Outsourcing in general presents a myriad of challenges to any OEM, but consider the ramifications of outsourcing medical device components and systems. Medical device OEMs must balance the need for consistent quality and conformance to product and regulatory requirements with the equally essential need to get new products to market quickly and efficiently. Given the level of investment needed to develop new products and shepherd them through the regulatory process, medical device manufacturers typically focus on product design, technological innovation, and market access to maximize their opportunity for success. Expending resources (both human and financial) on infrastructure to support an adequate manufacturing operation can quickly dilute focus from their core competencies.

Federal Electronics prides itself on providing the medical OEM with a seamless and efficient extension of their operation while conforming to the critical requirements imposed by the FDA and other regulatory bodies. As a vertically integrated EMS provider, we offer a suite of manufacturing, engineering, and supply chain management solutions, resulting in an efficient, cost-effective outsourcing alternative, seamlessly interfaced with your internal operations.

Our products can be found within:

• Ophthalmic diagnostic systems
• Cosmetic laser systems
• Orthopedic endoscopic systems
• Radiotherapy and diagnostic imaging systems
• Positron emission tomography imaging systems

Federal Electronics’ highly flexible vertical integration model can be configured to support a wide variety of outsourcing strategies and is especially effective if your intention is to expand the scope from lower level commodities (circuit cards, cable and harness assemblies, etc.) to subassemblies or system level assemblies.

Our manufacturing service capabilities include:

• Copper cable assemblies
• Copper wire harness assemblies (over 2000 points)
• Advanced technology circuit card assemblies (0201, µBGA)
• Fiber optic interconnect assemblies
  
• Functionally-tested sub-assemblies and system level assemblies

Quality
Quality starts with an accurate assessment of the customers’ requirements, the creation of controlled processes to support those requirements, and the existence of an auditing/reporting system that distills data and identifies trends before they become non-conformances -- driving to an effective preventative action. Our quality system permeates the entire organization, instilling confidence in manufacturing, engineering, and administrative processes.

Federal Electronics’ manufacturing and administrative processes are based on the highest standards, including:

• ISO 9001-2000
  
• IPC-A-610 to Class 3
• IPC-A-620 to Class 3
• Compliant with Current Good Manufacturing Practice as set forth in the Quality System Regulation

Engineering
Medical OEM’s are often hesitant to change their designs, as some changes may require regulatory review and approval -- a painful and time consuming process. The new product introduction process can be particularly challenging as well. Our engineering services are available to assist you in getting those new products and technologies to market quickly, but within the context of a well-controlled documentation management system that insures accuracy during the development and engineering change-order processes. These services include:

• Design for manufacturability and assembly
• Prototyping
• New Product Introduction (NPI) programs that get your products to market quickly and efficiently while establishing the processes and controls that will ensure compliance with the appropriate technical and regulatory requirements

Supply Chain Management
Federal Electronics employs a robust product configuration and supply chain management process that synchronizes daily changes in supply and demand and identifies points of misalignment for immediate action and communication. We also take conventional EMS supply chain management to the next level (often referred to as 3rd Party Logistics (3PL)) with the following types of services:

• Kitting services: Package outsourced assemblies in reusable containers in the reverse order of installation, delivered directly to a specific point on the customers’ flow line. This approach minimizes purchasing, receiving, inspection, stocking, and kitting transactions.
• Advanced Kitting services: Incorporate COTS items with the outsourced assemblies, further minimizing the number of transactions to be processed by the customer’s material acquisition team

Federal Electronics’ flexible menu of manufacturing, engineering and supply chain management solutions has been created to specifically address many of the generic challenges faced by medical device OEMs. This menu can be configured to support your unique operational requirements. We evolve as your strategy evolves, insuring your continued competitive advantage both today and tomorrow.