Tag Archive for: Requirements & Requirements Management Page 7
Tag Archive for: Requirements & Requirements Management
Navigating the New DOGE Impacted FDA: How MedTech Companies Can Build a Competitive Advantage
The Center for Devices and Radiological Health (CDRH) is a key branch of the FDA that is responsible for ensuring the safety and effectiveness of medical devices. Companies interact with the CDRH through premarket submissions, quality inspections, recalls, and a variety of other activities.
In 2025, the Department of Government Efficiency (DOGE) was established to streamline federal operations, reduce redundancy, and improve cost-effectiveness across agencies. While its goals are rooted in efficiency, the implementation has led to substantial structural and operational shifts that will have a profound impact on the industry.
For companies developing medical devices, understanding these changes is essential for navigating the evolving regulatory landscape. This blog will help you learn all about those changes and provide actionable strategies to stand above the competition while navigating the new frontier.
One of the most immediate and highly publicized impacts has been a reduction in staffing. The CDRH has experienced layoffs, hiring freezes, and a mandated attrition ratio. These changes have affected teams working on new technologies, slowing down review processes and resulting in a reduction in internal expertise.
Budget and Operational Adjustments
DOGE reforms have also reduced discretionary funding, increasing the CDRH’s reliance on user fees from industry sponsors. This shift has created operational bottlenecks, particularly in areas not directly supported by these fees, such as early-stage innovation and public health initiatives.
Regulatory Process Reforms
With fewer staff and resources, the CDRH has had to adjust some of its regulatory workflows. It has been reported that pre-submission meetings are less frequent, and review timelines have lengthened. While the agency remains committed to scientific rigor, the capacity to provide interactive feedback has diminished.
Despite the challenges mentioned above, CDRH plans to continue advancing its strategic priorities. The FDA has released its 2025 guidance agenda which includes the following amongst a larger list of items:
Cybersecurity in Medical Devices: Updated guidance on quality system considerations and premarket submissions.
AI Lifecycle Management and Change Control Plans: Recommendations for predetermined change control plans.
Use of Real-World Evidence in Regulatory Decisions: Revised guidance to support regulatory decision-making.
Updated Q-Submission Program Guidelines: Updates to improve feedback and meeting processes for device submissions.
These initiatives reflect CDRH’s ongoing commitment to modernization, even amid structural constraints resulting from DOGE actions.
In another move to improve efficiency and modernize the agency, the FDA has begun using Elsa, a generative AI tool to assist in the scientific review of medical device submissions. This tool will help automate repetitive tasks such as document parsing and data extraction, allowing human reviewers to focus on more complex portions during the evaluation. The rollout is expected to be complete by mid-2025, with early results showing promise in reducing review times and improving consistency.
Proven Strategies for Navigating the Changes
For those in the medical device industry, these changes present both challenges and opportunities. Companies that embrace the changes and take a proactive approach to interacting with the FDA will find themselves at the forefront of the new era.
Here are some key approaches to consider:
Prioritize Proactive Regulatory Planning: A clear and complete regulatory plan is a vital piece of every new product development project. It will be especially important now as you should prepare for longer review times and less interaction with reviewers. Build extra time for regulatory approvals and work with regulatory consultants to anticipate and address obstacles.
Maintain Clear Communication with the FDA: Given the FDA’s reduction in resources, clear and targeted communication is more important than ever. Leveraging the FDA’s pre-submission program allows you to gain valuable insights early in the submission process. Regular interaction will help build rapport with the agency while addressing concerns before they delay approvals.
Collaborate Across Teams to Document All Product-Related Information: Interdepartmental alignment is critical when interacting with the FDA. Your product development, QARA, and manufacturing teams must communicate effectively to address compliance needs and streamline decision-making. Working together to tell a cohesive and complete story about your device will be imperative when interacting with reviewers. It will be especially important in the future as AI tools may flag inconsistencies or gaps more rigorously than human reviewers.
Leverage Digital Transformation: Investing in digital tools is no longer optional for medical device product development teams. Modern platforms help teams track requirements, manage testing, and maintain documentation seamlessly. Digital platforms also ensure traceability, streamlining compliance audits, and reducing risks of regulatory missteps. Additionally, automated workflows and AI-powered solutions can reduce manual effort and free up critical resources to do what they do best, designing life-changing technologies.
When navigating regulatory pressures, Jama Software is the trusted partner MedTech companies need. Our platform empowers organizations to overcome compliance challenges while maximizing efficiency. Here’s how Jama Connect will help you navigate the changes at the FDA:
Simplify Regulatory Compliance: Jama Connect® simplifies compliance with FDA regulations by providing complete traceability throughout product development. Built-in templates for ISO 13485, ISO 14971, and FDA requirements help teams comply effortlessly with the regulations.
Reduce Submission Errors: Errors in FDA submissions can lead to costly delays and loss of potential revenue. Jama Software’s traceability matrix ensures all requirements are accounted for and verified, reducing the likelihood of mistakes that can delay review times or even result in resubmissions.
Accelerate Time-to-Market: Our real-time collaboration and requirement management tools optimize project workflows, reducing rework and enabling faster decisions. This means your products reach the market sooner, even when facing FDA review delays.
Improve Risk Management: With Jama Connect’s risk management capabilities, teams can capture failure modes and hazard analyses for medical devices, ensuring adherence to safety requirements under FDA guidelines.
Stay Aligned Across Teams: Jama Connect’s centralized platform fosters alignment between engineers, designers, and quality assurance teams. Eliminate silos, improve team collaboration, and keep every stakeholder fully informed at all stages of development.
Create a Competitive Advantage in the New Era of MedTech: The DOGE-era FDA brings unprecedented change to the MedTech industry. With the right strategies and tools, your organization can turn these challenges into opportunities to build resilience, operational efficiency, and create a competitive edge.
To streamline product development, tackle complex compliance requirements, and stay ahead in the fast-evolving MedTech landscape, consider partnering with Jama Software. Curious how Jama Software can help your team thrive? Learn More Today.
Jama Connect® Features in Five: Categories for Milestones
Milestone Tracking Made Simple with Jama Connect’s Categories Feature
Learn how you can supercharge your systems development process! In this blog series, we’re pulling back the curtains to give you a look at a few of Jama Connect’s powerful features… in under five minutes.
In this Features in Five session, Patrick Knowles, Senior Solutions Architect at Jama Software, demonstrates how Jama Connect’s Categories feature streamlines milestone tracking, boosts transparency, reduces risks, and ensures compliance.
VIDEO TRANSCRIPT
Patrick Knowles: Hello, I’m Patrick Knowles, Senior Solutions Consultant for Aerospace and Defense at Jama Software. In this video, I’ll demonstrate how teams can use Jama Connect’s Categories feature to improve visibility of deliverables at key development milestones throughout an airborne system’s product development cycle. This approach helps increase transparency, reduce risk, and ensure timely delivery of critical data.
When developing a complex system of systems such as an aircraft like an eVTOL, teams heavily rely on milestones. Tracking what is due at each milestone and certification stage can be a complex web of documents, schedules, and loose threads. Jama Connect’s Categories feature simplifies this by clearly organizing what’s due and when. This boosts transparency for engineering teams and reduces the risk of missed deadlines, as well as ensuring compliance with standards like ARP-4754 for systems such as an eVTOL.
Knowles: Solution. An organization administrator can set up milestone-specific Categories in Jama Connect. These Categories are assigned to the information due at each stage of a program, enabling teams to create filters, dashboards, and reviews for clear visibility. Unlike tags or other manual methods, Categories provide a structured error-resistant way to manage milestone data, reducing risks like copy-paste mistakes. Let’s open Jama Connect and learn how to enable this strategy in the tool.
The first step is to ensure Categories is enabled within the project. An organization administrator will enter the admin tab within their Jama Connect instance. From there, they will navigate to the category section of the tab and turn the toggle that enables Categories. After Categories is enabled, the administrator will begin to develop the specific Categories that will enable the team to track each milestone. The administrator will add a system development phase category by selecting add and populating the name. This will serve as the parent category, which the rest of the lifecycle milestones will be grouped underneath. From here, the administrator will add the rest of the milestones as individual Categories and move them under the system development phase parent.
It is a best practice in this case to use the move functionality rather than the copy functionality to keep the Categories trees simple and clean. Additionally, when complying with regulatory standards and requirements, it is best to clearly align your milestone. The milestones used throughout the rest of this example are derived from the ARP-4754B and its systems requirements process. This method can be expanded to any number of other regulatory docu ments as well. With all of the milestones created, the administrator has one last step to complete, assigning the parent system development phase category to the appropriate projects or enabling it to be globally accessible.
Knowles: After your team’s organization administrator has completed the creation of the milestone Categories, it is time to implement within the project. First, a user will go into a project and begin to categorize components, sets, and folders that belong to each of the Categories. It is easiest to categorize top-down from components, sets, and folders, and then to batch manage Categories of each of the item types within the logical organizers. With the organizers categorized, the user can then manage the Categories of the individual items within each organizer.
