Apr 18, 2019
About the Customer
The customer is a global leader in Medical Device Manufacturing and the sixth largest multinational producer of orthopedic products, including knee and hip replacement solutions. Engineering Industries eXcellence is leading the implementation of a complete state-of-the-art Manufacturing Execution System (MES) at the customer’s flagship production plant in order to digitalize their data collection, automate documentation and replace their existing 25-year old legacy system. At the end of this initiative, our team will have delivered a complete “top floor to shop floor” digital manufacturing solution, fully integrating the customer’s new MES with their DNC, PLM and 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 the customer, meeting the quality requirements of the FDA involved tedious data collection and documentation 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.
Business Drivers
- Replace legacy Manufacturing Execution System
- Manufacturing system synchronization
- Connect top floor to shop floor – improve transparency
- Move towards a paperless shop floor
- Create a single source of truth – one digital system on the shop floor as the central repository for manufacturing data, and make this data easily available to operators on the shop floor
About the Project
First, our team of 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 designed, developed and customized an end-to-end MES solution to replace the customer's existing legacy system, as well as a new DNC (Direct Numerical Control) system to provide the link between engineering, manufacturing planning and the machines on the shop floor.
Our team just completed the first implementation phase of this project, integrating the customer’s ERP system with the Production Order Management module of Opcenter Execution (Camstar). This integration will enable Electronic Work Instructions to be made available to operators on the shop floor, as well as automatic tracking of part counts (good and bad) and scrap reason codes. Our scope of work for this enterprise MES initiative includes:
- Designing and developing new MES (Opcenter Execution (Camstar) Medical Device Suite) and new DNC system (Shop Floor Connect for Siemens Teamcenter)
- Integrating new MES to new DNC system to centralize management of all production data
- Integrating new MES to existing ERP system to enable sharing of work order and production performance data
- Once development is complete, we will lead the validation phase, implement the 2 new systems, and provide 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 a number of manufacturers in this sector we are collaborating with on similar initiatives. 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. One manufacturer we spoke with told us that in a plant of 600 people, 35 of them were dedicated full-time and solely to walking from station to station and manually documenting data. Therefore, by going paperless, not only will this medical device manufacturer ensure consistent quality compliance, improve efficiency and streamline processes, but they will be able to reallocate their resources and personnel to more complex and value-driving activities within the enterprise.
Our team looks forward to continuing to work with this customer as we move to the next implementation phase of their digital transformation initiative. We will support each step of their journey until they finally achieve the paperless factory.
