Leading Medical Device Manufacturer

A medical device manufacturer building a greenfield assembly facility faced a compounding set of constraints: a fixed 6-month new product introduction (NPI) timeline, regulatory requirements for complete electronic device history records (eDHR), and the need to rapidly scale production from a handful of units per month — assembled by engineers — to hundreds of units per month built by an entirely new frontline workforce. Traditional MES platforms were disqualified upfront due to multi-year implementation cycles and disproportionate cost. Paper-based SOPs posed their own risks: onboarding a new team with static, paper-driven processes in a regulated environment creates version control gaps, traceability failures during audits, and a fragile foundation for scale.

Rather than inheriting the constraints of legacy MES architecture, the team invested in a composable frontline operations platform from Tulip, deploying a fully validated, cloud-based system across all assembly stations from day one. Engineers built over 90 apps to deliver dynamic, step-by-step digital work instructions — replacing static paper SOPs — while simultaneously capturing eDHR data at each production step. IoT-connected stations enabled real-time WIP tracking, equipment monitoring, and production flow visualization across the line. Test and repair workflows were embedded directly into the step-by-step app structure, eliminating separate documentation layers. The configuration-over-code architecture meant the team could build, iterate, and validate apps within the NPI window rather than waiting on vendor-led customization cycles.

The facility launched on schedule, meeting the 6-month NPI commitment with 100% paperless operations from the first production day — no paper fallback, no phased transition. Key outcomes:

• Traceability retrieval time: Reduced from days or weeks (paper-based) to minutes, covering material, personnel, and equipment genealogy
• NPI timeline: Met exactly as planned, a benchmark the team estimated a traditional MES implementation would not have achieved within the same window or budget
• Real-time visibility: Engineers gained continuous access to WIP levels, non-conformance trends, and line performance data, enabling rapid root cause identification and iterative process improvement during scale-up

The team is now expanding Tulip usage to additional use cases within the facility, with plans to replicate the model at other sites.

• Greenfield facilities are the ideal entry point for composable MES: Starting digital from day one avoids the change management burden of migrating legacy paper or MES workflows.
• NPI timelines can serve as a forcing function: A hard deadline — properly scoped — drove faster configuration decisions than open-ended rollouts typically allow.
• IoT-connected digital work instructions double as compliance infrastructure: Capturing eDHR data inline with operator guidance eliminates redundant documentation steps and closes audit gaps.
• Composable architecture compresses validation timelines: Configuration-based platforms reduce the GxP validation surface compared to bespoke MES builds, making regulated go-lives more predictable.
• Scale-up visibility is a first-order benefit: Real-time production tracking during ramp is operationally distinct from steady-state MES use — plan for it explicitly.