Tag Archive for: Jama Company and Community News

Tag Archive for: Jama Company and Community News

Expert Perspectives: An In-Depth Discussion with Jeremy Weiss from Alpha Financial Markets Consulting on Trends and Insights in the Insurance Industry

Welcome to our Expert Perspectives Series, where we showcase insights from leading experts in complex product, systems, and software development. Covering industries from medical devices to aerospace and defense, we feature thought leaders who are shaping the future of their fields.

In this blog post, we will recap a recent episode in which we speak with Jeremy Weiss from Alpha Financial Markets Consulting about trends and insights in the insurance industry.

Watch the full interview to learn more about:
  • The biggest challenges insurers face in managing the product filing process
  • How insurers can remain compliant while still being agile in product development
  • How technology is transforming the way carriers develop, manage, and file new products

VIDEO TRANSCRIPT

Kenzie: Welcome to our Expert Perspectives series where we showcase insights from leading experts in complex product systems and software development. Covering industries from medical devices to aerospace and defense, we feature thought leaders who are shaping the future in their fields. I’m Kenzie, your host, and today I’m excited to welcome Jeremy Weiss, the director of the Insurance Consulting Group at Alpha Financial Markets Consulting. With more than 10 years of experience, Jeremy works with multiple insurtech and technology organizations to develop their products to meet the needs of insurance carriers. He’s also very active in the AI space, imagining what the future of insurance looks like with AI.

Joining Jeremy is Kevin Andrewjeski, Jama Software’s own general manager. Kevin leverages more than a decade of experience and requirements and digital transformation to aid customers looking to modernize and transform their product development processes. We hope you enjoy this conversation on trends and insights that they’re seeing in the insurance industry. Without further ado, I’d like to welcome Jeremy and Kevin.

Kevin Andrewjeski: So thanks Kenzie. Hi everyone. Thanks for joining. My name is Kevin Andrewjeski. I’m the general manager for the finance and insurance space here at Jama Software. I’ve been with Jama for 11 and a half years and have had the pleasure of working with many of our customers in this space. Joining me today is Jeremy Weiss from Alpha FMC. Jeremy, if you would introduce yourself.

Jeremy Weiss: Yeah, great. Thanks Kevin. Jeremy Weiss, Director here at Alpha FMC. I lead our front office consulting practice, so product pricing, underwriting as well as distribution, sales and marketing. A variety of management consulting work both in the technology space as well as the business consulting space, but spend the majority of my time really at the intersection of those two.

Andrewjeski: Thanks Jeremy. So for today’s discussion and as part of our Experts Perspectives series, we want to have an in-depth discussion around trends and insights in the insurance industry. And Jeremy, before we kind of dive too deep into some of the things that you’re seeing, could you talk a little bit about the role of product management within the insurance space? What does that mean to folks in the insurance world?

Weiss: Yeah, great question. I would say there’s a number of definitions of how we think about product. There’s certainly the insurance product side, that is the filed product in most cases that’s being sold in the market that provides the coverage that folks are seeking with insurance. And then there’s other product definitions like an internal built product, et cetera. But for today, I think it’s really about that insurance product that’s really that insuring vehicle that is the coverages and sub-coverages that make up the entirety of what’s being protected under the insurance, at least in property and casualty, but very similar in the life space with protecting the human life, et cetera.

RELATED: Buyer’s Guide: Selecting a Requirements Management and Traceability Solution for Financial Services & Insurance

Andrewjeski: Thank you. Thank you for that. And when you look across the industry and as you’re interacting with the various clients that you’re seeing, are you seeing any trends as far as some of the challenges that are consistent across different insurers in the space?

Weiss: We built product for, gosh, over 100 years it seems at this point. So we’ve been doing it the same way for a while. Regulatory processes, although they’ve started a bit to come into a new modern age, it’s been a bit slow. When I look at trends, I think more organizations today than even two years ago are more focused on the product management function and they’re really saying, “How do I enable product into the future to be able to support the business better? How can I transform my products to better meet customer expectations? How can I do that more quickly? How can I shorten what is often a 6 to 12 plus month cycle of ideation of a product to actually getting something filed and in the market?”

So companies are really starting to see the opportunity there to say, “How do I be more efficient? How do I add tooling in that space?” And product largely has been an area that hasn’t had a lot of investment in, gosh, as long as I can remember. There haven’t been massive product management overhaul projects at really any of the clients that I’ve worked heavily with.

Andrewjeski: Yeah, I would agree. I think from our perspective, we see a lot of investment in the, say, software development side of product, but not necessarily in the product management space. And it seems to be a place where there has been less technology investment in the past. So not surprising to see that you’re seeing folks looking at that as an area for ways to improve. What are some of the things that you’ve seen people try to do to help with the inefficiencies in this space?

Weiss: Yeah, it’s interesting. So gosh, 10 years ago or so when we started to talk a bit about agile within an IT development, we talked about this concept of a product and building that minimum viable product and taking it to market. And we thought of it in that context more as a physical cardboard box that had a package in it, that was the product. I see in the product management space for insurance product, we’re starting to think about it in a bit more of those terms. So think about it a bit as the supply chain elements, right? So what are all those pieces and component parts that help us get to that ultimate end result?

So really looking at it more of the factory floor type model. What are all of the activities that need to be built into that product? Who does them? How do they happen? How long do they take? Where is there efficiency to be gained? What are the most important elements of that? What do we maybe do today that we don’t need to do tomorrow? So thinking about it in that factory model of how do I churn through product development more quickly to get to market, or at least to get to the regulatory side? That filings process, maybe I have a little less ability to influence how quickly that happens. I’m working with state regulators, et cetera, but at least I can get that kind of internal product making piece done and get to that regulatory start.

So I see folks really focused on what are the opportunities kind of looking internally. And when I say product management, and a lot of organizations, that doesn’t really mean one specific product organization. Certainly there are product managers that are accountable for maybe ideating or building the product, maybe managing the performance of the product, but you also have legal and compliance and IT and underwriting and a variety of other stakeholders really in the mix on what product management means, which adds to that complexity.

So really clearly defining what those roles are, what the underlying requirements are that make up a product, how it should function, how it should function in a system, how the filings should be prepared, all of that kind of makes up that overall product management factory model. And we see companies starting to take a deeper look at that, look at tooling that can help to support streamlining that model and getting all of those parties, those six, seven, eight parties that I talked about to one cohesive understanding and definition for that source of truth.

Andrewjeski: Got it. And one of the drawbacks we see from people still trying to manage a lot of this information say in Excel and sort of some of the other manual ways is if these teams aren’t aligned, it’s more likely that something would be missed or perhaps somebody is working off of maybe some outdated information and that will slow their filing process down because there’ll be rework and things like that. Are those some of the things that you’re seeing or are there other kind of bottlenecks or other areas where you’re seeing issues in the process?

Weiss: Yeah, there’s definitely a lack of documentation certainly. There’s organizations that have strong documentation, it just might not be in a super modern tool like Excel. That’s hard to keep up to date when you have those eight different parties or eight different parts of the organization all with multiple people in them really working on the same product definition. So that makes it really a challenge to keep documents up to date and really understand what that single definition of product is ultimately. It also impacts how we get to the regulatory process where I have to at times defend the product, why we made decisions, how it applies across different territories or geographies, et cetera. And so that can really be quite a challenge.

The other piece to comment I made previously, we’ve had a number of years of not a lot of investment in products. So a lot of these products have been sitting there largely in the market, but they haven’t changed a whole lot, right? And so a lot of those are individuals who maybe built that product at the beginning are no longer with the organization, and so the documentation maybe wasn’t kept up to date or was kept up to date with 80%. And so there’s a lot of question and answer trying to understand what did we do here, why did we get there, what’s actually filed, what are we selling, what’s developed in the system, and so that adds to that part of that challenge.

So now when organizations have a chance to look at it and do a refresh and say, “Okay, this is actually what our product is,” it’s about how do you get that in one spot and then how do you manage it going forward in that factory type model that keeps that product definition up to date. So you don’t ever have that problem of saying, “We just need to stop doing what we’re doing today and build a single version that actually reflects the product that we’re selling in the market and the product that the end customer thinks that they’re ultimately getting.”

Andrewjeski: Interesting. So it’s not just about trying to capture what this product does or is supposed to do, but also the context around why it evolved or how it evolved into that version of the product that they’re ultimately bringing to market and seeking to get regulatory approval for.

Weiss: Yeah, exactly. And there’s a few ways to look at that. Sometimes it’s just an insurance carrier wanting that knowledge to be recorded in some way, like a change log, right? Why did we make the change? What did we update? What was it? In some cases, to your point, from a regulatory approval perspective, if I’m changing business rules about how a product is applied, I do have to keep a record of what those were on a given day versus what they might be at a future moment in time after I update them in a system or keep them in the documentation.

RELATED: Simplify Complex Financial Product Development, Deployments, and Migrations with Jama Connect®

Andrewjeski: Yeah, so it sounds like there’s a lot of, as you mentioned, the product management role might mean and often means more than just the product organization. It might mean a lot of different stakeholders and a lot of different folks are involved in that process. And so really, one of the goals for improving this process is just better collaboration and better engagement from these various stakeholders along the way to make sure that everybody’s on the same page and things are happening kind of in an efficient manner. How do you see technology helping kind with this transition and trying to help bridge this gap or maybe break down some of these collaboration barriers that exist today?

Weiss: Yeah, there’s a variety of factors from a technology perspective. I think first and foremost, it’s about more of that workflow, routing of work, assigning tasks to someone. You know who’s on next and who needs to do it and when is it done. And I know that when I’ve completed my legal review, I pass it off to this person, maybe it goes back to the product manager, right? A system could be able to know that and automatically route it as part of that next step in the journey. And so you’re also able to give some context of why that is the step in the process.

And so that’s very much an important part that we need to see in tooling, as well as keeping that bit of a change log, those detailed requirements, all of the background that you want behind them. Maybe you’re able to easily see impact to the changes that you’ve made, right? If you make a lot of changes, what’s that going to do to your product? How does that impact what needs to be filed or what ultimately goes in a system? And so all of those pieces become a really important part of the journey.

Andrewjeski: Yeah. Obviously, one of the big buzzwords right now across not just this space but all of the industries is AI and how can AI help me do my job more efficiently and help make things easier. What role do you see AI playing in helping product management within the insurance space?

