Medical Device Manufacturing
Industry Challenges
Combining the challenges of traditional discrete manufacturing with a high level of regulatory control via the Food & Drug Administration (FDA) and international institutions, Medical Device Manufacturing presents a unique set of challenges. To stay competitive, manufacturers in this sector must balance costs and compliance, all while continuously innovating and consistently producing high-quality products. Growing cybersecurity concerns in an increasingly digitalized sector driven by the Industrial Internet of Things (IIoT) add to the list of pressing concerns that must be addressed with the right solutions.
Our Industry Solutions
1. Product Design Automation
Medical devices are expensive to develop, largely due to the long time-to-market between their design and productization. Our Design Automation team specializes in automating design processes and systems to help medical device manufacturers innovate cost-efficiently, develop higher-quality products and significantly reduce their speed to market. Our solutions automate existing design software functionalities, create rule-based design checks and digitalize the drawing generation process for optimal designs.
- Computer-Aided Design (CAD) Software Configuration
- Product Design & Analysis Automation
- Algorithmic & Convergent Modeling
- Generative Drawing Optimization
- Model-Based Definition (MBD) Automation
- Product Manufacturing Information (PMI) Generation
- Knowledge-Based Design Systems
2. Product Lifecycle Management (PLM)
The right Product Lifecycle Management (PLM) solution can provide the single source of truth for all medical device product design, development, planning and production data. This consolidated approach promotes accurate and informed decision-making across the product lifecycle. Starting with medical device design, our PLM solutions store 3D data as well as detailed properties of assemblies and components.
- Engineering (eBOM) & Manufacturing Bill of Materials (mBOM) Reconciliation
- Manufacturing Product Definition Management (Bill of Materials)
- Manufacturing/Assembly Process Definition Management (Bill of Process)
- Product Configuration & Quality Data Management
- Digital Work Instruction Design & Management
- Revision Control & Engineering Change Management
- Integration with ERP, MES & Downstream Systems
3. Manufacturing Execution Systems (MES)
Our end-to-end Manufacturing Execution System (MES) solutions manage and monitor all the work-in-progress on the medical device production floor. The goal of an MES is to improve productivity and reduce production cycle times by optimizing and synchronizing real-time manufacturing activities, often across globally distributed sites. Our MES solutions help companies digitalize and control the 5 M's of medical device manufacturing: men/women, machines, methods, measurements and materials.
- Production Order Management & Execution
- Detailed Production Scheduling & Planning
- Production Monitoring, Data Collection & Reporting
- Material Management & Genealogy
- Quality Testing, Audit Trail & Electronic Signature
- Quality Management & Statistical Process Control (SPC)
- Integration to Third-Party Systems (eDHR, ERP, SPC, SCADA, etc.)
4. Electronic Device History Recording (eDHR)
Medical device companies face challenges related to the management of Device History Records (DHRs), which are required by regulatory agencies to record production details for each product manufactured. Effort related to creating, maintaining, printing, tracking, reviewing and storing DHRs poses significant time and costs. Often built into MES, our Electronic Device History Recording (eDHR) solutions automate and streamline this process, saving costs and ensuring compliance.
- Electronic Device History Record (eDHR) Design & Execution
- Material & User Management
- Equipment Status Management
- Non-Conformance Reporting (NCR)
- Corrective & Preventive Action (CAPA) Management
- Electronic Device History Record Review & Release by Exception
- Electronic Signature & Workflow Enforcement
5. Digital Supply Chain (Tracking & Tracing)
Once in production, medical devices face a world of evolving standards, regulations and reimbursement rules. Companies must be prepared to respond to product issues, agency enforcement actions and recalls, all while continuing to innovate. Complete supply chain visibility leveraging our Digital Supply Chain (Tracking & Tracing) solutions drives the tracking and tracing of items, products and shipments to ensure authenticity and compliance at every step of the value chain to the end consumer.
- Item, Product & Shipment Serialization / Aggregation
- Item, Product & Shipment Tracing / Verification / Genealogy
- Real-Time Monitoring of Warehouse & Transportation Logistics
- Product Serialization Data Access, Management & Exchange
- Product Defect, Recall & Return Management
- Secure & Centralized Serialization Data Database
- Compliance Data Reporting to Government Systems
Engineering's Advantage
From data collection cloud applications to niche quality control systems to full-featured Manufacturing Execution Systems and advanced Digital Supply Chain traceability implementations, Engineering Industries eXcellence boasts a comprehensive digital transformation portfolio dedicated to meet the special needs, processes and requirements of the Medical Device Manufacturing industry. Our global team of experts partners with medical device innovators of all shapes and sizes to help them digitalize and optimize processes, minimize product and process risks, and ensure regulatory compliance for patient safety.
Fully Compliant Industry 4.0 Solutions:
- Government & Industry Regulations
- 21 CFR PART 11
- 21 CFR PART 820
- CGMP (Current Good Manufacturing Practices)
- IEC 60601
- IEC 62304
- ISO 13485:2016
- ISO 14971:2019
- ISO 9001
Interested in speaking to one of our Medical Device Manufacturing experts? Contact us at info@indx.com.
