Tag Archive for: Compliance & Regulation

In this blog, we recap our webinar, “Effective Strategies and Solutions for Successful SaMD Project Execution”. Click HERE to watch the entire webinar.

Empower your teams with insights and solutions that transcend the challenges of medical device software development.

Navigate the complex terrain of medical device software development and learn crucial insights and practical solutions to propel your projects forward.

In this webinar, Romer De Los Santos, Senior Consultant at Jama Software®, guides you through:

  • The new SaMD Framework, which features ISO-aligned document templates and customization capabilities
  • Variant Management in Jama Connect®, the key concepts required, and how it can revolutionize your workflow
  • Insights into the nuances of navigating complex medical device software projects
  • A brief exploration of the impact of US and EU regulations shaping the software landscape

Below is an abbreviated transcript of our webinar.

Effective Strategies and Solutions for Successful SaMD Project Execution

Romer De Los Santos: During this presentation, I’ll go over the challenges facing development teams working on medical device software, the key features of the Jama Connect SaMD Framework, and how you can use Jama Connect’s categories and reuse and sync features to manage releases and variants. A successful software development project in the medical device industry is a careful balancing act between documentation and development activities. Development teams have tight deadlines that are driven by market conditions. At the same time, they’re responsible for generating the required quality records according to each region where their device will be marketed. Since this isn’t a regulatory discussion, we’ll just focus on the EU and US as examples.

Medical device software development in the EU is governed by IVDR and MDR regulations. The risk classification in some software activities will differ depending on the regulation it falls under. Unlike in the US, there is no specific distinction between SiMD and SaMD software. It’s all considered medical device software. You’ll need to consider if the software you are developing is an accessory to a medical device or if is it a medical device on its own. If it is an accessory, it’ll need its own technical file. If it is sold as an integral part of the system, it should be included in the system’s technical file.

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

De Los Santos: In the US, there is a distinction between software in a medical device and software that is a medical device on its own. With the advent of AI, machine learning, cloud computing, and other innovations, the FDA has been drawing up new guidance to help modernize oversight on software development. The concept of device software functions are a key part of its modernization efforts. Each device software function has its own risk classification. The FDA has indicated that they intend to target their oversight over software that is an extension of one or more medical devices, software that transforms a mobile platform into a medical device by using attachments, displays, sensors, or including functions like a regulated medical device, software that performs patient-specific analysis and provides specific outputs or directives used in the diagnosis, treatment, mitigation, cure, or prevention of a disease or condition.

The Center for Devices and Radiological Health (CDRH) at the FDA created the Digital Health Policy Navigator to help manufacturers determine if their product’s software functions may be the focus of FDA oversight. This past September, the FDA released its new guidance on cybersecurity in medical devices. The guidance encourages the use of a secure product development framework when building software. It specifies some new deliverables such as a security risk analysis that is distinct from and in addition to the safety risk analysis specified in ISO14971.

Manufacturers will need to analyze security risks from the design and development phase through device maintenance and eventually to product end-of-life. Manufacturers are encouraged to use threat modeling to analyze security vulnerabilities in the environment where the device will be used. You’ll also need to consider all interfaces to and from the system and the Off-The-Shelf software (OTS) and Software of Unknown Provenance (SOUP) components that the system depends on. Software Bill of Materials (SBOMs) must be generated and analyzed for potential vulnerabilities. This represents more work for teams but is absolutely required in today’s interconnected world. In addition to all the required documentation for the design history file, developers also need to consider how to manage their fast development iterations, how to handle parallel development and variant and release management, how to properly triage and disposition defects, and how to manage third-party components that are part of their system.

RELATED: Jama Connect® for Digital Health Solution Overview

De Los Santos: The Jama Connect SaMD Framework is intended to alleviate some of the documentation burden while each company has its own procedures. The framework provides basic document templates that comply with requirements specified in IEC62304 and ISO14971. Furthermore, each document template includes a customizable export template for your convenience. It’s designed to keep things as simple as possible by minimizing the number of different item types and fields. The framework is versatile and includes the ability to trace to items outside of Jama Connect. This framework is designed to cover the most common use cases and is intended as a starting point for your own process. Jama Connect can easily be configured so that the tool adapts to your process rather than the other way around.

To watch the entire webinar, visit:
Effective Strategies and Solutions for Successful SaMD Project Execution

this image shows a graduation cap and a clock, indicating this pot will teach visitors quickly on the topic of space systems.

