Providien LLC has completed four acquisitions since its formation in June 2010. Chosen for their fit and complementary services, the additions include: Dynaroll Corp (Sylmar, CA), which specializes in the development of bearings as well as the precision manufacturing, assembly, and testing of advanced components for medical devices; San Diego-based Specialty Manufacturing, Inc (SMI), which provides plastic thermoformed component manufacturing, engineering, and design services; and Integra Biotechnical and Integra Carlsbad (formerly Plastics Engineering & Development, Inc), a vertically integrated medical device contract manufacturer that provides engineering, injection molding, and assembled finished, sterile goods.
I had a chance to tour the facilities, and it was easy to see how each division brings its own special niche to the company. While Dynaroll got its start as a bearings manufacturer, it has built its business model on determining the most efficient process for manufacturing each precision component. It has a line specifically dedicated for new product introduction. Similarly, Integra’s focus on turnkey manufacturing enables the company to provide a range of services from injection molding to packaging and assembly. Rounding out the group is SMI, which has a unique position as one of very few companies that can thermoform highly aesthetic, complex medical device enclosures and products.
As a group, the companies offer manufacturing, engineering (development and sustaining), regulatory expertise, and complete supply-chain support capabilities, including both warehousing the ability to ship direct to customers. They have in place 31,000 sq ft ISO Class 8 cleanrooms and offer EtO, E-beam, and gamma sterilization management.
In addition to putting together the technical expertise to blend the companies into a cohesive family, Providien also set out to put in place a highly skilled management team across key functional disciplines. All together, the company has more than 900 employees with projected sales of $85 million in 2013. Providien combined its Plastics Engineering & Development (PEDI), which has been in business since 1985, and Integra Biotechnical divisions under the Integra Biotechnical banner. The merger with Integra enables the company to offer a complete, vertically integrated manufacturing platform from product development and material procurement to injection molding, assembly, packaging, and sterilization management.
Dynaroll focuses on precision manufacturing, assembly, and testing of advanced components for medical devices, medical robots, surgical equipment and medical disposable products. In addition it supplies miniature and instrument bearings, a critical enabling technology in many cutting-edge medical devices and diagnostic and imaging systems. The immaculate facility boasts 45,000 sq ft divided between assembly stations and machining and provides “lights out” manufacturing, which is both efficient and green. Its assembly processes are validated, and it has established critical in-process and final inspection criteria. The company designs and develops custom fixturing for each assembly process. Every machine uses precontrol software to monitor Cpk and minimize inspection time.
Integra’s goal is to seamlessly meet customers’ needs by providing a greater level of service within a single business entity. Integra is FDA registered and ISO 13485 certified. By having a Tijuana-based manufacturing operation, the company is able to provide what it calls “a near-shore option for off-shore manufacturing needs.” The quality systems in place meet or exceed those of their medical OEM customers.
SMI fulfills a very special niche in medical thermoforming: it makes the housings for the really big equipment, like radiology machines. But it also does lots more. It offers pressure forming, twin sheet forming, thing gauge packaging, and CNC-machined aluminum tooling. But its specialty is the multi-part custom enclosures.
Pulling it all together
Providien says that it thinks and acts like a medical device company. In addition to ISO 13485, the company holds a Japan Certificate of Foreign Medical Device Manufacturer Accreditation, a CA Device Manufacturing License, and is UL recognized. In 2010, it received the Medtronic Supplier Excellence Award for molding. Its comprehensive capabilities—from precision components to assembled devices—are the foundation as a fully integrated medical device contract manufacturer.