Tag Archive for: Product Development & Management Page 3
Tag Archive for: Product Development & Management
Jama Software is always looking for news that would benefit and inform our industry partners. As such, we’ve curated a series of customer and industry spotlight articles that we found insightful. In this blog post, we share an article from VDA, titled “Automotive Industry Signs Memorandum of Understanding”, written by Lena Anzenhofer and published on June 23, 2025.
Automotive Industry Signs Memorandum of Understanding
Automotive industry signs Memorandum of Understanding for joint software development based on open source
Collaboration for more speed, efficiency, and security in software development and the basis for an open and collaborative ecosystem
With the support of the German Association of the Automotive Industry (VDA), 11 companies in the automotive industry have agreed on pre-competitive cooperation in open source software development.
A corresponding Memorandum of Understanding (MoU) was signed today at the 29th International Automotive Electronics Congress (AEK).
With the increasing importance and complexity of vehicle software, it is becoming critical for the industry to increase speed and efficiency in development while ensuring high quality and safety.
A significant portion of the vehicle software is not directly accessible to the user and therefore not differentiating. This fact allows the corresponding software modules to be developed jointly in an open and collaborative ecosystem.
In order to achieve the necessary functional safety for automotive series software, a groundbreaking development process for open source was developed in preparation for certification according to the relevant standards.
In addition, by providing executable software modules instead of detailed specifications, standardization and increased development speed are achieved through the so-called code-first approach.
The software development takes place in a transparent and vendor-independent environment of the Eclipse Foundation as part of the S-CORE project.
This ecosystem is open, both through software interoperability with relevant industry standards and for contributions and collaboration from other European and international companies.
The initiative’s timeline envisages that the software scope for series development of a platform for autonomous driving will be available in 2026.
The modular software scope can be adapted or expanded and then made available to the industry as a customized distribution for series development. This allows manufacturers and suppliers to focus on differentiating features while maintaining core components together. This creates a strong foundation for innovation – and the freedom to focus on what makes the difference for the customer.
“Together we are building a future-proof and powerful software ecosystem – open, transparent and secure,” VDA Managing Director Dr. Marcus Bollig said.
BMW Group Dr. Christoph Grote, SVP Electronics and Software
“The BMW Group believes that integrated ecosystems with open-source platforms and tools are a key driver for the development of mobility solutions. A shared code-first approach will be the foundation for functional innovations in our future products. We are committed to ECLIPSE S-CORE as a promising open-source approach for our upcoming projects.”
Continental AG Karsten Michels, Head of Product line “High Performance Computer”, BA “Architecture and Network Solutions”
“By uniting open-source and virtualization with safety certification and standardization, Continental’s contribution to an open and safe HPC Middleware Stack accelerates the transition to Software Defined Vehicles and significantly reduces time-to-market.”
ECLIPSE Foundation Mike Milinkovich, Executive Director
“Collaboration in the development of secure and open-source automotive platforms is a critical factor for the automotive industry. The Eclipse Foundation’s governance model enables open collaboration between OEMs, tiers, and tech players within the Eclipse SDV Working Group. We recognize the trust placed in us as the stewards of such a strategic initiative and embrace the challenge of making it a success.”
ETAS GmbH Dr. Thomas Irawan, CEO
“Building on our role as a pioneer in automotive platform software, we are driving industry-wide innovation through an open source ecosystem, accelerating time to market, and delivering safe and sustainable solutions for the mobility of tomorrow.”
HELLA GmbH & Co. KGaA Dr. Dietmar Stapel, Vice President Product Segment Radar
“We are pleased to support the Automotive Grade Open Source Ecosystem. Open, common standards are essential for secure integration and form the foundation for delivering innovative, value-added automotive features.”
Mercedes-Benz AG Magnus Östberg, Chief Software Officer
“As the creators of the automotive open source ecosystem, we are actively driving the future of automotive software with our code-first strategy. This is our clear commitment to open standards as the foundation for innovation.”
Qorix Markus Schupfner, CEO
“Qorix is committed to a powerful, open software ecosystem that combines functional safety and the speed of innovation – from architecture to production deployment.”
Robert Bosch GmbH Dr. Mathias Pilin, CTO Mobility
“We promote software solutions that integrate seamlessly across vehicle platforms, systems, and supplier technologies – for a software-defined mobility of the future.”
Valeo Brain Division Joachim Mathes, CTO
“Valeo has decided to join S-CORE and contribute key elements of its vOS to the stack. We are confident that a greater level of standardization and reuse will benefit the entire industry.”
Vector Informatik GmbH Dr. Matthias Traub, Managing Director
“With our joint initiative for an open software ecosystem for automotive ECUs, we are adding a powerful tool to the industry’s HPC full-stack toolbox.”
Volkswagen AG Dr. Oliver Seifert, Vice President R&D Infotainment and Connect at Dr. Ing. h.c. F. Porsche AG
“Through this open source ecosystem in automotive development, we shorten the time to market, reduce application development effort, and drive innovation.”
ZF Friedrichshafen Torsten Gollewski, Executive Vice President Corporate R&D Innovation & Technology
“Software development based on open source is the key to greater efficiency and speed. This is necessary to remain internationally competitive. The VDA initiative is a good example of the benefits that collaboration can bring.”
Jama Connect® Attains Level 2 TISAX Certification from TÜV SÜD
Jama Software, the industry’s leading requirements management and traceability solution provider, announced that it has achieved Level 2 Trusted Information Security Assessment Exchange (TISAX) certification from TÜV SÜD. TISAX is a security standard created by the German Association of the Automotive Industry (VDA).
Jama Connect is now the only requirements management application that is both TISAX and SOC 2 certified
This achievement underscores Jama Software’s unwavering commitment to information security and data protection. TISAX certification is a critical benchmark for meeting the stringent security requirements of German OEMs and their global supply chains, ensuring that sensitive customer and product data is handled with the highest standards of confidentiality, integrity, and availability.
For our customers, this certification unequivocally demonstrates that Jama Software’s solutions and processes embody the highest standards of information security. It empowers organizations to meet stringent compliance requirements, simplifies and accelerates procurement processes, and fortifies trust in an era of increasingly complex regulatory demands and cyber threats. With this certification, customers gain not just confidence but a decisive edge in addressing their most critical security challenges.
“Jama Software is committed to enabling the highest levels of security for our customers. In support of our rapid growth in the automotive sector, we have added TISAX certification to complement our market leading SOC 2 certified application,” said Neil Stroud, General Manager Automotive & Semiconductor, Jama Software.
Jama Software is focused on maximizing innovation success in multidisciplinary engineering organizations. Numerous firsts for humanity in fields such as fuel cells, electrification, space, software-defined vehicles, surgical robotics, and more all rely on Jama Connect requirements management software to minimize the risk of defects, rework, cost overruns, and recalls. Using Jama Connect, engineering organizations can now intelligently manage the development process by leveraging Live Traceability™ across best-of-breed tools to measurably improve outcomes. Our rapidly growing customer base spans the automotive, medical device, life sciences, semiconductor, aerospace & defense, industrial manufacturing, consumer electronics, financial services, and insurance industries.
