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Digital Devices: recent technological advancements are transforming the way orthopedic implants are designed and manufactured.

"Surely every medicine is an innovation; and he that will not apply new remedies must expect new evils; for time is the greatest innovator."

--Francis Bacon, "Essays, XXIV, Of Innovations"

The changes likely were confounding, at least incipiently. Consider for a moment the medical device world that Ed and Mary Burton re-entered last spring after a three-year absence: A realm of sophisticated equipment programming software, tighter tolerances, higher RPMs, shorter turnaround times and greater volumes. It was a world defined by cost pressures and shrinking reimbursement rates, where OEMs--like most companies in the post-recession era--demanded more from their suppliers for the same stipend; a world limited by dried-up venture capital, where nervous investors took fewer risks, leaving startups floundering for financing; a world burdened by complex, confusing new rules from a distant and often uncooperative U.S. Food and Drug Administration (FDA); and a world unnerved by a controversial excise tax that surely would stifle innovation.

But it also was a world that held tremendous promise, both for patients and entrepreneurs. Medical technology had surged so far forward in three years that it nearly was unrecognizable: From biodegradable polymer/bioglass composite implants to 3-Dprinted body parts and custom-made knees, the Burtons entered a radically changed industry in 2012.

"We were away from the [medical device] business for a few years and we've seen great advances in equipment and there are materials that are far more sophisticated than they were five or 10 years ago," noted Mary Burton, owner/vice president of sales and marketing at Medical Device and Implants LLC (MDI), a Lancaster, Pa.-based manufacturer of spinal and small bone implants, screws, plates and stabilizers. "Things have come so far from when we were here before, such as the ability to measure things without touching them and metals that are more machinable. The idea of being able to hold a part one time and do everything you have to do with it or to make it be what you want, without ever moving it, those are some great advancements."

Interestingly, Ed and Mary Burton hadn't really planned on returning to the medical device industry so soon. The mother and son had moved on professionally after selling their engineering and manufacturing services firm, Specialized Medical Devices Inc. (SMD, also headquartered in Lancaster), to Teleflex Inc. for $25 million in the spring of 2007. SMD was a subsidiary of HDJ Company Inc., a manufacturer of Swiss screw machine parts that Mary Burton founded in 1962. At the time of its acquisition, HDJ employed 140 workers and generated $14 million in annual revenue.

The Buttons helped transition their companies into the Teleflex corporate structure after the sale and then pursued separate career paths in other fields--Mary eventually landed in non-profits while Ed became involved in other businesses. And while their five-year non-compete agreements with Teleflex initially kept the pair from re-entering the device sector before April 2012, neither mother nor son strategized a return to their former glory until Ed Burton's brain/spine surgeon friend Perry Argires, M.D., suggested as much in the fall of 2011.

"He said,' Ed, we've been talking for years about doing this. It's time," Ed Burton recently told Lancasteronline.com.

The timing couldn't have been more serendipitous, actually: Almost concurrently with Argires' prodding, the Buttons learned that Teleflex was closing its Lancaster manufacturing plant and shifting production to a sister facility in Kenosha, Wis., idling all 88 employees. Many of those being displaced had previously worked for the Burtons, with some having started at Mary's original company.

Hence, the pair began devising their comeback. They leased and refurbished 15,000 square feet of space (in Lancaster) that ultimately can be expanded by 10,000 square feet. They also invested in "high-end" manufacturing, inspection and finishing equipment such as Citizen 7-axis Swiss turning centers, 4- and 5-axis Haas milling machines and a 4-axis laser market. The startup firm also installed a Class 100,000 cleanroom and invested heavily in equipment for finishing operations such as titanium anodization, laser marking, passivation, electro polish, micro deburring and vacuum heat treat.

The company name was inspired by the Burtons' sole focus on medical devices and implants, specifically orthopedic and spinal products. Mary contends the new business strategy helped her and her son make better investments and will keep the firm more closely focused on customers.

"We're definitely relationship builders," Mary Burton said during an interview with Lancasteronline.com. "We're not interested in getting an order and never seeing those people again. We want to create long-term relationships."

Intelligent Machines

Mary Burton might have to work harder to establish those relationships, however. During her respite from the medical device world, the global economy imploded and U.S. lawmakers passed healthcare reform, a powerful one-two combo that virtually KO'd corporate profits and prompted OEMs to re-examine their manufacturing expenses. Most, if not all, of the industry's largest players have tried to recoup lost revenue by streamlining their bloated vendor bases and conducting business with partners that provide the greatest breadth of services. Working with diversified vendors allows OEMs to focus on their core competencies and can help them reduce manufacturing costs by up to 30 percent, according to industry estimates.

