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

Empowering Complex Development with Responsible AI

Streamlining Efficiency and Compliance with Scalable Solutions

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

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

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

RELATED: Write Better Requirements with Jama Connect Advisor™

Today’s Systems Have Become More Complex

Systems of Systems (SoS)

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

AI Applications in Complex Product Development

1. Challenges in Product Development

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

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

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

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

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

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

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

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

2. AI Solutions to the Challenges

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

Automating Requirements Validation

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

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

Ensuring Regulatory Compliance

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

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

Accelerating Development Cycles

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

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

Enhancing Collaboration

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

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

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

Unlocking the Power of Jama Connect Interchange™ and MathWorks Integration

Keeping requirements and engineering tools in sync is crucial for effective product development. In complex product development, connecting requirements management with engineering tools is crucial for success.

When teams work in disconnected environments, the risk of errors and compliance gaps grows. An integration between Jama Connect Interchange™ and MathWorks tools like MATLAB and Simulink bridges this divide, creating a seamless, bidirectional flow of information. This connection ensures every team member, from system architects to design engineers, works in alignment with the most current data.

This powerful integration offers significant benefits that streamline development cycles and improve product quality. By automating the exchange of requirements and design data, teams can achieve greater efficiency and collaboration.

Key advantages include:

• End-to-End Traceability: Create a clear, auditable link from high-level requirements to detailed model elements.
• Reduced Errors: Minimize manual data entry mistakes and miscommunication between teams.
• Streamlined Collaboration: Enable systems and design engineers to work together effectively in their preferred tools.
• Simplified Compliance: Maintain a complete traceability chain to meet strict industry standards.
• Time and Cost Savings: Automate processes to shorten development cycles and allow teams to focus on innovation.

WATCH THE FULL DEMO BELOW

VIDEO TRANSCRIPT:

Patrick Garman: Hello, my name is Patrick Garman. In this demo, I’m going to walk through an example of using Jama Connect Interchange to share requirements with MathWorks tools, then bring that information back into Jama Connect^® for complete traceability. Here’s what you’ll see.

First, I’m going to export a set of requirements from Jama Connect to a ReqIF file using Jama Connect Interchange. Next, I’ll import that ReqIF file into the requirements editor in MATLAB and link those requirements to model elements in Simulink. Once those links are in place, I’ll use MATLAB’s native ReqIF export feature to create a new ReqIF package that includes both the requirements and their Simulink connections.

Finally, I’ll import that ReqIF file back into Jama Connect using Jama Connect Interchange, which will update any requirements that were edited in MATLAB, and also create a new set of model items in Jama Connect to represent the Simulink model elements.

By the end of this process, you’ll see how Jama Connect maintains end-to-end traceability between requirements and model elements, bridging the gap between systems engineering and model-based design. So here I have a Jama Connect project, and you see I have a set of functional requirements here. And these are some requirements that I want to link to elements of a model that I’ve built in Simulink. And I’m going to start this process by exporting these requirements into a ReqIF file. And ReqIF file is essentially an XML file type, but it is a format that is specifically designed to be a standard file type for requirements management tools to enable this kind of exchange of information.

RELATED: Jama Connect^® Features in Five: Jama Connect Interchange™ — ReqIF Import

Garman: All right, so I’m gonna start. I’ve already connected my Jama Connect instance to my Jama Connect Interchange. And so I’m going to come to our conversations page, and I’m going to start a new conversation. Just gonna give it first, I need to tell it what tool I’m going to be connecting with, and so we’re going to go with Simulink. And next. And then we need to pick if we have more than one Jama Connect connector, we’ve gotta tell it which one we want to export and import with, and then we just need to pull the project ID. So here we can see this is project two fifty one. So I can search by project using the API ID, or I can use a text search using this drop-down menu.

So this project is a Simulink demo. There we go. Just type a few letters. It pops up for me. And then I’m gonna give my conversation a name, and this is how I can know if I’m having several projects or even several sections of a project that are exchanging information with Simulink. We want to have separate conversations for those. So now I’ve created the conversation space in Jama Connect Interchange, and I want to start by exporting. So I’m gonna come to my export page. And here, I’m gonna start by selecting a location.

Step one: Location. There are a few different ways that our locations can export a baseline. For this situation, I’m going to stick to the container and I’m going to select my functional requirements, even that set of. So I need to select either the project root or a component, and I’ll have a chance to filter items out. But here, I’m gonna select this component and click next. And within that, if there were other sets of items, I could filter those out, but this is the one that I want. So I’m going to save.

Now then, on export, there is field mapping that I can select. For example, if I had more than one item type, more than just functional requirements, I could select which item types I want to include. But I can also set which fields I want to keep for each of these. So there may be several fields that I just don’t care about bringing into MATLAB Simulink because they’re not relevant to the work that I want to do there. Or I just don’t need them and that other thing. So I can turn off any of these fields that I don’t care about or don’t need to have in in Simulink. So I’m only exporting the specific data that I want to import into Simulink.

Alright, so in this case, I’m really just keeping the name, description, and rationale fields. So I can save that export mapping, and Jama Connect will also capture all of your relationship types just in case we again we’re pulling the relationships back in, but those are all mapped automatically. So from here I can just initiate export. And confirm. And depending on how many items this is, you know, six or seven items, it’s going to be really fast. Depending on how many items you are trying to export into ReqIF, that could potentially take longer. But from this log screen, can see the progress, especially if you use the funnel icon, include debug, it brings in, it gives you some status, but ultimately, it gives you this link where you can download the ReqIF file. So here, I’m just gonna drag and drop that onto my desktop so I can find it. And now I’m going to switch over to MATLAB. So starting here in Requirements Editor, because I need to import those requirements that I did previously. Here, I’m gonna delete. So for that, I’m going to first clear out what I had done previously. I can’t do that. So I’m just gonna import. We are importing from ReqIF, and I’m just gonna browse to find the file that I saved to my Desktop.

