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Next Generation Nuclear: Reactor Innovations Shaping 2025

The nuclear energy industry is about to undergo a significant change. A new generation of reactor technologies is emerging to offer safer, more economical, and efficient solutions as the world’s power demands rise. These cutting-edge concepts will transform our understanding of nuclear power, going beyond conventional models to provide clean and adaptable energy.

The main advancements in nuclear reactor technology that are anticipated to gain traction will be examined in this post. We will examine innovative designs such as Fast Reactors, High-Temperature Gas Reactors, and Molten Salt Reactors and talk about how they could transform energy production for a sustainable future.

The Evolution of Reactor Design

For decades, traditional nuclear power plants have been reliable sources of carbon-free electricity. However, the industry has moved to developing advanced reactors that improve upon these foundational designs. These next-generation technologies focus on passive safety systems, modular construction, and enhanced efficiency. This evolution allows them to not only generate electricity but also provide industrial heat, support renewable energy grids, and even address nuclear waste.

In addition to the advancements in modular construction and passive safety systems, the development of microreactors is gaining momentum. For instance, NANO Nuclear Energy’s KRONOS Micro Modular Reactor (MMR) represents a significant leap in reactor design. This high-temperature gas-cooled microreactor is designed to deliver 15 MWe (45 MWt) and can operate autonomously during grid outages. Its use of TRISO fuel and passive helium cooling ensures safety and resilience, making it a promising solution for energy resilience in urban and military settings.

We expect to see significant progress in regulatory approvals and pilot projects for these cutting-edge designs. This progress will bring us closer to commercial demonstrations that could reshape the global energy mix.

RELATED: Accelerate Nuclear Design Assessments and Reduce Certifications and Engineering Costs with Jama Connect^® for Nuclear Reactor Design & I&C Development

Innovations to Watch: MSRs, HTGRs, and Fast Reactors

Several advanced reactor types are leading the charge. Each offers unique benefits that make them suitable for different applications, from powering data centers to decarbonizing heavy industry.

Molten Salt Reactors (MSRs)

Molten Salt Reactors represent a significant departure from conventional water-cooled reactors. Instead of solid fuel rods, MSRs use nuclear fuel dissolved in a molten fluoride or chloride salt. This liquid fuel also acts as the primary coolant, operating at low pressure and high temperatures.

This design has inherent safety advantages. If the reactor overheats, a freeze plug melts, and the liquid fuel automatically drains into a secure containment tank where the reaction stops. While commercial applications are anticipated by the mid-2030s, important developmental milestones are expected in the coming year.

High-Temperature Gas Reactors (HTGRs)

High-Temperature Gas Reactors use gas, such as helium, as a coolant and operate at very high temperatures. The high temperature allows them to generate electricity with great efficiency and also makes them ideal for providing industrial process heat for applications like hydrogen production and chemical manufacturing.

The KRONOS MMR, developed by NANO Nuclear Energy, exemplifies the potential of HTGRs. This microreactor is not only designed for multi-decade use but also incorporates features like autonomous operation and resistance to cyber and physical threats. Its modular nature allows for scalability, making it suitable for diverse applications, including military installations and industrial use.

Fast Reactors

“Fast” neutrons are used in fast reactors to maintain the nuclear chain reaction. Compared to conventional reactors, this enables them to extract a notably greater amount of energy from uranium. This technology’s capacity to “breed” its own fuel and consume nuclear waste from other reactors, converting long-lived waste into a useful energy source, is one of its main advantages.

RELATED: Buyer’s Guide: How to Select the Right Requirements Management and Traceability Solution

Impact on the Future of Energy

These advanced reactor technologies promise to have a profound impact on the global energy landscape. Their key benefits extend beyond simple electricity generation.

Enhanced Safety and Cost-Effectiveness

New reactor designs incorporate passive safety systems, which safely shut down the reactor using gravity and convection without the need for external power or human intervention. This greatly improves the safety profile of nuclear energy.

These designs frequently incorporate modular construction. By producing smaller, standardized parts in a factory and drastically reducing construction schedules and costs, nuclear power can become a more affordable option, assembling them on-site.

The KRONOS MMR’s ability to operate independently of the main grid and its reliance on passive safety mechanisms highlight the strides being made in reactor safety. These features ensure that critical operations can continue uninterrupted, even in the face of external disruptions.

Integration with Renewable Energy

The operational flexibility of advanced reactors, like TerraPower’s Natrium, makes them ideal partners for renewable energy. They can ramp their power output up or down to balance the variable nature of wind and solar power, providing the grid with a consistent and reliable backbone of clean energy. This ability to integrate seamlessly with renewables is critical for building a stable, zero-carbon energy system.

Decarbonizing Industry

The high temperatures produced by reactors like HTGRs and MSRs can be used to provide process heat for heavy industries such as steel, cement, and chemical production. These sectors are historically difficult to decarbonize. By replacing fossil fuels with clean nuclear heat, advanced reactors can play a key role in helping these industries achieve climate goals.

Challenges and the Road Ahead

Advanced reactors have enormous potential, but there are obstacles in the way of their widespread deployment. Significant challenges that need to be addressed include managing early development costs, gaining public acceptance, and navigating complex regulatory environments.

But things are gathering steam as as investment in these technologies rises. For a number of innovative designs, we expect regulatory approvals to advance, opening the door for additional pilot projects and commercial demonstrations. These projects will provide essential real-world data on performance, safety, and economic viability.

As countries around the world expand their nuclear programs, the ongoing refinement of these technologies will continue. With a keen focus on digital engineering and operational efficiency, advanced reactors are poised to become a cornerstone of a clean, secure, and sustainable energy future.

Summary and Conclusion

The potential of nuclear energy is being transformed by advancements in nuclear reactor technology. The industry is moving toward safer, more adaptable, and more efficient power generation with designs like Molten Salt Reactors, High-Temperature Gas Reactors, and Fast Reactors setting the standard. Despite obstacles, these advancements will move us closer to a time when modern nuclear power and renewable energy sources coexist to meet the world’s energy demands without significant risk to the climate.