Weiss: I think when we look at the impact of artificial intelligence, I think we can think about it more from a development perspective as well of how can it take some of the requirements that we’re keeping and how does it turn those into code that are actually developed in the system. If I have really well-defined requirement, it should be relatively easy to transition those into a system, especially a low-code, no-code type system. If I’m keeping the documentation, I’m really almost 50% of the way there. So can we use AI to get them into a system? I don’t see a lot of carriers really to that point yet, but I could definitely see that happening maybe in the future.

I think we can do a fair amount of comparison as well with AI. So we probably hear a lot in the industry about document compare. You can certainly do that with product compare, comparing what product an individual has today versus what I may be trying to offer them for their future product tomorrow. Being able to see those differences. The same can be true in really helping with that legacy use case that I mentioned of, gosh, we have this old product, I hope this is what we filed. Can we compare our filing against the documentation that we have against maybe the documentation that someone else has and is kept on their desktop to understand the delta between the three? And so that can get you to hopefully that one version of the truth or maybe that one messy version that you need to go through to determine what is the truth. But it’s not as much today a manual compare. AI can really support that working more efficiently.

Andrewjeski: Yeah. And I think you mentioned the quality of the requirements really being a key there, right? The better that the product management team and the internal folks can do it, writing proper requirements, the easier it is for a machine to be able to interpret those requirements and create code or potential low-code, no-code situations like you mentioned. Also, we see test cases being a downstream impact of that as well, right? If we have properly written requirements, much easier for AI to be able to suggest or create ways for those requirements to be tested as well.

You mentioned the regulatory aspect, and obviously that is a huge factor in this space. Ultimately, it’s a race to sort of get into the regulatory review process. As those regulatory requirements are evolving, how can insurers ensure that they’re remaining compliant while still trying to be agile in this process and try to iterate and go faster like we’ve been talking about?

Jeremy Weiss: Yeah. I think it’s about keeping effective documentation, first and foremost, and that will streamline your ability to get to the filing and then hopefully reply to any of the objections that might come from a regulator so you’re able to move through that process more quickly. When you’re updating a product, certainly having that change log or change control log that you could surface to a regulator to have a conversation about what may be changing and why you’re updating the product, why it looks different in this new version, what necessitated the change, what specifically did you change, that log will be super helpful.

And then as you get through the process, really having that check the box review and approval process so that you understand when you have received regulatory approval back. Remember, a lot of the carriers that we work with are filing business across 50 states, right? And so they’re managing 50 different ways, or at least 35 or so different ways to do things. That’s a lot to track and manage, especially if you’re one person or a team of three maybe that are focused on the product. And so having that type of a view that gives you a dashboard for product X, where have I filed, where not, where am I waiting for information from an internal stakeholder, from external legal counsel, from the regulator, where are we at with objections, et cetera, that dashboard view can also be super helpful.

Andrewjeski: Yeah. And I would think as you get that feedback from those regulators, being able to tie that back to or go back to your notes or your records to be able to say answer those questions, whatever those questions be from the regulators, that’s where having that single source of truth that you talked about would be super helpful to be able to go and say, “Okay, if I’ve got a question about this, not only can I go look at what we wrote down, but I can get more of that context, more of the decisions, maybe look at where it was reviewed, where it was approved, or how it evolved into ultimately what we submitted for regulatory approval.” Something that would be challenging if you’re trying to manage that or search through a bunch of emails or other places where some of those decisions sometimes were ultimately made.

Weiss: Yeah. Replying to objections is, well, I would say it’s not really a fun process, right? But a lot of times you’re going to get the same objection or a similar type objection. So to your point, the reusability even of objection management is something that you can use tooling to consider how you manage that information, how you write the same response to this state that you already wrote to that state four months ago as part of that process, that definitely streamlines your ability to get them a response back, and hopefully their ability to review it quickly and approve the product so you can then go use it in the market in the states that you’re required to have that approval.

Andrewjeski: Yeah. And it sounds like, I mean, obviously we’ve talked about some of the evolution that you’re seeing and some of the ways that technology could be helpful in this process. Are you seeing insurers already taking this journey or investing in these areas or how early in the process are we?

Weiss: Yeah, it’s a great question. I think we’re seeing the start of this in more of the requirements management space, definitely coming out of IT or business analysis type activities, starting to maybe bleed over or enable into the product management function, largely a business function at the core. And so we’re starting to see some of that tooling have an impact slowly as we’re starting to think about it. I think if we could paint the picture on the back end of reusability of a product, a product definition of the individual requirements that make up a product, that will help the end users to see the need to do the work on the front end, right?

This isn’t easy. Tooling is not always the easiest to implement. It’s not like snap my fingers and magically we have our product definition written in a brand new tool that allows us to streamline it and manage it on the way forward. But if we see that benefit on the back end and can really understand how it impacts our entire process, I think we’ll start to see more traction over time. Folks are definitely feeling the pain of needing to get to market more quickly with product of the desire to have far more products tomorrow than I had in the market today to meet customers changing needs, needs of a business changing, et cetera. And so I think we’ll see that continue to increase as we move into the future, of the desire to have more bespoke product offerings that will actually make this even more important than it is today.

Andrewjeski: Yeah. And I think that right now, I guess, one of the other macro factors that we see in the market is there’s a lot of uncertainty, political uncertainty around tariffs, but also potentially less regulation occurring in the market as well. So that can be sort of paralyzing sometimes for companies figure out which direction to go or do we invest in new tooling or technology advancements for things like this. I mean, what is your approach or guidance? I mean, what have you seen in the space for people looking around at the macroeconomic marketing and being uncertain about whether now is the right time to make these kinds of changes?

“If we can get a break in some of the regulatory pressure, I would say there’s actually probably no better time to implement this than now. Because you hopefully have freed up some capacity to start to think about how we do this in the future. If there’s one thing we know about how politics impact the insurance world, it’s probably going to go back and forth at the state level, at the federal level over time, right? And so we’re going to see an increase in regulation, we’re going to see a decrease… And so we’re going to need tooling to support really both sides of that.”

RELATED: Bridging the Gap in Insurance Product Development: How Jama Connect Can Streamline Requirements Management

Weiss: Yeah. Well, if we can get a break in some of the regulatory pressure, I would say there’s actually probably no better time to implement this than now. Because, you hopefully have freed up some capacity to start to think about how we do this in the future. If there’s one thing we know about how politics impact the insurance world, it’s probably going to go back and forth at the state level, at the federal level over time, right? And so we’re going to see an increase in regulation, we’re going to see a decrease… And so we’re going to need tooling to support really both sides of that. But especially when we see an increase in regulation, the best time to do a project that supports that would be when there isn’t a significant amount of regulatory scrutiny or an increase in objections, et cetera. So now is probably that great time to implement that type of a product.

And I hear you on the tariff side, what will that do to construction costs on homes and buildings and autos, et cetera. And so that definitely is something to manage as we think about how that will impact investment on the way forward into the future. But what I will say is a lot of these solutions that are available in the market, really that can help to enable solution to these problems are not massive behemoth, super costly solutions. They don’t require thousands of hours of implementation expertise. It’s something that can be done on more of a smaller project scale. You can right-size it, maybe it start with one or two products, and then think about it growing into more of an enterprise implementation that can maybe house all of your products, but you don’t have to start there. You can start with a more smaller subset. Maybe it’s one business unit, for example, or even one single but somewhat complex product.

Andrewjeski: Yeah, no, that’s a good point about it isn’t an all or nothing proposition and that companies can find those ways to innovate or to try to innovate and test things out. And I think that that can be a good way for them to kind of dip their toe in the water, so to speak, of maybe making some of these changes rather than trying to change things on a massive level across all 50 states or all the products that they offer. And I guess in our lifetime, we’ve seen other uncertainty and other kind of macro challenges, right? And obviously not that long ago, companies in this space and across the globe were dealing with things like COVID where there was a lot of uncertainty. Can you draw any parallels, I guess, to the uncertainty that exists today and how companies got through that period of time, which was only a few short years ago?

Weiss: Yeah, I think it looked different for every company, and maybe that changed over time. But the organizations that decided to invest, maybe they paused for a while at the beginning of COVID. Let’s be realistic. Almost every organization pressed pause on a few things, maybe a lot of things. We were all living into what would eventually become a bit of a new normal for a period of time. But then the organizations that are the most successful in the market today are those that took those few years that we had and continued on that transformation journey. They didn’t go to sleep, they didn’t press pause. They said, “Let’s take this as an opportunity to continue to evaluate how we do business.”

Is how we do business in the market different today than two years ago? Yes, to some degree, but there’s a lot of parallels and a lot is still the same. And so the organizations that took that time to transform and double down on the operation and say, “Let’s take this as a chance to streamline what we’re doing. Let’s think about new products. Let’s ideate on what the market might look like coming out the other side of COVID.” Those are the organizations that are in the market today with new products or slightly different products, and more important than anything, they’re able to adapt to a changing market.

So in the tariff example and the political uncertainty example, they understand what that impact could be and they’re able to turn the corner quickly versus staring at how do I even go about developing a new product? Maybe that’s going to take me 18 months to get to market. Well, hopefully we’ll be through all the tariff pressure by then, and hopefully we’ll be at a more stable place politically and know what’s next. And so finding a way to be able to adapt quickly is super important today, and I think we can take COVID as a learning from the organizations that are most successful today.

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Andrewjeski: Yeah, it sounds like the folks that continued to invest throughout the uncertainty are now seeing a bit of a competitive advantage, right? Because the one thing that’s constant throughout time, and it’s not just now and back in COVID, it’s always is change is constant, right? And so the companies that are investing in ways to improve their process and improve the efficiency of the way that their teams, specifically in say the product management space, are able to adapt to those change allows them to deal with that uncertainty at a much higher pace than say some of the companies that are still trying to do these things in a very manual way.

Weiss: Absolutely. The one thing I will add is there’s no set it and forget it when it comes to transformation. So I can do all the planning effort and start a transformation program today on a two-year journey. That program will likely not be successful if I continue on that full two-year journey, and I don’t look at everything that’s happening around me. So organizations in the middle of transformation or even in transformation planning need to understand how am I going to take what’s happening in the broader ecosphere and understand the impacts to individual projects or programs or the overall direction that we’re going, find a way to assess what’s happening. And then being able to steer those transformation programs as well.

So you can’t forget completely about what’s happening around you, but you do need to keep your eyes on the ball and what you’re focused on and change that goal if you need to, if it makes sense. But definitely have everything working toward that shared goal or shared vision.

