Tag Archive for: Jama Connect Platform

Tag Archive for: Jama Connect Platform

The speakers of a webinar on the topic of requirements engineering for semiconductor.

This blog is a recap of our recent webinar. To watch the entire presentation, visit “Advancing Requirements Engineering in Semiconductor.”

Evolving Requirements Engineering: A Framework for the Semiconductor Industry

Unlike other industries, the semiconductor sector has no governing standards or regulations for developing and managing requirements and product data— despite being critical components of products across nearly every regulated industry. This absence makes aligning key methods and practices a critical lever for improving quality, reducing rework, and gaining a competitive edge.

In this webinar, Sarah Gregory, Principal Consultant, Systems & Requirements at Crary Labs LLC, and Steve Rush, Principal Solutions Consultant at Jama Software, explore how voluntary alignment on requirements engineering practices can elevate your processes.

What You’ll Learn:

Whether you’re defining your next generation of chips or improving process maturity across design teams, this webinar will help you align, simplify, and elevate your requirements engineering practices.

WEBINAR PREVIEW BELOW, CLICK HERE FOR FULL WEBINAR

WEBINAR TRANSCRIPT PREVIEW BELOW

Advancing Requirements Engineering in Semiconductor

Sarah Gregory: Thanks everybody for joining us today for a discussion about requirements engineering in the semiconductor industry. After over 20 years of tackling challenges of requirements within a semiconductor company myself, it’s really great to be collaborating with the folks at Jama Software on the upcoming launch of a Jama Connect solution that’s tailored for what we do. This webinar is an introduction to that solution, kind of a soft launch of a broader set of resources that will be released in just a couple of weeks, significantly expanding Jama Software’s engagement in a sector in so many ways that’s foundational to industries overall. In this webinar, we’re going to give a brief overview of the current state of semiconductor requirements practice. We’ll talk through some challenges that are common to semiconductor, some are drawn from my own industry experience, but also from outside research publications and collaborations. These challenges may sound familiar to you too. And then we’ll also talk about the value of intentional movement towards aligning product development data practices both within your company and or any specific company, but also for semiconductor overall.

And we’re definitely seeing folks start to pick up on that. These aren’t alignments that a third party data model or a standard is mandating for you either, but practices that have a solid return on investment in your context both financially and in terms of quality and efficiency. Better alignment accelerates time to market and helps you respond effectively to change. A phrase that I found useful working in semiconductor about requirements as well as requirements engineering generally is common enough, not identical, not uniform, not standard even, but common enough practices that an organization or team can coalesce around in order to build some efficiencies in their product development practice. There are many ways to move toward alignment on common enough practices, but we’ll share just a few today and Steve will show you what they look like in practice if you were to choose to try them out using Jama Connect. Steve will also introduce the Jama Connect semiconductor framework that will be launching on December 4th the same day as a Jama Software hosted Digital Engineering Summit in San Jose. We’ll tell you a little bit more about that before we end today too.

And of course, we’re going to take some questions. We may not have time to catch them all in our short time together today, but please do put them in the Q&A. What we don’t get to today we’ll try to tackle over the next few weeks and we’ll make available in the semiconductor area of the Jama Software website. Let’s get started. A key first step in any collaborative engineering activity is to make sure that when you’re using a term, you’ve got a shared understanding of what that term means. When each of you signed up to attend today, you brought your own mental model of what we might mean by semiconductor, so let’s take just a minute to orient on that with the model that Jama Software uses describing eight different categories of companies. Now, this isn’t the only way to represent semiconductor and there are certainly different degrees of difference or commonality among these groupings, so don’t get wrapped around the picture here or those categories, it’s just to let you know that yes, semiconductor as comprehended by Jama Software is a very broad and diverse sector with different data management needs.

RELATED: Jama Connect Features in Five: Review Center for Semiconductor Development

Gregory: For example, the requirements for a semiconductor chip, for a chip design, they’re going to different than the requirements for litho and etch equipment to fab that chip. Companies in some of the boxes may also exist in other industry categories and they could be subject to standards in those industries as well, so it’s all a matter of what an individual company does that it informs what information they need to manage and how they need to manage that product data. It’s also possible for two companies or more in the same subsegment to manage their product data in very different ways and then for there to be commonalities in company practices across those lines too. It’s not in the scope of Steve’s and my discussion today to dig into these differences within the segments, much less different data management practices among them. Just know that the work that Jama Software is doing to support requirements engineering and data governance in the semiconductor industry, beginning with this initial release of the new semiconductor solution comprehends the scope.

