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Outwit, Outplay, Outlast
Manufacturing advances make surgical instruments more durable and effective
Stacey L. Bell
Editor-at-Large
Contestants on television’s perennially popular Survivor must “outwit, outplay and outlast” their competitors to win the $1 million prize. In real life, orthopedic OEMs and their outsourcing partners must do the same to deliver the ultimate prize to millions of people: restoring function as effectively and quickly as possible.
 Improvements in machinery have led to the development of smaller surgical devices and instrumentation. Photo courtesy of Miltronics & Skye. |
“Today’s instrumentation is much more complex, and multiple components are being assembled into smaller instrumentation,” said Dennis Donovan, general manager of Centex Machining, Inc. in Round Rock, TX. “Some instruments have been reduced by over 80% in size during the past few years.” He noted that a few years ago, component tolerances were often about 5/1000 inch; today, 1/1000-inch tolerances are common.
Not only are parts getting smaller, orthopedic OEMs are seeking to tap new markets and, thus, creating new product lines. While hip, knee and other joint replacements used to be the province of older patients, more Americans in their 40s and 50s are opting for such procedures so they can continue their active lifestyles. As a result, implants need to have longer lifecycles and be constructed of more durable materials.
Even gender differences are influencing product development. In 2006, Zimmer introduced the Gender Solutions High-Flex Knee, the first knee replacement shaped to fit a woman’s anatomy. The company noted that women account for two thirds of the 400,000 knee replacement surgeries performed in the United States each year; therefore, the market existed for a narrower, thinner shape that would better fit this demographic.
“Companies are flexible enough to realize that the products they offer today may not fit everyone, and they are studying niches to find unmet needs and create more tailored implants and new markets,” explained Michael Gauthier, president of Gauthier Biomedical, Inc. in Grafton, WI. “Manufacturers today have the people, equipment, engineering and manufacturability to offer more advanced products.”
 Cutting-edge machinery allows manufacturers to create more intricate products with tighter tolerances and features. Photo courtesy of Centex Machining, Inc. |
Certainly, making orthopedic surgeons’ lives in the operating suite easier is another prime driver for innovation. “Within the next 20 years, it appears that the demand for orthopedic procedures will outpace the United States’ ability to produce enough surgeons to provide solutions. Therefore, as manufacturers, we need to come up with clever ways to help surgeons work faster and be more accurate with less skill so that they can perform more surgeries,” reported Patrick White, executive vice president of global research and development for Precimed, Inc. in Exton, PA. “One of our customers estimated that ORs could accommodate one more surgery each day if they switched to disposables.”
As a result of marrying the concepts of easing surgeons’ workloads while adding disposables to the operating suite, Precimed recently developed a disposable nitinol flex drill. “The cleanability and reusability of drills with a flexible shaft has always been a problem, so a disposable drill eliminates that concern for ORs,” explained Barbara Lyons, director of marketing for Precimed. “By incorporating nitinol, we’re also able to offer surgeons better flexibility without a wire rewrapping on itself.”
In their efforts to continue to shrink the size of surgical devices and instrumentation, while developing niche products and making them easier to use, orthopedic OEMs have turned to their outsourcing contract manufacturers for help. Incremental improvements in machinery, as well as new project management strategies, are smoothing the path to increased innovation.
Evolutions in Equipment
Just as surgical instrumentation is getting smaller and more complex, the equipment that creates these items is becoming more sophisticated as well. In years past, two-axis (X-Y) mills were adequate. That’s no longer the case.
“Today, customers need more than traditional milling and turning. They need for you to turn, mill, thread whirl, deburr—all on one machine. That requires multiple axis and tooling positions,” said Mark Saalmuller, national medical accounts manager for Tornos Technologies in Brookfield, CT. “The component stays stationary, and the tool moves in multiple directions at the same time to machine the part. Many customers are using these multi-axis machines to perform complicated milling or other operations on parts such as spinal screw heads. We can insert a series of specialized grooves in a spherical shape rather than in a straight line and machine similar grooves on the mating part, the yoke. Multi-axis milling makes it easier to add grooves for a tighter lock.”
Saalmuller added that more customers are adding accessories to machines to reduce scrap and produce better parts. For instance, many OEMs are requesting chiller systems so that there will be less thermal distortion on the equipment, allowing for more consistent parts throughout a run. OEMs also are asking for more inspection devices and equipment to be placed in machines.