RELATED: Transform Engineering Processes: Bridge Gaps Between Teams and Tools Effectively

Garman: So here we have that ReqIF I just created from Jama Connect. So we’ll open that. In these other settings, MATLAB automatically selects some things. I would say, you know, it automatically detects that it’s coming from Jama Connect. If you want to save this in a different location, you can do that here. Ultimately, we’re going to import these requirements. Alright. So here I have my second import, and you can see that these requirements have come through. Now then, I export the description rationale field. So why are they not showing up here? Because this is the MATLAB description and rationale field. For those Jama Connect elements, we need to come down here to custom attributes. And here we can see all of those, all of those fields as set that we exported. Alright. Now that we’re in MATLAB, this is our model that I want to start connecting things to. So in MATLAB, I’m going to select a model element here at the controller. And we will say that one point one is the one, so I can just right-click it and link from the controller. And I could even say, here we go, my Dryden Wind gust models are part of one point three. So again, I can create the link there. And let’s do one more. Let’s do this small gain one. We’ll link that to one point six. Okay. So now we’ve made we’ve added all of our links And and so now what we want to do is we want to take what we’ve done, I want to save it, but then I’m going to export this back to ReqIF.

Here, I can just reuse the original mapping from Jama Connect. If there are, you know, attributes that you want to remove, you can do that here. But the most important thing is we want to export links. So make sure that this export links box is checked, and then we can set a location. I’m gonna move this to our desktop again for easier finding. When we’re ready, we can just click export. So it’s running through everything. It’s gonna save that to our desktop. So, what we can do now is let’s come back to Jama Connect Interchange, and I’m going to switch to import because now we’ve pulled that data from MATLAB and Simulink and we want to bring it into Jama Connect. So I’m gonna go to my import in the same conversation. Click upload.

I’m gonna select that file that I just pulled out of Simulink. And we’ve already set the location, which we can edit if we need to, but we’re gonna leave it at the same location. And here we’re gonna map for the import. So we want to have our functional requirements mapped back to functional requirements in Jama Connect. And these others, these are those model elements that we want to bring back in. And so I’m gonna bring those in as Models. So I can select what item type in Jama Connect I want to have as a reference to those elements back in MATLAB Simulink. So I’ve turned those on. Now I’m gonna, oops, save our item type mappings. And I can switch to fields. And here, the same thing. I just want to map everything back to what it should be in Jama Connect. So here, I’m looking at those model elements. So we want to create this as a set. And we want to bring in the name of the set to the or the name of the collection from MATLAB to a set name in Jama Connect. But then we also have to establish these object types. So here are just Simulink objects. If we had, say, headers or information items, we could maybe map those differently. But we want to tell Jama Connect the Simulink objects should be brought in as folders, text, or models? And in this case, that’s the actual model elements. So we’ll bring them in as models, which is the item type that we map to in the first step.

So now Jama Connect is going to generate the mapping. So we are gonna pull here are the elements, the metadata elements that are found on these Simulink objects, and we just wanna map these back to an item in Jama Connect. So here description will go to description, name goes to name. And if we want to keep if there is a, you know, key, we could map that to an additional field. But once we’re done, we’re gonna click save.

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

Garman: Now we will move on to our next item type, which is functional requirements. And, again, functional requirements will come back in as a set. And we really only have to map those fields that we want to update. So here I can just leave that as a name, and here a functional requirement. We’ll go back to the functional requirement. And, again, we really don’t have to map many of these fields back if we’re not actually bringing in field-level updates. So here, I’m just gonna map the name. If I had made changes to the other fields in MATLAB, I would change those here. And the final step, I wanna go to relationships, and I just need to map these back into the appropriate even though they’re originally pulled from Jama Connect, and mapping them back to the relationship types that they were pulled from. The good thing about doing this import mapping is that you really only have to do it once. Once you’ve mapped everything in this conversation, you can just keep reusing this conversation and make updates as necessary.

Okay. Another thing you’ll notice with each of these relationships, have this option to reverse direction. And there, that is because some tools treat traceability in a slightly different direction. So, what is happening right now in Simulink, the way I created those is that the model element is actually upstream of the requirement. But in Jama Connect, we want the requirement to be upstream from the model. So I can just I can fix that by clicking this box to reverse direction. On each of these so that when it brings it in, they will be in the correct the relationships will be in the correct cardinal direction. Alright. So once we’ve done that, we can click save.

And now that we’ve mapped everything, we can initiate import. And Jama Connect is gonna ask us, “Do we want to update existing items?” And that’s what we want to choose for this, because we want to update the existing functional requirements, and those model elements will be brought in as new items. Now then, in future iterations, if we export these functional requirements and these model elements into Simulink again, say we’ve made updates, we want to redo it again, it’ll update the existing models that you’ve already imported. If you select create new items, it will only create new items. It will not update any existing items. So in this situation, I want to update the existing items. So we’ll confirm. And tells us to take a look at the logs page, and it’ll take a little bit for this to finish. So again, we’ll get a complete message when it’s done. But if we want to see more, we can enable this debug option.

And you can see that Jama Connect Interchange is evaluating, and it’s saying like, “look, no field changes happened” with these, so we’re not going to update those. But here we go. We do have a few fields that we had to update, and we’re creating those relationships because again, we linked three items. All right, so let’s go back into Jama Connect, and if I refresh my tree, you see that there’s this additional component here under my functional requirements. If I expand that, I have this set of models. And then here I have each of those models. So here is the controller. And you can see it has a link back to that element, the description field. And it is related to the transfer history with a “Satisfied By” Marker.

And that concludes the demo.  You’ve now seen how Jama Connect Interchange makes it possible to seamlessly exchange requirements with MATLAB and Simulink through the ReqIF standard. By moving requirements into MATLAB, linking them to model elements in Simulink, and then bringing those links back into GeometConnect, we’ve established full traceability between the system requirements and the model-based design. This integration helps your teams reduce errors, streamline collaboration across engineering disciplines, and maintain compliance with industry standards. Thank you for watching, and please reach out if you’d like to explore how Jama Connect can support your development process.

