Replace IBM Doors with easy to use MatrixALM

Overview of Application Lifecycle Management (ALM) systems

Application Lifecycle Management, or ALM, manages your software throughout its lifecycle. It's all about making sure everything works smoothly from start to finish. This includes planning what the software needs, designing it, writing the code, testing it, keeping it up-to-date, and ensuring it works well with other software. It goes beyond just outlining what the software should accomplish, which is the primary focus of a requirements management tool, like IBM Rational DOORS. 

An Application Lifecycle Management (ALM) system such as MatrixALM is much more comprehensive than a requirements management tool for complex Software as/in a Medical Device (SxMD) because it provides a complete toolkit for software development and oversees the entire lifecycle of the software as a product. This is particularly vital in medical software, where precision, reliability, and adherence to stringent health regulations are paramount. In essence, ALM offers a holistic approach, akin to having a fully-equipped navigation system, as opposed to just a single tool like a map. In this article we discuss Software as/in a Medical Device. You will this recorded as SxMD. 

Choosing the right ALM 

Developers face special challenges, in the SxMD space like having to stick closely to international rules set by bodies like the FDA in the US and the EU's Medical Device Regulation (MDR). An industry-specific ALM system helps with meeting these tough standards, making sure the software is safe and works well for patients. ALM also helps manage the complex process, reduces risks, and ensures the software is high quality and reliable. 

A solid ALM system improves teamwork, cuts down on development time, lowers the chances of mistakes, and leads to a better final product. Plus, it offers a clear way to handle changes, makes projects easier to see and understand, and helps with making smarter decisions. More importantly, the right ALM will be configurable to your unique business needs. We’ve developed a comprehensive checklist that encapsulates key considerations to keep in mind. Download our fully customizable ALM Evaluation Checklist to help with your ALM selection. 

Overview of IBM Rational DOORS

IBM Rational DOORS or IBM Engineering Requirements Management DOORS, which is often referred to as an ALM is a well-established and dependable requirements management tool belonging to the IBM eco-system that launched in the early 90s. It was built for advanced IT applications that have complex deployments to manage. Because of its maturity, and a one-size-fits-all approach, it’s used across a variety of industries, including Medical Devices. 

Rational DOORS supports traceability, change management, reporting, review, and approval processes, and offers a wide range of industry-specific features like aerospace and defense, automotive, and finance to name a few. This extensive functionality can ultimately hike up its cost and result in software that feels overloaded or unnecessarily complex. When tools are not intuitive to your specific use cases and workflows, users are often left unclear of what the next step is and must spend significant time upskilling to learn legacy systems resulting in a slow ramp-up time for new users. Furthermore, when tools are built for multiple purposes, there are a lot of features baked in that increase the cost for a user seat making it hard to collaborate with the entire team inside the platform. This results in misalignment and slower processes that go against modern teams that are trying to accelerate innovation. 

Understanding Matrix Requirements ALM

If your current requirements management tool is limiting your ability to manage projects effectively for the highly regulated SxMD industry, it might be time for an industry-specific Application Lifecycle Management (ALM) solution. MatrixALM was built after the founders experienced the growing pains and struggles of keeping up-to-date documentation as the industry changed from Waterfall, to V-model, and now Agile methodologies and no solutions they tried were powerful enough to handle complex SxMD development while meeting all their needs, so they built their own. 

Additionally, using an industry-specific ALM, like MatrixALM, that focuses solely on Software as/in a Medical Device provides even more benefits such as: 

• Tailored to SaMD and SiMD (SxMD). They’re built to handle complex regulatory compliance, like FDA and EU standards, which a generic ALM might not fully support. See how Spirotronic fast tracked regulatory approval using MatrixALM for a class IIb medical device.

• Risk management that is aligned with ISO 14971. In MedTech, risks aren’t just about budget or timelines, they’re about patient safety. A purpose-built ALM is better equipped to identify and manage these unique risks. See how IDMET navigates risks with ease using MatrixALM for their class IIa medical device.

• Accelerate development productivity. Designed to manage SxMD processes and workflows, comes with built-in features to support multiple product variants at scale, includes predefined and customizable project templates, and supports modern methodologies like agile and v-model. See how Meril builds a lean, effective quality system to help accelerate global growth with MatrixALM for their class III medical device.

• Industry expertise. An industry-specific company like MatrixALM is aligned with industry best practices, is informed of evolving changes in the landscape, and ready to meet those demands.