In this blog, we preview a section of our recent Whitepaper – To read it in its entirety, visit “Empowering Complex Development with Responsible AI”

Empowering Complex Development with Responsible AI

Streamlining Efficiency and Compliance with Scalable Solutions

Product and system development is entering a new era, driven by AI innovation. Highly regulated industries like aerospace, automotive, medical devices, and financial services are facing unprecedented challenges such as escalating regulatory scrutiny in some cases, rising product complexity, and the relentless demand to accelerate time-to-market. Navigating these challenges requires a balance of innovation, compliance, and efficiency.

Artificial intelligence is beginning to demonstrate its potential in requirements management by automating manual processes, enhancing decision-making, and streamlining compliance. However, harnessing AI’s full potential requires a commitment to responsible AI practices, ensuring transparency, fairness, and security.

This whitepaper explores how AI is shaping the future of product development, offering insights into its applications, best practices for governance, and the role of Jama Software and AWS in delivering scalable, secure, and responsible AI solutions.

RELATED: Write Better Requirements with Jama Connect Advisor™

Today’s Systems Have Become More Complex

Systems of Systems (SoS)

A System of Systems (SoS) is a collection of independent systems, integrated into a larger system that delivers unique capabilities
It is difficult to produce accurate predictive models of all emergent behaviors, so global SoS performance is difficult to design
Testing and verifying upgrades to a SoS is difficult and expensive (sometimes prohibitively) due to scale, complexity, and constant evolution

AI Applications in Complex Product Development

1. Challenges in Product Development

Complex product development demands businesses to manage an increasing number of variables, such as system interconnectivity, regulatory requirements, and shorter development
cycles. This intensifies the need for precise requirements management tools.

Modern systems, such as self-driving cars, embody system of systems architectures, integrating hardware, software, AI functionality, and cybersecurity. While this creates immense innovation opportunities, the complexity of these systems presents significant challenges:

Predicting behaviors accurately
Designing test frameworks for integration
Scaling verification and validation processes efficiently

These challenges are amplified as the systems grow in complexity and sophistication. Accurately predicting behaviors becomes increasingly critical as interconnected components interact
in unpredictable ways, potentially leading to performance issues, safety concerns, or unintended outcomes. Addressing this requires advanced modeling and simulation techniques capable
of capturing the intricate relationships across subsystems.

Designing effective test frameworks for integration presents its own hurdles. Comprehensive testing must account for the diverse interfaces, software dependencies, and hardware configurations found in modern systems. Without a robust plan, teams risk delays, inefficiencies, and gaps in system validation that can lead to compliance failures or product recalls.

Scaling verification and validation processes to match the demands of high-complexity systems also requires significant innovation. Traditional, manual methods are often unable to keep pace,
resulting in slowed time-to-market and increased resource consumption. Automated solutions offer a scalable pathway, providing traceability, consistency, and efficiency needed to manage
these complex operations effectively.

Ultimately, organizations must balance innovation with rigorous oversight to address these challenges while ensuring safety, reliability, and compliance. Adopting tools designed for enhanced requirements management, streamlined traceability, and automated testing is paramount for achieving these goals in an evolving technological landscape.

RELATED: Buyer’s Guide: How to Select the Right Requirements Management and Traceability Solution

2. AI Solutions to the Challenges

AI-driven solutions are addressing these challenges in profound ways:

Automating Requirements Validation

AI uses natural language processing (NLP) to verify that project requirements are complete, precise, and testable
By identifying ambiguous requirements early, businesses reduce the risk of failures
Automated test case generation cuts time and ensures that all requirements are tested

AI-driven solutions are fundamentally transforming the way businesses address traditional challenges in requirements management and validation. Through the use of natural language processing (NLP), AI automates the validation of project requirements by ensuring they are complete, precise, and testable. This advanced capability allows ambiguities or inconsistencies within requirements to be identified early in the development process. By addressing potential issues proactively, businesses can significantly reduce the risks associated with failures, enhancing overall project efficiency and success.

Ensuring Regulatory Compliance

AI tools can help map requirements to stringent regulatory standards in sectors such as aerospace, defense, automotive, and medical devices
Automated monitoring ensures continuous compliance throughout the product lifecycle, minimizing risks

Ensuring regulatory compliance is critical for organizations operating in highly regulated industries such as aerospace, defense, and medical devices. AI tools can play a pivotal role in this process by mapping requirements to stringent regulatory standards, ensuring that all necessary conditions are met without manual oversight. These tools offer automated monitoring, which enables continuous compliance throughout the product lifecycle. By reducing the likelihood of human error and streamlining the regulatory process, businesses can minimize risks and maintain adherence to evolving standards, ultimately supporting the success and longevity of their projects.

Accelerating Development Cycles

Predictive analytics can enable immediate impact assessments of change requests, minimizing rework and speeding up delivery timelines

Predictive analytics play a crucial role in accelerating development cycles by enabling immediate impact assessments of change requests. This capability minimizes rework, allowing teams to address potential issues swiftly and efficiently. By streamlining workflows and reducing delays, organizations can significantly speed up delivery timelines, ensuring that projects are completed on schedule while maintaining high-quality standards.

Enhancing Collaboration

Distributed teams benefit from AI-powered traceability that links requirements, tests, and design components in real time

Efficient collaboration is critical for success, especially for distributed teams. Jama Connect enhances collaboration by providing AI-powered traceability that seamlessly links requirements, tests, and design components in real time. By fostering better communication and streamlining the sharing of critical project information, Jama Connect empowers teams to work more cohesively, reducing misunderstandings and improving overall productivity.

TO READ THIS ENTIRE WHITEPAPER, VISIT: Empowering Complex Development with Responsible AI

Mergers and Acquisitions in MedTech: Positioning Your Company for Success

The MedTech Mergers and Acquisitions (M&A) scene is more active than ever. As global healthcare needs grow and regulatory landscapes shift, strategic acquisitions are becoming a key route to innovation, growth, and market expansion. For emerging MedTech companies, understanding this environment and positioning themselves smartly within it can shape their future.

