Sending a robotics manufacturer on its way to successful adoption of Tulip

Introduction 

In January 2024, the US Food and Drug Administration (FDA) published its Quality Management System Regulation (QSMR) final rule that aligns its requirements with ISO 13485:2016 – requiring that a medical device manufacturer’s quality management system meets regulatory expectations. Medical device manufacturers have until February 2026 to come into compliance, which incentivizes them to align with ISO 13485 requirements as soon as possible. 

A robotics manufacturer decided to start addressing ISO 13485 compliance by harmonizing and digitizing their manufacturing process and documentation. Their current processes were documented via multiple channels – such as spreadsheets, forms, and Standard Operating Procedures (SOPs).  

The robotics manufacturer determined that Tulip is the right solution for this digitization effort. Using Tulip will allow them to create a standardized yet flexible electronic device history record (eDHR) and achieve ISO 13485 compliance by enabling tracking and monitoring of non-conformities. 

To get off to the right start and avoid common adoption challenges, the robotics manufacturer hired a certified Tulip implementation partner – FrontWell Solutions.  

By working with FrontWell Solutions, the robotics manufacturer ensured they got several crucial steps right from the start and laid a strong foundation for their  citizen development journey:  

• Sound architectural concept including a scalable data model 
• Consistent User Interface (UI) design 
• Templates to guide future development by citizen developers 

Scope 

FrontWell Solutions worked closely with a core team from the robotics manufacturer to build functional applications (apps), template apps, and a governance and implementation concept to guide future Tulip development by employees at the robotics manufacturer. 
 

Functional apps were developed to digitize four processes:  

• Assembly work instructions for one component 

• Management of incoming purchase orders 
• Reporting and management of quality events 

• Management of product and material master data

The governance and implementation concept would serve as a foundational document to not only explain the design decisions implemented by FrontWell Solutions, but also to guide new app developers as they scale the digitization and build more applications in Tulip. 

The robotics manufacturer and FrontWell Solutions agreed on a 2.5-month timeline to deliver the functional apps, template apps, and the governance concept. 

Project Outcomes 

Approach: 

FrontWell Solutions adopted an agile development approach to complete the project within the tight 2.5-month timeline. Initially, the focus was on App Design and Development, with Governance Concept Design running in parallel towards the project's end. The implementation process involved steps such as an Initial Discovery Session, creation of Operational Flow Diagrams (OFDs), wireframing, app development, and informal testing. Each app underwent iterative development cycles based on real-time feedback from the robotics manufacturer, allowing for flexibility and continuous improvement. 

Success Factors: 

A few success factors stood out:  

1. Process First: FrontWell and the robotics manufacturer revised their current processes and corresponding documentation to ensure that they were optimized and up-to-date before digitization. This ensured that requirements were accurate before they were used as an input to app design and development. Walking the manufacturing floor during the Initial Discovery Session was also important for understanding the physical process. 
2. Emphasis on Design: By investing sufficient time upfront in design, FrontWell Solutions was able to accurately depict the process flow. This emphasis on thorough design not only clarified the scope of the apps but also facilitated seamless collaboration with the robotics manufacturer. The resulting apps were aligned with the robotics manufacturer’s expectations and went through the development lifecycle with limited re-work and iterations.  
3. Effective Monitoring of Progress: Both parties were determined to adhere to the agreed upon project plan, which ensured on-time project completion. The project timeline was closely monitored and reviewed at each weekly project meeting.
4. The Right Team: Limiting the project team to the right stakeholders allowed the project to progress in an agile matter. The robotics manufacturer supplied a core team of three members who attended the weekly project meetings, executed the required reviews and testing, and involved shop floor operators where appropriate. Throughout the project duration, attendance, engagement, and communication were strong, and scheduling was easy due to the limited number of attendees.

Result: 

All project goals were achieved: 2 process apps, 3 global apps, and 2 template apps were delivered along with a governance and implementation concept. By the end of the project, the robotics manufacturer had a scalable architecture & data model, a standard UI design, templates in Tulip, and a guide for future development efforts. 

By leveraging the partner model with FrontWell Solutions, the robotics manufacturer was able to successfully kick-off their Tulip journey and confidently prepare for ISO 13485 compliance.

  Author: Sonya Kavalam