Though vendor streamlining began well before the Burtons sold their business, the number of OEM suitors has increased significantly since then. Over the last several years, contract manufacturers and suppliers from other industries like automotive, aerospace and defense have infiltrated the device sector, lured by favorable long-term growth prospects and the natural extension of existing product development and manufacturing capabilities.

Such a move felt natural to PWI Inc. of Wichita, Kan., a supplier of coil windings and lighting systems for the aircraft industry. Last year, the 50-year-old company began tapping its experience with pick-and-place machinery and reflow ovens to make medical electronics for hospital beds, testing and monitoring equipment, sensors and wireless data transfer."It seemed like a natural transition," President Robi Lorik said."Being that we're already involved with FAA [the Federal Aviation Administration], learning to transition and qualify and be validated with the FDA wasn't that big of a step."

It wasn't a big step for RTI International Metals, either. The Pittsburgh, Pa.-based titanium mill product supplier purchased Remmele Engineering Inc. in January 2012 to expand its product and service offerings in the aerospace and medical device industries. With an established presence in the orthopedic, dental, endoscopy, laparoscopy and drug infusion markets, Remmele gives RTI the diversification it needs to compete in the $331 billion global device sector.

Both Ed and Mary Burton were relatively unfazed by the vendor consolidation and increased competition they encountered upon their return to the device industry (as one orthopedic industry executive noted: "They're not new trends but they continue to be what is going on in the market"). They did, however, notice some profound changes in customer demands (closer tolerances, more complex finishes) and machining technology (complementing multiple axes, automatic tool-break detection).

Ed Burton particularly was awestruck with the advancements in equipment programming software. Over the last half decade, CAD/CAM (computer-aided design/computer-aided manufacturing) software has enabled medical device makers to improve manufacturing efficiency, product quality and speed to market. CNC Software Inc. of Tolland, Conn., for example, offers variable depth roughing and finish tool inspection programming. The company's variable depth roughing software varies the point in which the tool insert contacts the surface to prevent notching and improve tool life, while its tool inspection program allows machinists to set definitive conditions under which tool inspections are performed--either after a certain number of passes, specific cut length or cut duration.

Swiss software developer Moldplus SA has created a suite of programming tools for draft angle analysis, surface manipulation, mold cavity geometry, mold runoffs and extensions, and electrode design. It also has introduced ProDrillV4 software that adapts to users' specific machining styles, from simple two-dimensional blocks to complex 5-axis parts.

Biomet Inc., Johnson & Johnson, Medtronic Inc. and Smith & Nephew plc have used software developed by PartMaker Inc., a division of Ft. Washington, Pa.-based Delcam plc, to manufacture bone screws, spinal hooks and plates, and orthopedic implant instruments. PartMakerVersion 2011 is a knowledge-based machining system that remembers the tool, material and process data necessary for efficiently machining individual part features. The software--suitable for CNC milling machines, wire-type electrical discharge machines, lathes, mill-turn centers and Swiss-type lathes--emphasizes tool management functions. One of its most practical features is a method for programming multi-axis lathes with live tooling, a technique designed to accelerate learning and enhance ease of use.

"There's a wide variety of programming software available for whatever type of screw machine you run. There's programming software that supports whatever milling equipment you're running and also works with your CMM [coordinate measuring machine], so everybody is on the same page," said Ed Burton, MDI's president. "You can receive your [machining] requirements in a [digital] file that goes right to your programming software for your equipment, which is an advancement in itself. Before that, you had to literally start from scratch, because you were only given a drawing with dimensions on paper. The CMM quality group programmer couldn't start until after manufacturing, once you provided them a part. Now, they can have a program ready before they even receive a part, making the whole process much more efficient. That's a big development. In the past, you didn't have software to help program these machines and you certainly didn't have the ability to program CMMs without a part until the acceptance of a file into your CMM computer system. That is a huge advancement over the last several years."

It's also one of the more sweeping advancements in implant manufacturing technology over the last decade. Equipment programming software, automation (robotics included) and improvements in such manufacturing techniques as laser welding are changing the way implants are designed and produced, creating geometries and biological scaffolds that are nearly impossible to replicate through conventional machining.

