Tag Archive for: Product Development & Management Page 6
Tag Archive for: Product Development & 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.
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.
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.
Choosing the Best Tool for Requirements Management in the Automotive Industry (Even If Your Suppliers Use Something Else)
Requirements management plays a vital role in the product development lifecycle, impacting everyone in the automotive industry—from project managers and architects to software teams, systems engineers, and senior executives. Whether you’re overseeing the development of advanced driver-assistance systems (ADAS) or managing the assembly of an entire vehicle platform, having a robust requirements management tool that helps support engineering governance can mean the difference between success and costly delays.
But here’s where it can get tricky. Your organization isn’t developing products in a vacuum. You’re constantly collaborating with a network of suppliers, each of whom may have their own preferred requirement management tools. The question then becomes, should you compromise your needs and processes to align with the tools your suppliers are using, or can you select the BEST tool for your needs and ensure seamless collaboration anyway?
Spoiler alert: The answer lies in selecting the right tool for your organization, regardless of what your suppliers are using. Here’s how you can make that decision with confidence.
Why Picking the Wrong Tool Could Cost You
Many automotive companies end up selecting requirements management tools solely because their suppliers use them. While this might seem like the easiest path to collaboration, it can actually result in more inefficiencies and frustrations down the road.
Key Challenges of Adopting the Wrong Tool:
Misalignment with Your Processes: Tools that don’t support your specific workflows or business goals can disrupt productivity.
Steep Learning Curves: Adopting a tool simply because others are using it can lead to excessive training needs. If the interface isn’t user-friendly or intuitive for your team, adoption rates may plummet.
Limited Scalability: What works for your supplier today may not meet your complex or evolving needs tomorrow.
Missed Opportunities: A mediocre tool can restrict innovation and time to market. When you’re stuck trying to make something work, you’re not maximizing efficiency or leveraging the full power of your processes.
The takeaway? It’s your team working day in and day out with the requirements management tool — not your suppliers. That means your organization’s specific needs should come first.
Must-Have Features in a Requirements Management Tool
Choosing the right software isn’t just about checking boxes. It’s about finding a tool that fits seamlessly into your automotive development environment and supports collaboration across your supplier network.
Here are some must-have features to look for:
1: Advanced Traceability
Traceability is vital in the automotive industry for safety-critical systems and regulatory compliance. The right tool should allow you to trace requirements across your entire system—from initial stakeholder needs to risks and mitigations to testing and validation. A tool that allows you to span the entire V-Model with high visibility and ease of tracking gaps and potential risks is key. Dashboard views and other means to obtain a holistic view of the progress of your project are essential for senior management to maintain a pulse on the project and ensure progress is being made with minimal risk.
2: Change Management and Version Control
Selecting a tool that allows for change to be controlled and easily reacted to is essential for a requirements management software. Suspect triggers allow downstream impacts to be easily identified and remedied. Proactive strategies and features like impact analysis, allow for change to be assed prior to making changes, allowing teams to prepare for the impact before it happens.
Ensure you look for a tool that is well-versed in your industry and understands the intimate details of the business challenges you face. Ideally, the tool you select will have frameworks and datasets that adhere to your regulatory and safety compliance standards. Standards and regulations, including ISO 21434:2021, ISO 26262:2018, and ASPICE, are essential, and the tool you select should help facilitate your compliance with these standards.
4: Cross-Tool Interoperability
One of the biggest concerns when choosing a tool that your suppliers may or may not be using is interoperability. Look for software that supports standards like ReqIF (Requirements Interchange Format) to facilitate seamless exchange of requirements with external stakeholders across your entire ecosystem. This ensures you can collaborate effectively without sacrificing your own processes.
5: AI and Automation Capabilities
Modern requirements management tools leverage AI to speed up processes and improve quality. Automation capabilities can also eliminate repetitive tasks, freeing up your team to focus on higher-value work. Automatic test case generation, glossary definition, risk detection, IP identification are now considered key to requirements management and will be the standard moving forward.
Your requirements management solution should grow with your organization. Whether you’re managing one project or dozens, the tool should adapt to increased complexity and size. Performance at scale should be a key consideration. You’ll always need a tool that is easy to administer. You should not need a specialized role to perform this task. Cloud hosting options provide flexibility and lowers cost of ownership. SOC2 hosting environments along with a product that is also SOC2 certified is essential when considering today’s ever-evolving security risks.
7: Configurable Workflows, Customized Reports, and Export Templates
Every team operates differently. A versatile tool will allow you to configure workflows, reports, and export templates so it fits with how you work, rather than forcing you to change your processes.