MatrixALM core capabilities 

MatrixALM ensures your software development process is reliable and follows strict regulations. It enables developers to build compliantly without needing to be experts in regulatory affairs. It streamlines every stage of the development lifecycle to effectively manage design controls from requirements to validations with end-to-end traceability to mitigate risks. 

Every feature and capability in MatrixALM is designed to enable Software as/in a Medical Device manufacturers to innovate faster, streamline and centralize requirements with full traceability across design inputs and outputs, develop compliantly, manage risk aligned with ISO 14971, generate audit-ready documentation with compliant Part 11 eSignatures and keep your team audit-ready. What's more, it’s made to scale with you as your needs evolve and has a Marketplace that you can explore to find valuable add-ons to increase your efficiencies.

IBM Rational DOORS requirements management comparison with MatrixALM

When it comes to requirements management in the SxMD space, it’s about empowering your R&D team to easily identify, analyze, mitigate, and manage them in a centralized, collaborative, and easily accessible way that accelerates development. 

Rational DOORS is a powerful requirements management tool for companies that can provide a license for every user who needs access to the requirements. For many companies, the high user license cost impedes effective collaboration in the platform. The workaround for this is to export in either Word or Excel to allow non-users to collaborate. However, if you need to import them back into the system, you’ll need to purchase another tool to import the changes and accept them as part of the review. 

Working in multiple disparate systems is not an intuitive way to manage requirements in today’s complex environments. If decisions are happening outside of the tool, you risk miscommunication, lost time, and an unclear and potentially non-compliant audit trail of changes. 

With Rational DOORS, requirements are organized in a hierarchical structure and can be traced to internal and external links, supports versioning, have unique IDs, offer change management workflows, and can scale to meet the needs of even the biggest company. However, with legacy software built on a legacy architecture, performance speed is likely to hinder productivity, and timeouts are frequently reported by customers with complex products with many requirements.

MatrixALM offers an intuitive approach to requirements management that supports complex requirements at a granular level at scale. It does everything DOORS can do regarding requirements management but outperforms it on speed, collaboration, and usability. 

MatrixALM uses a hierarchical tree structure that makes it easy to capture, define, and collaborate on requirements in a single view with guardrails in place to indicate when an item is being edited by someone else on the team. It includes rich-text fields for advanced formatting of text and adding images directly inside of them either by attachment or drawing them using DRAW.IO. MatrixALM has robust searching capabilities like search strings you can save for repeat use and full-text search capabilities to make filtering through a complex list effortless, whether you want to filter by stale objects or items with missing or suspect links, you’re only a few clicks away from having the visibility you need to keep your work on track without needing to be experts in regulatory affairs.

Managing change with MatrixALM is straightforward with robust change management capabilities, and workflows for reviewing and approving changes that simplify assigning reviews, collecting feedback, seeing results, and preventing unintentional changes while reviews are underway. Reviewers can annotate directly on the item for other reviewers to see, making providing feedback more comprehensive. MatrixALM makes it easy for reviewers to know what’s changed on an item in review with indicator icons that open version history so that feedback can be implemented in real time. You can even set up workflows that are activated by status labels to make it easier to know the status of review outcomes and have a clear view of the next steps.  

Exporting requirements from MatrixALM is available in multiple formats like Excel, PDF, and XML. Exporting can even be done according to your custom branding guidelines. And, because of the unique IDs, each item, report, or controlled document created includes embedded links allowing teams to directly access the item in the platform if further review or changes are needed.  

Risk management capabilities with IBM Rational DOORS and MatrixALM

Effective risk management is essential to any organization and goes beyond managing timelines and budgets. In the highly regulated SxMD space, it must be integrated with other development processes, ensuring that risk considerations are a part of the decision-making at every stage to ensure quality and patient safety. A strong risk management solution should enable you to identify potential risks early in the development lifecycle, facilitate and assess risks, prioritize risks, document mitigation strategies, continuously track and monitor risks, and support compliance with relevant standards and regulations. 

Rational DOORS, as mentioned earlier, is a one-size-fits-all requirements management solution built to address the needs of various highly regulated industries. It offers risk management that can be configured to meet the needs of most businesses and through their third-party integration partners, you can purchase more advanced risk management capabilities such as tracing potential risks associated with tests and identifying when tests need to be rerun due to changes in the system. 

