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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.

How The EU AI Act Impacts Medical Device Manufacturers

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 Med Device Online, titled “How The EU AI Act Impacts Medical Device Manufacturers”, written by Hilde Viroux, PA Consulting and published on November 18, 2024.

How The EU AI Act Impacts Medical Device Manufacturers

The EU AI Act (Regulation (EU) 2024/1689) is a landmark legislation that will shape the future of AI in Europe and is expected to be the baseline for similar legislation in other countries/regions. It will have a significant impact on the AI industry and society, as it will set new standards and rules for the development and use of AI systems, as well as create new opportunities and challenges for innovation and competitiveness. The EU AI Act attempts to regulate AI in a way that balances the benefits and risks of this transformative technology. The AI Act also will impact other industry sectors like the medical device industry for devices that include AI technology. Medical device manufacturers will have to comply with the AI Act.

All AI systems are classified in four risk classifications: unacceptable, high, limited, and minimal.

  • AI systems for which the risk is deemed unacceptable are banned from the market. These are, for example, untargeted scraping of facial images from the internet or CCTV footage, emotion recognition in the workplace and educational institutions, social scoring, and biometric categorization to infer sensitive data, such as sexual orientation or religious beliefs.
  • High-risk AI systems have a significant impact on people’s lives or rights, such as healthcare, education, law enforcement, or public services. These must comply with strict requirements, such as data quality, transparency, human oversight, and accuracy. High-risk AI systems will have to undergo a conformity assessment by a notified body that is specifically designated for AI systems before they can be commercially available.
  • Limited-risk AI systems can pose some risk to users, like chatbots, emotion recognition, or biometric categorization. These must provide clear information to users and allow them to opt out.
  • Minimal-risk AI systems like spam filters or video games are not expected to pose any risk. Although they are largely exempt from the regulation, they still must follow the general principles of safety and fairness.

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

The AI that is part of a medical device will fall in the high risk category and will require oversight by a notified body as it can have a significant impact on people’s lives.

The EU AI Act was published July 12, 2024, and will apply by August 2, 2026. However, some elements of the act become mandatory by August 2, 2025.

Providers of high-risk AI systems must implement a quality management system (QMS) that covers the following during the lifetime of the AI system:

  • Risk management to identify and mitigate the potential risks of the AI system to health, safety, and fundamental rights during the lifetime of the AI system
  • Data governance of training, validation, and testing data sets
  • Development and maintenance of the technical documentation: for products that already require technical documentation under other legislation (e.g., medical devices), the AI related technical documentation must be included in the existing technical documentation.
  • Data logging to ensure AI systems keep track of data during their lifetimes
  • Labeling providing information on the functioning of the AI system and its operation and maintenance
  • A design that ensures appropriate levels of accuracy, robustness, safety, and cybersecurity
  • Post-market monitoring, including collection and reporting of incidents and malfunctioning to the relevant authorities

The implementation of the QMS will be mandatory by August 2, 2025, as well as the identification of the economic operators.

The EU AI Act identifies a number of economic operators in the high-risk AI system life cycle, who all have specific obligations related to high-risk AI systems.

  • In addition to the obligations related to the QMS, providers of AI systems that are not based in the EU must appoint an authorized representative (AR) who is based in the EU and confirm the AR’s mandate from the provider.
  • The AR has to verify the DoC, the technical documentation, and that the appropriate conformity assessment procedure has been completed and is the liaison with the competent authority.
  • Importers of AI systems have to ensure the AI system conforms with the AI regulation and provide their name and address with the AI system. Importers have to work with the competent authorities on any actions initiated by them to reduce and mitigate risks posed by the AI system.
  • Distributors have to verify the AI system is accompanied by the appropriate instructions for use and bears the CE marking.
  • Users of AI systems have to use them in compliance with the instructions for use. They have to report any serious incident, unacceptable risks, or malfunctioning to the national supervisory authorities, the AI system provider, importer, or distributor.