Jama Connect® Features in Five: Space Systems 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, Cary Bryczek – Director, Aerospace & Defense Solution at Jama Software® – we will explore the Space Systems Framework available for Aerospace & Defense teams in Jama Connect.

VIDEO TRANSCRIPT

Cary Bryczek: Hi. I’m Cary Bryczek, Director of Aerospace & Defense Solutions at Jama Software. In this video, I’m going to introduce you to our Space Systems Framework available in Jama Connect. In this video, we will explore the benefits of using our pre-built template to get started with managing requirements, test cases, and architecture using our best practices inspired by industry standards and guidance from organizations like NASA and the European Space Agency.

With space systems exponentially growing in complexity, shortening development timelines due to mission need and customer demand, and cost reductions influencing the capabilities able to be delivered with the final design. Programs need to be able to get started quickly and begin the real work of engineering the system. Development and engineering tools need to be robust enough to tackle that complexity easy enough to deploy and then not get in the way of the real work of engineering the system.

Jama Connect and our Space Framework come preconfigured with a ready-to-use template. The framework is comprised of a requirements data model that provides requirements leveling and decomposition, a verification of validation data model that provides traceability to those requirements, an architecture data model that provides mechanisms to support systems architecture system functions, and allocation of requirements, and a data organization method that follows industry guidance with the best practices of data organization in Jama Connect. Let’s see what this looks like in Jama Connect.

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

Bryczek: The Space Framework comes with two pre-built requirement data models. The one I’m showing now represents a full spacecraft product breakdown structure. The example shows how Jama Connect can handle the complexity of a full NASA or ESA space program. The requirements data model allows needs and requirements to be flowed down and fully traced from the stakeholder expectations, to the concept of operations, to system level requirements, down to segment element subsystem and component requirements.

This trace data model, what Jama calls the relationship model, provides a mechanism to enforce consistency and creation of data as well as a consistent method to trace that data. This allows you to do faster analysis, measurement of expected versus actual traceability, complex filtering, and easy trace matrix generation and reporting.

The left side of the screen is the exploratory and is where the data is organized. The Space Framework comes with this pre-built spec tree ready for users to start authoring content right away. You can see that it too is organized hierarchically from the highest level of abstraction at the mission level and then down to the component level. You can navigate this traceability in the tree as well.

We recognize that not every space system will be developed by a single entity that requires this combined breath of customer implementing requirements and those of the implementing organizations. Your organization might be merely developing only a component of a larger space system. For this, we have a second Space Framework for integrated systems. Let’s look at this one more closely.

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

Bryczek: In this CubeSat example that comes with the framework, it’s easy to see how the data is organized in the exploratory in a system, subsystem configuration. Inside each of the subsystems, you can see the specific requirements, their verifications, architecture, and design descriptions. Traceability throughout the entire project can easily be analyzed at any level.

What I’m showing is the traceability from the stakeholder expectations all the way down the decomposition tree. I can see the system requirements verification and validation test cases. I can see the architecture, the subsystem requirements, and even the test runs, these real-time trace views not only show requirements decomposition, but test covers as well as allocation to architecture.

The framework supports, as I said, not just requirements, but architectures, V & V, even risk management and security. We’ve preconfigured the way you organized that here in the tree. So if I wanted to see the system architecture, I am able to see all of the elements that are going into making up the system architecture of this CubeSat I can also see how I’ve organized by system subsystem within the tree itself. That enables me to reuse easily and do variant management in this particular CubeSat security.

So, if you need to have security requirements or if you need to do heavy cyber security and you wanna import things like NIST 800 you can easily do that kind of a thing. Risk management threats and risks moving the development cycle with security earlier in that life cycle is a big deal, or understanding how safety is influencing the design. We easily allow you to track risk management and threat analysis in Jama as well.

The intent of this is to provide ready-to-use solutions based on customer feedback, industry trends, and best practices, such as those of ESA and NASA. This enables engineers to tackle the complexity of space systems develop faster and collaborate at the speed of need. If you would like to learn more about how Jama Connect can optimize your product development processes, Please visit our website at www.jamasoftware.com. If you are already a Jama Connect customer and would like more information on the Space Framework, 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

In part 3 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 click here for part 1 and here for part 2.

