As the importance of the diagnostics industry grows, whether through personalized medicines or to ensure costly analysis are optimally executed, manufacturers of diagnostic products are operating in a fast changing environment. They must ensure diagnostic device product quality while meeting growing demand in multiple markets. They must manage the increasing number and complexity of diagnostic equipment and test kits. And they must maintain their competitiveness where pricing and re-imbursement levels are uncertain.

In terms of maintaining competitiveness and increasing productivity, investments in 3D scanning for device sensor checks or automated inspections and voltage testing are often seen as the solution, however, delays and deviations will still occur at the remaining steps of the manufacturing process. Significant time may still be required to keep track of production, quality, inventory and maintenance operations, whilst ensuring quality. As a result, real gains in productivity may not be achieved by an ERP investment. For example, relying on paper based and hybrid systems to keep track of operations has important consequences, with Industry estimates for Life Sciences showing that:

  • Incomplete entries or manual transcription errors occur in 1 out of every 10 entries
  • A paper device history record (DHR) can take up to 8 hours to create
  • More than 25% of device history records have QA errors
  • Average review times are up to 12 hours per work order/lot/serialized device record

However, with Manufacturing Execution System (MES) solutions like Electronic Device History Records, Tool Dispensing/Management or Equipment Management, Medical Diagnostic manufacturers are achieving gains of >25% in productivity, as well as reducing the time and stress associated with managing manufacturing using paper and hybrid systems. The savings are considerable.

For manufacturers of Medical Diagnostic devices, there are particular challenges and it is essential that MES solutions are adapted specifically to deal with them. With a broad range of industry specific experience behind it, LZ Lifescience’s Shopfloor-OnlineTM Lifescience Edition product has been specifically developed to meet the challenges for Medical Diagnostic device manufacturing:

      • Essential functions like Electronic Device History Records (EDHR), Equipment Management, Overall Equipment Effectiveness (OEE) and Electronic Work Instructions (EWI) for Setup/Cleaning/Clearance

These are the core functions that deliver the highest productivity gains for most manufacturing operations. For example:

      • Electronic device history records can accelerate release times by 50-80%
      • Tool Dispensing can provide 100% verification of the tools used
      • Equipment Management can ensure compliant equipment usage in line with validated business rules
      • Electronic work instructions can add huge time gains as well as increased compliance for tasks that need to be carried out outside of the device history record (DHR) e.g. setup and cleaning records
  • Providing pre-defined workflow templates and a library structure for building master device history records. This drives down the implementation costs of Electronic Device History Records as well as making solutions simpler to support. The library structure with building blocks means that the same blocks can be re-used across many manufacturing lines. They can also be configured to run on any manufacturing line, without custom support or coding
  • Full integration with existing systems. Shopfloor-OnlineTM Lifescience Edition has been developed with a universal data interface (UDI) so it can integrate to a full range of control systems, ERP systems, training databases and many other systems. It integrates to ERP systems like SAP, Oracle, JDE, BPCS, QAD & IFS and many more. It can integrate to existing PLC/SCADA, OPC Server and other control system technologies.
  • Web based to avoid heavy IT footprint. Shopfloor-OnlineTM Lifescience Edition is a web based application that can be installed in your data center, which may not even be on site. It can be accessed from any existing PC, windows tablet or laptop using Internet Explorer instead of having many dedicated workstations for configuring and executing a system. This eliminates the need to purchase dedicated workstation PCs to access the application.
  • Modular licenses, only pay for what you need. Rather than charge customers for all modules, we will only charge for modules that you require.
  • Rapid Implementation and Manufacturing Gains: with typical implementation times of 3-6 months, Shopfloor-OnlineTM Lifescience Edition enables a Manufacturing team to get started quickly with:
    • Simple intuitive screens and drag & drop master device history record configuration. During operation, users work with popup forms that indicate the next steps and that work at the speed of the user. Data collected by the system is presented in easy to read tables and these tables can be configured to closely match your existing device history records or another format you require.
    • Pre-defined building blocks to get started quickly on setting up your existing product device history records, saving hours of work and paper creation.
    • Support for Business Case development and Training. Understanding the time constraints in manufacturing, LZ Lifescience has developed a rapid review process which can automatically calculate business benefits from key data. If you would like us to provide this for your business, please contact us.