8: Supply Chain Collaboration Features
While you shouldn’t need the exact same tool as your suppliers, features like shared requirements repositories, real-time commenting, and simplified export/import options make it easier to stay on the same page — even if you’re working on different platforms. Having a tool that allows you to invite external stakeholders into your reviews (at no cost) is a major benefit and consideration.
The Case for Putting Your Needs First
Imagine you’re working on a next-gen electric vehicle platform. While your suppliers might be focused on delivering specific components (like an ECU or software component), you’re responsible for the big picture. A tool that fails to give you high-level visibility simply because it aligns with your supplier’s processes? That’s a no-go.
When you select a tool based on your needs, you gain the following advantages:
Streamlined Internal Processes: You can focus on efficiency and alignment within your team without constantly adapting to external tools.
Improved Quality Management: With better traceability and error reduction mechanisms, your team is better positioned to meet high-quality standards.
Flexibility to Work with Any Supplier: The right tool ensures you can collaborate effectively with any supplier, regardless of what they’re using.
Making Collaboration Work Across Different Tools
If your suppliers aren’t using the same tool, how do you handle the exchange of requirements? The good news is that most modern requirements management tools include features that make cross-platform collaboration easier than you might think.
Here’s How You Can Ensure Smooth Collaboration Regardless of Tools:
Leverage ReqIF Standards: ReqIF facilitates reliable requirements exchange across your entire ecosystem. By adopting a tool with strong ReqIF support, you ensure compatibility with your suppliers, no matter what software they prefer.
Utilize Integrations and APIs: Many requirements management platforms offer direct integrations to popular tools such as Jira, Teamcenter, LDRA, Simulink, and other best of breed tools. APIs or third-party integration tools can help bridge the gap between systems, creating a smoother flow of information.
Define Common Terminology and Traceability Information Models: Consistent and clear data standards and traceability models reduce friction when exchanging files or tracing requirements. Establish these standards early in the collaboration process to ensure seamless communication across all stakeholders.
Invest in Training and Consulting Services: While the right tool should be intuitive, training ensures your team gains expertise in leveraging advanced features for cross-platform requirements exchange. Look for companies that will partner with you from the start with industry expert consultants and can consult with your on your journey to success. Avoid those that outsource or charge high consulting fees after you’ve started your project, which will result in cost and delays.
Choosing the best requirements management tool for your automotive projects is no small task. But if you prioritize your organization’s unique needs while leveraging cross-platform compatibility features, you can have the best of both worlds.
Your requirements tool should empower your team, streamline your processes, and enhance collaboration without forcing you to compromise. Don’t settle for “good enough” just to align with supply chain tools when you can choose what’s “best for us”—and still work seamlessly with partners.
Curious about which tool could be the best fit for your needs? Start exploring modern requirements management tool like Jama Connect so you can stay ahead in this era of increasing complexity in the automotive industry.
[Webinar Recap] Best Practices for Simplifying Variant Management
Effective variant management is essential for organizations navigating diverse and competitive markets, regulatory requirements, and evolving customer needs. By adopting best practices, teams can efficiently tailor requirements while maintaining alignment and traceability across complex product lines.
Jama Connect® offers flexible strategies to simplify the creation, adaptation, and tracking of multiple variants. These approaches facilitate efficient reuse, reduce complexity, and maintain traceability across complicated product lines.
Identify and adapt variants to meet shifting market, regulatory, and customer demands.
Streamline variant creation through smart reuse and cross-team alignment.
Use structured feature models to manage options and complexity.
Ensure compliance while evolving product variants.
Optimize product line strategy with better visibility into variation.
VIDEO TRANSCRIPT:
Matt Mickle: Welcome, everyone. We have a fun topic today, walking through variant management use cases with the goal of simplifying this sometimes complicated topic. I will start off by walking through some of the common use cases that we often hear, followed by some concrete examples of how we would see these within the industry. I’ll talk a little bit about how we’ll solve these within Jama Connect and then have some demonstration of this directly in the tool. I’ll do this for each use case as we proceed, and then we’ll move on to some Q&A and I’ll answer some of your questions.
So, what do I mean when I say variant management? Well, simply, I would describe variant management as any process or technique that is used to manage variability and assets within a project. This could be in the form of certain techniques, such as feature-based product line engineering, which we’ll talk a little bit more about later. Configuration management, product derivation or branch and merge. A product can vary in many ways, such as different features, material or components, premium services or levels of performance. Here are some examples you might recognize. Models of home appliances with different sizes or capabilities, like these refrigerators. Microcontrollers with a configuration of reusable IP blocks. Medical devices, such as insulin pumps or digital thermometers having an array of features based on setting, method of application or type of consumer. As well as everyday devices, such as smartphones or smartwatches with different uses or consumer profiles.
