare, automotive, aerospace, and consumer electronics. It helps engineers document product life cycles and can provide a framework for regulatory submissions. However, the traditional PLM architecture often falls short when applied to software-enabled products, such as medical devices with integrated software or software as a medical device (SaMD) applications. As software becomes increasingly vital in medtech, PLM faces challenges in managing frequent updates, new cybersecurity requirements, and integration of AI. Designed for simpler hardware products, PLM struggles to accommodate the use of open source, modern development tools, including the iterative nature of today's software development cycles. ALM Made for managing software-centric development, ALM focuses on regulated industries across the entire software development cycle — from planning to deployment and maintenance — within a single controlled environment that is more waterfall than agile in approach. However, in some cases, this structure can limit flexibility, making it challenging to integrate modern developer tools required for complex workflows and adapt to evolving practices like CI/CD. In fact, it's nearly impossible to combine all of this functionality within a single platform, given the wide variety of specialized tools on which developers rely. CLM CLM represents the next stage in life-cycle management, specifically tailored to address the unique challenges of both software and hardware development. It is purpose built for regulated industries, allowing compliance with evolving FDA guidelines like PCCP, by connecting best-of-breed development and quality tools to accelerate change management. At Page 3 #US52953524 SPOTLIGHT Connected Life-Cycle Management Streamlines Software Development for Medical Devices the same time, CLM integrates modern DevTools, thus enabling DevOps and CI/CD processes and building loyal developers who are free to use their preferred tools. Quality processes are enforced by embedding guardrails into existing development workflows, using tools such as Jira and GitHub. This automatic integration ensures that no project progresses without meeting compliance requirements, there are no redundancies in systems, and quality management system (QMS) procedures are followed without deviation. CLM Enables Compliance with PCCP While Safeguarding Against Cyberthreats Acting as a glue between best-of-breed development tools, CLM supports modern and AI/ML-based software development by streamlining documentation and traceability as required by the FDA and other regulatory bodies. It builds traceability from and within connected systems, managing software and hardware configurations, versions, and changes, from planning to post-market surveillance. CLM connects tools for testing, validation, complaint tracking, quality assurance, and compliance management processes, providing clear visibility into project progress, traceability coverage, quality, and compliance. A central release dashboard manages software and hardware release processes, including incremental and patch releases, as well as hotfixes. CLM also integrates with source code analysis (SCA) tools to generate and manage the software bill of materials (SBOM), simplifying the process of identifying and mitigating vulnerabilities across the software supply chain. SBOMs, now a critical requirement for all new FDA submissions, enhance patient safety by offering a detailed inventory of software components. This transparency helps manufacturers identify potential vulnerabilities and safeguard against cyberthreats that could disrupt care or harm patients. Post-market monitoring adds another layer of complexity, as manufacturers must continuously manage and track their SBOMs, addressing the constant flow of newly reported vulnerabilities in common third-party and open source components. CLM's automated integration with SCA tools ensures that SBOMs remain consistent, audit ready, and aligned with FDA submission requirements, minimizing security risks and protecting patients. Benefits of CLM The key benefit of CLM is that it allows medtech teams to perform change management faster and with less compliance overhead, accelerating time to market for new life-saving innovations. CLM streamlines and simplifies compliance with U.S. standards and international standards such as IEC 62304 (life-cycle requirements for medical device software and SaMD), ISO 14971 (a process for risk management of medical devices and SaMD), and ISO 13485 (the requirements for a quality management system specific to the medical device industry). CLM empowers developers and quality teams to work with modern DevTools and their existing PLM workflows, supporting DevOps and CI/CD processes. Purpose built for regulated industries, a CLM platform ensures compliance with constantly evolving FDA guidelines, such as PCCP, by integrating best-in-class development and quality tools. This approach allows medical software teams to release new software versions in days or weeks, significantly reducing the time frames typically associated with safety-critical environments. By facilitating CI/CD pipelines, CLM supports efficient software supply chain management, a key advantage of leveraging the PCCP framework. In addition, CLM enhances interoperability among diverse tools, which is crucial for effectively managing disparate systems. This capability proves especially valuable during integration challenges, such as those encountered in mergers and acquisitions, ensuring smooth operations and compliance continuity. Page 4 #US52953524 SPOTLIGHT Connected Life-Cycle Management Streamlines Software Development for Medical Devices Because modern CLM platforms connect to a variety of development tools, teams can continue to use their preferred tools while ensuring traceability. CLM allows for: » Process enforcement: Teams can define and configure their tools to impose guardrails in alignment with their QMS procedures, ensuring compliance at every stage of development. » Shifting cybersecurity left: Development teams can implement testing and security into the earliest phases of the application development process, allowing for early detection of vulnerabilities. » Real-time traceability: A CLM traceability matrix provides teams with real-time end-to-end traceability, allowing them to focus on critical tasks while ensuring regulatory requirements are met. » Automatic documentation generation: When milestones are completed, CLM automatically generates FDA- compliant documentation, including an SBOM required for product launch. » Component reuse: A CLM supports a system of systems or microservice architecture, which lets teams reuse components while managing their versions independently for easier updates and control. Trends IDC finds that 60% of life sciences companies plan