While multi-axis machines cut production time, they also allow manufacturers to create more intricate products with tighter tolerances and features. “Our five-axis milling and 13-axis Swiss CNC manufacturing cells allow us to drop complete, very geometrically complex medical devices, eliminating the need for post machining and finishing operations,” said Chris Rawlins, sales manager for Mentor, OH-based Miltronics & Skye.
Multi-axis machines typically range from three to 13 axes. The more axes a machine has, the more operations it can perform simultaneously, eliminating the need to move components from one piece of equipment to another and the associated set-up times.
In the fall of 2005, Madison, AL’s FMI Medical Instruments installed two multi-axis Mazak Integrex 200STs. These complex, seven-axis CNCs have nine coordinate systems that allow the company to complete multiple operations within a single set-up. “This type of CNC machine has been used in other commercial applications, but just recently FMI Medical saw the potential use of this kind of equipment in building medical instrumentation and devices. Within a few weeks of the installation, FMI began to derive huge cost savings in reduced labor expense as well as other benefits,” said Justin Roepe, FMI’s vice president of sales and marketing. Roepe pointed out that using the right equipment can shave considerable production time: a part that took two hours and 20 minutes to produce on several pieces of machinery at a competing facility was completed in just 38 minutes on the Mazak Integrex due to its ability to multitask operations within a single CNC.
Another piece of equipment often used in manufacturing electronics may prove helpful to orthopedic OEMs as well. The Esco—a coil-fed machine for very small parts—has been a staple in the dental industry for a few years and recently has attracted the attention of other medical companies, Saalmuller noted. “Because of cost containment concerns, more orthopedic OEMs are exploring new venues, including new machines and processes, in search of savings opportunities,” he said.
Significant savings opportunities also lie in using the most recent software offerings available, some experts said. “By using the latest 3-D modeling system and CAM software packages, we can help our clients meet some very aggressive product launch dates. We can have a prototype in their hands in a matter of days. During the past five years, the evolution in 3-D modeling software has been the biggest factor in making the manufacturing process more efficient and faster,” Rawlins noted.
Donovan agreed. “Today, you can’t afford to be a few versions behind on your CAD and programming software,” he said. “Constantly upgrading ensures you are making parts accurately and cost effectively.”
Donovan is a big fan of automation and software and noted that improving one’s ERP [enterprise resource planning] system also will pay large dividends. ERP systems give users access to real-time data and let you know exactly where product is at any given time. “This allows you to provide tight cost control on a process and make sure everything is progressing as planned,” Donovan explained. “Most systems also will automatically send a warning at the first indication of any trouble, allowing you to achieve the best results possible.”
Some contract manufacturers have incorporated robotics to further boost their production time. Last fall, FMI purchased a System 3R WorkMaster automation system to automate all part and tooling handling for two new Mitsubishi EA 12V Wire EDMs. The automation system significantly reduces labor expense and enhances the validation and repeatability of the manufacturing process, Roepe said.
Beyond Traditional Service
Contract manufacturers, like their orthopedic OEM customers, are studying the orthopedic market space, looking for trends and new ways they can help their clients—and their own companies—succeed.
“We’re seeing so much more product development recently—older products are being phased out, and companies are revitalizing their newer product designs to stay competitive and compete with smaller start-ups,” Rawlins said. “We’re also seeing a lot of consolidation.” Larger companies are purchasing start-ups to access their technology and enter a new market more quickly.
Miltronics & Skye now offers engineering services to its customers to help them with their design efforts. “We don’t do full product design yet, but we’re absolutely moving toward that goal,” Rawlins said. He noted that contract manufacturers are able to scrutinize a customer’s model and provide feedback that could save big bucks as well as aggravation. For instance, contract manufacturers will be able to assess whether a particular feature will be easy or expensive to mass produce and will know if a proposed material is experiencing shortages or long lead times—and offer alternative suggestions that could allow the product to get to market much more quickly.
Beyond assisting with product design, within the next few years contract manufacturers also may be helping their OEM clients complete market research. “I think contract manufacturers will be moving in this direction,” Gauthier said. “We’re currently involved in clinical evaluations. We’ll provide five to 10 pieces and get feedback from the surgeons. We then apply that information when modifying the design.”