Nearly every product you could think of has some amount of variation. And the process of managing those variants extends from the conception of the products, all the way into their description at the point of sale, and maintenance thereafter. So, one of these methods, which we will mention in the discussion today, is product line engineering or PLE for short. And for this, we’ll use the simple definition, a focus on engineering for a family of products with similar features, components or modules as a single product line to leverage commonality and variability, minimize the duplication of effort and maximize reusability.
Now, a couple of definitions that go along with that from the standards for product line engineering, from ISO 26550, the definition of a feature would be an abstract functional characteristic of a system of interest that end users and other stakeholders can understand. And from the product line engineering for feature-based product line engineering standard, ISO 26580, a product line would be a family of similar products with variations in features. So, product line engineering could be considered as the next step in maturity. Single system engineering. And as the ISO standard on software and system engineering for product line engineering and management states, product companies utilizing single system engineering and management approaches may end up with highly complex and low quality products. Low productivity, high employee turnover, and less than expected customer satisfaction.
Mickle: So, let’s instead talk about the benefits of moving from single system engineering into product line engineering. Product line engineering enables organizations to create product line architecture that allows for the systematic reuse of components, modules, and assets across different products within a product line. This promotes efficiency by reducing redundancy in the need to recreate similar functionalities for each product. By reusing existing components and assets, organizations can significantly reduce development costs. Product line engineering allows for economies of scale, as the investment in creating a core set of assets can be spread across multiple products, leading to cost savings in the long run.
With product line engineering, organizations can streamline the development process by leveraging existing components and architectures. Faster time to market for new products, since development efforts are focused on creating unique features, rather than rebuilding common functionalities. Product line engineering helps ensure consistency in products across the product line. By reusing well-tested and validated components, the likelihood of introducing defects or inconsistencies is reduced. And this will lead to higher overall product quality. As market demands change or new technologies emerge, product line engineering provides a framework that allows organizations to adapt and evolve their product line more easily. This enables the addition of new features or modification of existing ones without starting the development from scratch.
Product line engineering supports efficient configuration management, allowing organizations to define and manage variations and products through configuration, rather than by creating separated versions or desynchronized copies of content. This simplifies the task of handling different customer requirements or market-specific adaptations. Product line engineering makes maintenance and upgrades more manageable. Changes or bug fixes can be applied to common components, and then the updates can be propagated to all of the products within the line, ensuring that each product benefits from the improvements without having to undergo individual modifications.
And finally, product line engineering helps mitigate the risks associated with product development by relying on well-established and proven components. Since these components have been used and tested across multiple products, the likelihood of critical issues arising is reduced. Now, of course, there are many benefits for product line engineering, but there are a lot of challenges that a company goes through in order to try and move towards product line engineering. For example, let’s say a company starts out with a single product and then begins to build variants on that product, turning it into a product line. As the number of variants and variation between them grows, the ability to manage them becomes more and more challenging.
When a change is made, it’s important to assess not only the impact of that change within the product, where the change is made, but also in any products that are part of the same product line. If the change is against common requirements, then the decision is needed on whether they need variation. New versions or configurations of components of a system will need to be thoroughly reviewed with regards to how they interconnect. This becomes even more challenging and complex when considered as the product development data moves from one development application to the next. Throughout the supply chain, information about progress and change needs to flow and be collected in order to see overall status.
It’s very difficult to collect and understand this with only a single complex product and increases exponentially with variation. Now, within the context of the content included in Jama, the task of managing variants begins once there is any notion of more than one product being developed which has common requirements to another product. The question then arises of how to maximize reusability, and still understand the impact across multiple variants in the most efficient and effective way. Let’s go over a few ways that this presents itself and what the desired outcomes are. The first case is related to high-level requirements. And in this case, I’ll call it, the use case custom requirements.
Mickle: Those high-level requirements need to change for a given project. These input requirements could be things like specific market support for different markets that your product is in. It could also be different regulations for different regions, where your product is located and they have to go by different standards. Could also be that your customers are requesting your core product, but they want some customization to that core product. It could also be that you have different consumer profiles that you’re trying to match that product with, or it could be just an evolution from a previous year’s model that’s still in production.
In these circumstances, we may want to just be able to understand what the high-level requirements have as an impact on derived requirements design and test. So, we may need to filter out and keep track of what content stems from these input requirements. And we may need to test and produce documentation specifically related to that filter content. So, let’s imagine that our product team has been working through the lifecycle of creating an initial version of a product, and has developed many of the requirements and design, as well as written the tests against those requirements.