Now that the hard work is done, it is time to harvest the fruits of the labor. The simplest way to do this is to open the Categories tab in the project and select any of the milestone Categories. With one click, the user will see all the items associated with that milestone. However, this isn’t the only way to visualize the information. A best practice for viewing Categories is to set up filters. By developing filters that narrow in on the information due at the upcoming milestone, a team can target that work and ensure it is effectively completed. Once a filter is created, the user can even utilize it to narrow down the project’s explorer by right-clicking on the filter and selecting apply filter to explorer. This will automatically sort the explorer to only display the information within the specific filter. Additionally, a team can use this filtering to help expedite exports or reports related to this narrowed down amount of information.
Knowles: At Jama Software, we strive to ensure our customers are able to successfully implement and develop their products through the use of Jama Connect. Lifecycle milestones are no small feat, and the team here at Jama Software knows that. Creating a user-friendly and maintainable approach to developing and tracking data due at each lifecycle milestone is the driving force behind this Jama Connect features inside. By tracking data deliverables for lifecycle milestones in Jama Connect with Categories, a team will increase transparency, reduce the potential for error, and improve their data delivery process at Lifecycle Milestones. Through simple organization administration setup, a team can quickly align the work they are developing in Jama Connect to lifecycle milestones and improve their current processes. To find out more about tracking developmental milestones with Categories in Jama Connect, please visit our website at jamasoftware.com.
Vertical Aerospace Achieves New Heights with Jama Connect®
Vertical Aerospace is revolutionizing the aviation industry with sustainable, cutting-edge aircraft like the VX4. To meet ambitious goals and regulatory demands, they turned to Jama Connect. By integrating this powerful platform, Vertical Aerospace achieved seamless certification compliance, improved collaboration, and accelerated their innovation process. With Jama Connect’s Live Traceability™ and intelligent project management capabilities, they’ve streamlined complex workflows and stayed ahead in an industry demanding nothing less than first-rate precision and speed.
Kirsty Boyd: Here at Vertical, we are pioneering electric aviation. We’re transforming how the world moves, and through that, we’ve created the VX4. The VX4 is a masterclass in eVTOL aircraft built specifically for sustainable travel and the use case in order to move people faster, better, leaner, more efficiently. For certification, we have to be very black and white. We have to really understand our limitations, our performance of our aircraft. The decisions in the design process that go into those solutions needs to be very well understood. And as you go through the process, things change. Configuration management is a massive part of what we try and do, and we have to be able to prove to the regulator that we’ve identified what those changes are, we’ve dealt with them in an appropriate way, and that we’ve got traceability from top to tail of that.
Karl Mulcahy: So Jama Software is the name of our company, and Jama Connect is the name of our platform. Our platform helps customers to embrace live traceability across the product development lifecycle and ensure that innovation succeeds. It’s a collaborative platform to bring everybody together to make sure that we combine data sources and intelligently make better decisions about our projects, to help you identify gaps in your traceability, to help remove bottlenecks, but ultimately to help bring your industry expertise to companies like Vertical Aerospace and help realize their innovation faster.
Kirsty Boyd: Vertical understood that we needed requirements management in order to certify the platform. And so we did a trade study to analyze different tools that were available in industry. We were looking at cost, efficiency, how flexible they were, how we could tailor them, and we down-selected Jama Connect.
Karl Mulcahy: So Jama Connect helps to bring our industry expertise to forefront. And what that means is we can help provide common ways of working that we’ve used with other clients and working with industry bodies to help streamline compliance or certification mandates.
Kirsty Boyd: We’re trying to do something completely and utterly new here. We don’t have an option for second-rate. We have to use incredibly intelligent partnering in order to meet our timescales, our deadlines, our technology advancement. We don’t have a choice but to go for first-rate partnering.
Karl Mulcahy: Personally, I’m very proud to work with Vertical Aerospace. It’s something that’s brand new in terms of the industry. I know Vertical are at the forefront of the industry. My little boy does ask me a lot what I do for a living. I tell him I work with rockets and planes and to show him this maybe at some point, I’m sure he’s going to be very excited to see it. And maybe one day, he’ll ride in one too.
The Evolution of FDA Design Controls (21 CFR 820.30) and How Jama Software Supports Compliance
History of US Regulation
The US medical device industry is governed by a complex framework of regulations designed to ensure the safety and effectiveness of products. A thorough understanding of this history provides valuable insights into the development of 21 CFR 820.30 and its critical importance to the industry.
General Background
Medical devices have long played a pivotal role in modern healthcare, but the need for regulatory oversight only became apparent as unsafe and ineffective products led to accidents that caused massive human casualties, including losses of life. These risks are what drive the creation and enforcement of industry regulations. Early regulatory efforts focused primarily on pharmaceuticals, with little attention paid to devices until significant public health incidents highlighted their potential risks.
The Federal Food, Drug, and Cosmetic Act (FD&C Act)
Enacted in 1938, the FD&C Act marked a turning point in U.S. healthcare regulation. Initially focused on drugs and food safety, the Act introduced basic oversight for medical devices. However, it was not until the 1976 Medical Device Amendments that the FDA’s authority to regulate devices was significantly expanded due to another massive healthcare tragedy. These amendments established a classification system based on risk and required premarket approval for high-risk devices.
Quality System Regulation (QSR)
The QSR, introduced in 1996, revolutionized medical device regulation by emphasizing quality management throughout the product lifecycle. It expanded the FDA’s focus from inspecting end products to evaluating manufacturers’ processes, requiring the implementation of comprehensive quality systems. Central to the QSR are the design controls outlined in 21 CFR 820.30, which ensure that products are developed with quality and safety embedded in every stage.
Design controls were added to the QSR to address the growing complexity of medical devices and the risks associated with poor design practices. These controls mandate a systematic approach to device development, from initial planning to post-market monitoring. They are required for all Class II and III devices, as well as select Class I devices such as software or devices with measuring functions.
Class I – General Controls (Gloves, bandages)
Least regulated, and minimal harm to user/patient
Includes GMP, label regulations, and enterprise registration
Class II – Special Controls (NextGen Sequencing, PCR tests)
Includes General Controls plus additional special controls (performance verification, labeling, post-market surveillance)
Premarket Notification 510(k) required, but some exemptions
Class III – Premarket Approval (HIV assay, pacemaker)
Highest risk and most stringent regulation.
Requires Premarket Approval (PMA)
Design Controls
Design controls are a cornerstone of medical device quality management, providing a structured framework to ensure medical devices meet safety, efficacy, and regulatory standards.
Purpose of Design Controls
The overarching goal of design controls is to integrate quality into the design and development process. They help manufacturers:
Mitigate potential risks before products reach the market.
Deliver devices that reliably meet user needs and perform as intended.
Ensure alignment with regulatory requirements, reducing the likelihood of non-compliance.
Design controls are not merely a regulatory requirement but a best practice that enhances quality, reduces development costs, and minimizes post-market issues.
The 10 sections outlined in 21 CFR 820.30 provide a comprehensive framework for managing the design and development process:
1. Design and Development Planning
This section requires manufacturers to establish a detailed plan outlining development activities, responsibilities, and deliverables. Key considerations include:
Identifying project milestones.
Assigning roles and responsibilities.
Allocating resources effectively.
2. Design Input
Inputs define the requirements the device must meet, including user needs, regulatory standards, and intended use. Effective design input processes involve:
Collaborating with stakeholders to gather comprehensive requirements.
Prioritizing critical features.
Ensuring inputs are clear, measurable, and verifiable.
3. Design Output
Outputs represent the tangible results of the design process, such as specifications, drawings, and manufacturing instructions. To ensure quality, outputs must:
Be traceable to design inputs.
Include acceptance criteria.
Meet requirements for functionality and safety.
4. Design Review
Formal reviews are conducted at defined stages to evaluate progress and identify potential issues. These reviews involve cross-functional teams and should:
Assess compliance with inputs and outputs.
Document findings and corrective actions.
Provide a platform for collaborative problem-solving.
5. Design Verification
Verification confirms that design outputs meet the specified inputs. Activities may include testing, inspections, and analyses. Manufacturers must:
Use objective evidence to support verification.
Maintain thorough documentation of results.
6. Design Validation
Design Validation ensures that the devices conforms to user needs/intended uses at production equivalent units. Activities may include testing, inspections, and analyses. Manufacturers must:
Conducting usability testing with end-users.
Comparing performance against real-world scenarios.
Documenting validation results for regulatory review.
Performing a risk analysis to ensure patient safety.
7. Design Transfer
Transitioning from design to production requires careful planning to ensure manufacturing processes align with design specifications. Key steps include:
Collaborating with stakeholders to gather comprehensive requirements.