We have eight categories, a lot of overlap, but just as important so many differences sometimes even within a single company within one of those categories. And it’s those differences, the scope and the breadth of them that is a challenge that in many ways is unique to the semiconductor industry. Several industries, automotive, medical devices, even some areas of oil and gas have prescriptive standards that govern how product data is structured, developed and managed. If you’ve been following Jama Software for a while you’ve possibly noticed a lot of resources that enable companies across those industries to deploy Jama Connect to manage their requirements conforming to those standards. Jama Connect has several predefined traceability information models or data models and specific templates that are purpose-built to accelerate the work of companies that need to meet those standards. In semiconductor, we don’t have such a standard at the point of product definition. You may have your own mental model of the information architecture at your company or at least in the part of the company where you’re working.

And if you happen to work in a standards-adjacent area, for example, your company or the part of the company that you’re in provides devices to automotive, standards that govern the automotive industry may be familiar to you at least for that part of your business. Otherwise, even within the same subsector in semiconductor, you’re going to find a lot of differences, a lot of divergence in how companies may architect their product data. In the absence of prescriptive standards that govern product information architecture a lot of that information architecture has just grown up organically. Now, when you look across semiconductor as a whole you might see some resemblance in some areas, but in others the information to be managed is quite different. No standards, no common regulations, very different products, all leads to a lot of divergence in practice, and that divergence can create drag and inefficiencies. Now, that points to one of the common traits across many companies in the semiconductor industry too.

TO WATCH THE FULL WEBINAR, VISIT:
Advancing Requirements Engineering in Semiconductor

Two speaker's headshots alongside text describing this webinar on best practices for writing requirements.

In this blog, we recap a preview of our webinar, “Best Practices for Writing Requirements” – Click HERE for the full version.

Discover How to Remove Ambiguity and Improve Development Outcomes

Regardless of what terminology your teams use—”needs,” “features,” or “requirements”—the purpose of good requirements is to create a shared understanding of the promise, functionality, and value of the products you develop across all stakeholders. Ineffective requirements can lead to scope creep, delays, and poor product quality.

Watch our webinar to learn proven methods for writing better requirements to remove ambiguity and improve development outcomes.

In this insightful session, you will learn how to:

  • Create a simple, systematic, and standardized process that your teams can follow.
  • Separate requirements from design and establish a clear hierarchy.
  • Ensure complete traceability of requirements throughout the development lifecycle.

Below is a preview of our webinar. Click HERE for the entire presentation.

Below is an abbreviated transcript of our webinar.

Best Practices for Writing Requirements

Patrick Garman: Hello everyone, let me introduce myself and my co-host. I am Patrick Garman, I’m a Principal Solutions Consultant here at Jama Software, and I work with customers across multiple industries to optimize requirements management practices to help innovators succeed. Before coming to Jama Software, I had 10 years of product development experience and I’ve led teams to successful product launches in soft tech, consumer electronics, logistics, healthcare, government and public sector, and the financial services industries. And now I serve as the services lead for improving requirements quality at Jama Software. Joining me today as well is Danny.

Danny Beerens: Hi. Thank you, Patrick, for introducing me. I’m Danny Beerens, Senior Solution Consultant here at Jama Software, and I will be assisting Patrick today. I have nearly two decades of experience in system engineering, and I have successfully implemented, trained, maintained, and supported application lifecycle management application, specifically requirements management application. Throughout my career, I have worked on projects and collaborated with customers in the medical device, aerospace and defense, automotive, and semiconductor industries.

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

Beerens: So let’s start off today. Jama Software’s purpose is to help innovators succeed, as Patrick already mentioned. And the key to successful innovation is writing high-quality requirements for your products. We want you to walk away from this session with an understanding of why requirements are important and give you a useful framework from which to build your requirements-authoring skills. Basically, we are setting the groundwork here. We’ll expose you to the challenges in product development as they relate to requirements, and we will talk about how requirements help to bridge communication challenges. We’ll also provide you with important information and tools for authoring better requirements. So helping you write better requirements is why we are here, but what does that matter, why are we really here?

What we want and what I suspect you want too is to build safe and high-quality products, and requirements are an essential element in defining, designing, and developing great products. So yes, we want you to write better requirements, but writing better requirements is a means to a better end, a high-quality safe product, and good requirements also mean getting that great product with hopefully less communication friction, reduced rework, and building a work environment that encourages collaboration, transparency, and focuses on quality.

