Siemens Opcenter Execution Medical Device and Diagnostics

Challenges of Medical Device Manufacturing

Combining traditional discrete manufacturing with a high level of regulatory control, Medical Device Manufacturing presents a unique set of challenges. To stay competitive, companies in this sector must balance costs and regulatory compliance while consistently producing high-quality products. To address these challenges, Engineering leverages the proven Manufacturing Operations Management (MOM) software offering from Siemens designed for the specific needs and nuances of the Medical Device Manufacturing context. Engineering has a dedicated practice and a world-class team of experts with over 10 years of experience delivering MOM solutions, including all the products within the Siemens Opcenter portfolio, to medical device manufacturers of all shapes and sizes across the globe.

About Siemens Opcenter Execution Medical Device and Diagnostics (Camstar)

Within the Siemens Opcenter MOM offering, Opcenter Execution is a portfolio of industry and process-specific Manufacturing Execution Systems (MES) designed to enable organizations to monitor, control and manage all the activities, resources and work-in-progress (WIP) on the factory floor and across their enterprise during the execution of production.

Siemens Opcenter Execution Medical Device and Diagnostics (formerly known as Camstar Medical Device Suite) is a leading manufacturing execution solution for error-proofing processes, paperless manufacturing and electronic Device History Record (eDHR) management. It helps you accelerate innovation, reduce costs and deliver the highest quality products possible while making compliance a by-product of excellent manufacturing processes. Opcenter Execution Medical Device and Diagnostics (MDD) enables you to build and validate quality within the manufacturing process itself, instead of testing quality coming out of the process at every step. From raw materials to finished goods, Opcenter Execution MDD delivers a complete and self-auditing eDHR solution.

Opcenter Execution MDD automates and enforces complete control over the five “Ms” in Medical Device Manufacturing:

Opcenter Execution MDD helps you manage Man: automatically checks training and certifications before allowing a user to work at an operation or inspection.
Opcenter Execution MDD helps you manage Machine: ensures that only qualified equipment that is up-to-date on maintenance and calibration is used.
Opcenter Execution MDD helps you manage Method: enforces process sequence, ensuring that all steps and data collection are complete and providing instant feedback to guarantee compliance.
Opcenter Execution MDD helps you manage Material: ensures that operators use the right quantity of qualified materials, enforcing expiration dates, LIFO (Last In, First Out) and FIFO (First In, First Out) rules.
Opcenter Execution MDD helps you manage Measurement: ensures that all required data is collected as compared to specification limits and automatically triggers rework or non-conformance workflows.

Opcenter Execution MDD was built integrating best practices in Medical Device Manufacturing, enabling faster out-of-the-box implementation. The software is highly functional and flexible, and provides an advanced and intuitive user experience. It also integrates fully with other enterprise systems, such as PLM, ERP, Production Planning & Scheduling and Manufacturing Intelligence (MI) platforms, helping you reap the benefits of true closed-loop manufacturing.

Source: Siemens Opcenter Execution Medical Device and Diagnostics (Camstar Medical Device Suite)

Target Manufacturing Sectors

Siemens Opcenter Execution MDD is a proven MES solution for manufacturers of Class I, Class II and Class III medical devices as defined by the Food and Drug Administration (FDA), including:

Medical device manufacturing
Medical instrument manufacturing
Medical implant manufacturing
Healthcare device manufacturing (e.g. blood care, diabetes care, wound care)
Diagnostics, vision and imaging device manufacturing

Features of Siemens Opcenter Execution Medical Device and Diagnostics (Camstar)

Track and monitor all work-in-progress (WIP), resources and activities on the manufacturing floor in real time
Define, approve, distribute and enforce process and engineering changes to any facility and across global operations
Enforce the correct operator, machine, materials, processes and measurements at every process step
Enforce multi-tiered Bills of Material (BOMs) and configuration options
Qualify and detect data that is collected during manufacturing process and identify, analyze, solve and prevent problems while production continues
Collect integrated product, process and quality data in a structured electronic format to maintain a single as-built record
Track, record and centralize all information required for completed electronic Device History Record (eDHR), enabling review and release by exception
Manage and control labor resources and activities (non-productive activity reporting, time/attendance reporting, certification tracking, training records, tracing/prevention of unauthorized actions, role definition)
Guide and track personnel executing production with interactive work instructions, step validation and electronic signature requirements
Define and enforce equipment rules, properties, usage limits and maintenance (e.g. certification checks prior to use)
Track and manage the movement and storage of all materials, in-process items and finished products
Facilitate and manage labeling, weighing and dispensing activities
Real-time performance reporting against historic and/or expected results (OEE, resource utilization, resource availability, cycle times, conformance to schedule, SPC/SQC analysis based on parameters from control functions, etc.)
Monitor production processes and provide decision support to personnel to make improvements or corrections (within a single process, from one operation to the next, across operations)
Track and record production status and disposition of work in real time (personnel, materials, current status, alarms, rework, non-conformances)
Record all production and quality information, enabling full forward and backward traceability of components, products and supplied materials (genealogy)
Manage and enforce production order dispatching, sequencing, execution and changes
Access and update production documentation (work instructions, drawings, SOPs, part programs, engineering change notices, etc.)
Schedule work orders, and define sequence and timing of operations based on priorities and rules associated with specific equipment and/or product traits
Set process limits and automatically pause or prevent workflow execution until a predefined condition is met
Track and enforce quality throughout manufacturing process with focus on prevention and full compliance with industry regulations (ISA-95, GAMP 5, GxP, cGMP, 21 CFR Part 11, etc.)
Detect, sentence and/or repair non-conformances according to configurable rework processes (repair, RMA, AQL, etc.)
Configure dynamic actions based on business rules to enable quick response to events (containment, triage, hold, scrap, rework, Material Review Board (MRB), quarantine, etc.)
Allocate and control all resources utilized in manufacturing (equipment, tools, labor, skills, materials, procedures, documents, etc.)
Manage inventory (lot/container level), perform material calls and calls for replenishment
Integration with other enterprise systems (ERP, PLM, Quality/SPC, Manufacturing Intelligence, Production Planning & Scheduling, CRM, SCM etc.)

Benefits of Siemens Opcenter Execution Medical Device and Diagnostics (Camstar)

Achieve paperless manufacturing
Drive error-proof processes
Ensure complete electronic Device History Records (eDHR)
Reduce product review and release effort
Ensure quality and compliance
Reduce downtimes, rework and waste
Minimize cycle times
Facilitate change management
Optimize production activities in real time
Increase manufacturing process visibility
Improve control over processes and resources
Enable more informed decisions for continuous improvement
Synchronize processes in facility and/or across global enterprise

Our Partnership with Siemens Digital Industries

Engineering has achieved the Siemens Smart Expert Partner designation, which differentiates us as an industry and customer-validated expert in the Siemens Digital Industries software suite, specifically in their Digital Manufacturing products: Teamcenter Manufacturing, Shop Floor Connect (SFC), Shop Floor Integrate (SFI), Tecnomatix Plant Simulation, Tecnomatix Process Simulate, Opcenter Execution Discrete (SIMATIC IT UADM), Opcenter Execution Process (SIMATIC IT UAPI), Opcenter Advanced Planning and Scheduling (Preactor APS) and Siemens Opcenter Execution Medical Device and Diagnostics (Camstar Medical Device Suite). We are also certified in their Mendix and MindSphere Cloud solutions.

As a certified reseller, solution provider and system integrator for Siemens across several business units and portfolios, Engineering is the only Siemens partner in the world that has the combined vision, industry experience and technical expertise to deliver integrated solutions across all these different offerings.