Developing detailed production procedures.
Training staff on new processes.
Conducting pilot runs to identify potential issues.
8. Design Changes
Any changes to the design must be systematically evaluated for their impact on the device’s safety, performance, and regulatory compliance. Effective change control processes involve:
Identifying the need for changes early.
Conducting risk assessments for proposed modifications.
Updating documentation accordingly.
9. Design History File (DHF)
The DHF is a compilation of records that demonstrate compliance with design controls. It should include:
Evidence of adherence to each section of 21 CFR 820.30.
Documentation of design reviews, verifications, and validations.
A complete history of design changes.
10. Traceability in Design Controls
Traceability is a critical aspect of design controls, linking design inputs, outputs, verification, and validation activities. Comprehensive traceability matrices:
Simplify compliance audits by providing clear documentation.
Ensure that all requirements are addressed and verified.
Navigating IEC 62443: Strengthening Cybersecurity in Industrial Automation & Control Systems
Understanding IEC 62443
IEC 62443 is a comprehensive set of standards aimed at securing Industrial Automation and Control Systems (IACS) against cybersecurity threats. It provides guidelines for designing, implementing, and maintaining secure industrial automation systems, ensuring the integrity, availability, and confidentiality of these critical infrastructures.
Structure
This IEC series is organized into several parts, each focusing on different aspects of IACS security:
General: Introduces fundamental concepts, models, and terminology related to security.
Policies and Procedures: Focuses on establishing and managing security
Components and Requirements: Specifies technical security requirements for IACS components and secure product development practices.
Profiles: Defines industry-specific cybersecurity requirements and provides a structured approach to implementing measures based on cybersecurity profiles.
Evaluation: Describes assessment methodologies to ensure consistent and reproducible evaluation results concerning the requirements of individual parts.
IEC 62443-1-1: Covers terminology, concepts, and models, laying the foundation for understanding the standards.
IEC 62443-2-1: Provides guidance on establishing security programs for asset owners, aligning with standards like ISO/IEC 27001.
IEC 62443-3-3: Specifies system security requirements and security levels, detailing technical requirements for systems
IEC 62443-4-1: Focuses on secure product development lifecycle requirements, outlining how to develop secure products.
IEC 62443-4-2: Defines technical security requirements for IACS components, ensuring components meet specific security standards.
Recent Developments
This IEC series is continually evolving to address emerging cybersecurity challenges. Recent updates include:
IEC 62443-1-5: Introduced in September 2023, this technical specification outlines the scheme for IEC 62443 security profiles, providing a structured approach to implementing cybersecurity measures based on defined profiles.
IEC 62443-2-1: The second edition, released in August 2024, updates the security program requirements for IACS asset owners, aligning with evolving industry practices and emerging threats.
IEC 62443-2-4: The second edition, published in December 2023, revises the requirements for IACS service providers, ensuring that integrators meet current cybersecurity capabilities across various domains.
IEC 62443-6-1: Released in March 2024, this technical specification introduces a security evaluation methodology for IEC 62443-2-4, aiming to ensure consistent and reproducible assessment results.consistent and reproducible assessment results.
Enhances Cybersecurity in Industrial Automation: IEC 62443 provides comprehensive guidelines to protect industrial networks, control systems, and automation components from cyber threats. It helps in mitigating risks associated with unauthorized access, malware attacks, and insider threats.
Establishes a Risk-Based Approach: The standard encourages risk assessment and mitigation strategies based on the specific threats and vulnerabilities of an automation system. This ensures tailored security measures rather than a one-size-fits-all approach.
Defines Roles & Responsibilities: IEC 62443 categorizes the responsibilities of different stakeholders in industrial automation, including:
Asset owners (e.g., manufacturing plants, energy companies)
System integrators (those designing and configuring industrial systems)
Product suppliers (hardware and software vendors) Each entity must implement security controls based on its role in the automation.
Promotes Secure System Development & Lifecycle Management: The standard provides guidance on securedevelopment, configuration, and maintenance of industrial automation components, ensuring security is embedded from design to decommissioning.
Improves Compliance & Regulatory Alignment: Many governments and industries are aligning cybersecurity regulations with IEC 62443, making it essential for organizations to adopt the standard to stay compliant with industry best practices and legal requirements.
Encourages Interoperability & Secure Communication: By enforcing secure communication protocols and access controls, IEC 62443 ensures that automation systems can safely interact with IT networks, cloud services, and IIoT (Industrial Internet of Things) applications without compromising security.
Supports Business Continuity & Resilience: A strong cybersecurity framework reduces downtime caused by cyber incidents, ensuring uninterrupted industrial operations and minimizing financial losses.
How Jama Software Can Help Industrial Machinery Developers Stay Competitive in 2025
Layoffs in the industrial machinery sector are rising across Europe, reflecting growing pressures in an industry that is becoming increasingly complex. For machinery development engineers, systems engineers, and product managers, finding ways to streamline processes, ensure compliance, and get products to market faster is more important than ever. Enter Jama Software.
Jama Connect® is a powerful tool tailored to help machinery developers tackle challenges, reduce costs, and gain a competitive edge. By providing robust solutions for requirements management, risk mitigation, and team collaboration, Jama Software offers a way forward amid rising industry complexities.
This blog will explore the evolving industrial machinery landscape in 2025, highlight the challenges driving the need for efficiency, and show how Jama Software can help companies save money while maintaining their competitive advantage.
The Industrial Machinery Landscape in 2025
The industrial machinery sector is on the brink of transformation as we approach 2025. Innovation is surging, but so are challenges. Here are the key factors shaping the current landscape:
1. Increasing Complexity of Machinery Development
Today’s machinery is more advanced than ever. With the rise of automation, IoT, and advanced robotics, machines require intricate systems integrating hardware and software. This complexity demands precise requirements management and traceability to avoid costly missteps.
2. Growing Regulatory Demands
Industrial machinery must comply with stringent safety and regulatory standards, such as IEC 61508. Meeting these requirements adds layers of complexity, often requiring significant time and resources to ensure full compliance.
3. Cost Pressures and Market Competition
Global competition is intensifying, pushing businesses to innovate faster while keeping costs low. Additionally, labor shortages and economic instability in key regions, including Europe, are forcing companies to optimize their operations to maintain profitability.
4. Focus on Sustainable Development
Sustainability and energy efficiency are no longer optional but essential. Product developers must design machines that meet green standards while maintaining performance and reliability, which adds another layer of complexity.
Navigating these challenges requires a new approach to machinery development. That’s where Jama Software steps in.
How Jama Software Helps Save Money in Machinery Development
Jama Software is designed to meet the unique needs of industrial machinery developers. From cutting costs to boosting productivity, Jama Connect offers solutions that address some of the most pressing challenges in machinery development.
1. Efficient Requirements Management
With Jama Connect, machinery developers can manage complex requirements effectively. Here’s how it helps cut costs:
Clearer Specifications: Reduce rework by ensuring all stakeholders understand and agree on requirements from the start.
Live Traceability™: Track changes and link high-level requirements to detailed specifications, ensuring nothing falls through the cracks.
Faster Reviews and Approvals: Jama Connect’s collaborative review process significantly shortens approval times, reducing delays in development.
For example, FORT Robotics, an industrial robotics company, used Jama Connect to reduce their requirements approval process from weeks to just minutes, creating significant time and cost savings.
2. Enhanced Collaboration Across Teams
Siloed communication often leads to misaligned goals, increased errors, and wasted time. Jama Connect eliminates these inefficiencies by offering:
Real-Time Collaboration: Teams can work together across functions, share feedback, and resolve issues seamlessly in one platform.
Cross-Functional Visibility: Gain a comprehensive view of the development process, helping teams identify potential risks early.
This level of collaboration reduces miscommunication and minimizes resource wastage, which is especially important in cost-sensitive industries like machinery development.
3. Compliance Made Easy
Meeting compliance standards like IEC 61508 is both time-consuming and costly. Jama Software simplifies compliance by:
Providing Best Practice Frameworks: Teams can use pre-configured templates and guidelines tailored for safety-critical systems.
Ensuring End-to-End Traceability: From initial requirements to testing and maintenance, Jama Connect ensures that all steps comply with industry standards.
By streamlining compliance processes, Jama Connect helps reduce the risk of costly recalls or regulatory penalties.
4. Risk Mitigation
Every development project carries inherent risks, especially in complex machinery systems. Jama Software minimizes risks through:
Proactive Risk Identification: Built-in risk management features help teams identify potential issues early before they escalate.
Continuous Monitoring: Track risks throughout the development lifecycle, ensuring they remain under control.
Minimizing development risks saves both time and money, preventing costly setbacks that can derail a project.
5. Accelerating Time to Market
The faster you can get your product to market, the more competitive your business will be. Jama Connect speeds up product development with:
Streamlined Processes: Automated workflows and traceability reduce time spent on manual tasks.