RELATED: The Essential Guide to Requirements Management and Traceability

Beerens: So, let’s start with talking about why requirements are important. Requirements are the building blocks of product development and strong requirements lead to better products. Conversely, vague and unclear requirements cannot only lead to product issues but also to safety concerns. These quotes you see here from the US Food and Drug Administration Design Control Guidelines for Medical Device Manufacturers, and highlight the importance of quality requirement management in delivering safe products to the market. But these justifications for requirements can be applied to any industry or product. Keep in mind, that design control activities are intended to drive quality and safety into the product development process. And here, they are stating that requirements are the foundation to those safety activities.

Of course not all benefits of proper requirements management are related to safety, these also call out the impact to later product development lifecycle activities, finding that missing requirements or even ill-defined requirements can cause expensive redesign and rework, which makes sense considering the later issues are found in the product lifecycle, the more expensive the issue is to resolve, as you’ll need to circle back to previous phases to identify and address the issue at the root, and their impacts along the way. Requirements management activities are a way to avoid these issues from the start, thus reducing rework and redesign, and improving your quality. It also ensures you make the time to market. While the specific regulations and standards may vary, the same requirement management practices and principles are applicable to any industry.

CLICK HERE TO WATCH THIS WEBINAR IN ITS ENTIRETY:
Best Practices for Writing Requirements

Image of the person presenting this video's topic on Jama Connect® Features in Five: Review Center for Semiconductor Development.

Jama Connect® Features in Five: Review Center for Semiconductor Development

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, showcases Jama Connect’s Review Center, a robust collaboration tool trusted by leading semiconductor clients.

You’ll discover how the Review Center empowers teams to collaboratively review, approve, and sign off on requirements, tests, and risks within Jama Connect projects.

Key highlights include:

  • Version-controlled collaboration and decision tracking, allowing you to revisit who made decisions and their rationale at any time.
  • The ability to invite stakeholders and reviewers, even those outside your project or organization.
  • With these capabilities, Jama Connect serves as the single source of truth for all review comments and decisions.

 

VIDEO TRANSCRIPT

Mario Maldari: Hello. My name is Mario Maldari, and I’m the Director of Product and Solution Marketing here at Jama Software. Today, I’ll be walking you through a collaborative feature that is widely used across our semiconductor client base, which is our Review Center.

The Review Center allows for collaborative review, approval, and sign-off on requirements, tests, and risks within your Jama Connect projects. The collaboration and decisions made as part of the review are version-controlled and recorded so that at any given time, you can go back to see who made a decision and why. Invite stakeholders and reviewers, even if they are not part of your project or organization. This enables Jama Connect to be the single source of truth for all of your review comments and decisions.

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

Maldari: Let’s get started. After logging in to Jama Connect, I can send individual requirements and tests for review, or I can send multiple groups of requirements for review. As a moderator of a review, I will select these GPU PRD requirements and initiate a review. This opens our Review Center. I can set a date for the review. I can include related items such as test cases or other supporting documentation. I can set a formal review with unmodifiable changes and settings that my team has agreed upon, or I can conduct a peer review and choose the options I want for this particular review.

I can add users to the review and set them as reviewers or approvers. I can even include the email address of a stakeholder outside of my project or organization that I want to participate in the review. This is performed by using unlimited free reviewer licenses. Doing so helps keep all approvals and sign-offs in one centralized location, is and is always stored and versioned.

Let’s include Roger Dal, who is our IP product lead. Roger ultimately defines how the IP integrates into the SOC. He basically owns the what and the why to ensure the engineering team is building the right thing. His review and input is essential. Once I have added my participants, I can finalize the review and even add some custom instructions. Roger will get notified via email that he has been asked to review the requirements and can simply click on the link to open the project and begin his review.

Once inside Jama Connect, Roger could review the requirements, add comments, and approve or reject. He can notify users by at mentioning them in his comment. He can make comments on specific aspects of the requirement and qualify his question. This provides for a more granular and specific review, making the feedback more accurate and saving time for the moderator.

RELATED: Compliance Made Easy with Jama Connect for Automotive and Semiconductor Development

Maldari: When Roger is complete with his review, the moderator will get notified and can respond to comments and produce new revisions of the review. Once the moderator logs back into Jama Connect, he can review Raji’s comments and updates, respond, and produce a new revision, or finalize the review and close it. All comments history inversions are stored in the project.