Now they have just received word that there is a new customer that has invested the product and would like the same product the team is already developing, but with some customizations and their own custom branding. This customer would like to also introduce the product into a new market which has a different power and connectivity standard. Technically, the scope of the change is going to total about 10% of the overall content, but the needs need to be tested independently and the documentation needs to be specific to each variant. So, you could copy the content and make the changes in each product independently, but perhaps you would still prefer to just indicate the differences and otherwise make use of the content that currently exists.
Also, you might still be able to make use of much of the testing that is in place for anything that is not interfaced with the components that have changes. For this reason, our strategy would be to keep those products together in a single super-set project, and use a mechanism within Jama called categories to indicate the variation. As you can see from the diagram here, we have the category tree which references a product line with different variants. Those variants would then be applied to the top-level requirements within your project, and then derived appropriately throughout the traceability within that project to ensure that everything has a category for the variant in which it lives.
For those items that are common to multiple variants, those would also contain the category for each variant in which they apply. Let’s go ahead and take a look at how that looks within Jama. So, for this example, I’m going to use a project which we call 48 volt power assist here. And this is our product. And basically, within here we’re going to look at the different variants that this 48 volt power assist has. So, first of all, I can go over to this categories tab, and I can click on that and see the different variants associated with the different categories. These have been added within the organization admin section.
And within each of those categories, you’ll see that I have requirements associated with the category. I just have to see those by clicking on the category itself and then I’ll see throughout the tree what categories apply to which requirements, or vice versa, which requirements apply to those categories in this case. I can also create a filter based on anything that applies to that category. So, here I’ve got those same items, but now I’ve got the structure associated with it when I look at the reading view associated with this. That gives me the ability to, of course, do things like export it as a document and include those different heading structures.
How Jama Connect® Supports Trade Compliance for Vehicle Connectivity Systems
In this short demo, industry expert Fabian Koark walks through how Jama Connect helps organizations meet evolving trade compliance regulations — specifically the new 2025 update to U.S. Federal Regulation 15, targeting vehicle connectivity systems.
Learn how to classify architectural elements by trade restriction, integrate vendor data, and generate a Declaration of Conformity report – available in the latest Jama Connect for Automotive framework – directly within your existing requirements review workflows. See how Jama Connect’s dashboards, reporting, and structured data model simplify compliance tracking and streamline documentation for import/export controls.
Watch the demo to see how Jama Connect enables due diligence, traceability, and regulatory readiness in one connected platform.
VIDEO TRANSCRIPT
Fabian Koark: My name is Fabian, Fabian Koark. At the beginning of 2025, I published a discussion on my consulting service website, called consulting.com, about trade compliance and a new regulation for vehicle connectivity systems and then Jama Software and the colleagues from Jama Software approached me and asked the question, what to do in a requirements management environment to support trade compliance? And this is what this little webinar is about. We have very different import and export restrictions in the technology field. Some things are restricted for export and regulated by a critical material list, and others are restricted for import.
And in 2025, the Bureau of Industry and Security (BIS) published an update of the Federal Regulation 15 in part 791 Subpart D, that is specifically targeted towards vehicle connectivity system. And Lael Brianard summarizes pretty much this rule was established to really prevent, prohibit, in this case, Chinese and Russian adversaries to bring in software and hardware into connected vehicle on North American roads to make sure the customers are protected and the public is protected. But what to do now in our software and hardware engineering surrounding? Do we need a specific change to our hardware and software bill of material? For this context, in regulation was decided after a long review discussion that there will be no requirement for a specific format of a hardware software bill of material, but there will be, there is the requirement of a thorough due diligence that also delivers a Declaration of Conformity.
So everybody who imports part of their software and hardware for the connectivity system will have to show that due diligence was performed and has to deliver a Declaration of Conformity. So let’s see how the new release in Jama Connect is able to support this. A few things, as I mentioned before, there are the new regulation, import regulation for vehicle connectivity systems is just one, but there are other regulations. And so when we have a software and hardware development surrounding, and we have different types of classifications probably in our project, certain elements are unrestricted. Then we have a few elements that are not classified yet where it’s really unknown. We have things that are import restricted, for example, for this regulation, for vehicle connectivity systems, but we also have elements that are export restricted.