Recent activity shows that opportunity is abundant for companies that are prepared. Strategic buyers are on the lookout for innovative technologies, strong product pipelines, and solid regulatory foundations. But having a breakthrough product is not enough. Success in M&A hinges on preparation, documentation, and systems that can stand up to intense due diligence.

The Current M&A Landscape: A Shifting Landscape

The MedTech M&A scene has evolved dramatically over the past year, marked by fewer deals but significantly larger transactions. While deal volume dropped by over 40%, the average deal size surged to $636 million, driven by strategic acquisitions like Stryker’s $4.9B purchase of Inari Medical and Thermo Fisher’s $4.1B buyout of Solventum’s filtration business.

Strategic Focus: Bigger Bets, Sharper Targets

Major players like Johnson & Johnson and Medtronic continue to lead the charge, but their strategies are shifting. J&J, for example, has spent over $30B on acquisitions since 2022, including Shockwave Medical ($13.1B) and Abiomed ($16.6B). These deals weren’t just about scale as they targeted technologies that redefine standards of care, particularly in cardiovascular intervention.

Medtronic, meanwhile, is leaning into tuck-in acquisitions to transform slower-growth units into innovation hubs. With 11+ deals in the past five years, the company is focused on strategic adjacencies and long-term portfolio optimization.

Trends Driving the Market

Portfolio Shifts: Companies are divesting non-core assets and doubling down on high-growth areas like robotics, diabetes, and structural heart technologies.
Private Equity’s Role: PE firms are increasingly active, both as buyers and partners in divestitures, helping streamline portfolios and unlock value.
Cultural Fit Matters: Executives emphasize that successful deals go beyond financials. Shared values and aligned visions for patient impact are now critical to integration success.

What Strategic Buyers Seek: The Acquisition Criteria That Matter

To attract the right buyer, emerging MedTech companies need to align with what strategic acquirers value most. Here is what consistently matters:

Technology Differentiation & Market Position

Buyers want technologies that offer real clinical advantages such as better outcomes, simpler procedures, or cost savings. Proprietary tech backed by strong patents is especially attractive.

The best targets complement the buyer’s existing portfolio and address unmet clinical needs. Think AI diagnostics that plug into existing imaging platforms or minimally invasive tools that expand surgical options.

Regulatory Clarity

A clear regulatory strategy is a major plus. Companies that have engaged with the FDA, gathered solid clinical data, and understand approval pathways stand out.

Detailed documentation like pre-submission notes, trial protocols, and quality systems reduces risk and speeds up integration. It also boosts valuation.

Commercial Potential

Buyers assess market size, competition, and go-to-market strategy. Companies with clinical relationships, distribution channels, or early traction are more appealing.

Technologies that target large markets with clear reimbursement paths, and show signs of physician adoption, are especially valuable.

Financial Performance and Scalability

Even early-stage companies need to show a viable business model. Efficient use of capital, clear milestones, and scalable operations build credibility.

Detailed financials like cost breakdowns, revenue forecasts, and funding needs help buyers model ROI and integration scenarios.

RELATED: Buyer’s Guide: Selecting a Requirements Management and Traceability Solution for Medical Device & Life Sciences

Getting Acquisition-Ready: Preparing for Due Diligence

Due diligence represents the most critical phase of any acquisition process. Companies that invest in comprehensive documentation and systematic organization significantly improve their chances of successful transactions and favorable valuations.

Product Documentation

Keep everything up to date: design requirements, risk files, and testing protocols. Use document control systems to manage versions and changes.

Requirements management is key. Acquirers want to see how products were developed, validated, and maintained. Full traceability from concept to release builds trust.

Risk & Quality Systems

Risk documentation such as hazard analyses, mitigation controls, and post-market surveillance plans is essential. Quality systems should be fully implemented and certified (ISO 13485 is a big plus).

Design controls should be complete and easy to navigate: planning, inputs/outputs, reviews, V&V protocols, and change logs. A well-organized design and development file makes due diligence smoother and less risky.

Testing and Validation Evidence

Strong testing documentation is essential to prove your product’s safety and performance. This includes everything from software testing protocols and biocompatibility studies to electrical safety tests and clinical evaluations.

To stand out, companies should maintain:

Detailed test plans
Clear procedures
Organized results

This shows a systematic approach to validating product performance. When testing documentation is thorough and easy to navigate, acquirers can quickly assess technical risks and regulatory readiness.

Validation should not stop at product launch. Ongoing monitoring, post-market studies, and performance tracking signal a commitment to continuous improvement — something buyers value highly.

RELATED: Industry-leading Practices Modernize Legacy Public Health Software System, a Deloitte Customer Story

Intellectual Property and Regulatory Assets

Your IP and regulatory documentation are more than just paperwork — they are strategic assets. Patent portfolios, FDA submissions, and clinical data all play a key role in valuation and deal structure.

To prepare:

Keep patent files current
Document freedom-to-operate analyses
Develop a clear IP strategy

On the regulatory side, maintain organized records of:

FDA correspondence
Clinical trial data
Post-market surveillance reports

Well-managed documentation shows a strong compliance history and gives acquirers confidence in your ability to navigate future regulatory hurdles.

How Jama Connect^® Supports M&A Readiness

Requirements management and traceability are critical for M&A success and that’s where Jama Connect shines.

The platform helps companies maintain acquisition-ready documentation throughout the product lifecycle by:

Connecting requirements to design decisions, tests, and regulatory submissions — giving acquirers full visibility into development processes.
Organizing documents with version control — making it easy for due diligence teams to trace product history and compliance.
Generating detailed reports — showcasing the maturity of your quality management system and development discipline.
Supporting collaboration across teams and locations — ensuring documentation integrity even in distributed environments.

With Jama Connect, medical device and life sciences companies can confidently present their development story and proof of compliance, a major advantage during acquisition discussions.

