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August • September 2005 • Vol. XXIII No. 6 • An Arnold Publication |
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EDM Magic |
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Story and photos by C. H. Bush, editor |
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For every dark cloud there’s a silver lining. Or so goes the old saying. For the baby boom generation the dark cloud is rapid onset of senior citizenry, along with all the accompanying problems of becoming elderly. In fact, it is such a brewing storm cloud that the U.S. government nowadays spends a lot of its time worrying about how to pay for the increasing demands of that generation for medical and other services. For those of you who don’t keep track of such things, the baby boom generation was born in the years from 1946-1964. It has the distinction of being the largest generation ever in the United States, resulting from the economic and baby boom that happened in the years after the end of World War II. But if every dark cloud has a silver lining, where is it this time? Just ask anyone supplying medical services or devices to that aging population, and they’ll tell you. “We’ve already seen the beneficial impact of the baby boom generation in our business,” says Richard Anderson, vp manufacturing for El Dorado, CA’s Hayes Medical, Inc. “We design and produce orthopedic implants to replace worn hip and knee joints in the human body. We’ve seen the orthopedic market grow by sixteen percent in just the past couple of years. And we believe that’s only the beginning. We expect our sales to continue growing rapidly along with the aging of the baby boomers.” Modular and Custom Replacements Hayes’ products fall into two main categories. First is their UniSyn™ line of modular hip replacement parts. (See picture on the next page.) Second is their Consensus® line, which consists of six different sizes of hip and knee replacement components. “The UniSyn Hip Systems are designed to be flexible,” Anderson says. “The Unisyn is a three-piece system with each piece having ten to twenty different sizes that are fully interchangeable. The system allows surgeons to pick and choose just the right size of each component to fit each patient’s need. It also simplifies surgery by providing more surgical options and a logical, stepwise technique. In the end, operations go faster and easier.” The Consensus system, though not modular, comes in a variety of sizes, too. “We have six different types of hips and seven different sizes for each, and we have five different types of knees and six different sizes for each of those, too,” Anderson explains. “These products are not modular, but the surgeon generally can find a size that fits his patient and, if he can’t, we can custom design and produce a system to fit his needs.” How the System Works How does a surgeon go about choosing the right hardware for his patient and then making sure the surgery goes without a hitch?
“We have what are called templates,”
says Anderson, “which are overhead slides with a picture of the implant profile
on it. The doctor can look at an x-ray of his patient and compare it with the
template and say, ‘Okay, this is going to be about a size four.’ Then, once the
surgeon gets his patient open, he uses instrumentation which we call trials.
Trials are plastic versions of the implants the doctor can insert temporarily to
be sure he has the right size. When he has it right, he says, “Okay, this one
works best.’ He then removes the trial and implants the real system.” Anderson: “Typically what happens is one of our reps goes into surgery and takes with him all the sizes of trials and actual implants. That way, once the doctor makes a choice, the product he needs is right there waiting. Service is a big part of this business.” The trial parts are expensive, so once the surgeon is finished with them, they are sterilized and reused. The system has proven very successful over the years. Tools of the Trade How can six sizes of implant perfectly take care of the full gamut of sizes of the human race? “Actually they don’t have to be exactly right,” Anderson says. “The doctor has to get a size that is close to right, and then he may ream and broach the patient’s femur to get a close fit..” All this modification of the patient’s bone requires surgical instruments, also supplied by Hayes Medical. “An instrument set can have anywhere from fifty to a hundred instruments in it,” Anderson says, “so a set is very expensive. In the U.S. we don’t sell them. We make the investment and place the sets in the hospitals for the surgeons to use when they need them. We sell our products worldwide; throughout the U.S., Australia, Japan, Middle East, Central America, South America, and Europe. Typically, however, in Europe and elsewhere we sell the sets. Surgeons are very picky about their tools, so our instruments have to be user friendly and they have to have a quality look, as well. We spend a lot of money on research and design of our instrument sets.” Training To make sure surgeons fully understand how to use their products, Hayes offers a thorough training program. “First we train our sales reps,” Anderson says. “The sales reps go out to the doctors. The surgeons already know how to do the surgery, so for us it’s just a matter of familiarizing them with our instruments and products. We also have printed surgical protocols and videos that the surgeons can watch, plus we can bring the surgeon to our facility and supply artificial bones for them to practice on. We want them to go completely through a surgery from beginning to end using our instrumentation, so they become thoroughly familiar with our process.” Component Production Hayes Medical was started in 1992 by Daniel Hayes, PhD., a specialist in biomedical engineering, as a consulting firm. In 1996 the firm purchased U. S. Medical Products, a Texas company producing orthopedic hip and knee replacement products. Soon after that Hayes added to its capability by purchasing National Medical Specialty Incorporated, a medical distribution company. After that the company went through a year of agonizing reorganization and then finally decided to consolidate everything under one roof. “That’s when I came into the picture,” says Sterling Grover, Hayes manufacturing engineer in charge of production. “I had years of experience in both management and machining, which is what they needed. At that point we were jobbing out all our production work and my goal was to set up a production facility and get it going as quickly as possible. The goal was speed, efficiency and quality.” Grover’s predecessor and the man who hired him had already purchased several pieces of equipment before he arrived, Grover recalls. “He had already purchased a Haas HL-2 turning center, a Fadal vertical mill and a bunch of manual support equipment,” he says. “It was all brand new, it had never been used. They had never even pulled the plastic off or wiped off the cosmoline. They had no systems, travelers, that sort of thing, and they didn’t have any machinists either, so I had to start from scratch.” Today Grover’s production department runs two shifts, one eight-hour and a ten-hour second shift, and keeps 13 people busy in the shop. Overall the company employs 35 people. “Right now we produce inhouse about a third of the parts we sell,” he says. “And, because our parts are used for implants, quality and looks are critically important. The same goes for the surgical instruments we produce.” Grover says that when he first arrived and saw the Haas lathe sitting there he was somewhat doubtful that the machine could meet the quality standards. “At that time I had the view that a lot of people had, you know, that the Haas machines were lower end,” he says, “but that original machine sure changed my mind. After seven years that machine is still turning out titanium parts to meet tolerances of two tenths to a couple of thou. It meets our production requirements and delivers the quality we need. In fact, the machine performed so well that I recommended buying two more. So now we have two SL-20s, one with the big bore option. All three of the machines have been very reliable and have never let us down. I realize now when it comes to equipment you can’t judge by other people’s opinions. The Haas machines work great for our needs.” All parts produced at Hayes are checked on machine using a Western Gage air gaging system. “The system reads the amount of air flow over the part and gives us extremely accurate information about the part diameters,” he says. “It’s fast and reliable, which is what we need, though we also do inprocess and final inspection in our QC department using a Zeiss CMM.” R&D for the Future One of Hayes Medical’s major goals is to find ways to make its surgical implants faster and easier to use and less painful for patients who receive them. “We spend a lot of research time researching to find better instruments and techniques,” says Richard Anderson. “We're also working with surgeons on products and techniques to allow what they call minimally invasive surgery. The surgeons want to work with much smaller incisions to do the same surgery, so the instrumentation has to be down scaled to reduce the tissue damage done. The whole idea is to reduce patient trauma and to reduce recovery time to a minimum.” “In the shop we spend a lot of time trying to find ways to improve quality and speed production, so we can hold down the costs,” Grover adds. “We’re aware of rising medical costs,” Anderson says, “but we’re also aware of the need to give our end users, our patients, a pain-free, better quality of life. In the long haul, that’s our real goal. To give patients better lives.”
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