Bridging ALM and MBSE for Modernized Systems Engineering Practices
1: Introduction
In an era marked by rapid advancements in technology, the aerospace and defense industries face increasing complexity in systems engineering. Addressing these challenges requires a paradigm shift towards more integrated and collaborative workflows. This whitepaper explores the essential relationship between Application Lifecycle Management (ALM) and Model-Based Systems Engineering (MBSE), highlighting how bridging these disciplines can modernize systems engineering practices.
2: The Growing Complexity of Systems Engineering
The complexity of systems engineering has grown exponentially in recent years, driven by advancements in technology, globalization, and the increasing interconnectivity of systems. Modern systems often integrate a wide array of specialized components, from hardware to software, all of which must seamlessly function as a whole. This challenge is further compounded by the need for performance optimization, cybersecurity considerations, and adherence to regulatory and safety standards, which vary across industries and regions.
For example, in the aerospace sector, the development of next-generation aircraft requires the integration of advanced avionics, autonomous systems, and material innovations. These aircraft must not only meet stringent performance criteria but also comply with international safety regulations and environmental standards. Similarly, in the defense industry, modern weapon systems rely heavily on interoperability between software-driven subsystems, such as sensors, communication networks, and artificial intelligence algorithms, all of which must operate flawlessly in highly dynamic environments.
To manage this complexity effectively, systems engineers must adopt integrated methodologies that bridge gaps between disciplines and stakeholders. Traditional linear workflows and siloed engineering practices can no longer keep pace with the demands of today’s systems. The introduction of tools and frameworks like MBSE enables teams to visualize and validate system designs in a digital environment, ensuring all components meet specifications before physical prototypes are developed. Combined with ALM, MBSE enhances traceability and communication, fostering collaboration across various teams and ensuring that every aspect of the system remains aligned with the overall mission objectives.
By leveraging integrated approaches and modern engineering tools, organizations can address the escalating challenges of systems complexity, enabling them to deliver innovative solutions while minimizing risk and maintaining efficiency.
The demand for innovative, safe, and efficient systems in aerospace and defense has led to unprecedented levels of complexity. Systems engineering processes need to manage a significant volume of requirements, design models, stakeholder expectations, and compliance standards. Traditional engineering approaches fall short of addressing these demands effectively, creating the need for solutions that promote end-to-end traceability and model-driven development.
Application Lifecycle Management (ALM) is the framework that encompasses the entire lifecycle of a system, from concept and design to implementation, testing, and maintenance. ALM ensures alignment between business needs, development efforts, and operational goals.
3.2 What is MBSE?
Model-Based Systems Engineering (MBSE) represents a paradigm shift by focusing on the use of models as the primary means to design, analyze, and validate system behavior. MBSE emphasizes simulation, system-wide visualization, and clear documentation to foster collaboration and problem-solving.
4. The Value of Integration
Integrating ALM and MBSE enhances engineering by enabling a seamless flow of information and fostering cross-disciplinary collaboration. This integration is fundamental to achieving traceability between requirements, design, and verification, ensuring that projects meet critical objectives efficiently.
4.1 Improved Traceability
By linking tools like Jama Connect with system modeling tools, teams can create a direct trace from system requirements, design decisions, test cases, and compliance reports to the system model analyses, parameters, and behaviors. This level of traceability minimizes risks and helps ensure that the final product aligns with initial specifications.
4.2 Enhanced Collaboration
Bridging ALM and MBSE facilitates better communication among stakeholders by providing shared insights and clear documentation of system behaviors. This reduces misunderstandings and promotes alignment across all project phases.
4.3 Accelerated Development Cycles
Integrated workflows reduce redundancies, streamline handoffs, and eliminate rework, allowing engineering teams to accelerate system development while maintaining high quality and compliance standards.
Jama Connect is a powerful tool that brings cohesiveness to Model-Based Systems Engineering by enabling efficient requirements management, traceability, and collaboration throughout the system lifecycle. By integrating with MBSE processes, Jama Connect provides a centralized platform where teams can define, manage, and validate requirements while ensuring alignment with system models. Through its robust traceability features, Jama Connect ensures that every requirement is linked to design elements, testing artifacts, and verification processes, creating a comprehensive digital thread.
One of the key strengths of Jama Connect is its ability to foster collaboration among diverse stakeholders. The platform offers an intuitive interface for real-time communication, enabling engineers, project managers, and business teams to work together seamlessly, ensuring clarity and reducing the risk of misunderstandings. Additionally, Jama Connect’s alignment with compliance standards streamlines audits and regulatory reviews, essential for industries with rigorous certification requirements.
When linking Jama Connect with system modeling tools, such as SysML modeling solutions, Jama Connect facilitates continuous synchronization between system requirements and system architecture models. This reduces errors, eliminates redundancies, and supports iterative development, helping teams adapt to changes quickly. Ultimately, Jama Connect empowers organizations to align engineering objectives with business goals, ensuring that the end product meets customer needs and system specifications efficiently.
LemonTree.Connect™ for Enterprise Architecture
LemonTree.Connect™ acts as a bridge between ALM and MBSE tools, offering advanced capabilities for merging and synchronizing data to maintain consistency across systems models and requirements.
When used together, Jama Connect and LemonTree.Connect™ create a unified environment for modern engineering practices.
Jama Connect® Features in Five: Jama Connect Advisor™
Learn how you can supercharge your systems development process! In this blog series, we’re pulling back the curtains to give you a look at a few of Jama Connect’s powerful features… in under five minutes.
In this Features in Five video, Katie Huckett, Senior Product Manager at Jama Software, will introduce viewers to Jama Connect Advisor™, Jama Connect’s natural language processing (NLP) tool, designed to improve requirement quality.
In this video, learn how Jama Connect Advisor enhances your product management by:
Reducing authoring errors
Increasing clarity
Optimizing foundational product needs and requirements managed in Jama Connect Cloud
VIDEO TRANSCRIPT
Katie Huckett: Hi. I’m Katie Huckett, Senior Product Manager at Jama Software. In this video, I’ll introduce you to Jama Connect Advisor, an add-on to Jama Connect Cloud that uses engineering-based natural language processing to optimize requirements authoring. It helps you write effective, well-organized requirements with speed and accuracy.
We’ll explore how Jama Connect Advisor can enhance your product development by reducing errors, increasing clarity, and optimizing the foundational requirements managed within Jama Connect Cloud. Jama Connect Advisor is designed to help teams author complex requirements quickly and accurately using AI and engineering-focused natural language processing. It minimizes disruption to engineering workflows while improving quality. How does it work?
Jama Connect Advisor applies the globally recognized INCOSE requirements rules and EARS syntax patterns. Even experienced engineers find it challenging to follow all forty INCOSE rules and six EARS patterns while writing even a single requirement.
That’s where Jama Connect Advisor steps in to streamline the process and enhance productivity. Now I’d like to show you a demonstration of how Jama Connect Advisor enables teams to intelligently improve requirements quality and usability, minimize requirement ambiguity and contradictions, which are the source of seventy to eighty-five percent of rework, and save time authoring, reviewing, analyzing, and updating requirement statements.
Huckett: There are a few different ways that you can use Jama Connect Advisor within the Jama Connect Cloud application.
