In this blog, we recap our recent Whitepaper, “Navigating AI Safety with ISO 8800 in Road Vehicles”

Navigating AI Safety with ISO 8800 in Road Vehicles

Editor’s Note: This blog post is based off of content from our recent webinar, presented by Matt Mickle and Jody Nelson from SecuRESafe (SRES). To learn more about how SRES can help your team develop responsibly safe and secure products for the evolving automotive and industrial space, please visit SecuRESafe (SRES). 

The automotive industry is in the midst of a transformation, driven by the rise of autonomous systems and artificial intelligence (AI). With the promise of enhanced safety, efficiency, and reliability, these technologies are rapidly advancing. However, as the complexity of AI systems used in road vehicles grows, ensuring their safety continues to be a top priority. Key to achieving this is the emergence of new standards like ISO 8800, a pivotal framework for guiding AI safety practices.

AI-powered road vehicles introduce numerous safety challenges, from understanding edgecase scenarios to managing real-time decision-making under varying conditions. Without proper safety assurances, these systems pose risks that could compromise passenger safety and public trust.

Existing Standards and Their Limitations

Standards like ISO 26262 (Functional Safety) and ISO/PAS 21448 (SOTIF – Safety of the Intended Functionality) have laid solid foundations for addressing traditional safety concerns. However, they do not fully account for the dynamic and adaptive nature of AI systems. This gap underscores the importance of ISO 8800.

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Addressing the Gaps with ISO 8800

ISO 8800 aims to bridge the existing gaps by providing comprehensive guidelines tailored specifically to AI-driven systems and their unique challenges. Unlike traditional systems, AI operates in a highly dynamic environment where decision-making is continuously evolving based on real-time data inputs. This introduces complexity in ensuring predictable and safe behavior, especially in unprecedented situations.

One of the key contributions of ISO 8800 is its focus on the explainability and transparency of AI decisions. By mandating traceable decision-making processes, it ensures that the behavior of AI systems can be understood, audited, and, if necessary, corrected. This is crucial for building trust and accountability, particularly in high-stakes contexts such as autonomous vehicles. Additionally, ISO 8800 emphasizes robust testing methodologies that go beyond conventional verification techniques. These methodologies consider edge cases, rare events, and adaptive learning mechanisms to ensure the AI system performs safely under even the most unpredictable circumstances.

By addressing these and other critical facets, ISO 8800 not only enhances existing standards but also sets a forward-looking precedent for ensuring the safety and reliability of AI systems in a rapidly evolving technological landscape.

ISO 8800 Overview

ISO 8800 focuses on ensuring that AI systems deployed in road environments adhere to rigorous safety standards while maintaining adaptability to real-world challenges. The framework is built around several key pillars, including behavior modeling, risk assessment, and continuous improvement processes.

First, ISO 8800 emphasizes the creation of robust behavior models for AI systems. These models define how an AI system should act in varying scenarios, taking into account factors such as traffic conditions, weather changes, and unforeseen obstacles. By establishing clear behavioral expectations, ISO 8800 aims to prevent unpredictable AI actions that could compromise safety.

Second, the framework requires comprehensive risk assessment protocols. This involves identifying potential vulnerabilities and failure points in AI systems and implementing strategies
to mitigate these risks. Importantly, ISO 8800 promotes a proactive approach, encouraging developers to anticipate edge cases — rare and complex situations that may strain an AI system’s capabilities.

Lastly, continuous improvement is a fundamental aspect of ISO 8800. AI systems must undergo regular updates and evaluations to ensure optimal performance in evolving environments. The framework supports ongoing data collection and analysis, allowing developers to refine algorithms and adapt to new challenges over time. By addressing these areas, ISO 8800 provides a structured foundation for managing the intricacies of AI in road safety, paving the way for innovation that aligns with public trust and regulatory expectations.

Core Principles

• Transparency: Ensure clear visibility into AI decision-making processes.
• Robustness: Design AI systems to perform reliably even under challenging and unforeseen conditions.
• Fairness and Accountability: Mitigate biases in AI algorithms and establish accountability mechanisms for system failures.

Interoperability with Other Standards

One of ISO 8800’s strengths is its compatibility with existing safety standards, complementing ISO 26262 and SOTIF. Together, these frameworks create a holistic approach to managing road vehicle safety.

Benefits of ISO 8800 Adoption

The adoption of ISO 8800 brings forth a range of strategic and operational advantages for organizations working on AI-driven systems, particularly in safety-critical industries. One of the most significant benefits is the enhancement of trust in AI systems. By adhering to standardized guidelines that emphasize safety, transparency, and reliability, companies can demonstrate their commitment to ethical AI practices. This commitment builds confidence not only among regulatory bodies but also within the general public and the broader industry ecosystem.

Another crucial advantage is the reduction of safety risks. ISO 8800 provides a robust framework for identifying, assessing, and mitigating potential hazards associated with AI operations. This systematic approach reduces the likelihood of accidents, malfunctions, or unforeseen consequences, particularly in applications such as autonomous vehicles, healthcare technologies, and industrial automation. Furthermore, by minimizing risks, organizations can lower the potential costs associated with failures or liability claims.

Regulatory compliance also becomes significantly more streamlined with ISO 8800. The standard aligns closely with emerging global regulations, helping organizations stay ahead in meeting legal and procedural requirements. This proactive alignment not only speeds up product approvals but also positions organizations as leaders in regulatory adherence, further strengthening their market reputation.

