Tag Archive for: Compliance & Regulation

Image showing a driver monitoring their software defined vehicle.

In part 2 of this three-part blog series, we will overview our whitepaper, “Software Defined Vehicles: Revolutionizing the Future of Transportation” Download the entire thing HERE – Click HERE for part 1 and HERE for part 3.

Software Defined Vehicles Part 2: Revolutionizing the Future of Transportation

Communication and Connectivity Infrastructure

The software-defined vehicle architecture relies on a robust communication and connectivity infrastructure to enable seamless interaction between various software components and external systems.

  • In-Vehicle Communication: Within the vehicle, communication buses such as Controller Area Network (CAN), Local Interconnect Network (LIN), and Ethernet provide the means for data exchange between different ECUs and software modules. These communication protocols ensure efficient and reliable communication, allowing software components to share information and collaborate.
  • Vehicle-to-Vehicle (V2V) Communication: SDVs leverage V2V communication to exchange information with other vehicles on the road. This communication enables cooperative functionalities such as platooning, where vehicles travel closely together to improve traffic flow and fuel efficiency. V2V communication also facilitates the sharing of critical safety-related information, helping to prevent accidents and improve overall road safety.
  • Vehicle-to-Infrastructure (V2I) Communication: SDVs interact with infrastructure components through V2I communication. This communication enables vehicles to connect with traffic management systems, smart traffic lights, tolling systems, and other infrastructure elements. By exchanging data with the infrastructure, SDVs can optimize their routes, receive real-time traffic updates, and improve overall efficiency and convenience.
  • Vehicle-to-Cloud (V2C) Communication: Cloud connectivity is an essential aspect of the software-defined vehicle architecture. SDVs can connect to cloud-based services and platforms to access a wide range of functionalities, including software updates, navigation data, real-time traffic information, and personalized services. V2C communication allows for seamless integration with mobile apps, remote vehicle management, and advanced analytics for vehicle performance monitoring and predictive maintenance.

The communication and connectivity infrastructure in software-defined vehicles encompasses a robust ecosystem including In-Vehicle communication, V2V(Vehicle-to-Vehicle), V2I (Vehicle-to-Infrastructure), and V2C (Vehicle-to-Cloud) networks, facilitating seamless data exchange, real-time decision-making, and intelligent coordination, ultimately redefining the future of mobility through enhanced safety, efficiency, and personalized experiences.

Hardware and Software Integration

The software-defined vehicle architecture requires seamless integration between hardware and software components to ensure efficient operation and optimal performance.

  • Central Processing Unit (CPU): The CPU acts as the core computational unit, hosting the software applications and executing the necessary algorithms. It provides the processing power and memory resources required to run multiple software functions simultaneously.
  • Electronic Control Units (ECUs): ECUs are responsible for controlling specific vehicle subsystems, such as powertrain, braking, steering, and infotainment. In SDVs, ECUs are typically interconnected and communicate with each other and the central processing unit to exchange data and coordinate actions.
  • Sensors and Actuators: Sensors play a crucial role in SDVs by collecting data about the vehicle’s surroundings, environment, and internal conditions. This data, combined with software algorithms, enables advanced functionalities such as adaptive cruise control, lane-keeping assistance, and collision avoidance. Actuators, controlled by software commands, convert digital signals into physical actions, allowing the vehicle to respond to various driving scenarios.
  • Human-Machine Interface (HMI): SDVs incorporate advanced HMIs that provide intuitive and interactive interfaces for users. Touchscreens, voice recognition, gesture control, and augmented reality displays enable drivers and passengers to interact with the vehicle’s software features, entertainment systems, and personalized settings.
  • Interaction with External Systems (V2X): SDVs are designed to interact with external systems through Vehicle-to-Everything (V2X) communication. V2X encompasses V2V, V2I, and Vehicle-to-Pedestrian (V2P) communication, enabling modern cars to exchange data and information with their surroundings.

Through V2X, SDVs can receive real-time traffic updates, weather information, and road condition alerts. They can also send notifications to walkers and cyclists to enhance safety. V2X plays a crucial role in enabling cooperative driving, efficient traffic management, and improving overall road safety.

RELATED: Effectively Managing Cybersecurity in Jama Connect® for Automotive and Semiconductor Industries

Autonomous Driving and Software Defined Vehicles

Advanced Driver Assistance Systems (ADAS)

Autonomous driving progress is driven by the integration of Advanced Driver Assistance Systems (ADAS). The term ADAS encompasses a range of technologies and functionalities that assist drivers in the driving process and enhance safety. These systems leverage sensors, different software algorithms, and connectivity to provide features such as adaptive cruise control, lane assistance, automatic braking, and blind-spot detection.

Machine Learning and Artificial Intelligence

Machine Learning (ML) and Artificial Intelligence (AI) play a pivotal role in the advancement of autonomous driving capabilities within SDVs.

ML algorithms allow vehicles to learn from data and improve their performance over time. They can analyze vast amounts of sensor data, identify patterns, and make predictions or decisions based on that information. ML algorithms enable SDVs to recognize objects, interpret road conditions, and adapt to dynamic driving situations.

Artificial intelligence, in combination with ML, enables vehicles to perform complex tasks, such as object detection and classification, path planning, and decision-making. Algorithms can process data in real time, allowing vehicles to respond to changing road conditions and make informed decisions for safe and efficient navigation.

The integration of ML and AI in SDVs is an ongoing area of research and development. As the technology evolves, vehicles will be more capable of handling complex driving scenarios and achieving higher levels of autonomy.

Safety and Security Considerations

Autonomous driving and SDVs introduce new safety and security considerations that must be carefully addressed.

  • Safety: SDVs must meet stringent safety standards to ensure the well-being of passengers and other road users. Safety considerations include robust fail-safe mechanisms, redundancy in critical systems, sensor validation and calibration, and real-time monitoring of vehicle performance. Additionally, rigorous testing, simulation, and validation processes are essential to ensure the reliability and safety of autonomous functionalities.
  • Security: As vehicles become more connected and reliant on software, cybersecurity becomes a critical concern. SDVs must implement robust security measures to protect against potential threats such as unauthorized access, data breaches, and malicious attacks. Secure communication protocols, encryption mechanisms, intrusion detection systems, and over-the-air software updates with built-in security features are crucial for safeguarding SDVs against cyber threats.

Regulatory bodies and industry organizations are actively working to establish standards and guidelines to address the safety and security aspects of autonomous driving and SDVs.

RELATED: Jama Connect for Automotive

Over-the-Air Updates and Software Management in SDVs

Introduction to Over-the-Air (OTA) Updates

Over-the-Air (OTA) updates have revolutionized the way software is managed and updated in Software Defined Vehicles (SDVs). OTA updates enable the remote delivery and installation of software updates, patches, and new functionalities to vehicles without requiring physical intervention or visits to service centers.

