ERP Software

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ERP for Medical Equipment & Device Manufacturers

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 Make 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

+- Challenges Faced by 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

Complexity

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

+- WorkWise ERP Key Features for Medical Equipment Manufacturers

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

+- WorkWise ERP Software Additional Key Features & Functions

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

+- WorkWise ERP Solution Benefits

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

Ready to see how our powerful ERP software can benefit your business? Schedule your personalized, one-on-one demo today.

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All aspects of our company are now running through our ERP software. Having everyone work out of the same system and not have multiple programs that you have to jump back and forth through, has allowed us to get more done in less time.

Gary Volz

Software Developer

ACI

One of the main benefits we’ve experienced using WorkWise ERP is being able to get meaningful information we can use, versus getting data that requires more work to get the answers you’re looking for. The data is integrated and streamlined for efficient use which keeps our fixed costs lower and allows us to invest our capital into building better products.

Michael Ray

CFO

ACR

It doesn’t take all day to do our schedule anymore. Also, the Performance Management WorkBench lets us see what information we want to see, and what time we want to see it, in a nice visual way. Item Planning is also great. It’s so easy to look up specific information related to whatever we need to see.

Kelly Crowell

AMI President

American Metal Fab

What’s really nice is having everything in one package. My financials are in the same package as manufacturing and customer orders. Everything integrates seamlessly. Bringing in inventory management has been a huge benefit for us. Being able to jump between workbenches and different points of data has been really nice.

Pam Reynolds

Chief Financial Officer

CapstanAG

I would highly recommend WorkWise to other companies. It’s cost competitive, the Cloud ERP implementation has been great, the people have been great. WorkWise bends over backwards to help us. We feel that they’re on our side.

Don Lavrenz

President and CEO

The Industrial Controls Company

WorkWise has been a true leader in our ability to drive process change and productivity enhancement, and to assist us in our lean capabilities.

Jim Moldenhauer

IT Manager

Hampel

I would definitely recommend WorkWise ERP to anyone looking to improve their manufacturing processes. We’ve been utilizing the software for 20 years and have never regretted our decision.

Chris Reid

President

Service Stampings

WorkWise spent a lot of time with us in order to understand our manufacturing process. We’re fairly unique, and there’s not that many companies in the world that do what we do. WorkWise really made us feel like they understood what we were doing and where we were going.

Dave Manahan

Business Process Improvement Director

Strongwell

The team at WorkWise is phenomenal. I highly recommend WorkWise ERP to any company looking to improve their processes, improve their efficiency, become more productive and work with a company who really gets to know them and understands what they’re going through.

Mike Campise

IT Systems Specialist

RMF