Andrewjeski: Well, Jeremy, I appreciate the insights and the discussion on trends within the insurance space. And for folks that might want to learn more about Alpha FMC and how your group might be able to help them, how would they go about reaching out to you?

Weiss: Yeah, definitely. Visit alphafmc.com to learn more or adding me on LinkedIn, happy to have a conversation as well. As I mentioned at the beginning, we are in the management consulting space. We exclusively serve financial services organizations, so in the wealth and asset management as well as insurance domains with a number of experts across our solutions, really across all of insurance and much broader than that in financial services. But really the entirety of the business operation, technology operations, new technology enablement, as well as M&A type activity, all really in our sweet spot. And as I mentioned as well, really it’s that intersection of business and technology, much like a lot of what we talked about today, how do I leverage technology solutions to be able to enable the business to do things better and more efficiently than maybe they’ve ever been able to do them before.

Andrewjeski: Sounds great. Thank you, Jeremy, and appreciate the time and look forward to having you on again in a future session.

Weiss: Thank you. Appreciate it.

Kenzie: Thank you for joining us on this episode of our Expert Perspectives series. We hope you’ve enjoyed this conversation between Kevin Andrewjeski and Jeremy Weiss on trends and insights in the insurance industry. If you’re an existing customer and want to learn more about Jama Software, please reach out to your customer success manager or consultant. If you’re not yet a client, please visit our website at jamasoftware.com to learn more about us and how we can help optimize your processes. Thank you, and stay tuned for upcoming episodes of Expert Perspectives. Please note that the views expressed in these interviews and commentary are solely those of the individuals providing them and do not reflect the opinions of Jama Software.

Jama Connect® Maintains Its Position as the Top Leader in Requirements Management Software

Jama Connect® Maintains Its Position as the Top Leader in Requirements Management Software

Jama Connect has once again earned the #1 spot in G2’s Spring 2025 Grid® Report for Requirements Management Software—our fifth consecutive quarter as the overall leader.

This recognition further cements our position as the top-rated solution for requirements management, ahead of competitors like Polarion, IBM® DOORS®, and Codebeamer.

G2’s rankings are determined by real user feedback, along with data collected from online sources and social networks, all analyzed through their proprietary v3.0 algorithm. The Spring 2025 Grid Report, based on data gathered through February 25, 2025, highlights the industry’s top-performing tools.

And that’s not all — Jama Connect was recognized with multiple prestigious awards across various business sizes and regions, including:

    • Overall Leader
    • Momentum Leader
    • Small-Business Leader
    • Mid-Market Leader
    • Enterprise Leader
    • EMEA Leader
    • Europe Leader

Explore the full G2 Spring 2025 Grid Report for Requirements Management Software to see how Jama Connect stacks up.

RELATED: Best Practices Guide to Requirements & Requirements Management

Why This Recognition Matters

This accomplishment underscores our commitment to helping customers transition from document-based processes to a modern requirements management platform. Jama Connect empowers teams to manage complex product, systems, and software development with unmatched clarity and collaboration.

We owe this success to the incredible feedback from our users. Here’s what they’re saying:

“Product Design teams need a requirements management tool like Jama Connect. Using Jama Connect allows our software development team to have a well-organized and well-written set of requirements. It allows us to more easily maintain a baseline of features in our continuously evolving software.” — Mark M., Mid-Market, G2.com

“Jama Connect is not only a ‘document oriented’ ALM tool, it gives the organization the ability to map the project structure to the product structure, making it an easy entry point for R&D folks. Configured properly, it is a real technical and regulatory ‘single source of truth.’” — Frederic Fiquet, Director, Systems Engineering, G2.com

Thank You to Our Customers

Being named the Overall Leader by G2 is a direct result of the trust and support of our customers. Your feedback fuels our innovation and drives us to deliver the best possible platform for modern requirements management.

Thank you from all of us at Jama Software!

9 Strategies To Overcome Challenges In The EU Medical Device Market In 2025 And Beyond

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 MedDevice Online, titled “9 Strategies To Overcome Challenges In The EU Medical Device Market In 2025 And Beyond”, and written by Marcelo Trevino.

9 Strategies To Overcome Challenges In The EU Medical Device Market In 2025 And Beyond

Global frameworks offer valuable insights for Europe as the region is currently working to refine its regulatory systems. While Europe is a significant player in the medical device market, the MDR transition has created challenges driven in part by higher costs and timelines due to stricter requirements that have extended approval timelines, increasing costs for manufacturers. Additionally, a shrinking pool of notified bodies has created bottlenecks, delaying device reviews and approvals. The EU MDR demands extensive pre-market clinical data, which has raised costs and delayed approvals. Additionally, lack of harmonization across member states complicates emergency approvals, as seen during the COVID-19 pandemic. This has resulted in a significant number of medical device manufacturers deprioritizing Europe as a launch market, preferring regions with clearer pathways. However, medical device manufacturers, regulators, and other stakeholders have an opportunity to mitigate these challenges by implementing the following strategic solutions to ensure that Europe remains a hub for medical innovation.

1. Enhance Predictability and Transparency In Regulatory Processes

The unpredictability of the regulatory process under MDR poses a significant challenge for manufacturers. Structured dialogue provides a valuable solution by enabling early engagement with notified bodies. This process allows manufacturers to present their clinical strategies, product designs, and evidence plans, ensuring alignment on regulatory expectations. When regulators and manufacturers work collaboratively from the start, costly errors, such as insufficient clinical data or inappropriate trial designs, can be avoided. Additionally, regulators need to issue more detailed guidance to clarify what constitutes acceptable clinical evidence, particularly for innovative products. Leveraging real-world evidence (RWE) from other jurisdictions, such as data from FDA-approved devices, can further reduce redundant studies and expedite European approvals. Equally important is training regulators and notified body auditors in emerging technologies, ensuring that evaluations are both informed and consistent. By addressing these areas, Europe can create a regulatory environment that fosters clarity and efficiency.

2. Leverage Conditional Certification For Innovative Devices

Innovative devices often face challenges in providing long-term clinical data due to their novelty, which can delay market entry. Conditional certification offers a balanced pathway by allowing such devices to reach patients sooner while requiring ongoing evidence collection post-launch. For example, some devices to treat critical health conditions have been granted conditional certification through some notified bodies based on strong initial safety and efficacy signals. Through rigorous post-market clinical follow-up (PMCF), manufacturers can demonstrate continued safety and effectiveness, ultimately transitioning to full certification. Expanding this framework across Europe would allow more innovative devices to address unmet medical needs without undue delay. Regulators should formalize the conditional certification process with standardized criteria and timelines for post-market data submission, ensuring consistency across member states. This approach not only accelerates patient access to cutting-edge treatments but also provides manufacturers with real-world data to refine their products and strengthen market positions.

RELATED: 2025 Expert Predictions for Medical Device & Life Sciences: Innovations in Patient-Centered Care and the Future of Medical Device Design

3. Promote Innovation-Friendly Pathways

Globally, regions have implemented streamlined pathways to fast-track the approval of high-impact devices. Europe must adopt similar measures to remain competitive. The FDA’s Breakthrough Devices Program, which prioritizes devices for life-threatening conditions, provides an exemplary model. In Europe, the U.K.’s Innovative Devices Access Pathway (IDAP) offers a promising localized framework. By selecting devices with transformative potential, IDAP helps manufacturers navigate regulatory approvals while ensuring compatibility with the National Health Service (NHS). Expanding such programs across the EU would create harmonized support for innovative products. Additionally, establishing a centralized EU innovation authority could streamline fast-tracking efforts, provide consistent eligibility criteria, and coordinate expedited reviews with notified bodies. Such initiatives would encourage manufacturers to reprioritize Europe as a launch market for groundbreaking medical technologies.

4. Address Capacity Constraints In Notified Bodies

Limited capacity within notified bodies is a critical bottleneck in the regulatory process. These organizations often struggle to meet the demand for timely reviews due to a shortage of trained personnel and the increased complexity of MDR compliance. Expanding capacity requires investment in training new auditors and regulatory experts. Industry associations and governments should collaborate to develop accelerated certification programs, focusing on skills required for evaluating innovative devices. Additionally, digital transformation can enhance efficiency within notified bodies. Electronic submission platforms and real-time tracking systems can reduce administrative burdens, allowing experts to focus on substantive evaluations. Some notified bodies are also establishing dedicated innovation teams to prioritize reviews for novel devices, ensuring that cutting-edge products receive timely attention. Addressing these capacity constraints will streamline the review process, benefiting both manufacturers and patients.

5. Harmonize Regulatory Practices Across Europe

Fragmentation in regulatory interpretations among EU member states creates inconsistencies that hinder market entry for manufacturers. Harmonizing these practices is crucial to fostering a predictable and efficient system. Standardized criteria for conformity assessments would ensure that notified bodies across Europe apply uniform standards, reducing disparities in evaluation outcomes. Mutual recognition agreements (MRAs) with regions like the United States could further streamline market entry. For example, a device approved by the FDA could leverage its existing data for European approvals, reducing duplication of effort. Additionally, a centralized EU pathway for innovative devices would eliminate member state disparities, providing manufacturers with a clear and consistent process. Harmonization not only simplifies regulatory navigation for manufacturers but also enhances patient safety by ensuring uniform standards across the region.

6. Support Manufacturers Of Low-Risk Devices

While high-risk devices often garner attention, low-risk devices face their own challenges, particularly in meeting unclear data requirements under MDR. Regulators need to provide tailored guidelines for low-risk devices, detailing acceptable forms of evidence such as literature reviews, usability studies, and equivalence data. Simplifying approval pathways for these devices would reduce the regulatory burden, allowing manufacturers to bring products to market more efficiently. Collaborative initiatives, such as data-sharing consortiums, could further support manufacturers by pooling anonymized evidence from similar products. These measures would ensure that low-risk devices, which often address essential but less critical medical needs, reach patients without unnecessary delays.

7. Expand Collaboration And Education

Building a collaborative ecosystem is essential for addressing systemic challenges in the European regulatory framework. Regular industry–regulator forums can facilitate open communication, enabling stakeholders to share insights, identify bottlenecks, and co-develop solutions. Such forums also provide an opportunity to align best practices and refine regulatory processes. Education plays a key role in empowering manufacturers, particularly small and midsize enterprises, to navigate the complexities of MDR. Tailored training programs focused on structured dialogue, clinical evidence requirements, and post-market surveillance can equip these organizations with the knowledge needed to comply effectively. A collaborative and well-educated ecosystem benefits all stakeholders by fostering alignment and reducing inefficiencies.