RELATED: Jama Connect for Medical Device & Life Sciences Development Datasheet

Building Long-Term Value Through Strategic Preparation

The MedTech M&A landscape is evolving fast. As healthcare needs grow and technologies advance, new opportunities are emerging for companies that are ready.

Success isn’t just about having a great product. It’s about:

Operational excellence
Regulatory sophistication
Systematic development processes

Investing early in documentation, requirements management, and quality systems pays off. These capabilities lead to faster development, lower regulatory risk, and better product quality.

If you’re looking to strengthen your M&A readiness, start by evaluating your documentation systems. Book a demo with Jama Software to see how structured requirements management can streamline your development and boost acquisition appeal.

Note: This article was drafted with the aid of AI. Additional content, edits for accuracy, and industry expertise by Tom Rish and Decoteau Wilkerson.

An Inside Look at the Airborne Fire Control Radar Market: The Sky’s AI

These days, air superiority isn’t just about speed and firepower; it’s also about data and information. At the center of this data-driven battlespace is the Airborne Fire Control Radar (AFCR), a cutting-edge system that gives pilots unparalleled situational awareness. The AFCR systems on an aircraft act as its eyes and brain, enabling it to track, detect, and engage targets with remarkable accuracy from a considerable distance. They have a significant impact on the outcome of aerial engagements and the effectiveness of combat aircraft, making them vital to military aviation.

This blog will examine the ever-changing AFCR market. We’ll look at the current developments that are fueling its expansion, such as evolving geopolitical environments and technological advancements. The main participants in the industry, their difficulties, and the prospects for this crucial defense technology will also be discussed.

What is an Airborne Fire Control Radar?

Military fighters, bombers, and attack helicopters are the main aircraft equipped with the advanced sensor system known as an Airborne Fire Control Radar. An AFCR offers the high-resolution information required to direct weapons to a target, in contrast to conventional surveillance radar, which merely detects objects. It provides the aircraft’s fire control computer with the target’s range, altitude, speed, and trajectory. This enables the pilot or system to fire cannons or launch missiles with a high chance of hitting a target directly, even if the target is moving quickly or evasively.

It is impossible to exaggerate the significance of these systems. They enable a single aircraft to engage multiple threats at once, monitor large areas of airspace, and discriminate between friendly and hostile forces. To put it simply, an air force that has a better AFCR system has a clear combat advantage.

Current Drivers and Trends in the Market

A number of important factors are propelling the global AFCR market’s steady growth. The main drivers are global air force modernization and geopolitical tensions. Countries are investing in new-generation fighters with cutting-edge technology and updating their current fleets of aircraft with more sophisticated radar systems.

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

Developments in Technology

The primary force behind change in the AFCR market is technology. There are two noteworthy developments:

AESA Radar Dominance: The industry standard today is Active Electronically Scanned Array (AESA) radars. Because AESA systems can electronically steer their beams, they can track multiple targets in different directions simultaneously, unlike older mechanically scanned radars. They are essential for contemporary air forces because they are more dependable, more difficult to detect, and more resilient to electronic jamming.
AI and Cognitive Radar: “Cognitive” radars are being produced by combining machine learning and artificial intelligence. These systems have the ability to learn from their surroundings, adjust in real time to new threats, and more accurately separate targets from clutter. By lessening the pilot’s workload and accelerating decision-making, this technology has the potential to completely transform air combat.

Increasing Need for Unmanned Systems

A new area for AFCR systems has been made possible by the widespread use of Unmanned Aerial Vehicles (UAVs), also known as drones. Sophisticated, portable radars are necessary for advanced combat drones to conduct autonomous missions and surveillance. Compact and effective AFCR solutions designed for UAVs will become more and more necessary as their use in military operations grows.

Obstacles in the Market

The AFCR sector still faces many obstacles in spite of its expansion. These difficulties may affect development schedules, expenses, and the general growth of the market.

High Costs of Development and Production

The complexity of AFCR systems necessitates years of study and billions of dollars in funding. They are costly to manufacture and maintain because they require sophisticated electronics and exotic materials. The potential market size may be constrained by these exorbitant expenses, which may act as a deterrent for smaller countries seeking to update their air forces.

RELATED: Empowering Efficiency: Parry Labs Selects Jama Connect^® for Seamless Use, Unparalleled Traceability, and Streamlined Review Cycles

Tough Regulatory Obstacles

The export of sophisticated AFCR systems is strictly regulated since it is a vital military technology. To keep sensitive technology out of the wrong hands, governments enforce stringent regulations. Market expansion may be slowed by these export restrictions and international arms control laws, which can make international trade and cooperation more difficult.

Complexity of System Integration

One of the biggest engineering challenges is integrating a new radar system into an existing aircraft. Aircraft hardware types and avionics interfaces differ from manufacturer to manufacturer, creating interoperability challenges. For the radar to function flawlessly with the aircraft’s other avionics, mission computers, and weapon systems, significant hardware and software adjustments are needed. Program upgrades take longer and cost more because of this complexity.

Prospects for the Future and New Technologies

With ongoing innovation poised to unlock new capabilities, the AFCR market appears to have a bright future.

The shift to multifunction RF systems is among the most exciting developments. Future aircraft will use a single, integrated aperture that can do all of these tasks at once, rather than having distinct systems for communications, radar, and electronic warfare. This will significantly increase an aircraft’s capabilities while decreasing its size, weight, and power consumption.

The creation of distributed and networked radar is another expanding field. This idea uses real-time radar data sharing between various platforms, including fighters, drones, and satellites, to produce a single, complete image of the battlespace. This networked strategy increases the effectiveness and survivability of all friendly assets and makes it nearly impossible for an adversary to hide.

In conclusion, a market ready for innovation

A key component of the contemporary defense sector is the market for airborne fire control radars. The need for more capable and intelligent radar systems will only increase due to technological advancements and the ongoing requirement for air superiority. Despite ongoing regulatory obstacles and exorbitant costs, the industry is progressing. The sky’s eye is growing more potent than before with the introduction of AI-driven cognitive radars, multifunction systems, and networked capabilities, giving pilots the advantage they need to manage the air.