Let’s start by adding a new requirement. Once you’ve added your requirement into the description field, you’ll notice the highlighted text to analyze the prompt underneath the description field. Once you’re ready, go ahead and select the text that you’d like to analyze and select analyze selection.
Underneath the description field, you’ll see a quick summary of your INCOSE score as well as any errors found, if any. You can move on at this point and save your item, or you can go ahead and view the details if you’d like to make changes at this point. So I can see on the slide over panel, the text that’s been analyzed, what my INCOSE score is, eighty-seven percent, and then the different identifiers that I’ve flagged it for the INCOSE rules. Underneath, you’ll see the EARS errors, if any were found. You’ll also see some information about the EARS notation pattern that your requirement might align with. I’m gonna go ahead and save this item, and I’ll wait to make my changes in a moment.
Now that I’ve saved that, let’s say I want to analyze a whole group of existing requirements. I’m going to go ahead and analyze all items within my set on the side here. So I’ll select all items and you’ll notice the batch analyze button, appears in the top right-hand corner. Once you select that, you’ll be given a summary view of what will be analyzed. So you can see I’ve got seventeen items selected here. All seventeen of those items happen to have a Jama Connect Advisor-enabled field on it, and then we have thirty-four fields per, these items. So it appears we have two Jama Connect Advisor enabled fields, per each item within this group.
Once you select analyze, the slide of our panel will pop up on the right-hand side. You’ll notice your group of requirements. Each item is listed at the top within this drop-down. You can navigate with the drop-down or the directional arrows. And then underneath, we also have a field drop-down. So as I mentioned, we have two fields per item type on this particular example. So I can swap between those as well either using the drop down or the directional arrows to move through.
So now that I’ve come in here and I see the, recommendations, I’d like to go in and edit my item to make some changes. So here, I want to remove some of the items that were flagged. I’m gonna remove this and just update this to say, you know, users can create a login using we don’t wanna use pronouns, per that flag. So I’m gonna change this to using an Apple ID, email.
Huckett: I’m gonna update this to be an actual logical condition with or social media. And then I’m gonna remove the example of LinkedIn because I don’t necessarily need that, and I’ll just update that to end the sentence there. Once I’ve made my changes, I can select the text again in the edit quick edit mode, analyze the selection, and I can see here my INCOSE rule score is now a hundred percent. I still have to deal with my ears errors, but so far so good on INCOSE.
I can view my details again in the slide-over panel and update here. I can also close that back out, and I can return to my batch analysis results by selecting the latest analysis link at the top, and that will take me right back in where I was before I made those changes. Now I can go ahead and save my item and complete those changes going forward. If I want to work through these requirements across multiple sessions or maybe I just wanna have a benchmark of what my score was before I started making my edits, you can then generate a report within the slide-over panel.
That will open up in your reports history page where you can download the report into Excel.
Once you open the report that was generated, we have a few different tabs you can work through in the worksheet. The first one just gives you some general information. What’s the average score of your requirements, the minimum, and maximum score, your total number of valid requirements, and then if you did have any invalid requirements as well. The file analysis reports, tab will give you a complete breakdown of all the requirements that were analyzed, their score, and then any corresponding INCOSE flags that may have popped up within the analysis.
We also have an explanation of each INCOSE flag as long as with their associated description. And then if your, report did happen to include any invalid requirements for any reason, those will be included in their separate sheet as well. Thank you for watching this demonstration of Jama Connect Advisor. If you would like to learn more about how Jamala Connect can optimize your product development process, please visit our website at jamasoftware.com
If you are already a Jama Connect customer and would like more information about Jama Connect Advisor, please contact your Customer Success Manager or Jama Software Consultant.
How Smart Companies Turn Economic Challenges into Opportunities to Get Ahead
In the past, when economic uncertainty hits, most companies instinctively tighten their belts and cut spending to prepare for the worst. But what if this conventional wisdom is wrong? What if the smartest move during tough times is actually to invest more aggressively in technology and innovation? Let’s dig into the data and lessons we can learn.
Recent research from Accenture shows overwhelmingly that companies that scaled (and some even doubling down on) their technology investments during the COVID-19 pandemic didn’t just survive…they thrived, growing revenue 5X faster than their peers and competitors. And while the pandemic created a unique dynamic of economic, political, and social challenges, there are lessons here that can be learned during any economic uncertainty, including the headwinds we’re seeing right now.
It’s no secret that the pandemic wasn’t just a health crisis; it was a massive stress test for business resilience. However, companies that emerged stronger shared a lot of common characteristics, including investing heavily in cloud infrastructure, artificial intelligence (AI), and digital transformation while their competitors were thinking more shortsightedly by cutting costs.
In fact, these “LEADER” companies didn’t just weather the storm…they used it as a launching pad for unprecedented growth.
The “Leaders,” “Leapfroggers,” and the “Laggards”
Accenture’s comprehensive study included 4,300 companies across 25 countries and showed three distinct categories of technology adopters during the pandemic.
Leaders represent the top 10% of companies that had already established strong technology foundations before COVID-19. These organizations stepped up their adoption of cloud computing, AI, and IoT technologies when the crisis hit. Their strategic advantage? They were already positioned to scale quickly when opportunity knocked.
Leapfroggers make up 18% of the sample and represent perhaps the most interesting group. These companies accelerated what would typically be multi-year digital transformations into mere months. They moved aggressively (and strategically) from being technology followers to leaders, demonstrating that timing and execution matter more than just being first.
The “Laggards” are the bottom 25% of companies that only recently began investing in new technologies. The decision to invest was made primarily just to maintain basic operations during the pandemic. This “reactive” approach to technology adoption left Laggards struggling to keep pace with market changes. Many still feeling that impact now.
What we’re seeing is that the financial results speak volumes. The Leaders are now growing revenue 5X faster than Laggards — a huge increase from the 2x growth differential that existed pre-pandemic. The widening of this gap demonstrates that technology investments are creating compound advantages over (a short period of) time.
Strategic Technology Investments That Drove Growth
It’s also clear that the companies that succeeded during COVID-19 didn’t just increase their technology spending randomly; they made strategic investments and changes in specific areas that delivered immediate and long-term value.
Cloud Infrastructure
Cloud adoption emerged as the foundation for pandemic-era success. And for Jama Software customers, this should come as no surprise.
Among Leapfroggers, 80% had adopted some form of cloud technology by 2017, but this figure jumped to 98% by 2020. More importantly, 72% of Leaders accelerated their cloud security investments, while 68% increased their hybrid cloud spending.
This cloud-first approach provides the flexibility and scalability needed to support remote work, handle fluctuating demand, and rapidly deploy new capabilities – all of which was key to success during the pandemic, and now. Companies with robust cloud infrastructure could pivot quickly as market conditions change.
Artificial Intelligence and Machine Learning (ML)
The study showed that 59% of Leaders accelerated their AI and ML investments during the pandemic. These technologies allowed companies to analyze rapidly changing market conditions, optimize supply chains, and personalize customer experiences at scale. All factors that made the difference between success and failure during the pandemic.
AI-powered analytics helped companies identify new opportunities in real-time, while machine learning algorithms optimized everything from inventory management to customer service. Organizations who invest in these capabilities are able to make data-driven decisions faster than their competitors.
