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Medical Devices and Diagnostics Manufacturing

Improve Product Quality, Ensure Patient Safety, Increase Profitability

Innovative medical device and diagnostics companies must balance profitability with zero tolerance for product quality issues. Camstar enables these sometimes seemingly opposing goals with Medical Device Suite, an industry-specific configuration of the Camstar Enterprise Platform. Camstar’s Medical Device Manufacturing Execution System (MES) achieves these goals through eliminating non-value added activities, creating a self-auditing electronic Device History Record (eDHR), enforcing good manufacturing practices and regulatory compliance, and much more.


Improve More.

  • 100% ↓ paper in manufacturing
  • 80% ↓ final product review & release time
  • 75% ↓ cycle time due to efficiencies gained
  • 90% ↓ scrap with ‘right first time’ enforcement
  • 65% ↓ Manufacturing-related complaints


icon_role_exec  Benefits for Executives

Reduced Cost & Risk of Compliance: Eliminate the costs of labor for manual creation, review, research, and quality control of paper-based Device History Records.  Drive tighter, enterprise-wide compliance through an electronic Device History Record (eDHR) while eliminating human errors and oversights.  The resulting proven reductions in field product quality issues, complaints, and warranty claims lower product risk and protect your brand while lowered costs strengthen market share.

Stabilized Supply Chain: Improve planning and scheduling with real-time plant information. Diminish upstream and downstream supply chain disruptions through complete product and process enforcement and traceability. Joined with increased manufacturing velocity, enterprise-wide enforcement, traceability, and visibility generate highly predictable output quality yielding higher customer satisfaction.

Rapid NPI & Stabilization: Concurrent product and manufacturing process design streamlines design transfer, reduces new product ramp time, and brings innovative technologies more rapidly to market. Global manufacturing control and enforcement reduces variability throughout the design and manufacturing processes, stabilizes new products faster, provides for rapid deployment of engineering changes, and yields a more profitable initial launch.

Improved Profit Margin: Grow revenues by increasing manufacturing velocity and heightening predictability of product quality to generate larger quantities of final product.  Simultaneously decrease costs by reducing or eliminating paper, scrap, labor, inventory, and non-value added activities.  The simultaneous effects of an enterprise-wide Medical Device Manufacturing Execution System (MES) increasing revenues and reducing costs improve the profit margin at the most rapid rate – meeting or exceeding shareholder/investor expectations.

Enhanced Decision Making: Improve your decision making capabilities by gaining actionable intelligence from dashboards, preconfigured reports, and ad hoc reports correlating granular data from multiple, global, enterprise-wide sources.

Lean Enablement: Drive lean initiatives through shorter lots, automated poke-a-yoke, paperless manufacturing, end-to-end process control/enforcement/visibility, electronic procedures, operator certification, machine maintenance/calibration enforcement, and integrated electronic lean workflows and kanban.

icon_role_operations   Benefits for Operations

Improved Productivity: Eliminate or reduce non-value added Device History Record activities related to data collection, calculations, and documentation review.  An electronic Device History Record (eDHR) enables operators to focus time on making product rather than filling out paperwork.

Increased Throughput: Significantly increase overall throughput through real-time granular visibility into manufacturing and WIP, better process enforcements, and right first time production.

Increased Product/Process Yield: Reduce scrap and rework and improve first pass yield through systematic product/process enforcements by enforcing accurate data collections, usage of only authorized materials, utilization of the right procedures and equipment, certification of operators, and more.

Reduced Costs: Lower the costs of poor quality and good quality in manufacturing through reduction and/or redeployment of manpower, elimination of paper records (e.g., scanning, storage, paper, ink), and error-proofing at each step of the process (automated “poke-a-yoke”).

Increased Capacity: Improve utilization of assets and human capital through real-time visibility and elimination of non-value added activities.

Improved Ramp to Volume & Line Balancing: Decrease Ramp time and improve Line Balance through process standardization, process enforcement, and real-time visibility into operations.

Product and Process Traceability: Trace any product, lot or unit and its processes across the supply chain, a factory, multiple factories, or the entire enterprise. Traceability data includes forwards and backwards genealogy of materials consumed, processes and equipment utilized, parametric and quality data collected, exceptions, rework, dates and times, and electronic signatures.