Reuse of Requirements: Save time by reusing validated requirements for similar projects, eliminating redundancy.
Hannah Potter, Systems Engineer at IonQ, shared, “The review function has been a lifesaver… We can use our requirements and test plans for the basis of future designs, targeting our goal of continuing to build better and faster machines.”
6. Cost-Effective Scaling
For companies experiencing growth, scalability is a major concern. Jama Software is designed to scale with your business needs without requiring expensive customizations or additional tools. Its robust platform supports even the most complex systems with ease.
The industrial machinery sector is at a critical juncture. Developers who adapt to the current complexities will thrive, while those who cling to outdated processes risk falling behind. Jama Software provides the tools needed to stay ahead in this fast-changing market.
Here’s why you should consider Jama Software now:
Save money by eliminating inefficiencies and reducing rework.
Meet regulatory standards faster and with confidence.
Collaborate more effectively across teams and locations.
Mitigate risks to ensure smoother development cycles.
Stay competitive by launching high-quality machines faster.
Take the Next Step Toward Cost-Effective Machinery Development
Whether you’re dealing with mounting cost pressures, compliance challenges, or complex system requirements, Jama Software is the solution you’ve been searching for. With tools built specifically for industrial machinery developers, Jama Connect empowers your team to cut costs, save time, and maintain consistency in delivering innovative products.
Eliminate Gaps and Risks with Proven Traceability Best Practices
Achieve Live Traceability™ Across Complex Development Lifecycles
Manufacturers across industrial, consumer electronics, and energy sectors are under constant pressure to build smarter, more complex systems all while meeting strict safety, regulatory, and performance requirements. As development processes span more tools, teams, and geographies, maintaining visibility across the entire product lifecycle becomes a real challenge.
Join Jama Software’s Yannick Selg to discover how Live Traceability and Digital Thread strategies can give your teams the visibility and confidence they need to deliver innovative, compliant products faster.
What You’ll Learn:
Apply process best practices for end-to-end traceability in industrial manufacturing
Use Digital Thread strategies to connect engineering, quality, and compliance teams
Automatically detect gaps and risks in products and processes before they impact delivery
If your team is balancing complex requirements, specialized tools, and compliance demands, this webinar will show you how to stay ahead.
VIDEO TRANSCRIPT
Yannick Selg: Thank you very much. My name is Yannick Selg. I’m a Senior Solutions Architect here at Jama Software. I bring broad experience in PLM and ALM implementation, and I’m supporting our customers in the machinery, consumer electronics, and energy sectors here with all your technical questions and demos. And I’m looking forward to guiding you through our webinar today, talking a little bit about traceability. Let’s start by taking a look at our agenda for the webinar today. We have a lot of exciting content to cover. So as a first step, we’ll begin with a brief introduction where I will provide an overview of the potential impact of gaps in traceability and how these affect your organization’s and basically day-to-day project work. Next, we’ll dive into the concept of the digital threat, and I will explain what a digital threat is as well as its significance in product development nowadays and how it can enhance collaboration and data visibility across the product development lifecycle in your organization. We’ll also take a look at some key benefits and the impact of those benefits on the daily work.
Following that, we’ll talk about the importance of traceability and explore some key points for end-to-end traceability. I will also discuss the importance of traceability in product development and the key components that are involved in this traceability. Right after that, we will jump into a live demonstration. We will focus on identifying gaps and risks in the product development process when using Jama Connect®. I’ve prepared some use cases which will give you an idea about the tools, the methods, and also the techniques that are available in Jama Connect for the detection of risks and gaps in traceability. And we will close out at the end with a Q&A session. This is your opportunity to also ask questions that you may have about a topic that we are covering today, but also any other topics regarding Jama Connect in general or regarding Jama Software, our organization.
Now let’s take a closer look at the impact of gaps in traceability. And oftentimes, we see the number one impact that we have is rework when we talk about gaps in traceability. Rework is a very significant factor in product development, and depending on which source we are looking at, it often consumes a substantial portion of the project budget and also the project time. So studies have shown that depending on which study you’re looking at, between 40 and 70% of a project’s budget is often allocated to rework and, for example, rogue development due to lack of, for example, traceability, but also numerous other factors. So this means basically half or, oftentimes, more than half of the budget is spent in correcting errors and making changes after the initial work is already completed. And we can also see that the amount of money that an error costs and rework costs increases exponentially throughout the entire life cycle of the product.
So, for example, if an error is initially detected during the development phase of your product, it’s far cheaper to fix, but looking forward, if this error goes into production, the costs can be astronomical to fix these errors. So, in order to avoid situations like this, traceability and the digital threat can be quite a good answer to this. Now, what does the digital threat provide? So the digital threat is, well, I would say basically a communication or orchestration framework that integrates data across the entire product life cycle. This means basically that the information from various stages of the development… Well, in the best case, all stages of development, like, for example, design, manufacturing, or testing, as well as maintenance, are connected together seamlessly. And by connecting this information from different stages of the development, the digital threat basically ensures that all the relevant data is accessible by the right people at the right time.
And this connectivity is crucial for maintaining consistency and accuracy also during your entire development process, and having all the information available, as I said, at the right time. And maybe the key benefits that I want to point out here of the digital thread are that it provides a broad visibility into the development process. So this basically means that you can see what is happening in your development process, and you can also see changes. So this visibility basically allows you to manage changes more effectively and ensure that modifications are tracked and the impact of these modifications is understood in the early stages of the product development process. So with this comprehensive view, your organization can make informed decisions and mitigate risks that are associated with these changes even before they occur. Now, what are the benefits of having these frameworks in place? I already talked about this on a high level, but I want to point out a couple of, well, specific things here, which we also see later on in Jama Connect.
So one of the key benefits of having the digital threat is, of course, the improved collaboration within the project, but also within the entire organization. With all the data integrated as shown before, team members from different departments and from different projects can access the same information, which is basically creating and supporting better teamwork and communication in the entire organization. And this enhanced collaboration obviously leads to more efficient problem-solving and decision-making processes across the project, but as I said, maybe also across the entire organization. Next, the digital threat also provides better data visibility and accessibility in the organization because the relevant data is all connected and it’s all visible in real time. So stakeholders can easily get this up-to-date use, and we will see this in Jama Connect later on as well. Having this digital threat enabled will basically allow you to get real-time updates on the status of your project. And this improved visibility ensures that everyone is basically always working on the latest data, which is reducing errors, especially about, for example, having delayed information flow throughout different silos.
Selg: And this is the third point that I want to talk about, and probably also the most important one, as you will see on the next slide. So, traditional product development is often done in fragmented parts and isolated teams, but the digital threat breaks those barriers down and connects data and teams, and promotes a more integrated and cohesive approach to the development of your products. And this reduction of the silos is what all the organizations are striving for because it leads to smoother workflows and an overall very collaborative environment with very efficient communication streams. Now this is something that we see a lot with our customers, and I guess this model is quite familiar to you. You can see a, I would say, V model-inspired approach, but all the departments that are responsible for the different levels in here like, for example, the initial requirements identification of stakeholder requirements is done by a department, the system requirements are identified by a different department, implementation is, again, done by different departments and also in different tools. Same thing for the verification side of the V modeling here.
So maybe your work process will differ from the V-model, but still we observe a lot of silos that are working with their own tools like, for example, Word here or Excel as a requirement identification tool, which we see a lot with our customers. We also see, for example, Jira for software development, or Windchill or Teamcenter as a PLM software for hardware implementation. And we see Jenkins for automated testing. So, Jama Connect really connects with all those best-in-breed tools. And what we do here is we will set up what we call live traceability across the entire V-model, and we will eliminate the silos that we have seen before. So you can see on the entire V-model that we have here, all the levels are connected to each other, and Jama Connect is providing Live Traceability™ across the entire lifecycle of the V-model here by including information bidirectionally from all the tools that we can see around here to make sure that we have the full traceability available in Jama Connect.
Now, let us discuss the importance of traceability in product development and why it is critical to the success of any project. Basically, traceability ensures that all the requirements that we have are met and verified or validated throughout the entire product lifecycle. So this means on all the levels of the V-model, for example, that we have seen before. This also means that every requirement is tracked from its birth, from the inception of the requirement through the implementation all the way to the testing at the other end of the V-model. And by maintaining this level of oversight, we can basically ensure that nothing is overlooked and that the final product also meets the specified requirements that we have had from the beginning. Another key aspect of this traceability is also the role of traceability in terms of compliance. Many industries have very stringent standards and regulations that they must follow, and traceability allows your organization to demonstrate this compliance by providing, for example, a clear audit trail that might be required by auditors, and you can show how requirements were managed and fulfilled, and also traced.