SDVs leverage OTA updates to keep their software components up to date, introduce new features, improve performance, and address security vulnerabilities. OTA updates offer several benefits, including:

  • Efficiency and Cost Savings: OTA updates eliminate the need for vehicles to be taken to service centers for software updates, reducing downtime and operational costs. Manufacturers can deliver updates to a large fleet of vehicles simultaneously, streamlining the update
    process and reducing logistical challenges.
  • Flexibility and Adaptability: SDVs can evolve and adapt to emerging technologies and customer needs through OTA updates. Manufacturers can introduce new features, improve existing functionalities, and address software bugs or security vulnerabilities without requiring hardware modifications. This flexibility ensures that vehicles remain up to date and can leverage the latest advancements in software technology.
  • Improved Safety and Security: OTA updates enable manufacturers to promptly address safety-related issues and deploy security patches to protect vehicles against evolving threats. By delivering updates in a timely manner, SDVs can enhance the overall safety and security of the vehicle and its occupants.

OTA Update Process

The OTA update process involves several stages, including:

  • Software Deployment: Manufacturers develop and validate software updates through rigorous testing and quality assurance processes. The updates are then securely deployed to a cloud-based server or a dedicated update server.
  • Communication and Notification: SDVs establish a secure connection with the update server using cellular networks, Wi-Fi, or other communication channels. The vehicle’s software periodically checks for available updates and notifies the user about the update availability.
  • Download and Verification: If an update is approved, the vehicle downloads the update package from the server. The downloaded package is verified using digital signatures or other cryptographic methods to ensure integrity and authenticity.
  • Installation and Validation: The vehicle initiates the installation process, which involves updating the necessary software components. After installation, the updated software is validated to ensure correct functionality and compatibility.

Rollback and Recovery: In the event of an unsuccessful update or issues encountered after the update, SDVs may incorporate rollback mechanisms that revert to the previous version of the software. This ensures that the vehicle remains operational and minimizes potential disruptions.

Challenges and Considerations

While OTA updates offer significant benefits, there are challenges and considerations that need to be addressed:

  • Bandwidth and Connectivity: Reliable and high-bandwidth connectivity is crucial for successful OTA updates. SDVs must have robust communication capabilities to handle large update packages and ensure uninterrupted downloads and installations. In regions with limited connectivity, alternative solutions such as offline updates or staged deployments may be necessary.
  • Security and Authentication: OTA updates must be implemented with robust security measures to prevent unauthorized access and ensure the integrity and authenticity of update packages. Secure communication protocols, encryption mechanisms, and strong authentication methods are vital to protect against potential cyber threats and ensure the trustworthiness of the update process.
  • User Consent and Preferences: SDV users should have control over the update process, including the ability to schedule updates, opt-out if desired, and specify preferences for updates. Clear communication and user-friendly interfaces are essential to ensure transparency and a positive user experience.
  • Validation and Compatibility: Thorough testing and validation processes are crucial to ensure that updates are compatible with the vehicle’s hardware, software ecosystem, and existing functionalities. Manufacturers must validate updates to minimize the risk of introducing new issues or incompatibilities that could impact the vehicle’s performance and safety.
This has been part 2 of a three-part blog series overviewing our whitepaper, “Software Defined Vehicles: Revolutionizing the Future of Transportation”
Download the entire thing HERE and click here for part 1 and stay tuned for part 3 of this series.
Image showing a driver who is monitoring their vehicle stats with software on their smartphone.

In part 1 of this three-part blog series, we will overview our whitepaper, “Software Defined Vehicles: Revolutionizing the Future of Transportation” Download the entire thing HERE and visit part 2 HERE and part 3 HERE.

Software Defined Vehicles Part 1: Revolutionizing the Future of Transportation

Introduction

Software Defined Vehicles (SDVs) are a revolutionary approach to transportation that leverages software integration and virtualization technologies to enhance vehicle functionality, connectivity, and autonomy. SDVs are designed to adapt and evolve through the use of software updates, enabling new features, capabilities, and improvements without requiring extensive hardware modifications.

The concept of SDVs emerged from the increasing complexity and reliance on software in modern vehicles. Traditionally, vehicles relied on dedicated, hardware-based components for specific functions such as engine control, braking systems, and infotainment. However, with the rapid advancements in computing power and connectivity, the integration of software has become pivotal in transforming vehicles into intelligent, connected machines.

Advantages and Benefits

The adoption of SDVs brings forth a wide range of advantages and benefits for both manufacturers and consumers.

1. Flexibility and Adaptability: SDVs allow manufacturers to introduce new features and functionalities through software updates, eliminating the need for extensive hardware modifications. This flexibility enables vehicles to keep up with emerging trends and technological advancements.

2. Enhanced Connectivity: SDVs facilitate seamless connectivity with other vehicles, infrastructure, and external systems, enabling Vehicle-to-Vehicle (V2V), Vehicle-to-Infrastructure (V2I), and Vehicle-to-Everything (V2X) communication. This connectivity opens up opportunities for improved safety, traffic management, and optimized driving experiences.

3. Autonomous Driving Capabilities: SDVs play a crucial role in the development of autonomous vehicles. By integrating Advanced Driver Assistance Systems (ADAS), machine learning algorithms, and sensor data, SDVs can achieve various levels of autonomy, ranging from partial to fully autonomous.

4. Improved User Experience: SDVs provide enhanced user experiences through interactive cockpits, personalized infotainment systems, and seamless integration with mobile devices. Users can access a wide range of services, entertainment options, and customized settings to make their driving experience more enjoyable and convenient.

RELATED: Collaborative Planning, Validation, and Alignment for Cybersecurity with Jama Connect® for Automotive

Historical Background and Evolution

Early in the 21st century, when the automotive industry first began adding software for numerous vehicle operations, SDVs began to take shape. Electronic Control Units (ECUs) were invented, opening the door for the use of software in crucial systems including brakes, transmission control, and engine management.

The industry observed a shift towards centralized software architectures as computing power increased and networks advanced. This change made it possible to combine several ECUs into a single central processing unit, which decreased complexity and enhanced communication between various systems.

The development of SDVs was also expedited by improvements in virtualization technology and software-defined networking (SDN). By allowing many functions to execute on shared hardware resources, virtualization made it possible to create virtual instances inside of cars, improving efficiency, and ultimately cutting costs.

The day of completely autonomous vehicles is approaching as software, connectivity, and artificial intelligence come together. SDVs will continue to be essential in determining how transportation develops in the future, ushering in a new era of mobility and connection.

The Role of Software in Modern Vehicles

Traditional Vehicle Architecture

As mentioned above, traditional vehicle architecture relied heavily on dedicated, hardware-based components for various functions. Each function, such as engine control, braking systems, and infotainment, had its own dedicated hardware module or Electronic Control Unit (ECU). These ECUs operated independently, with limited communication between them.

While this architecture served its purpose, it posed challenges in terms of scalability, flexibility, and adaptability. Adding new features or making significant changes required physical modifications to the hardware, resulting in longer development cycles and increased costs.

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

Rise of Software Integration

The development of processing power, the shrinking of electrical components, and greater communication choices have all made it easier to integrate software into automobiles. In order to reduce the number of ECUs and simplify the overall architecture, vehicle makers are now able to conduct several operations on a single central processing unit.