Out-of-the-box reports are available for audits, and the review history is always accessible. All past and present reviews are in found in our Review Center. So at any given time, you can go back a year from now, two years from now, ten years from now, and see who approved the requirements, what the discussion was around the requirements, and how they evolved. As you can see, the Review Center allows for seamless collaboration for our semiconductor clients.

Ease of use and collaborative features keep users in the tool, preventing a siloed process across multiple tools. Everything is stored in one place, and it’s easy to see why decisions were made and who made them. Thank you for watching this video on our Review Center. To learn more, visit jamasoftware.com

To view more Jama Connect Features in Five topics, visit:
Jama Connect Features in Five Video Series

Jama Connect®: Built for Enterprise-Scale Success

Jama Connect®: Built for Enterprise-Scale Success

As organizations grow, the complexity of their projects multiplies. Managing tens of millions of requirements and thousands of simultaneous users can strain legacy systems that persist in the market. For large enterprises, a requirements management platform must do more than just store information; it must scale effortlessly, perform reliably under pressure, and provide clear, comprehensive insights. Jama Connect is engineered specifically to meet these enterprise-level challenges, ensuring that your teams can innovate without being hindered by their tools.

The Enterprise Challenge: Scaling Without Compromise

In a large-scale environment, systems are constantly tested by the sheer volume of data and user activity. A platform might work well for a small team in a startup mode, but how does it perform with 1,000s of users accessing and modifying tens of millions of requirements? The risk of slowdowns, data conflicts, and system instability becomes a major concern. Large enterprises need a solution that guarantees high performance, data integrity, and a seamless user experience, regardless of scale and volume. Users that experience performance issues will often abandon the tool and find other means to complete their work. For a requirements management process, this effectively causes more work, introduces defects, and undermines the value of having a single source of truth. This frequently occurs in legacy requirements management tools with antiquated architecture that do not scale well.

Jama Connect addresses this with an architecture designed for high-volume, high-concurrency environments and dynamic scalability. It allows organizations to manage complex and large product development lifecycles effectively, from initial concept to final launch and beyond, ensuring that every team member is aligned and productive while enjoying a positive user experience.

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

Supporting Hundreds of Thousands of Users Simultaneously

One of the most significant tests for any enterprise platform is its ability to support a large number of concurrent users without performance degradation. Jama Connect is architected to handle this demand, allowing global teams to collaborate in real time. Whether it’s engineers in one country, testers in another, and project managers in a third, everyone can access and update requirements simultaneously.

This capability is crucial for maintaining project velocity. Delays caused by system lag or user lockouts can create bottlenecks and push timelines back. Jama Connect’s robust infrastructure ensures that as your user base grows, the platform remains responsive and stable. This allows teams to focus on their work, not on waiting for their tools to catch up.

Managing Billions of Requirements with Ease

Modern products, from medical devices to aerospace systems to autonomous driving vehicles, can involve millions of individual requirements, test cases, and risk analyses. Managing this volume of data is a monumental task. Jama Connect is optimized to handle large amounts of requirements and other related assets, allowing enterprises to centralize all their requirements in a single, organized repository.

The platform’s performance isn’t just about storage; it’s about accessibility and usability. Users can quickly search, filter, and analyze millions of items to find the exact information they need. This efficiency is vital for making informed decisions and ensuring that all project components are aligned with top-level goals. For example, the ability to create a detailed requirement traceability matrix or view remains fast and fluid, even with extensive data sets.

The Power of Live Traceability™ at Scale

Traceability is the backbone of compliant and high-quality product development. In an enterprise setting, maintaining this traceability across integrated toolchains can be incredibly complex. As data is created across the V model, the number of requirements grows exponentially, and so do the numbers of traces. Jama Connect simplifies this interoperability. The concept of Live Traceability is to provide a dynamic, real-time view of the relationships across your integrated tool chain. For example, when integrated with a tool like Jira or a modeling tool, it is essential to know when a user story or aspects of the model have been updated and how it impacts requirements in your requirements tool.

As one team member updates a requirement, the impact of that change is instantly visible to everyone else. This immediate feedback loop is essential for impact analysis. Before committing a change, teams can see exactly which downstream items will be affected, preventing unintended consequences and reducing rework. When the requirements tool is integrated with other systems in your toolchain, it is essential that this process be scalable in order to handle the level of change that occurs at enterprise scale, where tens of thousands of requirements and tests can be impacted by upstream change.

