Tag Archive for: Product Development & Management

A lightbulb and gears showing the subject of this article as the Sparx Enterprise Architect Integration with Jama Connect.

Traceable MBSE™ in Action: Integrating Sparx Enterprise Architect with Jama Connect®

In the complex systems engineering landscape, maintaining Model-Based Systems Engineering (MBSE) across requirements and architecture is a major challenge. Engineers must ensure that high-level requirements flow seamlessly into architectural elements while managing changes across multiple tools.

With the integration between Sparx Enterprise Architect and Jama Connect®, teams can achieve Traceable MBSE™ with bidirectional synchronization of requirements, architecture elements, and diagrams. This enables a holistic view of system design, ensuring real-time traceability, impact analysis, and compliance with predefined processes.

In this blog, Atef Ghribi, Senior Solutions Architect at Jama Software, demonstrates the Sparx Enterprise Architecture integration with Jama Connect.

TRANSCRIPT

Atef Ghribi: Hello. My name is Atef Ghribi, and I’m a Senior Solutions Architect at Jama Software. Today, we will be walking through the Sparx Enterprise Architect integration. But before looking at the tools in action, let’s explore the goal we are trying to achieve as well as the following approach.

Some of the major questions that systems engineers are faced with are related to traceability and how to ensure its completeness based on predefined processes, methodologies, and rules. Making sure that there are no gaps in the process and that all the needs and high-level requirements are covered and satisfied by the lower-level requirements as well as architectural elements, and figuring out how to overcome the challenges of managing changes across the traceability chain, which in most of the cases spans over and across multiple tools. Applying that to the architecture context results in questions like, how do architecture changes impact requirements and vice versa?

As MBSE leaders and advocates, the question is how to make sure that MBSE is accessible and usable easily and efficiently to non-modelers without the need to take care of all the logistics and know what the architecture tools require. With integrations to architecture tools, including Enterprise Architect, Jama Connect enables its users to leverage traceable MBSE to work and interact with the architecture providing a holistic overview of the whole systems engineering process.

Traceable MBSE is a technical approach for the creation, consumption, and measurement of systems engineering data with Jama Connect frameworks for achieving Live Traceability™.  The way it works is by enabling bidirectional synchronization of requirements and architecture elements between Jama Connect and Enterprise Architect, as well as syncing diagrams and traceability from Enterprise Architect to Jama Connect as the central engineering management repository.

Jama Connect uses the data to enable intelligent engineering management, providing the ability to detect process risks and identify gaps, measure progress and coverage, and analyze the impact of changes. What we will see in the integration is a simple flow between requirements and architecture elements, starting by creating requirements within Jama Connect and transitioning to Enterprise Architect to start using those requirements in the architecture, where we will be creating architectural elements like blocks, allocating the new requirements to them by creating dependency traces. And that’s all we will need to do as users. The integration will then take care of syncing those changes from the architecture back to our central engineering data repository, Jama Connect. Let’s see this in action.

RELATED: Traceable MBSE™ in Jama Connect: Quickstart Guide

A flow chart showing the integration challenges of Traceable MBSE; traceability challenges, change management, integration complexity, and user accessibility.

Ghribi: What we see right now in front of us is the Jama Connect project that we are using for the integration, governed by this process or the so-called relationship rule diagram, where we can see the relationship rules that are defined and expected for this project. This will be the instrument that helps us measure the progress and coverage and identify the gaps later. What is interesting for us in the context of this integration are the two item types, system requirements, and architectural elements, as well as the relationship between them that enables users to allocate system requirements to architectural elements.

If we look at the left-hand side of the screen, we can see our project tree, which is the place where we store the content of our project. And we can there also find the system requirements that are managed within this project. So here as a system requirements engineer, I’m gonna be able to create a new system requirement that will be synchronized based on the integration to our Enterprise Architect. So keeping things simple, I’m gonna call this new system requirements.
We can select a type, and we can give it some text as a description. Let’s say description text. And we can save this one to our Jama Connect database.

The integration works now in the background to ensure a real-time synchronization of these changes into our respective EA project. If we also look at another location inside of our project, we can see the place where we defined the integration to sync our architectural elements. Both the diagrams as well as the architectural elements will be synchronized here. We will get back to this later to see how we change or how the changes that we’re gonna do in Enterprise Architect will be updated here.

Let’s switch now to Enterprise Architect and explore the project structure and see if we can find that new system requirement that we just created in Jama Connect. We are keeping the structure of this project simple. And for the sake of simplicity also, as you can see inside of the folder of requirements, we just have a plain list of our system requirements without any folders or any informational elements.

And as we can see, we can find the new system requirement that we just created listed here. So as an architect, I can now use that new input and go to my architecture and create a new architectural element. Save and close. That should create our new item in the Explorer for the project. Now we can start using that new element in our diagram, and you will be able to just place it inside of the diagram and link it. We can do the same for our requirement to create the traceability and allocate that requirement that we just got into the new architectural elements.

And just by creating the relationship as a dependency, we can make sure that now we have the traceability from our system requirements into our architectural element. We can now save the changes in this diagram. As an additional step, I will go to our requirements and start making some changes just to synchronize back and see how the description will change if we just add some changes from EA. Saving. And now we can go back to Jama Connect and explore the changes there.