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8. Embrace Digital Transformation

Digital tools have the potential to revolutionize regulatory processes and compliance. EUDAMED, Europe’s centralized database for medical devices, promises to enhance transparency and traceability. Accelerating its full implementation would allow manufacturers and regulators to streamline device registration, track certifications, and monitor post-market performance. Beyond centralized databases, artificial intelligence (AI) can play a transformative role in regulatory reviews. AI algorithms can analyze clinical data, identify gaps, and predict risks with greater efficiency, reducing the time required for evaluations. Additionally, real-time data collection from connected devices can enhance post-market surveillance, ensuring patient safety while providing manufacturers with actionable insights. Embracing digital transformation will not only streamline regulatory processes but also improve the overall quality and safety of medical devices.

9. Advocate For Legislative Revisions

While manufacturers must work within existing regulations, collective advocacy can influence future policies to better balance innovation and safety. Industry coalitions, such as MedTech Europe, can play a crucial role in presenting a unified voice to policymakers. By highlighting the economic and public health benefits of expedited innovation pathways, these coalitions can make a compelling case for regulatory reforms. For example, demonstrating how delays in device approvals affect patient outcomes and healthcare systems can galvanize support for streamlined processes. Advocacy efforts should focus on expanding conditional certification, simplifying requirements for low-risk devices, and creating harmonized pathways for innovative products. Engaging in public consultations and contributing to expert panels further ensures that manufacturers have a direct role in shaping the future regulatory landscape.

Conclusion

Innovation in medical devices is at a crossroads, where the imperative to advance technology must align with regulatory rigor and ethical responsibility. Structured dialogue, harmonized pathways, and collaborative frameworks provide a road map for fostering innovation in Europe.

A collaborative, forward-thinking approach among manufacturers, regulators, and policymakers will ensure that Europe remains at the forefront of medical technology advancements. By implementing different approaches targeting existing challenges, the European medical device market can overcome them, fostering an environment that supports both innovation and patient safety once again.

Through collaboration, transparency and by learning from the global best practices that also can target regional issues, Europe can recover its leadership in medical technology and ensure that innovative devices reach patients in need, contributing to the transformation of the future of healthcare.

With Hacks on the Rise, Manufacturers Hone Their Cybersecurity Smarts

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 IndustryWeek, titled “With Hacks on the Rise, Manufacturers Hone Their Cybersecurity Smarts”, written by Stephen Gold.

With Hacks on the Rise, Manufacturers Hone Their Cybersecurity Smarts

Cyber-maturity is finally catching up to digital transformation, a new Manufacturers Alliance study finds.

A chief information security officer, a chief information officer and a chief manufacturing officer walk into a bar. Unfortunately, this isn’t the opening line of a joke – they’re in the bar because they need a stiff drink. These are harrowing times for manufacturing professionals who, in an era of Industry 4.0, are trying to integrate their information technology and operational technology while defending against the dramatically rising threat of cyber criminals.

It’s not like they have a choice on whether to integrate their IT with OT such as machine automation, industrial control systems (ICS), robotics, programmable logistics controllers (PLCs) and building management systems (BMS). Successful IT/OT collaboration is critical to modern manufacturers’ digital strategies. Unfortunately, it’s also the portal where cyber criminals gain entry to the lifeblood of the company: factory operations.

In fact, IBM’s X-Force Threat Intelligence reported that in 2021, manufacturing surpassed finance and insurance as the top targeted sector of cyber bad actors. Today, 1 out of every 4 cyber-attacks on business are against manufacturers. And no wonder: Despite FBI guidance, manufacturers pay the requested ransom more often than other industries – and at typically higher rates.

The biggest challenge? Cybercriminals with a track record of innovation set the pace of change. But manufacturers aren’t simply circling the wagons. Just the opposite – they’re meeting the challenge head on.

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Catching Up Quickly

Manufacturers Alliance partnered with Fortinet recently to update a joint 2020 study on IT/OT convergence. They found that American manufacturers’ level of cyber maturity is catching up to their accelerated pace of digital transformation. This is vital because, while financial extortion related to data theft is a serious risk, infiltration of operating systems with the intent to sabotage or even shut them down poses an existential threat to manufacturers. (The cyber-attack on Clorox this August, which paralyzed manufacturing operations for weeks and led to shortages of Clorox products in stores across the country, is the most recent poster child for the risk that factories face.)

The Alliance-Fortinet survey of 155 U.S.-based mid-cap to large-cap industrial companies showed that a growing percentage of manufacturers are well on their journey with advanced anti-cybercrime programs and policies yielding impressive results. That journey, of course, starts with a large dose of reality. When asked to rank cybersecurity as a business risk, 80% put it in the top five, 10 percentage points higher than three years ago. And no wonder: that same percentage experienced at least one breach resulting in unauthorized access to data in the previous 12 months.

Thirty-six percent of respondents fell victim to a ransomware attack, up from 23% in our 2020 survey. And more specifically, the impact of OT breaches has significantly increased over the past three years. While 43% of manufacturers in both 2020 and 2023 said they experienced cybersecurity-related operational outages affecting productivity –

  • 29% saw operational outages that affected revenue in 2023, a jump of 10 percentage points from 2020
  • 26% saw a loss of business-critical data, 14 percentage points higher than in 2020
  • 21% experienced a loss of IP, a jump of 10 percentage points in three years

So, how can manufacturers come out ahead of cybercriminals? Strategies are changing quickly. For starters, more than 90% of manufacturers say they’re focused on implementing new solutions to address risks specifically affecting OT, more than twice the percentage of just three years ago. Roughly the same percentage of manufacturers are now subjecting OT equipment to IT or cyber review prior to procurement. Among that group, many are deploying network access controls, including quarantining new devices until approved by the internal cyber team.

RELATED: Requirements Traceability Diagnostic

Finding Cybersecurity Talent Is Tough

Even with growing sophistication on managing OT threats, manufacturers face one primary obstacle to ultimate success: finding in-house expertise to oversee the cyber threat, a high hurdle considering the broader skilled talent shortage being experienced. In our recent survey, roughly 8 out of 10 manufacturers pointed to scarcity of talent and expertise as a key barrier to effective breach response within the last year.

Of course, manufacturers are in the business of making stuff, not securing networks. So given the scope of OT cybersecurity, from vetting new equipment to responding to breaches, fewer than 10% of companies handle all aspects with in-house resources. Two-thirds combine in-house and external expertise, and about 20% rely on third-party service providers for most of their security needs.

Remember the CIO, CISO and chief manufacturing officer walking into a bar? A decade ago they would never have been seen together. Today, their collaboration, and the smooth and rapid integration of IT and OT, is the key to a successful and safe implementation of Industry 4.0.

2025 Expert Predictions for the AEC Industry: How Technology, Emerging Trends, and Innovation Will Shape the Industry in 2025 and Beyond

2025 Expert Predictions for the AEC Industry: How Technology, Emerging Trends, and Innovation Will Shape the Industry in 2025 and Beyond

As we look toward the next five years in the Architecture, Engineering, and Construction (AEC) industry, emerging technologies are set to revolutionize how buildings are designed, constructed, and maintained. From the rise of digital twins to the growing integration of AI and machine learning, the tools and strategies transforming the industry promise to boost efficiency, sustainability, and collaboration. As companies prepare for these advancements, understanding how these technologies will shape the landscape and adopting the right tools will be critical.

In part five of our annual predictions series, Joe Gould, Senior Account Executive at Jama Software, shares his insights on the trends, challenges, and innovations shaping the future of AEC.

We like to stay on top of trends in other industries as well. Read our predictions for Industrial & Consumer Electronics (ICE), Automotive, Aerospace & Defense, Semiconductor, and Medical Device & Life Sciences.

Question 1: What emerging technologies or digital tools do you believe will most significantly reshape the AEC industry in the next five years, and how can companies prepare to integrate these advancements effectively?

Joe Gould: 

  • Digital Twins – The use of digital twins to create real-time, virtual representations of physical assets is set to revolutionize operations and maintenance. This technology provides actionable insights, predictive maintenance, and enhanced asset performance management. Implement IoT sensors and connect data streams to develop digital twin capabilities. Start with pilot projects to showcase value and gradually expand their use.
  • AI and Machine Learning – AI-driven tools will enhance project planning, risk management, and resource optimization. Machine learning models can analyze historical data to predict delays, optimize schedules, and reduce costs. Integrate AI into existing workflows, such as predictive analytics for scheduling or automated quality control checks, to reduce manual errors and inefficiencies.
  • Modular and Prefabrication Technologies – Offsite construction and prefabrication are becoming more efficient with advancements in design automation and digital manufacturing tools. Adopt software platforms that integrate modular construction workflows with design and scheduling tools. Establish partnerships with prefabrication facilities.
  • Sustainability Focused Tools – These are tools for energy modeling, lifecycle analysis, and carbon tracking will drive environmentally responsible design and construction. Embed sustainability metrics into project KPIs and adopt tools that facilitate compliance with green building certifications like LEED or BREEAM.

RELATED: Jama Connect Advisor™

Question 2: As sustainability goals become increasingly prioritized, what role do you see software and product development playing in achieving more environmentally friendly and energy-efficient designs within the AEC sector?

Gould: Software and product development play a pivotal role in advancing sustainability and energy efficiency within the AEC sector by enabling more data-driven, holistic, and collaborative approaches to design and construction. Tools such as Building Information Modeling (BIM), energy simulation software, and lifecycle assessment platforms allow architects and engineers to optimize designs for energy performance, material efficiency, and reduced carbon footprints from the earliest project stages. Digital twins extend this capability by facilitating real-time monitoring and optimization of building performance throughout its lifecycle, ensuring long-term energy efficiency and reduced environmental impact. By leveraging these technologies, companies can not only meet regulatory demands but also position themselves as leaders in creating environmentally responsible and energy-efficient designs that contribute to a sustainable future.

Question 3: With remote and hybrid work now a permanent reality for many industries, how do you anticipate these work models impacting collaboration and innovation in the AEC space, especially regarding software and project management tools?