Koark: So the moment when we produce and release the product, we have to make sure that when we export it, it will be restricted to be exported to certain countries or when we export it, it has to be delivered with certain declarations and documentation. But how to get to this classification and how to get to a Declaration of Conformity, I want to show you that in a second. But first things first. If I want to classify something in Jama Connect and I want to, for example, have the classification of a trade restriction, then easiest way is I go into admin, I go into my pick lists and say, okay, I classify, everything is classified as a pick list in Jama Connect, like safety or security level and integrity level. And in this case, we introduced in the standard project in Jama Connect, the element and the pick list of a trade classification here with our different classification, general import restriction according to CBP or the export restriction by the critical material components list.
Then we take that and said, okay, where do we want to classify it? It depends on your approach. In our approach we really focused on the architectural elements. The architectural elements, no matter if it’s hardware or software, have to be classified. So we added the trade classification, but also other information like the vendor name and the vendor country to the architectural elements. And that allows us to, for example, then also pull this data and show the data in our dashboard.
Now, you will also recognize in your newest release of Jama Connect that in a report field you will have a new report called the Declaration of Conformity. What is the Declaration of Conformity? The Declaration of Conformity report is based on an existing review. That means we decided not to establish a new completely separate process. We said, okay, there is a review. There’s a verification process established in every engineering organization, and at one point in time review approval and peer reviews have to be done. So let’s use that existing process to also deliver the Declaration of Conformity. Means this will pick up an existing review and the content of it in a very specific format, and I will show you how this looks in a second. That means I have to establish a review on my specific elements, and that was already done in this particular project.
So already have a review, review. Nine in a revision, four existing, and we can go into that and take a look what we see here. So it is different elements in this regard and we already see that, we also see here the trade classification in our review view, and we see how certain things are classified. Now, once I get to, for example, a communication element like here, a transceiver module, I see this was classified with our regulation of focus today with a vehicle connectivity system, specific import restriction, and we have additional information for who’s the vendor and what’s the vendor country. And important here is as we are focusing on the elements, we also know that behavior is decided by the design specification, by the requirements that are connected to a specific element. And that’s why we can also see the different connected and specifying elements in our Jama Connect here and I can go one step deeper and then see what is actually specified here on the communication protocol.
Koark: So I have everything in one. Now how do I now get the Declaration of Conformity? That’s exactly what I do. I run my report and then go to the Declaration of Conformity. I know I want to have my Declaration of Conformity based on the review nine in the revision four, and I want to have a Word format because I want to maybe integrate the content into a bigger report and then I can run the report. How does this report look when it comes out of the system? It identifies who the different reviewer and approver were, what are the review comments? But also then really show the information that we already had in our review. We see this is a classified element and we have the vendor information.
Furthermore, what is also important on the specification side, when we really go one level deeper, not on the element, but on the requirement we see who recreated a requirement that is related to that and when was it last modified. And that overall gives us a great baseline for Declaration of Conformity to then report to the authorities, but also to really have a review, internal review and know where things are coming from in our software and hardware development. With that, we have kind of the document layer, we have the specification and elements layer, and we have the dashboards. And I think this will bring the industry in a good spot to track compliance regarding trade restrictions. And that’s all we want to show today. If you have any questions, if you need any help, you want to tune and change your Declaration of Conformity, the support team of Jama Connect is always available. And I hope you enjoy this new feature.
Jama Software is always looking for news that would benefit and inform our industry partners. As such, we’ve curated a series of customer and industry spotlight articles that we found insightful. In this blog post, we share an article from EE Times, titled “Strategies for Addressing More Complex Custom Chip Design”, and written by Abhishek Jadhav and published on March 21, 2025.
Strategies for Addressing More Complex Custom Chip Design
Unprecedented growth and demand for edge computing and high-performance computing (HPC) is creating new opportunities and significant challenges for custom chips. We spoke to Sondrel CEO Oliver Jones to discuss some of the approaches to addressing these needs.
Custom chip design is a multifaceted process involving many considerations, from power efficiency and performance trade-offs to manufacturing and packaging complexities. One of the primary challenges in this domain is managing power, performance and area (PPA) trade-offs.
Designers must carefully balance these factors to ensure that the final product meets the strict requirements of modern applications like AI at the edge or HPC workloads. Additionally, the process involves navigating geopolitical disruptions and supply chain constraints, which can delay production and increase costs.
Startups and established companies also face hurdles like limited resources, lack of access to advanced manufacturing facilities and navigating the intricate supply chain required for production. The role of specialized ASIC suppliers is to offer expertise in balancing power efficiency, managing supply chains and streamlining production.
“Selecting a turnkey supplier to handle a complete ASIC project is much more challenging than selecting an ASIC design house. There needs to be a high level of confidence and trust,” Jones said.