Lastly, adopting ISO 8800 can unlock new opportunities for innovation and collaboration. By integrating these standards into their development processes, companies create systems that are interoperable and compatible with broader networks. This fosters collaboration with partners, suppliers, and stakeholders while driving industry-wide advancements. Ultimately, ISO 8800 serves as a critical enabler of long-term success in building safe, reliable, and scalable AI systems.

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BEST PRACTICES FOR COMPLIANCE

Integrating ISO 8800 in Your Systems

• Start with a Gap Analysis: Identify areas where current practices fall short of ISO 8800 requirements.
• Develop a Comprehensive Safety Plan: Define clear safety goals and documentation protocols.
• Leverage Scalable Tools: Use model-based approaches to manage complexities in AI behavior.

Achieving compliance with ISO 8800 requires a well-structured and proactive approach. Begin by conducting a thorough gap analysis to evaluate your current processes against ISO 8800 standards. This initial step allows organizations to pinpoint specific areas where improvements are necessary, ensuring resources are allocated effectively. Following this, the development of a comprehensive safety plan is crucial. Such a plan should outline clear safety objectives, specify documentation procedures, and include ongoing evaluation mechanisms to ensure continuous improvement. It is essential to integrate roles and responsibilities across teams to foster
accountability and streamline implementation efforts.

Organizations should also invest in scalable tools to manage the inherent complexities of AI system behavior. Model-based approaches can be particularly effective, enabling teams to simulate, test, and validate system responses in a controlled environment. Additionally, prioritizing robust data management practices — such as ensuring data quality, traceability, and transparency — can strengthen the organization’s ability to identify risks and address them proactively. Regular training and awareness programs for staff are equally important to ensure alignment with compliance requirements and foster a culture of safety.

Finally, maintaining consistent communication with stakeholders, including regulatory bodies, industry partners, and end-users, helps build trust and demonstrates a commitment to adhering to ISO 8800. Establishing a feedback loop where compliance practices are periodically reviewed and refined will significantly enhance both reliability and long-term industry credibility.

By embedding these best practices, organizations can ensure a robust framework for safety and compliance while keeping pace with evolving industry standards.

DOWNLOAD THE ENTIRE WHITEPAPER TO LEARN MORE FAQS ABOUT ISO 8800:
Navigating AI Safety with ISO 8800 in Road Vehicles

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.

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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.

You Can Download the Memorandum of Understanding Here

Further quotes from the companies:

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.”

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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 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.

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Breaking Down Data Silos

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.

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The Road Ahead

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.

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 EE Times, titled “Strategies for Addressing More Complex Custom Chip Design”, and written by Abhishek Jadhav and published on March 21, 2025.

Strategies for Addressing More Complex Custom Chip Design

Unprecedented growth and demand for edge computing and high-performance computing (HPC) is creating new opportunities and significant challenges for custom chips. We spoke to Sondrel CEO Oliver Jones to discuss some of the approaches to addressing these needs.

Custom chip design is a multifaceted process involving many considerations, from power efficiency and performance trade-offs to manufacturing and packaging complexities. One of the primary challenges in this domain is managing power, performance and area (PPA) trade-offs.

Designers must carefully balance these factors to ensure that the final product meets the strict requirements of modern applications like AI at the edge or HPC workloads. Additionally, the process involves navigating geopolitical disruptions and supply chain constraints, which can delay production and increase costs.

Startups and established companies also face hurdles like limited resources, lack of access to advanced manufacturing facilities and navigating the intricate supply chain required for production. The role of specialized ASIC suppliers is to offer expertise in balancing power efficiency, managing supply chains and streamlining production.

“Selecting a turnkey supplier to handle a complete ASIC project is much more challenging than selecting an ASIC design house. There needs to be a high level of confidence and trust,” Jones said.

Flowchart explaining the turnkey model. (Inspired by source Sondrel)

In response to these challenges, some companies have adopted the turnkey model, which manages every stage of chip development—from initial concept to mass production. This approach simplifies the process for clients, especially startups lacking the resources or expertise to develop custom chips independently. By integrating services like architecture design, physical design and design for testing, turnkey providers reduce the risks and complexities associated with chip production.

For example, a turnkey provider’s partner ecosystem, including foundries like TSMC and GlobalFoundries, ensures a smooth transition from design to manufacturing. “Startups often have fantastic ideas but lack the capability and resources to translate them into hardware. We’re selective about who we work with, allowing us to provide closer attention and better service to each customer,” Jones explained.

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Case study: AI at the edge

In one example, a U.S.-based AI startup specializing in image and video recognition technology needed to develop an AI accelerator chip for edge applications, such as surveillance and facial recognition. This required a custom design to address challenges in architecture, packaging and supply chain management—areas particularly daunting for a startup with limited resources.

For this project, Sondrel helped the startup identify the need for a flip-chip CSP package with an ultra-low profile of 2.5 millimeters to meet the space and performance constraints. By pre-booking packaging slots, the lead time was reduced from 42 weeks to 12–16 weeks, accelerating the product’s time-to-market. The project integrated the startup’s proprietary AI IP to deliver a reliable and efficient chip that became central to the startup’s AI accelerator hardware.

By leveraging the provider’s ecosystem and expertise, the startup successfully developed a 16-nm FinFET chip in just two years.

The role of turnkey custom chip design houses

Startups face unique challenges in custom chip design, often struggling to access the resources and expertise needed to bring their ideas to life. Resource constraints can make it difficult to define optimal PPA trade-offs or secure manufacturing capacity. Additionally, supply chain disruptions, whether due to geopolitical tensions or market volatility, can create significant hurdles.

Edge AI applications, such as autonomous vehicles, smart cities and IoT devices, require custom chips capable of processing large amounts of data locally while minimizing power consumption. Similarly, HPC workloads, including scientific simulations and big data analytics, demand chips optimized for performance and scalability.

