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Medical Device Company

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Medical device manufacturing

The Challenges of Scaling Up Production

A Medical Device Manufacturer needed to complete a new product introduction (NPI) of a novel medical device in a new greenfield assembly facility. They had a 6-month timeline to start manufacturing the new devices at scale and needed to plan and implement DFA/DMA practices.

The team needed to increase production from a few units a month built by engineers to hundreds of units a month by frontline workers. The engineering team needed to enable the frontline workers to assemble the units and record their activities at each step of the way via an eDHR for compliance purposes.

In setting up the processes for building the product at scale, the team foresaw challenges around overwhelming new staff with changing instructions and recording information.

While considering these challenges, the engineering team decided that using paper-based SOPs and history records was not a viable or efficient solution for onboarding a completely new team.

Implementing a Cloud-Based Manufacturing and Documentation System

Instead of starting with paper-based processes for SOPs and a traditional MES for eDHR, the Medical Device Manufacturer decided to go paperless by investing in Manufacturing 4.0 technology in their new greenfield facility.

They implemented a validated solution using Tulip’s frontline operations platform to support all assembly operations with interactive apps. With the platform, they built 90+ apps to guide and track the build process step-by-step. They also included test and repair workflows as part of the step-by-step app to capture digital history records (eDHR).

While guiding the process with dynamic work instructions, they were also able to track production flow at every station. This allowed them to visualize the full production of the line to ensure they were meeting production targets as part of the scale-up. With this production data, they were able to find and resolve issues quickly and scale up to full production more efficiently and without as much waste.

Additionally, engineers were able to view in real-time device manufacturing progress, track WIP levels, and non-conformances. With this data, the engineers can identify trends in anomalies in real-time and rapidly find and resolve the root cause. Then, they could include improvements in the next version of assemblies or parts.

With digital work instructions and process control tracking, the engineering team can now collect manufacturing production performance data continuously.

The Results

The Medical Device Manufacturer’s new greenfield facility is not only 100% paperless with a digital DHR system, but their system is real-time. The team can perform material, personnel, and equipment traceability inquiries in minutes, not days or weeks.

Since working with Tulip, they were able to reach on-time product quality in the 6 months they had allotted for the New Product Introduction (NPI). They estimated that a similar solution based on a traditional MES would have required a much larger investment.

The team is excited about expanding their use of Tulip to new use cases within their new facility and be able to exemplify their Industry 4.0 approach so that they can replicate similar success at other sites and for other products.

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Day-in-the-life of a manufacturing facility illustration