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Shop Solutions: Medical Start-Up with Healthy Practices



With the economy barely showing signs of recovery and the demand for goods and services still depressed, one could wonder about the reasoning behind starting a manufacturing business, and probably find no encouragement. Not so for Paul Beckwith, founder of TraTek Inc. (Noblesville, IN). Beckwith claims to have no secret formula for starting a specialized machining operation in a difficult economy, but he has clear advantages.

With decades of making medical devices at a company he built to nearly 100 employees, Beckwith has a wealth of experience. He sold that company, never dreaming he’d return to machining until he awakened one day to find that what he loved to do was missing. "I was out of the business, but building an organization is what I do, and what I love. I get a lot of satisfaction from that, and I think I’m pretty good at it."TraTek's Shaun Smyser inspects dimensional accuracy of a finished orthopedic plate on an optical comparator

So, in June 2010, Beckwith decided to start anew. Knowing what he needed, he developed a business plan to specialize in making implantable devices and surgical instruments for the medical industry, and began its execution. "When you enter the medical industry, you don’t just open your doors, because without ISO 13485 certification, nobody will talk to you," explains Beckwith. "You have to have processes in place, with the ability to document repeatability and part traceability. I wanted to make sure I did this right and had everything set up correctly."

In November 2010, five months from the decisive day, TraTek opened for business in a 4000 ft2 (372-m2) space, with systems and processes ready to go.

Beckwith began with a lesson learned and honed throughout his career: hire good people. "It was having the right people that gave us a great start-up advantage," he says. "We hired an ISO 13485 expert, who was, previously, an ISO auditor. He just nailed everything. The auditor credited us with one of the best first audits he'd ever conducted."

Shaun Smyser, who was hired as TraTek’s engineering manager, came to TraTek with seven years’ experience in medical machining, and expertise in five-axis programming and machining. Smyser would quickly help build and implement the systems to support ISO compliance. TraTek does its own heat-treating, passivation, anodizing, inspection, and finishing. "This provides our customers more predictable deliveries," says Smyser, "and we don’t need to wait a week for a process, only to discover we have scrap. Doing everything ourselves is mainly to shorten lead time and turn-around for customers, but it also enables us to control the process and reduce cost."

The technology closest to Smyser, however, is the GibbsCAM CNC programming system, which he learned on his own, using it to program Willemin-Macodel and other five-axis and multi-task machines at his first employer. "Deciding on a CAM system and machines was easy," he says. "There are many companies that struggle to do what we do, making us think we have an unfair advantage because we never encounter problems. GibbsCAM and Willemin had proved to be an effective and highly efficient combination for all medical parts in my previous employment."

The shop now has four CNC machines, two Willemin-Macodel 408B, one 408MT, and a Citizen L20. Highlighting another advantage of the start-up, Smyser says TraTek has no conventional machines. The company makes everything it needs with CNCs. "We don’t like moving parts from machine to machine for secondary setups and operations, because that introduces inaccuracies and inefficiencies," he explains. "Our preferred technique is to set up the machine, run the NC program, and make parts, beginning to end, dropping them completed and untouched. It’s one reason we like Willemins." Beckwith concurs. Having the machines at his previous company, he likes the Willemin people and the support they provide. "Growing from making tiny precision parts for Swiss watches, they are the best machines in the world for small, precision parts."

TraTek machines parts from PEEK, titanium, stainless, cobalt chrome, and Nitinol to make spinal-fusion cages, components for hip and knee repair, anchors, connectors, plus three TraTek specialties: orthopedic hooks, screws, and plates. The hooks are screwed into bone to align and anchor rods in precise orientation for proper spinal correction and bone regrowth. The screws are of various types and sizes, including those with swiveling, locking heads for precise alignment of implants. The plates, machined from titanium, are used for corrective surgery, where a bone is surgically broken and screwed back together, and for repair of accidentally crushed or broken bones.

