Medical device OEMs regularly look to 3rd party contract manufacturers to handle their volume production as an alternative to building and staffing their own production line. When picking a contract manufacturing partner, they typically focus on three core aspects: quality, cost, and reliability. The right manufacturing partner can help medical device OEMs move faster and stay ahead of the market competition. What’s even better is a vertically integrated manufacturer as they have the ability to manage the entire process, from sourcing the raw materials, doing most — if not all — component manufacturing in-house, performing engineering and assembly, all the way through to final testing, packaging, sterilization, and shipping. This is exactly where Sterling Industries excels.

A Single Partner Solution

As a leading vertically integrated contract manufacturer of medical devices and components, Sterling provides end-to-end, turnkey solutions. The company caters to a vast and growing clientele comprising Fortune 100 OEMs alongside mid-size OEMs, scale-ups, and late-stage start-ups. “What makes us unique is the ability to bring unparalleled vertical integration to large OEMs and at the same time, right-size it for scale-ups and mid-size med-tech clients,” says David Van Slingerland, CEO of Sterling Industries. With a 40-year legacy in medical device manufacturing, Sterling understands their clients’ challenges and is able to offer a single-partner solution.

In the medical device industry, quality and compliance are always top-of-mind. Sterling offers scaled production, supplier consolidation, and other critical value chain services at low costs without sacrificing quality. The company rises to the challenge of the acute talent crunch in the market by augmenting client teams and equipping them with the capabilities required to get their products to market faster and in larger volumes. Unlike common machining or assembly shops, Sterling provides a wide range of specialized manufacturing capabilities, including laser and robotic welding, injection molding, and CNC machining.

Sterling also offers strictly controlled, monitored, and certified Class 7 (10,000) cleanrooms to ensure an ideal, sterilized environment for manufacturing, assembly, and packaging processes.

With its cleanroom capabilities, the company ensures high-quality injection molding, ultrasonic welding, testing, kitting, packaging, and mechanical and electronic assembly. The end-to-end cleanroom solution also encompasses product sterilization, 3PL, and distribution management services.

Helping Clients with People, Process, and Technology

Sterling’s innovative mindset and range of skills were instrumental in helping one of its customers who was struggling to mass-produce their single-use arthroscope economically. The device had a complex design with circuit boards, optoelectronics, fluid flow, and more. Sterling manufactured and assembled the device in its facility and also helped the client redesign the product to scale up the manufacturing process, producing up to a million arthroscopes per year.

“Our capabilities can be compared to a box of Lego bricks. Just like building various models using the Lego bricks, we leverage our people, our technology, and innovative processes to manufacture and assemble devices in any manner to help clients succeed,” says Van Slingerland. A team of highly talented, nimble professionals with extensive problem-solving capabilities ensures Sterling is agile enough to switch gears and work on any project, be it surgical visualization, testing solutions, patient and healthcare worker safety devices, or complex electronics.

Compliant and Capable Onshoring

Sterling serves as the go-to partner for OEMs and has always been attentive to their strict, comprehensive quality requirements. Prioritizing regulatory compliance, the company is an early adopter of ISO 13485:2016 and is 21 CFR Part 820 compliant, putting it at the forefront of producing high-quality, safe, and reliable medical devices.

Moreover, with facilities in the U.S. and Canada, Sterling is strategically positioned to benefit OEMs looking to re-shore or onshore with a resilient and reliable supply chain. The company is also focusing on new technologies, disposable, single-use devices, and microelectronics. Steering ahead, Sterling will continue to stay on top of the emerging industry trends and serve clients in the best possible way.