Simplify Airborne Systems Lifecycle Milestones with Categories
Gain Clarity, Reduce Risks, and Stay Compliant.
Struggling to keep track of deliverables across complex aerospace projects? You’re not alone. Managing deadlines and milestones often feels like navigating a maze of documents, spreadsheets, and shifting priorities.
In this webinar, you’ll discover how Jama Connect®’s Categories feature can bring order to your milestones, improve transparency, and align deliverables with key compliance standards like ARP4754.
What You’ll Learn:
How to Enable Categories: Simplify system development milestone tracking from start to finish.
Clarity on Deadlines: Learn how to make engineering deadlines easier to understand and act on.
Improving On-Time Performance: Organize milestone deliverables and optimize workflows to avoid delays.
Compliance Alignment: Map development milestones to standards such as ARP4754 with ease.
VIDEO TRANSCRIPT
Patrick Knowles: I’m Patrick Knowles. It’s great to meet all of you. Today, we are going to be looking at simplifying airborne systems, specifically lifecycle milestones, by using Categories in Jama Connect. As I mentioned, my name is Patrick Knowles. I’m a senior solutions consultant here. And it’s just a pleasure to work with y’all. I’m in our aerospace and defense vertical, so my expertise comes from that within the industry. And now I’m happy to be sharing that with you all as I work through consulting, as well as webinars. Today’s agenda, we’re going to tackle really the core problem, the complex challenge of milestone deliveries. From there, I’m going to introduce this category’s functionality and features to all of you. If it’s something you’re familiar with, this will be a breeze. If it’s something new to you, I hope this is a great introduction to how it works.
Then we’ll talk about how you categorize information specifically with some best practices. So, for even those who are used to using Categories, this should be a refreshing little bit with maybe some new tricks that you can utilize. And then finally, we’re going to talk about deploying this to your collaborative teams, which is really critical. Because if the data’s Categorized on day one and then the data changes or new data comes in, your teams are going to need to know how to manage this, how to look at the information. And it’s going to help solve that complex challenge of milestone delivery and some of the issues that we’re going to talk about there.
So, this complex challenge, deadlines, and stress. There’s data everywhere. It’s disconnected, it’s disparate, it’s annoying. That’s the core root problem here. But to elaborate on it, engineering in the digital age can feel like a maze. There’s sometimes a lack of top-down visibility to deliverables. So, if you’re a program manager or a lead systems engineer or a chief engineer, you might struggle to see all the work that your teams are doing. And sometimes there’s a lack of bottom-up visibility to the milestone. So, if you’re an engineer, you might not know about what milestone comes next, what’s due at that milestone. A lot of the time, that information is on a Word document or an Excel sheet, or maybe a Confluence page at best, where it’s listing out everything that’s due, but it doesn’t inherently connect to anything that is due and what those exact bits of information on.
And that leads to some unclear methods for contributing. How do I, as an engineer, ensure that we’re going to meet this deadline? I know what I see on my scrum board or I see from my manager, or whatever it might be, but maybe at the end of the day I don’t really understand exactly how my little bit of data is getting into that greater picture for this delivery to our customer or to our internal stakeholders. And then, of course, the common issue is always that data is disconnected, but that’s what Jama Connect is here to help with. We’re here to help you guide through that maze and to connect your data together to solve these key issues.
So, the risky scenario here is that your data is disconnected from a milestone, and that maybe you forget to deliver a certain part of the data, or you deliver outdated bits of data, or anything else that might happen there. And it’s pretty common across engineering. It doesn’t really matter where you work, there’s always this struggle to get everything ready from pencils down to delivery or whatever it might be. There are bigger views related to all of this work. There are stakeholders, customers, and, of course, the program leaders who need to see this information. And they need to see the most up-to-date, correct information. And without a clear way to connect your requirements specifically, because that’s what we’re going to mostly talk about here, is requirements. But without a really clear way to connect your requirements to your milestones or the rest of your data to milestones, you run the risk of simply leaving things behind.
Knowles: So, how can Jama Connect help? Well, the specific use case we’re going to talk about today is enabling our Categories functionality in the tool. And we’re going to line it up with milestones from regulatory documents. Specifically, this example is going to be based on ARP4754B. However, if you are running the NASA systems engineering life cycle and you know the milestones in there, you could also line this up to that or any other number of product lifecycle milestones. We’re going to categorize data directly into things. And that’s going to help you really line it up to each of these listed items over there in the screenshot on the right. And then your members of the team are going to be able to filter, and view this data, and see it grow and add to it. And it’s going to be very transparent for them, how they’re connecting their information to the greater milestone.
With our foundation laid, there on what the problem is, I want to talk more about what Categories are. So, what exactly is a Category? Why do we believe this is a great option for you and the team to try and enable within your tool? Specifically, Categories have a similar feel to some other features within Jama Connect, like tags and pick lists. However, Categories win out overall with this specific use case for a number of reasons. First and foremost, Categories are admin-enabled and controlled, so your general user can’t populate a Category. They can assign information to a Category, but they can’t create new ones. Which means that, unlike tags, this is a kind of configuration managed by your admins. Pick lists are also configuration managed by your admins. However, they aren’t globally accessible to all item types. You’re going to have to create a field for every single pick list that you want assigned different item types.
Categories, however, can be globally applied to an entire project or to the whole instance of Jama Connect. That means that you don’t have to go and assign them to each of your item types. They’re going to connect to folders. They’re going to connect to texts. They’re going to connect with your specific requirement types, whatever it might be. And so, that’s an advantage that Categories have. Also, Categories can be available across multiple projects or just one specific project, which helps if you have a kind of multi-layered approach to your Jama Connect development of requirements. Finally, I’ll explain why not to use tags and pick lists. Tags, again, are creatable and by the user, and prone to error. If you type a capital letter in the wrong spot or put the wrong vowel in the wrong place, that’s going to be there in perpetuity, unless you have really strong tag cleanup processes.
And pick lists and multi-selects, you have to create it for each item type. You have to maintain the pick list. And then if an item type is introduced to a project, you’re going to have to re-add that pick list to it, and so on and so forth. So Categories is a little broader, but also just as controlled. And so, you’re able to kind of manage in a smoother way. So, how do you set up Categories? Well, you go to admin, Categories. And then over there on the far right of the screenshot, you’ll see enable Categories is turned on. It’s defaulted off for most instances, so make sure you turn it on first. From there, we’re going to set up all the Categories you see in front of you on the screenshot, as well as any number of other Category you may want to enable.
Knowles: Now, once you’ve got everything enabled, it’s all about how do you Categorize the information. So, we’re going to walk through some instructions, some best practices, and then we’ll do some demonstration, of course, here at the end of this section of the slides on how you do all this work. The first thing, like we mentioned, is enabling Categories. You do that through the admin. You assign things to either projects or global within your Jama Connect instance, and then you start utilizing them. One of our best practices here is to manage Categories through logical organizers, so folders, sets, components. That allows you to then click into the list view of that logical organizer and then assign all the Categories to the items within it. You don’t have to do this. This is just one of the more efficient ways, especially if you’re enabling an architecture-forward approach within your database. And of course, you can manage Categories in bulk, otherwise this whole explanation wouldn’t make much sense.