IoT and Process Automation
The research showed that 70% of Leaders increased their Internet of Things (IoT) investments, while 60% accelerated (or invested in) robotic process automation (RPA) adoption. The outcome was that these technologies eliminated manual processes, reduced errors, and freed up human resources for higher-value activities.
The companies who invested in process improvement saw incredible outcomes. IoT sensors provided real-time visibility into operations, enabling predictive maintenance and optimized resource allocation. RPA handled routine tasks, allowing employees to focus on strategic initiatives and customer relationships. The investments paid dividends.
Investments in Collaboration
While collaboration may feel like a “soft skill” investment, it can make a huge difference to your bottom line.
70% of leading companies looked to aggressively increase funding for training to build an agile and collaborative organization. By prioritizing employee development and leveraging digital collaboration tools, these organizations foster better communication, faster decision-making, and more cohesive teamwork.
Examples of these investments included virtual platforms, real-time communication technologies, and programs that encouraged cross-functional alignment. The result? Improved project execution, enhanced innovation, and stronger connections across distributed teams, driving both operational efficiency and global scalability.
Three Strategic Imperatives for Digital Transformation
The research shows that the most successful companies during the pandemic followed three key strategic imperatives. These are the lessons that can guide any organization through economic uncertainty. Let’s call these the 3 Rs.
(R) Replatform to the Cloud
Leaders moved beyond basic cloud adoption to build what Accenture calls “Systems Strength.” This means reducing redundant technologies (maybe this can be our 4th R), eliminating disconnected data silos, and gaining the computing power and flexibility that cloud platforms provide.
But cloud replatforming isn’t just about moving existing systems to the cloud — it’s about rethinking (or reimagining) how technology supports business objectives.
Companies that approach cloud migration strategically can easily scale resources up or down based on demand, experiment with new capabilities quickly, and integrate disparate systems more effectively.
(R) Reframe with Innovation-First Strategy
Successful companies shifted from viewing technology as a cost center to treating it as a growth engine. 67% of Leapfroggers sought to aggressively increase revenue from non-core business lines, using technology to explore new markets and business models.
This innovation-first mindset encourages experimentation and rapid iteration – and it clearly pays off. Companies that embrace this approach can test new products, services, and market strategies without massive upfront investments.
(R) Reach Across All Business Functions
Technology investments delivered the greatest returns when they extended across entire organizations rather than being confined to IT departments. 65% of Leaders prioritized employee happiness through digital-based flexible work arrangements, compared to just 43% of Laggards.
This holistic approach to technology adoption creates seamless interactions between humans and machines, improved collaboration across departments, and built organizational capabilities that support long-term growth. There’s that “soft skill” investment again, paying off handsomely.
Prioritizing Employee Experience and Collaboration
If you’re reading this, we don’t have to tell you that the pandemic fundamentally changed how people work, and successful companies recognized that technology investments must support human needs as well as business objectives. We’re all living proof of that.
Digital-First Work Arrangements
Companies that thrived during COVID-19 didn’t just enable remote work; they reimagined work itself, perhaps for the first time in decades. They invested in collaboration platforms, digital communication tools, and virtual meeting technologies that made distributed teams as effective as co-located ones. While some company leaders feared working from home might decrease productivity, those who embraced the new way of working saw that employees actually adapted quickly and efficiently to the change. Many employees found that without office distractions, they were actually MORE productive and efficient.
And so the data shows that these investments in employee experience paid dividends in terms of productivity, retention, and recruitment. Companies with superior digital work environments began to attract top talent regardless of geographic location.
Human-Machine Collaboration
66% of Leaders focused on creating seamless interactions between humans and machines (the theme of the decade, maybe?). This approach recognized that technology should augment human capabilities rather than replace them. This is a practice we stand behind as an organization, always including “human in the loop” in our AI process workflows.
Successful companies designed workflows that leveraged both human creativity and machine efficiency. The successful balance was AI handling data processing and pattern recognition, while humans focused on strategy, relationship building, and creative problem-solving.
Agile and Collaborative Structures
70% of Leaders invested aggressively in training to build agile and collaborative organization structures. An investment that these companies recognized required corresponding changes in how teams work together.
Agile methodologies enabled rapid response to changing market conditions, while collaborative tools broke down silos between departments.
The outcome is that companies that have mastered both technology and organizational agility adapt quickly to new challenges and opportunities.
Quantifiable Benefits and ROI of Technology Investment
The financial returns from strategic technology investments during the pandemic were substantial and measurable.
Revenue Growth Acceleration
Like we said above, Leaders achieved 5x faster revenue growth than Laggards, showing a significant acceleration from the 2x advantage that existed before the pandemic. This widening gap clearly shows that technology investments create compound advantages over time.
Leapfroggers achieved 4x faster revenue growth than Laggards, proving that aggressive technology adoption can quickly close competitive gaps. These companies demonstrated that multi-year digital transformations can actually be done in months, achieving rapid ROI on their technology investments.
Operational Efficiency Gains
Companies that invested in automation and AI reported significant efficiency improvements. Process automation reduced manual effort by up to 50%, while AI-powered analytics accelerated decision-making and improved accuracy.
Cloud infrastructure investments provided both cost savings and operational flexibility. Companies could scale resources based on demand, reducing waste ($$$) while ensuring adequate capacity for growth.
Market Expansion Opportunities
Technology investments enabled companies to enter new markets and serve new customer segments. Digital platforms reduced barriers to entry, while data analytics provided insights into customer needs and preferences.
67% of Leapfroggers actively sought to increase revenue from non-core business lines, using technology to explore new opportunities. This diversification strategy was able to reduce dependence on traditional revenue sources and create multiple paths to growth.
Practical Lessons for Companies Facing Economic Downturns
The success stories from the pandemic provide a roadmap for any organization facing economic uncertainty.
Invest Aggressively in Core Technologies
Economic downturns create opportunities to gain competitive advantages while competitors are cutting costs. Companies should prioritize investments in cloud infrastructure, AI, and automation technologies that deliver both immediate efficiency gains and long-term strategic value.
Focus on technologies that eliminate manual processes, improve decision-making, and enable rapid response to market changes. These investments provide measurable ROI while building capabilities for future growth.
Compress Digital Transformation Timelines
Economic pressure creates urgency that can actually accelerate digital transformation. Companies should use downturns as opportunities to make bold changes that might be difficult during normal times.
Leapfroggers compressed multi-year transformations into months by focusing on high-impact initiatives and accepting some risk. This aggressive approach enabled them to emerge from the crisis stronger than before.
Focus on Employee Experience and Collaboration
Technology investments must support human needs as well as business objectives. Companies that prioritize employee experience through digital tools and flexible work arrangements will attract and retain top talent.
Invest in collaboration platforms, communication tools, and training programs that enable effective remote and hybrid work. These investments pay dividends in productivity, retention, and recruitment.
Embrace an Innovation-First Mindset
View technology investments as growth engines rather than cost centers. Look for opportunities to enter new markets, serve new customer segments, and create new revenue streams through digital capabilities.
Encourage experimentation and rapid iteration. Economic downturns provide cover for bold moves that might seem risky during normal times.
Building Resilience Through Strategic Technology Adoption
The pandemic taught us that economic disruptions are inevitable, but they don’t have to be devastating. Companies that invest strategically in technology during downturns can emerge stronger and more competitive.