The CNC 5-Axis Profile Grinders and robotic finishing system that Maumee, Ohio-based Hammill Manufacturing Company uses to generate the articulating geometry of its knees are far superior to the plunge-grinding and hand-polishing processes the firm employed when it first began manufacturing knees in the 1970s. Since then, the 58-year-old orthopedic implant company has manufactured and shipped 500,000 knees.

"We've seen a lot of technological changes over the last several decades and the pace of advancement is only going to accelerate," President John Hammill said. "Ten years ago, everything was driven from a blueprint. You put together a drawing showing a 2-D world and our job was to take that 2-D drawing and turn it into a manufacturing process. Today, everything begins with a [computer] model using data contained in the model. Instead of working to the drawing, today you're working to the model. The model controls everything--it controls the manufacturing process and drives the inspection methodology and controls the data points used for inspection. As new technology becomes more available and easier to use, everybody's adapting to it. It used to be that our guys couldn't make anything unless they had a good print. Now the first thing they ask for is the CAD model. With the CAD model, you're taking the opportunity for error away. If everybody is working to the same model, data translation errors are eliminated and inspection correlation improves."

A Personal Touch

Late last year, Vivek Srinivasan, Australia regional manager for London, United Kingdom-based information technology (IT) research and advisory services firm Leading Edge Forum, and Jarrod Bassan, a senior consultant with IT and professional services multinational CSC, published a report that predicts a virtual revolution in 3-D printing (also known as additive manufacturing) over the next few years. In a guest post they penned for the Dec. 7, 2012, edition of Forbes, the pair envisioned the technology infiltrating almost all aspects of society, inspiring lighter, more fuel-efficient aircraft and cars, longer-lasting home appliances and customized medical technology implants.

Medical device makers endeared themselves to additive manufacturing quite a few years ago, but the technique mostly was used to create medical models for surgery preparation, patient-specific surgical guides or patterns for implantable titanium casting. The actual implantation of 3-D-printed parts was rare.

Not anymore. Those procedures are becoming much more frequent now, thanks to companies such as MCP HEK GmbH (Germany), Ala Ortho (Italy) and Arcam AB (Sweden) that make 3-Dprinted acetabular hip cups and implants for trauma surgery. Arcam, in fact, recently debuted a new 3-D printer, the Arcam Q10, to improve productivity, accuracy and quality assurance. CEO Magnus Rene said the Q10 represents a" new EBM [electronic beam melting] generation, with a focus on continued industrialization of the technology."

One of the most valuable aspects of 3-D printing is its ability to produce novel porous structures and constructs. For example, intramedullary rods or femoral hip stems could be coated with low-density mesh or foam and then wrapped in a layer of high-density mesh or foam to promote vascularization. Likewise, the technology potentially can be used to replace cartilage in damaged or diseased knees.

Additive manufacturing also plays a key role in the development of customized implants, one of the healthcare industry's fastest-growing trends. Over the last decade or so, OEMs such as Biomet, Smith & Nephew, Stryker Corp. and Zimmer Holdings Inc. have recognized the benefits of individualizing their products (usually knees) to different patient groups and have launched implants designed for specific genders, geographies, or anatomies.

"In the case of the knee, there's always been the complaint that after someone had received a knee replacement that it never actually felt like their knee," noted Dax Strohmeyer, president of Upper Saddle River, N.J.-based Triangle Manufacturing Co., a company specializing in precision engineering and manufacturing of complex, tight-tolerance machined parts and assemblies, including hip, knee, shoulder and spinal implants. "It's different than the hip, where people who have had their hip replaced, a couple of days after leaving the hospital, they're feeling much better. By the time they fully recover from their surgery they can't really tell the difference. The knee was always something where patients thought,' I feel better but something is not quite me.' I think in that particular case, companies are going after trying to make the knee feel more like it was theirs originally and they don't have an implant in."

That "not quite me" feeling compelled several OEMs to design and launch new knees this year; in several cases, the companies started completely from scratch. DePuy Synthes' joint reconstruction division, for example," started with a blank page" and fashioned the Attune knee based on 10,000 hours of research to address patient dissatisfaction with their implant. The Attune features a Gradius Curve, Sofcam Contact and Logiclock tibial base designed to improve kinematics and reduce wear. The Logiclock feature also gives surgeons variability in size and fit.

Smith & Nephew's Journey II BCS knee uses" Physiological Matching" technology to customize fits. Through its LifeMOD human simulation software, company engineers conducted proprietary analysis of the bone, ligament and muscle forces that impact the knee, and then accounted for those forces within the implant design to restore anatomic shapes and normal motion.