To view more Jama Connect integrations, visit:
Jama Connect Integrations

This blog recaps a section of our recent webinar, to watch the entire presentation, visit Techniques to Manage Work Breakdown Structures.

Streamline Your Program Management: Techniques to Manage Work Breakdown Structures (WBS)

In aerospace and defense program management, success hinges on coordinating complex, interconnected projects while maintaining clear visibility across your entire program. When managing multiple systems and stakeholders, your work breakdown structure becomes the foundation that either strengthens or undermines your project’s success.

In this webinar, Cary Bryczek, Director of Aerospace & Defense Solutions at Jama Software, demonstrates how to incorporate MIL-STD-881F work breakdown structures into Jama Connect^® as part of your systems engineering processes.

Whether you’re managing space systems, information systems, or strategic missile programs, this webinar will show you how to streamline your program management with techniques to manage your WBS.

Key Takeaways:

• MIL-STD-881F fundamentals: Understanding the Department of Defense Standard Practice and how it improves acquisition communication
• Real-world implementation: See how MIL-STD-881F work breakdown structures can be incorporated into Jama Connect, including a live demonstration.
• Cross-functional alignment: Strategies to coordinate teams and manage interdependencies across complex defense programs
• Commodity-specific insights: How WBS elements apply to space systems, information systems, launch systems, and strategic missile systems
• Communication enhancement: Best practices for developing uniform WBS processes that improve stakeholder alignment and regulatory compliance.

Webinar Preview, Click HERE to Watch The Entire Presentation

TRANSCRIPT PREVIEW

Cary Bryczek: So, here’s a quick look at what we will cover today, and in the end we’ll have a Q&A of course. So, we’ll talk about some strategies for a work breakdown structure construction, obviously we’ll talk about what WBS is used for, we’ll look at a WBS hierarchy, and the product breakdown structure, talk about the differences, we’ll see a live example in Jama Connect, and we’ll finish up with maybe some possible extensions that you might use in Jama Connect through integration. So, what is a work breakdown structure? I went out there and did some research. Project management institute talks about a work breakdown structure being, that it defines a deliverable-oriented hierarchical decomposition of the work to be executed by the project team to accomplish the objectives.

Really, when you see these kinds of definitions, the important parts are the deliverable-oriented and the work. So, it’s not like a task list, it’s what you’re doing to produce the product or the system that you’re building. The Defense Acquisition University defines a WBS as a product-oriented family tree of hardware, software, services, data, and facilities. So, the theme really is this product-oriented and a tree composition of the work breakdown structures. And it’s not only composed of the product pieces itself, but the services and the data and the facilities and the results of the systems engineering efforts. So, it’s the effort plus the product itself. Who uses work breakdown structures? Really, they’re required or strongly recommended in various industries and government sectors, especially where project management, cost control, and systems engineering are critical.

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

Bryczek: With aerospace and defense contractors, they are required to submit a WBS as part of their proposals and their contracts. They are used for cost estimation, scheduling, and risk management. Construction and engineering firms, WBS is essential for managing large infrastructure projects. It’s often required by clients or even regulatory bodies. IT software development, project management professionals, so there’s a lot of people that are project management professionals that are using a WBS as part of their repertoire to deliver good projects, or even consult with organizations to deliver good project management practices.

WBS has lots of standards and guidelines to assist practitioners. So, in many cases, following the specific guidance within the documents is mandatory. Here I’ve just highlighted some notable guidelines, MIL-STD-881 is required for all ACAT programs, NASA also has a very prescriptive method to implement WBS, PMI has published books, and has lots of references available online for practitioners. The European, I didn’t capture this one, but the European Cooperation for Space Standardization, the ECSS group, in Europe, they provide detailed guidance as well on work breakdown structures through their management standards. And they reference principles from ISO 9000, and it really aligns their standards and their product assurance through a harmonized way to do work breakdown structures.

So, what’s the purpose of a WBS? It’s an assistant mechanism for any stakeholder really, in the development of a clear vision of the end products, or the outcomes to be produced by the product. So, it’s a framework for all of the deliverables throughout the life cycle. So, the WBS extends the product breakdown structure because it’s capturing all of the work that’s necessary for the project by adding in the non-product work. So, if you’re constructing a bicycle, well, I have to draft the CAD model, I have to review it, I have to do a lot of these things that are not necessarily part of the bicycle, a component, but these are part of the engineering activities. So, a work breakdown structure is not a to-do list, it’s not a schedule or an estimate, and it’s not really a tool to even make your life harder.

RELATED: Cybersecurity in the Air: Addressing Modern Threats with DO-326A

Bryczek: So, it supports very large projects so that you can eliminate risk, and also it will help you with the scope creep as well. So, you don’t want to do more work than what’s on that WBS, so it really helps people understand the scope of the kinds of activities that they’re producing because it is deliverable based. So, the benefits, it helps prevent work from slipping through the cracks, it helps people understand where the pieces fit into the overall project management plan. So, if you’re a software developer and you’re writing this one piece of the software requirement spec, or the software system spec, now you know why your deliverable is due, when, and how it fits in with the overall structure. It facilitates that communication and cooperation across the whole team, it also helps you prevent changes, that WBS is kind of like, this is the guide path for everything that you do. And it helps get team buy-in and helps build the team. it helps people get their mind around the project itself.