Using a representative plate for hand or foot surgery, Smyser describes a typical process for a Willemin 408B, a five-axis simultaneous multi-task machine. It begins with a blueprint or solid CAD model of the part, the largest of which is nearly 1.5 × 2.5" (38–63.5 mm). From a blueprint, everything is modeled in SolidWorks. Smyser prefers SolidWorks or Parasolid formats, these being the cleanest for his programming, relying on GibbsCAM thereafter. "When you get an imperfect model, you don’t want to experience the biggest time waster I’ve seen, struggling with software to make modifications or transfer files, back and forth between CAD and CAM," he explains. "With GibbsCAM’s modeling, I can modify anything for manufacturability and fix any CAD-model imperfections. It’s easy to use, and saves a lot of time."Geometric complexity of orthopedic plates doesn't allow working from a datum and requires five-axis machining.  Part features lie on different planes, at various angles from part axis as shown in GibbsCAM rendering

If he had to name a challenge, it would be conceptualizing the machining process and generating toolpath. Smyser begins by opening the CAD model in GibbsCAM, analyzing manufacturability, rotating, and aligning the part for positional fit on the smallest bar stock to eliminate roughing passes during a typical 12 to 50-piece part run for tests and approvals. Plate complexity doesn’t allow working from a datum. There are no flats against vertical walls, but multiple features at various angles. For extremely difficult parts, he uses GibbsCAM-generated models of workholding devices and vise jaws.

Once satisfied with positioning, he selects and extracts geometry for machining, which he says is very easy. Because many of the part features require machining on a tilt—a typical five-axis positioning routine—he does that for each plane with three mouse clicks. "It’s really simple to create coordinate systems to machine at various angles," he says.

Machining strategies are selected and executed, and toolpath generated ready for verification. In many instances, it’s as simple as that. "We’ve automated much of what we do, saved tool lists, saved speeds and feeds for each tool, for each material, so we don’t have to recreate anything done in the past. I retrieve what I need in GibbsCAM and generate toolpath. We’ve been able to turn around complex parts very quickly."

Another thing Smyser likes is the ability to do operations out of sequence, intentionally, not from poor planning, doing "risky sections" first, before doing the rest. He usually verifies each operation with GibbsCAM’s Cut Part Rendering, which shows stock and finish as it appears after toolpath removes material. Verification can be done at any time, for any operation, in or out of sequence, or all operations in sequence. "Then I post-process the whole thing and sort the operations afterward. It’s an easy drag-and-drop of an operation tile into a new location. Other systems force you to rerun the whole program with operations in the desired sequence; if you change one operation, you have to rerun and reprocess everything, both with toolpath generation and verification. With GibbsCAM, you can sort and reorganize as much as you want, and you’re ready for the machine in seconds."

With its competitive advantages, TraTek limits itself to taking customers through the iterative prototype stages, providing short runs for cadaver testing, bend, stress and failure testing, and final FDA approval, which may include submitting all the machining data, the specifications to which the part is made, and documentation of cleaning processes. "It’s difficult work for most shops, but that’s the way we want it," says Smyser. "We have a huge advantage, controlling everything to provide perfect, fully documented parts in the shortest time possible."

 

That doesn’t prevent having an eye toward the future, where TraTek sees expansion into doing the high-production runs customers require after FDA approvals. "One of our biggest advantages is that we are still small, with only nine employees, and we are managing our growth," Beckwith observes. "We aren’t solidly successful yet, but we’re going to do our best with a good team. I am very careful about the people I hire, and we will not grow fast unless we find the right employees. That’s something I learned in my previous company, and it’s the best advice I can give. Don’t grow faster than your ability to find the right people." ME

 

For more information on Gibbs and Associates, go to www.gibbscam.com, or telephone 805-523-0004.

 

 

 

Grinding for Aerospace Challenges

Those who supply the aerospace industry know a thing or two about challenges—super finishes, tight tolerances, rigid inspection, "frozen" processes, very difficult materials, and certification. If you don’t have the right certifications, don’t even bother approaching Tier 1 aerospace suppliers. Tolerance Masters (Circle Pines, MN) is just such a precision-machining supplier of parts and subassemblies for Tier 1 OEM commercial and military aircraft parts, engine and hydraulic components.

