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MACDEE, INC.
13800 Luick Drive
Chelsea, MI 48118-9588
USA
734-475-9165 (phone)
734-475-3825 (fax)

Web Site
www.macdeeinc.com

Founded
1964

Contacts
Mark Wellman
Vice President
markw@macdeeinc.com

Facility

MACDEE facility
18,000 sq. ft.

· temperature-controlled
· nine acres
· 40 minutes west of Detroit Metro Airport

Staff
60 employees

Certification
FDA-registered/1983
EN 46002 Approved
ISO Certified

Focus
· CNC Machining of plastic implants and instruments
· Injection Molding of plastic medical devices
· Product Cleaning & Assembly
· Contract Packaging

Background

MACDEE is a contract manufacturer of polymer-based medical devices, specializing in the manufacture of UHMWPE orthopaedic implants, plastic trials and instrumentation.

MACDEE was founded in 1964 as an injection molding company. The owners eventually added machining capabilities to the company to complement the successful injection molding business.

We subsequently became involved in manufacturing implants for the orthopaedic medical device industry in 1974.

Years of experience have provided MACDEE with the expertise to machine UHMWPE implants with a high degree of accuracy and perhaps the finest surface finish in the industry.

MACDEE logo
Precision Machined & Molded Plastics

CNC Machining — From 5-axis milling capabilities to live-tool turning centers with sub-spindles, we have over 27 pieces of equipment to service virtually any aspect of our customers' production needs. Since we only machine plastic, there is no risk of cross-contamination from other materials. MACDEE has machined a wide range of plastics, specializing in implant-grade UHMWPE. We have fabricated products from all of the commonly used plastics, most of the high-temperature resistant engineering plastics, and even several biodegradable polymers.

Injection Molding — MACDEE built its foundation on injection molding. We currently have seven presses, ranging in size from 30 to 150 tons of clamping force. We specialize in small to medium volume runs, but can also handle high production volume demands. Our presses can even be located within one of our several portable Class 10,000 Controlled Environment Rooms for molding that requires a high degree of protection from particulate contamination. We have molded products and components from virtually every thermoplastic resin that is used in the medical marketplace.

Product Cleaning, Assembly & Packaging — Product cleaning and product assembly, using components we have fabricated as well as those we purchase for our customers, is available to any of our customers. Many of our product assembly operations are conducted within our permanent Class 10,000 Controlled Environment Packaging Room.

Finished products and product assemblies are also packaged for sterilization, using our pouch sealing, gas flush/vacuum sealing or blister sealing equipment located within our Class 10,000 Packaging Room. Boxing, labeling and shrink-wrapping services are also available within our Packaging Department. These additional in-house capabilities allow our customers to receive a product packaged and ready for shipment to their sterilization source.

Quality Assurance — We are committed to shipping "zero defect" products on time and at a competitive price. All procedures and processes are controlled and documented according to the most recent ISO and QSR guidelines. We have the right equipment, including the latest CMM technology, and an experienced QC Department to ensure that our customers will receive products that meet their requirements.

Regulatory Compliance — MACDEE has been an FDA registered contract manufacturer of medical devices since 1983. We are also approved to EN 46002. Achieving these high standards demonstrates MACDEE's ongoing commitment to our medical device customers.

Technology — We work closely with our customers to ensure their final product can be made in a consistent and cost-effective manner. With over 38 years of experience in the plastics industry, and nearly 28 of those years serving the orthopaedic industry, our engineering department understands many of the functional requirements that may escape detection by others less experienced.

Once your design is finalized, our proprietary process technologies allow us to manufacture your product to exacting specifications that meet and often exceed your requirements. Our state of the art CAD/CAM systems are capable of IGES translation, solid modeling, 5-axis CNC code generation and off-line verification. All CNC programs are centrally located and controlled to assure repeatable performance over the product life cycle.

MACDEE's technology investments include a state-of-the-art production control system that provides automated material planning, scheduling, data collection and costing. By planning material and production requirements, analyzing real-time production information and costs, we deliver products on time and at the best possible value to our customers.

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