So, what do we have to do to create the statement of the work breakdown structure? So, a work breakdown structure is, first, you go through this process of identifying the system or the project end item to be structured. So, you’re trying to understand that scope, what is it that we’re building? And then, you take that product and you successively subdivide it into increasingly detailed and manageable subsidiary work products or elements. So, you’re taking this product, this bicycle, and you’re decomposing it. I have a frame, I have the front wheel, I have the rear wheel, I have the brakes… And then, what you’re going to do is take that product breakdown structure that’s been subdivided, and now use that to determine what the work breakdown structure is. So, you’re going to focus on these outcomes and identify these deliverables. So, the focus is supposed to be on the outcomes, not the activities needed to reach them.

TO WATCH THE ENTIRE WEBINAR, VISIT:
Techniques to Manage Work Breakdown Structures

Mergers and Acquisitions in MedTech: Positioning Your Company for Success

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

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

The Current M&A Landscape: A Shifting Landscape

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

Strategic Focus: Bigger Bets, Sharper Targets

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

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

Trends Driving the Market

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

What Strategic Buyers Seek: The Acquisition Criteria That Matter

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

Technology Differentiation & Market Position

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

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

Regulatory Clarity

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

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

Commercial Potential

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

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

Financial Performance and Scalability

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

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

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

Getting Acquisition-Ready: Preparing for Due Diligence

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

Product Documentation

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

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

Risk & Quality Systems

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

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

Testing and Validation Evidence

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

To stand out, companies should maintain:

• Detailed test plans
• Clear procedures
• Organized results

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

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

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

Intellectual Property and Regulatory Assets

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

To prepare:

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

On the regulatory side, maintain organized records of:

• FDA correspondence
• Clinical trial data
• Post-market surveillance reports

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

How Jama Connect^® Supports M&A Readiness

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

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

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

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

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

Building Long-Term Value Through Strategic Preparation

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

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

• Operational excellence
• Regulatory sophistication
• Systematic development processes

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

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

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

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

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

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

What is an Airborne Fire Control Radar?

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

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

Current Drivers and Trends in the Market

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

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

Developments in Technology

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

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

Increasing Need for Unmanned Systems

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

Obstacles in the Market

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

High Costs of Development and Production

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

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

Tough Regulatory Obstacles

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

Complexity of System Integration

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

Prospects for the Future and New Technologies

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

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

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

In conclusion, a market ready for innovation

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

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

This blog recaps a section of our recent webinar, to watch the entire presentation, visit Best Practices for Leveraging Systems Thinking in MBSE

Best Practices to Simplify MBSE: Unlock the Power of Systems Thinking

Model-Based Systems Engineering (MBSE) is transforming how organizations manage complexity in modern engineering projects. Yet, successful integration with existing tools and workflows can be challenging. By applying systems thinking, you can gain a holistic understanding of interconnected systems and adopt proven strategies to streamline your engineering processes.

Join a 1-hour webinar featuring INCOSE expert David Long, Director of Strategic Integration at INCOSE, and Aimi Langberg, Senior Solutions Consultant at Jama Software. They will share expert insights and actionable techniques to help you adopt MBSE with confidence.

In just one hour, you’ll learn:

• How systems thinking enhances decision-making and problem-solving in engineering
• Practical steps to transition from document-based processes to a unified model
• Proven strategies for aligning MBSE with industry best practices
• The role of AI in advancing systems engineering and MBSE adoption
• Expert tips for integrating these approaches into your workflows

The Video Below is a Preview of This Webinar.
To Watch The Entire Presentation, Visit Best Practices to Simplify MBSE: Unlock the Power of Systems Thinking

TRANSCRIPT PREVIEW

Aimi Langberg: My name is Aimi Langberg, and I’m a Solutions Consultant for Jama Software. To start off today, I have a very special guest to chat with me about systems thinking. David Long is an internationally recognized leader in systems engineering, with over 30 years of experience advancing and advocating for best practices across government and commercial organizations. Founder of Vitech and now president of Blue Holon, he has developed industry-leading MBSE methods and tools to help teams navigate digital transformation. As an INCOSE fellow and past president, David will be able to provide the framework for us to reference as we talk about concepts and application today. I’ll be back to continue our presentation after the interview. Hi David. Thanks for taking the time to talk with me. I’m excited for this opportunity.

David Long: Pleasure, Aimi. So am I.

Langberg: Great. You’ve been advocating and teaching about these concepts for a long time. And as organizations move from traditional document-based methods, I have found it really does require a mindset, like a total shift in mindset, to be successful. So, how do you define systems thinking, and what core principles are the most essential for effective engineering?

Long: I appreciate you starting it that way, Aimi, because systems thinking is the thought process that underlies systems engineering. So if you don’t go back to the core, you’re not going to get the model based right. So for me, systems thinking is all about focusing on the whole, the big picture, whereas we’ve been taught analytical thinking, which focuses on the parts in deep detail. So when you’re doing systems thinking, you’re looking at the whole, at the interactions, at the interrelationships between ideas and concepts, and you’re thinking dynamically across time because things aren’t static. In terms of core principles that you’ve got to apply when you’re looking at the system’s thinking, it’s the wholism, it’s the big picture. As Stanley McChrystal once wrote, you can’t understand a part without at least a rudimentary understanding of the whole. You can only make good decisions about the part if you have the context of the whole. Then you’ve got the interconnectedness, which is ever-increasing because of today’s technologies. The electronics and software that empower today’s products mean that really every piece is interconnected with every other piece.

I mentioned that, thinking dynamically across time, there are feedback loops. How are things changing? Go back to thinking that we did in school with predator-prey relationships. As prey populations rise, predator populations rise. As predator populations rise, prey populations fall. What are those feedback loops that are going on in our systems? And then the positive idea of emergence and the negative idea of unintended consequence. If you disassemble an airplane, it won’t fly. It’s only the engines working with the wing to provide lift, working with the fuselage to provide structure, and with the controls that will allow you to fly. But then that’s the positive emergence. What’s the negative emergence, the unintended consequences that we haven’t thought of? So those are the core principles that I think of when I start talking about systems thinking.