RELATED: Intelligent Engineering Management with Jama Connect Live Trace Explorer™

Ghribi: Now as we go back to Jama Connect, we can explore our architecture again and see if we can see that new system architectural element. Just need to refresh first our trajectory. And now we can see that new element that was just created inside of our Jama Connect database. Now I can also take a look at the diagrams and see that internal block diagram that just got updated by the integration. In addition to these updates inside of my Jama, I can see also the changes that were applied to my requirement. I can start seeing the changes, that were just, synchronized. I can also start comparing, and understanding what exact changes were now made and modified between the different versions of my requirement.

In addition to that, the traceability that we just created inside of Enterprise Architect can also be seen here. If I go and open the live trace view inside of Jama Connect and scroll up to see how my architectural elements are synchronized and traced to system requirements, I can see the relationship between the new system requirements and the architectural element that was created inside of Enterprise Architect, also inside of charmer.

What we can also see in this view are all the gaps related to all the architectural elements that do not have any system requirements allocation. We can see the same information from the system requirements perspective, this time covering more system requirements. So if we just narrow down our trace view to our system requirements on the left-hand side of the screen and to our architectural elements on the right-hand side of the screen, we can start also seeing all those other system requirements that do not have any coverage or allocation into architectural elements based on the predefined process assigned to this project. We can see the same information also in our dashboard.

So if we use filters and widgets, we can simply see that information in real time and be able to capture any gaps in the process before it’s too late. Now Jama Connect helps us also to get a holistic overview of our project just by using the Live Trace Explorer™ I can just expand here on my project and open a full coverage view that compares the project or the state of my project to the process assigned to it and defines and shows a trace score in real time where I can focus on the exact KPIs and metrics that are relevant for me. For our case today, the architectural elements cover our system requirements where we can trust the progress and see the covered percentage in real time.

As soon as anything changes within Jama Connect or in Enterprise Architect, these values will be updated in real-time, and we can keep track of the progress. Thank you for watching this session on the Enterprise Architect integration for Jama Connect. If you are an existing customer and want to learn more, please reach out to your customer success manager or consultant.

If you would like to learn more about how Jama Connect can optimize your product development process, please visit our website at jamasoftware.com. If you are already a Jama Connect customer and would like more information about release management via reuse and synchronization, please contact your Customer Success Manager or Jama Software Consultant.

To view more Jama Connect integration demos, visit our
Jama Connect Features in Five Integration Series

The New ARP4754B and Techniques in Jama Connect® for Airborne Systems

ARP4754B, released on December 20, 2023, is a standard from SAE International that provides recommendations for the development of civil aircraft and systems, focusing on ensuring safety and compliance with regulations. It covers the entire aircraft development cycle, from system requirements through verification and validation. The latest revision includes new methods for safety analysis, such as Model-Based Safety Analysis (MBSA) and Cascading Effects Analysis (CEA). It is mandatory for all aircraft and systems worldwide, including emerging eVTOLs and UAVs, to demonstrate compliance with aviation regulations. This guideline aligns with ARP4761A, which was released on the same date, for safety assessment processes and offers increased flexibility in selecting validation and verification methods.

ARP4754B Applied in Jama Connect for Airborne Systems

ARP4754B and ARP4761A are both crucial guidelines, and the alignment between the two new versions has been enhanced to streamline development and safety assessments. In addition to the inclusion of the two new safety analysis methods, ARP4754B now places a stronger emphasis on identifying and mitigating unintended behaviors. It now includes consensus methods for demonstrating compliance within the development planning process and has also enhanced its flexibility in validation and verification.

Jama Connect can be used throughout the system development process as the primary system to manage the requirements and full product traceability. Figure 1 from ARP4754B outlines the relationships between the lifecycle and integral processes, which provide guidelines for safety assessment, electronic hardware and software lifecycle processes, and the system development process described herein.

An aircraft / systems development process model adapted from SEA ARP4754B

There are always numerous ways to tailor the use of Jama Connect. Here’s how the updates to ARP4754B influence requirements management and how our Airborne solution is pre-configured to support them.

1: Adoption of Model-Based Systems Engineering (MBSE)

  • MBSE Integration: Updates encourage the use of MBSE to handle the increasing complexity of aircraft systems.
  • Modeling Languages: Use of modeling languages like SysML to create detailed system models that include requirements, behavior, and structure.

Jama Connect for Airborne Systems Model-Based Techniques

  • Model-Driven Requirements: Requirements are captured and managed within the Jama Connect data model, providing requirements management techniques that support model-based representations. The Solution comes pre-configured with element types that correspond to the levels of requirements called out in ARP4754B, function elements, WBS, verifications and validations, and safety-related elements. Jama Connect constrains the data to follow the traceability rules which enable rapid analysis, automated trace matrix generation, and querying and reporting.

List of model-driven requirements such as function, aircraft requirement, system requirement, and more.

  • Synchronization of Models and Textual Requirements: Ensuring consistency between textual requirements and model-based representations requires synchronization mechanisms. Jama Connect is often used in conjunction with SysML tools and all leading vendors offer native integrations.

Figure 2: Model-based elements replace documents and the Jama Connect for Airborne Systems’ traceability schema maintains consistency.