Most medical devices manufacturers will have their economic operators (AR, importer, distributor) already identified and in place as this is also a requirement under the medical device regulations. However, it will be important that contracts with those economic operators are updated to include the obligations related to the AI Act.

The obligation to report complaints, as part of the post-market surveillance becomes mandatory by August 2, 2025.

The EU AI Act foresees the creation of a European database where all providers, ARs, and the AI systems will be registered. It establishes a governance structure for the oversight and enforcement of the regulation. It creates a European Artificial Intelligence Board (EAIB), composed of representatives from national authorities and the European Commission, to provide guidance, advice, and recommendations on AI matters. It also designates national competent authorities and notified bodies to monitor, audit, and certify AI systems and their providers.

To support innovation, member states will establish AI regulatory sandboxes where providers of AI systems can develop, test, and validate innovative AI systems in a controlled environment. Spain, for instance, has launched one of the first pilot sandboxes under its State Agency for the Supervision of Artificial Intelligence (AESIA). This pilot sandbox aims to align with Spain’s National AI Strategy and is anticipated to serve as a model for other EU member states. Other member states, such as Germany, are working on regulatory frameworks that would facilitate similar testing environments, and some countries are implementing sandboxes specifically for sectors like mobility, public procurement, and healthcare. The EU Commission also provides guidance and support to standardize these efforts across the region, aiming to accelerate safe AI development through regulated testing environments.

Full compliance to the EU AI Act will be mandatory by August 2, 2026, with AI systems meeting the requirements, the sandboxes established, and the notified bodies designated and fully operational.

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Consequences Of Non-Compliance

The EU AI Act introduces a system of sanctions and remedies for non-compliance or infringement of the regulation. It empowers national authorities to impose administrative fines of up to 4% of the annual worldwide turnover of the provider, user, importer, or distributor, depending on the severity and duration of the breach. It also allows national authorities to order the withdrawal, recall, or modification of non-compliant AI systems, as well as to suspend or prohibit their use or supply. In addition, it grants the right to compensation to individuals or organizations that suffer harm or damage as a result of non-compliant AI systems.

Pitfalls To Avoid

From a high-level perspective, the requirements seem similar to the general requirements for medical devices, like QMS, economic operators, and notified bodies.

However, there are some things to watch out for. For example, the notified body designated for medical devices may not be designated for the AI Act, resulting in device manufacturers having to deal with two different notified bodies and inspections for the same product. Two notified bodies’ numbers will have to be referenced on the label and in the declaration of conformity.

Medical device manufacturers that are using AI as part of their device or device software should be assessing the AI Act requirements and ensuring they are built into their QMS, as the due date is less than a year out. Having a QMS compliant to ISO 13485 that satisfies medical device regulations is not sufficient. The QMS must cover cybersecurity requirements as well for high-risk AI systems to protect against tampering, data breaches and other security risks.

Conclusion

Although the requirements in the AI Act seem very similar to what is already required for medical devices, like having a QMS, control over economic operators, post-market surveillance, and conformity assessment with a notified body, compliance with EU medical devices regulations is not sufficient to meet the AI Act requirements.

Manufacturers should be aware and start their compliance journey sooner rather than later to meet the various due dates of August 2025 and 2026.

Quality Management System Regulation: Final Rule Amending the Quality System Regulation – Frequently Asked Questions

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 the U.S. Food & Drug Administration, titled “Quality Management System Regulation: Final Rule Amending the Quality System Regulation – Frequently Asked Questions”

Quality Management System Regulation: Final Rule Amending the Quality System Regulation – Frequently Asked Questions

Update: August 7, 2024

The revised part 820 is now titled the Quality Management System Regulation (QMSR). When referring to the rule that is currently effective, the FDA uses the term “Quality System (QS) Regulation” or “QS regulation.” Because both the QMSR and the QS regulation are located in part 820, wherever possible, the FDA has used the terms “QS regulation” and “QMSR.”