Several years ago, Precimed purchased a metal injection molding company so that it could offer both metal and plastic injection molding capabilities. “Instrumentation in the traditional reconstructive markets—hips, knees, shoulders—is moving away from traditional metals to disposables and near disposables,” White said. Precimed’s new metal injection capabilities will allow the company to create very complicated, small metal components in high volumes.
“Although orthopedics traditionally wasn’t a high-run business—1,000 to 2,000 units was considered high run—when you think disposables, you think volume. There is going to be a paradigm shift in this industry,” White continued, adding that it will be an exciting time. “Breakthroughs in developing new, reusable instruments tend to be more incremental now, whereas disposable instruments will open up paths to do things in a revolutionary way.”
Change is afoot at FMI as well. Last October, the company completed its move into a new 57,000 square-foot facility, more than tripling its former manufacturing space. The company is downright bullish on the future of orthopedics, which has experienced double-digit growth in all areas—joint reconstruction, trauma and spine—each year for several years, with similar gains expected for the foreseeable future. FMI also is expanding its offerings; a segregated clean room for additional part cleaning, device packaging and labeling is slated to open in March. In addition, it is implementing a new business management system for internal inventory control, forecasting and possible consignment inventory.
On the Horizon
Advances in equipment, software and management strategies are allowing OEMs to continue to create devices and surgical instruments that will outplay and outlast their predecessors. What changes do experts expect to see in the coming years?
Nearly everyone who spoke with ODT expects great growth in the spinal area. “The reconstructive market appears to have become commoditized on the implant side, so everyone is racing toward spinal solutions,” White said.
Miltronics & Skye is working on a total disk replacement system. “It allows surgeons to remove a disk in the spine and replace it with an artificial disk as opposed to fusing the spine together,” Rawlins explained. As a result, the patient gains more mobility, and the surgery is completed faster.
White also expects to see major breakthroughs surrounding stem cell therapies. “There will then be a huge need for development of delivery systems, scaffolds and structures to put inside the human body,” he said.
When the FDA approved new cleaning validation standards in 2006, it simultaneously set the stage for a hot trend for 2007: OEMs evaluating the designs of each of their offerings to see how well they can be flushed, Gauthier said. “We’re seeing more interest by our customers in re-examining their current products, since what was allowed in the past may not be going forward. We’re helping a number of companies with testing, making samples and then changing the design of their products,” he noted.
Finally, all the brilliance and innovation in the world count for little if the ultimate customers—surgeons—don’t like or feel comfortable using a particular instrument or device. Therefore, Donovan noted, the key for the future success of orthopedic offerings will rest in OEMs creating training and education centers for doctors.
“We need to show surgeons what we’re bringing to the market and see what changes will be needed and how they will actually use it. Surgeons drive change in the marketplace, and they’re demanding more from OEMs. They want products that work, and they want training and surgery sites so they can learn to use products optimally,” Donovan said.
Innovation, combined with surgeon training, will ensure that tomorrow’s devices allow patients to perform well in the ultimate competition: the game of life.
From the Operating Room: Surgeons’ Perspectives
How happy are orthopedic surgeons with the offerings being presented by OEMs today?
“Instrumentation systems are quite nice at this point. They’re small so we can do surgery much less invasively. They’re lighter, which makes them easier to store, and we need fewer open at once. The color coatings make them easier for the surgery team to identify implants and instrumentation correctly, which saves time during surgery. In short, the orthopedic industry has been very responsive to surgeons’ and patients’ needs with advanced instrumentation, materials, design and ancillary technologies—including computer-assisted technologies, which create more reproducible results and enhance quality, which benefits both surgeons and patients,” said William Robb, MD, chairman of the Department of Orthopedic Surgery at Evanston Northwestern Healthcare in Evanston, IL. Robb echoed the thoughts of numerous surgeons who recently spoke with ODT about which orthopedic offerings are their favorites and areas in which they’d like to see further development.
According to the American Academy of Orthopaedic Surgeons’ Orthopaedic Practice in the U.S. 2005-2006, the top five areas of orthopedic practice are adult knee joint replacement, arthroscopy, sports medicine, adult hip joint replacement, and shoulder and elbow joint replacement. ODT spoke with experts in all of these areas.