MatrixALM has fully integrated risk management to help you pinpoint product-related risks, be alerted when a requirement changes, track risks to mitigation actions, validate their effectiveness, and is aligned with both ISO 14971 and ISO 13485. With MatrixALM risks are systematically identified, assessed, managed, and monitored throughout the software development lifecycle, contributing to more successful and predictable project outcomes. With MatrixALM, risks can be defined according to customizable templates and formulas and you can set up various risk categories to support multiple risk analysis methods and targets. You can easily trace risk controls and mitigations to your design inputs and outputs ensuring that all requirements are properly evaluated and risks are managed. 

For added clarity, MatrixALM has dashboards that provide detailed information for your risk items like risk before mitigation (RBM) and risk after mitigation (RAM) stats so you can quickly visualize risk and identify potential areas of concern. The Risk Matrix Dashboard provides a structured view to easily identify high-risk areas, prioritize risk, inform decisions around risk management strategies, and monitor and control risk. The Risk Stats Dashboard provides a snapshot view of your risk distribution both before and after risk mitigation, the number of risks by zone, and the percentage of risks by zone so you can evaluate the impact of mitigation measures more effectively. 

Traceability and impact analysis with IBM Rational DOORS and MatrixALM

Traceability is crucial in Software as/in a Medical Device development because it provides a clear and detailed map of how each piece of a component or system is connected, from start to finish. This visibility is essential for understanding the relationships and dependencies between different objects that reflect design phases, like requirements, design, coding, and testing. It ensures that changes and updates are made safely and effectively, without unintended consequences. Traceability also helps in maintaining compliance with standards and regulations, facilitates easier troubleshooting and bug fixing, and supports thorough impact analysis for any proposed changes. Overall, it's key to maintaining the quality, integrity, and success of a software project.

Rational DOORS allows you to link requirements between their modules and third-party integration solutions that enable you to manually link risk management and automated test cases. With DOORS you use drag-and-drop functionality to link artifacts together, and you can define the relationships between different items inside and outside of DOORS to enforce your standards and help ensure consistency. 
Setting up your traceability in DOORS is time-consuming and isn’t intuitive due to the legacy interface, there is a lot of setup involved and more than 2 hours of training videos just around configuration. To satisfy a multitude of industries, the traceability options are vast which can complicate the experience in the platform. 

Traceability in MatrixALM is live, straightforward, and set up in one place. You’ll have a clear category relation and everything you need to satisfy regulatory demands without needing hours of training to understand how to get started. It begins by configuring your traceability rules. The traceability rules overview is color-coded and includes an intuitive legend to show which uplinks and downlinks are mandatory or optional for the item categories you define. You’ll easily see which categories need to be traced to others and it includes your test cases and risk management so you have everything you need to satisfy regulatory obligations. 

With MatrixALM, you leverage interactive dashboards that make ensuring alignment simple. The Traceability Overview dashboard gives you a high-level view of the status of all your traces. You can drill down into the status simply by clicking on the chart and if you have a large list, you can filter it. There is also a Trace Details dashboard that provides a view at the category level to make it easier to see a visual representation of the completeness of your traces or linked items. There is also a Trace Graph dashboard that lets you visualize the interrelation of your traces to gain enhanced clarity and assurance that your traces are correct at the most granular level and are coded to align with the traceability rules you have configured. 

In the SxMD market, impact analysis is crucial for understanding the full effect of proposed changes within the application, identifying potential risks associated with the changes, and ensuring the change does not compromise the quality of the final product. MatrixALM makes it easy for you to analyze how a change in one area can affect other interconnected parts to help identify potential problems or risks.

Integration with third-party tools

When it comes to modern development, every organization has unique needs, processes, and preferred tools to work with. Integrations allow for a customized solution that fits specific requirements and team needs while enhancing functionality and effectiveness. Integrations improve efficiency and productivity by automating data sharing and process triggers between your ALM and other tools to reduce time spent on manual data entry.

Rational DOORS being part of the IBM ecosystem integrates with many IBM tools and has a large network of integration partners who offer a variety of applications and extensions. If you’re looking to integrate tools outside their ecosystem, you’ll need to have an engineer who is familiar with their DOORS Extention Language (DXL) which is most similar to C and C++. 

MatrixALM was built to support connectivity while enabling compliant traceability and includes native integrations with Jira Clouds, Jira Server, and GitHub that make it easy to create a ticket in the external product, see issue statuses, remove existing links, pull content from external sources, or use labels to filter for items to streamline communication on development work, while enabling teams to work in their tool of choice. 

