In recent years, there has been a lot of discussion about Software-defined Vehicles (Software-defined Vehicles). However, in fact, other electronic products have also increasingly relied on software. This means that manufacturers must master a new development process to ensure transparency, traceability, and compliance.
Striking a balance between flexible Agile methodologies and the strict regulations of the V model is the biggest challenge faced by Navya, which focuses on the development of autonomous driving systems. The company has launched the first commercially viable autonomous shuttle. Its software team employs Agile methodologies and uses a combination of various tools, similar to many other companies. However, there is insufficient synchronization between teams, no mandatory processes to adhere to, and a lack of visibility into the development process. This conflicts with the stringent regulatory requirements for functional safety in the mobility industry.
Medtronic’s Neuro Modulation division faces a similar situation. Although the development team is satisfied with functionality, isolated, manually integrated tools weaken transparency, making it difficult to trace from requirements to source code and to export the documentation required for compliance audits submitted to the FDA.
What they need is an Application Lifecycle Management (ALM) solution. ALM is the organizational pillar of the software lifecycle, from initial requirements gathering to design, testing, deployment, and maintenance. By integrating various stages, ALM can help companies optimize processes, support collaboration among all departments involved in development, and significantly improve product quality.
Key Features of an ALM System
To meet current manufacturing standards, an ALM system should have several core features. The most critical are comprehensive documentation management and fine-grained traceability to ensure compliance with all relevant regulatory requirements.
Additionally, integration with existing IT systems is also very important. The ALM system must be able to synchronize data from different sources without manual intervention. Only in this way can all relevant data be consistently and accurately managed on a centralized platform, allowing all participants to access the latest and correct information.
A robust ALM should also support Agile development methodologies such as Scrum or Kanban, enabling teams to work in short iterations, quickly integrate feedback, and make real-time adjustments.
Medtronic’s Neuro Modulation division has established the following criteria when evaluating ALM software:
·Good user experience, clear visualization, and easy navigation;·
·Traceability;·
·Flexible configuration options to support compliance;·
·Powerful core functionalities: requirements management, source code management, quality management, testing capabilities, documentation management;·
·Reasonable total cost of ownership (TCO).
Additionally, ALM software must also feature complete integration, robustness, flexibility, and cloud capabilities. Navya’s requirements are almost identical—ultimately, both companies chose PTC‘s Codebeamer.
Medtronic’s Director of Patient Care Software Sarb Singh-Kaur stated: “We must trace from customer needs all the way back to product requirements, design, testing, and source code.Codebeamer is the only tool that allows us to achieve this smoothly.” For Navya, the flexibility of environment configuration and dynamic objects was the main reason for their choice.
Successful Implementation of ALM
Introducing an ALM system often comes with challenges. The most common is employee resistance. To alleviate this, comprehensive change management is needed, actively involving all relevant personnel in the change process and enhancing their awareness of the benefits of the new system.
Moreover, it is crucial to adjust processes to meet the requirements of the ALM system. The more willing a company is to critically examine existing workflows, redesign when necessary, and break down existing structures, the higher the likelihood of success.
At Medtronic’s Neuro Modulation team, process changes were synchronized with the introduction of the ALM software. To build new internal processes, the company configured trackers, projects, roles, and workflows. Sarb Singh-Kaur stated: “We completely restructured our processes and used Codebeamer as a tool to drive change. We were ready in less than 30 days.”
Another important aspect is data migration: existing data must be migrated carefully, and the system must be integrated with existing IT infrastructure. Only in this way can all important information remain centralized, consistent, and accessible at all times, allowing the ALM system to become a reliable foundation for planning, development, and management.
Connecting Software and Hardware
Since software-defined electronic products still rely on hardware, it is essential to connect the software, electronics, and mechanical development teams as seamlessly as possible. If they work in isolation, engineers and developers will spend a lot of time searching for the information they need—and often cannot confirm whether the data is up to date. When relevant data changes but cannot be viewed in a timely manner, errors and inconsistencies may be discovered late, leading to delays and increased costs.
Many companies have adopted PLM (Product Lifecycle Management) systems in hardware development. By integrating ALM with PLM, they can address all the aforementioned issues, ensuring that the digital and physical components of products remain consistent throughout their lifecycle. They have a “Digital Thread” that helps ensure product quality, achieve innovation through more efficient processes, and shorten time to market. The digital thread enables traceability, supporting the management of requirements, changes, configurations, and testing, and ensuring compliance with regulatory requirements.
Embedded software remains a significant driver of innovation. Companies that enable their teams to collaborate efficiently will lead in the innovation race.
Author/PTC Business Development Director Tobias Fürtjes, PTC Company Electronics and High-Tech Industry Consultant Steven Humphrey