“AI at the edge and HPC are where we see the strongest demand,” Jones said.

Considering the rapidly evolving landscape, collaboration among design houses, foundries and ecosystem partners is critical. The ability to integrate advanced process nodes, innovative packaging solutions and robust supply chain strategies will define the future of custom chip design.

To address these issues, turnkey providers have developed foundry-agnostic approaches that offer greater flexibility. These approaches involve designing chips in a way that can be manufactured across different foundries without being tied to a single supplier, allowing companies to adapt to changing manufacturing capacities and avoid bottlenecks.

By maintaining strong relationships with multiple foundries, providers can secure wafer allocations and advanced packaging solutions, reducing lead times and minimizing risks. Selecting the right kind of chip packaging plays a key role here, and turnkey providers help companies to adopt the latest and innovative packaging solutions.

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Advanced packaging and open source add to the mix

While turnkey models provide a valuable solution, other strategies are also emerging to address the challenges of custom chip design. Collaborative research initiatives and public-private partnerships are playing an increasingly important role in driving innovation. For example, government-backed programs in Europe and North America are funding projects aimed at developing next-generation semiconductors.

Open-source hardware initiatives are another promising avenue. By providing a shared foundation for chip design, these initiatives can lower costs and accelerate development timelines—particularly for startups. Additionally, advancements in design automation tools are making it easier for companies to optimize PPA trade-offs and streamline the development process.

Innovative packaging solutions are a critical component of modern chip design, enabling manufacturers to achieve higher levels of integration and performance. Techniques like flip-chip and wafer-level packaging are becoming increasingly popular for applications in edge AI and HPC.

Flip-chip packaging allows direct electrical connections between the chip and the substrate, reducing signal interference and improving thermal management. Wafer-level packaging, on the other hand, integrates the packaging process directly on the wafer, enabling a smaller form factor, improved performance and lower production costs. These methods not only improve performance but also reduce the overall size and power consumption of chips.

For instance, in the aforementioned case study, using a flip-chip CSP package with an ultra-low profile of 2.5 millimeters significantly reduced lead times and enhanced the chip’s performance. This example underscores the importance of packaging innovations in meeting the demands of next-generation applications.

As edge computing and HPC continue to grow, the demand for custom chip design will only increase. The future of the semiconductor industry will be shaped by advancements in process technology, innovative packaging solutions and collaborative ecosystems. Companies that can effectively address the challenges of custom chip development will be well-positioned to lead in this dynamic market.

To achieve this, industry stakeholders must prioritize collaboration, investing in partnerships that span design, manufacturing and supply chain management. By working together, they can overcome the barriers to entry and accelerate the development of chips that power the next wave of technological innovation.

The custom chip design process is a testament to the complexity and ingenuity required to meet the demands of edge AI and HPC. Through a combination of innovative strategies and collaborative efforts, the industry is redefining what is possible, paving the way for a future where technology continues to push the boundaries of performance and efficiency.

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 Synopsys^®, titled “Synopsys Bold Prediction: 50% of New HPC Chip Designs Will Be Multi-Die in 2025”, and written by Michael Posner and Shekhar Kapoor and published on January 21, 2025.

Synopsys Bold Prediction: 50% of New HPC Chip Designs Will Be Multi-Die in 2025

Monolithic chips have been the workhorses behind decades of technological advancement. But just as the industrial revolution saw workhorses replaced with more efficient and powerful machinery, the semiconductor industry is on the cusp of a similar revolution.

Multi-die and chiplet-based designs — which integrate multiple specialized dies in a single package or stack integrated circuits vertically — stand to deliver far greater performance and flexibility than monolithic chips, capable of supporting the insatiable processing demands of high-performance computing (HPC) and AI-driven workloads. But pursuing these advanced chip designs has required the deepest of pockets and most advanced R&D capabilities.

Until now.

Multi-die technologies, tools, flows, and IP have matured rapidly. Engineering expertise has evolved. And foundry capacity continues to expand. With this in mind, we predict 50% of new HPC chip designs will be 2.5D or 3D multi-die in 2025.

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Foundries preparing for wave of 2.5D and 3D multi-die designs

It takes more than R&D to bring 2.5D and 3D multi-die designs to market. It also requires high-bandwidth, low-latency interconnects (3DIO), advanced manufacturing processes with sufficient capacity, and sophisticated design tools and IP.

Open industry standards like UCIe (Universal Chiplet Interconnect Express) continue to mature, helping simplify and strengthen the connectivity between heterogeneous chiplets while reducing risk and accelerating design cycles. The increased adoption of UCIe for HPC, AI, data center, and edge applications is driving significant demand for 2.5D and 3D multi-die designs.

In addition to the maturation and proliferation of advanced interconnects, foundries are preparing for the oncoming wave of 2.5D and 3D multi-die designs. This includes new manufacturing processes that offer denser bumps and higher performance. Additional package, interposer, and integration options provide cost and architectural flexibility. And expanded production capacity means more designs and prototypes can be brought to market.

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Advanced multi-die design tools and IP

Developing these cutting-edge chips would not be possible without the most advanced design solutions, and Synopsys remains at the forefront of 2.5D and 3D multi-die innovation. Our comprehensive and scalable multi-die solutions, including design automation tools and IP, enable:

• Early architecture exploration
• Rapid software development and system validation
• Efficient die/package co-design
• Robust die-to-die and chip-to-chip connectivity
• Improved manufacturing and reliability

In particular, our 3DIC Compiler is the industry’s only unified exploration-to-signoff platform for 2.5D and 3D multi-die designs. Certified by all major foundries, it supports feasibility exploration, multi-die partitioning, and foundry technology selection for prototyping and floorplanning. This enables analysis-driven design implementation (including advanced packaging and die-to-die routing) with golden signoff verification.