Software Defined Vehicles Part 3: Revolutionizing the Future of Transportation

Future Trends and Considerations in Software Defined Vehicles

Evolution of Software Defined Vehicles

Software Defined Vehicles (SDVs) are continually evolving, driven by advancements in technology and changing consumer expectations. Several future trends and considerations will shape the future of SDVs:

  • Increased Autonomy: SDVs will continue to progress towards higher levels of autonomy, with advancements in sensor technology, artificial intelligence, and machine learning. Fully autonomous vehicles that can operate without human intervention in specific environments and conditions will become more prevalent.
Image showing SAE J3016 levels of driving automation

Image courtesy of SAE International, SAE J3016™ Update

  • Connectivity and V2X Integration: SDVs will further integrate with Vehicle-to-Everything (V2X) communication, allowing vehicles to interact with other vehicles, infrastructure, and pedestrians. This connectivity will enable cooperative driving, efficient traffic management, and improved overall safety and efficiency on the roads.
  • Edge Computing and Cloud Integration: The integration of edge computing capabilities in SDVs will enhance real-time data processing and decision-making at the vehicle level. Additionally, cloud integration will enable seamless access to services, personalized settings, and advanced analytics for vehicle performance monitoring and predictive maintenance.
  • Advanced User Interfaces and Experiences: SDVs will feature enhanced user interfaces, including augmented reality displays, natural language processing, and gesture recognition. These interfaces will provide more intuitive and immersive user experiences, allowing drivers and passengers to interact seamlessly with the vehicle’s software features and services.

Regulatory and Legal Considerations

The development and deployment of SDVs bring forth a range of regulatory and legal considerations that need to be addressed:

  • Safety Regulations: Governments and regulatory bodies are actively developing safety regulations specific to autonomous vehicles and SDVs. These regulations aim to ensure the safety of occupants, pedestrians, and other road users, covering aspects such as system performance, emergency response protocols, and liability frameworks.
  • Data Privacy and Security: As SDVs generate and process vast amounts of data, protecting user privacy and ensuring data security become paramount. Legislation regarding data collection, usage, and storage will need to be in place to safeguard user information and prevent unauthorized access.
  • Liability and Insurance: The shift towards autonomous driving and SDVs raises questions about liability in the event of accidents or system failures. Clear guidelines and legal frameworks must be established to determine liability and insurance coverage in autonomous driving scenarios.
  • International Standards and Harmonization: Harmonization of standards across different regions and countries is crucial for the widespread adoption and interoperability of SDVs. Collaborative efforts among governments, industry stakeholders, and standardization bodies are necessary to establish common standards and facilitate global deployment.

Ethical Considerations

The development and deployment of SDVs also raise several ethical considerations that require careful consideration and discussion:

  • Decision-Making in Critical Situations: SDVs may encounter critical situations where split-second decisions need to be made, potentially involving the safety of occupants, pedestrians, or other vehicles. Determining ethical guidelines and frameworks for decision-making in such situations is essential to ensure responsible and ethical behavior.
  • Job Displacement and Economic Impact: The advent of autonomous driving technology may impact various industries, including transportation, logistics, and ride sharing. It is important to address the potential job displacement and economic impact of SDVs and explore strategies to mitigate any negative consequences.
  • Social Equity and Accessibility: SDVs should be designed and deployed in a manner that ensures accessibility and social equity. Considerations should be given to individuals with disabilities, elderly populations, and those who cannot afford traditional modes of transportation, ensuring that SDVs contribute to inclusivity and equitable access to mobility.

RELATED: The Software Factory: A Modern Approach to Software Development

Decision-Making in Critical Situations: SDVs may encounter critical situations where split second decisions need to be made, potentially involving the safety of occupants, pedestrians, or other vehicles. Determining ethical guidelines and frameworks for decision-making in such situations is essential to ensure responsible and ethical behavior.

The Road Ahead for Software Defined Vehicles

The future of software defined vehicles holds immense potential for completely transforming the way we commute and interact with transportation systems. Several key areas will shape the trajectory of SDVs in the coming years:

  • Shared Mobility: SDVs will more than likely play a significant role in shared mobility services such as ride sharing and carpooling. Autonomous SDVs will enable more efficient utilization of vehicles, reduce traffic congestion, and provide cost-effective transportation options for individuals and communities.
  • Smart Cities Integration: SDVs will be integral to the development of smart cities. Through V2X communication, SDVs will interact with smart infrastructure, traffic management systems, and other vehicles, optimizing traffic flow, reducing emissions, and enhancing overall transportation efficiency.
  • Electric and Sustainable Mobility: The integration of SDVs with electric and hybrid powertrains will push the adoption of sustainable mobility solutions. Electric SDVs will contribute to reducing greenhouse gas emissions and dependence on fossil fuels, fostering a cleaner and more environmentally friendly transportation ecosystem and mindset.
  • Mobility as a Service (MaaS): SDVs will be a cornerstone of the Mobility as a Service concept, where transportation is viewed as a service rather than individual vehicle ownership. SDVs will be seamlessly integrated into multi-modal transportation networks, providing on-demand mobility options and personalized travel experiences.