Langberg: That’s really helpful. And I like these unintended consequences. The idea of mentioning that, because we always talk in engineering about the unknown unknowns, and that’s kind of what this goes back to. What are some common misconceptions you encounter about MBSE or the systems thinking approach?

RELATED: What is MBSE? Model-Based Systems Engineering Explained

Long: So at the systems thinking level, the first thing that I’ll say, and it’s not a misconception, but we can fall into the trap, it’s the idea that systems thinking is more important than analytical thinking. The reality is that we need both. We need the big picture thinking that looks at the interactions, but also we need to do really good deep analytical thinking. And the other idea at systems thinking level is that somehow systems thinking is a skill that’s limited to the few. I’m a big believer that we’re actually born tuned towards systems thinking. If you look at a two-year-old or a three-year-old, they will frequently ask why? Why? Why? What they’re trying to do is to connect how things work. They’re looking for those interactions, those relationships. Western education actually takes us and makes us deep analytical thinkers. Now that’s good, that’s a lot of technological advance, but we have to re-prime that system’s thinking pump.

So we all have the capability if we tend to it. If we shift then and look at MBSE as we’re implementing SE today, the first myth is that somehow MBSE is different than systems engineering. It’s not this different thing. It’s a modern approach taking advantage of today’s technologies. Second myth would be that MBSE equals SysML or any other notation, any other language. The reality is MBSE is all about leveraging today’s digital capabilities. The unprecedented computing power, the unprecedented storage capability that we have to better represent and analyze the systems that we’re trying to build. We can be more explicit, more coherent, and more consistent, and we can leverage that computational power to simulate before and during the build to deliver better results. So MBSE is just SE done in today’s environment with today’s technologies.

Langberg: I like the way you described that because I agree, I’ve encountered that misconception as well about trying to equate to the system SysML. It’s not about a language, a modeling language; it’s about us all speaking the same language as far as SE goes. And that’s what I think MBSE is often trying to bring in to the technology.

Long: And one of the challenges there, Aimi, is that systems engineering is still as much of an art and a craft as it is a formal discipline. And so MBSE is forcing us to mature the principles and understand the underlying foundation. And that’s why it can sometimes feel like it’s different than SE, it’s why sometimes SysML can be confused with BEAN MBSE, but if we’ll recognize that we’re maturing the practice as we go digital, I think that helps the journey.

Langberg: And that’s one of the big topics all the time is about how do we do these digital transformations. Are organizations doing enough to foster systems thinking? As we move towards these transformations, are there simple techniques to get started or ideas you have at the grassroots level?

RELATED: A Path to Model-Based Systems Engineering (MBSE) with Jama Connect

Long: So I would argue that traditional organizations are not doing enough to really foster systems thinking. A traditional organization is built on an industrial mindset, the mindset that allowed us to do factories. And that’s a mechanistic mindset which says if each of you will do your bit part, then the whole thing will assemble and work. And if we’re working simple problems, precedented problems, if we’ve mastered the design and we’re building a million of these cogs, that works. But that’s not what we’re really doing. We’re doing things that are more complicated and more complex.

So I think organizations need to promote big picture thinking. I think they need to not only communicate what it is they want somebody to do, but what the context is for that work, and what the greater context is for what the organization is delivering. If we seek to understand not only the solution that we’re building, but the problem we’re trying to solve, that yields fresh insights from the problem space and actually allows each of us as specialists to bring our knowledge to say, oh, that’s what you’re trying to do. Well, there’s this interaction that we haven’t thought about or have we tried thinking about this.

Now, if you go back in time, we had integrated product teams. That’s a simple starting point. Empower those integrated product teams with an understanding of context and problem and get them to collaborate across bounds, and you’ll get better systems thinking. If we talk about what can I do as an individual, what if my organization is not pushing this? Well, rather than just focusing on the processes that we do, focus on why we’re doing what we’re doing. What’s this problem that we’re trying to solve? How are we trying to solve it? And then what are we doing? That understanding of larger context of relationship and dependencies are really important. What you’re building, what’s it connected to? When you’re building what you’re building, who are you dependent upon, and who’s dependent upon you?

And the last thing that I’ll say here is there’s a very simple technique out of business analysis that’s helpful here, and it’s called SIPOC, S-I-P-O-C, and it stands for supplier; understand who’s feeding you stuff. Inputs: What are the inputs to you or the inputs to what you’re building? Processes; that’s what you’re doing, that you’ve got through analytical thinking. Outputs: What are you generating? And then customers or consumers, who is consuming that? And if you individually think about SIPOC for what you’re building and you how you’re building it, you’ll be better connected and you’ll start to foster at least a systems thinking understanding of your part of the puzzle.

TO WATCH THE ENTIRE WEBINAR, VISIT:
Best Practices for Leveraging Systems Thinking in MBSE

Tech Giants Turn to Nuclear Power for AI’s Energy Appetite

Artificial intelligence is revolutionizing industries at breakneck speed, with UBS CIO estimating global company spending $480 billion on AI infrastructure in 2026. This technological leap comes with an enormous energy cost. As AI workloads and data centers consume unprecedented amounts of electricity, tech giants are making a bold strategic pivot toward nuclear energy partnerships to meet their growing power demands while maintaining carbon-neutral commitments.

The energy requirements for training and running AI models have reached critical levels, forcing companies to seek reliable, preferably clean, power sources that can operate around the clock. Unlike solar and wind energy, nuclear power provides consistent baseline electricity that doesn’t fluctuate with weather conditions—a crucial advantage for data centers that require uninterrupted power supply.

AI’s Explosive Energy Demands Drive Infrastructure Crisis

The computational power required for artificial intelligence applications has created an energy consumption challenge that traditional power grids struggle to accommodate. Modern AI data centers consume significantly more electricity than conventional facilities, with some requiring the equivalent power of small cities to operate effectively.