3DIC Compiler also integrates with 3DSO.ai, our AI-driven system analysis and optimization solution. The integrated solutions help maximize system performance and quality of results for thermal integrity, signal integrity, and power network design.

We also offer the highest performance, lowest latency, lowest power, and smallest area die-to-die IP solutions, including UCIe and proprietary controllers, physical layer devices (PHYs), and verification IP. The UCIe-based IP is compliant with the latest UCIe specification, and the proprietary die-to-die IP delivers 40Gbps performance, maximum die-edge and power efficiency, low latency, and support for standard and advanced packaging technologies.

Our 2.5D and 3D multi-die solutions have helped achieve several silicon successes across multiple foundry processes. Customer adoption and foundry capacity continue to increase. And 3DIO standards continue to mature.

For these reasons and more, we believe at least half of new HPC chip designs will be 2.5D or 3D multi-die in 2025.

This blog contains excerpts from a whitepaper titled, The Comprehensive Guide to Successfully Adopting MBSE, written by Lou Wheatcraft. 

Adopting MBSE: Challenging the Status Quo in Product Development

For product development teams to successfully implement a practice such as model-based systems engineering (MBSE), it requires the willingness of an organization to perhaps change processes and even tooling. Often, companies choose to stay with the status quo, but at what cost? Here’s a look at how adopting MBSE might help your teams, and the cost of not adopting MBSE.

Understand the Need to Move for Change 

What is the Risk of Staying with the Status Quo?

For the MBSE Implementation Project Team to be successful, management must recognize the need to change. How can management be convinced? Three words – RETURN ON INVESTMENT (ROI)!

Think about these questions: 

• What has been the impact of the current, poorly executed product development efforts?
• What is the overhead associated with the current document-based approach?
• What are the current quality issues facing the organization that is catering it to profits: Failures, recalls, returns, warranty costs, lawsuits, negative reviews on social media, decreasing market share?

The ROI argument usually works with management especially when they can be convinced that by investing in a data-centric practice of SE tailored to the organization’s needs, the overall product development process, product quality, time to market, and profitability can be improved as discussed previously.

What is the ROI of Adopting MBSE?

To entice anyone — especially an entire organization — to make a change, proving ROI on the resource investment is key. Here are some key points to consider:

• The more effective the Systems Engineer (SE) processes, the less rework and fewer cost and schedule overruns.
• By moving to a data-centric practice of SE, the probability of achieving a competitive advantage can be improved by removing obstacles to being able to deliver products on time, on budget, and that meet or exceed customer and quality expectations.
• From a cultural perspective, the personnel responsible for product development and will be most affected by the change must be shown, and how the change will benefit them.

Combating Opposition to Change

A good process is not one that is something people have to do in addition to their job, rather it is one that helps people do their job more effectively. – LOU WHEATCRAFT

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Get Team Buy-In

To get buy in from the product development teams, the MBSE Implementation Project Team must:

• Understand what problems the product development teams are having and show them how moving to a more data-centric practice of SE will address those problems and make their job easier than the current document-centric approach. If the change results in more work or makes communication harder, the battle will be lost. For example, the lead engineer or project manager may already be over their head and working 50–60-hour weeks. Requiring them to learn how to use a new tool or set of tools and implement a new process may be too much of a load for them to bear! However, if they are provided with a dedicated person that has the training, knowledge, and experience in the new processes and tools to help implement the changes and train other team members, they will be much more receptive. They will also be much more receptive if this results in them having to work fewer hours and having fewer crises to deal with each day!
• Be convinced of the utility of the changes, how the changes result in a better product and result in less rework for them. Frequently the reason project team members are working long hours is because they are always fighting fires, going from one crisis to another, which resulted from the lack of the proper SE tools, processes, data, and information in the first place! The culture needs to be changed from one of firefighting to one of fire prevention. As time passes, they will become advocates for the changes that have been made and welcome further change.

The MBSE Implementation Project Team’s mission statement will be something like: “Improve our product development processes by adopting MBSE within the organization by moving from a document-centric to a data-centric practice of systems engineering.” Along with this mission statement, they will need to define a set of specific goals and objectives along with measures of success. Once defined, they will need to get agreement from management on these goals, objectives, and measures.

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Get Management Buy-In

Project success is dependent on having a high-level, C-suite project champion and getting management buy in. A major challenge for the project will be convincing management and other key stakeholders that it is time for adopting MBSE and moving from a document-centric to a data-centric practice of SE and knocking down the walls of resistance. Some common reasons for them not wanting to move to a data-centric practice of SE include:

• “We have been doing product development using our current processes for years, why should we change?”
• “Implementing SE from a data-centric perspective may work for others, but not for us.”
• “This all seems very complicated, we don’t have the knowledge, experience, or tools.”
• “Our current SE work products, like requirements, are managed in an RMT. FFBDs, and other diagrams we are currently using are models, so aren’t we already adopting MBSE?”
• “It is too expensive to procure the needed SE toolset, maintain the tools, and train our people to use those tools.”
• “We don’t have the budget to incorporate SE from a data-centric perspective at this time.”
• “The expense and associated process to get new SE toolset installed on organizational computers is too great.”
• “We would have to make signification IT infrastructure upgrades to accommodate the additional volume of data and performance requirements of the new SE tools.”
• “We deal with the development of classified systems; controlling access and maintaining security will be too difficult.”