Architects of Zimmer's shrewdly named Persona knee, meanwhile, referenced a Bone Resection Atlas to build anatomically accurate implant shapes and sizes. The Atlas allowed designers and engineers to study the morphology of hundreds of bones, representing a diverse global population, to precisely define anatomically accurate implant shapes and sizes.

Though the recent class of new knees is designed to improve fit and address patient dissatisfaction, none can truly be considered "customized" implants, experts contend. "There aren't a whole lot of companies out there right now doing legitimate custom implants where they are one-offs of your MRI," Strohmeyer argued. "We happen to be doing business with one right now that is the only one in the market that I know of that is 100 percent custom. They developed technology that takes the MRI and translates that into a CAD model. The CAD model comes to us, we program off the CAD model and then we manufacture an exact replica of what came off the MRI."

Strohmeyer didn't identify the company that uses MRI to customize knee implants but it most likely is ConforMIS Inc. of Burlington, Mass. Last fall, the 9-year-old firm launched its FDA-cleared iTotal Patient-Tricompartmental Knee Replacement System, which uses proprietary software that incorporates data from MRIs and computed tomography scans to generate a 3-D model of a patient's knee. The model is used to design and manufacture an implant that conforms to the precise area in need of repair (hence the first part of the company's name--the second part stands for minimally invasive surgery). The company uses computer-driven machining or prototyping tools to fabricate the artificial joint, a process that takes four to six weeks, as well as customized surgical tools (called "iJig") for implanting it.

Designed as an alternative to traditional total knee replacements which come in a limited range of sizes and shapes, ConforMIS' technology precisely matches each implant to the shape and curvature of the individual joint. The iTotal system also allows surgeons to avoid many of the sizing and fit issues that can compromise surgical results. Strohmeyer and other manufacturers believe that ConforMIS' customized approach will become the gold standard for future joint replacements.

"If I can have a knee that was perfectly matched for me versus a size 6R that is kind of close but may not be exact, why wouldn't I take the one that is matched for me?" asked James Manning, medical account/program manager for PCC Structurals Inc., a Portland, Ore.-based manufacturer of complex metal components and products that serves the medical, aerospace, power, and general industrial markets. "If the technology is there, which brings the price in line with normal processes today, why wouldn't you want that? It's like going to the store to buy a pair of jeans. If all they had was size 30, 35 and 40 and you were a 33 you would either squeeze into the 30s or swim in the 35s. But if the store had 33s that were an exact fit for you, you'd buy those. I think patient-matched implants are going to be a big part of the future."

In 1975, Intel co-founder Gordon Moore projected that computer power (the number of transistors on a computer chip) would double every two years, give or take a few months. So far, history has proven him right. Consider the pace at which ordinary cell phones morphed into handheld communication devices and bulky portable music players shrunk to the size of a matchbook. Similar warp-speed innovations occurred in the medical industry: bioabsorbable stents, regenerative tissue, "bionic" limbs and orthopedic implants that wirelessly relay data like movement and applied forces directly to surgeons.

In the 36 months that Ed and Mary Burton of MDI spent pursuing outside interests, technology had given rise to a whole new slate of manufacturing and medicinal advancements. And more are on the way. "It's really anybody's guess where it will go from here," Hammill said. "Technology is advancing so fast, and the people who can take the technology and make real world applications from it are going to achieve a competitive advantage. The reality facing manufacturing companies today is evolve or become extinct. It's basic Darwinism. The real opportunity is adopting the available technology and applying it to your next challenge."

Spoken like a true futurist.

Related Article: Additive Manufacturing: Hype or Future Hope for Orthopedics?

Science-fiction writers are the con summate visionaries. Collectively, they've conjured up countless numbers of inventions that ultimately have come to pass, from airplanes, spaceships and submarines to cell phones, electronic books, robots and computer eyewear (the latter novelty is marginal; Google Glass cannot store human memories like the spectacles worn by venture altruist Manfred Macx in Charles Stross's 2005 novel "Accelerando").

Many ideas, of course, are just too preposterous for the real world (pumpkin houses, ebony teeth, plant-grown meats and see-through pants immediately come to mind) while others are simply impracticable. For the most part though, science-fiction scribes have been fairly accurate prognosticators, especially about healthcare. Aldous Huxley, for example, presaged the arrival of genetic engineering back in 1931 and Philip K. Dick amazingly predicted the advent of spray-on skin in 1960. A dozen years later, Martin Caidin published "Cyborg," the novel that inspired both a television series ("The Six Million Dollar Man") and the evolution of bionic body parts.

