

Siloed CMO processes are no longer effective. It's time for a modern, flexible solution to support your success.
Legacy CMOs are siloed and costing you more time, money, and resources than you know. MPE Inc. is creating a new commercialization platform built specifically to bring medical devices to market through unified design, development, manufacturing, and lifecycle support services.
Our commercialization platform sndures that your medical devices go to market:
- Quickly: Getting your product to marketing as soon as 12-18 months, compared to the leading 3-7 years with the legacy process.
- Less Costly: In-house resources such as supply management paired with our integrated services eliminate hidden costs throughout the product lifecycle.
- Transparently & Predictably: Creating a streamlined, transparent process that's scalable with your market demand, and setting your device up for FDA approval the first time.
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MANUFACTURING
MPE has invested in the manufacturing processes for the most expensive custom parts or critical quality components of the BOM
SUPPLY CHAIN
MPE has built out a global supply chain for commodities to complete medical device assembly
WAREHOUSING/3PL
MPE has created warehousing and 3PL model to deliver complete medical systems globally on time at lower cost
SUPPLY CHAIN SOLUTIONS
- Global Supply Chain Team: North America and Best Cost Country Sourcing Strategy
- Supplier Quality Management Program including regulatory compliance and change control
- Supplier Consolidation
- Access to latest technologies
- Product traceability ensure on-going regulatory compliance
MANUFACTURING FLOW LINE BENEFITS
- Currently, 80% of the products we manufacture utilize one-piece flow assembly. This process allows the finished product to come off the line packaged, labeled and ready to ship.
- Savings associated with medical device cosmetic expectations during final assembly
- Product Validation and Test
- With our one-piece flow process you can expect:
- Savings associated with connecting final assembly with the highest cost BOM component processes.
- Cost of quality savings mitigated via final assembly build validation.
ISO 5 CONTROLLED ENVIRONMENT CELL
ISO 5 CONTROLED ENVIORNMENT. ESD SAFE. TEMPERATURE, HUMIDITY, LUMINEX CONTROLLED
MPE’s authorized personnel and highly skilled assembly team manufacture specialty components and sub-assemblies critical to your architecture.
ISO 5 CONTROLLED ENVIORNMENT. ESD SAFE. TEMPERATURE, HUMIDITY, LUMINEX CONTROLLED
MPE’s authorized personnel and highly skilled assembly team manufacture specialty components and sub-assemblies critical to your architecture.

OUR CONTROLLED ENVIORNMENT IS CAPABLE OF:
- Temperature control
- Humidity control
- Air Filtration with Positive Room Pressure
- Lighting @ 800-950 Lux
- Restricting access to trained & authorized personnel
- Unique material handling protocols
- Application specific clothing & body covering
ELECTROSTATIC DISCHARGE (ESD) SAFE
- Compliant to ANSI S20.20 “Protection Of Electrical And Electronic Parts, Assemblies And Equipment”
- ESD compliant packaging
- De-ionizing equipment
- Special Material Handling Equipment
- Continuously monitored ESD workbenches
CLEAN ENVIRONMENT
- HEPA filtered, Laminar Flow assembly stations: ISO 14644-1, 2015E Class 5
- Filtered, compressed, ionized air blow off guns: ISO 8537-1, 2010 Class 3 ISO S20.20
- Standards validated through 3rd Party Auditing: Hi-Pot, ASTM, F24 particle, EN 12464, Luminance
FINAL ASSEMBLY TEST AREA INCLUDES
HI POT
AND CONTINUITY
TESTING
PNEUMATIC
TESTING
HIGH & LOW
PRESSURE GAS
SYSTEMS
OS,
FIRMWARE BURN-IN,
S/W INSTALL
APPLICATION SPECIFIC
TESTING PER
CUSTOMER REQUEST
WAREHOUSING & 3PL
FLEXIBLE STRATEGIES DRIVE PRODUCT DELIVERY SOLUTIONS AT LOWER COST. MPE CAN DEVELOP AN INVENTORY MANAGEMENT PROGRAM THAT FITS YOUR COMPANIES NEEDS, WHETHER IT’S DIRECT SHIPMENT TO THE END USER OR SETTING A MIN/MAX KANBAN PROGRAM.
MPE has invested in
- A new distribution center to manage finished medical device inventory and execute logistics strategies driving operational efficiencies:
- Cost savings associated with avoiding intercompany transit costs
- Savings configured to order at time of shipment
- Savings attributed to order replenishment via Kanban pull order systems Inventory carrying cost savings
- Same day shipment benefits without associated excessive inventory costs
- Lower regulatory risks with MPE 3PL tied to ISO 13485 certification
Our Systems
- Custom Packaging Development
- ISTA package testing
- International Shipping
- Customer Inventory Management
- KANBAN programs
- Warehouse and direct shipment to your customer
CONTACT US TODAY TO LEARN MORE ABOUT OUR SOLUTIONS AND HOW WE CAN MAKE THIS HAPPEN FOR YOU.