Sound familiar? Often the pushback can be attributed to a lack of understanding the risks associated with the current state of the organization, understanding the benefits of moving toward a more data-centric practice of SE, and what level of SE capability is appropriate for the organization.

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Adopting MBSE: The Road to Success

To inspire a shift from a document-centric to a data-centric practice of SE in your organization, it’s vital to show both teams and management the value and expected ROI in doing so. Moving away from a current way of doing things isn’t always an easy road, but the risks of staying with the status quo are often great—and the rewards for changing processes and culture are often even greater.

An organization will be successful in practicing SE from a data-centric perspective when it is considered to be the “gold standard” for system development within the organization. However, the road to success is long — it takes very strong, unwavering leadership and experience to get this done right. It is human nature to try to push back and say that it isn’t possible, but it is.

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 MedDevice Online, titled “9 Strategies To Overcome Challenges In The EU Medical Device Market In 2025 And Beyond”, and written by Marcelo Trevino.

9 Strategies To Overcome Challenges In The EU Medical Device Market In 2025 And Beyond

Global frameworks offer valuable insights for Europe as the region is currently working to refine its regulatory systems. While Europe is a significant player in the medical device market, the MDR transition has created challenges driven in part by higher costs and timelines due to stricter requirements that have extended approval timelines, increasing costs for manufacturers. Additionally, a shrinking pool of notified bodies has created bottlenecks, delaying device reviews and approvals. The EU MDR demands extensive pre-market clinical data, which has raised costs and delayed approvals. Additionally, lack of harmonization across member states complicates emergency approvals, as seen during the COVID-19 pandemic. This has resulted in a significant number of medical device manufacturers deprioritizing Europe as a launch market, preferring regions with clearer pathways. However, medical device manufacturers, regulators, and other stakeholders have an opportunity to mitigate these challenges by implementing the following strategic solutions to ensure that Europe remains a hub for medical innovation.

1. Enhance Predictability and Transparency In Regulatory Processes

The unpredictability of the regulatory process under MDR poses a significant challenge for manufacturers. Structured dialogue provides a valuable solution by enabling early engagement with notified bodies. This process allows manufacturers to present their clinical strategies, product designs, and evidence plans, ensuring alignment on regulatory expectations. When regulators and manufacturers work collaboratively from the start, costly errors, such as insufficient clinical data or inappropriate trial designs, can be avoided. Additionally, regulators need to issue more detailed guidance to clarify what constitutes acceptable clinical evidence, particularly for innovative products. Leveraging real-world evidence (RWE) from other jurisdictions, such as data from FDA-approved devices, can further reduce redundant studies and expedite European approvals. Equally important is training regulators and notified body auditors in emerging technologies, ensuring that evaluations are both informed and consistent. By addressing these areas, Europe can create a regulatory environment that fosters clarity and efficiency.

2. Leverage Conditional Certification For Innovative Devices

Innovative devices often face challenges in providing long-term clinical data due to their novelty, which can delay market entry. Conditional certification offers a balanced pathway by allowing such devices to reach patients sooner while requiring ongoing evidence collection post-launch. For example, some devices to treat critical health conditions have been granted conditional certification through some notified bodies based on strong initial safety and efficacy signals. Through rigorous post-market clinical follow-up (PMCF), manufacturers can demonstrate continued safety and effectiveness, ultimately transitioning to full certification. Expanding this framework across Europe would allow more innovative devices to address unmet medical needs without undue delay. Regulators should formalize the conditional certification process with standardized criteria and timelines for post-market data submission, ensuring consistency across member states. This approach not only accelerates patient access to cutting-edge treatments but also provides manufacturers with real-world data to refine their products and strengthen market positions.

RELATED: 2025 Expert Predictions for Medical Device & Life Sciences: Innovations in Patient-Centered Care and the Future of Medical Device Design

3. Promote Innovation-Friendly Pathways

Globally, regions have implemented streamlined pathways to fast-track the approval of high-impact devices. Europe must adopt similar measures to remain competitive. The FDA’s Breakthrough Devices Program, which prioritizes devices for life-threatening conditions, provides an exemplary model. In Europe, the U.K.’s Innovative Devices Access Pathway (IDAP) offers a promising localized framework. By selecting devices with transformative potential, IDAP helps manufacturers navigate regulatory approvals while ensuring compatibility with the National Health Service (NHS). Expanding such programs across the EU would create harmonized support for innovative products. Additionally, establishing a centralized EU innovation authority could streamline fast-tracking efforts, provide consistent eligibility criteria, and coordinate expedited reviews with notified bodies. Such initiatives would encourage manufacturers to reprioritize Europe as a launch market for groundbreaking medical technologies.

4. Address Capacity Constraints In Notified Bodies

Limited capacity within notified bodies is a critical bottleneck in the regulatory process. These organizations often struggle to meet the demand for timely reviews due to a shortage of trained personnel and the increased complexity of MDR compliance. Expanding capacity requires investment in training new auditors and regulatory experts. Industry associations and governments should collaborate to develop accelerated certification programs, focusing on skills required for evaluating innovative devices. Additionally, digital transformation can enhance efficiency within notified bodies. Electronic submission platforms and real-time tracking systems can reduce administrative burdens, allowing experts to focus on substantive evaluations. Some notified bodies are also establishing dedicated innovation teams to prioritize reviews for novel devices, ensuring that cutting-edge products receive timely attention. Addressing these capacity constraints will streamline the review process, benefiting both manufacturers and patients.