Training large language models and maintaining AI inference capabilities demand continuous, high-intensity computing power. These operations cannot afford power interruptions or fluctuations that occur with renewable energy sources dependent on weather patterns. The reliability factor makes nuclear energy an attractive solution for sustained AI operations.

Data center operators face mounting pressure to expand capacity while meeting corporate sustainability goals. This dual challenge has accelerated interest in nuclear partnerships as a viable path forward for powering next-generation computing infrastructure.

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

Nuclear Renaissance Through Advanced Reactor Development

The nuclear energy sector is experiencing renewed momentum through innovative reactor technologies designed specifically for modern energy demands. Small modular reactors (SMRs) and advanced nuclear systems offer enhanced safety features, reduced construction timelines, and flexible deployment options that appeal to tech companies.

Dedicated next-generation nuclear facilities can be built closer to data centers, reducing transmission losses and improving grid reliability. Advanced reactor designs incorporate passive safety systems and simplified operations that address historical concerns about nuclear energy deployment.

Nuclear developers are actively pursuing projects that can deliver power within the next decade, aligning with tech companies’ aggressive expansion timelines. This convergence of technological advancement and market demand is creating unprecedented opportunities for SMR-powered nuclear energy growth.

Strategic Partnerships Transform Energy Landscape

Amazon, Microsoft, Alphabet/Google, and Meta, which contribute most of the global spending on AI infrastructure according to UBS CIO, have emerged as leaders in forging partnerships with nuclear energy developers, recognizing that traditional renewable sources cannot fully meet their expanding cloud and AI datacenter energy requirements. These collaborations represent billions of dollars in commitments toward nuclear power development.

Amazon’s approach includes investing in SMR technology and securing long-term power purchase agreements with nuclear developers. The company’s strategy focuses on deploying nuclear power near major data center clusters to ensure reliable electricity supply for cloud computing and AI services.

Microsoft has signed a 20-year nuclear power purchase agreement with Constellation Energy that will help restart the Crane Clean Energy Center’s Three Mile Island Unit by 2028.

Alphabet/Google has announced partnerships aimed at bringing gigawatts of nuclear capacity online by 2030, emphasizing the need for carbon-free energy that operates continuously. The company’s nuclear strategy complements its existing renewable energy portfolio while addressing the specific demands of AI workloads.

Meta’s nuclear initiatives focus on securing clean energy sources that can support the company’s ambitious AI research and deployment goals. These partnerships demonstrate how social media and technology platforms are adapting their energy strategies to accommodate next-generation computing requirements.

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

Nuclear Power’s Competitive Advantage for Data Centers

Nuclear energy offers unique advantages that align perfectly with data center operational requirements. The consistent power output eliminates concerns about energy storage systems and backup generation typically required with intermittent renewable sources.

Cost predictability represents another significant benefit, as nuclear fuel costs remain relatively stable compared to fossil fuel price volatility. Long-term power purchase agreements with nuclear facilities provide tech companies with budget certainty for their expanding operations.

The carbon-neutral profile of nuclear energy helps tech giants achieve environmental commitments without compromising operational reliability. This combination of sustainability and dependability positions nuclear power as an essential component of future data center strategies.

Powering Tomorrow’s Digital Infrastructure

The convergence of AI’s energy demands and nuclear power capabilities marks a transformative moment for both industries. Tech companies are demonstrating that meeting ambitious technological goals requires innovative approaches to energy procurement and infrastructure development.

These nuclear partnerships signal a fundamental shift in how major corporations approach energy planning for next-generation computing workloads. As AI continues expanding across industries, the demand for reliable, clean power will only intensify, making nuclear energy an increasingly critical component of digital infrastructure strategy.

The success of these early partnerships will influence broader industry adoption and accelerate nuclear energy development timelines. Organizations planning significant AI deployments should evaluate nuclear power options as part of their long-term energy strategies.

Note: This article was drafted with the aid of AI. Additional content, edits for accuracy, and industry expertise by Mark Levitt and Vlad Tanasescu.

Jama Connect^® Named #1 in G2 Fall 2025 Requirements Management Report

We are thrilled to announce that Jama Connect has once again been recognized as the undisputed #1 leader in G2’s Fall 2025 Grid^® Report for Requirements Management Software. This achievement marks our seventh consecutive quarter at the top, a direct result of the trust and feedback from our valued customers.

This continued leadership solidifies our standing ahead of competitors like Polarion, IBM^® DOORS^®, and Codebeamer. Your reviews and partnership have propelled us to the forefront of the industry, and for that, we are immensely grateful.

Explore the full G2 Fall 2025 Grid Report for Requirements Management Software!

A Testament to Customer Trust and Strong Relationships

G2 reports are a powerful reflection of the user experience, compiling authentic reviews and data to rank software solutions. Being named a leader is a significant honor because it comes directly from the people who use our platform every day to build the next generation of innovative products.

In the Fall 2025 report, Jama Connect’s performance was exceptional, earning accolades that highlight our strong customer partnerships and global reach. We didn’t just maintain our leadership position; we expanded our recognition across multiple new categories.

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

Leading the Way: A Look at Our Fall 2025 Badges

Our success this quarter is a testament to the versatility and power of Jama Connect. We are proud to have earned badges across several key areas, demonstrating our strength for businesses of all sizes, worldwide.

Here are the accolades we received in the G2 Fall 2025 report:

• Overall Leader: For the seventh straight quarter, we are the #1 solution in Requirements Management. We also earned Leader badges for Enterprise, Mid-Market, and Small Business segments.
• Best Relationship: This new recognition underscores our commitment to partnership. We received this badge for Overall, Enterprise, and Mid-Market, reflecting the high-quality support and collaboration our customers experience.
• Regional Leader: Our global presence is stronger than ever. We were named a Regional Leader in Asia Pacific, EMEA, and Europe, showing our platform’s effectiveness across international markets.
• Momentum Leader: This badge recognizes our continued growth and innovation in the market, proving we are consistently evolving to meet modern development challenges.