Gould: With remote and hybrid work becoming the norm, the AEC industry is seeing some interesting shifts in how teams collaborate and innovate. While it used to be all about in-person meetings and site visits, now software and project management tools are stepping up to bridge the gap. Cloud-based platforms make it easier than ever for teams to share updates, track progress, and stay connected no matter where they’re working from. This new way of working is also pushing companies to adopt more streamlined workflows and better communication practices, which can actually spark innovation!

Question 4: How do you foresee AI and machine learning influencing decision-making and risk management in AEC projects? What are some challenges or limitations the industry might face in adopting these technologies?

Gould: AI and machine learning are definitely shaking things up in the AEC industry, especially when it comes to decision-making and risk management! These technologies can analyze massive amounts of data — like project schedules, historical performance, and even weather patterns — to predict potential delays, budget overruns, or safety risks before they happen. It’s like having an early warning system that helps teams make smarter, faster decisions. On top of that, AI can optimize workflows, improve resource allocation, and even suggest more efficient designs.

RELATED: Six Key Challenges in the Architecture, Engineering, Construction, and Operations (AECO) Industry and How to Solve Them with Jama Connect®

Question 5: As a follow up question: Do you have any concerns or anticipate any negative impacts as it pertains to AI & ML.

Gould: I believe there are some challenges to getting these tools up and running. One big hurdle is the quality of data — if your data isn’t clean or consistent, the AI’s predictions won’t be reliable. There’s also a learning curve; not everyone in the industry is ready to fully embrace these new tools, so training and change management are crucial. Plus, while AI is great for identifying trends, it still relies on human expertise for context and final decisions. So, while the potential is huge, there’s still some work to do in terms of adoption and integration in my opinion.

Question 6: Given the current emphasis on data-driven project management and predictive analytics, what strategies would you recommend for AEC firms to better leverage data for optimizing project outcomes and resource allocation?

Gould: If AEC firms want to get more out of data-driven project management, it starts with organizing their data. Centralizing everything — budgets, schedules, progress updates —into tools like BIM or Procore makes it easier to analyze and act on insights. Predictive analytics can then help spot issues early, like delays or resource shortages, so teams can adjust before problems escalate. The key is to train people to use the data effectively and start with small pilot projects to build confidence. When everyone’s on the same page and using the same data, decisions get smarter, and projects run smoother.

Question 7: Are there any additional insights you have regarding predictions, events, or trends you anticipate happening in 2025 and beyond?

Gould: Looking ahead to 2025 and beyond, I think we’ll see a bigger push for sustainability in AEC, with more focus on net-zero buildings and carbon tracking tools. AI and automation will likely play an even larger role in design and project management, making workflows faster and more efficient. Plus, digital twins and smart buildings will continue to grow, especially as IoT tech gets better. The challenge will be adapting quickly while balancing innovation with practicality, but the opportunities for transformation are huge!

FDA Issues Comprehensive Draft Guidance for Developers of Artificial Intelligence-Enabled Medical Devices

Jama Software is always looking for news that would benefit and inform our industry partners. As such, we’ve curated this recent press release from the U.S. Food & Drug Administration, titled “FDA Issues Comprehensive Draft Guidance for Developers of Artificial Intelligence-Enabled Medical Devices” and originally published on January 6, 2025.

FDA Issues Comprehensive Draft Guidance for Developers of Artificial Intelligence-Enabled Medical Devices

Guidance Shares Strategies to Address Transparency and Bias, while Providing Key Considerations and Recommendations on Product Design, Development and Documentation

Today, the U.S. Food and Drug Administration issued draft guidance that includes recommendations to support development and marketing of safe and effective AI-enabled devices throughout the device’s Total Product Life Cycle. The guidance, if finalized, would be the first guidance to provide comprehensive recommendations for AI-enabled devices throughout the total product lifecycle, providing developers an accessible set of considerations that tie together design, development, maintenance and documentation recommendations to help ensure safety and effectiveness of AI-enabled devices. This guidance complements the recently issued final guidance on predetermined change control plans for AI-enabled devices, which provides recommendations on how to proactively plan for device updates once the product is on the market.

“The FDA has authorized more than 1,000 AI-enabled devices through established premarket pathways. As we continue to see exciting developments in this field, it’s important to recognize that there are specific considerations unique to AI-enabled devices,” said Troy Tazbaz, director of the Digital Health Center of Excellence within the FDA’s Center for Devices and Radiological Health. “Today’s draft guidance brings together relevant information for developers, shares learnings from authorized AI-enabled devices and provides a first point-of-reference for specific recommendations that apply to these devices, from the earliest stages of development through the device’s entire life cycle.”

The draft guidance includes recommendations for how and when, in marketing submissions, sponsors should describe the postmarket performance monitoring and management of their AI-enabled devices. The proposed recommendations reflect a comprehensive approach to the management of risk throughout the device total product life cycle. The FDA encourages sponsors to engage with the agency early and often, and to use this guidance, once finalized, to guide their activities throughout the life cycle of the device, including during planning, development, testing and ongoing monitoring.

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Importantly, this draft guidance also includes the FDA’s current thinking on strategies to address transparency and bias throughout the life cycle of AI-enabled devices. The draft guidance describes specific recommendations intended to help a sponsor demonstrate they have addressed risks associated with bias and provides suggestions for the thoughtful design and evaluation of AI-enabled devices.

Notably, this announcement is specific to AI-enabled devices. Today, the FDA also published draft guidance with recommendations regarding the use of AI to support development of drug and biological products. The publication of these guidances, among other actions, continues to demonstrate the agency’s efforts to provide transparency and to help ensure product safety and effectiveness while supporting innovation in this rapidly growing field.

The FDA is requesting public comment on this draft guidance by April 7, 2025. In addition to general comments, the FDA is specifically requesting public comment on the draft guidance’s alignment with the AI lifecycle; the adequacy of the recommendations to address concerns that may be raised by emerging technology such as generative AI; the approach to performance monitoring (including use of a performance monitoring plan as a means of risk mitigation for AI-enabled devices); the type of information about AI-enabled devices that should be conveyed to users and the most appropriate approach to deliver that information. The FDA will also hold a webinar on February 18, 2025, to discuss the draft guidance.

Related Information
Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations – Draft Guidance for Industry and FDA Staff
FDA – Artificial Intelligence and Machine Learning in Software as a Medical Device
FDA’s list of Artificial Intelligence and Machine Learning-Enabled Medical Devices
FDA Blogs: The Promise Artificial Intelligence Holds for Improving Health Care and A Lifecycle Management Approach toward Delivering Safe, Effective AI-enabled Health Care

Shaping the Future of MedTech: Insights from Industry Leaders on AI, Innovation, and Regulatory Challenges

In this blog, author Vincent Balgos discusses the 2024 MedTech Conference, which took place in Toronto, CAN, from October 15 – 17, 2024.

Shaping the Future of MedTech: Insights from Industry Leaders on AI, Innovation, and Regulatory Challenges

Jama Software made its debut appearance at 2024 MedTech Conference in Toronto, CAN recently, and it was an inspiring experience. In addition to meeting passionate medical technology developers, learning the latest innovation trends, and establishing networking connections, I had the opportunity to attend a few panels/talks that wanted to share some insights.

Keynote: Medtech in Motion: Shaping the Future of Health Care Innovation

Attendees (left to right) Peter Arduini – President & CEO at GE Healthcare; Mike Mahoney – Chairman & CEO at Boston Scientific; Roy Jakobs – CEO at Philips; and Joanne Wuensch – Moderator.

With the keynote introduction and brief overview of med tech evolution provided by by AdvaMed’s President, the main event was a panel of Chief Executive Officers from GE Healthcare, Boston Scientific, and Philips discussed key factors that are forging the path of industry innovation.

Artificial Intelligence’s (AI) continual emergence in the conversation of innovation with application for both internal and external purposes. On the external side, AI’s predictive approach is a dominant talking point, supporting medical professionals on complex data analytics by identifying trends, correlations, etc., to help inform clinical decisions at scale. On the internal application, generative AI technology was mentioned as a potential factor to streamline efficiencies with improved internal processes and workflows within the organization. This is a topic that both AdvaMed President and GE Healthcare CEO have previously posted about, highlighting AI’s benefit on both the external and internal fronts that is already reaching patients’ bedsides and company’s processes (respectively) now. These tech-enabled efficiencies are proving to be a potential game changer in the way medical devices operate and develop products. An interesting un-answered question is the integration of AI into an ecosystem of tools, processes, and products, and its impact on the overall value.

The CEO panel unanimously agreed that removing bottlenecks, reducing inefficiencies, and leveraging automation are key for continual innovation in the med industry. With resources becoming limited and the complexity of technology increasing, there’s a continual search for innovative ways to develop safe and effective products faster. To paraphrase, any efforts to allow the development team to focus more on development activities and automate the routine, mundane tasks such as documentation provide teams more time to do the more challenging tasks.

Looking forward five years from now, the discussion turned to how to balance the fast innovation trend seen in emerging/non-traditional markets and the safety and effectiveness performance expectations of the medical industry.

  • Is there a way to harmonize both to develop safe products, but at accelerated velocity?
  • Also, how will regulations keep up with the pace of innovation, especially AI?

While FDA proactiveness is helping guide the industry, there are still a lot of unknowns that need to be discovered, derisked, and regulated appropriately.

On the second bullet, Jama Software can support the acceleration of development processes by streamlining the requirements, verification/validation, and risk management all within a single tool. By leveraging the out-of-the-box solutions, traceability to quality best practices becomes an automated byproduct, where can easily create technical documentation at the push of a button. By making routine documentation activities routine, developers can then focus on the more challenging aspects of product development, thereby increasing the velocity and efficiency of innovation. To learn more, please contact us.

 

Attendees (from left to right) Janet Trunzo – Moderator; Dr. Michelle Tarver – FDA Office of the Center Acting Director; Dr. Jeffrey Shuren – FDA Office of the Center Director; Dr Daniel Canos – Director, Office of Clinical Evidence and Analysis; Dr Owen Faris – Director, Office of Product Evaluation and Quality; and Troy Tazbaz. – Director, Digital Health Center.

Pictured (from left to right) Dr. Michelle Tarver – FDA Office of the Center Acting Director; Dr. Jeffrey Shuren – FDA Office of the Center Director.