So, some of the tips, tricks, and best practices. Here, we’ve got the managing in bulk. And I’ll show you how to do that live. We’ll view categorized information in the exploratory via a filter, and so we’ve got to set up filters. Of course, those same filters can be exported or sent to reports, and then you can use multiple Categories on the same item. So, if one item is going to be delivered at the first milestone and you want to continue to deliver it at the next milestone, you simply add both Categories to it. And finally, you can always create baselines of everything filtered. So, these filters that we’re going to use to shrink down and narrow down the exploratory are also going to be very, very useful for baselining, for exporting, and for a number of other things.
So, now it’s time to demonstrate some of these best practices. The first things first is enabling Categories. As we discussed earlier, there’s this enable Categories button here on the far right. Once enabled, you’ll be able to add Categories with the add button here. Doing that is as simple as populating a single field with the information and hitting add. I, of course, have the whole system ddevelopment phase added already, and so I want to show you exactly what that looks like, how these things got nested underneath each other, and so on and so forth, by adding an eighth step. So, for today, the webinar phase is what we’re going to add to our development phases here. When we add, it’s going to actually add it at the top level. And so, then we need to drag it down into the system development phase.
We are going to use the move functionality here, as that’s the best practice in this scenario, where the copy Category functionality is better for using this for variant management. Now you can see that the webinar phase has been added to the system development phases. And you can also see that the system development phase is a project Category. This was done by managing access here on the right side, where you can pick the specific projects you’d like this Category to be assigned to. Or if this is something you want globally accessible, you can use the globally accessible button here. When you hit that, you’ll see that it turns orange and has a globe, instead of the project specific icon that you saw originally.
Now let’s look at how we categorize information within the tool. Our screenshots were showing this functions portion of this project, and so we’re going to dive into that to continue the continuity of this example. This specific set here, we’ll view the details of it, and we’ll simply scroll down and manage Categories. So, if we wanted to add that eight system development phase, webinar phase, we’ll simply select it, and click add and it will be added to this set of information. From there, we can bulk edit everything underneath the set by selecting all the items and clicking manage Categories. Same pop-up shows up, and we’re able to add that eighth phase of the lifecycle.
Now, this is really, really fantastic. If we want to go see everything in the eighth phase of the lifecycle, we can select the Categories feature over here. We can expand our system development phase and select webinar phase, where we see the items that were added there, including the set up here, and are able to kind of view this information in the list view. Now, if we wanted to see this in the explorer, we would go to filters and we’re just going to rely on this pre-built one here. And we’re going to right click apply filter to explorer. This is going to show us the information in a more succinct way. And we’ll talk more about this as we go on.
Knowles: Now that we’ve looked at how to enable Categories, we want to talk about how we develop this and deploy this data and these Categories for your collaborative team. I talked a little bit about this and showed you these exact steps here to narrow down your explorer tree, but what really is the benefit here? Well, you can set up a simple filter that’s based on the Category itself and right-click apply that filter to the explorer. This lets teams see just the information they need to care about coming up, especially if your sets, components, and folders are all categorized. This will show a team that, hey, we need to make sure all of the aircraft functions are populated for this coming milestone, because that set is there. Same with the aircraft validations, the requirements, and the plans and assessments.
Each of those logical organizers are categorized, showing the team this is something that is due at the upcoming milestone. The team then will populate information underneath that and they will categorize those items as well to bring them into the overall filter. Now, public filters are just kind of one of the ways we want to see this deployed to the team. We also need to demonstrate to the team how do you bookmark the filters, and how do you even manage Categories in general? So, in the next step here, I’m going to demonstrate managing Categories for single items, as well as a couple other little nuances within the tool that the teams will need to understand as they go ahead and use this in the deployed environment.
When deploying this information to the teams, it’s really critical that you’ve set your filters to be public. A quick way to note if something is public is if it’s got the asterisk next to the name here. You can always right-click and edit your filter and click the make public, and that will denote that it is public to all users using this project. Once your filters are all built out, you’re going to have them there. You’re going to teach your users exactly how to use them, of course, with the apply filter to explore. But also, if they need to send these for a review and get signatures on them or add a baseline, there’s also these features available to them.
And of course, bookmarking is really, really critical. Without it bookmarked, you can see I’m now missing phase one, so I have to go to all, and then go find phase one, and add it to my bookmarks and it’ll now show up in my bookmarked section here. Users most of the time are going to be adding new items to the tool. And so, if we add a new item here, we’re going to populate this new item, a new item for webinar. And that’s going to be our example item here to show that once we’ve saved it, this is when we get to add the Categories. It’s not a field that’s available directly when editing a brand new item. It shows up after the fact here down at the bottom with the managed Categories button.
You’ll then grab the applicable Categories that you want to add to this item, save it, and you’ll see them here. This helps, and it automatically adds things to the filter. You’ll see here that we’ve gone up in the number of items, and our new item for the webinar right here is now part of the filter automatically. Additionally, you can show your users that they can come directly here in the category section to see the same information, just without the filter and without some of those right-click functionalities that you get to see when you’re in the filter section. It’s been fantastic to work with you all today and show off these features in the tool.
Jama Software is always looking for news that would benefit and inform our industry partners. As such, we’ve curated a series of customer and industry spotlight articles that we found insightful. In this blog post, we share an article from AEC Business, titled “Construction’s Next Leap: AI as a Strategic Partner”, and written by Aarni Heiskanen and published on May 24, 2025.
Construction’s Next Leap: AI as a Strategic Partner
In this episode of the AI AEC Show, Aarni Heiskanen welcomes back René Morkos, PhD, the visionary founder and CEO of ALICE Technologies, to explore the latest advances in artificial intelligence for construction scheduling and project optimization.
The Shift: Generative AI Comes to Construction
Since their last conversation, René highlights the most significant change in the construction tech landscape: the rapid rise of generative AI and large language models (LLMs). These tools are fundamentally altering how project data is accessed, analyzed, and leveraged across the industry.
René explains how ALICE Technologies has embraced this transformation by developing two AI-driven scheduling agents. These agents don’t just generate optimized schedules—they can also interact conversationally with planners, offering insights into delays, critical tasks, progress updates, and more. This represents a leap from static scheduling tools to dynamic, intelligent collaboration.
One persistent challenge in construction is fragmented and unstructured data. AI offers a promising way forward. René points to solutions like Trunk Tools, which allow users to query entire project datasets in natural language—”Show me the change orders” or “Summarize this RFI”—without needing to manually sift through files.
This democratization of data access, powered by AI, is eliminating a long-standing bottleneck in construction project management.
A Platform for Optimization
René also discusses how ALICE’s platform not only helps plan construction projects but actively explores “what-if” scenarios—testing and comparing thousands of possible construction strategies. This simulation-based approach enables teams to reduce risk, save time, and improve project outcomes with confidence.
Looking forward, René envisions an increasingly automated construction planning ecosystem. As he puts it, we’re moving toward a future where the question is not just “what’s the plan?” but “what’s the best possible plan, and how do we know?” AI will provide the answers.
Takeaway: AI is not just a support tool—it’s becoming a decision partner in designing, scheduling, and executing construction projects.