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

2. Enhanced Integration of Safety and Requirements Management

  • Safety-Driven Requirements: The updates emphasize integrating safety assessments directly into the requirements management process. This means that safety considerations become a foundational aspect of requirement definition and management.
  • Iterative Feedback Loop: There is a stronger focus on creating an iterative process where safety analysis results inform requirement updates, and changes in requirements trigger reassessment of safety analyses.

Jama Connect for Airborne Systems Safety & Requirements Management Techniques:

  • Traceable Within the Model: The outputs from safety analyses are captured and managed directly in Jama Connect. Our Airborne Systems solution provides the data model for a consistent trace and data strategy between safety, requirements, and tests.
  • Requirements Annotation: Requirements have built-in attributes for safety-related information, such as hazard classifications and safety integrity levels.
  • Tool Integration: Jama Connect integrates seamlessly with safety analysis tools such as ANSYS Medini, the LDRA tool suite and others to ensure seamless data flow and traceability between safety assessments and requirements.
Jama Connect Airborne Systems framework showing in an explorer tree with a side-by-side comparison of how it follows SAE ARP4754B requirements structure.

Figure 3: Jama Connect for Airborne Systems solution on the left and SAE ARP4754B (page 102) on the right.

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

3. Improved Traceability Requirements

  • Bidirectional Traceability: Enhanced emphasis on maintaining bidirectional traceability between requirements, design artifacts, implementation, and verification activities.
  • Traceability to Safety Objectives: Requirements must be directly linked to safety objectives and hazard analyses derived from updated safety assessment processes.

Jama Connect for Airborne Systems Solution Techniques:

  • Robust Traceability Matrices: The solution comes preconfigured with views and filters required by ARP4754B. These sophisticated traceability matrices that map requirements to design elements, test cases, and safety analyses are also exportable. The Airborne Systems solution has out-of-the-box export templates that can also be tailored.
  • Automated Traceability: Instead of authoring content and then creating a trace to its related content after the fact, use the “Add Related” functionality built into Jama Connect. This use of automated trace creation to manage traceability reduces the risk of human error and improves efficiency.
Jama Connect Airborne Framework item types.

Figure 4: Constrained set of data choices ensures users create consistent traces.

We’ve shared 3 of the 6 ways Jama Connect’s Airborne Solution supports ARP4754B influence requirements management.
Want the full picture? Download the whitepaper to explore them all!

The New ARP4754B and Techniques in Jama Connect for Airborne Systems Whitepaper

Understanding ISO 13849: The Foundation of Functional Safety in the Machinery Sector

Understanding ISO 13849: The Foundation of Functional Safety in the Machinery Sector

Like many industries, functional safety is a critical part of machinery design – ensuring the protection of operators, equipment (and surrounding environments) from hazardous situations. To help maintain functional safety in industrial manufacturing, most organizations use ISO 13849, a globally recognized standard that provides comprehensive guidelines for achieving and validating functional safety in machinery control systems. In this blog, we’ll look at the importance of ISO 13849, key components, and how it shapes functional safety in the machinery sector.

According to an informal ISO/TC stakeholder survey, more than 89% of machine builders and more than 90% of component manufacturers and service providers use ISO 13849 as their functional safety standard.

What is ISO 13849?

Officially titled “Safety of machinery – Safety-related parts of control systems”, ISO 13849 is an official standard that outlines the principles for designing and assessing the safety-related parts of control systems (SRP/CS). These are systems that directly influence the safety functions of a machine, e.g., emergency stops, interlocks, and protective barriers.

  • ISO 13849-1: Focuses on general principles for design and performance.
  • ISO 13849-2: Covers validation procedures for ensuring the compliance of safety functions.

By following this standard, manufacturers can reduce the likelihood of machinery-related accidents and improve overall safety compliance.

RELATED: IEC 61508 Overview: The Complete Guide for Functional Safety in Industrial Manufacturing

Why is ISO 13849 Essential in the Machinery Industry?

Is it mandatory? Well, no.

However, the machinery sector operates in environments where equipment malfunctions can lead to severe injuries, fatalities, and property damage. Functional safety – as defined by ISO 13849 – helps mitigate these risks by emphasizing:

  • Reducing Risk: Identifying potential hazards and designing systems to minimize them.
  • Reliability: Ensuring that safety-related control systems perform their intended functions under all expected conditions.

It’s also important to note that compliance with this standard can also help teams avoid legal and financial repercussions if something does go wrong.

ISO 13849 bridges the gap between innovation and safety, enabling manufacturers to integrate cutting-edge technology without compromising operator protection.

Animated figure wearing safety gear and checking off a safety checklist for ISO 13849 core principles.

Key Info about ISO 13849

ISO 13849 revolves around several core principles:

1: Performance Level (PL) – Performance Level quantifies the reliability of safety functions, categorized from PL a (lowest) to PL e (highest). Factors influencing PL include:

  • Hardware structure.
  • Diagnostic coverage (DC).
  • Mean time to dangerous failure (MTTFd).
  • Common cause failure (CCF) protection.

2. Risk Assessment and Reduction – Part of this standard is the emphasis on conducting thorough risk assessments to identify potential hazards and determine the necessary PL for mitigation.