For companies using external tools to manage key information or just want to have a source of truth outside of Matrix Requirements, you can synchronize data between systems using the Agile Sync module and our converter Java template that supports Confluence (clouds or server), Team Foundation Server, GitHub, Zephyr for Jira, Pivotal Tracker, Jira (clouds). 

For teams working in tools where there isn’t an existing integration in place, you can leverage our REST API, or SDK to create more functionality between your mission-critical software. Matrix Requirements has a well-documented REST API to enable access to all functions inside the Matrix application and an SDK where you can create custom scripts for things like command tools, web apps, mobile apps, and more that will run within NodeJS. The SDK includes a UI Plugin template with the source map and source code that you can build on top of in order to integrate your plugin into the Matrix web application. There is also a Marketplace within the Matrix platform where you can explore add-ons, templates, and modules to install on your instance, based on your needs. 

Matrix Requirements is dedicated entirely to the SxMD industry and is constantly evolving to include more native integrations, add-ons, plugins, and templates to improve the day-to-day operations. By facilitating customization, automation, and efficiency in workflows with a wide range of external tools and services, Matrix is enabling a more cohesive software development process. 

Usability and Administration

Good usability and robust admin features for configurability are vital because they directly impact user adoption, productivity, and satisfaction. No matter how powerful or comprehensive a software's features and tools are, they're only valuable if users can access and use them effectively. Clear, intuitive interfaces and customizable options allow users to tailor their software to their specific needs, making workflows more efficient and reducing the learning curve. This importance is magnified in environments where time and accuracy are critical, such as in software development and project management. When tools are easy to use and adapt to various needs, they encourage broader use within the organization, leading to better collaboration, faster problem-solving, and more innovative solutions. Essentially, the real power of software lies not just in its capabilities, but in its accessibility and adaptability to users' unique contexts.

Rational DOORS while a revolution at the time, was built on a legacy architecture and has been around for more than thirty years and struggles to keep up with modern demands. Rational DOORS was built for a different era, with less emphasis on scalability, flexibility, and user experience. While Rational DOORS has not been sunset, there haven’t been significant enhancements to improve functionality to keep up with new development trends. Configuration and administration of DOORS is complex and requires a skill set that is difficult to find on the market making it hard to manage it internally without having a full-time dedicated admin to support it and hard to onboard new admins if one should leave the company or costly to outsource the maintenance. 

IBM has introduced Rational DOORS NG and encourages users to migrate to the new system. However, due to it being a legacy system, there is no clear upgrade path to follow and any customizations teams have already spent time building in DOORS will not transfer over into DOORS NG. Users have been reluctant to make the switch as they wait for key features and functionality to be embedded into DOORS NG. 

MatrixALM is a highly customizable and easily configurable modern software that supports agile, v-model, and waterfall methodologies. The administrative interface is easy to learn and supports alterations even after the initial account setup so that it can scale and grow alongside your company. Most companies are up and running within days or a few weeks and if there are questions during implementation, simply reach out to our responsive support team. Most people receive a resolution to their problem within hours and if you’re looking for support with importing and converting data, custom script creation, cyber security guidance, or even audits of your newly established instance, you can take advantage of the Platinum Support package for to get you up and running in no time. 

Matrix Requirements has recently launched a program to further support onboarding and aid in upskilling new team members and each customer has a dedicated customer success manager who is available to help you effectively configure and utilize your solution within your organization.  

Conclusion and Recommendations

In summary, while Rational DOORS might have been a strong tool in the past, modern ALMs offer more advanced, user-friendly, and flexible solutions that are better suited to today's dynamic and collaborative software development environment. With Rational DOORS, new features will be slow to release due to the complex nature of developing on legacy architectures and you expect that speed and performance will decrease. 

Transitioning to a modern Application Lifecycle Management (ALM) solution is a strategic move for any organization looking to stay competitive in the fast-paced software development landscape. They support contemporary development practices such as agile, DevOps, and CI/CD, facilitate efficient workflows, enhance collaboration, and accelerate time to market. 

MatrixALM is designed to address the specific challenges of SxMD development, including compliance with regulatory standards. It facilitates the management of the entire lifecycle from conception through design, development, testing, deployment, and maintenance with built-in features for risk management, traceability and documentation. MatrixALM helps ensure that products not only meet the high standards of safety and efficacy required for SxMD but also accelerate the time to market. In an industry where the cost of failure can be extremely high, both in financial terms and in terms of patient health, an industry-specific ALM can provide the structured, compliant, and efficient approach needed to succeed.