In today’s age of design renaissance, fast-growing medical device companies seek the quick introduction of new and superior products to the market that are cost-effective as well. Innovative medical devices and assemblies require tight tolerances, rapid design iterations, and careful material selection. This is where specialized contract manufacturers can provide a competitive edge for medical device companies. An arena that RevZero specializes in with the deployment of advanced multi-axis mills, dedicated Swiss lathes, and dozens of in-house secondary operations such as harperizing, bead-blasting, laser-marking, chemical passivation, assembly, and clean-packaging. “Medical device companies gain access to advanced machining resources, efficiency, speed, and quality by outsourcing to specialized contract manufacturers,” says Kirk O’Brien, CEO, RevZero.
The RevZero team being fully invested in real-time machine monitoring continually researches and identifies the best practices in machining, manufacturing, automation, and business management. These best-practices are integrated faster than competitors to offer optimum service and support for their customers. The company’s machine monitoring software enables real-time data collection, which is critical for process understanding, cost control, and capacity planning.
According to O’Brien, successful product development involves early and rapid design iterations, prototyping, regulatory compliance considerations, a disciplined ramp-up for launch, and scalability for replacement orders and growth. Each stage requires different strategies. O’Brien says, “To support prototyping and development, we have a streamlined communication path where our customer’s engineering and development teams can work directly with our applications engineers and QA team to make changes in-process to produce the perfect part with the fewest design iterations.”
Our focus is not on being the largest contract manufacturer but providing the best precision machining of plates, screws, and implantable devices
For product launches, RevZero optimizes the matrix by careful scheduling and programming families of parts, then delivers all the required components for kit building and distribution. Their comprehensive documentation from the ramp-up process makes it easy to keep pace with the replacement orders. “We dedicate capacity as needed and always keep space available for additional machines or workcell changes,” adds O’Brien.
Citing one of their success stories, O’Brien mentions a recent project that involved prototyping new trauma plates on their 5-axis CNC mills. The project started with revision 0 and by the time the order shipped, they had made five revisions to support the customer-requested changes arising from the design for manufacturability reviews. Then, to facilitate volume production, the RevZero team used an automated bar-fed mill-turn machine capable of machining plates in a single operation, which saved several processing steps, cutting cost and time, all while enhancing quality and consistency.
RevZero occupies a sweet spot in the medical device spectrum in terms of the ideal size such that their clients stand to gain the best aspects of what any small or large business can offer. RevZero provides the strengths of a lean owner-operated business focused on agility, responsiveness, and low-overhead while having sufficient structure and budget to invest in modern machines, software, training, safety, and regulatory compliance. “Our focus is not necessarily on being the largest contract manufacturer but providing the best precision machining of plates, screws, and other implantable medical devices,” says O’Brien.
Amidst an expansion spree, RevZero in 2018 completed the construction of a Lean finishing department, space for more CNC machines, and a larger temperature-controlled QA lab with high-end CMM and vision systems. Looking to the future, RevZero is continually investing in process automation with the inclusion of new machines every quarter. On the drafting table are plans to move into a new and modern location in 2020 with a team comprised of highly skilled employees and interns who are excited to be a part of the future of advanced manufacturing.
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