The key is to view economic uncertainty not as a threat to be weathered, but as an opportunity to build advantages that competitors can’t easily replicate. Technology investments made during difficult times often deliver the highest returns because they’re made with focus and urgency.
Organizations considering technology investments during economic downturns should remember that the gap between leaders and laggards continues to widen. The companies that act decisively now will be positioned to capture disproportionate growth when conditions improve.
For teams managing complex development processes, ensuring regulatory compliance, and coordinating global collaboration, the lessons from pandemic-era success stories are particularly relevant. Strategic technology investments can streamline operations, reduce manual effort, and create scalable systems that support both current needs and future growth.
Explore Jama Connect Today
Ready to transform your organization’s approach to requirements management and compliance? Jama Connect has helped hundreds of the world’s leading companies scale and thrive during uncertainty. Discover how our platform can help you reduce documentation time, ensure regulatory compliance, and build the collaborative workflows that drive sustainable growth — even in challenging economic conditions.
Disclaimer: This blog post was written with the assistance of AI, particularly the portions summarizing Accenture Research. This blog post was edited and reviewed for accuracy by Kenzie Jonsson, Mario Maldari, and Decoteau Wilkerson.
Jama Connect® Continues to Dominate as the #1 Leader in Requirements Management Software
We’re proud to share that Jama Connect has once again proven its excellence, securing the #1 spot in G2’s Summer 2025 Grid® Report for Requirements Management Software! This marks the sixth consecutive quarter that we’ve been named the overall leader, solidifying our position as the go-to solution for teams managing complex product and software development lifecycles.
This recognition, driven by the feedback and trust of our users, continues to place Jama Connect ahead of competitors like Polarion, IBM® DOORS®, and Codebeamer. It’s a testament to our commitment to innovation and customer satisfaction.
G2’s Grid Reports rank software solutions based on real user reviews, data from online sources, and analysis via G2’s proprietary algorithm. With this rigorous evaluation, the Summer 2025 report highlights the industry’s top performers, and Jama Connect leads the pack yet again.
For this quarter, Jama Connect achieved a customer satisfaction score of 97, accompanied by over 150 unique reviews praising our ease of use, unmatched collaboration features, and ability to streamline traceability across projects.
This quarter, Jama Connect didn’t just hold onto its top spot — we earned recognition across a wide array of categories. Here’s a breakdown of the accolades we garnered in the G2 Summer 2025 report:
Overall Leader
Momentum Leader
Small-Business Leader
Mid-Market Leader
Enterprise Leader
EMEA Leader
Europe Leader
These achievements underscore the versatility and scalability of Jama Connect, making it an ideal choice for teams of any size, across multiple industries and regions.
What Our Users Are Saying
We owe this success to the valuable insights shared by our customers, whose feedback drives us forward. Here are just a few highlights from recent G2 reviews:
“Jama Connect is extremely intuitive. Team members are able to use it immediately without any prior training. We do have a training program that is recommended for the entire team but that serves to show everyone how to take the best out of the tool.” – Alexandre, Systems Engineer, Mid-Market
This recognition bolsters our mission to help organizations transition from outdated document-based processes to a modern requirements management platform. With Jama Connect, teams can achieve:
Enhanced clarity and accountability through real-time collaboration
Seamless traceability to manage requirements, risks, and test cases
Compliance with industry-specific regulations and standards
Our continued focus on innovation ensures that we meet the evolving needs of organizations navigating increasing product complexity and regulatory demand.
A Heartfelt Thank You
This milestone is not just our achievement but a shared success with our users. Your trust and feedback inspire us to deliver outstanding solutions that simplify your workflows and enhance your product lifecycle management.
Thank you for being part of this incredible journey. Rest assured, we’re committed to pushing the boundaries of what’s possible with requirements management.
Thank you for choosing Jama Connect as your partner in solving complex challenges! Here’s to continuing this legacy of excellence together!
Jama Software is always looking for news that would benefit and inform our industry partners. As such, we’ve curated a series of customer and industry spotlight articles that we found insightful. In this blog post, we share an article from VDA, titled “Automotive Industry Signs Memorandum of Understanding”, written by Lena Anzenhofer and published on June 23, 2025.
Automotive Industry Signs Memorandum of Understanding
Automotive industry signs Memorandum of Understanding for joint software development based on open source
Collaboration for more speed, efficiency, and security in software development and the basis for an open and collaborative ecosystem
With the support of the German Association of the Automotive Industry (VDA), 11 companies in the automotive industry have agreed on pre-competitive cooperation in open source software development.
A corresponding Memorandum of Understanding (MoU) was signed today at the 29th International Automotive Electronics Congress (AEK).
With the increasing importance and complexity of vehicle software, it is becoming critical for the industry to increase speed and efficiency in development while ensuring high quality and safety.
A significant portion of the vehicle software is not directly accessible to the user and therefore not differentiating. This fact allows the corresponding software modules to be developed jointly in an open and collaborative ecosystem.
In order to achieve the necessary functional safety for automotive series software, a groundbreaking development process for open source was developed in preparation for certification according to the relevant standards.
In addition, by providing executable software modules instead of detailed specifications, standardization and increased development speed are achieved through the so-called code-first approach.
The software development takes place in a transparent and vendor-independent environment of the Eclipse Foundation as part of the S-CORE project.
This ecosystem is open, both through software interoperability with relevant industry standards and for contributions and collaboration from other European and international companies.
The initiative’s timeline envisages that the software scope for series development of a platform for autonomous driving will be available in 2026.
The modular software scope can be adapted or expanded and then made available to the industry as a customized distribution for series development. This allows manufacturers and suppliers to focus on differentiating features while maintaining core components together. This creates a strong foundation for innovation – and the freedom to focus on what makes the difference for the customer.
“Together we are building a future-proof and powerful software ecosystem – open, transparent and secure,” VDA Managing Director Dr. Marcus Bollig said.
BMW Group Dr. Christoph Grote, SVP Electronics and Software
“The BMW Group believes that integrated ecosystems with open-source platforms and tools are a key driver for the development of mobility solutions. A shared code-first approach will be the foundation for functional innovations in our future products. We are committed to ECLIPSE S-CORE as a promising open-source approach for our upcoming projects.”
Continental AG Karsten Michels, Head of Product line “High Performance Computer”, BA “Architecture and Network Solutions”
“By uniting open-source and virtualization with safety certification and standardization, Continental’s contribution to an open and safe HPC Middleware Stack accelerates the transition to Software Defined Vehicles and significantly reduces time-to-market.”
ECLIPSE Foundation Mike Milinkovich, Executive Director
“Collaboration in the development of secure and open-source automotive platforms is a critical factor for the automotive industry. The Eclipse Foundation’s governance model enables open collaboration between OEMs, tiers, and tech players within the Eclipse SDV Working Group. We recognize the trust placed in us as the stewards of such a strategic initiative and embrace the challenge of making it a success.”
ETAS GmbH Dr. Thomas Irawan, CEO
“Building on our role as a pioneer in automotive platform software, we are driving industry-wide innovation through an open source ecosystem, accelerating time to market, and delivering safe and sustainable solutions for the mobility of tomorrow.”