"We consistently deliver tolerances of ±50 millionths [0.0013 mm] for parts ranging from hydraulic valve bodies to rotary components such as engine fuel nozzles, regulator sleeves, and turbine blades," says Tolerance Masters’ John Hartmann. "Our envelope size is small to medium parts. We’re not involved in much structural or large enclosure work. That’s not who we are. When it comes to components of the hydraulic systems in an aircraft or power-generation project, however, that’s us."

Hartmann goes on to explain Tolerance Masters’ capabilities when it comes to tolerances: "We’re capable of meeting with ease under a micron," he says. "A micron is 40 millionths [0.001 mm]. Half a micron is probably the limit for gage compatibility and inspection, so when you get down to the arena of 20 millionths [0.0005 mm], that is especially difficult to repeat. In a grinding tolerance we’re working within a tenth [0.003 mm] on many applications. For surface finishes, we are capable of achieving well under a 2-µm finish, which is practically a mirror finish. For flatness, the same micron can be met. When you’re talking about precision-ground cylindrical parts, you’re talking about a process that has to hold a tenth consistently."The real draw of the Studer S33 (shown here set up for shaft grinding) was increasing Tolerance Masters' capability and flexibility for profile grinding and multiple surface face grinding

 

Don Affeldt, vice president, engineering and procurement, explains that grinding is one of Tolerance Masters' core competencies. "We’ve always bought high-end grinders. The most recent are the Studers from United Grinding Technologies [UGT; Miamisburg, OH]. These machines are very capable, and we are quite comfortable when working within the tenth tolerance band. We’ll have parts that are plus/minus a few tenths, which are made to order for these Studers."

Affeldt says they had always known about the Studer grinders and had seen them in their competitor’s plants running parts and components similar to those Tolerance Masters runs. "When we got that first Studer in here, we liked it so much, we’ve now moved up to Studer’s 40" machine, the S33. The real draw for this machine was to increase our capability and flexibility, regarding profile grinding, multiple-surface face grinding, a type of multitasking grinding. We knew we had to step in a direction that was going to offer all those things. The S33 is everything we expected and more. The capabilities, flexibility, the ease of setup—there seems to be an endless array of types of software applications and other applications yet to be learned. We’re finding out that the Studer S33 is going to be a mainstay in what we do here."

 

Tolerance Masters does some larger submarine hydraulic components that would "seriously task our older machines, but the Studer S33 is an ideal choice for the job," says Hartmann. An example of highly complex, precise machining, grinding, and assembly required is for a butterfly disk and shaft assembly. "The butterfly disk is made out of Inconel 718, a high-temperature alloy. The butterfly disk and shaft assemblies function within an exhaust airflow system on an auxiliary power unit [APU] for the aerospace industry. These products control bleed air flow on a power-generation product for airframe applications," says Hartmann.

 

Before the required four-part assembly can take place, Tolerance Masters must build all necessary components. The construction of the butterfly disk and mating shaft alone requires many core capabilities, including CNC turning, five-axis milling, sphere and groove grinding, wire EDM, and lapping—all performed in-house.

Next, the shaft needs a carbide coating. Before this coating can be properly applied, numerous grinding operations are necessary to qualify the treated surfaces. Once the shafts are ground and the coating successfully applied, further grinding operations are performed using specifically designed diamond wheels. This supplementary grinding process is necessary to obtain a precise coating thickness of 0.006" (0.15 mm). After all the grinding on the Studer S33 is complete, each unit is given a final microfinish of 8 rms.

Finally, once all components are successfully constructed, including the linkage and locking crank, each unit is assembled, creating the final product. To properly align the hole locations against the butterfly disk with the mating shaft, a uniquely designed assembly fixture is made and used to perform a four-axis milling operation. The manufacturing of the set pin holes also requires specially designed taper reamer tools.

For traceability, Tolerance Masters follows the AS9100B Quality System, which has a rigid regulation on traceable lot control by manufacturing lot release. Affeldt explains: "Once a job is closed, all product, both conforming and nonconforming, is stamped, approved, and archived. For any special process involved in the part production, whether you are inspecting it, heat-treating it or plating it, there is a subset regulatory body called NADCAP, a quality system that is in conjunction with AS9100B. Most aerospace suppliers are required to use NADCAP sources. NADCAP is a regulatory body that manages, qualifies, and certifies special processors. That’s their regulatory charter, our charter is AS9100B, but we normally must use suppliers with NADCAP certifications," he explains.