Decreased WIP and FG Inventory: Improved process and product visibility, multi-level tracking, reduced scrap, smaller lots, and faster cycle times drive reductions in WIP and FG inventory.

icon_role_compliance  Benefits for Quality & Compliance

Enforce compliance: Ensure regulatory requirements for 21 CFR Part 11 and 820 are enforced across all manufacturing operations with a complete self-auditing electronic Device History Record and Electronic Signatures.

Reduce Risk Exposure: Systematic enforcements reduce risk by ensuring the right material with the right machine and the right data with the right operator in the right method at the right time.

Reduce Line and Site Variability:
 Standardize processes across operations within a site and between sites ensuring product consistency.

Better Traceability: Search across all manufacturing and quality related data related to a work order, lot, unit, operator, material, piece of equipment, etc. in a matter of seconds.

Reduce Quality Incidents/Complaints/Recalls: Systematic enforcements and electronic Device History Records (eDHR) prevent quality escapes due to human error. And if the worst were to happen, recall exposure is significantly reduced via full traceability allowing for detailed recall containment of the affected – and only the affected – material.

Reduce Release Time: Rapidly release final products with fewer personnel through a self-auditing electronic Device History Record (eDHR) that allows for exception only review.

Faster & Accurate Impact Analysis: Search and filter for suspect lots/units based on criteria such as component lots/sub-assemblies, equipment used, revision of specifications, and operators.

Better Product & Process Design: Receive accurate data on product and process performance, actual occurrence rate of failure modes, identification of common failures by product/process, and via collaboration with product and process engineers.

icon_role_it   Benefits for IT

Shop Floor to Top Floor Visibility: Utilize native, robust dashboard capabilities to provide relevant, real-time information to every stakeholder from Executives to Machine Operators.

Adaptable User Interfaces: Easily and rapidly configure user interfaces for each stakeholder that matches the way they work. Increase user speed and eliminate unnecessary steps during manufacturing.

Single Manufacturing Standard: Standardize IT systems across all operations, accounting for and better enabling multiple concurrent manufacturing processes and assets.

Reduced Total Cost of Ownership: A single, modular enterprise manufacturing IT platform eliminates disparate and redundant systems and applications increasing system value while lowering total cost of ownership. Further reduce costs with significant out-of-the-box functionality and best practices avoiding custom coding and development.

Exceeded Expectations: Provide your stakeholders with the robust, modern IT systems that meet their needs for MES, eDHR and visibility. Satisfy their requirements for ease of use and rapid configuration. Exceed user expectations with a configurable UI.

Full Scalability: A complete enterprise platform architecture for manufacturing, quality, and intelligence that grows and adapts with you.  Supports frequent change and reconfiguration – managed by users.  Assure your company with top performance and 24 X 365 reliability.

icon_role_randd Benefits for R&D and Engineering

Rapid NPI & Stabilization: Concurrent product and manufacturing process design reduces new product ramp time bringing innovative technologies more rapidly to market.  Reducing variability throughout the design and manufacturing processes stabilizes the new product faster yielding a more profitable initial launch.

Enhanced Modeling & Testing: Accurately understand manufacturing capabilities through integrated modeling and testing that leverages manufacturing and product past performance.  Eliminate many variables in your next new product introduction.

ECO Visibility & Performance: Understand the impact in real-time of systemically enforcing an engineering change order (ECO).  View performance impact immediately, prevent/control downstream effects, and verify post-change results through effectivity monitoring and system alerts.

icon_role_supplychain Benefits for the Supply Chain

Stabilized Supply Chain: Improve supply chain planning and scheduling with real-time plant information. Diminish upstream and downstream supply chain disruptions through complete product and process enforcement and traceability.  Joined with increased manufacturing velocity, enterprise-wide enforcement, traceability, and visibility generate highly predictable output quality yielding higher customer satisfaction.

Visible Supply Chain: Complete supply chain visibility by removing the manufacturing ‘black hole’. Enable true end-to-end supply chain management.

UDI Compliance: Capture UDI as part of the eDHR correlating material, component, operator, and product information with the device.  This complete as-built manufacturing audit trail provides rapid troubleshooting, root-cause analysis, and resolution.  Contain suspect product versus casting a wide net and eliminate significant enterprise risk.

Camstar Systems