Self-Hosted and Cloud: Flexible Deployment Options for Your Requirements Management with Jama Software
Efficient requirements management is vital for the success of any organization, especially in industries like aerospace, defense, and government, where compliance, security, and accuracy are paramount. Jama Software provides a sophisticated and adaptable requirements management solution, ensuring that your teams stay ahead in competitive and highly regulated fields.
But did you know that Jama Connect® isn’t only available as a cloud solution? Depending on your organization’s unique needs, you can also choose a self-hosted deployment option. This flexibility is the perfect answer for industries requiring strict data sovereignty, air-gapped environments, or regulatory compliance.
While Jama Connect is well-known for our cloud deployment option, we actually originated as a self-hosted product more than twenty years ago. And two decades later, we remain committed to delivering the best platform and customer experience for our self-hosted and cloud customers.
Curious about which deployment option best suits your business? This post will break down when to choose Jama Connect Cloud versus the self-hosted deployment. We’ll also answer frequently asked questions to help you make informed decisions.
When to Choose Jama Software Cloud vs. Self-Hosted
Jama Connect Cloud and Jama Connect Self-Hosted both empower effective requirements management. However, certain use cases demand one option over the other.
Jama Connect Cloud
Best for organizations that value ease of deployment, automatic updates, and seamless access. Key benefits include:
Automatic Updates and Maintenance: Benefit from the latest features and security enhancements without manual effort.
Anywhere, Anytime Access: Teams can access data on-demand, enabling global collaboration without roadblocks.
Cost Efficiency: Eliminate the need for large IT infrastructure spendings; we handle hosting for you.
Geographically Distributed Hosting: To ensure reliability and security, Jama Software hosts data in highly secure and strategic cloud locations. For customers in the US, we host data in Oregon, with a backup in Ohio. For EMEA customers, data will not leave the EU in line with GDPR. Two copies of the data is hosted in Ireland, with a backup in Germany. Jama Connect add-ons – Jama Connect Interchange™ and Jama Connect Advisor™ – can also be hosted in the US or EU.
Ideal for industries like tech startups, mid-sized enterprises, and companies prioritizing agility and scalability in requirements management.
Jama Connect Self-Hosted
Organizations working in highly regulated industries often need tighter control over their data. This deployment ensures robust security and customization on your own infrastructure. Benefits include:
Data Sovereignty: Maintain control of sensitive data and ensure compliance with local regulations.
Air-Gapped Environments: Operate without internet connectivity, ideal for sectors like aerospace and defense that mandate offline solutions.
Regulatory Compliance: Handle development processes under strict standards like ITAR, ECJU, and EAR.
Ideal for industries such as government, aerospace, and defense, where security and compliance are non-negotiable.
Jama Connect Deployment Options
Jama Connect ensures that your needs are met, whether you lean toward cloud solutions or prefer in-house deployment. Here’s how Jama Connect offers robust flexibility in deployment:
Cloud Deployment
Our cloud-based SaaS solution takes the burden of infrastructure management off your shoulders. It ensures faster setup, seamless updates, and scalability as your teams grow. Collaborate easily across distributed teams while we manage the heavy lifting of security and operational efficiency.
Self-Hosted Deployment
Need control down to the last detail? Self-host Jama Connect within your IT infrastructure. This option provides your team with complete autonomy over data, operational configuration, and security measures. Your infrastructure, your rules.
Do you have questions about configuring a self-hosted deployment? Our experts are here to help. Schedule a consultation to explore the best option for your business.
FAQ: Common Questions About Jama Software Deployment Options
Still not sure which deployment is right for you? Below are answers to some frequently asked questions.
Is switching between Jama Connect Cloud and Self-Hosted possible?
Yes, we offer migration support to ensure your data transitions smoothly between deployment types when upgrading or restructuring operations.
Do both deployments support compliance with industry standards?
Absolutely! Whether cloud-based or on-premises, Jama Connect supports compliance with requirements like ISO 26262, DO-178C, DO-254, and other critical regulatory standards. Your choice of deployment will not limit compliance functionality.
What level of IT support is required for the self-hosted deployment?
Self-hosted deployments require your organization to manage backups, updates, and server maintenance. However, we provide technical guidance to your IT teams to ensure a smooth setup.
Does the cloud option support multi-location teams?
Yes! With the cloud deployment, all team members, regardless of their geographic location, can work collaboratively without latency or access issues.
What security measures are in place for both deployment options?
For Self-Hosted: You’ll adhere to your internal security protocols (including CMMC security requirements) and configurations.
Jama Software Provides a Smarter Approach to Requirements Management
When it comes to requirements management, there’s no “one-size-fits-all.” Jama Connect adapts to your unique organizational needs, whether you need a hands-off cloud solution or an air-gapped, team-managed infrastructure.
Experience seamless collaboration, reduce compliance risks, and ensure stakeholder alignment across your organization with Jama Software. Are you ready to optimize your requirements management process?
Explore our deployment options and see how Jama Connect aligns with your vision of compliance, security, and efficiency.
Empowering Complex Medical Device and Life Sciences Development with Responsible AI and Machine Learning
Artificial intelligence (AI) and machine learning (ML) are transforming industries across the globe, and the medical device and life sciences sectors are no exception. Today, the development of complex medical devices is being accelerated and optimized with the integration of responsible AI. From enhanced product design to improved compliance and streamlined workflows, AI is allowing teams to accelerate their workflows.
This blog aims to explore the expected impact of AI on medical device development — including current industry trends, regulatory considerations, and how companies like Jama Software are empowering organizations to leverage AI responsibly.
Types of AI Medical Devices
AI medical devices are rapidly transforming healthcare by introducing advanced diagnostic, therapeutic, and monitoring capabilities. Among the 950 AI-powered medical devices currently identified, several core categories stand out:
Diagnostic Tools: AI-driven diagnostic devices are designed to assist in identifying diseases and conditions with greater accuracy and efficiency. These include imaging systems equipped with machine learning algorithms to detect abnormalities in X-rays, MRIs, and CT scans, as well as AI software for analyzing pathology reports or genetic data. Such tools are especially beneficial in early disease detection, reducing diagnostic errors, and improving patient outcomes.
Monitoring Devices: Another significant category is AI-enabled monitoring devices. These systems continuously track patient vitals, such as heart rate, blood pressure, glucose levels, or oxygen saturation, and can alert healthcare providers to early warning signs of complications. Wearable sensors and remote patient monitoring platforms powered by AI are playing a crucial role in providing real-time health insights, especially for chronic disease management.
Therapeutic Systems: AI-powered therapeutic devices support or enhance treatment strategies. Examples include robotic surgery platforms with AI for precise surgical execution, as well as AI software that tailors treatment plans using patient-specific data. These systems are helping doctors optimize therapies and deliver more effective and personalized care.
Decision Support Applications: AI-based decision support tools are designed to assist clinicians in making informed decisions. These devices analyze vast amounts of medical data to provide evidence-based recommendations or predict potential complications. They are widely used to guide treatment strategies and manage complex conditions with a data-driven approach.
