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 Manufacturability 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 1000 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, cleanroom 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.