- Functional Applications - Manufacturing Execution Systems (MES)
- Platform as a Service (PaaS) - Device Management Platforms
- Healthcare & Hospitals
- Facility Management
- Quality Assurance
- Additive Manufacturing
- Manufacturing System Automation
- System Integration
- Testing & Certification
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.
Medical Device Company
About The Customer
The Medical Device Manufacturer is a company that needed to introduce a new medical device in a new assembly facility. They wanted to scale up production from a few units a month to hundreds of units a month and enable frontline workers to assemble the units and record their activities for compliance purposes. They wanted to implement a paperless solution that would streamline their processes and improve efficiency.
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.
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