By focusing on these categories, it becomes clear that AI medical devices are not only advancing the standard of care but also addressing critical gaps in healthcare delivery through innovative applications of artificial intelligence.
Medical device manufacturers are leveraging AI and ML in several groundbreaking ways. The U.S. Food and Drug Administration (FDA) has already approved over 950 AI-enabled medical devices as of mid-2024. This reflects a dramatic rise over the past decade and highlights the growing adoption of AI technologies. Here are key areas where AI is making a difference in medical device development:
Current Regulations for AI and ML in Medical Device Development
While the potential of AI is evident the successful adoption of these technologies requires adherence to evolving regulatory frameworks. The FDA has been actively addressing the need for guidelines in this space, ensuring a balance between innovation and safety.
FDA Guidance and Regulations
The FDA oversees AI-enabled devices through various pre-market pathways, including:
Premarket Notification (510(k))
De Novo Classification
Premarket Approval (PMA)
To accommodate the complexities associated with adaptive AI/ML-enabled devices, the FDA has released multiple resources, such as the 2024 Artificial Intelligence and Machine Learning Action Plan, which outlines the agency’s vision for regulatory oversight. Key highlights include:
Development of Good Machine Learning Practices (GMLP).
Introduction of frameworks for Predetermined Change Control Plans, allowing for post-market updates to AI systems without requiring new approvals.
Enhanced transparency for AI-powered medical devices.
New FDA Guidance: To learn more about recent guidance provided by the FDA, read these two articles:
Beyond the U.S., regulatory developments in Europe, including the EU AI Act and MDR compliance, are impacting how organizations worldwide approach AI implementation in medical devices.
Staying compliant demands robust traceability, stringent risk management protocols, and adherence to data security standards.
Trends and Insights for AI-Powered Medical Device Development
The trajectory of AI in medical device development is poised to grow exponentially, driven by several key trends:
Shift to Software-Defined Devices
Medical devices are increasingly becoming software-centric. Traditional hardware is giving way to platforms that can be continuously enhanced through software updates.
Integration of Generative AI
Generative AI algorithms are now being used by medical device manufacturers to create simulations, generate testing data, and optimize device designs. Companies like NVIDIA are spearheading this trend with platforms supporting robotics and digital surgery.
Rise of Collaboration and Ecosystem Growth
Partnerships between MedTech companies, academic institutions, and tech giants are fueling innovation. Startups like Moon Surgical and Aidoc demonstrate how collaborations can lead to cutting-edge AI implementations in laparoscopy and diagnostic tools.
Broader Applications Beyond Radiology
While radiology remains at the forefront, AI is expanding rapidly into fields like:
Neurology: Detecting brain activity anomalies.
Cardiology: Spotting arrhythmias through AI-powered stethoscopes.
Oncology: AI-enabled tools for precision cancer diagnosis.
Jama Software’s AI Initiatives for Medical Device Development
With the rise of AI-enabled medical devices, Jama Software is focused on how organizations can incorporate AI applications in their product development processes to improve quality and accelerate development. Here are a few example use cases Jama Connect® is focused on:
Jama Connect Advisor™
Jama Connect Advisor analyzes your product requirements against industry standards such as INCOSE Rules and EARS Notation, then recommends improvements. This fast, accurate analysis and advice helps your requirements align with engineering-focused natural language and best practices.
Benefits of using Jama Connect Advisor:
Improves the quality, accuracy, and usability of your requirements across your organization.
Assists development teams in standardizing the process and language of requirement authoring.
Saves time for authoring, reviewing, and updating requirement statements.
Helps deliver programs and projects on time and on budget.
Reduces the risk of late-stage errors.
Test Case Intelligence
Streamline verification and accelerate to market with AI-generated test cases derived from requirements.
Intelligent PDF Parsing
Quickly parse PDFs and Office files, match to existing IP, or generate new requirements for review and collaboration. AI enhances reuse, speeds RFPs, streamlines supply chain collaboration, and boosts product quality.
Integration of AI and ML is already accelerating and changing medical device development. From enabling groundbreaking technologies to revolutionizing patient care, AI is laying the foundation for the medical devices of tomorrow. However, success in this domain requires balancing innovation with compliance, backed by robust tools that alleviate complexity.
Jama Software’s AI solutions empower organizations to tackle these challenges head-on, reducing risks, streamlining workflows, and ensuring quality at every step of medical device development.
Want to see how AI can streamline your product development?
Book your free demo today and experience the power of AI in revolutionizing requirements management for medical devices.
Navigating the New DOGE Impacted FDA: How MedTech Companies Can Build a Competitive Advantage
The Center for Devices and Radiological Health (CDRH) is a key branch of the FDA that is responsible for ensuring the safety and effectiveness of medical devices. Companies interact with the CDRH through premarket submissions, quality inspections, recalls, and a variety of other activities.
In 2025, the Department of Government Efficiency (DOGE) was established to streamline federal operations, reduce redundancy, and improve cost-effectiveness across agencies. While its goals are rooted in efficiency, the implementation has led to substantial structural and operational shifts that will have a profound impact on the industry.
For companies developing medical devices, understanding these changes is essential for navigating the evolving regulatory landscape. This blog will help you learn all about those changes and provide actionable strategies to stand above the competition while navigating the new frontier.
One of the most immediate and highly publicized impacts has been a reduction in staffing. The CDRH has experienced layoffs, hiring freezes, and a mandated attrition ratio. These changes have affected teams working on new technologies, slowing down review processes and resulting in a reduction in internal expertise.
Budget and Operational Adjustments
DOGE reforms have also reduced discretionary funding, increasing the CDRH’s reliance on user fees from industry sponsors. This shift has created operational bottlenecks, particularly in areas not directly supported by these fees, such as early-stage innovation and public health initiatives.
Regulatory Process Reforms
With fewer staff and resources, the CDRH has had to adjust some of its regulatory workflows. It has been reported that pre-submission meetings are less frequent, and review timelines have lengthened. While the agency remains committed to scientific rigor, the capacity to provide interactive feedback has diminished.
Despite the challenges mentioned above, CDRH plans to continue advancing its strategic priorities. The FDA has released its 2025 guidance agenda which includes the following amongst a larger list of items:
Cybersecurity in Medical Devices: Updated guidance on quality system considerations and premarket submissions.
AI Lifecycle Management and Change Control Plans: Recommendations for predetermined change control plans.
Use of Real-World Evidence in Regulatory Decisions: Revised guidance to support regulatory decision-making.
Updated Q-Submission Program Guidelines: Updates to improve feedback and meeting processes for device submissions.
These initiatives reflect CDRH’s ongoing commitment to modernization, even amid structural constraints resulting from DOGE actions.
In another move to improve efficiency and modernize the agency, the FDA has begun using Elsa, a generative AI tool to assist in the scientific review of medical device submissions. This tool will help automate repetitive tasks such as document parsing and data extraction, allowing human reviewers to focus on more complex portions during the evaluation. The rollout is expected to be complete by mid-2025, with early results showing promise in reducing review times and improving consistency.
Proven Strategies for Navigating the Changes
For those in the medical device industry, these changes present both challenges and opportunities. Companies that embrace the changes and take a proactive approach to interacting with the FDA will find themselves at the forefront of the new era.