Noah S. Finkel, MD, FAAOS, FACS, chief of staff at Huntington Hospital in Huntington, NY, said he thinks that orthopedic OEMs may actually be too good at introducing innovations. “As soon as a new idea is written or talked about, someone is out there selling it,” he noted. “The problem in medicine is that we learn by numbers. We need to know how it affects 100,000 women, not 25. A lot of incredible technologies and discoveries are coming on the market, but they may not be proven good or better than the gold standard. They may turn out that way, but we don’t know that at the point of introduction. It also would be helpful to see impartial studies that are not financed by the carriers making the equipment.”
That said, many innovations in the marketplace have made surgical life easier and more productive for surgeons. “Many of the newer instruments are more ergonomic, and when they’re designed for a specific procedure, they make our surgical life easier,” reported David Markel, MD, chief of orthopaedic surgery at Providence Hospital in Southfield, MI. “For example, retractors designed specifically for minimally invasive knee or hip procedures allow far less of a struggle and enable increased speed and efficiency in the OR.” Dr. Markel also finds the newer knot-tying equipment for arthroscopic procedures very helpful.
In 2002, Dr. Robb instituted minimally invasive knee replacement procedures in his practice. Two-and-a-half years later, he added computer-assisted surgery, an innovation that has helped his practice greatly, he said.
“Computer-assisted technology complements minimally invasive techniques and brings even more reproducibility to the results,” he said. “Both the actual surgery and the patient’s recovery time are more predictable.”
Sometimes doctors are taking the matter of better design into their own hands. Michael L. Pearl, MD, shoulder and elbow surgeon at Kaiser Permanente in Los Angeles, CA, actually helped create his favorite products. “My anatomic studies and design work with Zimmer have provided me with a geometrically correct total shoulder replacement system with excellent press fit and ingrowth characteristics. This new system allows me to achieve my surgical goals more consistently and effectively. The reverse shoulder replacement system that we developed also fits patients’ anatomy better and affords better range of motion with greater stability than existing designs.”
Among the developments doctors are hopeful will soon appear on the horizon:
• Better interfaces. David Heck, MD, FAAOS, ABOS, clinical scholar and informaticist at the Institute for Health Care Research and Improvement at the Baylor Health Care System in Dallas, TX, noted that he likes the movement toward using more antireflective surfaces and larger font sizes on monitors and instrumentation. However, there is still room for improvement, he said. “More height and boldness in fonts is helpful in rapidly identifying instrumentation,” he said. “Incorporating larger monitors with more screen real estate so we have a more functional dashboard to consult would be better, too.”
• Navigation. Dr. Pearl looks forward to the day when navigation allows for easier and more precise shoulder reconstruction, both in joint replacement surgery and for soft tissue procedures. “We have many ways to stabilize the glenohumeral joint now, open and arthroscopic,” he commented, “but there has never been any objective way of quantifying how much translation and range of motion is affected by the procedure. Navigation has great promise to advance these procedures and increase the precision of shoulder arthroplasty as well.”
• Recordkeeping. “We need more products that will integrate with the hospital’s software programs so that once we leave the OR, we’re done with the recordkeeping of that particular procedure,” Dr. Markel noted. “We need RFID-like technologies that will identify which implant has been used in which patient.”
Dr. Robb seconds that idea. “We need to establish both local and national implant databases,” he said. “We’re implanting more and more materials, more implants, and patients are living longer. We need a way—for example, through bar coding processes—so patients can identify what they’ve had done at an earlier time and so doctors are able to find patients that had a particular implant. National databanks already are present in other countries, and I think the industry needs to support establishing such a database in the United States.”
• New materials. Dr. Robb pointed out that high-density polyethylene remains the material of choice for knee replacements, but fundamental improvements are still needed, particularly in durability. He’d welcome alternative materials and designs.
• Biologicals. Others are hopeful that more artificial tendons and ligaments are on the way. “We need a better assortment of options and better ways of introducing them into the body,” Dr. Pearl said. “There are a few scaffolds on the market, mostly offered as a small, square sheet of material, but there are no tools designed for sewing them in place. We need more systems designed to match specific body parts. They should come with sutures or anchoring systems attached so we don’t have to invent a new surgical technique at each operation.”
Dr. Finkel also would like to see the development of artificial bone and tendons. “To be able to stimulate a tendon to regenerate itself would be incredibly helpful for the aging phenomenon,” he said. “Right now we’re using cadaver tendon, but if a patient could simply take a pill…The aging process is destructive to the human tendon structure, so this area represents a great need.”