This is very critical for passing regulatory inspections and potentially avoiding legal issues at the end and liabilities when delivering a product. And last but not least, traceability also plays, of course, a very important role in enhancing the quality of your products by tracking requirements and the implementation of requirements as well, so extending the traceability out from the requirement space also in the implementation space allows us to identify potential gaps and risks very early in the development process. And this early detection basically is what allows us to address these issues before they even become major problems, which ultimately ensures a higher quality of products and reduces the likelihood of this costly rework that we have been talking about in the very beginning. Now I would like to talk a little bit about the key components of Jama Connect for successful traceability and how we can support in setting up traceability before we just jump into the demo, because these will be the topics that we will now see in Jama Connect.
So I have divided it in three major parts. The first topic that we’re going to talk about is the requirements part, which is the Trace View that supports your engineers in identifying risks and gaps in the daily work, but we also have the option to use the Live Tracer Explorer, which will monitor the traceability of the entire project in real time in a bird’s eye view and gives decision-makers a lot of information to work with regarding the current health and traceability of the entire project. The next topic that I would like to talk about is validation and verification. With the relationship settings and the traceability of Jama Connect, we are able to create so-called Quality Gates, which will allow us to monitor various issues that might occur, like, for example, having approved system requirements without having test cases assigned to them. This gives you the opportunity to get a live overview of critical decompositions in your project and act on them accordingly. And the third topic here is change management because we don’t only have traceability for a static system, but Jama Connect also allows us to manage change.
The first thing that we are going to take a closer look at here is the impact analysis, which supports us understand the risks and the potential impact of change before we actually perform the change. And we will also take a look at the control mechanism called Suspect Links, which supports to manage change efficiently across different levels and allows us to make sure that we do not forget any important points when a change has been performed and the changes are propagated throughout all the required levels. All right. Now let us take a closer look at Jama Connect and go through the creation of traceability. So in here, in Jama Connect, in the middle in our dashboard, we can see our traceability information model, which is basically the backbone of our requirements decomposition and which guides our engineers through the entire process. My system is a smart temperature control system, which is basically a thermostat that can be managed with your mobile phone. And here, we have an example picture how this object will look like that I will use for the demonstration today.
Selg: Now, when we look at the dashboard, we can see a traceability model that is, I would say, inspired by the V model. We have the stakeholder requirements on level one, we have the system requirements on level two, we have the subsystem requirements on level three, and we have an extended traceability in software with user stories, this will be used for our demonstration today, but we also have the possibility to have, for example, design descriptions which can be implemented in your hardware systems like, for example, PLM systems achieve the same effect. And we have the right-hand side of the V model with our subsystem verifications, system requirements, and ultimately our stakeholder validations in this case. So now from this user story, we have a link into Jira and the engineer would now work his daily practices. In Jira, would perform his daily task, the user story that we can see here is bidirectionally and continuously integrated with Jama Connect, so all the changes that we perform in Jira will be captured in Jama Connect and vice versa.
If the software engineer wants to understand the entire traceability and digital threat, he can jump with the click on the Jama Connect link, into Jama Connect, he will see the synchronized user story, and from here, he can open the Trace View and understand the decomposition of the user story all the way up through our decomposition process up to the highest level. So we can come from the user story one level up our subsystem requirement, which is decomposed from a system requirement, and ultimately, we are back at our remote control stakeholder requirement, which is the initial requirement that our user story is decomposed from. Now, this Trace View can be used on an individual level to perform daily activities as an engineer, but it provides far more than that. If we take a look at our second use case, we can now, for example, take a look at an entire set of system requirements and the Trace View is scalable and also supports taking a look at an entire set.
Now this comes in especially handy if you’re, for example, a Q&A engineer and you want to check the coverage of our system requirements with tests. So we can open the filter and filter for verifications against our system requirements, and Jama Connect will indicate a gap in coverage with a red exclamation mark. So, what we can do from here we can either create new verification cases or we can add coverage and link to already existing verification cases, either within our project or Jama Connect also supports cross-project referencing to create the coverage directly right here. Okay. As the next step, we want to understand what happens if change occurs after we already created and approved our requirements. To understand this, I have prepared a third use case where we going to take a closer look at our remote control stakeholder requirement. So I guess we all know the situation. We have been working on a product, and six months into the development process, stakeholders or customers are coming in and asking for changes of initial stakeholder requirements.
Jama Connect allows us to perform an impact analysis at every stage of the development, and due to the traceability that we have established through all the levels, Jama Connect will show me the impact that a potential change would have on this, for example, stakeholder requirement. And what we can see here on a direct relationship level, it would impact two validations as well as two system requirements. But on the second degree of separation, we would also impact system architectures, subsystem requirements, and further verifications, as well as already created defects. And Jama Connect supports us to understand to the end degrees of separation, the impact of a change of our initial stakeholder requirement and gives us the opportunity to create informed decisions based on data, which will give us good insights about the potential duration and the cost of a change because it shows us which elements in our product will be affected by this change.
Now if this change then needs to be performed, and this is what I’m going to do now in the next step as a demonstration, we need to have a control mechanism in place that allows us to understand that a change has been made and the downstream objects in our process need to be potentially reviewed. On the right-hand side here in our widget section, the color of the relationships switched from gray to red. This indicates in Jama Connect what we call a suspect link. A suspect link means that the upstream object, in this case, our stakeholder requirement, has been changed, and then the system will notify the engineers that they need to take a look at the downstream elements, in this case, the system requirements and the attached verifications and check if the change of our initial stakeholder requirement impacts the objects one level below. If yes, we can open the objects and perform the change and clear the suspect link.
If the change of the requirement does not have an impact on our downstream objects and the engineer is not required to perform any changes, it can clear the suspect links directly from the interface that we have right here to indicate again that no changes are required, and the widget that we can see here will switch colors directly again. Now we have been focusing quite a lot on the actual doing level right now, but Jama Connect also provides features that give us an insight from a bird’s eye view to really understand the full traceability and decomposition across our project. Now my demo project has 266 items in this project. So a fairly small project overall, but already quite complex to oversee with this amount of data in it. Production projects will have far more data, so the Live Trace Explorer comes in quite handy here especially.
Selg: So what we can do to open this bird’s eye view on our project, we can open the Live Trace Explorer, and now within seconds, Jama Connect will create a real-time overview about the decomposition of our project and will provide a trace score here in the upper right-hand side corner to give me an overview or a health check of the decomposition in my project. Now, what can we see here in this view? First of all, the view shows us the degree of decomposition between the different levels in our process. For example, what we can see here. Out of all my stakeholder requirements that are indicated with this puzzle icon in here, 80% have system requirements derived from them. So this means if you continue with the project, if the current state, 20% of the initial stakeholder requirements are by default, not even considered in the product development, hence, you can never reach the requirements that are there because we don’t even consider them during the development process.
On the next level, we can see the further decomposition, we can see our system requirements that have been decomposed and the next level of decomposition, which, in this case, would be the subsystem requirements. And here, we can see the decomposition rate falls rapidly. Only 12.5% of my system requirements have subsystem requirements attached to them, but the traceability doesn’t stop here due to our bidirectional integration with all the best-in-breed tools and the example that I’ve shown you before with Jira, we can also see the decomposition process from subsystem requirements into user stories and extend the traceability with this view into Jira directly because we have synchronized the information between the two systems. And ultimately, to conclude the left side of the V model, we can also include defects in our breakdown that we can see here.
Now, on the right-hand side, we can see the coverage of tests. We have here, for example, the decomposition of verification. So how many subsystem requirements are covered with verifications, in this case, it’s 72.22%, but only 50% of those verifications are to be assigned to a test plan, which guarantees that they will be tested at a certain point in time. Now, between the different levels, we can see green or red lines, which is Jama Connect indicating to us the validity of the links. So what we can see here between the level is the amount of suspect links that we have between the levels, and this basically shows us how many percent of changes have been incorporated between the levels. And all of this information will go into an internal calculation, which will finally give us a trace score and an overall health check of the project.
Now this is not just a visual representation of your Jama Connect system, but it’s also interactive with a click on, for example, the system requirement decomposition right here, Jama Connect will now open again to trace you with pre-configured filters to show us exactly the decomposition of our initial stakeholder requirements into system requirements. And from here, again, we can start creating missing coverage with new items or we can create missing coverage with already existing items in the system. Again, also if required, cross-project referencing as well. Now with all this traceability information, and the bird’s eye view, and this traceability model as backbone that we have here, Jama Connect also allows us to create so-called dashboards, which we call quality gates that support us in understanding certain key aspects of your project.
Therefore, as a best practice, what we see a lot of our customers do is create a separate dashboard called quality gates where we can create different dashboards that give us certain set of information, for example, regarding rogue development, which means user stories that are created in Jira synchronized to Jama Connect automatically, but are not connected to any subsystem requirements, for example. Or we can also see, for example, in my case, all the approved stakeholder requirements without a test case here on the right-hand side, and all the approved system requirements without a test case here on the left-hand side. And this is quite a good example, what is used heavily with our customers, especially across the consumer electronics industry, because, of course, you don’t want to have approved system requirements that don’t have a test case available.