"None of what we do at Tolerance Masters can really be outsourced," says Affeldt. "We may have done some outside blanking, but when it comes down to the geometry and the processes, all that stays in house. Not only are the manufacturing prints controlled, but the actual manufacturing process is traceable and controlled. It’s a ‘frozen process’ and must be kept that way. You can’t change any aspect of a manufacturing process. Frozen programs are controlled by engineering, and they’re the only ones capable of doing any kind of process edit of the program or part, so it’s pretty set as to what the operator has to do to make the part.

"Another control is a written process, and virtually every step of the process has to be approved by QA as it’s performed, step by step. Further, some parts require 100% inspection of every feature—we see that more and more as prints will designate which features are key characteristics and must adhere to the requirement for 100% inspection," Affeldt explains.

"You get established as a supplier of these high-end components," Hartmann says, "and the security is that your customer is not likely to take the contract away from you, and they’re not inclined to pursue a low-cost option given the type of machined parts that we are competing against with other qualified suppliers. All of the processes to make these components can take years in proving out a manufacturing process and reaching a very low DPPM [defective parts per million]."

Affeldt explains that high volumes in this industry might be several hundred batch runs. There are only so many planes, and you’re not going to run into the volumes you’d find in some commercial applications, telecommunications, electronics, or automotive. In this industry, high volume would mean a maximum of 500–1000 pieces of a fuel regulator valve, or something of that nature. Aerospace is not a high-volume business. ME

 

For more information on United Grinding Technologies, go to www.grinding.com, or telephone 937-847-1253; for information on Tolerance Masters go to www.tolerancemaster.com, or telephone 763-717-9845.

 

 

 

Hydraulic Press Boosts Productivity

 

Evolving with technology and market demands is nothing new for ILSCO Corp. (Cincinnati). The company is no stranger to staying connected to the demands of changing times, meeting market demands, and running an efficient manufacturing operation. Founded in 1894 as a family-owned business, ILSCO began as the Incandescent Light and Stove Company selling gas systems. After 1910, municipal lighting systems made gas systems obsolete, so ILSCO introduced a single-cylinder gas engine which enabled an electric current to run from a generator to outlets throughout a house. As electrical systems continued to replace gas systems, the company produced battery connectors.

In 1935, the company introduced one of the first solderless terminals that are now recognized as the forerunner of many modern connectors. In the 1960s, ILSCO was the innovator of the aluminum mechanical setscrew connector which is an industry mainstay today. Currently, ILSCO is the largest direct supplier of mechanical connectors to OEMs in the US and Canada, as well as a supplier to the wholesale and electrical utility markets. The company is privately held with over 600 employees in six locations throughout the US, Mexico, and Canada, including 220 employees at their 250,000 ft2 (23,226-m2) plant in Cincinnati.

ILSCO produces 15,000 UL-listed electrical components in copper and aluminum. To make all these efficiently, the company continually evaluates and upgrades its manufacturing technology and equipment to meet market conditions and demands. For many years, ILSCO relied on mechanical presses for their forming operations. At one point they had up to 50 mechanical presses, ranging from 5 to 150 tons (4.54–136 t), on their shop floor. Today, it is quite a different scenario. There are only 15 presses, primarily due to more efficient, automated equipment and operations.

For ILSCO, Greenerd designed and manufactured a 75-ton (68-t) press with an integral knockout cylinder mounted in the main ram of the press for punching, trimming, and marking electrical connectors in aluminum up to 1/2' (12.7-mm) thick, and forming in copperFor example, in the past, a majority of the connectors were made from copper rather than aluminum. However, as technology changed aluminum production, so did the ratio. Over time, with the availability of aluminum extrusions, and the decreased cost of aluminum, the mix switched to aluminum over copper. ILSCO was able to receive a "shaped" extrusion, and depending on the part, machine it, and stamp and form it on a press. Eventually, ILSCO gained efficiencies from using aluminum extrusions, and was able to reduce the number of mechanical presses to 15 for forming and blanking parts.

