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June 20, 2024

The Role of the Software Architect in Agile Medical Device Development

By Summary by IT Revolution

In a recent presentation at the 2024 Enterprise Technology Leadership Summit Virtual Europe, Tom Baker, Robot Behavior Software Architect from Medtronic, and Luca Ingianni, an independent consultant, shared valuable insights from their experience working on Hugo, Medtronic’s cutting-edge surgical robot. Their journey explored the evolving role of the software architect in an agile setting within the highly regulated medical device industry.

Medtronic, one of the world’s largest medical device companies with over 95,000 employees across 150+ countries, faces the challenges of developing complex, safety-critical cyber-physical systems like Hugo. The surgical robot consists of three main components: a cart with a robotic arm that holds surgical instruments, a surgeon console where the surgeon operates the robot using joysticks and monitors, and a tower for power supply and communications. Developing such a system involves numerous computers, close hardware-software interaction, and strict adherence to regulations.

Defining the Architect’s Role

A central question that Baker grappled with was: What does a software architect actually do in this context? Traditional stereotypes depict architects as isolated figures in ivory towers, drawing boxes and arrows to represent system designs. However, Baker and Ingianni discovered that this narrow view can be a trap. Architects who focus solely on abstract designs risk becoming disconnected from both the business goals and the day-to-day realities of software development.

Instead, they propose that the architect’s true role is to support the organization by facilitating communication and focusing on delivering value. Architects must engage meaningfully with stakeholders at all levels, from product managers to developers. By building trust and understanding the “why” behind technical decisions, architects can more effectively guide the development process.

Bridging the Gap Between Business and Development

One key challenge architects face is balancing the needs of product management with the concerns of developers. Product managers prioritize new features that deliver patient impact, while developers are invested in the codebase they have created. Architects must navigate these tensions and avoid becoming bottlenecks by trying to control every aspect of development.

Instead of retreating into a “cozy middle” of abstract design, architects should actively engage with both sides. They must communicate the value of proposed software changes in non-technical terms to the business while also deeply understanding and collaborating with developers on the actual implementation. Clear boundaries and a shared vision are essential for fostering trust and efficient collaboration.

The Importance of Communication

Baker and Ingianni emphasize that the architect’s role is primarily one of communication rather than pure technical development. Architects must translate business requirements for developers and relay developers’ concerns and ideas back to product management. By serving as a bridge between these two worlds, architects ensure that critical information flows uninterrupted and that everyone has the knowledge they need to make informed decisions.

Interestingly, this insight applies not just to medical device development but to software projects across industries. While the stakes may be higher and the regulations stricter in the medical field, the fundamental principles of effective communication and collaboration remain the same.

Balancing Documentation and Agility

So, where do the traditional “boxes and arrows” fit into this new understanding of the architect’s role? Baker and Ingianni suggest that while documentation remains important, especially for regulatory compliance, it should not be the architect’s primary focus. Instead, diagrams and documentation should be viewed as communication tools to support shared understanding and decision-making.

Architects can leverage the same tools and repositories as developers to generate documentation directly from the codebase. For example, rather than relying solely on sequence or state diagrams, architects might describe system behavior through integration tests. This approach ensures that documentation stays up-to-date and reflects the actual implementation.


The journey of Tom Baker and Luca Ingianni at Medtronic’s Surgical Robotics Division highlights the evolving role of the software architect in agile medical device development. By focusing on communication, collaboration, and delivering value, architects can avoid the trap of isolation and instead become vital connectors within their organizations.

While the medical device industry faces unique challenges, the lessons learned are broadly applicable. Architects across industries must actively engage with stakeholders, bridge the gap between business and development, and leverage documentation as a tool for shared understanding. By embracing these principles, architects can successfully guide their teams toward delivering high-quality, safe, and effective software systems.

Watch Baker and Ingianni’s full presentation in our video library here.

And sign up for the next Enterprise Technology Leadership Summit here.

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