Note: This article was drafted with the aid of AI. Additional content, edits for accuracy, and industry expertise by Mario Maldari, Cary Bryczek, and Decoteau Wilkerson.

In this blog, we recap “Engineering Governance: The Engine Behind Automotive Excellence” – Click HERE to read the entire Whitepaper.

Engineering Governance: The Engine Behind Automotive Excellence

The automotive industry is a world of constant change. Engineering governance is the invisible engine that keeps everything humming smoothly.

Innovation to support AI-powered software-defined vehicles, electric and hybrid drivetrains, and sustainability initiatives are navigating where the automotive sector is going. But while technology makes headlines, what happens behind the scenes to manage the complexity of automotive development to stay on the right course is just as critical.

What Is Engineering Governance?

Engineering governance is a system of policies, processes, and standards that guides everything from vehicle design to production. It serves as the GPS for automotive engineering teams to ensure that they are building the right vehicles in the right way, so that every decision aligns with regulatory, safety, and quality standards and the broader goals of the company. It helps with the unification of the hardware and software siloes to not only avoid defects resulting in costly recalls and accelerate product development, but also provide an holistic operational overview of the complete engineering organization reducing risks and driving efficiency.

When designing a new hybrid, for example, engineering governance ensures that the final product adheres to emissions laws, passes stringent safety tests, and meets customer expectations. It
touches every stage of a vehicle’s lifecycle — from initial design to when it rolls off the assembly line and beyond.

AI is accelerating development of systems to enhance safety, enable convenience, and make maintenance more effective. Engineering governance will ensure that concerns about cybersecurity risks and ethical decision-making are addressed. OEMs face the significant challenge of seamlessly integrating diverse software from hundreds of suppliers. Modern premium vehicles have more than 100 million lines of software code — far exceeding the 14 million lines of code in the Boeing 787 Dreamliner. Dealing with safe-critical, non-safe, secure, open-source, and proprietary software, each with its own requirements and standards, necessitates robust engineering governance, efficient collaboration, and cutting-edge tools to ensure that the systems coexist harmoniously.

RELATED: The Impact of ISO 26262 on Automotive Development

Why Engineering Governance Matters

For automotive companies, failure to follow strong engineering governance risks expensive recalls, lawsuits, and fines, as well as harm to customer health and property, leading to significant negative brand impact. Here’s why getting it right matters so much:

Ensuring Compliance with Regulations: Automotive companies operate within a tightly regulated environment. Engineering governance provides a structured approach to ensure compliance with all relevant regulations across markets where vehicles are sold.
Managing Risks Proactively: Helps identify and mitigate risks early before they escalate. Without comprehensive safety and quality testing, defects might surface after vehicles are delivered to customers, rather than during development when fixes are much less costly.
Maintaining Quality Standards: A robust framework ensures that vehicles meet or exceed performance and reliability specifications without cutting corners during design, manufacturing, or testing. It enables a comprehensive view of all aspects of vehicle safety by unifying hardware and software development siloes.
Driving Innovation Responsibly: Innovation without governance can spiral into impractical or unsafe ideas. Engineering governance ensures innovation is balanced with feasibility, compliance, and cost control. Companies racing ahead with autonomous vehicle technology, for example, need engineering governance to ensure that these vehicles undergo rigorous safety tests, align with evolving regulations, and deliver innovations responsibly.
Achieving Sustainability Goals: Sustainability has become a business imperative for automakers in response to demands from governments and consumers. Engineering governance helps automakers achieve sustainability goals by embedding eco-friendly practices into every stage of development and production.

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

Engineering Governance Scenarios

Here’s how engineering governance plays a role at every step in the development of any new vehicle or system:

Design Phase: Ensures vehicles comply with emissions standards and fuel efficiency standards in the United States, the European Union, and other regions.
Testing and Validation: Frameworks ensure rigorous testing of every component — from the engine to the suspension system and software. Engineers follow defined processes to simulate driving conditions to ensure safety and durability.
Supply Chain Oversight: Identifies system or parts suppliers whose products and processes meet quality and sustainability standards.
Post-Market Monitoring: Even after vehicles are sold, engineering governance mechanisms monitor performance through data collection to identify recurring issues and develop structured response plans to ensure quick fixes that reduce customer dissatisfaction.

For automotive executives, engineering governance is more than a technical concern; it’s a business strategy driving competitive advantage by ensuring that reliable, innovative, and compliant vehicles hit the market faster than the competition. It builds customer trust, bolsters investor confidence, and helps companies stay ahead of the constant changes in regulations.

How Jama Software Helps

Jama Software empowers automotive companies to excel in their engineering governance initiatives by providing a centralized platform called Jama Connect^® that ensures traceability, compliance, and collaboration across complex development projects. By facilitating real-time alignment between teams and maintaining a clear connection between regulatory requirements, development processes, and business goals, Jama Connect helps streamline decision-making and reduce risk. This enables organizations to confidently manage innovation, comply with regulatory standards, and accelerate time to market — all while maintaining high levels of quality and accountability.

To learn more about Jama Connect for Automotive, visit jamasoftware.com/solutions/automotive/

TO DOWNLOAD THE ENTIRE WHITEPAPER, VISIT:
Engineering Governance: The Engine Behind Automotive Excellence

In this blog, we preview a section of our recent customer story. To download the entire story, visit “Onera Health Chooses Jama Connect® to Provide Flexibility and Consistency for Sleep Diagnostic System Development Customer Story”

Onera Health Chooses Jama Connect to Provide Flexibility and Consistency for Sleep Diagnostic System Development Customer Story

About Onera

Onera Health develops clinical-grade remote diagnostics and monitoring solutions, making home polysomnography broadly accessible and user-friendly for anyone who needs it, wherever they are.

Customer Story Overview

Onera Health has developed a sleep diagnostic system utilizing four patch-based sensors that patients could apply at home. Initially, the Onera STS 1 product development team conducted pilot studies and relied on Microsoft Excel and Word to manage requirements and create the necessary documentation for successful Medical Device Directive (MDD) and Food and Drug Administration (FDA) submissions.