And especially for a quality engineer, having a real-time overview like this, showing you how many items are in an approved state, but also don’t have a test case available is quite handy to get a good overview about a specific part of your project that you want to have. And with a click on this dashboard, which is updated in real time, we will see all the system requirements in one list that don’t have a test case available and we can now start either now creating work or engineers or we can go start going to the objects themselves and start creating new verification cases or, again, related to existing verification cases, which are somewhere in the system. Now this concludes my live demonstration of Jama Connect regarding identifying gaps and risks in traceability. Thank you very much for attention.
Learn how you can supercharge your systems development process! In this blog series, we’re pulling back the curtains to give you a look at a few of Jama Connect’s powerful features… in under five minutes.
In this Features in Five session, Máté Hársing, Solutions Architect at Jama Software, explores the Change Management capabilities in Jama Connect, showing how regulated industries can streamline their compliance and efficiency across the product lifecycle.
VIDEO TRANSCRIPT
Máté Hársing: Hi, I’m Máté Hársing, Solutions Architect at Jama Software. Welcome to this Features in Five video on Change Management with Jama Connect. If you’ve ever worked in a regulated industry like MedTech, you know that change is inevitable, whether it’s from updated standards, customer feedback or internal improvements, where every change must be documented, assessed, and validated, because in our industry, changes can literally be life-critical. Without the right tools, managing change quickly turns into a mess, email threads, disconnected spreadsheets, and siloed tools. That leads to missed impacts, compliance risks, and wasted time.
Jama Connect helps bring order to that chaos with structured change management, and it doesn’t stop at development. After a product is approved, field feedback, manufacturing updates, or regulatory changes also need to be reviewed and connected to related items. Without a system in place, tracking those changes through email or spreadsheets risks letting things slip through the cracks.
So what goes wrong without Jama Connect? Teams can’t easily see what’s impacted by a change. Requirements, test cases, and risks live in separate tools. Manual versioning makes it hard to track who changed what and why. Unverified changes can lead to audit issues or delays. Here is how Jama Connect helps. During development, Live Traceability™, Versioning, and the Suspect Link tool help teams stay aligned and act fast. Impact Analysis and Version comparison give clarity before making a change. For released products, formal change requests pull in all affected items, and reviews in the review center bring visibility, collaboration, and confident decision-making.
Hársing: Here is a Trace View of our device’s system requirements. You can see everything it touches, subsystem requirement verifications, and associated risks. Now, we will simulate a change to this system requirement. Once the change is made, the suspect tool automatically flags impacted items downstream, letting us know that in this case, this particular version of the verification case no longer covers the updated requirement and has to be updated. This is what we call reactive change management. Switching to Impact Analysis, we can preview all linked items before implementing the change so our engineering and quality teams can assess the ripple effect and plan accordingly. This is known as proactive change management. It helps us assess the complete cost of a change across as many degrees of separation as our item’s traceability has, as well as providing filters to focus on specific domains, such as verifications in this case, drowning out the noise of any other items we don’t want to see for the time being.
Next, we will use the compare versions view to see what changed. Clearly marked, easy to digest, with intuitive red line/green line differentiation. This is especially helpful during design reviews or when responding to auditors. You’ll notice there is a comprehensive audit trail captured here, who changed what, when and why, so that we can create complete accountability in Jama Connect. And here’s how we handle the change to an approved product. We create a change request item, pull in related artifacts using an easily predefined filter, and send everything through a review. All stakeholders can review the changes in context, see the differences, and provide feedback, ensuring the change is well-documented and fully assessed. The change request can be finalized while we see all the related items and can make sure all the necessary changes in the scope of the change request have been implemented.
Hársing: Jama Connect supports seamless change management across the full product lifecycle, from controlled updates during development to formal change requests for approved products, ensuring traceability, visibility, and compliance every step of the way. Thank you for watching this demonstration of change management in Jama Connect. If you would like to learn more about how Jama Connect can optimize your product development processes, please visit our website at jamasoftware.com.
Expert Perspectives: The Shift Towards Systems Engineering in the Architecture, Engineering, and Construction (AEC) Industry
Welcome to our Expert Perspectives Series, where we showcase insights from leading experts in complex product, systems, and software development. Covering industries from medical devices to aerospace and defense, we feature thought leaders who are shaping the future of their fields.
Robust requirements management in the construction industry, enabling teams to better meet client needs, comply with regulatory standards, and deliver projects efficiently
The adoption of systems engineering in construction projects
The challenges faced in implementing these methodologies, and how major companies are adapting to this change
Kenzie Ingram: Welcome to our Expert Perspectives series where we showcase insights from leading experts in complex product, systems, and software development. Covering industries from medical devices to aerospace and defense, we feature thought leaders who are shaping the future in their fields. I’m Kenzie, your host, and today I’m excited to welcome Burzin Tampal, a well-respected Senior Requirements Manager from Toronto, Canada with more than 10 years of experience in systems engineering.
Burzin has worked on major projects within infrastructure, energy, and mining markets across all phases of the project lifecycle. He specializes in developing and implementing processes for requirements management, verification and validation, and interface management on complex projects. Joining Burzin is Jama Software’s own Joe Gould, a seasoned Senior Account Executive with extensive experience in sales within the architecture, engineering, and construction industry. Today, Burzin and Joe will be speaking with us about the shift towards systems engineering in the architecture, engineering, and construction (AEC) industry. Without further ado, I’d like to welcome Burzin Tampal and Joe Gould.
Joe Gould: Hello, everyone. I’m Joe Gould, Senior Account Executive with Jama Software, and welcome to today’s interview with an expert. I’m thrilled to have Burzin Tampal with us, a seasoned expert in systems engineering. Today, Burzin will be sharing insights into the challenges and benefits of adopting a systems-focused approach in the AEC industry. Burzin, thank you for joining us. It’s a pleasure to have you here.
Burzin Tampal: Thank you, Joe. I’m honored to be here.
Gould: Great. Well, Burzin, let’s jump right in. Can you describe your journey and what prompted the shift towards adopting systems engineering in construction projects?
Tampal: Certainly. So I’ve had the opportunity to work in the medical, financial, and software development sectors prior to working on major projects in the AEC where I initially started off in the rail and transit division. Unfortunately, not all projects were successful by project management standards and most ended either over budget, over schedule, or had quality issues. These projects would sometimes lead to lawsuits, and I had heard that this was somewhat typical for these projects.
I was quite concerned that this was status quo for a 200 plus year old industry, so I started doing some independent research and went down a path which led me to learning more about systems engineering. I came across a popular study. You might know or heard of it. It’s the 2015 Chaos Report by The Standish Group. And although it was not specific to the rail and transit industry, I felt it was very applicable.
If my memory serves me correctly, the outcome stated that something like the top three, the top five reasons, rather, for failed projects was related to poor requirements management practices. I guess I really tried to right the ship after that. I could start to see where the current practices on these major engineering and construction projects were failing to meet the needs of the complex project.
And after gaining some modest successes, I was determined to rethink how we implement systems engineering best practices efficiently across all engineering and construction projects. I developed my own strategy for deploying a lean systems engineering solution on projects, and I’ve been using systems engineering principles on all construction projects ever since.
Gould: That’s great. It’s fascinating to hear how your organization’s moved towards systems engineering. I know that shift can often come with its own set of challenges, but I’d love to see this thought leadership in our industry, Burzin. Next question, can you explain how requirements management plays a role in your construction projects?
Tampal: Absolutely. So requirements management, as most people think about it, has typically been used on systems projects, which inherently have a lot of complexity. If we take a step back, however, without getting into details about a rigorous process or beneficial tools, requirements management at its core is simply meant to track and trace stakeholder needs and project requirements throughout the project lifecycle with the end goal of ensuring compliance and satisfying the stakeholder needs.
Now, I can’t think of a project, systems or not, which wouldn’t benefit from the practice with that definition. One that is meant to ensure that the handed over project meets the needs of the client as formally agreed to. So with that in mind, requirements management really forms the backbone of systems engineering and even project management to a certain degree on engineering and construction projects that I’ve been working on.
Gould: Yeah, it sounds like requirements management really sounds like a crucial aspect here, Burzin. I imagine keeping track of requirements in a way that aligns all stakeholders can make an absolute huge difference.
Tampal: Absolutely. 100%. That’s fundamental.
Gould: So tell me what benefits you’ve experienced moving to a more systems engineering focused approach.
Tampal: Well, where do I start? There are many obvious benefits of using systems engineering that you could read about in a lot of systems engineering materials. The INCOSE Handbook is a great resource. But I think I’ll expand on some of the benefits that are not typically highlighted. So the first benefit I would mention is consistency. Leveraging a standard systems engineering process enabled consistent outputs and deliverables.