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

Performance and Reliability You Can Trust

For an enterprise, downtime is not an option. Jama Connect is built on a modern, service-oriented architecture that delivers the performance, scalability, and reliability required for mission-critical projects. It is designed to integrate smoothly into existing enterprise IT ecosystems, offering flexible deployment options, whether on-premises or in AWS cloud.

This focus on enterprise-grade performance means that teams can depend on Jama Connect to be available and responsive when they need it most. Performance of the tool is measured “at the glass,” ensuring that the user experience is the main focus. The P75 load time for cloud hosted environments is under 3 seconds. The platform’s advanced architecture is optimized for handling complex queries and large data loads, ensuring that generating reports, conducting reviews, and navigating trace relationships is always a fast and efficient process.

The ultimate definition of scale is that user experience remains consistent regardless of the amount of data in the system. Jama Software’s focus on user-experienced performance proves that while managing billions of requirements, the user experience (measured via P75 load times) remains consistent and well within best practices. No other tool in the industry can make such a claim because no other tool in the industry combines the modern architecture and performance monitoring of Jama Connect.

Conclusion: Scale Your Innovation with Confidence

When shopping for a requirements tool, there are many considerations: features, price, and industry position. One of the main aspects to consider is scalability and growth. If you are serious enough to be seeking out a requirements management tool, you understand the value of formalized requirements to your business and are certainly expecting your business to grow and be successful. Why invest in a tool today that won’t be able to grow with you tomorrow?

For large enterprises, selecting a requirements management platform is a strategic decision that impacts productivity, quality, and time to market. The solution must be able to grow with the organization and handle the complexities of modern product development.

Jama Connect proves itself as a true enterprise-grade platform by delivering exceptional performance, supporting hundreds of thousands of concurrent users, and managing billions of requirements with ease. With Jama Connect, enterprises can scale their operations and ambitions without being limited by their tools, empowering them to build the next generation of innovative products with confidence.

Headshot of the speaker on this webinar, based on the topic of AI-Assisted Engineering.

This blog previews a section of our webinar on AI-Assisted Engineering. To watch the entire presentation, visit, AI-Assisted Engineering: Shaping the Future of Requirements Management

[Webinar Recap] AI-Assisted Engineering: How Data, Governance, and Trust Are Shaping the Future of Requirements Management

AI is transforming how engineering teams write, verify, and manage requirements. Across consumer electronics, industrial manufacturing, and energy, teams are leveraging it today to innovate faster, strengthen quality, and enhance compliance—from generating draft requirements and identifying risks to automating verification and ensuring governance.

In this session, Patrick Garman, Manager of Solutions & Consulting at Jama Software, explores how AI-assisted and autonomous engineering are shaping the future of product development and what it means for your organization.

What You’ll Learn:

  • AI-assisted authoring to generate structured, high-quality requirements
  • Maintaining end-to-end visibility across regulations, requirements, models, and tests
  • Predictive analytics to detect conflicts, gaps, and compliance risks early
  • Autonomous verification with suggested test coverage and verification methods
  • Building governance and ethical practices into AI-enabled engineering workflows
  • Leverage AI to accelerate innovation while maintaining compliance and safety across consumer electronics (Right to Repair, ESPR) and industrial manufacturing (ISO 13849, IEC 61508)
  • How Jama Connect® supports smarter decision-making and accelerates innovation

BELOW IS A PREVIEW OF THIS WEBINAR. WATCH THE ENTIRE PRESENTATION HERE

TRANSCRIPT PREVIEW

Patrick Garman: Hi, and welcome, and thank you for joining us today to talk about AI-assisted engineering. My name is Patrick Garman, and I’m the Solutions Manager for Industrial and Consumer Electronics here at Jama Software. I’m here today to talk about the rise of AI in requirements management, what’s coming and what’s already here, and what do you need to know to prepare. And I’m also going to be joined by Katie Huckett, our product line manager for Jama Connect Advisor™ and AI for a chat about Jama Software’s point of view on AI and to answer some common questions. We all know AI has moved from theory to practice, and you don’t have to imagine tools that can, for example, analyze requirements against INCOSE rules and flag where they are out of compliance because Jama Connect Advisor already does this. But what if in addition to analyzing your requirements, AI could actually draft requirements and structured syntax, automatically generate verification plans, and keep traceability intact across the development lifecycle.