With the development of the company’s second-generation commercial product, the Onera STS 2, and its integration into Onera’s enhanced end-to-end solution, Onera Health took an active approach in recognizing and acknowledging the increased complexity of its second product. The company began seeking a more structured procedure for managing requirements, tests, and risks.

The new solution needed to provide better access, efficiency, and collaboration for teams working in different disciplines so they could accelerate development with conﬁdence. Onera Health chose Jama Connect because it enabled faster iterations, greater consistency of requirements after changes are made, and visibility into risks and related mitigations.

RELATED: Buyer’s Guide: Selecting a Requirements Management and Traceability Solution for Medical Device & Life Sciences

With Jama Connect, Users Experience:

Faster iterations on requirements due to less time spent in alignment, review, and audit meetings
Consistency of requirements, terminology, conﬁgurations, and documents for all teams affected by design changes
Visibility into risk identiﬁcations and mitigations for internal and regulators’ teams

“We needed a more structured approach due to the complexity involved in maintaining consistency across our entire documentation set. With our ﬁrst generation, tracking the impact of a design change or updates impacting multiple disciplines was time-consuming and came with its own challenges.” – PIETER ERMERS, FOUNDER AND VP QUALITY & REGULATORY, ONERA HEALTH

Challenges

Complexity of product design, regulations, and document strategy lacking efficiency, scalability, consistency, and accessibility.

Managing requirements and tests, while maintaining document consistency, was generally challenging due to product and regulatory complexity, as well as the limitations of an on-premises document database. Additionally, accessing the database required a VPN which can slow work or interrupt progress when the connection was down.

“We chose Jama Connect because of its intuitive user experience, cloud-based availability, and ﬂexible output that our global team needed. Jama Software Consultants were very supportive in helping us understand how to set up Jama Connect to achieve our goals.” – PIETER ERMERS, FOUNDER AND VP, QUALITY AND REGULATORY, ONERA HEALTH

RELATED: Jama Connect for Medical Device & Life Sciences Development Datasheet

Evaluation

One cloud-based system, accessible and user-friendly, with integrated collaboration and reviews, automated test input, and ﬂexible reporting.

The evaluation demonstrated that Jama Connect could easily be accessed and used to manage requirements, tests, and risk based on its intuitive user interface, authoring, collaboration, reviews, and veriﬁcation. Automated input of test results and ﬂexible output in generating reports provide a tailor-ﬁt to the company’s needs.

“When making changes in a requirement used in multiple sensors, we must maintain consistency of requirements, tests, and documents across teams and disciplines. Jama Connect’s structured approach for automatically checking that everything is covered is very beneﬁcial for us.” – PIETER ERMERS, FOUNDER AND VP, QUALITY AND REGULATORY, ONERA HEALTH

Outcomes

With Jama Connect, the Onera team has experienced the following beneﬁts:

Faster iteration on requirements due to less time spent in alignment, review, and audit meetings
Consistency of requirements, terminology, conﬁgurations, and documents for all teams affected by design changes
Visibility into risk identiﬁcations and mitigations for internal and regulators’ teams

Learn how Jama Connect helps medical device companies succeed with higher quality and faster time to market.

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Onera Health Chooses Jama Connect to Provide Flexibility and Consistency for Sleep Diagnostic System Development

In this blog, we recap our recent Datasheet, “Accelerate Nuclear Design Assessments and Reduce Certifications and Engineering Costs with Jama Connect® for Nuclear Reactor Design and I&C Development.”

Accelerate Nuclear Design Assessments and Reduce Certifications and Engineering Costs with Jama Connect^® for Nuclear Reactor Design and I&C Development

Designing and constructing nuclear systems and facilities, with instrumentation and control systems, is one of the most intricate and regulated endeavors any organization can undertake. The process of managing, defining, and tracing functional, safety, security, design, performance, independence, reliability, and special treatment requirements for complex nuclear reactors, along with their facilities, systems, subsystems, structures, and components, is compounded by strict, country-specific regulatory guidance and standards.

The design process is iterative and driven by continuous risk, safety, hazard, accident, and security analysis and mitigations. Revisions during and post-design and construction, based on safety/risk assessments and regulatory feedback lead to rework and reengineering, increasing costs and elongating timelines.

Effective requirements management, end-to-end traceability across the entire systems engineering process, continuous risk analysis and mitigations across the entire design cycle, and a single source of truth for systems engineering data aggregated across the digital thread are critical for project success. Failure to accurately categorize safety and security functions, classify structures, systems and components (SSCs), and assess the criticality of initiating events and hazards in compliance with the applicable regulations (IEAE, ONR, etc.) can delay certifications and project completion, dramatically increase costs, and jeopardize the safe state of the nuclear plant.

KEY BENEFITS

Streamline safety design assessments: Jama Connect offers a single source of truth for the digital safety assessment of a nuclear system, including qualitative hazard evaluations, probabilistic safety assessments, design failure, accident, and dose consequence analysis, FHA, security analysis, and combined risks mitigations.
Enhance collaboration across development teams and supply chain: Jama Connect natively enables co-development within the supply chain and external subcontractors, and improved communication and alignment between cross-functional teams and with external safety assessors.
Achieve end-to-end traceability across your development toolchain: Jama Connect’s Traceability Information Model™ outlines an end-to-end process for the requirements and design definition and decomposition, V&V, risk/safety/security analysis, and system implementation. With Live Traceability™, exchange system implementation specific data like models, architectures, parts/assemblies, tasks continuously with MBSE, PLM, work management, and P&ID tools.
Automate risk categorization and classification: Replace manual, error-prone categorization of risks and classes by letting Jama Connect automatically assess and calculate the criticality, categorization and classification of events, functions, and SSCs.

Jama Connect for Nuclear Reactor Design and I&C Development is purpose-built to guide engineers through the systems development and digital safety assessment of a nuclear system, automatically measure the completeness and quality of traceability across the entire digital thread, and enable the automated creation of digital safety reports.