While this may sound underwhelming, it was actually the foundation for many of the other benefits we were able to attain. Some other more common benefits include a reduction in error quality issues, which meant reduced corrective effort, improved communication, which resulted in reduced duplication of effort. And once the processes were standardized and we were getting consistent outcomes, we could then implement process efficiencies which resulted in reduced resources or effort required to perform the work.
Gould: Wow, that’s excellent. It’s great to hear that you’ve realized those tangible benefits. Sometimes there are those moments where new processes open up even more possibilities.
Gould: So what are some of the unique challenges construction projects face compared to say traditional industries like automotive or aerospace when it comes to implementing systems engineering, Burzin?
Tampal: That’s a great question. There are a lot of unique challenges. So conceptually, systems engineering best practices involve the requirements development process to be performed collaboratively with all stakeholders participating in the creation, review, and approval of the project requirements set. Traditional industries specializing in manufacturing and product development such as the automotive industry benefit from the ability to own their requirements management process from inception.
Most major architecture, engineering, and construction or AEC projects, however, are managed based on project requirement input documents and schematics in PDF, especially in the public sector. While it might not seem like much of a challenge at first, the fact that the initial baseline of project requirements is provided in a PDF document requires a great deal of upfront effort to review, extract, and manage project requirements.
Additional challenges include the fact that request for proposal (RFP) and contract documents are typically created by multiple people or teams in silos from each other over a long period of time. This practice tends to lead to incomplete requirements causing scope gaps, duplicate requirements causing duplicate effort, and even conflicting requirements causing quality issues across the project requirements set.
A final legal review of those requirements and edit of those documents typically compounds the challenges by adding a layer of ambiguity to the requirements set. Furthermore, different contract models and strategies come with their own unique set of challenges, almost always impacting efficiency of requirements change management.
Gould: I think I’ve been through some of those PDF reviews before, Burzin, so that makes a lot of sense. Construction does seem to have a unique constraints compared to industries like automotive or aerospace. Can you talk a little bit about the challenges of keeping everyone in sync and aligned on a complex project?
Tampal: Absolutely. It’s commonly known that communication is key. This is even more so true when it comes to large projects where there’s a complex stakeholder relationship structure involving a mix of clients, contractors, suppliers, sub-consultants, vendors, and third parties. Ensuring that you are providing the most up-to-date information to the correct stakeholders is certainly a challenge.
Since construction projects can range in duration from weeks to years and even decades, key things to consider include the frequency, mode, and the level of detail in communications. Ensuring everyone is aligned and contributing towards the next major milestone involves meticulous planning and consistent monitoring and execution.
Gould: So Burzin, staying aligned on a complex project has to be a major priority for everyone, especially with so many moving parts in construction projects.
Tampal: Absolutely. At times there can be up to a hundred or more stakeholders that you have to manage and keep informed.
Gould: That’s a lot of alignment. Definitely a lot of alignment. So Burzin, how do you handle the integration of evolving project requirements throughout the construction process? I mean, what best practices do you follow to manage changes without disrupting progress?
Tampal: Well, this is certainly a challenge on all projects and more so on large complex AEC projects. We all know the inverse relation graphic of cost of changes over time on a project and the opportunity to influence or make a change on a project where there is more opportunity and lower cost to implement a change early on in the project life cycle and much less opportunity and higher cost to implement a change later in the project life cycle.
Without an industry-recognized requirement software tool like Jama Connect®, it would nearly be impossible to identify the changes, perform an impact assessment, review the changes with the change control board for approval, and then implement all the approved changes, ensuring all impacted requirements and other items are resolved as required. Because changes during construction are typically more costly, we want to ensure that the project is adhering to a well-defined configuration management and change control process.
Some of the best practices that we implement include using a functional tool to track the proposed changes, trace the changes to all impacted items, this could be evidences or other requirements, include all relevant stakeholders in the CCB or Change Control Board when reviewing and deciding to approve a change, and adequately communicating the approved change to teams for all impacted items. Although this will not eliminate disruption, this will greatly reduce the potential of negatively impacting the project’s quality, schedule, or budget.
Gould: Wow. It sounds like balancing evolving requirements with project stability is no small feat, especially in a field as dynamic as construction. I’m sure your approach to managing this balance is a key factor in keeping your projects on track despite the inevitable changes.
Tampal: Absolutely.
Gould: So Burzin, what role does technology such as software tools for requirements management play in the shift towards systems engineering, do you think?
Tampal: Well, throughout this interview, I’ve mentioned many challenges which come with the territory when participating in construction projects, particularly large and complex AEC projects. Technology such as software tools for requirements management play an integral role in the shift towards deploying a standards-based systems engineering solution in line with industry best practices.
The technology shift has contributed to both increasing the complexity on projects as well as providing software tools that can better calculate, simulate, and manage the solution. Projects have already shifted to digital delivery, and leveraging the best tool fit for purpose is detrimental to project success.
When used correctly, requirements management tools such as Jama Connect, design management software such as AutoCAD, MBSE tools for modeling, and construction management software such as Autodesk Construction Cloud or ACC can significantly reduce the effort required to produce a deliverable while improving the quality at the same time. However, with the available software tools in the market, it is becoming increasingly more important to ensure the tools can integrate with each other and establish a digital threat,d and streamline the overall process.
Over the past two years, there have been a boom in artificial intelligence and machine learning. We are now in a time where data is the most valuable currency, and therefore, understanding how to get the most out of the technology and software solution deployed on a project is detrimental to long-term success.
Gould: I couldn’t agree more. It sounds like technology really supports teams in navigating the complexities of systems engineering. I can imagine that certain features in requirements management tools make a significant impact on how effectively you implement this approach.
Tampal: Absolutely.
Gould: Well, Burzin, I think we’re out of time. I want to thank you so much for sharing your insights and your experiences with us today. It’s been for me incredibly valuable to hear about your journey in integrating systems engineering. We appreciate your time and openness and look forward to seeing the continued success of your projects. Burzin, thank you again.
Tampal: Thank you for having me, Joe. Appreciate it.
Ingram: Thank you for joining us in this episode of our Expert Perspectives series. We hope you’ve enjoyed this conversation between Burzin Tampal and Joe Gould on systems engineering and architecture engineering in construction industries. If you’re an existing customer and want to learn more about Jama Software, please reach out to your customer success manager or consultant.
If you’re not yet a client, please visit our website at JamaSoftware.com to learn more about us and how we can help optimize your development processes. Thank you and stay tuned for our upcoming episodes of Expert Perspectives. Please note that the views expressed in the interviews and commentary are solely those of the individuals providing them and do not reflect the opinions of Jama Software.
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[Webinar Recap] Empowering Complex Development with Responsible AI
AI is reshaping the way teams manage complexity in product development — but in regulated industries like aerospace, defense, automotive, and medical devices, responsible AI adoption is critical.
In this webinar, our expert Katie Huckett will explore how AI is transforming modern development processes, the ethical considerations of AI adoption, and the latest AI-driven innovations in Jama Connect®.
What You’ll Learn:
How AI is streamlining requirements management with automation and predictive insights
Best practices for responsible AI adoption in compliance-heavy industries
Jama Connect’s AI-powered features that enhance requirements quality, traceability, and risk mitigation
Our Amazon Web Services (AWS) partnership and how it enables secure, scalable AI-driven workflows
Below is an abbreviated transcript of our webinar.
Katie Huckett: Welcome everyone. Thank you for joining us today for this exciting webinar. Empowering Complex Development with Responsible AI. In today’s rapidly evolving world, industries like aerospace, defense, automotive, medical devices and financial services are facing unprecedented challenges. As products and systems become increasingly complex, ensuring regulatory compliance requirement clarity, and test coverage has never been more critical. Artificial intelligence is transforming the way we approach these challenges, offering powerful tools to automate tedious processes, enhance decision-making and improve requirement quality. But with AI’s potential comes a responsibility to ensure fairness, transparency, security, and compliance.
By the end of this session, you’ll gain a deeper understanding of how AI can accelerate development while maintaining accuracy, compliance, and ethical integrity. I’ll be your speaker today. My name is Katie Huckett. I bring over 15 years of product management experience and enterprise solutions. I’m one of Jama Software’s senior product managers, where I play a key role in bringing Jama Connect Advisor™ to life, as well as our AI strategy and roadmap for the future evolution of our AI offerings. In this webinar, we’ll explore the role of AI and complex product development in regulated industries. What is responsible AI and how is it used? Our partnership with Amazon Web Services, including our commitment to AI governance and security, ensuring AI aligns with industry standards and best practices.