HELLA GmbH & Co. KGaA Dr. Dietmar Stapel, Vice President Product Segment Radar
“We are pleased to support the Automotive Grade Open Source Ecosystem. Open, common standards are essential for secure integration and form the foundation for delivering innovative, value-added automotive features.”
Mercedes-Benz AG Magnus Östberg, Chief Software Officer
“As the creators of the automotive open source ecosystem, we are actively driving the future of automotive software with our code-first strategy. This is our clear commitment to open standards as the foundation for innovation.”
Qorix Markus Schupfner, CEO
“Qorix is committed to a powerful, open software ecosystem that combines functional safety and the speed of innovation – from architecture to production deployment.”
Robert Bosch GmbH Dr. Mathias Pilin, CTO Mobility
“We promote software solutions that integrate seamlessly across vehicle platforms, systems, and supplier technologies – for a software-defined mobility of the future.”
Valeo Brain Division Joachim Mathes, CTO
“Valeo has decided to join S-CORE and contribute key elements of its vOS to the stack. We are confident that a greater level of standardization and reuse will benefit the entire industry.”
Vector Informatik GmbH Dr. Matthias Traub, Managing Director
“With our joint initiative for an open software ecosystem for automotive ECUs, we are adding a powerful tool to the industry’s HPC full-stack toolbox.”
Volkswagen AG Dr. Oliver Seifert, Vice President R&D Infotainment and Connect at Dr. Ing. h.c. F. Porsche AG
“Through this open source ecosystem in automotive development, we shorten the time to market, reduce application development effort, and drive innovation.”
ZF Friedrichshafen Torsten Gollewski, Executive Vice President Corporate R&D Innovation & Technology
“Software development based on open source is the key to greater efficiency and speed. This is necessary to remain internationally competitive. The VDA initiative is a good example of the benefits that collaboration can bring.”
Jama Connect® Attains Level 2 TISAX Certification from TÜV SÜD
Jama Software, the industry’s leading requirements management and traceability solution provider, announced that it has achieved Level 2 Trusted Information Security Assessment Exchange (TISAX) certification from TÜV SÜD. TISAX is a security standard created by the German Association of the Automotive Industry (VDA).
Jama Connect is now the only requirements management application that is both TISAX and SOC 2 certified
This achievement underscores Jama Software’s unwavering commitment to information security and data protection. TISAX certification is a critical benchmark for meeting the stringent security requirements of German OEMs and their global supply chains, ensuring that sensitive customer and product data is handled with the highest standards of confidentiality, integrity, and availability.
For our customers, this certification unequivocally demonstrates that Jama Software’s solutions and processes embody the highest standards of information security. It empowers organizations to meet stringent compliance requirements, simplifies and accelerates procurement processes, and fortifies trust in an era of increasingly complex regulatory demands and cyber threats. With this certification, customers gain not just confidence but a decisive edge in addressing their most critical security challenges.
“Jama Software is committed to enabling the highest levels of security for our customers. In support of our rapid growth in the automotive sector, we have added TISAX certification to complement our market leading SOC 2 certified application,” said Neil Stroud, General Manager Automotive & Semiconductor, Jama Software.
Jama Software is focused on maximizing innovation success in multidisciplinary engineering organizations. Numerous firsts for humanity in fields such as fuel cells, electrification, space, software-defined vehicles, surgical robotics, and more all rely on Jama Connect requirements management software to minimize the risk of defects, rework, cost overruns, and recalls. Using Jama Connect, engineering organizations can now intelligently manage the development process by leveraging Live Traceability™ across best-of-breed tools to measurably improve outcomes. Our rapidly growing customer base spans the automotive, medical device, life sciences, semiconductor, aerospace & defense, industrial manufacturing, consumer electronics, financial services, and insurance industries.
Simplify Airborne Systems Lifecycle Milestones with Categories
Gain Clarity, Reduce Risks, and Stay Compliant.
Struggling to keep track of deliverables across complex aerospace projects? You’re not alone. Managing deadlines and milestones often feels like navigating a maze of documents, spreadsheets, and shifting priorities.
In this webinar, you’ll discover how Jama Connect®’s Categories feature can bring order to your milestones, improve transparency, and align deliverables with key compliance standards like ARP4754.
What You’ll Learn:
How to Enable Categories: Simplify system development milestone tracking from start to finish.
Clarity on Deadlines: Learn how to make engineering deadlines easier to understand and act on.
Improving On-Time Performance: Organize milestone deliverables and optimize workflows to avoid delays.
Compliance Alignment: Map development milestones to standards such as ARP4754 with ease.
VIDEO TRANSCRIPT
Patrick Knowles: I’m Patrick Knowles. It’s great to meet all of you. Today, we are going to be looking at simplifying airborne systems, specifically lifecycle milestones, by using Categories in Jama Connect. As I mentioned, my name is Patrick Knowles. I’m a senior solutions consultant here. And it’s just a pleasure to work with y’all. I’m in our aerospace and defense vertical, so my expertise comes from that within the industry. And now I’m happy to be sharing that with you all as I work through consulting, as well as webinars. Today’s agenda, we’re going to tackle really the core problem, the complex challenge of milestone deliveries. From there, I’m going to introduce this category’s functionality and features to all of you. If it’s something you’re familiar with, this will be a breeze. If it’s something new to you, I hope this is a great introduction to how it works.
Then we’ll talk about how you categorize information specifically with some best practices. So, for even those who are used to using Categories, this should be a refreshing little bit with maybe some new tricks that you can utilize. And then finally, we’re going to talk about deploying this to your collaborative teams, which is really critical. Because if the data’s Categorized on day one and then the data changes or new data comes in, your teams are going to need to know how to manage this, how to look at the information. And it’s going to help solve that complex challenge of milestone delivery and some of the issues that we’re going to talk about there.
So, this complex challenge, deadlines, and stress. There’s data everywhere. It’s disconnected, it’s disparate, it’s annoying. That’s the core root problem here. But to elaborate on it, engineering in the digital age can feel like a maze. There’s sometimes a lack of top-down visibility to deliverables. So, if you’re a program manager or a lead systems engineer or a chief engineer, you might struggle to see all the work that your teams are doing. And sometimes there’s a lack of bottom-up visibility to the milestone. So, if you’re an engineer, you might not know about what milestone comes next, what’s due at that milestone. A lot of the time, that information is on a Word document or an Excel sheet, or maybe a Confluence page at best, where it’s listing out everything that’s due, but it doesn’t inherently connect to anything that is due and what those exact bits of information on.
And that leads to some unclear methods for contributing. How do I, as an engineer, ensure that we’re going to meet this deadline? I know what I see on my scrum board or I see from my manager, or whatever it might be, but maybe at the end of the day I don’t really understand exactly how my little bit of data is getting into that greater picture for this delivery to our customer or to our internal stakeholders. And then, of course, the common issue is always that data is disconnected, but that’s what Jama Connect is here to help with. We’re here to help you guide through that maze and to connect your data together to solve these key issues.
So, the risky scenario here is that your data is disconnected from a milestone, and that maybe you forget to deliver a certain part of the data, or you deliver outdated bits of data, or anything else that might happen there. And it’s pretty common across engineering. It doesn’t really matter where you work, there’s always this struggle to get everything ready from pencils down to delivery or whatever it might be. There are bigger views related to all of this work. There are stakeholders, customers, and, of course, the program leaders who need to see this information. And they need to see the most up-to-date, correct information. And without a clear way to connect your requirements specifically, because that’s what we’re going to mostly talk about here, is requirements. But without a really clear way to connect your requirements to your milestones or the rest of your data to milestones, you run the risk of simply leaving things behind.
