Studies/News
Brazilian VISA Certification Expands Global Footprint
Autocam Medical is targeting the fast-growing Brazilian economy and its burgeoning need for high-tech medical devices. Last year, the company became a VISA-certified contract manufacturer in Brazil and has established a local manufacturing presence in São Paulo to produce an array of precision-machined surgical implants and instruments, including bone screws, plates, drivers and drill bits. In addition, it has developed an important strategic alliance with US-based Jewel Precision to manufacture, sell and distribute surgical trays and cases throughout South America. All Autocam Medical facilities are linked to a centralized quality and management system that services OEM customers worldwide through a single, local point of contact.
“Because it’s one of the fastest-growing economies in the world, the opportunity in Brazil is enormous. The healthcare market there is very attractive. Our São Paolo operation supports our local customers, and also helps grow our global business.”
- Thomas O’Mara, Executive Vice-President
See related article in Orthopedic and Technology Magazine
Autocam Medical to exhibit at the 2012 AAOS Annual Meeting in San Francisco
2012 American Academy of Orthopaedic Surgeons Annual Meeting,
February 7-11, 2012,
Moscone Center, San Francisco, CA. Visit us at booth 2828.
Experience the best in orthopedic education, research and technology, Autocam Medical will be exhibiting February 8-10 in the New Exhibitors Area in booth 2828 at the Moscone Center.
Autocam Medical specializes in the contract manufacturing of precision-machined implants, instruments and components for exacting medical OEM partners. Please visit us in booth 2828 at AAOS 2012 to discuss how Autocam Medical can become an integral resource for product development, launch, or improvement, including the entire value stream.
We understand how critical it is for the proper integration of all instruments and implants, from the drill – to the driver – to the screw and plate. Our orthopedic implant and instrument knowledge, combined with advanced machining experience is backed by the latest lean medical manufacturing principles and decades of precision CNC turning, grinding and milling expertise. Autocam Medical offers customized tool grinding for fast development turn around. We employ advanced SPC processes and state-of-the-art tracking and quality measuring systems, including assistance with testing and validation, all designed to move a quality product to market faster. Autocam Medical’s deep understanding of materials, including 17-4, 440A, 440C, 455, and 465 grade Stainless-Steel, titanium and exotic alloys, along with in-house secondary finishing processes keep tight control over the manufacturing process and allow for single-source partnering.
All three of our United States facilities, Massachusetts, Michigan and California are 13485:2003 and 9001:2008 certified and we are now certified in Brazil.
Look For Autocam Medical at NASS in Chicago
North American Spine Society, 26th Annual Meeting,
November 2-5, 2011,
McCormick Place Lakeside Center, Chicago, IL. Visit us at booth 2834.
Talk to us about becoming your global single-source contract manufacturer of precision-machined spine implants, instruments and components. When customers involve our engineering team early to consult for manufacturability, Autocam Medical can significantly add value to bringing a product to market.
Autocam Medical announces Getaway Drawing at ODT Forum
OEM’s can register for the ODT Forum Expo for free and enter to win a getaway to Sleeping Bear Dunes.
The Sleeping Bear Dunes National Lakeshore was voted the most beautiful place in America by ABC’s Good Morning America.
In a national contest where ABC’s Good Morning America asked viewers to help them find America’s most beautiful place, this 35 mile stretch of Lake Michigan coastline received tens of thousands of votes – beating out places like Aspen, Colorado; Cape Cod, Massachusetts; Grand Tetons, Jackson Hole, Wyoming; Lanikai Beach, Oahu, Hawaii; Point Reyes, California and Sedona, Arizona.
OEMs, can register for the ODT Forum Expo, September 14-15 and win a chance to stay in beautiful Northern Michigan. In order to enter the drawing they simply visit the Autocam Medical Booth at the Expo, booth 205-206, and enter their name to win a travel package to the Homestead Resort in Glen Arbor, MI.
Autocam Medical to Exhibit at ODT Forum Expo
Orthopedic Design and Technology Forum Supplier Expo – ODT
September 14-15, 2011, Fort Wayne, Indiana.
Please visit us at booths 205 and 206, talk to us about becoming your global single-source contract manufacturer of precision surgical implants, instruments and components. Autocam Medical is a Gold Sponsor of this event.
Case Study: Precision-machined Vascular Component
Challenge: A leading Cardiovascular OEM called in Autocam Medical to address quality problems they were incurring with a component from another outsource vendor. This quality problem was negatively effecting their delivery requirements.
Autocam Medical’s Solution: Autocam Medical was asked to use their expertise in manufacturability and capabilities to deliver the required quality component that could be produced in high volumes, with a “quick” start-of-production from approval of First Article validation parts. The First Article validation parts, 250 pieces, were sent on July 1. In less than two weeks from First Article validation parts being approved over 9,000 production parts were sent, followed by another 11,000 pieces in six business days, and over 63,000 pieces the following month. Autocam Medical’s ability to ship in excess of 15,000 pieces per week for the following year exceeded the customers’ expectations and needs, and all with zero defects.