Key Software Components in Vehicles

Modern vehicles incorporate many key software components that enable advanced functionalities and connectivity, including:

1: Operating Systems: Cars now feature sophisticated operating systems that manage and coordinate various functions within the car. These operating systems provide a platform for running applications and managing hardware resources.

2: Middleware: Middleware acts as a bridge between the operating system and the applications, facilitating communication and data exchange. Middleware enables the smooth integration between different software components and ensures interoperability throughout the vehicle.

3: Application Software: Application software in vehicles includes a wide range of features, such as connectivity services, ADAS, entertainment systems, and engine management. These programs make use of user inputs, communication protocols, and sensor data to offer a positive and rich user experience.

4: Connectivity Modules: Many vehicles now come equipped with connectivity modules, such as Bluetooth, Wi-Fi, and cellular networks. These modules enable communication with external systems, including smart phones, cloud services, and other vehicles, facilitating data exchange and access to various services.

5: Sensor Integration: Sensors play a critical role in modern vehicles, collecting data related to things like the vehicle dynamics, environment, and driver inputs. Software algorithms process this gathered data to enable advanced features like adaptive cruise control, lane-keeping assistance, and collision avoidance. This is all setting the foundation for autonomous driving capabilities.

RELATED: The Impact of ISO 26262 on Automotive Development,

Fundamentals of Software Defined Vehicles

Overview of Software Defined Networking (SDN)

Software Defined Networking (SDN) is a key technology that underpins the concept of Software Defined Vehicles (SDVs). SDN decouples the control plane from the data plane in networking infrastructure, enabling centralized control, and programmability of network functions.

In the context of SDVs, SDN allows for the centralized management and control of vehicle networks, facilitating efficient communication and coordination between various software components. SDN provides a flexible and scalable framework for routing and managing data flows within the vehicle architecture.

By leveraging SDN principles, SDVs can dynamically allocate network resources, prioritize data traffic, and adapt to changing network conditions. This flexibility is crucial for enabling real-time communication and coordination between vehicle subsystems, external systems, and the cloud.

Virtualization and Containerization Technologies

Virtualization technologies play a vital role in the implementation of SDVs. They enable the creation of virtual instances or virtual machines (VMs) within vehicles, allowing multiple functions to run on shared hardware resources.

Virtualization provides several benefits like resource optimization, improved scalability, and simplified management. By utilizing virtualization, manufacturers can consolidate functions onto a single hardware platform, reducing hardware cost and complexity.

Containerization technologies like Docker and Kubernetes are also gaining popularity in the automotive industry. Containers provide a lightweight and portable method for packaging applications and their dependencies. They also enable the isolation of applications, allowing for efficient resource utilization and simplified deployment across different vehicle platforms.

Containerization further enhances the flexibility and agility of SDVs, enabling the seamless deployment and management of software components within the vehicle ecosystem.

Centralized and Distributed Architectures

SDVs can be implemented using either centralized or distributed architectures, depending on the specific requirements and design considerations.

Centralized Architecture: In a centralized architecture, a central processing unit (CPU) or a powerful computing platform acts as the brain of the vehicle. It hosts the control logic, manages software components, and coordinates communication between different subsystems. The centralized approach simplifies hardware complexity and facilitates efficient resource utilization. However, it also poses challenges related to single points of failure and potential performance bottlenecks.

Distributed Architecture: In a distributed architecture, software functions are distributed across multiple computing platforms or ECUs within the vehicle. Each ECU handles specific functions or subsystems, such as powertrain, chassis, or infotainment. Distributed architectures offer improved fault tolerance and performance optimization. However, they require robust communication protocols and coordination mechanisms to ensure seamless operation.

The choice between centralized and distributed architectures depends on factors such as the complexity of the vehicle’s functions, performance requirements, scalability, and safety considerations.

This has been part 1 of a three-part blog series, stay tuned for parts 2 and 3 of this series. Click HERE to download the “Software Defined Vehicles: Revolutionizing the Future of Transportation” whitepaper.

Image showing pilot operating a plane to symbolize the importance of DO-326A in cybersecurity.

In this blog, we’ll recap our whitepaper, “Cybersecurity in the Air: Addressing Modern Threats with DO-326A” Click HERE to read the entire paper.

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

Introduction

Not long ago, getting on an airplane meant being largely out of touch with everyone on the ground for the duration of one’s flight. Of course, there were in-flight telephones for those who could afford them, and pilots could connect with personnel on the ground in case of emergency, but the rank-and-file passenger had limited options for connecting with the world outside the aircraft.

The 21st century has changed flying from a largely isolated endeavor that exists in a closed loop to one that integrates with ground systems through the miracle of the Internet. For travelers who want to enjoy their own personal entertainment options, conduct business, or take advantage of downtime to do online shopping, accessing the Internet during a flight is a tremendous boon. For air freight carriers and their customers, Internet connectivity improves visibility and streamlines supply chains with better real-time information.

Of course, the advantages of connectivity come with disadvantages as well. The more airborne systems are interconnected with the broader Internet, the more vulnerable systems are to hacking. In 2015, a researcher was kicked off a United Airlines flight after tweeting about security vulnerabilities; the researcher claimed to have accessed in-flight networks multiple times between 2011 and 2014, including one time when he allegedly commandeered the plane. In 2016, the US Department of Homeland Security hacked the system of a Boeing 757 using “typical stuff that could get through security.” And in 2022, Boeing announced a software update to repair a vulnerability that could allow hackers to modify data and cause pilots to miscalculate landing and take-off speeds.

Aviation cybersecurity has become a critical issue across the globe. Not only do millions of passengers depend on airlines to get them safely from point A to point B every day, but manufacturers, shipping services, and militaries rely on aircraft systems to support supply chains and execute missions. Cyberattacks have skyrocketed since the onset of the COVID-19 pandemic; a 2022 report found a 140% increase in cyberattacks against industrial operations — including four attacks that caused flight delays for tens of thousands of passengers.

Clearly, aviation systems can be vulnerable to malicious actors. For developers and manufacturers in the aviation industry, DO-326A provides compliance guidelines to address the vulnerabilities of avionics systems.

To create the safest, highest quality vehicle, REGENT knew that they must implement a world-class development process.
See how Jama Connect® plays a key role in that process

What is DO-326A?

Known as the “Airworthiness Security Process Specification,” DO-326A (and its European counterpart, ED-202) is the aviation cybersecurity standard developed jointly by the Radio Technical Commission for Aeronautics (RTCA) and the European Organisation for Civil Aviation Equipment.

The original edition, DO-326, was issued in 2010; its revised version, DO-326A, was issued in 2014. The standard became mandatory in 2019.

The DO-326A/ED-202A set focuses primarily on how to prevent malware that can infect avionics systems during both development and flight operations. A cyberattack on these critical systems can impact how the aircraft works and potentially endanger operators and passengers. DO-326A/ED- 202A describes the Airworthiness Security Process that one should follow.