Knowles: So, how can Jama Connect help? Well, the specific use case we’re going to talk about today is enabling our Categories functionality in the tool. And we’re going to line it up with milestones from regulatory documents. Specifically, this example is going to be based on ARP4754B. However, if you are running the NASA systems engineering life cycle and you know the milestones in there, you could also line this up to that or any other number of product lifecycle milestones. We’re going to categorize data directly into things. And that’s going to help you really line it up to each of these listed items over there in the screenshot on the right. And then your members of the team are going to be able to filter, and view this data, and see it grow and add to it. And it’s going to be very transparent for them, how they’re connecting their information to the greater milestone.
With our foundation laid, there on what the problem is, I want to talk more about what Categories are. So, what exactly is a Category? Why do we believe this is a great option for you and the team to try and enable within your tool? Specifically, Categories have a similar feel to some other features within Jama Connect, like tags and pick lists. However, Categories win out overall with this specific use case for a number of reasons. First and foremost, Categories are admin-enabled and controlled, so your general user can’t populate a Category. They can assign information to a Category, but they can’t create new ones. Which means that, unlike tags, this is a kind of configuration managed by your admins. Pick lists are also configuration managed by your admins. However, they aren’t globally accessible to all item types. You’re going to have to create a field for every single pick list that you want assigned different item types.
Categories, however, can be globally applied to an entire project or to the whole instance of Jama Connect. That means that you don’t have to go and assign them to each of your item types. They’re going to connect to folders. They’re going to connect to texts. They’re going to connect with your specific requirement types, whatever it might be. And so, that’s an advantage that Categories have. Also, Categories can be available across multiple projects or just one specific project, which helps if you have a kind of multi-layered approach to your Jama Connect development of requirements. Finally, I’ll explain why not to use tags and pick lists. Tags, again, are creatable and by the user, and prone to error. If you type a capital letter in the wrong spot or put the wrong vowel in the wrong place, that’s going to be there in perpetuity, unless you have really strong tag cleanup processes.
And pick lists and multi-selects, you have to create it for each item type. You have to maintain the pick list. And then if an item type is introduced to a project, you’re going to have to re-add that pick list to it, and so on and so forth. So Categories is a little broader, but also just as controlled. And so, you’re able to kind of manage in a smoother way. So, how do you set up Categories? Well, you go to admin, Categories. And then over there on the far right of the screenshot, you’ll see enable Categories is turned on. It’s defaulted off for most instances, so make sure you turn it on first. From there, we’re going to set up all the Categories you see in front of you on the screenshot, as well as any number of other Category you may want to enable.
Knowles: Now, once you’ve got everything enabled, it’s all about how do you Categorize the information. So, we’re going to walk through some instructions, some best practices, and then we’ll do some demonstration, of course, here at the end of this section of the slides on how you do all this work. The first thing, like we mentioned, is enabling Categories. You do that through the admin. You assign things to either projects or global within your Jama Connect instance, and then you start utilizing them. One of our best practices here is to manage Categories through logical organizers, so folders, sets, components. That allows you to then click into the list view of that logical organizer and then assign all the Categories to the items within it. You don’t have to do this. This is just one of the more efficient ways, especially if you’re enabling an architecture-forward approach within your database. And of course, you can manage Categories in bulk, otherwise this whole explanation wouldn’t make much sense.
So, some of the tips, tricks, and best practices. Here, we’ve got the managing in bulk. And I’ll show you how to do that live. We’ll view categorized information in the exploratory via a filter, and so we’ve got to set up filters. Of course, those same filters can be exported or sent to reports, and then you can use multiple Categories on the same item. So, if one item is going to be delivered at the first milestone and you want to continue to deliver it at the next milestone, you simply add both Categories to it. And finally, you can always create baselines of everything filtered. So, these filters that we’re going to use to shrink down and narrow down the exploratory are also going to be very, very useful for baselining, for exporting, and for a number of other things.
So, now it’s time to demonstrate some of these best practices. The first things first is enabling Categories. As we discussed earlier, there’s this enable Categories button here on the far right. Once enabled, you’ll be able to add Categories with the add button here. Doing that is as simple as populating a single field with the information and hitting add. I, of course, have the whole system ddevelopment phase added already, and so I want to show you exactly what that looks like, how these things got nested underneath each other, and so on and so forth, by adding an eighth step. So, for today, the webinar phase is what we’re going to add to our development phases here. When we add, it’s going to actually add it at the top level. And so, then we need to drag it down into the system development phase.
We are going to use the move functionality here, as that’s the best practice in this scenario, where the copy Category functionality is better for using this for variant management. Now you can see that the webinar phase has been added to the system development phases. And you can also see that the system development phase is a project Category. This was done by managing access here on the right side, where you can pick the specific projects you’d like this Category to be assigned to. Or if this is something you want globally accessible, you can use the globally accessible button here. When you hit that, you’ll see that it turns orange and has a globe, instead of the project specific icon that you saw originally.
Now let’s look at how we categorize information within the tool. Our screenshots were showing this functions portion of this project, and so we’re going to dive into that to continue the continuity of this example. This specific set here, we’ll view the details of it, and we’ll simply scroll down and manage Categories. So, if we wanted to add that eight system development phase, webinar phase, we’ll simply select it, and click add and it will be added to this set of information. From there, we can bulk edit everything underneath the set by selecting all the items and clicking manage Categories. Same pop-up shows up, and we’re able to add that eighth phase of the lifecycle.
Now, this is really, really fantastic. If we want to go see everything in the eighth phase of the lifecycle, we can select the Categories feature over here. We can expand our system development phase and select webinar phase, where we see the items that were added there, including the set up here, and are able to kind of view this information in the list view. Now, if we wanted to see this in the explorer, we would go to filters and we’re just going to rely on this pre-built one here. And we’re going to right click apply filter to explorer. This is going to show us the information in a more succinct way. And we’ll talk more about this as we go on.
Knowles: Now that we’ve looked at how to enable Categories, we want to talk about how we develop this and deploy this data and these Categories for your collaborative team. I talked a little bit about this and showed you these exact steps here to narrow down your explorer tree, but what really is the benefit here? Well, you can set up a simple filter that’s based on the Category itself and right-click apply that filter to the explorer. This lets teams see just the information they need to care about coming up, especially if your sets, components, and folders are all categorized. This will show a team that, hey, we need to make sure all of the aircraft functions are populated for this coming milestone, because that set is there. Same with the aircraft validations, the requirements, and the plans and assessments.
Each of those logical organizers are categorized, showing the team this is something that is due at the upcoming milestone. The team then will populate information underneath that and they will categorize those items as well to bring them into the overall filter. Now, public filters are just kind of one of the ways we want to see this deployed to the team. We also need to demonstrate to the team how do you bookmark the filters, and how do you even manage Categories in general? So, in the next step here, I’m going to demonstrate managing Categories for single items, as well as a couple other little nuances within the tool that the teams will need to understand as they go ahead and use this in the deployed environment.