Flowchart explaining the turnkey model. (Inspired by source Sondrel)
In response to these challenges, some companies have adopted the turnkey model, which manages every stage of chip development—from initial concept to mass production. This approach simplifies the process for clients, especially startups lacking the resources or expertise to develop custom chips independently. By integrating services like architecture design, physical design and design for testing, turnkey providers reduce the risks and complexities associated with chip production.
For example, a turnkey provider’s partner ecosystem, including foundries like TSMC and GlobalFoundries, ensures a smooth transition from design to manufacturing. “Startups often have fantastic ideas but lack the capability and resources to translate them into hardware. We’re selective about who we work with, allowing us to provide closer attention and better service to each customer,” Jones explained.
In one example, a U.S.-based AI startup specializing in image and video recognition technology needed to develop an AI accelerator chip for edge applications, such as surveillance and facial recognition. This required a custom design to address challenges in architecture, packaging and supply chain management—areas particularly daunting for a startup with limited resources.
For this project, Sondrel helped the startup identify the need for a flip-chip CSP package with an ultra-low profile of 2.5 millimeters to meet the space and performance constraints. By pre-booking packaging slots, the lead time was reduced from 42 weeks to 12–16 weeks, accelerating the product’s time-to-market. The project integrated the startup’s proprietary AI IP to deliver a reliable and efficient chip that became central to the startup’s AI accelerator hardware.
By leveraging the provider’s ecosystem and expertise, the startup successfully developed a 16-nm FinFET chip in just two years.
The role of turnkey custom chip design houses
Startups face unique challenges in custom chip design, often struggling to access the resources and expertise needed to bring their ideas to life. Resource constraints can make it difficult to define optimal PPA trade-offs or secure manufacturing capacity. Additionally, supply chain disruptions, whether due to geopolitical tensions or market volatility, can create significant hurdles.
Edge AI applications, such as autonomous vehicles, smart cities and IoT devices, require custom chips capable of processing large amounts of data locally while minimizing power consumption. Similarly, HPC workloads, including scientific simulations and big data analytics, demand chips optimized for performance and scalability.
“AI at the edge and HPC are where we see the strongest demand,” Jones said.
Considering the rapidly evolving landscape, collaboration among design houses, foundries and ecosystem partners is critical. The ability to integrate advanced process nodes, innovative packaging solutions and robust supply chain strategies will define the future of custom chip design.
To address these issues, turnkey providers have developed foundry-agnostic approaches that offer greater flexibility. These approaches involve designing chips in a way that can be manufactured across different foundries without being tied to a single supplier, allowing companies to adapt to changing manufacturing capacities and avoid bottlenecks.
By maintaining strong relationships with multiple foundries, providers can secure wafer allocations and advanced packaging solutions, reducing lead times and minimizing risks. Selecting the right kind of chip packaging plays a key role here, and turnkey providers help companies to adopt the latest and innovative packaging solutions.
While turnkey models provide a valuable solution, other strategies are also emerging to address the challenges of custom chip design. Collaborative research initiatives and public-private partnerships are playing an increasingly important role in driving innovation. For example, government-backed programs in Europe and North America are funding projects aimed at developing next-generation semiconductors.
Open-source hardware initiatives are another promising avenue. By providing a shared foundation for chip design, these initiatives can lower costs and accelerate development timelines—particularly for startups. Additionally, advancements in design automation tools are making it easier for companies to optimize PPA trade-offs and streamline the development process.
Innovative packaging solutions are a critical component of modern chip design, enabling manufacturers to achieve higher levels of integration and performance. Techniques like flip-chip and wafer-level packaging are becoming increasingly popular for applications in edge AI and HPC.
Flip-chip packaging allows direct electrical connections between the chip and the substrate, reducing signal interference and improving thermal management. Wafer-level packaging, on the other hand, integrates the packaging process directly on the wafer, enabling a smaller form factor, improved performance and lower production costs. These methods not only improve performance but also reduce the overall size and power consumption of chips.
For instance, in the aforementioned case study, using a flip-chip CSP package with an ultra-low profile of 2.5 millimeters significantly reduced lead times and enhanced the chip’s performance. This example underscores the importance of packaging innovations in meeting the demands of next-generation applications.
As edge computing and HPC continue to grow, the demand for custom chip design will only increase. The future of the semiconductor industry will be shaped by advancements in process technology, innovative packaging solutions and collaborative ecosystems. Companies that can effectively address the challenges of custom chip development will be well-positioned to lead in this dynamic market.
To achieve this, industry stakeholders must prioritize collaboration, investing in partnerships that span design, manufacturing and supply chain management. By working together, they can overcome the barriers to entry and accelerate the development of chips that power the next wave of technological innovation.