What better way to start the last conference day than having breakfast while listening to the FDA Center of Radiological Health (CDRH) panel sharing some of their leading thoughts on trending topics within the industry. With introductions by Terumo CEO and announcing the upcoming retirement of Dr. Jeff Shuren (Director). Next was the introduction of Dr. Michelle Tarver as the incoming Director, where Dr. Tarver gave an introductory speech, highlighting her focus on a patient-first approach, providing access and equity to safe and effective medical devices to general population, and her visions for continuing and evolving FDA’s path for regulatory guidance for industry, including the Home as a Health Care Hub initiative.

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

After the panel introduction, the audience was encouraged to ask questions. Some (paraphrased) questions and responses are below:

[Editor’s Note: These responses are paraphrased from the FDA and not actual FDA statements. Please also note that Jama Software is not a regulatory consultant. These are observations only.]

How is FDA providing medical care access to more underserved patient population, particularly the women population?

Response: One of the key strategic priorities for CDRH in 2022-2025 is advancing heath equity for all patients and evaluations that take into account is the diverse population for which they are intended.

Jama Software: After the conference, an online search resulted in an Executive Summary for more information. Referencing the introductory speech, Home as a Health Care Hub seems to be a key factor in broadening all patients’ access to healthcare.

How does industry streamline their submissions processes and success rate to the FDA? It is very costly to the organization for each resubmit & re-address cycle.

Response: Before formal submission, it is highly recommended to consider pre-submissions as part of the regulatory strategy. This allows early interactions between FDA and the organization to help answer questions, identify gaps in the submission, and provide general guidance for a successful pathway.

Jama Software: Based on my experience, pre-submissions are standard of practice to help derisk many unknowns and help successfully navigate through the complicated submission process, especially with novel technologies or indications of use scenarios. I’d consider FDA as more of a partner than “overlord” as they have the shared goal of providing safe and effective medical to US patient population. If done correctly, pre-submissions save organizations time and money, since many of the questions / issues are proactively addressed.

While the FDA has been proactive in providing regulatory guidance on Artificial Intelligence development and applications, there are still many open questions, especially in generative AI and post market scenarios. What are some key areas that are in discussion (e.g., validation of generative AI)?

Response: Generally acknowledged that there is a lot to still discuss since it is an evolving technology. The 2023 draft guidance on “Marketing Submission Recommendations for a Predetermined Change Control Plan fo Artificial Intelligence/Machine Learning (AI/ML) – Enabled Device Software Functions” provides some considerations in how to manage change, especially in the post-launch scenarios. Since GenAI is continually learning and adapting to new data, there will be focus on post-market topics and how to handle AI’s dynamic state. This includes validation strategy and some general guidance. In addition, some general questions for organization to consider during AI development are:

  • What are the general problem statements that AI is trying to solve?
  • What are the large language models (LLM) being used for the device? Does the LLM support the devices intended use case(s)? Or is it the rationalization part of AI that is assessing data?
  • Would a separate AI be needed to monitor / manage the device’s AI?

Defining these approaches may help understand the associated benefits and risks with these new devices.

Jama Software: Previous FDA documents (1, 2) also shed some light on what the regulatory framework could look like in the future, so encourage research and comprehensive documentation of AI’s software requirements, testing, and associated risks.

Overall, breakfast with FDA was an insightful experience to understand what the regulatory body is thinking around current topics. When it comes to complex medical device development, Jama Software can support regulatory and quality compliances to key standards (Design Controls, ISO 13485) to allow teams to streamline their work efficiencies, reduce rework, and accelerate product launches to market.

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

Below are a few additional thoughts and insights gleaned from the speakers at the MedTech conference:

Medical Cybersecurity Digital Health Technologies

Panelists:

Tech-Enabled Efficiency

To go faster, what tools and processes can be used to automate the more mundane tasks?

Digital Health Coverage is Limited

The regulators and industry are still trying to catch up. This is why hospitals are getting attacked, breeches, etc. Software is becoming more and more prominent, plus the software with connections introduces a huge vulnerability for bad actors. We’re still trying to wrap our heads around this. Final guidance on cybersecurity was released in 2023. There must be a cybersecurity plan included in your final submission.

Faster is Not Always Better

Unlike consumer electronics or social media, medical device & life sciences industry likes innovation, but having the latest innovation is not always great – the tradeoff is reliability, safety, and effectiveness. Just because you CAN go faster with innovation and development time, doesn’t mean you should. Because we deal with patients, we have to keep quality in check. We need to take a more thoughtful, steady, and proactive approach. If we don’t understand the software, we are putting a lot of our patients at risk.

Longitudinal Thinking and Applications

The CEO of GE and Philipps mentioned this twice in their speech. In this area, they want to have longitudinal traceability OUTSIDE of the device – worrying about the infrastructure, the users, the medical records, and other aspects of the product or the organizations. The impact isn’t on my device, there’s a broad impact.

In your submissions, in terms of cybersecurity, you must have good documentation. Define your problem, what are your indications of use, what is your environment of use (is this a connected device, where are the digital connections and vulnerabilities). What the FDA is looking for is a story to take a more risk-based approach to developing and approving products.

In medical device development, we used to have this thought: If you’re not sure of something, go back to the documentation. Trust it but verify it.

The new thinking is that you should never trust it and always verify. Documentation is becoming more complex, and teams sometimes aren’t documenting in the way that they should.

2025 Expert Predictions for the Automotive Industry: AI, Sustainability, and the Road Ahead

2025 Expert Predictions for the Automotive Industry: AI, Sustainability, and the Road Ahead

The automotive industry is undergoing a seismic transformation, driven by advancements in AI, machine learning, electric vehicles, and sustainability initiatives.

In part two of our annual predictions series, Jama Software’s industry experts — Neil Stroud, General Manager of Automotive & Semiconductor; Stefan Stange, Managing Director; Matt Mickle, Director of Solutions and Consulting; and Ádám Gősi, Account Executive — share their insights on the most pressing challenges and groundbreaking innovations shaping the future of automotive.

From the rise of software-defined vehicles to overcoming supply chain disruptions and achieving ambitious sustainability goals, this year’s predictions offer a compelling roadmap for manufacturers looking to stay competitive and thrive in the years ahead.

We like to stay on top of trends in other industries as well. Read our predictions for Industrial & Consumer Electronics (ICE) HERE and stay tuned for future topics, including Aerospace & Defense, Medical Device & Life Sciences, Energy, and Semiconductor.

Question 1 – With the rising integration of AI, machine learning, and autonomous systems, how do you foresee these technologies reshaping automotive and semiconductor operations? What are the most promising applications and potential challenges?

Neil Stroud: The industry has undergone somewhat of a reset of expectations around autonomy. Solving the challenges related to autonomous vehicles is harder than we all thought. Generally, we are now laser-focused on the software-defined vehicle and developing the related systems that allow mass deployment of L2+ and L3 capable vehicles. This will ultimately lead into autonomy anyway.

It’s great to see robotaxi solutions gaining traction with L4 (ODD limited L5) and humans slowly becoming more open to getting in a vehicle with no driver. This is a massive mindset shift.

AI/ML has a massive role to play in all of these areas.

Stefan Stange: Development complexity and quality expectations will increase exponentially while the development time and cost must decrease, modern tools and processes supported by AI will support to solve these challenges.

Matt Mickle: With automotive, AI is exponentially increasing the development of systems that will enhance safety, enable convenience, and make maintenance more reliable. Overall, this is shifting the perspective of the driving experience entirely. This does come with concerns around risk especially in regards to cybersecurity, and with ethical decision making.

On the semiconductor side AI is helping to optimize design of chip architecture and enhance performance with AI-assisted tooling providing better analytics. Risks here are also in cybersecurity as well as supply chain risks due to things like export controls and potential tariffs.

Ádám Gősi: The challenge I think will define future development is intellectual property and how certain tools and models are handling sensitive data. Besides this, it is important to establish the responsibilities. In safety-critical development there always has to be a human expert to control the result. These factors will determine if it is worth investing in developing a new AI model or maybe adopting an existing one. Customers often don’t have their own definition of what they are expecting of an AI, they expect us to show them our best interpretation so far. This could lead to a trap of over-promising. With my limited knowledge, I see the current era as the “gold rush era” – some AI developers don’t have a clear target just hoping to hit the big prize.

Question 2 – As a follow-up question: Do you have any concerns or anticipate any negative impacts as it pertains to AI & ML?

Stroud: As someone who has worked in functional safety for almost 20 years, I’m still concerned about the industry’s ability to develop systems that have the appropriate levels of safety where AI is involved. As humans, we expect the autonomous world to be a safer world and reduce the number of accidents, injuries, and deaths on our roads. However, there are plenty of high-profile examples where we are falling short.

Stange: Safety and security are a must, not losing the data authority.

Mickle: Definitely many concerns with things like AI being used maliciously in cybersecurity attacks, Energy consumption and waste issues due to the massive amounts of computational energy needed, unpredicted failures or AI hallucinations, etc. but these need to be considered and worked through as progress is inevitable and unavoidable.

Gősi: In safety-critical development there always has to be a human expert to control the result.

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

Question 3 – With the rapid progression toward electric vehicles (EVs) and autonomous driving, what technological advancements do you think will be critical to automotive innovation over the next few years, and how can manufacturers stay competitive?

Stroud: The industry has to keep investing in battery technology to increase the range capabilities of vehicles as well as extending useful battery lifetime. It will be interesting to see how well alternative fuels such as hydrogen become mainstream. I do think there will be new data that comes to light that shows that electrification isn’t necessarily the holy grail that we expect. Building batteries is taking a major toll on the planet so there may well still be a combustion engine resurgence. Also, there is a macroeconomic challenge in that 80% of the world EV batteries come from China.

There is also a significant electrical grid infrastructure challenge to solve that is hugely expensive. As the number of EV’s grows, it will be theoretically possible to intelligently use power stored in unused vehicles to supplement the grid for supply. However, the grid we have today is fundamentally unidirectional (i.e. power station to consumer). Making this bidirectional is a massive and costly challenge.

Over the coming years, there is no doubt the industry will continue to get autonomous operation to a more reliable, safe, and therefore more mass-deployable state. As a result, new car ownership and usage business models will emerge enabled by technological advancements.

Stange: Development complexity and quality expectations will increase exponentially while the development time and cost must decrease. The use of modern and forward-thinking solutions will help.. Defining and following reliable processes and partnerships enabling a collaboration network by using best-in-class solutions with full traceable Agile for the development and manufacturing process should be the goal.