Here are some key approaches to consider:
Prioritize Proactive Regulatory Planning: A clear and complete regulatory plan is a vital piece of every new product development project. It will be especially important now as you should prepare for longer review times and less interaction with reviewers. Build extra time for regulatory approvals and work with regulatory consultants to anticipate and address obstacles.
Maintain Clear Communication with the FDA: Given the FDA’s reduction in resources, clear and targeted communication is more important than ever. Leveraging the FDA’s pre-submission program allows you to gain valuable insights early in the submission process. Regular interaction will help build rapport with the agency while addressing concerns before they delay approvals.
Collaborate Across Teams to Document All Product-Related Information: Interdepartmental alignment is critical when interacting with the FDA. Your product development, QARA, and manufacturing teams must communicate effectively to address compliance needs and streamline decision-making. Working together to tell a cohesive and complete story about your device will be imperative when interacting with reviewers. It will be especially important in the future as AI tools may flag inconsistencies or gaps more rigorously than human reviewers.
Leverage Digital Transformation: Investing in digital tools is no longer optional for medical device product development teams. Modern platforms help teams track requirements, manage testing, and maintain documentation seamlessly. Digital platforms also ensure traceability, streamlining compliance audits, and reducing risks of regulatory missteps. Additionally, automated workflows and AI-powered solutions can reduce manual effort and free up critical resources to do what they do best, designing life-changing technologies.
When navigating regulatory pressures, Jama Software is the trusted partner MedTech companies need. Our platform empowers organizations to overcome compliance challenges while maximizing efficiency. Here’s how Jama Connect will help you navigate the changes at the FDA:
Simplify Regulatory Compliance: Jama Connect® simplifies compliance with FDA regulations by providing complete traceability throughout product development. Built-in templates for ISO 13485, ISO 14971, and FDA requirements help teams comply effortlessly with the regulations.
Reduce Submission Errors: Errors in FDA submissions can lead to costly delays and loss of potential revenue. Jama Software’s traceability matrix ensures all requirements are accounted for and verified, reducing the likelihood of mistakes that can delay review times or even result in resubmissions.
Accelerate Time-to-Market: Our real-time collaboration and requirement management tools optimize project workflows, reducing rework and enabling faster decisions. This means your products reach the market sooner, even when facing FDA review delays.
Improve Risk Management: With Jama Connect’s risk management capabilities, teams can capture failure modes and hazard analyses for medical devices, ensuring adherence to safety requirements under FDA guidelines.
Stay Aligned Across Teams: Jama Connect’s centralized platform fosters alignment between engineers, designers, and quality assurance teams. Eliminate silos, improve team collaboration, and keep every stakeholder fully informed at all stages of development.
Create a Competitive Advantage in the New Era of MedTech: The DOGE-era FDA brings unprecedented change to the MedTech industry. With the right strategies and tools, your organization can turn these challenges into opportunities to build resilience, operational efficiency, and create a competitive edge.
To streamline product development, tackle complex compliance requirements, and stay ahead in the fast-evolving MedTech landscape, consider partnering with Jama Software. Curious how Jama Software can help your team thrive? Learn More Today.
The Evolution of FDA Design Controls (21 CFR 820.30) and How Jama Software Supports Compliance
History of US Regulation
The US medical device industry is governed by a complex framework of regulations designed to ensure the safety and effectiveness of products. A thorough understanding of this history provides valuable insights into the development of 21 CFR 820.30 and its critical importance to the industry.
General Background
Medical devices have long played a pivotal role in modern healthcare, but the need for regulatory oversight only became apparent as unsafe and ineffective products led to accidents that caused massive human casualties, including losses of life. These risks are what drive the creation and enforcement of industry regulations. Early regulatory efforts focused primarily on pharmaceuticals, with little attention paid to devices until significant public health incidents highlighted their potential risks.
The Federal Food, Drug, and Cosmetic Act (FD&C Act)
Enacted in 1938, the FD&C Act marked a turning point in U.S. healthcare regulation. Initially focused on drugs and food safety, the Act introduced basic oversight for medical devices. However, it was not until the 1976 Medical Device Amendments that the FDA’s authority to regulate devices was significantly expanded due to another massive healthcare tragedy. These amendments established a classification system based on risk and required premarket approval for high-risk devices.
Quality System Regulation (QSR)
The QSR, introduced in 1996, revolutionized medical device regulation by emphasizing quality management throughout the product lifecycle. It expanded the FDA’s focus from inspecting end products to evaluating manufacturers’ processes, requiring the implementation of comprehensive quality systems. Central to the QSR are the design controls outlined in 21 CFR 820.30, which ensure that products are developed with quality and safety embedded in every stage.
Design controls were added to the QSR to address the growing complexity of medical devices and the risks associated with poor design practices. These controls mandate a systematic approach to device development, from initial planning to post-market monitoring. They are required for all Class II and III devices, as well as select Class I devices such as software or devices with measuring functions.
Class I – General Controls (Gloves, bandages)
Least regulated, and minimal harm to user/patient
Includes GMP, label regulations, and enterprise registration
Class II – Special Controls (NextGen Sequencing, PCR tests)
Includes General Controls plus additional special controls (performance verification, labeling, post-market surveillance)
Premarket Notification 510(k) required, but some exemptions
Class III – Premarket Approval (HIV assay, pacemaker)
Highest risk and most stringent regulation.
Requires Premarket Approval (PMA)
Design Controls
Design controls are a cornerstone of medical device quality management, providing a structured framework to ensure medical devices meet safety, efficacy, and regulatory standards.
Purpose of Design Controls
The overarching goal of design controls is to integrate quality into the design and development process. They help manufacturers:
Mitigate potential risks before products reach the market.
Deliver devices that reliably meet user needs and perform as intended.
Ensure alignment with regulatory requirements, reducing the likelihood of non-compliance.
Design controls are not merely a regulatory requirement but a best practice that enhances quality, reduces development costs, and minimizes post-market issues.
The 10 sections outlined in 21 CFR 820.30 provide a comprehensive framework for managing the design and development process:
1. Design and Development Planning
This section requires manufacturers to establish a detailed plan outlining development activities, responsibilities, and deliverables. Key considerations include:
Identifying project milestones.
Assigning roles and responsibilities.
Allocating resources effectively.
2. Design Input
Inputs define the requirements the device must meet, including user needs, regulatory standards, and intended use. Effective design input processes involve:
Collaborating with stakeholders to gather comprehensive requirements.
Prioritizing critical features.
Ensuring inputs are clear, measurable, and verifiable.
3. Design Output
Outputs represent the tangible results of the design process, such as specifications, drawings, and manufacturing instructions. To ensure quality, outputs must:
Be traceable to design inputs.
Include acceptance criteria.
Meet requirements for functionality and safety.
4. Design Review
Formal reviews are conducted at defined stages to evaluate progress and identify potential issues. These reviews involve cross-functional teams and should:
Assess compliance with inputs and outputs.
Document findings and corrective actions.
Provide a platform for collaborative problem-solving.
5. Design Verification
Verification confirms that design outputs meet the specified inputs. Activities may include testing, inspections, and analyses. Manufacturers must:
Use objective evidence to support verification.