3. Validation – Validation ensures that the implemented safety functions meet design specs and operate correctly under foreseeable conditions. ISO 13849-2 provides specific procedures for this step.

4. Diagnostics and Redundancy – Built-in diagnostics and redundant systems enhance reliability, preventing failures from leading to unsafe conditions.

Implementing in Functional Safety Design

Successfully implementing ISO 13849 needs a structured approach:

  • Risk Assessment: Analyze the machinery’s operational scenarios to identify risks.
  • Determine Safety Requirements: Define safety functions and their corresponding Performance Levels.
  • Design Safety Systems: Develop control systems with redundancy, diagnostic coverage, and robust design principles.
  • Validation: Test and validate by comparing to ISO 13849-2 to make sure you’re compliant.

Benefits of Choosing to Comply

Adhering to ISO 13849 delivers a lot of advantages for machinery manufacturers and operators:

  • Enhanced Safety: Reduces the risk of accidents and improves operator confidence.
  • Regulatory Compliance: You’ll meet international safety standards, facilitating market entry and reducing liability.
  • Cost Efficiency: Minimizes downtime and damage from malfunctions.
  • Reputation Management: Demonstrates a commitment to safety and reliability, boosting brand credibility.

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

Challenges and Best Practices

Implementing ISO 13849 can be challenging, especially for manufacturers unfamiliar with its requirements. Some common obstacles could be:

  • Complexity in Risk Assessment: Accurately determining Performance Levels requires expertise.
  • Integration with Legacy Systems: Retrofitting older machines can be resource intensive.
  • Validation Procedures: Comprehensive testing can be time-consuming.

Some thoughts on overcoming these challenges:

  • Engage Experts: Don’t go it alone – collaborate with functional safety specialists.
  • Use Certified Components: Choose components that meet ISO 13849 requirements.
  • Invest in Training: Help your team succeed! Equip them with the knowledge to apply the standard effectively.

ISO 13849 serves as a cornerstone of functional safety in the machinery sector. By following its guidelines, manufacturers can design systems that not only meet regulatory standards but also provide robust protection against operational risks. In an industry where safety is paramount, ISO 13849 ensures that innovation and reliability go hand in hand.

Note: This article was drafted with the aid of AI. Additional content, edits for accuracy, and industry expertise by Steven Meadow and McKenzie Jonsson.

Graduation hat on a ticking clock showing this videos five minute topic of release management in jama connect using reuse and synchronization.

Jama Connect Features in Five: Release Management via Reuse & Synchronization

Learn how you can supercharge your systems development process! In this blog series, we’re pulling back the curtains to give you a look at a few of Jama Connect’s powerful features… in under five minutes.

In this Features in Five video, Máté Hársing, Solutions Manager at Jama Software, demonstrates how Jama Connect helps teams streamline release management with its reuse and synchronization capabilities.

VIDEO TRANSCRIPT

Máté Hársing: Hello and welcome. My name is Máté Hársing, and I’m a Solutions Architect at Jama Software. In this video, we’re going to explore how Jama Connect helps teams streamline release management with its reuse and synchronization capabilities. Managing multiple product releases often introduces challenges such as tracking changes across different product versions, ensuring teams work on release branches without disrupting the main project, merging updates without losing critical information or creating inconsistencies, maintaining traceability and compliance in industries with strict regulatory requirements.

Without the right tools, these challenges can lead to delays, increased costs, and risks of errors. Jama Connect addresses these challenges with its reuse and synchronization capabilities.

By allowing you to duplicate projects or components, Jama Connect creates a release branch where teams can work independently. The platform provides powerful comparison tools at the item, set, and project levels, enabling you to see changes clearly.

When it’s time to merge updates, Jama Connect gives you full control, allowing you to select specific changes while maintaining traceability and alignment. Now let’s see this in action. I’ll start by showing the main branch of the project and how it’s in sync with a specific release branch, release 2.0. This release branch is a separate project that will include updates and modifications specific to this version once we start working on it. As you can see, so far, the synchronization is fully intact between these two projects.

RELATED: Jama Connect® Features in Five: Reuse & Sync

Hársing: Now let’s take a look at the synced items widget starting at the item level. This widget shows the relationship between this specific operational time requirement in the main project and the release branch. You can see they are currently in sync, meaning there is no difference between them. If I change the operational time for release two zero to a higher number, as we want to ensure higher user satisfaction, you’ll see they are now out of sync.

By clicking on the button, we can see the red line differentiation between the main branch requirement and the release-specific requirement for release 2.0. Moving up to the set level, we can view how entire groups of requirements are synced. This provides a broader perspective, allowing teams to manage changes across multiple related items efficiently. Let’s add a new requirement to release 2.0 and delete an existing one so that you can see how the information will show up when comparing the two sets between the main branch and release 2.0.

Finally, at the project level, you can see an overview of synchronization across the entire project. This is particularly useful for tracking overall progress and ensuring alignment between the main branch and the release.

Now I’ll demonstrate how to merge changes back into the main project. Jama Connect allows you to make different kinds of merges. For instance, you can accept specific changes, reject others, or use the consolidation option to manage conflicting requirement descriptions side by side. This ensures the two versions of a requirement can be refined into a common denominator, maintaining clarity and consistency.