Mickle: AI has been coined as the next major platform shift or technology super cycle and will be the primary change for the upcoming years until we have greater machine intelligence or perhaps “machine consciousness” or Artificial Super Intelligence where AI actually outperforms humans across the board.

Gősi: As release cycles are ever shorter, products and software have to be released before fully developed. Over-the-air updates will be an important factor. Automakers will be able to update less developed rapidly depreciating models. ADAS sensors will become more refined, but incrementally. The current hardware is capable of fully self-driving. Software and regulation/local law are the limiting factors. Battery technology could see an improvement in general with the range increasing. Western Manufacturers will have to bring down the costs and improve on software quality, like Asian EV manufacturers.

Question 4 – Sustainability is a growing focus in the automotive industry. How do you see product design, materials, and manufacturing processes evolving to meet environmental goals and what role will software play in supporting these sustainable initiatives?

Stroud: There are many aspects to this. Making vehicles even more recyclable is fundamental. This impacts not only the materials used within the vehicle but also the design and construction of the vehicle. There is always the tradeoff between the value of recycled materials versus the cost of the effort to break the old car down into distinct recycled parts.

We are already seeing huge effort being put into efficient scalability and reuse when it comes to vehicle chassis platforms and software reuse.

Finally, manufacturing has a key role to play. The continuous march towards the truly smart factory that not only allows for mass-customization but also the ability to manufacture multiple models on the same production line even to the point where a single MaaS line can produce for multiple OEMs. These megafactories will be super-efficient and because there are fewer of them, the environmental impact will be lower.

Stange: The complexity also to guarantee sustainability will increase and must be handled with a professional and scalable software and process.

Also, the market expectation in regard to design, materials, individuality and related manufacturing processes will increase and be a game changer for success.

Mickle: Systems are being designed more with an end of life in mind and with reusability and modularity as a backbone. We’ve seen this shift for many years now with SDVs and it will only grow. Data provided by AI driven software will help drive optimization in the lifespan of all areas of the development process and supply chain, enhancing efficiency to reduce waste and understand better how things can be reused.

Gősi: Sustainability goals are not supporting the real cause in my belief. If EVs are going to continue being the supported trend by governments, and therefore manufacturers, then the battery manufacturing and recycling process needs to be improved to be more sustainable.

Question 5 – As software-defined vehicles become the new standard, what shifts do you anticipate in software development and cybersecurity practices to support seamless updates, driver experience, and vehicle safety?

Stroud: Software is eating the world. The challenges faced by OEMs in the software domain is immense. The modern vehicle contains hundreds of millions of lines of code. More than a modern commercial or military aircraft. This problem is compounded as the software comes from hundreds of third-party vendors and it is the responsibility of the vehicle manufacturer to integrate and test everything for correct operation and ensure it is still safe, secure and performant. This need must drive a mindset shift in the way systems are designed as well as breaking down the barriers between the OEM’s and the suppliers. The ones that will succeed are the ones that foster seamless interfaces between organizations. This will directly impact safety and security in a positive way as well as accelerating innovation.

Stange: A car becomes more and more a computer with wheels with exponential increase of requirements regarding software, updates on weekly basis also considering cybersecurity. Manufacturers have to balance between cost and security and develop cars that allow access to like a iPhone or computer but with higher and better security and safety strategies.

That means, car software platforms have to change and improve dramatically in the next years.

Mickle: Increased automation and traceability throughout the toolchain, using AI to analyze data and improve efficiency by providing that data intelligently to influence rapid change and execution.

Gősi: On the high level over the over-the-air updates and software updates and development need to be improved at the majority of OEMs and suppliers.

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

Question 6 – How is the automotive industry preparing to address challenges in the supply chain, particularly with semiconductor shortages, and what strategies could help improve resilience and adaptability in the face of future disruptions?

Stroud: The recent semiconductor supply constraints were a wakeup call for the industry. Vehicle shipments were being held up because of the lack of availability of the smallest sub-$1 components. As a result, I see two behaviours emerging. Some OEM’s are naturally building strategic partnerships with the semiconductor suppliers and trying to contractually guarantee supply. This gets interesting as the majority of semiconductor companies are ‘fabless’ and rely on companies such as TSMC, Global Foundries and SMIC. The other strategy is to take matters into your own hands and develop your own chips (ASIC) that provide exactly the functions that are needed versus the inevitable compromise that often happens with an off-the-shelf standard product. Companies like JLR are starting down this path. However, it’s not for the faint-hearted. Chip design is not easy and it’s expensive especially if you want to gain the benefits of the latest bleeding edge process nodes. Also, you will still be dependent on the same fab companies that serve the rest of the industry.

Stange: I see OEM collaborating more and more with start up´s in the semiconductor or EV market to assimilate the needed know how, strategies and flexibility reacting fast to the market needs. So, for example VW collaborates with Rivian and announced using their Software platform for the next Audi´s and VW´s and Aston Martin is collaborating with Lucid.

Mickle: Investment in local suppliers as well as diversifying the regions from which supplies are acquired. Also designing for flexibility and modularity such as with chiplets.

Gősi: Shortages don’t seem to be a problem nowadays. The supply chain needs to be more agile and detect risks sooner to avoid the delays caused by the JIT method.

Question 7 – The concept of “mobility as a service” is gaining traction in urban areas. How do you think automotive companies should adapt to this trend, and what new types of partnerships or innovations do you foresee in this area?

Stroud: MaaS will ultimately drive massive change in the way the mobility of the population happens. We already see that the current generation generally has a dramatically different view on driving and vehicle ownership. We’ve already witnessed the disruption that rideshare created. The car OEMs will have to adapt and develop new business models that go beyond the traditional purchase and lease models of today. There will be intermediary companies that emerge (that could be subsidiaries) that provide such services. I also envisage tighter integrations with the insurance companies as the volume of individual vehicle data that’s available will allow for hyper-tailoring of such services.

Stange: From my perspective, we have started mobility as a service already in urban areas with apps like FreeNow or Uber and more will come. Important is, that everything somehow has to be networked with the support of intelligent systems and software.

Also, the infrastructure, for example, intelligent charging points, parking, and availability has to improve. The way of thinking about mobility as a service has already changed for the younger generation, while my older son still likes cars for fun and as a status is my younger son just considering how to get from A to B fast, cheap, and safe.

Gősi: This is a business question between OEMs and local governments. From a product perspective, they would need cheap-to-produce and cheap-to-maintain and easy to drive vehicles that can serve those users. Manufacturers will have to further optimize their platform strategy for this specific application.

Question 8 – Are there any additional insights you have regarding predictions, events, or trends you anticipate happening in 2025 and beyond?

Stroud: I strongly believe that it is not the technology that will limit the deployment of these new technologies but the legislation. Every single country has a different set of rules and that will have a significant impact. We also have to overcome the challenges of dealing with ethical AI. Autonomous crash scenarios will have to be ‘calculated’ differently depending upon geographic location. Naturally, this is a highly sensitive topic but one that must be solved.

Stange: 2025 will be a challenging year for Automotive specially and Europe, unclear EV strategies, Asian competition, high taxes, energy and labor costs, and political struggles – everything will push the auto industry to slimline their way of thinking, developing, and manufacturing. On the other side, there will be a lot of opportunities for the innovators, the startups, and the companies, that reinvent themselves and restructure in a healthy way, these are the ones, we are happy to support.

Gősi: Unless there is a major shift in strategy and execution, the traditional European OEMs will lose their market-leading position. Innovative US and innovative and competitive Asian manufacturers will take over the leading position.

Editor’s Note: Responses reflect a mix of British and American English, depending on the respondent.

[Webinar Recap] Write Better Requirements with Jama Connect Advisor™

In this blog, we recap the “Write Better Requirements with Jama Connect Advisor™” webinar.
Click HERE to watch it in its entirety! 

Achieve Project Success with Clear, Effective Requirements

In this webinar, the speakers provide insights on how to leverage Jama Connect Advisor™, an easy-to-use, cutting-edge requirements authoring, editing, and analysis tool. Jama Connect Advisor uses Natural Language Processing (NLP) and evaluates and scores requirements against INCOSE EARS guidelines, enabling teams to create industry-compliant requirements, reduce risk, and improve efficiency throughout development.

You will learn how to:

  • Boost requirements clarity and writing speed as well as develop team skills with guided authoring
  • Track progress and improve requirements quality over time with downloadable reports
  • Improve the quality and usability of large volumes of requirement statements effortlessly with Batch Analysis
  • Save time on authoring, reviewing, and updating requirements
  • Confidently assess project readiness through requirements maturity analysis
  • Minimize rework risk due to ambiguity and contradictions

Below is an abbreviated transcript and a recording of our webinar.

The video above is a preview of this webinar – Click HERE to watch it in its entirety!

VIDEO TRANSCRIPT

Write Better Requirements with Jama Connect Advisor

Jeremy Johnson: Thank you so much to everybody that’s joining us today. This is a pretty special time for us to be able to take a new capability to market. From a product management and product development standpoint, it’s an extremely exciting time for us. So again, I appreciate everybody’s time in joining us here today.

Before we transition into the main portion of the session here, I want to provide a short introduction and an overview of our agenda. We’ll talk a little bit, for those who aren’t familiar with us, a little bit about Jama Software. We’ll talk a little bit about the trends in product development, and some of the challenges that we see in requirements authoring. We’ll also of course introduce you to Jama Connect Advisor, who it’s for, and how it works. We’ll get into a demonstration. We’ll also talk a little bit about our customer success program, specifically our customer success authoring workshop, and how we are now including and embedding the technology and the capabilities around Jama Connect Advisor into that consulting offering.

And then, as Juliette mentioned, our special guest, Sheila King will go into the requirements quality focus that she’s helping implement at Rockwell Automation, and we’re super excited and happy to have her. And then, we should have some time at the end of the session for some questions as well.

But again, starting with and moving into Jama Software’s role in the product development ecosystem, our vision and our purpose as an organization is to ensure that innovators succeed. And as you’ll see from today’s discussion and demonstration, that’s really at the core of what drove our introduction of Jama Connect Advisor.

From a broader solution standpoint, Jama Connect is the number one requirements management provider in the marketplace. We help teams with requirement management and product development through live traceability that also spans not only requirements, but the verification and validation components on the test side, risk management, and other key data that drives those processes forward.

The value that we hope these innovative organizations, our customers, derive is really focused around things like cycle time reduction, helping speed time to market, enabling through live traceability the ability to gain visibility and control over the organization’s product development processes, and really drive streamlining, really drive a tremendous amount of value, and ultimately ensure compliance and managing risk.

