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Sunburst EMS Provides Virtual Manufacturing Facility for Medical Device Startup InaVein InaVein's TRIVEX is flanked by InaVein's VP Operations Joe Burke(left) and Sunburst VP Sales & Marketing Dave Fahey. By Michael L. Martel, US Tech Web Editor West Bridgewater, MA — How can a small company — with all of four employees — take advantage of a potentially huge emerging market for its innovative vascular medical devices? That was one big question facing Joe Burke, VP Operations for InaVein, a Lexington, Mass. startup company with a great product and great ideas but no infrastructure in place to get it out to the industry. Founded in 2007, InaVein specializes in developing vascular products to assist clinicians in treating the full spectrum of conditions caused by peripheral venous disease. The answer came from an equally innovative company, Sunburst EMS, a traditional electronics assembler in West Bridgewater, Mass. that has reinvented itself to become a soup-to-nuts "complete order fulfillment" oriented company that goes beyond simply building the electronics within a device, to every stage of assembly, delivery, and even servicing. Burke and his colleagues bought the technology for their unique and innovative vascular surgical tool from its developer, and refined it to become InaVein's TRIVEX™ System, the first technology to provide surgeons with a minimally invasive technique to remove varicose veins safely and efficiently under direct vision, known as Transilluminated Powered Phlebectomy. The first generation system was introduced in 2000, and the current system was launched in 2004. The TRIVEX System consists of a Control Unit, a Cart/Stand and two handheld devices: one wand equipped with a light source, and the other configured with a cutting tool. The surgeon operating the system removes varicose veins in a way that is more complete, faster, and involves fewer incisions compared to traditional removal techniques. Since 2000, thousands of patients worldwide have had their varicose veins removed completely, quickly and safely using this system. Getting it Together "When we acquired the technology, we understood that different components in the system, from electronics to molded parts, were manufactured in different locations including the U.S. and Mexico. What we wanted to do was bring the manufacturing and assembly closer to home for greater control of quality, cost, delivery, and other factors" Burke says. "In making our decision to work with Sunburst, we considered a number of factors. One of the most important was their ISO 13485 Certification, which is a key standard for companies seeking to manufacture medical electronic devices; plus, they are FDA registered. This is extremely useful as you engage in a complete order fulfillment relationship; I can be confident that my quality system will easily integrate into the dedicated work cell, drastically reducing audit exposure risk and expense." ISO 13485, published in 2003, is an important quality management standard and represents the requirements for a comprehensive management system for the design and manufacture of medical devices. "Other factors weighing in their favor include their wide range of capabilities such as circuit board assembly, mechanical assembly, and cable assembly. The ability to build the entire unit, and their proven track record of successful implementation of similar turn-key manufacturing services for other clients, was instrumental in deciding to partner with Sunburst EMS." Business end of the deveining system — the wand on the left contains a fiber optic light source, the other a cutting tool. The contractor proceeded to configure a dedicated cell within its facility to manufacture the product, according to Dave Fahey, Sunburst's Vice President of Sales and Marketing. "This partnership with InaVein involved the establishment of a custom designed, in-house, micro-facility, a stand-alone, vertically-integrated work cell dedicated to the Trivex system that will ensure quality, on-time deliveries and complete order fulfillment. This "Complete Order Fulfillment" approach is a build-to-order system that includes turnkey supply chain management, the manufacture of electromechanical subassemblies, the later stages of final assembly also known as "box build", and final product test. Sunburst warehouses the parts as well as the finished goods inventory. Upon receipt of an order, Sunburst personnel assemble, package and ship completed units directly to InaVein's customers worldwide from the dedicated manufacturing cell. Depot repair and reverse logistics are also handled by the EMS provider through this cell. Tracking numbers and shipment data are electronically transmitted back to InaVein so its customer service and accounts receivable systems are always up to date. Complete Order Fulfillment According to Fahey, "Our ability to provide complete order fulfillment to InaVein or any company significantly differentiates Sunburst EMS in a highly competitive marketplace and offers benefits to the OEM that have not been traditionally associated with a local EMS supplier. Some progressive companies at this level have further positioned themselves into their customer's value chain by acting as `virtual' manufacturing facilities, providing these services as well as providing reverse logistics for the products they have assembled." This function, Fahey adds, is often an afterthought to the OEM but is a logical service to off-load to an EMS provider. The EMS already has parts on hand to support repair/replacement and it has already invested in developing the expertise to assemble the product. QC technician at Sunburst checks out a complex assembly. "When properly executed, it eliminates the need for the OEM to invest in any logistics, supply chain, or operational infrastructure. This is extremely attractive and important to leading-edge medical device, clean energy tech, and other high-tech companies who need to invest their scarce capital in R&D and Sales/Marketing." The manufacturing cell is operated by a team of multi-skilled operators who have complete responsibility for quality and delivery performance within the cell. Providing training on manufacturing concepts like lean manufacturing, process flow, set-up time reduction, total productive maintenance (TPM) and problem-solving/continuous improvement methodologies go a long way toward building a high-performance manufacturing cell. The custom cell is designed to function as an extension of the OEM's business. The communication protocol is established straight from the OEM to the personnel in the manufacturing cell with limited involvement from all levels within the organization. This makes the manufacturing team a virtual work-force for the OEM. "What is notable here is the direct and instantaneous communication that has been set up between Sunburst and InaVein" Burke adds. "It's a seamless, automatic, and totally transparent system. Any time an order is received, a product shipped, or a product returned for modification or repair we know about it, and our efforts are coordinated without duplication or confusion. Sunburst EMS handles everything including inventory, product testing, packaging, shipping and coordination with the customer." InaVein manufactures other products for vascular applications, and has plans to introduce more as the company grows. "Partnering with a company that has the certification, capabilities, and range of expertise that we need in order to bring our products to the marketplace makes all the difference in the world," Burke says. "A great product won't go anywhere unless you can build it, ship it, and service it effectively." Contact: Sunburst EMS, 70 Pleasant Street, West Bridgewater, MA 02379 508-580-1881 fax: 508-586-4516 Web: http://www.sunburstems.com