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

Hársing: I’d like to emphasize that both reusing and synchronizing are permission-controlled so that only appointed team members can execute these tasks. Each dedicated project can also be baselined creating a snapshot in time. This is invaluable for generating submission-ready documentation, especially in regulated industries such as medical device design and development. Additionally, any change made in either project, the main branch or the release branch, propagates reactive change management capabilities via the Suspect Link tool. This feature automatically flags impacted items, ensuring teams can quickly assess and address the downstream effects of any modification.

These features reduce risks, improve collaboration, and ensure compliance by keeping everything organized and transparent. Jama Connect simplifies release management so you can focus on delivering high-quality products.

Thank you for watching this demonstration of release management via reuse and synchronization in Jama Connect. If you would like to learn more about how Jama Connect can optimize your product development process, please visit our website at jamasoftware.com. If you are already a Jama Connect customer and would like more information about release management via reuse and synchronization, please contact your Customer Success Manager or Jama Software Consultant.

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

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.

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

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.

 

[Webinar Recap] Transform Engineering Processes: Bridge Gaps Between Teams and Tools Effectively

In this blog, we recap our recent webinar, “Transform Engineering Processes: Bridge Gaps Between Teams and Tools Effectively” – Click HERE to watch it in its entirety.

 

Transform Engineering Processes: Bridge Gaps Between Teams and Tools Effectively

Engineering organizations face challenges delivering complex products on time, within budget, and with high quality. Teams often work with different tools, creating data silos that slow the digital engineering process. These gaps lead to missed requirements, delays, and defects.

In this webinar, our Jama Software experts Preston Mitchell, Vice President of Solutions & Support; Mario Maldari, Director of Product & Solution Marketing; and Vincent Balgos, Director of Solutions & Consulting, discuss how Jama Connect®, and our Jama Connect Interchange™ add-on, address these challenges through key use cases.

What you’ll learn:

  • Traceable Agile: Integrate systems engineering and software teams using Jama Connect + Jira to drive quality and speed.
  • Scalable FMEA Process: Empower reliability and risk management teams with Jama Connect + Excel for efficient FMEA analysis.
  • Universal ReqIF Exchange: Seamlessly import, export, and round-trip ReqIF exchanges across requirements tools with Universal ReqIF, enabling teams to co-develop requirements with stakeholders and partners.

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

VIDEO TRANSCRIPT

Preston Mitchell: We are here to talk about how to save precious engineering time, and each of us is going to cover a specific use case that we think will help your teams save a lot of time, utilizing both Jama Connect, as well as Jama Connect Interchange. And when you think about where is most of the time wasted in engineering teams, we typically find it’s something that visually looks like this. It’s siloed teams and tools across the system engineering V model, and we really find that these things are the number one cause of negative product outcomes.

You know them, you’re probably intimately familiar with them. It’s a lack of identification of defects, missed requirements, or lack of coordination. A lot of manual steps to connect things, maybe requirements that live in one tool, and your system testing that lives in a different tool. And a lot of this can be highly manual, which is really a tough thing when you have to satisfy some of the industry regulations that a lot of our customers work with.

As we all know, kind of late detection of issues really leads to a huge cost in order to correct that with a project. You can kind of see in this bar graph here, that I’ve got on the left the different phases, going to the right of a typical product development. So you’re starting in the requirements definition and design, and moving all the way to acceptance testing. Typically, the number of faults or problems are introduced very early in the requirements definition and design phase. But the problem is they aren’t found until later in the project, like during integration or system testing. And even if you get to the acceptance testing level, you can see the exponential increase in cost to fix these expensive errors. These is not Jama Connect’s numbers, these numbers are from sources at The International Council on Systems Engineering (INCOSE) and National Institute of Standards and Technology (NIST). So you can really take away from this is the fewer errors that we introduce early, or the faster or sooner that we identify those issues, the better off we’re going to be and the more engineering time we are going to save.

How do we do this? Well, Jama Software, we are the number one requirements management and Live Traceability™ product in the market. We really bring a lot of resources and technology to bear to help you manage your product development, whether that’s complex and highly scaled types of products. We help you bring all the collaboration and reviews online. And we help you, number one, integrate the different state of the product across the many disparate tools that you might have in your engineering departments, and, specifically, that’s going to allow you to then measure and improve your traceability.

RELATED: Jama Connect Interchange™ for Software and Product Development Teams: Live Traceability Realized

Mitchell: We work with a lot of the key industries that you see here at the bottom, and in particular, like Vincent, you work with the medical devices. I think your use case that you’re going to cover is going to be very built off of that medical device industry. But really, a lot of the use cases we’re going to cover today are applicable to all of these industries.

We are the leader, and we’d like to be bold about it. We are number one according to G2 in terms of requirements management and traceability tools. So we encourage you to check out the different ratings and how we stack up against our competitors.

The ultimate goal that we want to get you to is saving that time. So moving from disparate, siloed teams and tools to an actual integrated system of Live Traceability. We actually have benchmark data from all of our cloud customers, where we can actually show a correlation between the customers that have a greater traceability score, meaning all the expected relationships have been built out. We find that they have 1.8x faster time to defect detection, nearly 2.5x times lower test case failure rates, and then typically a 3.5x higher verification coverage. So it behooves you and your engineering teams to think about how can we actually integrate, and save ourselves time, and that’s just going to create a higher-quality product down the line.