As far as organizations that we work with, we span medical device, automotive, industrial, machinery,and software, and this is just a sampling of the customers that we have the pleasure of partnering with. We have over 800 customers globally. These organizations span from smaller startup organizations to large global enterprises.

So with that very short intro to Jama Software, I now would like to review some of the complexity and challenges that we see today in product development, and of course to introduce you to Jama Connect Advisor.

Related: Jama Connect Advisor™ Datasheet

Katie Huckett: Thanks, Jeremy. I’m really excited to talk about Jama Connect Advisor today and some of the things that are happening in the environment that led us to develop this solution. Today’s systems have become much more complex, and the emergence of the system of systems architecture has become the dominant approach for devices in all sectors, whether it’s aerospace, automotive, medical, and even consumer products. The system of systems is actually a collection of independent subsystems that are integrated into larger systems and deliver the unique capabilities required by users. The challenge is that it is difficult to predict accurate, predictable models of all emergent behaviors. So global systems of systems performance is difficult to design. That leads to testing and verification. Verifying upgrades to existing systems of systems is difficult and expensive as well, which is hard to scale. These are some of the factors that have led us to think about how we can help.

Another question we asked ourselves is why is requirements authoring so hard? If we look at the industry approaches for requirements authoring, we looked at the International Council on Systems Engineering’s (INCOSE) Guide for Writing Requirements. There’s a need to exercise a core subset of 40 rules in the INCOSE Rules for Writing Requirements, and in addition to that, an assessment of 49 requirement attributes. So just following INCOSE alone requires a substantial amount of training and understanding and then applying it, which can take a lot of time.

We’ve also found that EARS, the Easy Approach to Requirements Syntax, is being adopted by many organizations developing complex systems of systems. That includes Airbus, Bosch, Dyson, Honeywell, Intel, NASA, Siemens, and others. What EARS does is gently constrain the textual requirements. The EARS patterns provide guidance for writing a requirement sentence and provides syntax structure with an underlying rule set. Even these industry preferred approaches are challenging to apply, so we’re looking at how we might address that.

So today, just as a brief example, product requirements quality drives fidelity and efficiency in the product development cycle. If you look at this automotive example, there are many systems. It’s a complex system of systems that are dependent on each other. Any of these systems can lead to confusing the operator or systems operating optimally. If you look at the traditional V model of approaching systems engineering, the requirements are fundamental at the very early phase. So immediately after your needs analysis, you need to have really clear, concise, accurate requirements definitions.

The negative outcomes of poorly written requirements has been well-documented. It often leads to delayed time to market, late stage errors in the product, inaccurate translation of stakeholder needs into product attributes, and the lack of development team synergy. As teams are very organic today, the requirements need to be documented clearly and in an understandable way so that the team can execute with high performance. And then, ultimately failure and verification and validation can happen without high quality requirements.

Related: How the EARS Notation Supports Effective Requirements Management and Live Traceability™ 

Huckett: A secondary challenge is the training and reinforcement of requirements authoring skills. The lack of proper requirements can lead to product issues, and it’s a significant challenge in today’s environment. 30% of engineering degree holders are nearing retirement globally, and in the US 79% of American workers agree that to retain or increase their future employability, they need to continue with their learning and development. Computer scientists, 47.5% participate in work-related training to maintain and extend their skills, and engineers almost 60% do the same. So onboarding, retaining, and training system engineers remains a significant challenge.

With those items as a background, I’d like to introduce Jama Connect Advisor. Jama Connect Advisor is an add-on for Jama Connect Cloud. It’s an intelligent natural language advisor that improves the quality of requirements. It allows you to author intricate product requirements quickly, easily, and with precision. It is powered by engineering-based natural language processing, so not a general-purpose aid. It is engineering language-based. The advice provided is based on the industry-recommended best practices for the INCOSE rules and EARS notations.

Jama Connect Advisor has a very significant side benefit, while you use it, it augments skills and reinforces organizational preferences while authoring. So not only is Jama Connect Advisor doing the pragmatic work of improving requirements quality, but your systems engineers are learning how to do that more quickly and efficiently over time with its use.

When we look at Jama Connect Advisor’s capabilities, its features include analysis and advice from industry-leading practices, INCOSE rules, and EARS notation. The application is designed to put these two together to increase the quality, accuracy, and efficiency of requirement statements. So that’s its unique value. The guidance is provided seamlessly while you are editing in Jama Connect, which we’ll demonstrate in a moment. So really, the advantages are that experts can work faster confirming the application of INCOSE and EARS as they go, sharing their expert knowledge across the organization.

CLICK HERE TO WATCH THE ENTIRE WEBINAR:
Write Better Requirements with Jama Connect Advisor™

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2025 Predictions for Industrial Project/Product Development: AI, Sustainability, and the Future of Connected Devices

2025 Predictions for Industrial Project/Product Development: AI, Sustainability, and the Future of Connected Devices

As the Industrial, Consumer Electronics, and Energy (ICE) industry races toward 2025, a landscape of rapid innovation, complex challenges, and transformative potential emerges.

In part one of our annual predictions series, we asked Richard Matt, Lead Consultant at Aspen Medical Risk, and our own industry expert Steven Meadows, Principal Solutions Lead at Jama Software, to weigh in on the industrial product, systems, and software trends they are anticipating in the coming year and beyond.

From the groundbreaking impact of AI and augmented reality to the evolving role of software development in enabling smarter, more secure devices, these predictions highlight both opportunities and hurdles. The conversation also touched on critical concerns, including bias in AI, job displacement, and the urgent need for sustainable product design.

Read on as experts explore what’s next for the industrial industry, addressing pivotal questions about technological evolution, environmental responsibility, and the innovations that will drive the next wave of progress.

We like to stay on top of trends in other industries as well. Read our predictions Automotive, Aerospace & Defense, Semiconductor, Medical Device & Life Sciences, and Architecture, Engineering, and Construction (AEC).

Question 1 – With the rapid pace of technological evolution, which emerging technologies (such as AI, IoT, or 5G) do you believe will most significantly impact the consumer and industrial electronics landscape by 2025, and why?

Richard Matt: Leveraging the connectivity between products in ways that increase value.

Steven Meadows: Artificial intelligence (AI) is set to be a game-changer for both the industrial and consumer electronics sectors. It will enhance user experiences through smarter product interactions, enable personalized recommendations, and deliver more accurate, predictive outcomes in how products are used and optimized.

Augmented reality (AR) is another transformative technology that is significantly enhancing both personal experiences and business operations. In the consumer electronics space, AR has elevated gaming and entertainment to new heights. Meanwhile, in the industrial sector, AR has become a key tool for remote assistance, real-time data visualization, and fostering better collaboration across teams.

Quantum computing is still in its early stages, but its potential to revolutionize computing power and unlock new applications is already becoming clear. Areas such as cryptography and optimization stand to benefit greatly, and as AI continues to demand ever-greater computational resources, quantum computing will play a crucial role in supporting the complex calculations and neural networks that drive advanced AI systems.

Question 2 – As a follow-up question: Do you have any concerns or anticipate any negative impacts as it pertains to AI & ML?

Matt: My only concern is lazy implementation that doesn’t look left and right for novel synergies and intuitive interfaces.

Meadows: While I believe that the benefits of AI will ultimately outweigh its negative impacts, there are a few key areas that warrant concern:

Bias is a well-recognized issue that requires continued attention and regulation. If AI systems are trained on biased data—whether related to gender, race, or other factors—there is a risk that these biases will be perpetuated in decision-making processes. Addressing discrimination and ensuring fairness in AI outcomes should be a top priority.

Job displacement is another major concern, particularly for workers in industries like manufacturing, customer service, and transportation. These sectors may be among the most affected by automation, and it’s crucial to consider how to support workers through retraining and job transition initiatives.

RELATED: Jama Connect® for Robotics Datasheet

Question 3 – As sustainability becomes a focal point, how do you see product design and manufacturing processes in electronics evolving to meet environmental goals? What specific innovations or practices could make the biggest difference?

Matt: When product retirement becomes an integral part of product development, sustainability will be addressed naturally and effectively.

Question 4 – The push towards smart and interconnected devices is stronger than ever. How do you anticipate software development will need to adapt to support increasingly sophisticated, integrated, and secure consumer and industrial electronics?

Matt: Software development needs to mature as an integral part of product development instead of a technical specialty that keeps to itself.

Meadows: As the demand for smart, connected devices keeps growing, software development will have to keep up by making sure everything works smoothly together, processes data in real-time, and stays secure. Developers need to focus on building systems that can easily connect with different devices and platforms, using AI and machine learning (if applicable) to make devices smarter and more predictive. Edge computing will become more common, so devices can handle data quickly on-site, cutting down on delays. Security will be key, with stronger protections like encryption and regular updates to fend off cyber threats. As devices get more complex and data-heavy, software will also need to be scalable and energy-efficient, reducing its environmental impact. Ultimately, software will have to help devices work together, provide secure and personalized experiences, and keep everything running sustainably.

Question 5 – Supply chain resilience and component shortages remain major concerns. How do you think electronics companies can leverage technology and software solutions to manage these challenges and improve supply chain agility?

Matt: Electronics companies can create a supply chain database with predictive algorithms that direct when to engage alternative suppliers.

RELATED: The Top Challenges in Industrial Manufacturing and Consumer Electronic Development

Question 6 – Data privacy and cybersecurity risks continue to grow with the rise of connected devices. What proactive steps do you recommend electronics firms take to safeguard consumer data and ensure robust cybersecurity standards in product development?

Matt: There are not that many attack vectors, so give cybersecurity a sliver of attention with qualified personnel. That is all you need to stop 80% of cyberattacks.

Meadows: To protect consumer data and keep devices secure, electronics companies should take a proactive, “security-first” approach right from the start of product development. This means using end-to-end encryption to keep data safe, adding multi-factor authentication (MFA) for user logins, and making sure devices have secure boot processes to stop unauthorized changes. Regular security checks and penetration tests should be part of the process to spot weaknesses before products are released.

Question 7 – Are there any additional insights you have regarding predictions, events, or trends you anticipate happening in 2025 and beyond?

Matt: Only ‘motherhood and apple pie’ suggestions:

Find something that gives a customer base a significant need and build a minimum-viable product around fulfilling that need.

Be laser-focused on your customer’s abilities and needs.