Sterling Industries
Delivering Precise Medical Devices & Components, Year After Year

Encompassing everything from simple bandages to ultra-high-tech pacemakers, the U.S. medical device market is the largest in the world. More than a decade ago, the medical device manufacturing industry witnessed an increasing focus on design and simplicity, impelled by software and technologies. And innovation contributed to a change in power from the pharmaceutical to the medical device industry. Nowadays, there is strong demand for intuitive, technological medical devices — with a faster time-to-market than ever before. Hospitals, medical facilities, and other markets are pushing medical device manufacturers to be more secure, innovative, cost-effective, and efficient. Medical device OEMs have always relied on third-party vendors for cost-competitive sourcing and operational agility. However, the volume of outsourcing has significantly increased recently as OEMs outsource greater portions of the product value chain, including value-add activities originally maintained in-house. On the flip side, where many contract manufacturers just buy and assemble the components according to the clients’ directives, Sterling Industries removes the external suppliers and manufactures almost all components in-house to offer a better cost and quality to their customers. “We are vertically integrated, and manufacture a high percentage of the components required in the final assembly of our clients’ medical devices,” states David Van Slingerland, CEO of Sterling Industries.

Sterling Industries is an end-to-end contract manufacturer of medical devices and components. Sterling Industries also helps companies — from Fortune 100s to mid-size device OEMs to start-ups — scale from launch to full production, with consistent and immaculate quality, process, and compliance.

Responding to the changing market trends hasn’t been difficult for Sterling Industries as it has grown with key market elements over time. One of the recent trends that have influenced the market is single-use products; because of infection concerns, re-sterilization costs, and other issues, the market for disposable products has grown. Apart from this, reshoring of services is also gaining popularity, and with the impact of COVID, it is accelerating even faster. Reshoring is helping North American healthcare providers to control their supply chain effectively, making domestic manufacturing more attractive. Not to mention, large medical device OEMs are also changing their strategy in two ways: firstly, they are acquiring technology to add to their portfolio as opposed to performing the R&D themselves. For instance, medical device OEMs are acquiring tried and true products that have regulatory approval as well as some market acceptance to scale it once taken under control. To help these OEMs, Sterling Industries has added Class 7 clean room and positioned themselves to produce single-use disposables in a sterile environment. The company is also working with “scale-ups” who are willing to merge or be acquired by large OEMs, and taking on the commercialization of their products. This, in turn, aids quickly scaling device start-ups to increase the value of their exit when they sell to large OEMs.

We are vertically integrated, and manufacture a high percentage of the components required in the final assembly of our clients’ medical devices

Sterling Industries provides close support and a wealth of manufacturing knowledge to their customers when it comes to single-use disposables, starting from conception to commercialization. As single-use disposables typically employ various plastics, it gets a bit intricate for the customers to understand the injection molding world. So, Design for Manufacturing and Design for Assembly are two pivotal things Sterling addresses in order to reduce product cost — critical for single-use disposable devices. In addition to this, the Sterling team also has superior expertise in electronics, plastics, and metals, including small tubes, needles, CNC milling turning, ultrasonic welding, and much more.

In a bid to offer something extra, Sterling Industries offers an end-to-end approach to its clients. The team understands the manufacturing, design, and regulatory side of product development, which is critically important these days. As “scale-ups” are very lean companies, they tend to lack manufacturing, regulatory, and other commercialization expertise around distribution. Sterling Industries fills all the gaps as it has an established process in place that starts with Design Transfer, Design for Manufacturing, quality assurance, sterilization, lot tracking, and all the key steps required to bring a medical device to market. Further, the company understands multi-jurisdiction distribution and regulations and advises clients accordingly. “We utilize a very methodical and structured approach as regards to medical device manufacturing, and have the ability to fill in all the gaps in a full lifecycle process of the device,” asserts Van Slingerland.

Sterling Industries’ unique value proposition can be best explained with a client success story. The client fabricated their own first-generation, single-use arthroscope device, securing FDA approval. The only problem was with the design; it was not compatible with commercialized, scaled production. In this regard, the client engaged with Sterling Industries to completely redesign the manufacturing process. Without altering the functionality of the device, Sterling brought some different approaches to building it. After Sterling Industries’ Design for Manufacturing improvements, the client was able to produce a million devices a year. As arthroscopes up to now have been reusable and required costly sterilization between procedures, the client intended to deliver a single-use device at a feasible cost without having the major upfront capital outlay. The client took almost six years to develop their first-generation design; after Sterling Industries came on board, they were able to develop the second generation within nine months. With all its capabilities, Sterling Industries was able to scale up the manufacturing process from 1,000 devices per year to a million per year, with a highly manufacturable design that kept all the regulatory processes in place.

This is one of the many instances where Sterling Industries has proven its excellence in driving fulfilling results for its clients. Looking ahead, the company will be delivering new projects and continuing to help its OEM customers, both large and small. Similarly, Sterling will continue its move towards expanding single-use devices, clean room capabilities, and injection molding capabilities in-house. “From a geographic perspective, we already deal with customers all over the world. We are also planning to establish a physical facility in the EU, on top of our facilities in Canada and the U.S.,” concludes Van Slingerland.