I’d be curious to pause right here. We have a poll. I’d be interested in asking, if you take a step back and think about your R&D teams, all the different tools and teams that you have, what percentage would you say today in your organization is actually fully covered by Live Traceability? 100%, 50%, 0%? I’d be kind of interested in the scale on that. So we should see a poll pop up here, and I’ll give you a couple of seconds to answer that.

Now, we see some answers coming in. Thank you. Yeah, as to be expected, it’s not anywhere near 100%. Most of the companies that we work with are struggling with this, and so this is where we really want to help them out. And how do we do that? Well, our Jama Connect Interchange add-on to Jama Connect is a really powerful tool that we’re going to walk you through today, and it’s going to allow you to automate the connection between your data and process.

So we’re going to cover three use cases. I’m going to talk briefly first about Traceable Agile™, and this is how we integrate systems and software teams, using Jama Connect and a very popular tool that a lot of our software organizations use, which is Atlassian Jira. So we’ll talk about that Traceable Agile use case. Then Vincent is going to cover the Scalable FMEA Process, so how to utilize the power of the functions that are in Excel, and bringing those functions to bear inside of Jama Connect, so that you can do risk management and reliability management, but tied in with your requirements and testing. And then, finally, we’ll end on Mario covering Universal ReqIF Exchange, and this really enables you to co-develop with partners and suppliers across Jama Connect, but also maybe even different requirements management tools. So let’s dive in.

 

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

Mitchell: So when you think about Traceable Agile, Agile software, it’s a methodology, as well as a philosophy. It’s been around software teams for a long time, and it works well. It’s been widely adopted, and widely successful. At the same time, a lot of complex products are not made up of solely software. They have to actually be integrated in with the hardware and perhaps other mechanical aspects of these products that you’re building. So there’s a balance, right? There’s a balance of being completely Agile, but also making sure that you follow some process.

And kind of where we find that Agile sometimes can break down when we talk with software engineering leaders. They have these very common questions that they bring up, and it’s what keeps them up at night. How do I know which requirements have been missed? Am I actually covering everything? How do I know that I’m actually testing all of my requirements, and which ones of those have failed? The fourth bullet there, how do I identify rogue developments? It’s like, how do I make sure my teams are not gold-plating the product, and we’re actually meeting the stakeholder or the user needs that we’re trying to deliver to? And then, finally, change. Change is a given in this fast-paced environment, so how do I know when impacts are made? When changes are made in the software or in the hardware, how do I know what those impacts are across?

So the solution to this is Traceable Agile. It’s really no change to how your software teams may work today using Atlassian Jira. Really, what we are adding on is the ability to auto-detect gaps and measure and take action on those. And so I’m going to step into Jama Connect to give you a little bit of a demonstration here.

THIS IS A PREVIEW OF OUR WEBINAR, WATCH IT IN ITS ENTIRETY:
Transform Engineering Processes: Bridge Gaps Between Teams and Tools Effectively

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.

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

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.

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.

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

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

People talking to each other with a stack of books to discuss the topic of SOTIF for automotive requirements engineering.

In this blog, we’ll recap a section of our recent Expert Perspectives video, “Integrating Safety of Intended Functionality (SOTIF) Into the Automotive Requirements Engineering Process” – Click HERE to watch it in it entirety.

Expert Perspectives: Integrating Safety of Intended Functionality (SOTIF) Into the Automotive Requirements Engineering Process

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

In this episode, we speak with Dr. Hasan Ibne Akram on the topic of Integrating Safety of Intended Functionality (SOTIF) Into the Automotive Requirements Engineering Process.

Watch this video to learn more about:

  • The differences between SOTIF and functional safety
  • How to define and manage safety requirements addressing system limitations and edge cases
  • How to conduct a hazard analysis and risk assessment to cover intended functionality

Below is a preview of our interview. Click HERE to watch it in its entirety.

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

Kenzie Ingram: Welcome to Our Expert Perspective series where we showcase insights from leading experts in complex product systems and software development, covering industries from medical devices to aerospace and defense, we feature thought leaders who are shaping the future in their fields. I’m Kenzie Ingram, your host.

And today I’m excited to welcome Dr. Hasan Ibne Akram, an entrepreneur, computer scientist, book author, and CEO of engineering service company Matrickz based in Munich, Germany. With more than 17 years of experience in the automotive industry and working for two of the major German automotive OEMs, Dr. Akram brings a wealth of knowledge to this conversation. Today, we’re excited to showcase a discussion between Matt Mickle, Jama Software’s Director of Automotive Solutions, and Dr. Akram, on integrating safety of intended functionality, also known as SOTIF into the automotive requirements engineering process. Without further ado, I’d like to welcome Dr. Akram and Matt Mickle.

Matt Mickle: Thanks everyone for joining us today. My name is Matt Mickle. I’m the Director of Solutions for Automotive and Semiconductor at Jama Software. And I’m joined here today by Dr. Hasan Ibne Akram. Thanks very much for joining us today and answering some questions around integrating SOTIF into the automotive requirements engineering process. Dr. Akram, maybe we could start by just you telling us a little bit about yourself and your history with SOTIF and other industry standards and just a little bit about your background.