Related webinar: Verifying Security in a Safety Context: Airworthiness and DO-326A/356A

What is Airworthiness/Airworthiness Security Process?

“Airworthiness security” involves protecting an aircraft from intentional unauthorized electronic interaction, including malware, ransomware, and other cyber threats.

The Airworthiness Security Process (AWSP) is intended to establish that aircraft will remain safely operable if it is subjected to unauthorized interaction.

DO-326A outlines the Airworthiness Security Process in seven steps:

1. Plan for Security Aspects of Certification (Aircraft Level Planning/System Level Planning)
2. Security Scope Definition (Threat Assessment Process)
3. Security Risk Assessment (Threat Assessment Process)
4. Decision Gate (Threat Assessment Process)
5. Security Development (Definition of Security Measures and Requirements)
6. Security Effectiveness Assurance (Verification and Validation of Security Measures and Requirements)
7. Communication of Evidence (PSecAC Summary Reporting)

To read this entire whitepaper, visit: Cybersecurity in the Air: Addressing Modern Threats with DO-326A


In this blog, we present a preview of our customer story, ” Global Industry Leading Automotive Application Developer dSPACE Migrates from Legacy Requirements Management Platform to Jama Connect®” – To download the entire story, CLICK HERE

Global Industry Leading Automotive Application Developer dSPACE Migrates from Legacy Requirements Management Platform to Jama Connect®

As part of a global modernization initiative, dSPACE partners with Jama Software® to migrate decades of data, increase collaboration, simplify compliance, and integrate processes across best-of-breed tools.

About dSPACE

  • Founded: 1988 in Paderborn, Germany (North Rhine-Westphalia)
  • Expertise: Solutions for automotive applications, including autonomous driving, E-mobility, power trains, V2X and connected services, communication systems, body and comfort electronics, and chassis.
  • Other Industries Served: On- and off-road commercial vehicles, aerospace, energy, rail, marine, machinery & power tools, and academia.
  • Mission: Enable technology and mobility pioneers to make life safer, cleaner, and easier.

dSPACE is one of the world’s leading providers of simulation and validation solutions that are used for developing connected, autonomous, and electrically powered vehicles.

Mainly automotive manufacturers and their suppliers use the company’s end-to-end solution range to test the software and hardware components of their new vehicles long before a new model is allowed on the road. dSPACE is not only a sought-after development partner in vehicle development, but engineers also rely on dSPACE’s expertise in aerospace and industrial automation.

dSPACE’s portfolio ranges from end-to-end solutions for simulation and validation to engineering and consulting services as well as training and support. With more than 2,400 employees worldwide, dSPACE is headquartered in Paderborn, Germany; has three project centers in Germany; and serves customers through regional dSPACE companies in the USA, the UK, France, Japan, India, China, Korea, and Croatia.

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

Needs and Evaluation Criteria

  • New, modern solution that supports Agile development
  • Enhanced integration capabilities – particularly with Azure DevOps
  • Improving user acceptance with a tool that met all stakeholder needs
  • Ability to migrate data from IBM® DOORS® Classic without losing significant data

Why dSPACE Chose Jama Connect®

  • Ability to view items from a document and single-item perspective
  • Wide range of robust functionality and maturity, namely: Configuration management, Live Traceability™, reviews, import, and export
  • Ability to migrate data from DOORS without loss and reconstruct the data in an easier, more modern model
  • Strong network of integrations enabled by Tasktop
  • Easy administration
  • Cloud-based software as a service (SaaS)

Migration Objectives

  • Transfer all legacy data from DOORS to Jama Connect
  • Limit business disruption due to complex interdependencies
  • Recreate the structure of data in Jama Connect to reduce complexity while ensuring no data loss

Outcome and the Future

  • Fits every team’s individual needs – from simple to highly complex
  • Strong cross-project collaboration
  • Bi-directional data flow with Azure DevOps
  • Cloud-based solution with flexible license model allows external partners and suppliers to participate in the same platform
  • Out-of-the-box configurations and templates help dSPACE comply with key regulations and prepare for audits with less effort and time
  • Ongoing partnership with Jama Software for best practices, configuration help, and training

TO READ THE FULL CUSTOMER STORY, DOWNLOAD IT HERE:
Global Industry Leading Automotive Application Developer dSPACE Migrates from Legacy Requirements Management Platform to Jama Connect®


Image showing a clock with a graduation had, symbolizing that the viewer will be learning about SaMD.

In this video, we’ll discuss the Software as a Medical Device (also known as SaMD) framework in Jama Connect.

Jama Connect® Features in Five: SaMD Framework

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 the powerful features in Jama Connect®… in about five minutes.

In this Features in Five video, Romer De Los Santos – Senior Consultant at Jama Software® – will go over some highlights of the Software as a Medical Device (also known as SaMD) framework in Jama Connect.

VIDEO TRANSCRIPT

Romer De Los Santos: Hello. My name is Romer De Los Santos and I’m a senior consultant here at Jama Software. In this video, we’ll go over some highlights around Jama Connect’s new Software as a Medical Device (also known as SaMD) framework.

Anyone who has worked developing medical device software has struggled with balancing the creation and maintenance of the required documentation with the day-to-day struggle of developing and testing software. And because software cycles are highly iterative, they are incompatible with traditional waterfall development.

Jama Connect’s new SaMD framework is designed to help alleviate the burden of documentation so that your team can focus on development. This purpose-built framework allows users working on both simple and complex software projects to use Jama Connect right out of the box. Its design was born from over 20 years of hands-on experience developing medical device software.

Some highlights of this framework include:

  • Templates like Software Development Plans that are designed to be compliant with IEC62304. These documents come with a customizable report that you can modify with your own branding.
  • Built-in risk analysis designed to be compliant with ISO14971 that takes advantage of Jama Connect’s built-in look-up table feature.
  • A new SOUP/OTS item type is designed to capture information about third-party developed software components in compliance with the FDA’s guidance on Off the Shelf, (or OTS)Software Use In Medical Devices.
  • A new External Resource item type to capture and trace items tracked outside of Jama Connect.

Let’s take a closer look.

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

De Los Santos: The SaMD framework gives new medical device manufacturers a great starting point. It has been designed to with regulations like IEC 62304 and ISO 14971 in mind. However, manufacturers are still required to define their own quality management system.

Although regulations specify what needs to be documented, there’s no universally accepted document name or format. Jama Connect can be configured to use your company’s own jargon and the document templates required by your own quality management system.

The framework is organized into four major components in a document-centric structure. This means that items are organized into documents rather than by function.

This structure is easier for new users to recognize and work on. It also facilitates the generation of documents that will be submitted to the system of record of your choice.

For your convenience, the framework includes customizable export templates for multiple documents. You can change the logo, headers, footers, fonts, and style of your document to match your company’s branding requirements.

Project-level documentation includes planning documentation such as the Software Development Plan and Software Verification Validation Plan.

IEC 62304 has specific requirements for software development plans that have been incorporated into the template for your convenience.

