Medical Manufacturing With Backbone

On any given day, there can be as many as 2,000 different components circulating around the production floor at Engineered Medical Systems (EMS). EMS specializes in manufacturing complex medical instrumentation, most of which is used for spine related procedures.

EMS began as a prototype services company for medical instrumentation and grew into one focusing primarily on the production of instrumentation for the spinal market. The company also developed a predicate instrument refurbishment program with full traceability and tracking of design issues, a service available to EMS customer engineers.

As an instrumentation supplier to major medical customers, EMS’s working environment is that of a production job shop. Production of instrumentation is unique in that most job orders involve relatively small quantities for replenishment, except in cases of instrumentation launches when quantities can run a bit higher.

“Our challenge is keeping both the equipment and manpower running efficiently and producing to maximum potential, no matter what volumes a job calls for. We accomplish this through real time demand scheduling, which not only allows us to meet customer delivery expectations, but also effectively distribute the thousands of constantly changing small quantity projects across our various machining equipment and manufacturing processes,” said Reggie Crawford, general manager and COO of EMS. “Additionally, we often have to contend with requests from customers for special projects that can be out of the ordinary for our industry.”

Many of these requests originate from instrumentation designers that are continuously working with physicians to improve upon device designs to lessen the impact of surgeries, making them less invasive. Such improvements and new ideas filter down to suppliers, such as EMS, that will advise as to a design’s manufacturability and make recommendations for efficiently producing the instruments.

At EMS, customers present a new instrument design, which the EMS engineering department will review. After that manufacturability review, EMS makes design recommendations, provides a prototype of the design, trial launches the design, and initiates full production.

EMS manufactures medical instruments using equipment that includes CNC vertical machining centers (3, 4 and 5-axis mills), turning centers (lathes, Swiss-style, and multi-tasking), EDMs (wire and sinker), gun drilling machines, and abrasive waterjet machines. Other processes performed are TIG welding, laser welding, laser marking, part cleaning, and inspection. Within this equipment lineup, 30 machines are from Mazak Corp.

Over the past seven years, EMS has advanced from 3 and 4-axis machining to complex 5-axis machining and multi-tasking turn-milling operations. Its list of Mazak machines includes several NEXUS 410A vertical machining centers, VARIAXIS 500-5X II 5-axis machining centers, QUICK TURN NEXUS Series turning centers, and INTEGREX 100-IV multitasking machine.

Crawford stressed the fact that 5-axis and multi-tasking machines are musts for today’s medical instrument shops. Such machines as the shop’s Mazak VARIAXIS 500-5X II and INTEGREX 100-IV allow EMS to machine parts complete in one setup and eliminate the risk of errors associated with machining in multiple setups.

“Any time you can machine a part in one setup, the result is a much higher quality part. Yes, we could machine our more complex parts on 4-axis mills, but that would involve several different setups,” explained Crawford.

For its equipment, EMS’s strategy hinges on four expectations: it has to consistently perform to the required tolerances, provide high speed cutting and tool change, be reliable, and backed by exceptional service. Response time is also very important when it comes to service because idle equipment means losses in revenue and delays in scheduling and shipping dates.

“We choose equipment whose service contractors are dependable and staffed with expert technicians available within 24 hrs. We purchase Mazak equipment because it meets our expectations in both the equipment and with its local distributor, Pinnacle Machine Tools, which provides us exceptional service,” said Crawford.

EMS’s machine tools must be dependable and easy to set up because demand volumes vary as much as the jobs themselves. Jobs typically fall into one of four categories – launches, replenishment, prototype or predicate instrument refurbishment. Most medical instruments are produced from stainless steel, but EMS also works with aluminum, titanium, and various plastics.

For EMS, ideal jobs are those under the launch category. These jobs are the production of several instruments that will comprise surgery kits and typically involve lot sizes in the hundreds. They are the most cost-efficient jobs because the required front-end work is distributed over many parts, thus reducing their individual cost.

According to Crawford, constantly varying job types and volumes are basically what differentiate medical instrumentation manufacturers, such as EMS, from those manufacturers in the high-volume environment of producing medical implants. And as such, EMS has developed its own special proprietary strategies when it comes to manufacturing.

EMS is in a continual improvement mode when it comes to its operating structure, people and processes. The shop strives to incrementally bolster its knowledge and manufacturing expertise to successfully meet customer requirements, yet do so in ways that add value and keep the business profitable.

EMS maintains profitability because it continuously invests in advanced manufacturing equipment technology. However, complex-machining operations, such as those done on the shop’s 5-axis and multitasking machines, do require skilled hands at the controls.

To ensure a deep pool of skilled machinists for its CNC equipment, EMS encourages employees to follow a sequential career path that progresses individuals from operators, to setup/operators, to programmers. Operators basically tend to machines, setup/operators can set up machines and run them, and programmers can program, set up, and run the shop’s CNC machines.

Achieving the machinist status takes time and experience. The programmer level is the most advanced, and those who achieve it command higher pay.

Crawford pointed out that the Mazatrol programming language on the shop’s Mazak machines does make advancing through the machinist ranks easier. Programming, as well as changing programs, is much simpler with Mazatrol, and the Mazak control allows for both conversational and EIA programming, added Crawford.

EMS does the majority of its part programming at its machines on the shop floor. This practice, together with the Mazatrol conversational programming, fosters an environment conducive for EMS machinists to learn new skills and grow in their profession – another reason EMS chose Mazak machines.

“Our belief is that when you program machines from a separate office, it creates a ‘culture of operators’ on the shop floor, as opposed to machinists who can set up, program, and run machines. We want every one of our employees to have the opportunity to develop and grow their skills and to be continuously challenged by the work they do,” said Crawford.

“It takes a team effort to be successful in the medical manufacturing market, and our team is outstanding. From receipt of request for quote to shipping product out the door, our people perform their respective job functions to the best of their abilities with passion and attention to detail. Our team realizes the importance of our work and how it is vital to the performance of instruments used on the spine. We instill in our people to work as if working for the Lord – the one who created life. It is this mantra that has made EMS what it is today,” said Crawford.


About Mazak Corporation

Mazak Corporation is a leader in the design and manufacture of productive machine tool solutions. Committed to being a partner to customers with innovative technology, its world-class facility in Florence, Kentucky, produces over 100 models of turning centers, Multi-Tasking machines and vertical machining centers, including 5- axis models. Continuously investing in manufacturing technology allows the Kentucky Mazak iSMART Factory™ to be the most advanced and efficient in the industry, providing high-quality and reliable products through its “Production-On-Demand” practice. Mazak maintains eight Technology Centers across North America to provide local hands-on applications, service and sales support to customers. For more information on Mazak's products and solutions, visit www.mazakusa.com or follow us on Twitter and Facebook.