Listed are resources pertaining to the Quality Management System Regulation requirements and resources for implementing a quality management system:

  1. “AAMI/ISO 13485:2016, A Practical Guide
  2. “AAMI TIR102:2019, U.S. FDA 21 CFR mapping to the applicable regulatory requirement references in ISO 13485:2016 Quality Management Systems
  3. IMDRF/GRRP WG/N47 FINAL:2024 (Edition 2), “Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices”

On January 31, 2024, the FDA issued a final rule amending the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) Regulation under 21 CFR 820 to align more closely with the international consensus standard for Quality Management Systems for medical devices used by many other regulatory authorities around the world.

This rule amends 21 CFR 820 by incorporating by reference the quality management system requirements of the international standard specific for medical device quality management systems set by the International Organization for Standardization (ISO), ISO 13485:2016. The FDA has determined that the requirements in ISO 13485 are, when taken in totality, substantially similar to the requirements of the QS regulation, providing a similar level of assurance in a firm’s quality management system and ability to consistently manufacture devices that are safe and effective and otherwise in compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The rule amends the title of the regulation and establishes additional requirements that clarify certain expectations and certain concepts used in ISO 13485. These additions ensure that the incorporation by reference of ISO 13485 does not create inconsistencies with other applicable FDA requirements. This revised part 820 is referred to as the Quality Management System Regulation (QMSR). The FDA has made conforming edits to part 4 (21 CFR part 4) to clarify the device Quality Management System (QMS) requirements for combination products. These edits do not impact the CGMP requirements for combination products.

This action continues the FDA’s efforts to align its regulatory framework with that used by other regulatory authorities to promote consistency in the regulation of devices and provide timelier introduction of safe, effective, high-quality devices for patients.

This section provides answers to frequently asked questions related to the final rule. These questions and answers provide clarity and do not introduce any new policies or modify any existing policies.

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Q: Why is the FDA taking this action?

A: The FDA is focused on advancing and continually improving the quality, safety, and effectiveness of medical devices to meet patient needs. This action, if finalized, will harmonize key areas of a device manufacturer’s Quality Management System and will more closely align the United States with many other regulatory authorities around the world.

Q: What is the FDA doing to prepare for harmonization of the Quality System regulation with ISO 13485?

A: The FDA intends to engage in a variety of implementation activities including, updating information technology systems, training FDA staff responsible for assessing compliance with medical device quality management system requirements, developing an inspection process, revising relevant regulations and other documents impacted by this rulemaking, and communicating and educating stakeholders, including affected FDA staff, on the change.

Q: What training will FDA staff do?

A: FDA staff will be trained on the final rule, the revised inspection process and changes to associated policies and procedures. Additionally, broader Quality Management System trainings have been, and will continue to be, deployed within the FDA to familiarize affected staff with quality management system concepts and requirements.

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Q: How will this rule impact FDA staff and programs?

A: FDA will continue to conduct its operations to protect public health, including inspections, incorporating the requirements of the rule. The greatest impact will likely be to internal trainings, which will be needed to familiarize staff with the new regulation as well as any updates to procedures, processes, and policies as a result of the change.

Q: Will there be a new inspection process?

A: FDA will develop a new inspection process to align with the requirements of the new Quality Management System Regulation (QMSR). The process will be developed for implementation when the rule takes effect (i.e., two years from publication).

Q. Now that FDA has incorporated ISO 13485:2016, what happens if the standard is revised?

A: Any future revisions to this standard would need to be evaluated to determine the impact of the changes and whether the QMSR should be amended. If needed, amendments to the QMSR will be implemented through rulemaking.

Q. When will the new regulation be effective?

A: The rule is effective two years after publication in the Federal Register. Until then manufacturers are required to comply with the QS regulation. The FDA will begin to enforce the QMSR requirements upon the effective date, February 2, 2026.