Voices from Our Community

The praise and constructive feedback from our users on G2 are the driving force behind our innovation. Your insights help us refine our platform and better serve your needs. Here is what some of our users have been saying:

“Jama Connect is a powerful tool for requirements management and offers a wide range of features. Until now, the traceability of requirements was very difficult or even impossible. Jama Connect solves this problem 100%.” – Verified User, Renewables & Environment, Enterprise

“In the past, all requirement-related information was scattered across Jira, Confluence, Word, and Excel, making it difficult to know whether anything was truly up to date. With Jama Connect, we have centralized most of this information into a single, reliable source of truth. The transition is still ongoing, but the shift in mindset is already bringing greater clarity, consistency, and confidence to our work.” – Verified User in Manufacturing, Mid-Market

Driving Modern Requirements Management Forward

This G2 recognition reinforces our mission to help organizations move beyond outdated, document-centric processes. Jama Connect provides a modern platform designed for the complexities of today’s product development landscape.

With Jama Connect, teams can:

• Improve clarity and collaboration with a single source of truth.
• Ensure complete traceability across requirements, risks, and tests.
• Streamline compliance with industry-specific regulations and standards.
• Accelerate development cycles without compromising quality.

RELATED: The Benefits of Jama Connect: Supercharge Your Systems Development and Engineering Process

A Sincere Thank You to Our Customers

We could not have achieved this milestone without you. Your partnership, feedback, and trust are the cornerstones of our success. These G2 awards are not just for us; they are a shared victory for every team using Jama Connect to solve complex challenges and build amazing products.

Thank you for making us the #1 choice for requirements management. We are committed to continuing this journey of excellence with you.

Learn More

See for yourself how Jama Connect leads the competition. Explore the complete G2 Fall 2025 Grid Report for Requirements Management Software today.

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

How to Master Traceability in Medical Device Development

As an engineer in the medical device industry, you’re tasked with creating innovative products that are both safe and effective. However, this core mission is often overshadowed by the immense pressure of regulatory compliance and documentation. As technology advances and products get more complex, that task gets even more complicated. Managing traceability between thousands of requirements, risk items, and test activities can feel like a “paperwork” burden that pulls you away from what you’d rather be doing: designing and testing new products.

This article offers a practical guide to transform traceability from a time-consuming chore into a strategic advantage. We’ll explore how to build a robust traceability model that not only satisfies regulators but also helps you build better, safer products faster.

TL;DR: Stop treating traceability as an end-of-project scramble. By implementing a single source of truth with Live Traceability™, you can connect requirements, risks, and tests in real-time. A modern platform like Jama Connect^® automates this process, helping you identify gaps early, reduce rework, and free up your team for more efficient product development.

The High Cost of Inefficient Traceability

When traceability is managed with disconnected documents and spreadsheets, it becomes a significant bottleneck. This manual approach is not just inefficient; it introduces substantial risks that can derail a project and kill the team’s morale. For complex medical devices, the consequences of poor traceability are severe:

• Project Delays: Manually creating and updating traceability matrices consumes hundreds of hours, often at the end of a project that results in pushing back launch dates.
• Compliance Risks: Incomplete or inaccurate traceability is a common reason for audit findings and can jeopardize FDA submissions and technical file reviews under the EU MDR.
• Increased Rework: Without a clear line of sight between requirements and tests, design changes can have unforeseen impacts, leading to costly rework late in the development cycle.
• Reduced Innovation: Engineers spend valuable time on administrative tasks instead of focusing on design, testing, and innovation.

The key takeaway: Treating traceability as a final-step documentation exercise is a high-risk strategy. The true cost isn’t just the time spent on paperwork, but the project delays, compliance failures, and missed opportunities that result from it. You can assess your own risk by taking a Requirements Traceability Diagnostic.

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

How-To: Best Practices for Ensuring Medical Device Traceability

To move from a reactive to a proactive approach, you need to integrate traceability into the fabric of your development process. Here are four actionable steps to make that happen.

Step 1: Establish a Single Source of Truth

The foundation of effective traceability is a centralized platform where all product development data resides. When requirements, risk analysis, and test cases live in a single system, you eliminate the confusion and errors caused by separate documents.

A single source of truth ensures that every team member—from systems engineering to quality assurance—is working with the most current and approved information.

• Benefit: Creates consistency and provides a complete, auditable record of your design history.
• Impact: Reduces miscommunication and errors, ensuring all teams are aligned.

Step 2: Implement Live Traceability™

A static, manually created traceability matrix is outdated the moment it’s finished. Live Traceability, in contrast, creates a dynamic, real-time map connecting every requirement to its corresponding risks and test cases.

With Live Traceability, you gain instant visibility into the health of your project. If a requirement changes, you can immediately perform an impact analysis to see which downstream requirements, risk mitigations, and test items are affected.

• Benefit: Allows you to identify and address gaps in coverage early in the process.
• Impact: Drastically reduces audit preparation time and minimizes the risk of missing critical connections.

Step 3: Integrate Risk Management into Your Workflow

For medical devices, traceability isn’t just about connecting requirements to tests; it’s about proving that every potential hazard has been identified, analyzed, and mitigated. This is a core expectation of standards like ISO 14971.

By managing risk within the same platform as your requirements, you can directly link risk control measures to the design requirements that implement them. This creates a closed-loop process that demonstrates comprehensive risk management.

• Benefit: Ensures product safety is a continuous focus that woven into all project milestones, not a separate, check-box activity.
• Impact: Builds a safer, more reliable product and provides clear evidence of compliance for regulators.

Step 4: Streamline Collaborative Reviews and Approvals

Formal design reviews are a critical part of the development process, but they can be slowed down by manual feedback cycles via email or comments in disjointed documents. A modern platform streamlines this with a dedicated review center.

This allows stakeholders to comment, vote, and approve items in a structured, collaborative environment. All feedback is captured in one place, creating a clear and permanent audit trail of every decision.