to increase hiring for software developers, data scientists, and prompt engineers in 2025 compared with only 16% that plan to decrease such hiring (source: IDC's Life Sciences Generative AI Survey, August 2024). In addition, "improving product compliance, quality, and safety" and "product innovation" were among the top priorities for medtech companies in IDC's April 2024 Supply Chain Survey. The Future: CLM as a Core Enabler for AI, DevOps, and CI/CD in Medtech » The AI revolution: CLM tools are built to support SaMD and AI-based medical software by streamlining the entire SDLC from conception to deployment and enabling frequent releases in accordance with the PCCP. » CI/CD enablement: CLM integrates modern software development practices, allowing medtech companies to release software faster, all while remaining compliant. » FDA alignment: Companies using CLM will be better positioned to take advantage of the flexibility offered by the PCCP, releasing software 10–100x more frequently, resulting in better quality as well as more innovative capabilities. » The road ahead: Companies that don't embrace CLM solutions risk falling behind their competitors in bringing new software to market and delivering fully updated, rigorously tested versions that meet the demands of modern software development. Considering Ketryx Ketryx was founded in 2021 as one of the first CLM solutions for the life sciences industry. The company's AI-powered software interoperates with best-of-breed development tools to enable medical software teams to simplify change management, establish traceability, maintain FDA compliance, and create secure and reliable devices. Page 5 #US52953524 SPOTLIGHT Connected Life-Cycle Management Streamlines Software Development for Medical Devices As a CLM platform, Ketryx strives to ensure that any software developer can become a regulated developer with minimal training, allowing them to concentrate on coding and product impact instead of documentation and repetitive handoffs of regulatory submission tasks. Ketryx is designed to help regulated software teams match the pace of unregulated sectors. It does so by automatically generating FDA-compliant documentation from active workspaces, thus removing onerous documentation burdens. In addition, Ketryx was created to enforce QMS procedures and curtail process deviation using popular development tools like Jira and GitHub, ensuring no project progresses unless it is compliant. Ketryx's ability to enforce standards across FDA, ISO, and EU MDR requirements is a differentiator, ensuring a manufacturer's data, documents, and processes are validated and are submission ready for regulators. These process enhancements streamline compliance and speed time to market while upholding the highest-quality standards. Key Pain Points Addressed by Ketryx CLM » Time savings: Ketryx allows regulated teams to release high-quality, safe software at the speed of unregulated industries, empowering developers to focus on innovation rather than cumbersome compliance processes. » Optimization of existing investment: As an overlay connecting QMS and DevTools, Ketryx allows teams to preserve their investment in existing infrastructure, with developers staying within Jira or GitHub for all tasks while quality controls SOPs. » Safety: Ketryx automates the process of creating an audit trail, reducing the time spent transferring data between tools and validating compliance while reducing the potential for human error. » Audit readiness: Ketryx creates an immutable and fully traceable audit trail, eliminating the need for teams to manually document every step. » Preventing process deviation: Ketryx enforces SOPs in development tools such as Jira and GitHub with built-in guardrails that enforce zero process deviation. » PCCP readiness: By leveraging Ketryx and its simplified change management, manufacturers can take advantage of cloud and AI/ML technologies to release more quality versions of medical device products more frequently. Challenges As a new and smaller software provider for the life sciences industry, Ketryx must compete against larger and more established companies offering more traditional and industry horizontal offerings such as PLM and ALM, which are widely used in other manufacturing industries. Page 6 #US52953524 SPOTLIGHT Connected Life-Cycle Management Streamlines Software Development for Medical Devices Conclusion A CLM platform streamlines software development by connecting disparate tools and automating manual tasks like traceability, process enforcement, and documentation. It breaks down silos between teams and tools, eliminating the need to duplicate work across multiple systems. Using a CLM platform empowers quality and engineering leaders to deliver fully tested, compliant software more efficiently. Medtech companies unable or unwilling to adopt CLM will find it increasingly difficult to compete as regulatory demands evolve and software becomes an even greater differentiator. About the Analyst Michael Townsend, Research Director, Life Sciences Commercial Strategies Michael Townsend is a research manager for IDC Health Insights responsible for commercial life sciences and life sciences commercial strategies. He provides research-based advisory and consulting services as well as market analysis on key topics within the commercial life sciences industry. Mr. Townsend's research expertise includes sales and marketing, supply chain, manufacturing systems, and emerging technologies and market trends. MESSAGE FROM THE SPONSOR Ketryx is the first and only AI-powered connected application lifecycle management platform for the life sciences industry. Our automation-based software enables companies building regulated software to accelerate development through modern cloud-based tools while improving quality and compliance. By overlaying and connecting existing product development and quality tools, Ketryx creates a real-time, traceable, single source of truth. Teams expedite time to market by automating documentation while enforcing SOPs across connected systems. Learn more about using Ketryx for AI/ML-powered devices by visiting https://www.ketryx.com/use-case/ai-ml-med-device or by checking out our webinars at https://www.ketryx.com/learn/webinars. Using a CLM platform empowers quality and engineering leaders to deliver fully tested, compliant software more efficiently. Page 7 #US52953524 SPOTLIGHT Connected Life-Cycle Management Streamlines Software Development for Medical Devices The content in this paper was adapted from existing IDC research published on www.idc.com. IDC Research, Inc. 140 Kendrick Street Building B Needham, MA 02494, USA T 508.872.8200 F 508.935.4015 Twitter @IDC blogs.idc.com www.idc.com This publication was produced by IDC Custom Solutions. 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