5. Harmonize Regulatory Practices Across Europe

Fragmentation in regulatory interpretations among EU member states creates inconsistencies that hinder market entry for manufacturers. Harmonizing these practices is crucial to fostering a predictable and efficient system. Standardized criteria for conformity assessments would ensure that notified bodies across Europe apply uniform standards, reducing disparities in evaluation outcomes. Mutual recognition agreements (MRAs) with regions like the United States could further streamline market entry. For example, a device approved by the FDA could leverage its existing data for European approvals, reducing duplication of effort. Additionally, a centralized EU pathway for innovative devices would eliminate member state disparities, providing manufacturers with a clear and consistent process. Harmonization not only simplifies regulatory navigation for manufacturers but also enhances patient safety by ensuring uniform standards across the region.

6. Support Manufacturers Of Low-Risk Devices

While high-risk devices often garner attention, low-risk devices face their own challenges, particularly in meeting unclear data requirements under MDR. Regulators need to provide tailored guidelines for low-risk devices, detailing acceptable forms of evidence such as literature reviews, usability studies, and equivalence data. Simplifying approval pathways for these devices would reduce the regulatory burden, allowing manufacturers to bring products to market more efficiently. Collaborative initiatives, such as data-sharing consortiums, could further support manufacturers by pooling anonymized evidence from similar products. These measures would ensure that low-risk devices, which often address essential but less critical medical needs, reach patients without unnecessary delays.

7. Expand Collaboration And Education

Building a collaborative ecosystem is essential for addressing systemic challenges in the European regulatory framework. Regular industry–regulator forums can facilitate open communication, enabling stakeholders to share insights, identify bottlenecks, and co-develop solutions. Such forums also provide an opportunity to align best practices and refine regulatory processes. Education plays a key role in empowering manufacturers, particularly small and midsize enterprises, to navigate the complexities of MDR. Tailored training programs focused on structured dialogue, clinical evidence requirements, and post-market surveillance can equip these organizations with the knowledge needed to comply effectively. A collaborative and well-educated ecosystem benefits all stakeholders by fostering alignment and reducing inefficiencies.

RELATED: Traceable Agile™ – Speed AND Quality Are Possible for Software Factories in Safety-critical Industries

8. Embrace Digital Transformation

Digital tools have the potential to revolutionize regulatory processes and compliance. EUDAMED, Europe’s centralized database for medical devices, promises to enhance transparency and traceability. Accelerating its full implementation would allow manufacturers and regulators to streamline device registration, track certifications, and monitor post-market performance. Beyond centralized databases, artificial intelligence (AI) can play a transformative role in regulatory reviews. AI algorithms can analyze clinical data, identify gaps, and predict risks with greater efficiency, reducing the time required for evaluations. Additionally, real-time data collection from connected devices can enhance post-market surveillance, ensuring patient safety while providing manufacturers with actionable insights. Embracing digital transformation will not only streamline regulatory processes but also improve the overall quality and safety of medical devices.

9. Advocate For Legislative Revisions

While manufacturers must work within existing regulations, collective advocacy can influence future policies to better balance innovation and safety. Industry coalitions, such as MedTech Europe, can play a crucial role in presenting a unified voice to policymakers. By highlighting the economic and public health benefits of expedited innovation pathways, these coalitions can make a compelling case for regulatory reforms. For example, demonstrating how delays in device approvals affect patient outcomes and healthcare systems can galvanize support for streamlined processes. Advocacy efforts should focus on expanding conditional certification, simplifying requirements for low-risk devices, and creating harmonized pathways for innovative products. Engaging in public consultations and contributing to expert panels further ensures that manufacturers have a direct role in shaping the future regulatory landscape.

Conclusion

Innovation in medical devices is at a crossroads, where the imperative to advance technology must align with regulatory rigor and ethical responsibility. Structured dialogue, harmonized pathways, and collaborative frameworks provide a road map for fostering innovation in Europe.

A collaborative, forward-thinking approach among manufacturers, regulators, and policymakers will ensure that Europe remains at the forefront of medical technology advancements. By implementing different approaches targeting existing challenges, the European medical device market can overcome them, fostering an environment that supports both innovation and patient safety once again.

Through collaboration, transparency and by learning from the global best practices that also can target regional issues, Europe can recover its leadership in medical technology and ensure that innovative devices reach patients in need, contributing to the transformation of the future of healthcare.

In this blog, we recap our recent whitepaper, “Leveraging Jama Connect and Jira for Enhanced Requirements Management” – Click HERE to download it in its entirety.

Leveraging Jama Connect and Jira for Enhanced Requirements

Think you can manage your complex software requirements with Word and Jira alone? Think again.

In software development, teams need tools that enable them to manage requirements, ensure traceability, and adapt to changes without losing sight of their goals. Many companies rely solely on Atlassian Jira, often paired with Word or Excel, to handle requirements and track development tasks.

While Jira is highly effective for tracking implementation progress, it lacks essential features for managing requirements throughout the entire development lifecycle.

The limitations of using Jira alone can lead to costly setbacks, such as rework, missed deadlines, delayed rollouts, and compromised quality. These challenges stem from a lack of traceability, inefficient review processes, limited project visibility, and an incomplete definition of the system.

This eBook explores these issues and introduces a solution: integrating Jama Connect with Jira. Jama Connect enhances requirements management, enables Live Traceability™, streamlines reviews, and provides real-time insight into development progress.

Together, Jama Connect and Jira empower teams to achieve better software development outcomes

1. The Limitations of Using Jira Alone for Requirements Management

Lack of Traceability

The challenge of managing requirements with flat or disparate files like Word or Excel is significant. Teams that use these tools alongside Jira often struggle to keep requirements aligned with development tasks. Manual traceability in these formats is resource-intensive, prone to errors, and leaves significant gaps in coverage.