However, ILSCO was not satisfied with their full-revolution mechanical presses for safety and setup reasons. "We consider full-revolution presses old technology. They are laborious to set up and are not on the leading edge of safety," explains Keith Tipton, manufacturing engineer. So ILSCO began to investigate hydraulic press technology.

"The more we learned about hydraulic, the more interested we became," says Tipton. "In addition to our initial reasons for wanting to replace the full revolution presses, it was evident we could benefit in several more ways by getting into hydraulic press technology." Besides solving maintenance and setup difficulties, hydraulic press technology would allow ILSCO to consolidate dies and reduce the number of mechanical presses by providing adjustable stroke length and adjustable tonnage.

Through industry research, inquiries to sales distributors and plant visits, ILSCO was led to a plant that had a variety of hydraulic presses on their floor. The majority of these were from Greenerd Press & Machine Co. Inc. (Nashua, NH). Based on Greenerd’s design and manufacturing expertise and reputation, ILSCO selected Greenerd to design and manufacture a hydraulic press for them. Greenerd designed and built a 75-ton (68-t) press with an integral knockout cylinder mounted in the main ram of the press for punching, trimming and marking electrical connectors in aluminum up to ½" (12.7-mm) thick, and forming in copper.

"With the addition of the Greenerd press, we significantly increased productivity in several ways, says Tipton. "The adjustable stroke length and tonnage capabilities provide us with tremendous versatility. Due to the large 18" (457-mm) stroke on the Greenerd press, we were able to standardize our dies to replace three mechanical with the one hydraulic press."

Also, press setup time has been reduced by as much as 85% at ILSCO. The Greenerd press has pre-programmed controls with stored part numbers and "recipes" so that the press is ready to go, requiring little setup time. After programming input, the press will find its setup parameters, the operator will load the die and then run the job.

The Greenerd hydraulic press features a removable press table that makes it quick and easy to drill and tap tool-mounting holes or resurface the table. The hydraulic press also runs quieter than the mechanical presses, creating a more desirable shop-floor environment.

Also, the Greenerd hydraulic press has state-of-the-art operator guarding with infrared light curtains that conform to PSDI (Presence Sensing Device Initiation). Also, hydraulic presses instantly, easily stop at any point in their stroke, make them inherently safer than mechanical presses.

ILSCO also discovered benefits they never counted on when they purchased the Greenerd press. For example, using the mechanical press, a copper part was fracturing during the forming process. Copper is intrinsically challenging due to its material-flow characteristics. The hydraulic press solved this issue by producing a more even, constant pressure throughout the stroke. And this capability will likely lead to more projects being transferred to the Greenerd press, including the manufacture of compression lugs which also present material-flow issues that the mechanical presses have difficulty with.

Company-wide, ILSCO produces millions of pieces per month, and orders can range anywhere from a few pieces to well over 100,000. "Our customers demand the highest quality and we need the technology and equipment to deliver it," says Fred Robinson, manufacturing engineer. "Quality standards can be as high as defects occurring in only 100 ppm. "

Over the past 20 years, ILSCO has increased its automation and, at the same time, gained in productivity. For example, in some applications, CNC robotic cells perform primary operations, with secondary operations finishing the job on a press. "This was another reason we wanted a press that was easier to set up," says Robinson. "Keeping the job as automated as possible means fewer chances for errors, and it results in a more efficient process." Currently, ILSCO is using the hydraulic press to produce about 15,000 specialty connectors per month. Once the company transitions all the dies to the Greenerd press, the company expects production to double within about six months.

Andrew Quinn, ILSCO president, concludes: "In manufacturing, ILSCO has a strong focus on quality and safety. This has established us as an industry leader. Investing in hydraulic press technology is an excellent example of how we continuously strive to improve our operations." ME

 

For more information on Greenerd Press and Machine Co. Inc., go to www.greenerd.com, or telephone 800-877-9110.

 

This article was first published in the November 2011 edition of Manufacturing Engineering magazine.  Click here for PDF

 

 

 

 

 

 

 


Published Date : 11/1/2011

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