RELATED: Jama Connect® Customer Validated Cloud Package for Medical Device and Life Sciences

De Los Santos: While IEC 62304 does not require a separate Software Verification or Validation Plan, it does require specific information about how verification and validation will be performed. This document template includes sections for the required information.

System-Level Documentation includes documents that define the requirements, testing, and design of the whole system. It can include items like User or Stakeholder Needs, Design input documents, Product Requirements Specifications, and Software Architecture documents.

Sub-System Level Documentation can be organized into individual components, software or otherwise. Each component includes the requirements, test cases, and design documentation.

The Risk Management Plan, FMEAs, and risk analysis are centralized in the Risk component. By default, the FMEA and risk analysis are organized as you would see them in Excel. It also takes advantage of Jama Connect’s built-in look-up matrix feature to do your risk calculations.

Of course, not all medical device software projects are multi-component projects. A software project that consists of a single software component doesn’t need to have system and subsystem-level requirements. In this case, remove the System Requirement and System Architecture item types from the relationship diagram to create a single-level structure.

OTS/SOUP components are documented through a new item type that is specifically designed to capture the information specified in the FDA’s guidance on OTS Software Use in Medical Devices.

RELATED: EU Medical Device Regulation (EU MDR) FAQs: Industry Expert Insights

De Los Santos: Jama Connect allows you to trace the specific sections of your design documentation that utilize third-party components to this item type. This makes tracking where these software components are used easy.

Finally, we’ve added a catch-all item called External Resource. External Resource items allow you to trace items that may be tracked outside of Jama Connect. This can be items like instructions for use, labeling, package inserts, specifications, schematics, and pretty much anything else you need to trace.

I hope you got a lot out of this quick look at the new SaMD framework in Jama Connect. If you want to learn more about Jama Connect and how it can optimize your product development process, please visit our website at jamasoftware.com – If you’re already a Jama Connect customer and would like more information about Medical Device Software, please contact your customer success manager or a Jama Software consultant.

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


 

traceable agile development

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

Automotive, aerospace and defense, and industrial companies have largely adopted Agile within rapidly growing software factories to speed time to market in order to stay competitive. These software factories have largely succeeded in speeding up software development for companies within the industries that have adopted it, but maintaining quality is still a key concern. The inability to coordinate development across engineering disciplines has led to product recalls, quality complaints, and has created significant internal challenges to satisfy functional safety requirements from regulators and confidently deliver high-quality software. These challenges — and resulting outcomes — are often so severe that leadership of the software factories have been let go.

Fundamental Questions We Hear

When we ask software factory leaders, “what keeps them up at night?” We consistently hear the following five questions:

  • How do I know which product requirements have been missed?
  • How do I know which product requirements are not fully covered by test cases?
  • How do I know which product requirements have failed to pass tests?
  • How do I identify rogue development activity?
  • How do I know if changes have been made at the system and / or hardware level that impact the software team?

These are fundamental questions that should be answerable from leading Agile tooling, but they are not. The reason is that Agile tools focus on tasks (define, assign, status, complete, delete) and have no notion of the current and historical state of the project. Tasks are not tied to any state of the project which often leads to drift from the actual needs and requirements of your customer or end user. As a result, these questions are not answerable with Agile tools like Jira and Azure DevOps. Project management tools like Jira Align answer important questions around staffing, sprint planning, and cost allocation, but do not address the critical questions above focused on the real-time state of the software development effort against the approved requirements.

RELATED: What is a Scaled Agile Framework (SAFe) and How Does it Help with Complex Software Development?

The Answer? Traceable Agile.

How do you best speed software and overall product development and still achieve the quality expectations of customers and company leadership? The answer is Traceable Agile. Traceable Agile speeds the FLOW of software development but also maintains the current and historical STATE of the development effort and auto-detects issues early in the software development process. Traceable Agile recognizes that developer activity is best managed as a FLOW using tasks in a tool such as Jira. What is needed to achieve Traceable Agile is to pair a system with Jira that manages the STATE of the development effort at all times. By keeping STATE and FLOW tools separate but integrated, no change is required to software developer process and tools. This is significant. Software leadership can now answer their critical questions without having to undergo a major process and tool change with resistant developers which would slow down development and/or increase staff attrition.

RELATED: How to Achieve Live Traceability™ with Jira® for Software Development Teams

So how does Traceable Agile work in practice?

Here is an overview and diagram of Jama Connect® maintaining the STATE of development activity and Jira providing the FLOW.

  1. Task activity continues as normal in Jira and risk is auto-detected in Jama Connect by comparing all user stories and bugs in Jira to the expected development and test activity for each requirement in Jama Connect.
  2. All exceptions are identified —the ones that answer the questions that keep software factory leadership up at night — such as requirements with no user stories, user stories with no requirements, requirements with no test cases or test results, etc.
  3. After the exceptions are inspected in Jama Connect, management can take action and assign corrective tasks in Jira as just another task in the queue for a developer.

 

traceable agile software development

 

RELATED: Extending Live Traceability™ to Product Lifecycle Management (PLM) with Jama Connect®

This is a fully automated process that leverages automated synchronization of meta data between Jira and Jama Connect via Jama Connect Interchange™. The only metadata that needs to be synchronized from Jira to make Traceable Agile possible is as follows: ID, Created Date, Creator (User), Modified Date, Modifier (User), Title, Status, Link (URL), Relationships. On inspection in Jama Connect of an issue, one simply clicks on the link to go to Jira if more information is required to diagnose.

Many of our leading clients have already implemented Traceable Agile and are significantly improving their Traceability Score™ which we have demonstrated leads to superior performance on quality metrics in our Traceability Benchmark Report.

Feel free to reach out to me to learn more and I will respond.

RELATED: In this video, we will demonstrate and discuss Traceable Agile™
and how speed and quality make software factories and safety-critical industries possible.


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 excerpts from an article, sourced from MedTech Dive, titled “UK regulators name 3 approved bodies to ease device certification bottleneck” – originally written by Nick Paul Taylor and published on August 31, 2023.

UK regulators name 3 approved bodies to ease device certification bottleneck

A MHRA leader hailed the action as “almost doubling capacity for medical device assessment in the U.K.”

Dive Brief:

  • The Medicines and Healthcare Products Regulatory Agency (MHRA) has designated three more bodies to certify medical devices in the U.K.
  • As a result of Brexit, the U.K. is requiring manufacturers of all except the lowest-risk devices to apply for UK Conformity Assessment (UKCA) certification from an approved body. The approved bodies perform the same role as the notified bodies that issue CE marks to devices sold in the European Union.
  • MHRA’s designation of three approved bodies helps address a capacity shortage that led the government to stagger the transition from CE marks to UKCA certification.

RELATED: Failure Modes, Effects, and Diagnostic Analysis (FMEDA) for Medical Devices: What You Need to Know

Dive Insight:

MHRA automatically moved the U.K.’s three existing notified bodies, BSI, SGS and UL, to the approved body scheme when the country split from the European Union. Since then, efforts to add capacity have proceeded slowly. The U.K. affiliate of DEKRA, a notified body in the EU, became the first new approved body for medical devices 11 months ago.