Benefit to the Customer: Autocam Medical’s capabilities benefited the customer by providing an alternative supplier who could provide high-quality product with fast start-up, and capacity that exceeded customers’ needs.
Processes: SAS-16 Multi-spindle Screw Machine
Speed to Market / Prototype to High-volume Production
Case Study: Surgical Flex Drill
Challenge: The Medical Device OEM was receiving surgeon complaints about unsuccessful hip surgeries due to dull flex drills; these complaints were jeopardizing the customer’s business. Autocam Medical was brought in to address the drill performance issues and develop a high quality, quick-turnaround solution.
Autocam Medical’s Solution: The customer received physician feedback that their original flex drills were so dull, they would bind or break during surgery. Because of Autocam Medical’s earlier work with the customer’s R&D group on a different drill design, the OEM asked Autocam Medical to take a look at this new problem. Autocam Medical listened carefully to the customer’s request and used an “all hands on deck” approach to identify the critical issues and provide a new solution. In only seven days, they developed, manufactured and delivered 50 improved drills – enough to satisfy the surgeons’ requirements and restore the business relationship. The Autocam Medial Quality team measured the new parts at 100% function, the parts were geometrically correct and the customer was extremely satisfied with the speed and accuracy of the parts. This positive feedback resulted in an extended production run.
Benefit to the Customer: Autocam Medical addressed the critical issues, and provided solutions to quickly repair the OEM’s business relationship with it’s physicians.
Processes: CNC Turning, CNC Milling, CNC Grinding, Secondary Finishing, Subassembly
Problem Solving / Speed to Market
Case Study: Micro-machined Vascular Surgical Component
Challenge: The customer needed a proof-of-concept and validation parts on a newly designed component, a barbed pusher body, for their vascular-closure device. The part was less than .170” in length with a maximum diameter of Ø.083” stepping down to Ø.042” where the barbs are located, and had a Ø.021” center thru-hole. Weekly volume requirements were up to 7,500 parts.
Autocam Medical’s Solution: Purchased first CNC Swiss lathe, and in less than two weeks from delivery, Autocam Medical produced and delivered 200 First Article parts to the customer. Delivery of production parts began six days after delivery of First Article parts, with a total of 3,000 parts delivered in the first nine days. A second CNC Swiss lathe was delivered to Autocam Medical, with First Article parts from it produced in 3 days of machine receipt. Within first 10 months from program initiation Autocam Medical produced and delivered to the customer over 333,500 parts. This monthly average of 33,350 parts delivered, exceeded the customers minimum needs of 7,500 pieces delivered per week.
Benefit to the Customer: Autocam Medical completed prototype-to-high-volume production of a complex tight-toleranced part in less than six weeks from order placement. This allowed the customer to implement a quick product launch for their second generation vessel closure device.
Processes: CNC Swiss Lathe
Responsiveness / Speed to Market / Prototype to High-volume Production
Autocam Medical Gets Exclusive License for Surgical Cases in South America
Autocam Medical has been granted exclusive license to manufacture, sell and distribute surgical cases and trays to Medical Device OEMs in South America. The company will partner with Jewel Precision, an industry leader in manufacturing sterilization cases for the medical device industry. Jewel is widely recognized in North America for its innovative design and manufacturing of high-quality sterilization cases and trays and dependable customer service. Autocam Medical Executive Vice President, Tom O’Mara, sees exciting potential in this new venture, “We plan to leverage both companies’ strengths to expand our product offerings and work together to service this rapidly growing market. Jewel’s excellent quality and reputation for superior service will be a great compliment to our local manufacturing expertise in Brazil.”
Autocam Medical Certified as Contract Manufacturer in Brazil
Autocam Medical (Kentwood, MI) announces that they have earned certification for contract manufacturing in Brazil through the government regulatory agency, VISA. Preparation for this certification has taken Autocam Medical-Brazil nearly one year to complete, and according to sources, they are the first American Company to achieve certification as a Contract Manufacturer of Machined Components for Medical use in Brazil. The company has a dedicated manufacturing facility in São João da Boa Vista, (State of São Paulo) to serve Brazilian Medical Device OEMs.
According to Tom O’Mara, Autocam Medical’s Executive Vice President, this new certification is a significant step forward for the company, “Brazil has been an important market for Autocam Corporation since 1998. Expansion into this high growth market for our Medical Division is a logical extension since we have a great management team and manufacturing expertise in Brazil.”
Headquartered in Kentwood, Michigan, Autocam Medical is a single-source provider of complex, highly engineered precision-machined components. It is a key member of the Autocam group of companies, which was founded in 1988 and now includes 11 facilities on four continents. For 23 years, Autocam Medical has leveraged its parent company’s award-winning manufacturing expertise and applied it to the unique needs of the global Medical Device market. It also has dedicated medical-device component manufacturing operations in Michigan, Massachusetts and California.