When deploying this information to the teams, it’s really critical that you’ve set your filters to be public. A quick way to note if something is public is if it’s got the asterisk next to the name here. You can always right-click and edit your filter and click the make public, and that will denote that it is public to all users using this project. Once your filters are all built out, you’re going to have them there. You’re going to teach your users exactly how to use them, of course, with the apply filter to explore. But also, if they need to send these for a review and get signatures on them or add a baseline, there’s also these features available to them.
And of course, bookmarking is really, really critical. Without it bookmarked, you can see I’m now missing phase one, so I have to go to all, and then go find phase one, and add it to my bookmarks and it’ll now show up in my bookmarked section here. Users most of the time are going to be adding new items to the tool. And so, if we add a new item here, we’re going to populate this new item, a new item for webinar. And that’s going to be our example item here to show that once we’ve saved it, this is when we get to add the Categories. It’s not a field that’s available directly when editing a brand new item. It shows up after the fact here down at the bottom with the managed Categories button.
You’ll then grab the applicable Categories that you want to add to this item, save it, and you’ll see them here. This helps, and it automatically adds things to the filter. You’ll see here that we’ve gone up in the number of items, and our new item for the webinar right here is now part of the filter automatically. Additionally, you can show your users that they can come directly here in the category section to see the same information, just without the filter and without some of those right-click functionalities that you get to see when you’re in the filter section. It’s been fantastic to work with you all today and show off these features in the tool.
Jama Software is always looking for news that would benefit and inform our industry partners. As such, we’ve curated a series of customer and industry spotlight articles that we found insightful. In this blog post, we share an article from AEC Business, titled “Construction’s Next Leap: AI as a Strategic Partner”, and written by Aarni Heiskanen and published on May 24, 2025.
Construction’s Next Leap: AI as a Strategic Partner
In this episode of the AI AEC Show, Aarni Heiskanen welcomes back René Morkos, PhD, the visionary founder and CEO of ALICE Technologies, to explore the latest advances in artificial intelligence for construction scheduling and project optimization.
The Shift: Generative AI Comes to Construction
Since their last conversation, René highlights the most significant change in the construction tech landscape: the rapid rise of generative AI and large language models (LLMs). These tools are fundamentally altering how project data is accessed, analyzed, and leveraged across the industry.
René explains how ALICE Technologies has embraced this transformation by developing two AI-driven scheduling agents. These agents don’t just generate optimized schedules—they can also interact conversationally with planners, offering insights into delays, critical tasks, progress updates, and more. This represents a leap from static scheduling tools to dynamic, intelligent collaboration.
One persistent challenge in construction is fragmented and unstructured data. AI offers a promising way forward. René points to solutions like Trunk Tools, which allow users to query entire project datasets in natural language—”Show me the change orders” or “Summarize this RFI”—without needing to manually sift through files.
This democratization of data access, powered by AI, is eliminating a long-standing bottleneck in construction project management.
A Platform for Optimization
René also discusses how ALICE’s platform not only helps plan construction projects but actively explores “what-if” scenarios—testing and comparing thousands of possible construction strategies. This simulation-based approach enables teams to reduce risk, save time, and improve project outcomes with confidence.
Looking forward, René envisions an increasingly automated construction planning ecosystem. As he puts it, we’re moving toward a future where the question is not just “what’s the plan?” but “what’s the best possible plan, and how do we know?” AI will provide the answers.
Takeaway: AI is not just a support tool—it’s becoming a decision partner in designing, scheduling, and executing construction projects.
Self-Hosted and Cloud: Flexible Deployment Options for Your Requirements Management with Jama Software
Efficient requirements management is vital for the success of any organization, especially in industries like aerospace, defense, and government, where compliance, security, and accuracy are paramount. Jama Software provides a sophisticated and adaptable requirements management solution, ensuring that your teams stay ahead in competitive and highly regulated fields.
But did you know that Jama Connect® isn’t only available as a cloud solution? Depending on your organization’s unique needs, you can also choose a self-hosted deployment option. This flexibility is the perfect answer for industries requiring strict data sovereignty, air-gapped environments, or regulatory compliance.
While Jama Connect is well-known for our cloud deployment option, we actually originated as a self-hosted product more than twenty years ago. And two decades later, we remain committed to delivering the best platform and customer experience for our self-hosted and cloud customers.
Curious about which deployment option best suits your business? This post will break down when to choose Jama Connect Cloud versus the self-hosted deployment. We’ll also answer frequently asked questions to help you make informed decisions.
When to Choose Jama Software Cloud vs. Self-Hosted
Jama Connect Cloud and Jama Connect Self-Hosted both empower effective requirements management. However, certain use cases demand one option over the other.
Jama Connect Cloud
Best for organizations that value ease of deployment, automatic updates, and seamless access. Key benefits include:
Automatic Updates and Maintenance: Benefit from the latest features and security enhancements without manual effort.
Anywhere, Anytime Access: Teams can access data on-demand, enabling global collaboration without roadblocks.
Cost Efficiency: Eliminate the need for large IT infrastructure spendings; we handle hosting for you.
Ideal for industries like tech startups, mid-sized enterprises, and companies prioritizing agility and scalability in requirements management.
Jama Connect Self-Hosted
Organizations working in highly regulated industries often need tighter control over their data. This deployment ensures robust security and customization on your own infrastructure. Benefits include:
Data Sovereignty: Maintain control of sensitive data and ensure compliance with local regulations.
Air-Gapped Environments: Operate without internet connectivity, ideal for sectors like aerospace and defense that mandate offline solutions.
Regulatory Compliance: Handle development processes under strict standards like ITAR, ECJU, and EAR.
Ideal for industries such as government, aerospace, and defense, where security and compliance are non-negotiable.
Jama Connect Deployment Options
Jama Connect ensures that your needs are met, whether you lean toward cloud solutions or prefer in-house deployment. Here’s how Jama Connect offers robust flexibility in deployment:
Cloud Deployment
Our cloud-based SaaS solution takes the burden of infrastructure management off your shoulders. It ensures faster setup, seamless updates, and scalability as your teams grow. Collaborate easily across distributed teams while we manage the heavy lifting of security and operational efficiency.
Self-Hosted Deployment
Need control down to the last detail? Self-host Jama Connect within your IT infrastructure. This option provides your team with complete autonomy over data, operational configuration, and security measures. Your infrastructure, your rules.
Do you have questions about configuring a self-hosted deployment? Our experts are here to help. Schedule a consultation to explore the best option for your business.
FAQ: Common Questions About Jama Software Deployment Options
Still not sure which deployment is right for you? Below are answers to some frequently asked questions.
Is switching between Jama Connect Cloud and Self-Hosted possible?
Yes, we offer migration support to ensure your data transitions smoothly between deployment types when upgrading or restructuring operations.
Do both deployments support compliance with industry standards?
Absolutely! Whether cloud-based or on-premises, Jama Connect supports compliance with requirements like ISO 26262, DO-178C, DO-254, and other critical regulatory standards. Your choice of deployment will not limit compliance functionality.
What level of IT support is required for the self-hosted deployment?
Self-hosted deployments require your organization to manage backups, updates, and server maintenance. However, we provide technical guidance to your IT teams to ensure a smooth setup.
Does the cloud option support multi-location teams?
