Background
A global medical technology company embarked on a strategic initiative to build an innovative platform that connected Internet of Things (IoT) devices across its med tech product portfolio. The platform spanned multiple software and hardware teams operating across regions. Each team needed to contribute to a tightly integrated ecosystem to deliver their work packages on time with highly coupled dependencies.
To deliver this complex platform at scale, the organization sought to implement a Scaled Agile Framework (SAFe) to improve alignment, accelerate value delivery, and increase its ability to respond to changing market, regulatory, and customer needs.
The objective was not only to adopt SAFe as a delivery framework, but to establish a consistent, enterprise-level agile operating model. The model needed to enable coordination across multi-functional development teams to improve dependency visibility and support predictable delivery in a highly regulated environment.
Company size
Revenue
Scope
2,000+ employees
$5B+
Digital organization
The Challenge
Delivering an integrated IoT platform across a global portfolio introduced significant complexity beyond a usual scaled agile transformation. The software and hardware teams operated on fundamentally different development lifecycles, tooling, and release cadences. Hardware timelines were often fixed with long lead times, while software teams needed flexibility to iterate rapidly—making integration planning and dependency management a critical risk area. Misalignment between these work streams could result in late-stage integration issues, regulatory delays, or incomplete system functionality.
The scale of the organization further compounded these challenges. Teams were distributed globally, with varying levels of agile maturity. Dependencies across teams and vendors were not always visible, limiting the ability to proactively manage risks and coordinate delivery. At the same time, the organization needed to continue delivering product milestones while undergoing a major operating model shift, requiring a thoughtful and sustained change management approach.
In a regulated med tech environment, the transformation also had to balance speed and adaptability with predictability, quality, and compliance. Without a clear, integrated delivery model that aligned software and hardware development, leadership lacked confidence in timelines, integration readiness, and overall value delivery.
Timeframe
Scope
Deliverables
1+ year
Comprehensive digital maturity assessment across 5 + sites
Executive readouts
Detailed scorecards
Recommendations
Our approach
We implemented a pragmatic, integration-focused SAFe model that emphasized real-world execution over theoretical purity. Starting with SAFe principles, we tailored constructs such as Agile Release Trains (ARTs), Program Increments (PIs), and ceremonies to better support hardware–software integration and IoT platform development.
A core focus of our approach was making dependencies explicit and actionable. We facilitated integrated PI planning sessions that brought the teams together to identify, map, and sequence dependencies early. Visual dependency boards, integration milestones, and shared system demos were introduced to ensure teams aligned on when and how components would converge. This allowed risks to be surfaced and addressed before they impacted delivery.
To support integration at scale, we aligned teams around shared value streams rather than siloed components, ensuring ownership of end-to-end outcomes. We introduced synchronization points between planning cycles and adapted SAFe roles and artifacts to reflect regulatory and engineering realities. Change management was embedded throughout, including leadership coaching, role-based training, and ongoing facilitation to reinforce consistent ways of working across regions.
By continuously inspecting and adapting the SAFe implementation, the organization achieved improved cross-team alignment, greater predictability in integration milestones, and faster, more confident delivery of a complex IoT-enabled med tech platform.
Assessment approach
Framework
Phases
Hybrid: In person and virtual assessments
Biotech industry standard assessment tailored to meet the client needs
Site preparation
Assessment
Executive readouts
Our approach
We implemented a pragmatic, integration-focused SAFe model that emphasized real-world execution over theoretical purity. Starting with SAFe principles, we tailored constructs such as Agile Release Trains (ARTs), Program Increments (PIs), and ceremonies to better support hardware–software integration and IoT platform development.
A core focus of our approach was making dependencies explicit and actionable. We facilitated integrated PI planning sessions that brought the teams together to identify, map, and sequence dependencies early. Visual dependency boards, integration milestones, and shared system demos were introduced to ensure teams aligned on when and how components would converge. This allowed risks to be surfaced and addressed before they impacted delivery.
To support integration at scale, we aligned teams around shared value streams rather than siloed components, ensuring ownership of end-to-end outcomes. We introduced synchronization points between planning cycles and adapted SAFe roles and artifacts to reflect regulatory and engineering realities. Change management was embedded throughout, including leadership coaching, role-based training, and ongoing facilitation to reinforce consistent ways of working across regions.
By continuously inspecting and adapting the SAFe implementation, the organization achieved improved cross-team alignment, greater predictability in integration milestones, and faster, more confident delivery of a complex IoT-enabled med tech platform.
Assessment approach
Framework
Phases
Hybrid: In person and virtual assessments
Biotech industry standard assessment tailored to meet the client needs
Site preparation
Assessment
Executive readouts
Key Client Successes
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