Dr. Hasan Ibne Akram: Absolutely. Thank you so much, Matt, for having me here. It’s amazing that we are having this conversation because this is very relevant today.
So my background in automotive started way back in 2005. So I was still a student, but I really wanted to go for a start-up. And back then, I landed a project with Continental. It was a braking system calculation project, and that’s how I got into automotive. And kept doing automotive stuff ever since.

And then, when I started my safety journey, I actually had no clue. So the first encounter to safety was a long time ago when I was actually working at a [inaudible 00:02:30] OEM as an external consultant. I was more responsible for the software. And during the lunch break, the functional safety colleague of that OEM, and in German, we call it FuSi, Funktionale Sicherheit, we used to call it FuSi. So I asked him, “What FuSi, the thing that you’re doing all the time? What is it about?” And quite condescendingly, he said, “We assume that whatever you guys are doing over there, every line of code, everything that you will do will go wrong.”

RELATED: Jama Connect® for Automotive

Akram: That was kind of like a light bulb moment for me. “Wow, that’s interesting. What happens when everything goes wrong? What do we do?” That was really my genesis of the functional safety journey. And SOTIF didn’t exist back then, was doing ISO 26262. And during my PhD, I was specialized in automotive cybersecurity, so cybersecurity and functional safety, I really wanted to bring them together.

And then, we realized, the automotive industry realized that, hey, there is something missing. Because with traditional safety, the definition of traditional safety is all about malfunction, if something goes wrong. Even when we’re doing security, it’s beyond malfunction, it’s all about attack now.Now comes autonomous vehicle, kind of like ADAS’s features, active distance control, automated emergency brake, active cruise control, and different levels of autonomy, Level 1, Level 2. The definitions came much later, but the idea of SOTIF was, hey, there’s something inherently required, there’s something required, something missing, inherently missing in the current standard because there can be hazards beyond malfunction.

It’s all about intention and this is where SOTIF was created, that we will talk about safety of the intended functionality. And my involvement, like you wanted to ask, my involvement with all these standards, I was following these standards before from the very ideas because the community is very, very close community. All the safety people in my podcast, I had Hans-Leo Ross, I had people who are the… Hans-Leo Ross even showed the birth certificate of ISO 26262 because he literally wrote the first lines and everything of ISO 26262. And I was privileged to be around these people who are actually shaping the future of these standards and how the engineering work will be done in the autonomous vehicle sphere and safety will be defined. So yeah.

RELATED: The Impact of ISO 26262 on Automotive Development

Mickle: Nice. Well, that must’ve been quite enthralling at the time. So you mentioned that there was this gap sort of missing for functional safety and that SOTIF sort of filled that gap. Could you describe some of the key differences that are there between the standards?

Akram: Absolutely. So the key difference is, like I said, there was a gap. The gap was pretty evident, we’re talking about malfunction. If there is a fault, that fault would lead to a hazard, that’s ISO 26262, that’s traditional functional safety.

Now, what happens if there is nothing wrong in the vehicle, no malfunction, and we still have a hazard? So let me give you a metaphor. Imagine that you have a knife and you bought the knife. Your intention is to chop vegetables. So it’s a very sharp knife. The functionality is great, you’re chopping the vegetable, there is no malfunction, you’re chopping the vegetable. Now, by mistake, unintentionally, you cut your finger with it, it’s a hazard. Now, there is no malfunction still in the knife, the knife is 100 percent functional, it’s your intention that was to chop vegetables, but somehow, unintentionally, you cut your finger. And that’s where the safety of the intended functionality came in.

The famous example of such hazard is this high profile Tesla incident that happened, I don’t know, five, six years ago, where in a junction, because of the lighting condition, Tesla’s ADAS system could not recognize a truck that was passing the junction. And the driver happened to be watching Harry Potter and he didn’t pay attention. And this was fatal, I mean, the driver died. This was such a fatal accident. And there was nothing wrong in Tesla’s ADAS functionality, it’s just that this certain condition, there was no malfunction, this certain condition was not trained, and the ADAS system was not able to detect under certain lighting condition.

And that was the reason, but when we entered, when we started with this, it turned out vastly complex, the whole sphere of SOTIF, when you’re talking about the environment. I’ve just given you one example. So the environment is theoretically infinite. There can be infinite situations and there can be situations that we don’t know about. And the fact of the matter is, we don’t know what we don’t know. When you know something, you can take measure, that’s traditional ISO 26262. Now, we have this unknown unknown. You don’t even know what you don’t know. So that makes it extremely challenging and that’s why the whole process of autonomous vehicle development is going to be a continuous development process, we’ll have to continuously learn and incorporate safety and all those.

THIS HAS BEEN A PREVIEW OF OUR VIDEO AND TRANSCRIPT –
CLICK HERE TO WATCH THIS INTERVIEW IN ITS ENTIRETY:
Expert Perspectives: Integrating Safety of Intended Functionality (SOTIF) Into the Automotive Requirements Engineering Process

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

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

As patient-centered care takes center stage, the medical industry is witnessing an unprecedented transformation in how devices are designed, developed, and regulated. From the rise of direct-to-patient products and AI-enabled diagnostics to the challenges posed by cybersecurity and evolving regulatory landscapes, 2025 promises to be a pivotal year for medical innovation.