Without proper traceability, teams have limited visibility into their project’s true status, which can lead to costly rework and project delays. In fact, lack of traceability is one of the leading causes of negative project outcomes. When you can’t see how requirements connect to development and testing, the project suffers, and costs escalate — especially if defects are discovered later in the lifecycle. According to research done by INCOSE, the cost of fixing a defect can be up to 110 times more expensive if it’s found during validation rather than early on.

Jama Connect’s Live Traceability solves this problem by creating a digital thread through every level of development, from customer needs to verification and validation. This digital thread ensures that all requirements are covered and connected to development tasks, giving teams confidence that they’re meeting their goals and satisfying customer needs. Later in this paper, we’ll explore the many ways Live Traceability can dramatically improve your development process.

RELATED: Traceable Agile™ – Speed AND Quality Are Possible for Software Factories in Safety-critical Industries

Inefficient Requirement Reviews

Reviewing requirements using Word documents can be frustrating and inefficient. A business requirements document often contains hundreds or even thousands of requirements. Teams must wait for the entire document to reach a draft state before circulating it for feedback. Stakeholders then provide comments through a combination of Word’s review features and emails, creating a fragmented and time-consuming process.

In this scenario, the burden falls on the business analyst to compile feedback, chase down reviewers, and manage multiple rounds of review cycles. This process is not only inefficient but also risks missed feedback or inconsistencies, as it’s difficult to track changes from one review cycle to the next.

Jama Connect’s Review Center streamlines this process. It allows teams to break down reviews into manageable parts and send specific sections out for feedback. Instead of waiting for an entire document to be finalized, teams can initiate reviews iteratively. The Review Center also automatically creates a baseline at the start of each review, providing a clear record of the requirements’ state before any feedback or changes are made. This reduces review cycles and accelerates consensus, saving valuable time and resources.

Business Analysts and Stakeholders are Frustrated

The lack of an end-to-end tool connecting stakeholders, business analysts, and software development teams is a major gap. Traceable Agile™ in Jama Connect is the answer. With Traceable Agile, there is no change for software teams and the development process is supported for both business analysts and stakeholders. Learn more here >>

2. The Value of Creating a Digital Thread with Jama Connect and Jira

Providing Development Insight

Jira is a powerful tool for tracking development tasks, prioritizing work, and managing sprint schedules. However, it lacks comprehensive visibility into whether requirements are actually being met. If development tasks, such as user stories, aren’t directly linked to requirements, it’s impossible to know how close the project is to meeting customer needs.

Unlinked development tasks open risks like scope creep, rogue development, or unintentional changes that affect other parts of the system. In these cases, teams may spend time on tasks that aren’t aligned with the project’s core requirements, leading to wasted resources and delayed timelines.

By integrating Jama Connect with Jira, teams can bridge this gap. Jama Connect retains the requirements context, while Jira provides insight into development progress. Each team can work within its tool of choice while sharing critical information, such as real-time updates on task status. This integration enables project managers to see how development is progressing against requirements, ensuring that every task is necessary, and every requirement is covered.

Only Jama Connect Delivers a Digital Thread that is Measurable and Live Traceable Across Best-of-Breed Tools Jama Connect’s digital thread connects best-of-breed tools like Jira and Cameo and enables you to auto detect risk early across all engineering disciplines. This has been shown to enable proven improvement to the product development process.

Clear Definition of System Requirements

A common misconception about Agile is that formal requirements documentation is unnecessary. Some teams try to decompose customer needs into user stories in Jira, thinking that’s sufficient. However, this approach has limitations. User stories describe specific interactions or functions from a user’s perspective, but they don’t provide the comprehensive requirements needed for a full system definition.

Traceable Agile ensures that every requirement and feature is documented, versioned, and kept up to date, providing a clear, evolving definition of the system. Unlike user stories, requirements offer a functional description of what the system must do, ensuring alignment with customer needs. With Jama Connect, you get a single source of truth for the system, one that evolves over time and reflects the current state of requirements, while also keeping a record of every change that’s made.

RELATED: Buyer’s Guide: Selecting a Requirements Management and Traceability Solution

Companies Choose Agile for Speed, Jama Connect Delivers Speed AND Quality

Jama Connect solves common challenges with Agile initiatives, such as maintaining standards compliance, coordinating hardware and software teams, managing defects, reducing rework, and ensuring customer quality. Traceable Agile speeds the flow of software and hardware development and maintains the current and historical state of development quality to auto-detect issues early. Watch the demo >>

TO READ THIS DATASHEET IN ITS ENTIRETY, VISIT:
Leveraging Jama Connect and Jira for Enhanced Requirements

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 IndustryWeek, titled “With Hacks on the Rise, Manufacturers Hone Their Cybersecurity Smarts”, written by Stephen Gold.

With Hacks on the Rise, Manufacturers Hone Their Cybersecurity Smarts

Cyber-maturity is finally catching up to digital transformation, a new Manufacturers Alliance study finds.

A chief information security officer, a chief information officer and a chief manufacturing officer walk into a bar. Unfortunately, this isn’t the opening line of a joke – they’re in the bar because they need a stiff drink. These are harrowing times for manufacturing professionals who, in an era of Industry 4.0, are trying to integrate their information technology and operational technology while defending against the dramatically rising threat of cyber criminals.

It’s not like they have a choice on whether to integrate their IT with OT such as machine automation, industrial control systems (ICS), robotics, programmable logistics controllers (PLCs) and building management systems (BMS). Successful IT/OT collaboration is critical to modern manufacturers’ digital strategies. Unfortunately, it’s also the portal where cyber criminals gain entry to the lifeblood of the company: factory operations.

