Digitalized Compliance for Medical Devices
About the Customer
The customer is a leading global medical device manufacturer that designs, develops and produces products for different medical fields including cardiology, interventional radiology, orthopedics, electrophysiology and surgical management. The manufacturer was named among the top 100 medical device companies in 2018. They are also the sixth largest multinational producer of orthopedic products, including knee and hip replacement solutions.
Project Summary
Our Industries eXcellence team led the implementation of a complete state-of-the-art Manufacturing Execution System (MES) at the customer's flagship U.S. production plant in order to digitalize their data collection, automate documentation and replace their existing 25-year old legacy system. By the end of this initiative, our experts had delivered a complete “top floor to shop floor” digital manufacturing solution, fully integrating the customer's new MES with their Direct Numerical Control (DNC), Product Lifecycle Management (PLM) and Enterprise Resource Planning (ERP) systems.
The Customer’s Need
Combining the requirements of traditional discrete manufacturing with a high level of regulatory control via FDA and international authorities, Medical Device Manufacturing presents a unique set of challenges. For this customer, meeting the quality requirements of the FDA involved tedious Manufacturing Data Collection and Document Management processes that were being executed manually, on paper and requiring a high number of dedicated human resources. Every knee and hip replacement that left the customer’s production facility had to be accompanied by an enormous amount of documentation covering every step of its lifecycle. The customer knew that the time and resources spent on creating medical device records manually were unsustainable to stay competitive, so they looked towards automation.
The Business Drivers
- Replace legacy Manufacturing Execution System (MES)
- Manufacturing system synchronization
- Connect business level to shop floor – improve transparency
- Move towards a paperless shop floor
- Create a single source of truth via one digital system that acts as the central repository for all manufacturing data, and make this data easily available to operators on the shop floor
About the Project
First, our team of medical device industry specialists led an in-depth analysis of the customer's requirements to better understand their most pressing challenges and recommend the right solutions to address them. The analysis identified electronic Device History Record (eDHR) Management as the best and most cost-effective solution to improve process efficiency while ensuring quality control and regulatory compliance at the same time.
In order to enable eDHR and digitalize Work-In-Progress (WIP) on the shop floor, our Industries eXcellence team then designed, developed and customized an end-to-end MES solution to replace the customer's existing legacy system, as well as a new Direct Numerical Control (DNC) system to provide the link between engineering, manufacturing planning and the machines on the shop floor. Our scope of work for this enterprise MES initiative included:
- Designing and developing a new MES leveraging Siemens Opcenter Execution Medical Device and Diagnostics (previously Camstar) software
- Designed and developed new DNC system leveraging Shop Floor Connect (SFC) for Siemens Teamcenter software
- Integrating MES to DNC system to centralize management of all production data
- Integrating MES to existing ERP system to enable sharing of work order and production performance data
- Leading the validation phase, implementing the 2 new systems and providing end user and system support
Engineering's Advantage
So, what is the real, measurable value gained by companies going paperless in the Medical Device Manufacturing environment? This customer is just one of many manufacturers in this sector with whom we are working on similar projects. Simply put, the use of paper to meet the stringent data collection and quality compliance requirements in this industry leads to a significant waste of time and resources whose skills could be better utilized in more value-add tasks. By going paperless, not only did our customer ensure consistent quality compliance, improve efficiency and streamline processes, but they will now be able to reallocate more of their resources and personnel to more complex and value-driving activities within their enterprise.