Jama Software’s nuclear framework is oriented towards and based on the guidance of the NRIC for the usage of digital engineering tools for nuclear DSAs (digital safety assessments), the guidance of IAEA and ONR for the Categorization and Classification of Functions and SSCs, and IEC 61513, and IEC 61508 for the development of I&C systems.

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

Here’s how Jama Connect can help your team streamline processes, improve safety outcomes, and meet regulatory requirements:

End-to-End Traceability Across All Levels

With Jama Connect, you can ensure complete traceability across the design and engineering process – from product definition and design to V&V, safety and security classifications, categorizations and analysis, and product implementation. Our platform connects every design element — from mission-level objectives down to individual components, assemblies, and parts. Live Traceability not only satisfies regulatory demands but also provides critical insights into how changes at any level and any stage impact the entire system.

Traceability at every level: From mission needs and platform designs, to systems, subsystems to individual components, Jama Connect traces risks, requirements, V&V, and implementation elements are connected in an iterative, risk-driven process.
Event-function-SSC traceability: Map initiating events, safety, and security functions, and SSCs seamlessly, helping ensure safety-critical events are covered at every level.
Dynamic risk-response integration: Feed critical information like initiating events, identified hazards, safety, security and reliability requirements, and special treatments directly into the design, ensuring risks are evaluated and mitigated throughout the lifecycle.

Streamlined Safety Design Assessments

Regulatory requirements for nuclear reactor certification differ from country to country, but the principles of risk/safety/security analysis, safety and security classification, and categorization remain universal. Jama Connect simplifies this process by guiding teams through compliance-specific workflows.

Safety and security classification and categorization: Automate initial and final classification of safety/security functions, SSCs, and events. Automatically assign safety categories using calculated fields and lookup metrics based on global or country-specific nuclear standards.
Iterative compliance support: Conduct preliminary safety assessments early and refine security functions as the design evolves. Ensure that every regulatory stage is met with precision, from early safety categorizations to final licensing approvals.
Digital export for documentation: Generate detailed certification-ready documentation of classification assignments, risk analyses, and hazard outcomes for key documentation items like safety and security cases or preliminary and final design safety reports.

Seamless Integration Across Digital Engineering Tools

To ensure every aspect of the development process stays connected and enable the DSA (Digital Safety Assessment), Jama Connect integrates with industry-standard tools used for model-based systems engineering (MBSE), product lifecycle management (PLM), and after simulation:

- MBSE: Collaborate effectively by connecting Jama Connect with tools like Cameo Systems Modeler (aka CATIA Magic) or Enterprise Architect to exchange architecture, models, and design data.
- PLM: Sync parts, assemblies, and change requests with PLM tools like PTC Windchill, Aras PLM, or Siemens Teamcenter to manage parts and mechanical implementations efficiently.
- P&ID: Diagram synchronization (either direct or via PLM) with tools like PTC Creo or Siemens NX.
- Software development and work management: Easily sync tasks, stories, and epics with tools like Jira or Azure DevOps to ensure software requirements are implemented.
- Digital threads: Create and manage a fully integrated digital thread that ties all relevant data from requirements and designs, V&V, MBSE, PLM, simulation and visualization, safety assessment, and risk management, enabling end-to-end traceability, completion measurements, change impact analysis, and the automatic detection of gaps and risks.

Risk Analysis and Hazard Management

Risk analysis is the backbone of safety in nuclear reactor design. Jama Connect supports rigorous risk, safety, and security analysis throughout the iterative design lifecycle, from the initial qualitative hazard evaluation to the analysis of initiative events, classification and categorization of functions and SSC, DID analysis to the probabilistic safety assessments, SSA, and DCA.

Initiating events from qualitative hazard evaluation: Identify events that could jeopardize the safe state of the nuclear power plant. operation, including those rooted in design, external hazards, or past regulatory findings.
Hazard analysis and mitigation – probabilistic safety assessment: Collect and analyze identified hazards, assess severity, and create safety requirements that feed directly into system updates. Out of the box HARA and HAZOP data models.
SAA, FHA, DQA, and combined risks: Conduct severe accident analysis, fire hazard analysis, dose consequence analysis, combine/enveloped risk assessments, and derive mitigations and special treatments as part of Jama Connect’s end-to-end traceability.

RELATED: Overcoming Top Challenges in the Energy Storage Industry with Jama Software

Enhanced Efficiency and Collaboration

By centralizing all information within a single source of truth, Jama Connect eliminates inefficiencies, reduces rework, and fosters alignment between teams.

Agile-compatible iterations: Adapt requirements and designs iteratively as new risks or design details emerge.
Collaborative team environment: Share updates and insights in real time, ensuring stakeholders, engineers, and regulators remain aligned at every stage. Easy to initiate and complete reviews and approvals.
Automated workflows: Save time by automating time-intensive, repetitive tasks like hazard categorization and safety classification.

AI-enabled Intelligent Engineering

AI analysis and automation with Jama Connect Advisor™ improves productivity and product development outcomes.

Requirements quality intelligence: Enhance the quality and clarity of requirement language to significantly reduce a major cause of defects.
Test case intelligence: Streamline verification by automatically generating test cases derived from requirements.

For additional AI initiatives under consideration, go to labs.jamasoftware.com

Organizations at the forefront of nuclear innovations — including those overseeing and developing small modular reactors (SMRs) — recognize Jama Connect as a transformative tool in navigating the unique challenges of the industry.

From guiding teams through compliance workflows to empowering iterative risk analysis, Jama Connect for Nuclear Reactor Design and I&C Development is reshaping how the nuclear industry approaches design and certification. Its ability to combine traditional systems engineering approaches with modern digital iterative processes and digital safety assessments are redefining what’s possible in a nuclear reactor development.

