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MES for Medical Devices

MES for Medical Devices
MES for Medical Devices enforce highly efficient, compliant manufacturing processes.

When is it time to upgrade to MES for Medical Devices? Manufacturing Execution Systems (MES) digitalize the monitoring and control of quality and efficiency processes. Many Medical Device manufacturers are still wrestling with the repercussions of legacy paper-based processes – drowning in manual non-value-added activities that slow their progress and keep them in the dark. With compliance requirements mounting, recalls on the rise, and margins getting squeezed, you simply can’t compete with companies already on their digitalization journey.

Manufacturers of every stripe are implementing and employing Manufacturing Execution Systems (MES), but you need MES built specifically to meet the Medical Device & Diagnostic (MD&D) industry’s specialized needs, and this includes discrete, batch, and combination device manufacturers. MES for Medical Devices enforce highly efficient, compliant manufacturing processes that accelerate the delivery of innovative products, at the highest levels of quality.

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MES for Medical Devices
MES for Medical Devices enforce highly efficient, compliant manufacturing processes.

Goals of MES for Medical Devices

Goals of MES for Medical Devices
Goals of MES for Medical Devices

A MES solution tailored to the MD&D industry should: 

  • Create a paperless manufacturing environment across batch and discrete operations 
  • Deliver a self-auditing electronic Device History Record (eDHR) and electronic Batch Record (eBR) 
  • Eliminate non-value-added activities 
  • Enforce good manufacturing practices and regulatory compliance 
  • Error-proof manufacturing processes 
  • Accelerate and control configuration and change management.
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Goals of MES for Medical Devices
Goals of MES for Medical Devices

Results of Adopting MES for Medical Devices

Results of Adopting MES for Medical Devices

Medical Device manufacturers who have adopted MES for Medical Devices report the following results:

  • Less paper in manufacturing
  • Less final product review & release time
  • Less cycle time due to efficiency gains
  • Less scrap with ‘right first time’ enforcement
  • Less manufacturing-related complaints

With MES for Medical Devices, you are empowered to maximize profit margins by simultaneously increasing revenues and decreasing costs – launching you to new levels of growth and profitability. Find out more about the results you can expect across key performance metrics below.

Medical Device manufacturers who have adopted MES for Medical Devices report the following results:

  • Less paper in manufacturing
  • Less final product review & release time
  • Less cycle time due to efficiency gains
  • Less scrap with ‘right first time’ enforcement
  • Less manufacturing-related complaints

With MES for Medical Devices, you are empowered to maximize profit margins by simultaneously increasing revenues and decreasing costs – launching you to new levels of growth and profitability. Find out more about the results you can expect across key performance metrics below.

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) or electronic batch record (eBR) 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: Streamline design processes with concurrent product and process design transfer, reducing new product ramp time, and bringing innovative technologies more rapidly to market. Effective change management is essential to gaining process control and enforcement, significantly reducing variability. MES for Medical Devices provide this control with centralized authorship of manufacturing process changes that can be rapidly and accurately deployed across your enterprise, allowing you to improve time to market without sacrificing quality. 

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.

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Benefits for IT

MES for Medical Devices: 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/eBR and visibility. Satisfy their requirements for ease of use and rapid configuration. Exceed user expectations with a configurable user interface (UI).

  • 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/eBR and visibility. Satisfy their requirements for ease of use and rapid configuration. Exceed user expectations with a configurable user interface (UI).

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) and electronic batch record (eBR) 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.

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Benefits for R&D and Engineering

MES for Medical Devices: R&D and Engineering

  • Rapid NPI & Stabilization: Streamline design processes with concurrent product and process design transfer, reducing new product ramp time, and bringing innovative technologies more rapidly to market. Effective change management is essential to gaining process control and enforcement, significantly reducing variability. MES for Medical Devices provide this control with centralized authorship of manufacturing process changes that can be rapidly and accurately deployed across your enterprise, allowing you to improve time to market without sacrificing quality. 
  • 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.

  • Rapid NPI & Stabilization: Streamline design processes with concurrent product and process design transfer, reducing new product ramp time, and bringing innovative technologies more rapidly to market. Effective change management is essential to gaining process control and enforcement, significantly reducing variability. MES for Medical Devices provide this control with centralized authorship of manufacturing process changes that can be rapidly and accurately deployed across your enterprise, allowing you to improve time to market without sacrificing quality. 
  • 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.

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 (eDHR), electronic batch record (eBR) and Electronic Signatures. 

Reduce Risk Exposure: Reduce risk with systematic enforcement and forward and backward genealogy that assures your operator has the material, process parameters and data to make real time, in-line decisions. 

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 associated with a work order, lot, unit, operator, material, piece of equipment, etc. in a matter of seconds. 

Reduce Quality Incidents/Complaints/Recalls: Prevent quality escapes due to human error with systematic enforcements and electronic device history records (eDHR) and electronic batch record (eBR) to 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 self-auditing electronic device history record (eDHR) and electronic batch record (eBR) that allow 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.

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Benefits for the Supply Chain

MES for Medical Devices: 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: Enable true end-to-end supply chain management by removing the manufacturing ‘black hole’ and achieving complete supply chain visibility. 
  • 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.

  • 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: Enable true end-to-end supply chain management by removing the manufacturing ‘black hole’ and achieving complete supply chain visibility. 
  • 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.

Solution


MES for Medical Devices - Camstar Medical Device Suite

Camstar Medical Device Suite

Remain cost-competitive in today’s MD&D environment.

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