Innovation and Collaboration

The realization of the full potential of SDVs requires innovation and collaboration among various stakeholders:

  • Industry Collaboration: Collaboration among automotive manufacturers, technology companies, and other industry players is essential for advancing SDV technologies. Partnerships can facilitate the sharing of expertise, resources, and best practices, accelerating the development and deployment of SDVs.
  • Research and Development: Continued investment in research and development (R&D) is crucial to drive innovation in SDV technologies. R&D efforts should focus on areas such as sensor technology, artificial intelligence, cybersecurity, and human-machine interfaces to further enhance the capabilities and safety of SDVs.
  • Regulatory Frameworks: Governments and regulatory bodies play a pivotal role in fostering the growth and safe deployment of SDVs. Regulatory frameworks need to strike a balance between safety requirements, innovation encouragement, and flexibility to accommodate evolving technologies and business models.
  • User Acceptance and Education: User acceptance and education are vital for the successful adoption of SDVs. Public awareness campaigns, educational programs, and interactive demonstrations can help familiarize people with SDV technologies, address concerns, and build trust in autonomous and software-driven systems.

Challenges and Considerations in Implementing Software Defined Vehicles

The implementation of Software Defined Vehicles comes with a set of challenges and considerations that need to be addressed for successful integration and deployment into the world. This chapter explores key challenges and provides insights into addressing them effectively.

Safety and Security

  • Safety Assurance: Comprehensive testing, validation, and verification processes should be in place to assess the functionality, reliability, and performance of SDV software and hardware components. Rigorous safety standards and protocols must be followed throughout the development lifecycle.
  • Cybersecurity: SDVs are susceptible to cybersecurity threats, including hacking, malicious attacks, and unauthorized access. Robust security measures, such as encryption, intrusion detection systems, and secure communication protocols, should be implemented to protect SDVs from potential vulnerabilities.
  • System Failures and Redundancy: SDVs should incorporate redundancy mechanisms and fail-safe systems to handle unexpected software or hardware failures. Redundant sensors, backup power sources, and fail-over mechanisms can enhance the robustness and reliability of SDVs.

Data Management and Privacy

  • Data Collection and Usage: SDVs generate vast amounts of data that need to be collected, processed, and analyzed. Clear guidelines and policies should be established regarding data collection, usage, and retention, ensuring compliance with privacy regulations and protecting user data.
  • Data Sharing and Interoperability: SDVs should have the ability to securely share relevant data with other vehicles, infrastructure systems, and service providers to enable efficient traffic management, cooperative driving, and enhanced situational awareness. Common data formats and interoperability standards should be developed to facilitate seamless data exchange.

Infrastructure and Connectivity

  • Communication Infrastructure: Robust communication infrastructure is crucial for the successful operation of SDVs. Reliable and high-bandwidth connectivity, including 5G networks and dedicated V2X communication channels, should be available to support real-time data exchange and enable effective communication between vehicles and infrastructure systems.
  • Infrastructure Readiness: The deployment of SDVs requires appropriate infrastructure readiness, including road markings, signage, and intelligent transportation systems. Governments and city planners need to invest in infrastructure upgrades and adaptations to support SDVs and ensure a smooth transition to an autonomous and connected transportation ecosystem.

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

Conclusion

It’s clear that the emergence of Software Defined Vehicles represents a transformative shift in the automotive industry and the way we perceive transportation and possibilities. SDVs have the potential to improve safety, enhance mobility, reduce congestion, and contribute to a more sustainable and connected future.

However, the successful integration of SDVs into our society requires concerted efforts from various stakeholders. Addressing technical challenges, developing robust regulatory frameworks, investing in infrastructure, and building public trust are crucial for realizing the full potential of SDVs.

As we navigate the complexities and opportunities presented by SDVs, it is essential to prioritize safety, inclusivity, ethical considerations, and public engagement. By fostering collaboration and embracing innovation, we can shape a new future.

This has been part 3 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 here for part 2.
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: Traceable Agile – Speed AND Quality Are Possible for Software Factories in Safety-critical Industries

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.

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.


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.