Maintain thorough documentation of results.
6. Design Validation
Design Validation ensures that the devices conforms to user needs/intended uses at production equivalent units. Activities may include testing, inspections, and analyses. Manufacturers must:
Conducting usability testing with end-users.
Comparing performance against real-world scenarios.
Documenting validation results for regulatory review.
Performing a risk analysis to ensure patient safety.
7. Design Transfer
Transitioning from design to production requires careful planning to ensure manufacturing processes align with design specifications. Key steps include:
Collaborating with stakeholders to gather comprehensive requirements.
Developing detailed production procedures.
Training staff on new processes.
Conducting pilot runs to identify potential issues.
8. Design Changes
Any changes to the design must be systematically evaluated for their impact on the device’s safety, performance, and regulatory compliance. Effective change control processes involve:
Identifying the need for changes early.
Conducting risk assessments for proposed modifications.
Updating documentation accordingly.
9. Design History File (DHF)
The DHF is a compilation of records that demonstrate compliance with design controls. It should include:
Evidence of adherence to each section of 21 CFR 820.30.
Documentation of design reviews, verifications, and validations.
A complete history of design changes.
10. Traceability in Design Controls
Traceability is a critical aspect of design controls, linking design inputs, outputs, verification, and validation activities. Comprehensive traceability matrices:
Simplify compliance audits by providing clear documentation.
Ensure that all requirements are addressed and verified.
How Jama Software Can Help Industrial Machinery Developers Stay Competitive in 2025
Layoffs in the industrial machinery sector are rising across Europe, reflecting growing pressures in an industry that is becoming increasingly complex. For machinery development engineers, systems engineers, and product managers, finding ways to streamline processes, ensure compliance, and get products to market faster is more important than ever. Enter Jama Software.
Jama Connect® is a powerful tool tailored to help machinery developers tackle challenges, reduce costs, and gain a competitive edge. By providing robust solutions for requirements management, risk mitigation, and team collaboration, Jama Software offers a way forward amid rising industry complexities.
This blog will explore the evolving industrial machinery landscape in 2025, highlight the challenges driving the need for efficiency, and show how Jama Software can help companies save money while maintaining their competitive advantage.
The Industrial Machinery Landscape in 2025
The industrial machinery sector is on the brink of transformation as we approach 2025. Innovation is surging, but so are challenges. Here are the key factors shaping the current landscape:
1. Increasing Complexity of Machinery Development
Today’s machinery is more advanced than ever. With the rise of automation, IoT, and advanced robotics, machines require intricate systems integrating hardware and software. This complexity demands precise requirements management and traceability to avoid costly missteps.
2. Growing Regulatory Demands
Industrial machinery must comply with stringent safety and regulatory standards, such as IEC 61508. Meeting these requirements adds layers of complexity, often requiring significant time and resources to ensure full compliance.
3. Cost Pressures and Market Competition
Global competition is intensifying, pushing businesses to innovate faster while keeping costs low. Additionally, labor shortages and economic instability in key regions, including Europe, are forcing companies to optimize their operations to maintain profitability.
4. Focus on Sustainable Development
Sustainability and energy efficiency are no longer optional but essential. Product developers must design machines that meet green standards while maintaining performance and reliability, which adds another layer of complexity.
Navigating these challenges requires a new approach to machinery development. That’s where Jama Software steps in.
How Jama Software Helps Save Money in Machinery Development
Jama Software is designed to meet the unique needs of industrial machinery developers. From cutting costs to boosting productivity, Jama Connect offers solutions that address some of the most pressing challenges in machinery development.
1. Efficient Requirements Management
With Jama Connect, machinery developers can manage complex requirements effectively. Here’s how it helps cut costs:
Clearer Specifications: Reduce rework by ensuring all stakeholders understand and agree on requirements from the start.
Live Traceability™: Track changes and link high-level requirements to detailed specifications, ensuring nothing falls through the cracks.
Faster Reviews and Approvals: Jama Connect’s collaborative review process significantly shortens approval times, reducing delays in development.
For example, FORT Robotics, an industrial robotics company, used Jama Connect to reduce their requirements approval process from weeks to just minutes, creating significant time and cost savings.
2. Enhanced Collaboration Across Teams
Siloed communication often leads to misaligned goals, increased errors, and wasted time. Jama Connect eliminates these inefficiencies by offering:
Real-Time Collaboration: Teams can work together across functions, share feedback, and resolve issues seamlessly in one platform.
Cross-Functional Visibility: Gain a comprehensive view of the development process, helping teams identify potential risks early.
This level of collaboration reduces miscommunication and minimizes resource wastage, which is especially important in cost-sensitive industries like machinery development.
3. Compliance Made Easy
Meeting compliance standards like IEC 61508 is both time-consuming and costly. Jama Software simplifies compliance by:
Providing Best Practice Frameworks: Teams can use pre-configured templates and guidelines tailored for safety-critical systems.
Ensuring End-to-End Traceability: From initial requirements to testing and maintenance, Jama Connect ensures that all steps comply with industry standards.
By streamlining compliance processes, Jama Connect helps reduce the risk of costly recalls or regulatory penalties.
4. Risk Mitigation
Every development project carries inherent risks, especially in complex machinery systems. Jama Software minimizes risks through:
Proactive Risk Identification: Built-in risk management features help teams identify potential issues early before they escalate.
Continuous Monitoring: Track risks throughout the development lifecycle, ensuring they remain under control.
Minimizing development risks saves both time and money, preventing costly setbacks that can derail a project.
5. Accelerating Time to Market
The faster you can get your product to market, the more competitive your business will be. Jama Connect speeds up product development with:
Streamlined Processes: Automated workflows and traceability reduce time spent on manual tasks.
Reuse of Requirements: Save time by reusing validated requirements for similar projects, eliminating redundancy.
Hannah Potter, Systems Engineer at IonQ, shared, “The review function has been a lifesaver… We can use our requirements and test plans for the basis of future designs, targeting our goal of continuing to build better and faster machines.”
6. Cost-Effective Scaling
For companies experiencing growth, scalability is a major concern. Jama Software is designed to scale with your business needs without requiring expensive customizations or additional tools. Its robust platform supports even the most complex systems with ease.
The industrial machinery sector is at a critical juncture. Developers who adapt to the current complexities will thrive, while those who cling to outdated processes risk falling behind. Jama Software provides the tools needed to stay ahead in this fast-changing market.
Here’s why you should consider Jama Software now:
Save money by eliminating inefficiencies and reducing rework.
Meet regulatory standards faster and with confidence.
Collaborate more effectively across teams and locations.
Mitigate risks to ensure smoother development cycles.
Stay competitive by launching high-quality machines faster.
Take the Next Step Toward Cost-Effective Machinery Development
Whether you’re dealing with mounting cost pressures, compliance challenges, or complex system requirements, Jama Software is the solution you’ve been searching for. With tools built specifically for industrial machinery developers, Jama Connect empowers your team to cut costs, save time, and maintain consistency in delivering innovative products.
