Siloed CMO processes are no longer effective. It's time for a modern, flexible solution to support your success.

The new pathway to capital equipment commercialization.

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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COMPLETE MEDICAL DEVICE SYSTEM STRATEGY

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