Sterling Industries Company Profile

Sterling is a North American-based contract manufacturer and assembler of medical devices and components. We help clients — whether Fortune 100 OEMs, mid-sized medical device companies or late-stage “scale-ups” — deliver successful products by providing scaled production, Design for Manufacturing expertise, supplier consolidation and other critical value chain services.

• We specialize. Manufacturing for medical means the strictest process and quality controls are at the core of what we do, and who we are.
• We are our clients’ partners. Helping them launch and scale with regulatory compliance and supply chain optimization.
• We are experienced. With 40 years of excellence in medical device manufacturing, our clients understand the realworld value of experience and expertise.
• We are here. North American made by highly trained teams, from design engineers to customer service to the manufacturing floor.
• We are right-sized. We treat small- and mid-sized projects with the same care as our largest scale production runs.
• We are well-priced. With expertise in Design for Manufacturing (DFM) and sourcing, we optimize cost without sacrificing quality.

Manufacturing Capabilities

We design our manufacturing workflow, top to bottom, for success. Sterling provides complete, end-to-end solutions, and we regularly manufacture all or most of our clients’ devices’ components.

From simple devices, to disposables, to complex medical electronic devices… we have the tooling, skills, and experience to meet our customers’ diverse manufacturing requirements; we’re proud to have produced a broad spectrum of products in our decades-long history as a top contract manufacturer for the medical device industry.

CNC Machining

• CNC Milling – 3, 4 & 5 axis milling
• CNC Turning – up to and including 7 axis turning with live tooling and sub-spindles
• CNC Threading

Welding - Robotic, Manual & Ultrasonic

• MIG and TIG (both Robotic and Manual)
• Laser Welding (small format)
• Ultrasonic Welding
• Ultrasonic Heat Staking

Metal Finishing

• Polishing – Wet and Dry
• Bead blasting
• Chrome plating
• Anodization
• Powder Coating
• Anti-Microbial Painting
• Electro-polishing
• Ultrasonic washing

Injection Molding & Low Pressure Molding

• Multi-cavity insert molding
• Complex Over-Molding (metals and plastics)
• Low Pressure Over-Molding of electronics (encapsulation for biocompatibility)
• Liquid Silicone Rubber molding

Assembly & Packaging - White Room & Clean Room (Class 7)

• Sterile pouch and tray sealing
• High speed packaging lines
• Full packaging development including box types, labeling, artwork, etc.
• ESD Safe (Electro Static Discharge)
• Robotic Pick and Place
• Shrink tube application

Class 7 (10,000) Clean Room

• Sterile pouch and tray sealing
• Assembly – kitting and packaging, IFUs, labeling
• Low to High Volumes
• Sterilization Management (Gamma and ETO)
• Pad printing, laser marking

Laser Tube Forming & Processing

• Large format 3KW 3-D fiber tube laser
• Small format for metal needles and tubing
• High throughput, high repeatability
• CNC tube forming and bending
• Laser marking

Electronics

• Soldering
• ESD assembly (Electro Static Discharge)
• PCB testing
• Post assembly testing
• Maintain multiple partners to assist with design and manufacturing of PCBs
• Optics

Automation

• Robotics
• High speed assembly
•  High speed packaging
• Robotic Pick and Place
• Vision Inspection
• Inter-process Integration

Logistics, Supply Chain & Sterilization Management

• End-to-end Supply Chain Management
• 3PL and Distribution Management
• Sterilization Management – Gamma and ETO
• Real-time supply chain optimization tools
• Materials procurement and management of outside service providers
• Materials Management expertise

Quality

At Sterling, we understand the life-changing potential of the devices and components that we manufacture; we also fully embrace the strict, regulatory environments in which they are designed, manufactured and used. Repeatable quality is the key to success, both our clients’ and our own. That’s why we’ve built our entire business around a rigorous and sophisticated Quality Management System, fully integrated into our ERP software with production and change control management, with complete electronic document control.

ISO 13485:2016 registered; C-TPAT and 21 CFR part 820 compliant; FDA and Health Canada registered facilities.

Facilities

Having facilities on both sides of the U.S./Canada border is advantageous for many of our customers, allowing us to optimize component manufacturing and assembly strategies for different markets, as well as tax and tariff jurisdictions; this can be of benefit in terms of both component and materials importing, as well as exporting of finished medical devices.