In part five of our annual predictions series, Richard Matt – Medical Product Consultant at Aspen Medical Risk Consulting, and Vincent Balgos – Director, Solutions & Consulting at Jama Software, share their insights on the future of medical devices. Together, they explore how digital solutions are reshaping patient care, the hurdles the industry must overcome, and the exciting possibilities for advancing remote monitoring, telehealth, and AI-powered solutions.

We like to stay on top of trends in other industries as well. Read our predictions for Industrial & Consumer Electronics (ICE) HERE, Automotive HERE, Semiconductor HERE, and Aerospace & Defense HERE – Plus, stay tuned for our future topic, AECO.

With patient-centered care becoming increasingly important, how do you see software and digital solutions transforming the design and development of medical devices in the next few years?

Richard Matt: Software development needs to mature to a place of contributing equally with other specialties instead of excelling independently. Far too many companies are being held back by technical siloing, usually led by software. The tragedy is that software personnel are among the most creative and productive employees. Their collaboration needs to mature to a place of creating opportunities for other specialties to be as efficient and achieve this together.

Vincent Balgos: There is a growing trend of direct-to-patient products (hearing aids, CGM’s, smartwatch apps) that includes complex software and digital solutions. In addition, most traditional med devices are now connected to the internet or other devices. I’d expect this trend to continue in this digital age, but with that growth, there will be some unintended side effects. Specifically, cybersecurity threats will continue to become a significant factor during the design, development, and on-market phases of the product.

RELATED: Integrate Cybersecurity and Safety Risk Management in Jama Connect® to Simplify and Accelerate Medical Device Development

Regulatory compliance and data security are paramount in life sciences. What advancements in software do you think will be most effective in managing compliance and protecting sensitive patient data?

Matt: Big data will become more available and utilized systematically to provide answers to questions that have been answered inadequately for decades. Protecting patient data is a simple matter of awareness and giving cybersecurity the sliver of attention it needs to close off the dominant attack vectors.

Balgos: In recent conferences I’ve attended (and read about), AI/ML continue to dominate the discussion around software advancements. Whether providing internal value to organizations, or external facing with AI/ML enabled devices, the impact that AI/ML has (generative, predictive) will play a major factor in the security of data (whether positive or negative). The regulatory guidance of AI/ML is still evolving so it’ll be interesting to see how it unfolds in the future.

As AI and machine learning continue to evolve, what role do you see these technologies playing in medical diagnostics, treatment personalization, and device functionality by 2025?

Matt: AI and ML will continue to evolve, as they have for generations. We have made recent, significant steps forward in natural language recognition, but the integration of that forward movement with diagnostics and treatment personalization will continue to be slow and incremental.

Balgos: The expansion of AI/ML in various traditional areas of med devices is continuing to grow at an exponential rate. Looking at FDA’s dataset, the # of authorized AI/ML enabled devices continue to grow YoY as much as 40% with applications in new areas. Currently, predictive AI is supporting medical professions with their clinical assessment/decisions in a supportive role and seems to be the common use case. But there are current talks now on how generative AI could add potential value in these device areas as well.

What are the biggest hurdles the industry faces in adopting cutting-edge software solutions in device manufacturing and patient care? How can companies proactively address these challenges?

Matt: The biggest hurdle is technical siloing, which software leads very capably. Companies can proactively address this challenge by implementing a systems-approach to problem solving / product development that respects all the technical contributions needed to succeed and ensures software personnel use their exceptional abstraction abilities to work in collaboration with the rest of the company.

Balgos: Some of the biggest hurdles my customers talk to me about are the evolving regulatory landscape, continuing pressures to accelerate development, scalability and ongoing resource and budget constrictions. For changing regulatory, I do recommend folks to work with a qualified regulatory affairs profession for guidance (and is now required in EU). For acceleration, scalability and resource constraints, companies are proactively looking for ways to maximize efficiency and looking to innovative ways to help organizations (e.g., AI applications).

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

How do you foresee the growing demand for remote patient monitoring and telehealth impacting product development for medical devices? What innovations do you think are necessary to support these shifts?

Matt: COVID was an unplanned stress test on our remote work capabilities. We need to analyze the results of that stress test to identify strengths and weaknesses to build into our next generation products and services.

Balgos: Based on the new FDA CDRH Director’s speech at MedTech Conf 2024, these demands coincide with their Home as a Health Care Hub initiative where these homestead digital solutions are becoming more at the forefront of healthcare for many patients. With these increasing interests and demands, I think connectivity of these devices will continue to rise, AI/ML will play a major factor in delivering value, and also improvements in the human factors/usability aspects of these devices will be something to watch. Transitioning from a professionally trained clinical staff to the general population, there will need to be a shift in developing these at home devices to be extremely ‘easy to use’, especially with those that struggle with technology, complex processes, and tedious tactile tasks.

With these innovations, there will be some side effects such as cybersecurity, post market updates, and the interoperability of all these devices. While they seem daunting, I’m confident that industry will rise to the challenge as they have with other previous challenges

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

Balgos: In early 2026, the FDA’s final rule on the Quality Management System Regulation (QMSR) will be effective, thereby incorporating ISO 13485 elements into the current Quality System Regulation (QSR). QMSR will supersede QSR.