Now, MHRA has designated TÜV SÜD, Intertek, and TÜV Rheinland UK. The designation clears the three bodies to certify general medical devices and empowers TÜV Rheinland UK to assess in vitro diagnostic (IVD) products. IVD capacity is lagging behind, with MHRA having designated four bodies in total.

In a statement, Laura Squire, chief healthcare quality and access officer at MHRA, hailed the addition of the three approved bodies as “almost doubling capacity for medical device assessment in the U.K.” It is unclear how many applications each approved body is capable of handling.

RELATED: Elevating Your Medical Device and Life Sciences Product Development Processes with Jama Connect®

Even so, the designations go at least some way toward addressing a long-standing concern. The Regulatory Horizons Council identified the “lack of capacity in approved bodies within the U.K.” as a risk to patient safety and access to devices in a report two years ago.

Responding to the report early this year, the government accepted recommendations about addressing bottlenecks in device approval, notably the shortage of approved bodies, and taking mitigating steps to ensure the supply of products after the transition to UKCA. The concerns informed the decision to keep accepting devices with CE marks through 2028 or 2030, depending on the regulation.


Image for the blog, "EU Medical Device Regulation (EU MDR) FAQs: Industry Expert Insights"

EU Medical Device Regulation (EU MDR) FAQs: Industry Expert Insights

Are you grappling with the intricacies of the EU Medical Device Regulation (EU MDR) and searching for clear answers to your most pressing questions? Look no further!

In this blog post, we’ve teamed up with subject matter expert Saby Ágai, Senior Professional Services Consultant at Jama Software®, who will shed light on the complex world of medical device compliance.

Overview + General Information

Why was the MDD (Medical Devices Directive) updated?

Saby Ágai: MDD entered into force in 1993, 30 years ago. There have been many changes over these three decades. There have been technological changes since then, software for example has more attention now than it had 30 years ago.

Patient demographics characteristics have changed, now it is a more aging population than it was 30 years ago. Medical device safety should correspond to these changes.

MDD was primarily focused on medical device commercialization criteria rather than looking at patient safety from a holistic perspective.

What are the most important changes introduced by the EU Medical Device Regulation?
  • EU MDD was focused on commercialization guardrails and market clearance criteria first.
  • EU MDR accounts for the full technological landscape, establishing guardrails for the regulation, manufacturing, and commercialization of medical devices.
Given that timelines may continually change, what is the latest information regarding extensions?

Transition Timelines Chart

RELATED: What the New Medical Device Regulations (EU MDR) Mean for You

Implementation/Adaptation + Need for Process Improvement

The EU MDR has changed how medical devices are covered. What opportunities and challenges might this expansion present for manufacturers?

Opportunities:

  • Manufacturers can deliver to the market higher levels of safety for their medical devices.
  • Manufacturers can be more aware and in control of their medical device lifecycle.
  • Potentially this could result in less recalls and less rework, and fewer customer complaints. There is also an opportunity for an easier pathway to other markets like US, Canada, Japan, and others.

Challenges:

  • Steep learning curve to adopt to the new regulation
  • Lack of professional, lack of experiences how to adopt to the new regulations
  • Optimizing efforts and resources spent on the adoption of MDR
What strategic steps should medical device companies and regulatory experts take to ensure a successful transition in light of the changes brought on by the MDR and its effect on CE markings?

Manufacturers should have a plan for MDR transition

  • Expert panel of the EU could be involved to receive professional support
  • Regulatory professionals should be competent to the new regulations
  • Best practices across the medical industry should be utilized for the transition
How can medical device manufacturers improve their Quality Management Systems (QMS) to be better at compliance? What new approaches can be used to make business growth and product innovation possible?

New quality management processes should be developed to correspond to the requirements of the MDR. Manufacturers should also revisit their core processes including quality assurance, risk management, and post-market process to see if re-implementation needed to ensure compliance with new MDR.

Related: Learn about the continual rollout of the EU Medical Device Regulation (MDR) and In-Vitro Device Regulation (IVDR) and the impact they’re having on the medical device industry:

Data & Documentation

What impact does the EU MDR’s demand for increased device traceability and technical documentation have on promoting patient safety and regulatory visibility? What potential advantages and obstacles might exist when attempting to reach these outcomes?

Patients will benefit from the increased focus on safety and regulatory visibility on medical devices that MDR demands. On the other hand, novel technologies in medical devices may suffer from delays to be available early for patients. It is a balance though between efficiency and safety that always was there. The increased volume of technical documentation can lead to higher levels of design awareness for the manufacturers, on the other hand the increased resources needed to get there need to be financed.

How can medical device manufacturers collaborate with notified bodies and competent authorities to ensure a streamlined and efficient certification process?

There is a conflict of interest that does not allow the Notified Body and Authorities to provide consulting on MDR compliance for the same manufacturer that registered for certification. Manufacturers can help the certification process by signing up for certification on time. Manufacturers also can streamline certification processes by involving competent and experienced professionals to fulfill the Person Responsible for Regulatory Compliance (aka PRRC) role.

RELATED: CE Marking for Medical Device Software: A Step-By-Step Guide

Innovation

Can you explain the new EU MDR’s structure and how it supports innovation and patient safety?

Here is a great resource for that: https://www.leanentries.com/wp-content/uploads/mdr-table-of-contents.pdf. MDR is taking a holistic view on patient safety by broadening its scope to the full lifecycle of medical devices.

What are some key differential requirements that organizations will need to comply with?

Chart showing 6 stages of the structure of the EU MDR Technical Documentation

Let’s investigate the products listed in Annex XVI of the MDR and discuss the effects this will have on both manufacturers and healthcare providers. How can stakeholders take advantage of this inclusion to create positive results?

Those products are subject to the MDR, even though those are without an intended medical purpose. These products previously were unregulated products and the MDR introduces new manufacturing and surveillance requirements. A positive result is the higher level of transparency of the design, manufacturing and post market activities of these products. Users of such products benefit from a higher level of safety when using these products.

Will the stricter regulatory requirements of the EU MDR hinder or promote innovation in the medical device industry?

There is always a balancing between introducing novel technologies to patient treatments that potentially can save or extend our life as a patient versus using only high level of safety assured medical devices. If the current MDR hinders or promotes innovation only time will tell.

How can manufacturers balance the need for compliance with the desire to bring innovative products to market in a timely manner?

Market regulations are prescriptive to the given market. Manufacturers probably will deliver slightly different functionalities for essentially the same medical devices depending on how the market regulation allows for more open for novel technologies.

Patient Safety

How does the EU MDR change clinical evaluation requirements? And how can the industry adapt to these changes while continuing to prioritize patient well-being and efficacy?