Choosing the Best Tool for Requirements Management in the Automotive Industry (Even If Your Suppliers Use Something Else)
Requirements management plays a vital role in the product development lifecycle, impacting everyone in the automotive industry—from project managers and architects to software teams, systems engineers, and senior executives. Whether you’re overseeing the development of advanced driver-assistance systems (ADAS) or managing the assembly of an entire vehicle platform, having a robust requirements management tool that helps support engineering governance can mean the difference between success and costly delays.
But here’s where it can get tricky. Your organization isn’t developing products in a vacuum. You’re constantly collaborating with a network of suppliers, each of whom may have their own preferred requirement management tools. The question then becomes, should you compromise your needs and processes to align with the tools your suppliers are using, or can you select the BEST tool for your needs and ensure seamless collaboration anyway?
Spoiler alert: The answer lies in selecting the right tool for your organization, regardless of what your suppliers are using. Here’s how you can make that decision with confidence.
Why Picking the Wrong Tool Could Cost You
Many automotive companies end up selecting requirements management tools solely because their suppliers use them. While this might seem like the easiest path to collaboration, it can actually result in more inefficiencies and frustrations down the road.
Key Challenges of Adopting the Wrong Tool:
Misalignment with Your Processes: Tools that don’t support your specific workflows or business goals can disrupt productivity.
Steep Learning Curves: Adopting a tool simply because others are using it can lead to excessive training needs. If the interface isn’t user-friendly or intuitive for your team, adoption rates may plummet.
Limited Scalability: What works for your supplier today may not meet your complex or evolving needs tomorrow.
Missed Opportunities: A mediocre tool can restrict innovation and time to market. When you’re stuck trying to make something work, you’re not maximizing efficiency or leveraging the full power of your processes.
The takeaway? It’s your team working day in and day out with the requirements management tool — not your suppliers. That means your organization’s specific needs should come first.
Must-Have Features in a Requirements Management Tool
Choosing the right software isn’t just about checking boxes. It’s about finding a tool that fits seamlessly into your automotive development environment and supports collaboration across your supplier network.
Here are some must-have features to look for:
1: Advanced Traceability
Traceability is vital in the automotive industry for safety-critical systems and regulatory compliance. The right tool should allow you to trace requirements across your entire system—from initial stakeholder needs to risks and mitigations to testing and validation. A tool that allows you to span the entire V-Model with high visibility and ease of tracking gaps and potential risks is key. Dashboard views and other means to obtain a holistic view of the progress of your project are essential for senior management to maintain a pulse on the project and ensure progress is being made with minimal risk.
2: Change Management and Version Control
Selecting a tool that allows for change to be controlled and easily reacted to is essential for a requirements management software. Suspect triggers allow downstream impacts to be easily identified and remedied. Proactive strategies and features like impact analysis, allow for change to be assed prior to making changes, allowing teams to prepare for the impact before it happens.
Ensure you look for a tool that is well-versed in your industry and understands the intimate details of the business challenges you face. Ideally, the tool you select will have frameworks and datasets that adhere to your regulatory and safety compliance standards. Standards and regulations, including ISO 21434:2021, ISO 26262:2018, and ASPICE, are essential, and the tool you select should help facilitate your compliance with these standards.
4: Cross-Tool Interoperability
One of the biggest concerns when choosing a tool that your suppliers may or may not be using is interoperability. Look for software that supports standards like ReqIF (Requirements Interchange Format) to facilitate seamless exchange of requirements with external stakeholders across your entire ecosystem. This ensures you can collaborate effectively without sacrificing your own processes.
5: AI and Automation Capabilities
Modern requirements management tools leverage AI to speed up processes and improve quality. Automation capabilities can also eliminate repetitive tasks, freeing up your team to focus on higher-value work. Automatic test case generation, glossary definition, risk detection, IP identification are now considered key to requirements management and will be the standard moving forward.
Your requirements management solution should grow with your organization. Whether you’re managing one project or dozens, the tool should adapt to increased complexity and size. Performance at scale should be a key consideration. You’ll always need a tool that is easy to administer. You should not need a specialized role to perform this task. Cloud hosting options provide flexibility and lowers cost of ownership. SOC2 hosting environments along with a product that is also SOC2 certified is essential when considering today’s ever-evolving security risks.
7: Configurable Workflows, Customized Reports, and Export Templates
Every team operates differently. A versatile tool will allow you to configure workflows, reports, and export templates so it fits with how you work, rather than forcing you to change your processes.
8: Supply Chain Collaboration Features
While you shouldn’t need the exact same tool as your suppliers, features like shared requirements repositories, real-time commenting, and simplified export/import options make it easier to stay on the same page — even if you’re working on different platforms. Having a tool that allows you to invite external stakeholders into your reviews (at no cost) is a major benefit and consideration.
The Case for Putting Your Needs First
Imagine you’re working on a next-gen electric vehicle platform. While your suppliers might be focused on delivering specific components (like an ECU or software component), you’re responsible for the big picture. A tool that fails to give you high-level visibility simply because it aligns with your supplier’s processes? That’s a no-go.
When you select a tool based on your needs, you gain the following advantages:
Streamlined Internal Processes: You can focus on efficiency and alignment within your team without constantly adapting to external tools.
Improved Quality Management: With better traceability and error reduction mechanisms, your team is better positioned to meet high-quality standards.
Flexibility to Work with Any Supplier: The right tool ensures you can collaborate effectively with any supplier, regardless of what they’re using.
Making Collaboration Work Across Different Tools
If your suppliers aren’t using the same tool, how do you handle the exchange of requirements? The good news is that most modern requirements management tools include features that make cross-platform collaboration easier than you might think.
Here’s How You Can Ensure Smooth Collaboration Regardless of Tools:
Leverage ReqIF Standards: ReqIF facilitates reliable requirements exchange across your entire ecosystem. By adopting a tool with strong ReqIF support, you ensure compatibility with your suppliers, no matter what software they prefer.
Utilize Integrations and APIs: Many requirements management platforms offer direct integrations to popular tools such as Jira, Teamcenter, LDRA, Simulink, and other best of breed tools. APIs or third-party integration tools can help bridge the gap between systems, creating a smoother flow of information.
Define Common Terminology and Traceability Information Models: Consistent and clear data standards and traceability models reduce friction when exchanging files or tracing requirements. Establish these standards early in the collaboration process to ensure seamless communication across all stakeholders.
Invest in Training and Consulting Services: While the right tool should be intuitive, training ensures your team gains expertise in leveraging advanced features for cross-platform requirements exchange. Look for companies that will partner with you from the start with industry expert consultants and can consult with your on your journey to success. Avoid those that outsource or charge high consulting fees after you’ve started your project, which will result in cost and delays.
Choosing the best requirements management tool for your automotive projects is no small task. But if you prioritize your organization’s unique needs while leveraging cross-platform compatibility features, you can have the best of both worlds.
Your requirements tool should empower your team, streamline your processes, and enhance collaboration without forcing you to compromise. Don’t settle for “good enough” just to align with supply chain tools when you can choose what’s “best for us”—and still work seamlessly with partners.
Curious about which tool could be the best fit for your needs? Start exploring modern requirements management tool like Jama Connect so you can stay ahead in this era of increasing complexity in the automotive industry.