• Benefit: Accelerates feedback loops and decision-making.
• Impact: Ensures that all approvals are documented and traceable, strengthening your Design and Development File.

From Burden to Benefit with Jama Connect

Implementing these best practices is far simpler with a purpose-built tool. Jama Connect is designed to help medical device teams master traceability and accelerate efficient product development.

By providing a single platform with Live Traceability, integrated risk management, and collaborative review workflows, Jama Connect helps you build your traceability matrix as you work. This transforms it from a document you create at the end of a project into a powerful, real-time tool you use throughout the project.

Customer success stories highlight the impact. For example, Dexcom achieved a 60% improvement in systems engineering efficiency by using Jama Connect to manage its complex requirements. Similarly, Vave Health significantly reduced the time spent on traceability matrices, accelerating its development and path to FDA clearance.

The most important benefit: Jama Connect empowers engineers to focus on what they do best—designing and building life-changing medical devices—by turning the “paperwork” of traceability into an automated, value-adding process.

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

FAQs: Medical Device Traceability

Q: What is a traceability matrix in medical device development?
A: A traceability matrix is a document or table that demonstrates the relationships between user needs, design inputs (requirements), design outputs (specifications), risk control measures, and verification and validation activities (tests). While traditionally created in spreadsheets, modern solutions like Jama Connect provide Live Traceability, which is a dynamic, real-time view of these connections, making it far more accurate and less time-consuming to manage.

Q: How does traceability help with FDA and EUMDR compliance?
A: Regulatory bodies like the FDA (under the new QMSR) and the EU (under MDR) require manufacturers to prove that their device is safe and meets all specified requirements. A complete traceability record is the primary evidence used to demonstrate this. It shows auditors that every requirement has been tested, every risk has been mitigated, and the entire development process was conducted under a state of control.

Q: Can we integrate Jama Connect with our existing engineering tools?
A: Yes. Jama Connect is designed to serve as the central hub for requirements and risk management while integrating with other best-of-breed tools in your ecosystem, such as Jira, Azure DevOps, and various testing suites. This creates a connected toolchain that provides end-to-end traceability without forcing your teams to abandon the specialized tools they rely on.

Take Control of Your Traceability Process

Stop letting manual traceability processes create bottlenecks and introduce risk. By adopting an integrated approach, you can pass audits with confidence, accelerate your time-to-market, and empower your engineers to focus on innovation.

Ready to see how you can transform your product development process? Schedule a personalized demo to learn more about Jama Connect for Medical Device Development.

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

In this blog, learn about Co-Development with Partners using Jama Connect

Jama Connect^® Features in Five: Co-Development with Partners

Discover how Jama Connect empowers seamless co-development with your partners! In this Features in Five session, Mario Maldari, Director of Product and Solution Marketing at Jama Software, demonstrates how Jama Connect’s Review Center enables secure collaboration, granular access control, and iterative feedback cycles. Learn how to streamline cross-company collaboration, maintain a single source of truth, and accelerate your time to market!

VIDEO TRANSCRIPT

Mario Maldari: Hello. My name is Mario Maldari, and I’m the Director of Product and Solution Marketing at Jama Software. Today, we’ll be discussing how Jama Connect allows for co-development with partners while maintaining full control over access.

In a co-development scenario, you can share a Jama Connect project with your partner and utilize our granular permission to control access and information. You can also utilize our comprehensive Review Center and invite partners and stakeholders to participate in requirement reviews. Jama Connect is number one in enabling partner codevelopment. Thousands of engineers are already collaborating across companies today.

Some of the unique Jama Connect features that enable this collaboration are multi-tenant SaaS, no IT involvement required, centralized control of user administration and access rights, a comprehensive and collaborative reuse center, cross-company collaboration, including at mentions, subscribing, and chat streams. The Jama Connect Review Center is number one in partner codevelopment reviews.

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Maldari: Some unique Jama Connect features of our Review Center are iterative review cycles with a dedicated work stream for early-stage peer reviews and final approval reviews, reviewer and approval role control, approval role delegation, related items included in reviews for context and completeness, a reviewer role at no added cost. This includes external partners, stakeholders, allowing for co-development and collaboration. In this video, we will explore how Jama Connect’s Review Center enables co-development with partners.

Arms-length relationships are moving to co-development to speed time to market. Only Jama Connect enables you to include partners in your development process and control their access. Let’s explore how this is achieved in Jama Connect today.

Any artifact or set of artifacts in Jama Connect can be sent to the Review Center. Let’s select a set of stakeholder requirements and create a new review. There are a number of options and configurations that can be selected according to your review process. Internal reviewers can be added as approvers or reviewers. External partners and stakeholders can also be invited to the review simply by adding their email address. They are provided a free license that allows them to participate in the review as codevelopers or partners.

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Maldari: This allows for all review comments and sign-off from internal and partner teams to be kept in Jama Connect as a single source of truth. In this case, Jim, the project manager, will add Mario as an external stakeholder to participate in the review. Mario will receive an email with instructions and a link inviting him to participate in the review. He can simply click on the link and is able to see all of the requirements that are part of the review and comment, approve, or reject as appropriate. Here is the email that Mario has received from Jim Arlo inviting him to participate in the review. You can click on the link, open the review, and Jama Connect’s simple UI provides an easy way to go through each requirement and collaborate with the internal team. Requirements can be approved or rejected, and new versions of the review created based on updates and subsequent revisions. This can be an iterative and collaborative process between internal teams and external stakeholders.

The end result is quality requirements that are agreed to by both teams. Jama Connect’s Review Center was designed for ease of use and for collaboration with both internal and external teams, allowing for Jama Connect to be the single source of truth for co-development teams. Thank you for watching this Features in Five video on how to use Jama Connect to co-develop with your partners and suppliers. For more information, please reach out to your customer success manager or go to our website at jamasoftware.com

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