In fact, IBM’s X-Force Threat Intelligence reported that in 2021, manufacturing surpassed finance and insurance as the top targeted sector of cyber bad actors. Today, 1 out of every 4 cyber-attacks on business are against manufacturers. And no wonder: Despite FBI guidance, manufacturers pay the requested ransom more often than other industries – and at typically higher rates.

The biggest challenge? Cybercriminals with a track record of innovation set the pace of change. But manufacturers aren’t simply circling the wagons. Just the opposite – they’re meeting the challenge head on.

RELATED: Traceable Agile™ – Speed AND Quality Are Possible for Software Factories in Safety-critical Industries

Catching Up Quickly

Manufacturers Alliance partnered with Fortinet recently to update a joint 2020 study on IT/OT convergence. They found that American manufacturers’ level of cyber maturity is catching up to their accelerated pace of digital transformation. This is vital because, while financial extortion related to data theft is a serious risk, infiltration of operating systems with the intent to sabotage or even shut them down poses an existential threat to manufacturers. (The cyber-attack on Clorox this August, which paralyzed manufacturing operations for weeks and led to shortages of Clorox products in stores across the country, is the most recent poster child for the risk that factories face.)

The Alliance-Fortinet survey of 155 U.S.-based mid-cap to large-cap industrial companies showed that a growing percentage of manufacturers are well on their journey with advanced anti-cybercrime programs and policies yielding impressive results. That journey, of course, starts with a large dose of reality. When asked to rank cybersecurity as a business risk, 80% put it in the top five, 10 percentage points higher than three years ago. And no wonder: that same percentage experienced at least one breach resulting in unauthorized access to data in the previous 12 months.

Thirty-six percent of respondents fell victim to a ransomware attack, up from 23% in our 2020 survey. And more specifically, the impact of OT breaches has significantly increased over the past three years. While 43% of manufacturers in both 2020 and 2023 said they experienced cybersecurity-related operational outages affecting productivity –

• 29% saw operational outages that affected revenue in 2023, a jump of 10 percentage points from 2020
• 26% saw a loss of business-critical data, 14 percentage points higher than in 2020
• 21% experienced a loss of IP, a jump of 10 percentage points in three years

So, how can manufacturers come out ahead of cybercriminals? Strategies are changing quickly. For starters, more than 90% of manufacturers say they’re focused on implementing new solutions to address risks specifically affecting OT, more than twice the percentage of just three years ago. Roughly the same percentage of manufacturers are now subjecting OT equipment to IT or cyber review prior to procurement. Among that group, many are deploying network access controls, including quarantining new devices until approved by the internal cyber team.

RELATED: Requirements Traceability Diagnostic

Finding Cybersecurity Talent Is Tough

Even with growing sophistication on managing OT threats, manufacturers face one primary obstacle to ultimate success: finding in-house expertise to oversee the cyber threat, a high hurdle considering the broader skilled talent shortage being experienced. In our recent survey, roughly 8 out of 10 manufacturers pointed to scarcity of talent and expertise as a key barrier to effective breach response within the last year.

Of course, manufacturers are in the business of making stuff, not securing networks. So given the scope of OT cybersecurity, from vetting new equipment to responding to breaches, fewer than 10% of companies handle all aspects with in-house resources. Two-thirds combine in-house and external expertise, and about 20% rely on third-party service providers for most of their security needs.

Remember the CIO, CISO and chief manufacturing officer walking into a bar? A decade ago they would never have been seen together. Today, their collaboration, and the smooth and rapid integration of IT and OT, is the key to a successful and safe implementation of Industry 4.0.

Jama Connect^® Stands Alone as the Leader in Requirements Management Software

We are thrilled to share that Jama Connect has been named the Overall Leader in G2^®’s Winter 2025 Grid Report for Requirements Management Software!

This recognition is particularly meaningful because G2’s rankings are based on verified user reviews and insights from real customers, analyzed through their proprietary v3.0 algorithm. The Winter 2025 Grid Report reflects data collected through November 19, 2024, highlighting the best-performing tools in the field.

But that’s not all — Jama Connect received multiple accolades across all business sizes and regions, including:

• Overall Leader
• Momentum Leader
• Small-Business Leader
• Mid-Market Leader
• Enterprise Leader
• EMEA Leader
• Europe Leader

Learn more about the Winter 2025 G2 Grid for top Requirements Management Software products:
DOWNLOAD IT HERE

Why This Recognition Matters

This accomplishment underscores our commitment to helping customers transition from document-based processes to a modern requirements management platform. Jama Connect empowers teams to manage complex product, systems, and software development with unmatched clarity and collaboration.

We owe this success to the incredible feedback from our users. Here’s what they’re saying:

“Jama Connect is not only a ‘document oriented’ ALM tool, it gives the organization the ability to map the project structure to the product structure, making it an easy entry point for R&D folks. Configured properly, it is a real technical and regulatory ‘single source of truth.” — Frederic Fiquet, Director, Systems Engineering, G2.com

“Product Design teams need a requirements management tool like Jama Connect. Using Jama Connect allows our software development team to have a well-organized and well-written set of requirements. It allows us to more easily maintain a baseline of features in our continuously evolving software.” — Mark M., Mid-Market, G2.com

RELATED: Buyer’s Guide: Selecting a Requirements Management and Traceability Solution

We are committed to providing the best possible experience for our users, and being named the overall leader by G2 is a testament to the success and satisfaction our customers have found with Jama Connect.

From all of us at Jama Software, thank you!