ERP for Medical Equipment & Device Manufacturers

For The Medical Equipment Industry

ERP Software for Medical Equipment Manufacturers

Medical devices is a fast growth segment in the health care industry. The demand for devices is accelerating from two particular areas, emerging foreign markets where the devices are relatively new, and in the U.S. with its aging population.

Medical devices manufacturers face unique challenges when compared to other equipment manufacturers. Not only do they face the product complexity, the demand for more variety by customers, the competitive pressures, and the downward price pressures; they also face the following unique complexities.

What Makes the Medical Equipment Market Unique?

New Technology and Trends in Medical Technologies

New technologies, new standards, and new regulations are continuously being introduced into the medical device market. Staying on top of these changes can make the difference between success and failure. Collaborating with doctors, medical experts, engineers, regulators and suppliers of technology must be quick and pervasive. Medical device manufacturers can also suffer when these changes cause time-to-market issues for new or modified products.

Regulatory Challenges

The medical device industry is subject to a long list of regulations, standards and compliance items. These include FDA, ISO, Federal hazardous substance and other local or international mandates. These regulations can differ slightly within geographies and sometimes have particular nuances. A manufacturer must comply with these regulations or risk penalties or malpractice lawsuits. These same regulatory items can also contribute to expensive redesigns in some of the products.

Quality Challenges

With medical malpractice, competitive challenges, and customer demands for more features and functions, maintaining quality standards has become even harder. Medical device manufacturers must be more exacting and persistent with their quality and documentation efforts. Recalls can be expensive for the cost of product replacement, but can be even more damaging to company image, and future product reputation.

Effective & Low-Cost Support

Another challenge for medical equipment manufacturers is access to low-cost, on-call 24/7 technical support. Medical devices are used around the clock across the globe, and require timely support to avoid costly problems.

WorkWise ERP Software for Medical Equipment Manufacturers

  • Fast Growth
  • Large foreign potential markets
  • Aging population
  • Time to market
  • Health care reform
  • Home care potential
  • Innovation/change
  • Fast innovation cycles, short product lifecycles
  • Controlling product design changes
  • Fast paced changes- technologies, materials, electronics
  • Regulatory changes
  • Need to collaborate with doctors, medical experts
  • Product, material, and technology obsolescence
  • Regulation/Quality
  • Regulatory Compliance such as Quality System Regulation
  • FDA 21 CFR Part 11
  • GMP compliance (multi-level passwords, activity logs QSR (Medical Device Model for Quality Assurance)
  • ISO9001/ISO9002 (Quality System-Model for Quality Assurance)
  • ISO13485 (ISO9001 Biomedical particular requirements)
  • EN46001 (European Medical Device for Quality Assurance)
  • Traceability
  • Recalls
  • Medical liability/quality risks
  • Margins
  • Customer demand for lower prices
  • Customer demands for more features, functions and solutions
  • Rising material costs
  • High inventory levels
  • Push for lower total cost of ownership for the product
  • Inefficient operations
  • Large number components and operations in products
  • Variety in features, functions, and special orders
  • Longer and larger supply chains
 Total Solutions
  • Need for comprehensive aftermarket service and support
  • Requirement for readily available aftermarket parts
  • Mandated full warranty coverage and extended time coverage
  • Quicker turnaround for quotes and estimates
  • Better customer service
  • Focus on product performance rather than features, functions
  • Instant availability of support and repair documentation
  • Call centers with access to product traceability
Supply Chain Weaknesses
  • Fluctuating raw material prices
  • Unreliable suppliers
  • Poor delivery performance
  • Need to outsource
  • Need greater insights into supplier activities
Mixed Modes
  • Make to stock
  • Assemble to order
  • Build to order
  • Configure to order
  • Repeat and tweak
  • Engineer to order
Mixed Methods
  • Lean Manufacturing
  • Kanban
  • MRP & MPS
  • JIT
  • 5s
  • MES
  • Role based manufacturing
  • TQM, Six Sigma, Kaizen
Regulations / Quality
  • Engineering change orders
  • Quality management system
  • CAPA
  • FDA 21 CFR Part 11, GMP
  • Document management
  • Supplier score carding
Product Life Cycle Management
  • Customer portal
  • CRM-Customer
  • Product configuration
  • Document and file management
  • Engineering change orders
  • Supplier traceability
  • Product serial no., batch/lot, component, device traceability
  • As built BOM and routing
  • Build histories
  • Quality archives
  • CRM-Support
  • Warranty
  • Component to parent/inheritance
  • RMA’s
Customer Service
  • Quoting and estimating
  • Complex orders
  • Product configuration
  • Copy and tweak order creation
  • Direct Fulfillment
  • Customer portal
  • Customer relationship manager
After Market Sales and Support
  • CRM-Call center
  • eCommerce
  • Warranty
  • Customer portal
Manufacturing execution
  • Product configuration
  • Visual scheduling
  • Shop Floor Control
  • Work in process manager
  • Asset utilization manager, CMMS/EAM
  • Mobile data collection
  • Kanban
  • Kaizen
  • 5s
  • Performance management
  • Human resource management
Supply Chain
  • Inventory management
  • Supplier portal
  • Purchasing
  • Bill of material
  • Engineering change orders
  • JIT
  • Warehouse management
Cost Management
  • Job cost
  • Standard cost
  • Multi-layered cost application
 Production Planning
  • Material requirements planning
  • Master scheduling
  • Product configuration
  • Available to promise
  • Lot traceability
 Finance and Accounting
  • Accounts Recievable
  •  Cash Receipts
  •  Human Resources
  • Multi-level passwords with logs and audit trails (GMP compliance)
  • Multi-currency, international shipping
  • Forward and backward lot traceability
  • Electronic signatures with transaction audit traceability
  • Role based screens and applications
  • Blanket purchase orders
  • Document archiving
  • Asset purchased and tracking system
  • Back flushing
  • Rules based configurations
  • Kitting
  • Cumulative lead time
  • Cost application of design, research and other special costs
  • Modular design capability
  • Rules based quotations and configurations
  • Sales order to job link
  • What-if quotes and costing
  • Available to promise
  • Shop order explosion
  • Matrix bills
  • Features and options
  • Multi-level pricing
  • Smooth forecast error
  • Substitutes and alternatives
  • Family forecasting
  • Serialized inventory
  • Attribute management
  • Easy to comply and track all regulation and compliance requirements
  • Complete product and component traceability, serial no., batch/lot, component
  • Improve lifecycle management
  • Improved lead times and reduce waste through implementation of lean strategies
  • Strengthen inventory and warehouse management with use of barcode technology
  • Improved collaboration and relationship with the doctors, medical experts, engineers, and suppliers
  • Ability to handle multiple planning models, configurations
  • Lower costs and waste thru lean practices
  • Better visibility into all aspects of your operations
  • Improved supply chain management and cost control
  • Precise execution throughout the business
  • Flexibility in adapting products to specific customer wishes
  • Better control over design changes
  • Real time feedback to stay on top of all activities and performance
  • Ease of doing business for the customer
  • Enhanced productivity for the shop floor
  • Low cost efficient operations
  • Better customer fill-rates and delivery promises
  • Improved lifecycle management
  • Effective aftermarket sales and support
  • Improved quality with Kaizen, TQM
  • Extend value add programs (solutions)
  • Optimize production capacity
  • Insights into accurate product costs with full view and application methods
  • Manage high level receivables
  • Project and manage cash flow

Ready to Learn More?

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