The MDR has more rigorous clinical evaluation requirements, necessitating robust clinical data to support the safety and performance claims of the device. For each device, the manufacturer must plan, establish, document, implement, maintain and update a post-market surveillance (PMS) system that is proportionate to the risk class and appropriate for the type of device. The PMS system actively and systematically gathers, records and analyses data on the quality, performance and safety of a device throughout its entire lifetime. Post-market clinical follow-up (PMCF) is a continuous process that updates the clinical evaluation. It is conducted in accordance with a PMCF plan that is an element of the overall PMS plan.

What opportunities does the EU MDR present for enhancing patient safety through better data collection and analysis?

Clinical evaluation and post-market related information will be more transparent for the medical devices; therefore, manufacturers will have more opportunities to analyze device safety based on adverse events of similar types of devices.

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

Post-Market Surveillance

How does the increased emphasis on clinical data and post-market surveillance impact medical device manufacturers’ approach to product development and monitoring?

Clinical and post-market data collection should drive the design effort by transferring efficacy and safety related subjects back to development. Also, the analyses of similar products post market reporting enable manufacturers to enhance the safety of their medical device designs.

How can manufacturers leverage the new post-market surveillance requirements to proactively identify and address potential issues with their products?

MDR mandates and sets requirements for the post-market surveillance process. PMS process should be part of the manufacturer’s Quality Management System.

Manufacturers can use proactively the data gathered as part of the post-market activities for the following:

  • to update the benefit-risk determination and to improve the risk management;
  • to identify the need for preventive, corrective or field safety corrective action;
  • to identify options to improve the usability, performance and safety of the device;
  • to detect and report trends.

Conclusion

How will the EU MDR impact medical device companies operating outside the EU but wishing to access the European market?

For new arrivals, the new MDR is a demanding legislation to comply with in the European Union. Currently the conformity assessment bodies have limited bandwidth for new devices. Therefore, new manufacturers should assess the timing nature of their market access. For medical device companies operating outside the EU, there are further requirements set in the MDR in Article 11 on Authorized representatives.

How can Jama Software help organizations more easily comply with regulations like EU MDR?

Jama Software provides a solution for medical device manufacturers to adapt easily and to response quickly to the changes that the EU MDR demands. It’s achieved by providing best practices in medical device design in the context of the MDR.


IoMT Image showing a doctor and patient discussing a chart

Embracing the Future of Healthcare: Exploring the Internet of Medical Things (IoMT)

Internet connected devices, part of the Internet of Things (IoT) are everywhere. These devices, often referred to as “smart” devices are in our homes, cars, offices, and gyms. Therefore, it is no surprise that smart devices are making their way into our healthcare environments. In the ever-evolving landscape of healthcare, technological advancements continue to revolutionize the way we diagnose, monitor, and treat patients. Among these groundbreaking innovations, the Internet of Medical Things (IoMT), also called Healthcare IoT, has emerged as a powerful force, combining the power of the internet and medical devices to improve patient care, enhance efficiency, and drive positive health outcomes. This article delves into the world of IoMT, exploring its potential and highlighting its significance in shaping the future of healthcare.

Understanding IoMT

IoMT refers to a network of medical devices, sensors, software applications, and healthcare systems interconnected through the internet. These interconnected devices gather and exchange vital data, enabling healthcare providers to remotely monitor patients, track health conditions, and make informed decisions in real-time.

RELATED: Elevating Your Medical Device and Life Sciences Product Development Processes with Jama Connect®

How IoMT Transforms Healthcare

  1. Remote Patient Monitoring: IoMT allows healthcare professionals to remotely monitor patients’ health conditions in real-time. Connected devices, such as wearables and implantable sensors, collect valuable health data, including heart rate, blood pressure, glucose levels, and more. This continuous monitoring helps in the early detection of abnormalities, enabling prompt intervention and preventing complications.
  2. Enhanced Patient Engagement: IoMT empowers patients to actively participate in their own healthcare. Connected devices enable individuals to monitor their health parameters, track progress, and access personalized health information through user-friendly mobile applications. This increased engagement and access to information promote medical compliance, leading to improved health outcomes.
  3. Efficient Healthcare Delivery: IoMT streamlines healthcare delivery by automating processes and reducing human error. Smart devices integrated with electronic health records (EHR) systems enable seamless data sharing, eliminating the need for manual data entry. This enhances the accuracy and speed of medical documentation, enabling healthcare providers to focus more on patient care.
  4. Predictive Analytics and AI: IoMT-generated data, combined with advanced analytics and artificial intelligence (AI), provides powerful insights for healthcare decision-making. Machine learning algorithms can analyze vast amounts of patient data to identify patterns, predict disease progression, and support personalized treatment plans. This data-driven approach improves diagnostics, enhances treatment outcomes, and reduces healthcare costs.

Challenges and Security Considerations

While the IoMT brings forth numerous benefits, it also presents challenges and security concerns that must be addressed. Privacy and data security are critical considerations when dealing with sensitive patient information. In addition to privacy concerns, healthcare data is used to devise and implement patient care plans, and incorrect or altered data can result in detrimental, rather than successful care. Robust security measures, including encryption, access controls, and regular system audits, must be implemented to safeguard patient data from potential cyber threats.

The Impact of IoMT on Healthcare Professionals

The Internet of Medical Things (IoMT) not only benefits patients but also has a significant impact on healthcare professionals. With IoMT, healthcare providers can access real-time patient data, allowing for more proactive and informed decision-making. This immediate access to critical information enables doctors and nurses to remotely monitor patients, detect potential issues early on, and intervene promptly. By leveraging IoMT, healthcare professionals can optimize their workflows, reduce administrative burdens, and focus more on delivering quality care to their patients. Additionally, IoMT facilitates collaboration and consultation among healthcare providers. Through secure data sharing and telemedicine applications, specialists from different locations can review patient information, discuss treatment plans, and provide expert advice. This seamless connectivity between healthcare professionals promotes knowledge sharing, enhances diagnosis accuracy, and enables comprehensive, multidisciplinary care. IoMT enables healthcare providers to leverage the collective expertise of a network of professionals, ultimately improving patient outcomes and optimizing resource allocation.

RELATED: Requirements Traceability Diagnostic

IoMT in Remote and Underserved Areas

One of the most significant advantages of IoMT is its potential to address healthcare challenges in remote and underserved areas. In regions with limited access to healthcare facilities, IoMT offers a lifeline by bringing medical expertise and resources virtually. Remote patient monitoring through connected devices enables healthcare professionals to remotely assess patients’ vital signs, chronic conditions, and recovery progress. This capability is particularly valuable for individuals living in rural areas, elderly patients, and those with limited mobility. Furthermore, IoMT can bridge the gap between patients and specialized healthcare services. Through telemedicine, patients in remote locations can consult with medical specialists without the need for long-distance travel. This reduces the burden on patients and their families, improves access to specialized care, and enhances health outcomes. The IoMT’s ability to deliver healthcare remotely has the potential to revolutionize healthcare delivery, ensuring that quality care reaches even the most underserved populations.