The custom chip design process is a testament to the complexity and ingenuity required to meet the demands of edge AI and HPC. Through a combination of innovative strategies and collaborative efforts, the industry is redefining what is possible, paving the way for a future where technology continues to push the boundaries of performance and efficiency.
Jama Software Provides a Single, All-in-One Solution for Requirements, Risk Management, and Validation
Organizing requirements, managing risk, and ensuring validation are complex processes on their own. For teams in the medical device industry, these tasks are even more challenging due to stringent regulatory standards and the critical nature of the products themselves. Jama Connect®, a robust software tool designed specifically for such pressures, offers a seamless, all-in-one solution.
What to Look for In a Requirements Management Tool
At the 2024 INCOSE Healthcare Conference, one of the presenters delivered an insightful presentation highlighting the essential features their organization identified as necessary in a requirements management solution to effectively support complex risk management procedures.
This blog post provides a detailed breakdown of how Jama Connect is specifically designed to address each of these critical areas discussed during the presentation.
End-to-End Traceability for Risk Analysis and Validation
Why It’s Important: Without clear traceability, unverified requirements or overlooked risks can result in delays, missed compliance, or worse, product failure.
How Jama Connect Helps:
Jama Connect provides traceability across all items in the development process, linking risk analysis elements to requirements, mitigations, and verification items.
Suspect triggers and impact analysis. Any upstream change triggers “suspect links,” highlighting potential downstream impacts, so no critical changes are overlooked. Impact analysis features allow for a proactive approach to understanding the scope of a change BEFORE it occurs.
Configurable views and export templates ensure efficient reporting to compliance agencies, showing validation evidence clearly and concisely.
Example: Teams can easily export views with verification columns from Jama Connect into Word or Excel for seamless external reporting.
Supports seamless data imports from applications like Microsoft Excel or Word, using reusable import wizards for faster and repeatable imports.
Pre-configured framework for Medical Device & Life Sciences, reduces time-to-value, allowing teams to get up and running quickly.
SOC2 Compliance, combined with the robust capabilities of a Validated Cloud and Validation Kit, provides systems engineers with effective solutions to meet stringent security and regulatory compliance requirements.
Additionally, the focus on user experience allows for a fast time to value across project teams.
Flexible Configurations for Different Workflows
Why It’s Important: Medical device companies don’t all operate under the same workflow, and tools must accommodate that diversity.
How Jama Connect Helps:
Pre-configured frameworks for compliance streamline setup time while allowing for configuration to suit unique organizational processes.
Provides users with the Traceability Information Model, visualizing traceability chains to ensure nothing falls through the cracks.
From aligning with new SOPs to creating testing and validation workflows, customization ensures this tool adapts as projects evolve.
Scalable Solution for Large Projects
Why It’s Important: Medical device development often spans multiple teams and product lines, increasing complexity.
How Jama Connect Helps:
Provides for the ability to break large projects down into smaller, manageable subcomponents while maintaining traceability across product lines.
Supports cross-project traceability and reusability, which is ideal for future scaling.
This modular approach makes it easy for businesses to simplify operations without losing sight of critical compliance elements.
Risk management and requirements traceability go hand-in-hand, forming a critical component of any successful project. A well-configured tool should seamlessly align with your existing processes while offering the flexibility to adapt to your specific needs.
To illustrate, here are three examples of how Jama Connect’s Traceability Information Model can be configured to enhance and support a comprehensive risk management process. These configurations are designed to streamline workflows, improve traceability, and ensure better alignment with your risk management objectives.
Example 1 (from Jama Connect’s Medical Device Framework)
Example 2 (from Jama Connect’s Medical Device Framework)
Example 3: Customized Workflow
Conclusion:
Jama Connect is a purpose-built solution designed to meet the complex and stringent requirements of the medical device industry. Offering robust capabilities like end-to-end traceability — from risk analysis through to verification — it ensures seamless oversight across the entire development lifecycle. With capabilities, such as FMEA and alignment with critical regulatory standards for the medical device industry, Jama Connect simplifies compliance and elevates requirements management to the next level.
With award winning usability, Jama Connect features an intuitive interface, customizable configurations, and powerful change management capabilities. These features enable teams to work efficiently while staying aligned with regulatory needs. By fostering real-time collaboration and bridging the gaps between stakeholders, Jama Connect empowers organizations to accelerate product development without compromising on safety or quality.