Yes! With the cloud deployment, all team members, regardless of their geographic location, can work collaboratively without latency or access issues.
What security measures are in place for both deployment options?
For Self-Hosted: You’ll adhere to your internal security protocols (including CMMC security requirements) and configurations.
Jama Software Provides a Smarter Approach to Requirements Management
When it comes to requirements management, there’s no “one-size-fits-all.” Jama Connect adapts to your unique organizational needs, whether you need a hands-off cloud solution or an air-gapped, team-managed infrastructure.
Experience seamless collaboration, reduce compliance risks, and ensure stakeholder alignment across your organization with Jama Software. Are you ready to optimize your requirements management process?
Explore our deployment options and see how Jama Connect aligns with your vision of compliance, security, and efficiency.
Empowering Complex Medical Device and Life Sciences Development with Responsible AI and Machine Learning
Artificial intelligence (AI) and machine learning (ML) are transforming industries across the globe, and the medical device and life sciences sectors are no exception. Today, the development of complex medical devices is being accelerated and optimized with the integration of responsible AI. From enhanced product design to improved compliance and streamlined workflows, AI is allowing teams to accelerate their workflows.
This blog aims to explore the expected impact of AI on medical device development — including current industry trends, regulatory considerations, and how companies like Jama Software are empowering organizations to leverage AI responsibly.
Types of AI Medical Devices
AI medical devices are rapidly transforming healthcare by introducing advanced diagnostic, therapeutic, and monitoring capabilities. Among the 950 AI-powered medical devices currently identified, several core categories stand out:
Diagnostic Tools: AI-driven diagnostic devices are designed to assist in identifying diseases and conditions with greater accuracy and efficiency. These include imaging systems equipped with machine learning algorithms to detect abnormalities in X-rays, MRIs, and CT scans, as well as AI software for analyzing pathology reports or genetic data. Such tools are especially beneficial in early disease detection, reducing diagnostic errors, and improving patient outcomes.
Monitoring Devices: Another significant category is AI-enabled monitoring devices. These systems continuously track patient vitals, such as heart rate, blood pressure, glucose levels, or oxygen saturation, and can alert healthcare providers to early warning signs of complications. Wearable sensors and remote patient monitoring platforms powered by AI are playing a crucial role in providing real-time health insights, especially for chronic disease management.
Therapeutic Systems: AI-powered therapeutic devices support or enhance treatment strategies. Examples include robotic surgery platforms with AI for precise surgical execution, as well as AI software that tailors treatment plans using patient-specific data. These systems are helping doctors optimize therapies and deliver more effective and personalized care.
Decision Support Applications: AI-based decision support tools are designed to assist clinicians in making informed decisions. These devices analyze vast amounts of medical data to provide evidence-based recommendations or predict potential complications. They are widely used to guide treatment strategies and manage complex conditions with a data-driven approach.
By focusing on these categories, it becomes clear that AI medical devices are not only advancing the standard of care but also addressing critical gaps in healthcare delivery through innovative applications of artificial intelligence.
Medical device manufacturers are leveraging AI and ML in several groundbreaking ways. The U.S. Food and Drug Administration (FDA) has already approved over 950 AI-enabled medical devices as of mid-2024. This reflects a dramatic rise over the past decade and highlights the growing adoption of AI technologies. Here are key areas where AI is making a difference in medical device development:
Current Regulations for AI and ML in Medical Device Development
While the potential of AI is evident the successful adoption of these technologies requires adherence to evolving regulatory frameworks. The FDA has been actively addressing the need for guidelines in this space, ensuring a balance between innovation and safety.
FDA Guidance and Regulations
The FDA oversees AI-enabled devices through various pre-market pathways, including:
Premarket Notification (510(k))
De Novo Classification
Premarket Approval (PMA)
To accommodate the complexities associated with adaptive AI/ML-enabled devices, the FDA has released multiple resources, such as the 2024 Artificial Intelligence and Machine Learning Action Plan, which outlines the agency’s vision for regulatory oversight. Key highlights include:
Development of Good Machine Learning Practices (GMLP).
Introduction of frameworks for Predetermined Change Control Plans, allowing for post-market updates to AI systems without requiring new approvals.
Enhanced transparency for AI-powered medical devices.
New FDA Guidance: To learn more about recent guidance provided by the FDA, read these two articles:
Beyond the U.S., regulatory developments in Europe, including the EU AI Act and MDR compliance, are impacting how organizations worldwide approach AI implementation in medical devices.
Staying compliant demands robust traceability, stringent risk management protocols, and adherence to data security standards.
Trends and Insights for AI-Powered Medical Device Development
The trajectory of AI in medical device development is poised to grow exponentially, driven by several key trends:
Shift to Software-Defined Devices
Medical devices are increasingly becoming software-centric. Traditional hardware is giving way to platforms that can be continuously enhanced through software updates.
Integration of Generative AI
Generative AI algorithms are now being used by medical device manufacturers to create simulations, generate testing data, and optimize device designs. Companies like NVIDIA are spearheading this trend with platforms supporting robotics and digital surgery.
Rise of Collaboration and Ecosystem Growth
Partnerships between MedTech companies, academic institutions, and tech giants are fueling innovation. Startups like Moon Surgical and Aidoc demonstrate how collaborations can lead to cutting-edge AI implementations in laparoscopy and diagnostic tools.
Broader Applications Beyond Radiology
While radiology remains at the forefront, AI is expanding rapidly into fields like:
Neurology: Detecting brain activity anomalies.
Cardiology: Spotting arrhythmias through AI-powered stethoscopes.
Oncology: AI-enabled tools for precision cancer diagnosis.
Jama Software’s AI Initiatives for Medical Device Development
With the rise of AI-enabled medical devices, Jama Software is focused on how organizations can incorporate AI applications in their product development processes to improve quality and accelerate development. Here are a few example use cases Jama Connect® is focused on:
Jama Connect Advisor™
Jama Connect Advisor analyzes your product requirements against industry standards such as INCOSE Rules and EARS Notation, then recommends improvements. This fast, accurate analysis and advice helps your requirements align with engineering-focused natural language and best practices.
Benefits of using Jama Connect Advisor:
Improves the quality, accuracy, and usability of your requirements across your organization.
Assists development teams in standardizing the process and language of requirement authoring.
Saves time for authoring, reviewing, and updating requirement statements.
Helps deliver programs and projects on time and on budget.
Reduces the risk of late-stage errors.
Test Case Intelligence
Streamline verification and accelerate to market with AI-generated test cases derived from requirements.
Intelligent PDF Parsing
Quickly parse PDFs and Office files, match to existing IP, or generate new requirements for review and collaboration. AI enhances reuse, speeds RFPs, streamlines supply chain collaboration, and boosts product quality.
Integration of AI and ML is already accelerating and changing medical device development. From enabling groundbreaking technologies to revolutionizing patient care, AI is laying the foundation for the medical devices of tomorrow. However, success in this domain requires balancing innovation with compliance, backed by robust tools that alleviate complexity.
Jama Software’s AI solutions empower organizations to tackle these challenges head-on, reducing risks, streamlining workflows, and ensuring quality at every step of medical device development.
Want to see how AI can streamline your product development?
Book your free demo today and experience the power of AI in revolutionizing requirements management for medical devices.