Gene Roddenberry's "Star Trek" franchise has been equally as influential, fostering the development of jet injectors (a parody of the high air pressure hypodermic injections administered by Dr. Leo nard McCoy), handheld disease detectors (modeled after those nifty tricorders Spock and Captain Kirk used to survey new planets) and 3-D printing (based loosely on the "replicators" that kept the Enterprise crew clothed, well-fed and flying.

Otherwise known as additive manufacturing or free form fabrication, 3-D printing creates objects through successive layers of material, fusing individual cross-sections (slices) of molecules until a complete product is formed. The concept of additive manufacturing is similar to "Star Trek's" replicator, but the technology is markedly different--whereas the replicator worked by rearranging subatomic particles to form molecules and assemble them into desired products--3-D printing uses digital files generated by software design tools such as CAD (computer-aided design) to create microscopically thin layers (usually between 0.03 mm and 0.20 mm) that are melded into place with a liquid binder, thermal print head, laser or electron beam. As these layers build up, the desired 3-D object slowly takes shape.

Additive manufacturing has existed for nearly 30 years, but it traditionally has been used to make prototypes rather than finished products. Recent technological advancements, however, have broadened the scope of viably printable materials, thus enabling the machines to produce finished items from such substances as titanium, cobalt chromium, stainless steel and polyetherketoneketone (PEKK).

Additive manufacturing is bound to become a big part of future orthopedics, considering the technology currently is being used by companies like Ala Ortho of Italy, MCP HEK of Germany and Arcam AB of Sweden to produce acetabular hip shells and customized implants for trauma surgery. At least 1,000 acetabular hip shells made by electron beam melting (EBM) have been implanted in patients over the last several years, industry research shows, though that number most certainly will rise as more manufacturers take advantage of 3-D printing to create customized device geometries, complex scaffold structures and porous surfaces that significantly improve bone ingrowth.

Some 3-D systems even allow the properties and internal structure of the material being printed to be varied. Within Technologies, for example, offers titanium medical implants with features that resemble bone. The British firm's femoral device is appropriately dense in areas where stiffness and strength are required, but it also has strong lattice structures that encourage osteointegration.

Working at such a fine level of internal detail allows the stiffness and flexibility of an object to be determined at any point. The company currently is working to develop other lattice structures, including aerodynamic body parts for race cars and special insoles for stiletto-heeled shoes.

While some experts doubt the ability of 3-D printing to reinvent or revolutionize manufacturing, others insist the enhanced performance of additively manufactured items will help drive the technology forward. The process already has proven itself in the craniomaxillofacial realm. Last year, Belgian additive manufacturer LayerWise NV built a 3-D printed lower jawbone that was implanted in an 83-year-old woman suffering from an infection. The 3-D printing made it possible to create a lightweight titanium implant with articulated joints, cavities that foster muscle attachment and grooves to guide nerve and vein regrowth.

Oxford Performance Materials of South Windsor, Conn., had similar success with its 3-D-printed skull implant. Surgeons used the company's OsteoFab Patient Specific Cranial Device within weeks of its U.S. Food and Drug Administration approval in late winter to replace 75 percent of an American patient's skull. Few details of the surgery have emerged, and only basic information about the implant itself exists. According to a company news release, the OsteoFab device is comprised of PEKK, a biocompatible bone-like material that does not interfere with X-rays. The implant was printed using an EOS P800 laser sintering printer.

Oxford President and CEO Scott DeFelice called the OsteoFab technology" a highly transformative and disruptive platform that Hill substantially impact all sectors of the orthopedic industry." Such an outlook perhaps explains the 13-year-old company's plans to expand beyond the skull to other bone replacements, opening up the revolutionary new technology to a multimillion-dollar industry.

"We see no part of the orthopedic industry being untouched by this," a jubilant DeFelice proclaimed.

If additive manufacturing is indeed transformational, then no part of the orthopedic industry will want to be untouched by it.--M.B.

Michael Barbella * Managing Editor
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Title Annotation:FEATURE: Implant Manufacturing
Author:Barbella, Michael
Publication:Orthopedic Design & Technology
Article Type:Company overview
Date:May 1, 2013
Words:4139
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