Maybe even take stakeholder text or regulatory language and translate it directly into models or requirements artifacts. And looking ahead, predictive AI, using AI to highlight gaps, surface risks, or conflicts between requirements before they turn into costly defects downstream. And again, all of this is either already happening or will be available very soon. Let’s think about AI-assisted requirements authoring, models that automatically generate draft requirements, and structured syntax like EARS that saves hours of work for your engineers because you are going to start with a set of draft requirements that can be based and pulled from your existing IP, your previous development efforts to kickstart new product development. Think about autonomous verification planning, using AI to suggest verification methods. Even write test cases with detailed test steps and coverage analysis directly linked to requirements. For example, our test case intelligence tool takes requirement statements and generates context-specific test cases with detailed test ups and links these automatically to requirements for traceability. And thinking of traceability, what about contextual traceability?

RELATED: Jama Connect Advisor™

Garman: Think about an AI tool that can match requirements semantically, helping you uncover impacts you might not otherwise have discovered until later in the development cycle. Or consider maybe importing a large set of requirements from an external store and having Jama Connect suggest where there might be links to existing requirements, drastically reducing what is currently a very manual and, well, very important, often tedious process. Using natural language to construct models, so think about being able to translate stakeholder inputs or regulatory text into SysML or requirements artifacts automatically. This is already happening to write software code. You think of Git’s Copilot, where you can enter a plain language prompt for a function or code script and it will generate the code for you.

And again, taking that further to predictive analytics. So again, using AI to predict requirements conflicts or uncover requirements conflicts, uncover gaps, surface risks before they become downstream defects. Now let’s take a minute and talk about how is this going to impact consumer electronics and industrial manufacturing companies? Well, for consumer electronics, this is going to mean faster innovation cycles. Requirements can be captured, written, and connected more quickly so products get to market faster. AI can also monitor regulations like right to repair and ESPR and flag when requirements need updating. Finally, AI lets us mine customer reviews and support tickets for insights that automatically generate or update product requirements.

In industrial manufacturing, the benefits are really in handling complexity. AI can help decompose large systems of systems projects like commercial elevator systems, industrial robots into consistent requirement hierarchies. It can automate the generation of safety compliance artifacts for standards like ISO 13849 or IEC 61508. And by feeding back IOT and sensor data, AI can also help us to write predictive maintenance and after sales requirements. Ultimately, for requirements management, it means faster authoring and verification, proactive compliance tracking, better use of real-world data, and competitive differentiation through speed and quality.

RELATED: Manage by Exception: Data-Driven Practices to Improve Product, Systems, and Software Quality

Garman: So this all sounds great. And the good news is that, again, this is all either available today or will be very soon. So what do you need to know to be ready? Well, when we think about preparing for AI-assisted and autonomous engineering, the first thing to recognize is that data readiness is absolutely key. We all know the saying, garbage in, garbage out, and it’s maybe never been more applicable. AI is really only as good as the information that it has to work with. So that means our requirements, our traceability links and test evidence need to be structured, high-quality, and consistent. And companies that invest in clean, well-governed data models, the kind that are supported by Jama Connect, will be in the best position to take advantage. Second, and I can’t stress this enough, it’s important to keep in mind that AI is not a replacement for engineers.

It is an augmentation. Think of it like a copilot. It can draft requirements, review, and analyze gaps, but accountability still sits with the engineering team. There must be human overview and review of these requirements. And that brings us to governance and trust. So we need validation workflows to make sure that no AI-suggested requirement ever bypasses human review, and audit trails will need to clearly capture what was generated by AI versus what was authored or approved by humans. And we’re going to need new KPIs to measure the impact. For example, what percentage of requirements are drafted by AI versus humans? How much time did we save in verification planning? Are defect rates dropping because we are catching missed requirements earlier? And finally, there is a strategic advantage to being an early adopter.

TO WATCH THE ENTIRE WEBINAR, VISIT:
 AI-Assisted Engineering: Shaping the Future of Requirements Management

Mergers and Acquisitions in MedTech: Positioning Your Company for Success

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.

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

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

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

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.

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

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

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

About Onera

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

Customer Story Overview

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

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

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

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

With Jama Connect, Users Experience:

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

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

Challenges

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

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

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

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

Evaluation

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

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

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

Outcomes

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

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

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

TO DOWNLOAD THE ENTIRE CUSTOMER STORY, VISIT:
Onera Health Chooses Jama Connect to Provide Flexibility and Consistency for Sleep Diagnostic System Development