Structured Collaboration in Semiconductor Development
Any semiconductor product development team has experienced the challenge of managing data from different components of a highly complex system of systems. In today’s hypercompetitive market, requirements management is a high-stakes effort navigating tight operational margins with little room for data integrity errors. Because different components of a semiconductor product may evolve along different timelines, building a coherent product from multiple data streams requires new methodologies and practices to continuously deliver these products to the market quickly and with high quality – no easy feat!
Many of these organizations struggle to keep pace with the rapidly changing product development environment, especially when their teams work in silos using either business applications (Word, Excel) or legacy requirements management systems to house their definitional data. As businesses continue to shift focus to faster time-to-market and customer-driven product development, deeper structured collaboration amongst teams is not only desired but necessary.
What is Structured Collaboration
Structured collaboration is centered around the idea that people can work and interact with one another, moving toward specific and measurable goals. This approach works in two parts, utilizing technology and process frameworks to define new and innovative ideas that drive business outcomes.
By combining asynchronous but interdependent collaboration with elements of content management (content about your product or system), development process management, and task management — all integrated into a workflow process that coordinates multiple activities from several teams — cross-functional teams can produce the results that drive the business forward.
The absence of structured data and practices early in the Product Lifecycle can lead to wasted time, untraceable changes, lost context for decisions that were made, and missed opportunities for innovation.
Bringing together innovators across cultures, organizations, and geographic regions to accomplish goals can revolutionize a sector. It also presents unique challenges with each group having their own standards and entrenched way of tackling the task at hand. So, how do these teams tackle complicated divides without their differences becoming impediments?
Unify Goals: When cross-functional teams have a shared purpose and unified goals for developing a product, innovation, or service, they can better overcome challenges inherent to collaborating in a complex environment.
Clarify Roles: Clearly communicating expectations for how and when each team member will be asked to participate helps alleviate the uncertainty that comes with collaborating in a new way. Documenting areas of accountability and tracking collaboration each step of the way keeps programs moving forward smoothly.
Encourage Expression of Unique Points of View: Unlocking the creativity needed for innovation requires harnessing insights and unique perspectives across different stakeholders. Encouraging team members to speak up and share alternative perspectives results in robust and better-considered ideas for implementation. Having representation from across the team will also help better assess the impacts of decisions made and identify issues before they become problems.
Use the Right Tools: We’re fortunate these days to have a wealth of collaboration tools from Slack, Discord, and Microsoft Teams to Zoom and Google Meet. As teams seek real-time input and feedback critical to capturing insights, these tools serve a vital purpose. These only scratch the surface in eliciting the type of collaboration necessary for modern systems engineering, though.
Enable Cross-Team Alignment with Live Traceability™
While meetings, emails and instant messaging channels serve a purpose, they are insufficient for making and tracking key decisions that impact an entire silicon program. Modern systems engineering must include means for live data to be shared and accessed by teams anywhere in the world at any point in time.
As members of the product team seek to communicate requirements and project status across departments, roles, and geographic boundaries, the golden age of sharing documents and spreadsheets will no longer serve its purpose. Without a digital thread that connects people and processes — from definition to delivery — development teams face increased risk, challenges meeting compliance, and delays that can impact time-to-market and product and systems stability.
Live Traceability™ in Jama Connect® provides a single-source of truth, cross-team collaboration, and end-to-end visibility which forms the digital thread through siloed complex product, systems, and software development.
Eliminate Collaboration Silos to Enable Strategic Partnerships
Today’s semiconductor ecosystem requires companies to consider strategic partnerships as they sell into varied dynamic and often integrated markets such as robotic factory automation, autonomous driving, and AI-enhanced medical diagnostic equipment. With these new partnerships and integration comes greater sharing of data across distributed teams, business units, and with partner companies. Teams that operate in silos with legacy systems will not be equipped to meet demands set by the market.
For engineers accustomed to working in internal, siloed groups, these new partnerships present previously unforeseen challenges. Structured and strategic team collaboration and careful data governance and security are critical to improving the product development process for all participants – and this includes everyone across the supply chain.
People working together is at the very core of all product development. For companies to turn the research of today into the products of tomorrow, it is critical that their teams stay connected, synchronized and unified. By aligning business objectives with a system in place that allows for structured reviews and collaboration, teams can elicit feedback, review product features with stakeholders in real-time and track critical decisions across teams and locations. Simply put, it gives companies that ideate, design, develop and deliver highly complex semiconductor products a critical edge in an industry where the speed, precision, and quality of process enable the speed, precision, and quality of products.
Jama Connect provides a robust yet flexible framework to enable accelerated design and development. Contact us to learn more about reducing collaboration friction through shared data across your semiconductor system of systems.
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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