The Future of IoMT: Advancements and Opportunities

IoMT is rapidly evolving, with continuous advancements and exciting opportunities on the horizon. As technology progresses, we can expect further integration of IoMT with AI and machine learning algorithms. These advancements will enable more accurate diagnostics, personalized treatment plans, and predictive analytics, leading to precise and targeted healthcare interventions and improved patient outcomes. Moreover, the emergence of 5G technology will play a pivotal role in unlocking the full potential of IoMT. The high-speed and low-latency capabilities of 5G networks will support real-time data transmission, facilitating seamless connectivity between devices and healthcare systems. This will revolutionize telemedicine, remote patient monitoring, and enable new applications such as robotic surgeries and augmented reality-based medical training.

Conclusion

The Internet of Medical Things (IoMT) represents a revolutionary paradigm shift in the healthcare industry, offering immense potential to improve patient care, increase efficiency, and drive positive health outcomes. By harnessing the power of interconnected medical devices, sensors, and advanced analytics, IoMT enables remote patient monitoring, enhances patient engagement, streamlines healthcare delivery, and leverages predictive analytics. Despite challenges, with careful attention to security and privacy, IoMT has the potential to shape the future of healthcare, ushering in an era of personalized, connected, and data-driven medicine.

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


Digital Thread

In this blog, we preview a section from the new eBook, “CIMdata: Digital Thread in Aerospace and Defense”
Click HERE to download it.

Recent CIMdata research on behalf of the Aerospace and Defense PLM Action Group member companies in collaboration with PTC clearly indicates that digital thread investment within the ecosystem of industrial users, their customers, suppliers, and solution providers is poised for rapid growth. Initial implementations of targeted digital thread solutions have provided proof points of value and essential learnings. Now, rounds of investment are ramping up, guided by these early achievements and with expectations driven by the value potential revealed.

The concept of a digital thread providing automated linkage of multiple representations of a product, each tuned to the needs of various creators and consumers along the lifecycle, is very powerful. Until recently, tracing these linkages has been primarily a manual process, extracting product information from myriad heterogeneous systems and relating them in ad hoc reports. But now, with recent advances in commercial PLM solutions, the digital thread, with automated linkages and traceability, has become a practical possibility, even for industries with complex products, such as aerospace & defense.

In response, industry leaders have implemented targeted digital thread solutions and envision expanding these solutions throughout the product lifecycle. With the newness of this approach there is not much available in the way of lessons learned or value achieved. This lack of real data is a barrier to broader investment within industry. On the solution side, providers are constantly seeking additional insight into investment drivers within industry.

Future Digital Thread Investment Priorities

Looking to the future, industry leaders are taking a broader view of the digital thread’s value potential, with more investment in production and service use cases. They view the next stage as more complex and transformative to their companies. Fortunately, several have been successful in establishing programs that enjoy strong support from a well-informed and motivated senior management. However, many others have not.

All Top 5 pain points being targeted in future implementations relate to accessibility and traceability across data elements, especially traceability of requirements throughout the product lifecycle. Systems engineering is featured prominently in many responses, including ranking as the top new value opportunity being targeted in future digital thread implementations, which aligns with CIMdata’s view that systems engineering is a principal driver of the digital thread.

Digital Thread Investment Priorities

RELATED: Requirements Traceability Diagnostic

Strategies for Success

An area of divergence between industry leaders is in the focus of their implementations. For some, the focus is providing interfaces to source applications to extract and associate product data artifacts and attributes. For others, the key is the association and traceability of dependencies between artifacts in support of a use case. And for a few, the focus is on data governance, which they believe is foundational for enabling a richer and more extensive set of product lifecycle use cases.

The number one inhibitor to formulating and executing a digital thread strategy is “lack of interoperability between different vendors’ tools and systems.” The number one proposed means for mitigation is to “increase support of standards.”

Images showing digital thread bar chart for strategies for success

Solution Technologies

Key Technical Considerations

Core to the value of digital thread is traceability across multidiscipline sources and derivative product-related artifacts along the product lifecycle and throughout the extended enterprise.

The digital thread value landscape is distributed across a heterogeneous value chain from customer to OEM to partners and multiple tiers of suppliers. This reality drives the need for data interoperability and elevates the importance of standards and openness of enabling solution architectures.

Proven technical solutions exist for enabling the digital thread, and leading solution providers are investing heavily in research guided strategies and roadmaps to further strengthen their offerings.

Data is the foundation of the digital thread. This reality elevates the importance of sound data governance and a cleansed repository, especially as use case implementations proliferate and must be interlinked into an extended thread.

Bar chart showing Product Lifecycle Data stats

Technologies in Use Today

The technologies used to link product lifecycle data segregate into three tiers as shown in Figure 16. The top tier, which has the longest history, includes PLM and PDM, followed by ERP, and custom applications. The middle tier consists of application and data integration tools. These are followed by the third tier of newer specialty technologies for combining data from multiple sources and establishing linkages and traceability. We can expect the ranking of these specialty technologies to rise significantly over the next few years.

Solution Capability and Provider Alignment

Attitudes on the topic of solution capability and provider alignment are mixed. Some industry leaders are quite critical, especially regarding data model accessibility and flexibility to comply with a corporate data governance strategy. Other interviewees are somewhat neutral or slightly positive. They feel that some providers are moving in the right direction; some are not. Several feel that solution capabilities have improved significantly overall in the last 5-10 years and that, despite some remaining gaps, are now fully capable. Some express satisfaction that “good partnering” is happening.

RELATED: Reduce Project Risk in the Product Development Process

Jama Software® Solutions

Jama Software®’s industry-leading platform, Jama Connect®, helps teams manage requirements with Live Traceability™ through the systems development process for proven cycle time reduction and quality improvement. The number-one problem product engineering organizations face is managing requirements traceability spanning siloed teams and tools (e.g., design, hardware, software, test, risk, quality) which creates an increased risk of negative outcomes such as extensive rework, delays, and cost overruns.

Jama Connect enables digital engineering for innovative organizations in aerospace, automotive, medical, and industrial verticals. The future of product development relies on agile and transformative digital engineering techniques. Jama Connect helps customers solve their toughest challenges and simplify complex mission-critical system development across complex partner and supplier ecosystems.

Jama Connect seamlessly integrates with the product development technology stack. Organizations can take advantage of Jama Connect’s integration solutions with market-leading tools for design and simulation, task management, lifecycle management, quality assurance, and testing. Teams can work in their preferred tools while ensuring all requirements are verified and validated to achieve complete traceability.

V Model image showing Jama Connect integrating with several additional platforms

Live Traceability with Jama Connect Delivers:
  • 1.8X faster time to defect detection
  • 2.1X faster time to execute test cases
  • 2.4X lower test case failure rates
  • 3.6X higher verification coverage

Jama Software’s benchmark study for monitoring and measuring traceability through its Traceability Score™ has shown that companies that have a higher traceability score in the digital thread have faster cycle times and defect detections. This allows companies to be nimble and be twice as fast in releasing products vs. companies that do not monitor and measure traceability in their product lifecycle. Requirements Traceability Benchmark

This has been an excerpt from the eBook, “CIMdata: Digital Thread in Aerospace and Defense”
Click HERE to download the full version.