Jama Connect’s AI-driven innovations leveraging AWS AI tools and discuss how AI enhances traceability, compliance verification, and validation while keeping human expertise in control. We’ll have a brief question and answer portion before we conclude today. Let’s dive in. Starting with Jama Software and our role in the product development ecosystem. Our vision and our purpose is to make sure that innovators can efficiently achieve success, and as you’ll see from today’s discussion, that’s really at the core of what drove our introduction for Jama Connect Advisor. From a broader solution standpoint, Jama is the number one requirements management provider in the marketplace.
We help teams with requirements management and product development through live traceability that also spans not only requirements, but the validation and verification components on the test side, risk management, and other key data that drives those processes forward. The value that we hope these innovative organizations or customers derive is really focused around things like cycle time reduction, helping speed time to market, enabling through live traceability, the ability to gain visibility and control over the organization’s product development processes, and really drive a tremendous amount of value and ultimately ensure compliance and risk management.
Huckett: As far as organizations that we work with, we span medical device, automotive, industrial machinery, software. This is just a sampling of customers that we have the pleasure to partner with. We have over 800 customers globally. These organizations span from smaller startup companies to large global enterprises. So with that very short intro to Jama Software, I would now like to review some of the complexity and challenges that we see today in product development and of course to introduce you to Jama Connect Advisor. Today’s systems have become much more complex and the emergence of the system of systems architecture has become the dominant approach for devices in all sectors, whether it’s aerospace, automotive, medical, and even consumer products.
The system of systems is actually a collection of independent subsystems that are integrated into larger systems and deliver the unique capabilities required by users. The challenges that is difficult to predict accurate, predictable models of all emergent behaviors. So Google’s systems of systems performance is difficult to design. That leads to testing and verification verifying upgrades to existing systems of systems is difficult and expensive as well, which is hard to scale. These are some of the factors that led us to think about how we can help. In today’s landscape, complex product and software development and manufacturing require organizations to balance innovation, compliance, and efficiency.
Industries today face increasing regulatory scrutiny, rising product complexity, and pressure to accelerate time to market. Let’s take a look at the role of AI in modern requirements’ management. Modern products are no longer purely mechanical. They integrate hardware, software, AI, and cybersecurity. For an example, a self-driving car must integrate advanced driver assistance systems, cloud connectivity, AI-powered decision-making, and functional safety. AI-driven requirement validation ensures that specifications are complete, testable, and free from ambiguities, preventing integration failures later. There’s also regulatory pressures and compliance challenges.
Industries such as aerospace, medical device, automotive, again, must comply with strict safety and cybersecurity standards. AI can map requirements to relevant regulations, ensuring compliance is automated and continuously monitored. There’s also a push for faster development cycles. Traditional product life cycles are shrinking due to market competition and innovative demands. AI-powered predictive impact analysis helps developers understand the effects of changes instantly reducing rework and speeding up time to market. There’s also a huge burden of manual processes. Many organizations still rely on spreadsheets, disconnected documents, and siloed teams to manage requirements.
AI-powered natural language processing can automatically detect inconsistencies, duplications, and incomplete requirements, improving efficiency. As well as a large need for better communication, collaboration, and visibility. So as teams become more distributed, cross-functional collaboration is more difficult. AI-powered requirement linking and automated traceability ensure that all stakeholders have real-time insights into requirement changes. AI is transforming requirements management by automating manual error-prone processes such as automatic requirement classification. AI can analyze text and categorize requirements by priority, risk, or compliance relevance.
Huckett: There’s also duplicate and conflict detection. AI can identify duplicate or conflicting requirements, reducing errors. There’s also a need for enhancing accuracy and requirements traceability, so AI can help ensure that every requirement is properly linked to tests, regulations, and design components, reducing compliance risk. We also have improved decision-making through predictive analytics. AI enables teams to make data-driven decisions faster and with more confidence. As product complexity increases, traditional requirement management cannot scale effectively. AI-driven tools and Jama Connect will automate compliance, enhance traceability, and improve decision-making, helping industries stay ahead of regulatory and market demands.
AI is not replacing engineers, it is augmenting their capabilities, enabling teams to develop safer, more compliant, and more innovative products faster. The rapid adoption of AI-driven tools in highly regulated industries brings immense opportunities for efficiency, automation, and innovation. However, AI also introduces ethical regulatory and governance challenges that must be addressed to ensure fairness, compliance, and trustworthiness in AI-driven decision-making. This section will explore the principles of responsible AI, regulatory hurdles, best practices for governance, and real-world examples of AI successes and failures.
As AI systems increasingly influence safety-critical industries, organizations must ensure their AI solutions adhere to ethical AI practices to prevent bias, misinformation, and harm. Responsible AI encompasses the following core principles. Fairness, which is your AI models must be free from bias to ensure equitable outcomes. Transparency, AI decision-making should be explainable and understandable. Accountability, organizations must take responsibility for AI-driven decisions. And of course, privacy and security, AI systems must protect sensitive data and prevent misuse.
AI is used in mission-critical applications such as aerospace and defense, where we have autonomous drones and AI assistance surveillance. In automotive, we have AI-powered advanced driver assistance systems, and in medical devices we have AI-driven diagnostics and robotic surgery. If AI models are not carefully designed, tested, and governed, unintended biases, errors, or security vulnerabilities could lead to catastrophic consequences. Not to mention the complexity of navigating regulations in a variety of industries. So for example, in aerospace and defense, AI and avionics and defense systems must comply with several standards.
Medical devices, we have the FDA Good Machine Learning Practices sets guidelines for AI-driven medical software. And in the automotive industry, AI in autonomous vehicles must meet ISO 21448 and ISO 26262. AI relies on large data sets, often containing sensitive information. Organizations must ensure compliance with regulations such as GDPR, which protects EU citizens data from misuse. There’s HIPAA, which governs healthcare AI solutions in the US and the California Consumer Privacy Act, which regulates AI handling consumer data. To build trustworthy and responsible AI organizations need robust governance frameworks that ensure AI models remain fair, explainable, and compliant over time.
Organizations should implement structured AI governance frameworks such as NIST AI Risk Management Framework, which provides a structured approach for assessing AI risks. In the way of the ISO/IEC 42001, which is an AI management systems standards, which establishes best practices for AI governance. We also have the IEEE Ethically Aligned Design, which focuses on human-centric AI development. For example, a medical device manufacturer developing an AI-powered diagnostic tool can use the NIST AI Risk Management Framework to ensure the model’s explainability, fairness, and reliability.
Huckett: AI models degrade over time as real-world conditions change, so organizations must continuously monitor AI performance for bias and drift, gather feedback from domain experts, users, and regulatory bodies, and implement AI auditing mechanisms to detect unintended outcomes. Let’s talk about a few real-world examples. So we have here a couple of case studies of successful AI adoption. So AI-assisted radiology tools have improved early cancer detection by 30% leading to better patient outcomes. One of the key factors in the success was the AI models were trained on large diverse datasets and continuously validated by human radiologists.
Another example, AI-driven predictive maintenance in commercial aircraft has reduced downtime by 25%, saving airlines millions in operational costs. One of their key factors for success was AI predictions were cross-validated with human engineering teams before implementation. And here we have a few real-world examples that are really cautionary tales in AI adoption. In 2018, an AI-driven hiring system was found to be biased against female candidates because it had been trained primarily on resumes for male applicants. So the lesson learned here is that AI models inherit bias from historical data emphasizing the need for bias audits and fairness checks.
And several self-driving car crashes occurred due to AI, misidentifying obstacles, pedestrians, or unexpected road conditions. So their lesson learned is that AI models require continuous real-world testing and human oversight to handle edge cases effectively. By proactively managing AI risks, organizations can unlock AI’s full potential while ensuring safety, fairness, and compliance in their industries. At Jama Software, we are committed to delivering responsible, scalable, and secure AI solutions to help our customers manage complexity in highly regulated industries. By partnering with AWS, we ensure that AI and Jama Connect is secure, responsible, and purpose-built for the industries we serve.
Enhancing efficiency without compromising compliance. AWS is at the forefront of AI and machine learning innovation, offering scalable, secure, and cutting-edge AI solutions that power businesses across many different industries. With industry-leading AI services, AWS enables organizations to automate complex tasks, extract insights from data and enhance decision-making with state-of-the-art machine learning models. From natural language processing to generative AI and predictive analytics, AWS provides flexible enterprise-grade AI tools that drive efficiency, improve accuracy, and accelerate product development, all while ensuring security, compliance, and responsible AI governance.
By leveraging AWS AI, companies can turn vast amounts of data into actionable intelligence, unlocking new possibilities for innovation and transforming the way they work. AWS’s AI and machine learning solutions are designed to scale effortlessly with business needs, supporting everything from small AI experiments to large enterprise applications. AWS AI services comply with industry-specific security standards, including HIPAA for healthcare applications, GDPR and CCPA for data privacy, ISO 27001, SOC 2, and FedRAMP for cloud security and governance. Amazon Web Services is deeply committed to the responsible development and deployment of artificial intelligence.