To learn more about managing your nuclear requirements, tests, and risks with Jama Connect, visit jamasoftware.com

TO DOWNLOAD THE FULL DATASHEET, VISIT: Accelerate Nuclear Design Assessments and Reduce Certifications and Engineering Costs with Jama Connect for Nuclear Reactor Design & I&C Development

In this blog, we recap our recent customer story, “Dexcom Achieves 60% Systems Engineering Efficiency Improvement with Jama Connect” – Click HERE to download it in its entirety!

Dexcom Achieves 60% Systems Engineering Efficiency Improvement with Jama Connect^®

Centralized requirements, Live Traceability™, and enhanced collaboration power Dexcom’s development of life-changing CGM technology.

About Dexcom:

Develops, manufactures, produces, and distributes Continuous Glucose Monitoring (CGM) systems for diabetes management
Headquartered in San Diego, California, USA

Dexcom was founded in 1999 to make diabetes management better with the world’s first real-time, integrated CGM system, the Short-Term Sensor (STS). This, and subsequent generations of the device now named the G series, combines hardware, software, and firmware to deliver an optimal user experience for making decisions about insulin and food intake.

After most of its history as a single product company, Dexcom developed Stelo, a wearable glucose biosensor available over-the-counter for people with type 2 diabetes who don’t require insulin.

RELATED: Buyer’s Guide: Selecting a Requirements Management and Traceability Solution for Medical Device & Life Sciences

CHALLENGES

Siloed Tooling: A document-centric approach and legacy tools created barriers to adoption and collaboration across engineering disciplines.
Traceability Gaps: Lack of a uniﬁed view of traceability made change management complex and created confusion across teams.
Regulatory Overhead: Manual processes for generating regulatory document templates caused signiﬁcant delays and administrative burden.
System Complexity: Managing a complex set of interconnected hardware, software, and embedded requirements lacked a single source of truth.
Disconnected Ecosystem: Poor connectivity between requirements management and other engineering tools hindered end-to-end visibility.

Dexcom’s products combine software, hardware, and ﬁrmware, each with their own requirements and tests that must be managed and traced for compliance. As the company scaled, the existing processes, which relied on a mix of legacy tools, spreadsheets, and documents created information silos. Teams were often uncertain if they were working with the latest requirements, leading to rework and inefficiencies.

Generating audit-ready documents for regulatory compliance was a time-consuming, manual effort. The engineering and quality organizations invested signiﬁcant time in manual documentation to ensure their products were always safe, effective, and compliant.

“We have a lot of smart people who joined Dexcom with expectations about doing great things. Having them spend a signiﬁcant amount of their time manually copying and pasting in spreadsheets and Word documents is not the best use of their talent and expertise,” says Sri Harsha Maramraju, Senior Manager, Systems Design Engineering at Dexcom

RELATED: Application of Risk Analysis Techniques in Jama Connect to Satisfy ISO 14971

EVALUATION CRITERIA

A central repository to keep all stakeholders informed of requirements status and changes.
An intuitive user experience to encourage broad adoption and cross- functional collaboration.
Full end-to-end traceability of all requirements and tests to support design controls and compliance.

Dexcom identiﬁed the need for a modern, centralized platform to manage requirements, tests, reviews, and documentation. The goal was to ﬁnd a system with an intuitive interface and clear traceability to improve efficiency, stakeholder engagement, and compliance readiness. After a thorough evaluation of several leading solutions, the stakeholders selected Jama Connect. The platform’s exceptional usability, robust traceability visualization, and deep-rooted acceptance in the medical device industry made it the clear choice.

Key evaluation areas where Jama Connect excelled were its ease of use and powerful document generation capabilities. Another critical factor was its ability to provide clear visibility into the end-to-end traceability of all hardware, software, and ﬁrmware requirements and tests.

“Other tools have traceability, but only Jama Connect has a visual, conﬁgurable model that shows exactly what traceability looks like and accommodates our product’s complex conﬁguration.” Sri Harsha Maramraju – Senior Manager, Systems Design Engineering at Dexcom

For regulatory compliance, Jama Connect stood out with its out-of-the-box framework for medical device development, which simpliﬁes alignment with stringent quality and safety standards.

“The built-in support for standards like ISO 14971 and the validated package included with Jama Connect give us the conﬁdence to demonstrate that we are following industry best practices,” says Maramraju.

RELATED: Jama Connect for Medical Device Development

OUTCOMES

Streamlined change management and reviews for monthly releases using Jama Connect’s Review Center.
Achieved a 60% productivity boost for the systems engineering team, enabling faster project completion.
Successfully migrated active projects to Jama Connect, ensuring a smooth transition to a modern platform.
Driving reuse of requirements and tests across projects to support product line engineering (PLE) goals.

“If you’re building a centralized ecosystem for product development and design controls for the long term, you can rely on Jama Connect. Its usability, traceability, and industry-wide acceptance make it a cornerstone of our engineering process.” – Sri Harsha Maramraju – Senior Manager, Systems Design Engineering at Dexcom

Dexcom now depends on Jama Connect to efficiently manage requirements, changes, and reviews for its aggressive release cadence. Having one centralized place for these activities has improved systems engineering efficiency by 60%. The intuitive collaboration and review functionality in Jama Connect has increased stakeholder engagement. Quality and Regulatory teams now actively participate in the process within the tool, appreciating the structure and auditability it provides. “The conversation has shifted. Instead of discussing tool limitations, our teams now have productive, data-driven discussions about the work itself within Jama Connect. When other departments see what we are doing, they ask how they can get their projects onto the platform too,” says Maramraju.

Jama Connect’s Live Traceability™ has enabled Dexcom to track requirements through all stages of development, with integrations that sync requirements data to development activities in other tools like Jira. Looking forward, Dexcom is leveraging Jama Connect to drive reuse and synchronization of requirements across different platforms, a key step toward their product line engineering goals.

TO DOWNLOAD THE ENTIRE CUSTOMER STORY, VISIT:
Dexcom Achieves 60% Systems Engineering Efficiency Improvement with Jama Connect

In this blog, we recap our customer story, “INBRAIN Chooses Jama Connect® to Provide Clarity, Stability, and Confidence in Quality Control for Neural Implant Systems Development.”