Michael Barbella, Managing Editor09.10.13
Arthur C. Clarke had an uncanny connection with the number three. The enigmatic and little-known link extended well beyond the late futurist’s affinity for the digit, manifesting itself in ways that often defied explanation: He was, for example, one of the three best-known and beloved science-fiction authors of the latter 20th century (Robert A. Heinlein and Isaac Asimov rounded out the trifecta); he served as a radar instructor for the British Royal Air Force during World War II, but became a pilot and flying officer in 1943; he married and formally separated from his wife within six months in 1953 (that same year, he received the Stuart Ballantine Medal from the Franklin Institute for advancing the notion of a geosynchronous satellite for communication purposes); he signed a three-book publishing deal in the early 1970s, releasing the first novel in 1973; he received the Telluride Tech Festival Award of Technology in 2003; and, perhaps most mystifying, some orbital dimensions of the asteroid named in his honor—Clarke 4923—are divisible by three (2001 would have been a more appropriate moniker to commemorate Clarke’s science-fiction classic, but the number already was assigned to Albert Einstein).
Clarke, however, clearly baited destiny at times. He tended to lump his scientific rules and theories into groups of three á la Sir Isaac Newton, starting with the 1968 Law of Revolutionary Ideas and culminating with the addition of a third law of prediction (better known cumulatively as Clarke’s Laws) in a 1972 revision of his iconic “Profiles of the Future” essay compendium. The brilliant prognosticator added a fourth law to the 1999 edition of “Profiles”—“for every expert there is an equal and opposite expert”—but that decree generally is not as widely accepted as the first three and certainly not as revered as the third.
Clarke’s Laws are a paradox of sorts, lacking any real basis in hard facts or science. They challenge both conformity and logic by blurring the line between fantasy and reality, and pushing the boundaries of conventional wisdom. While they originally were intended to be a guideline for predicting future scientific developments, Clarke’s Laws—particularly the third (naturally)—have allowed the science in mainstream science-fiction to transcend human technological limitations (i.e., the teleportation machine in “Travel by Wire,” the fourth spatial dimension in “Technical Error” and the hot-hydrogen balloon-supported aircraft that attempts a Jupiter landing in “A Meeting with Medusa”). Such inventions are completely justifiable under Clarke’s third Law: “Any sufficiently advanced technology is indistinguishable from magic.”
Over the last four decades, Clarke’s third Law has become the most popular of the four—and the most controversial. Science-fiction aficionados, futurists, journalists and bloggers alike have taken Clarke to task for daring to associate magic with modern technology. “What qualifies as magic?” io9 contributing reporter Esther Inglis-Arkell asked in a late April blog post. “Naturally, any alien or time traveler trying to put one over on a gullible new species can represent a technology as magic. That is the basis of the law. But I’m not sure that’s correct. When it comes to technology versus magic, the point isn’t the advanced state of the technology, the point is the exclusivity of the trick.”
Clarke, however, never assented to the criticism. In an interview with Venezuelan futurist and transhumanist scholar José Luis Cordeiro several years before his 2008 death, Clarke defended his Third Commandment and reaffirmed his belief in the increasingly accelerated pace of technology. When Cordeiro asked whether he’d consider revising any of his now-famous laws, Clarke confidently replied, “They stand as they are. Some technologies were pure magic only 20 years ago, and they are reality today, just like your digital camera and recorder.”
Clearly, Clarke’s list of technological magic is incomplete. It doesn’t include such obvious innovations as the Internet, iPhone, iPad, face scanners or virtual reality, nor does it incorporate medical advancements like minimally invasive surgery, bioresorbable stents, tissue regeneration, cloning or bionic body parts. Manufacturing equipment—particularly the machines used to create those cutting-edge medtech products—are excluded as well, though Clarke’s passion for mathematics and physics could explain the oversight.
Nevertheless, modern manufacturing marvels such as Swiss turning equipment, computer numeric controlled (CNC) milling equipment and micro abrasive waterjet machines are worthy candidates of Clarke’s list, having worked their own technological magic in recent years to create medical device parts with more complex geometries and tighter tolerances. Traditional CNC machining, for instance, has evolved from a heavily “front-end-loaded” process to a significantly faster, labor-saving digital procedure that helps minimize error and improve product quality. Similarly, Swiss turning machinery abandoned the cams and feed gears that defined its early success for the servo drives, encoders and precision ball screws needed to manufacture small electrical components and semiconductors.
“Manufacturing is definitely alive and well,” said Robert Murphy, vice president of Datron Dynamics Inc., a Milford, N.H.-based sales, service and support division for high-speed machining manufacturer Datron AG. “The medical industry is especially dynamic because all the companies we engage with are looking for outside-the-box technology to stay competitive. They’re fabricating extremely complex parts and in many cases, these parts are getting smaller and more precise. It’s really driving [machining] technology.”
From G-Codes to Software
Nineteenth- and early 20th-century manufacturing machines were not the most bewitching creatures (at least not by Clarke’s standards). They tended to be big, bulky monstrosities, and were based on a numerical control (NC) system first introduced in the 1800s to run textile looms and player pianos.
Machinist/salesman John T. Parsons of Traverse, City, Mich., was the first to envision an NC system, having conceptualized the idea while fulfilling a manufacturing contract for helicopter rotor blades during World War II. In 1949, he received U.S. Air Force funding to develop a numerical manufacturing technique involving servo controls (the use of pulse width modulation to remotely control servos); thanks to trial-and-error with the rotor blade contract, Parsons discovered that positional data input through a paper punch application system—scoffed at by aerospace behemoth Lockheed Corporation—could hasten manual processes and improve machining precision.
Parsons first worked with the Massachusetts Institute of Technology to create an experimental numerically controlled contour milling machine but he parted ways with the prestigious school after researchers negotiated their own government contract for a NC milling machine in 1950. Unlike Parson’s original punched card design, MIT’s plan used standard seven-track punch tape for input, with three of the tracks controlling different axes of the machine and the other four encoding various control data. MIT’s machine made its debut in September 1952 to critical acclaim despite its hefty $360,000 price tag ($3.11 million in 2013 dollars) and dizzying matrix of 250 vacuum tubes, 175 relays and numerous moving parts that reduced its production reliability.
By the mid-1950s, a proliferation of NC machining projects were underway at various companies, including one comprised of the MIT group that shafted Parsons out of a government contract. Many of the machines developed during this time used punch tape cards created by a typewriter-like machine known as the “flexowriter.” The cards were fed into a large control unit adjacent to the machinery and imprinted with a programming sequence called G-Code, named after the company that developed it, Gerber Scientific Instruments.
While it sounds downright Paleolithic now, the method was remarkably effective. A Boeing report at the time deemed numerical control a proven way to “reduce costs, reduce lead times, improve quality, reduce tooling and increase productivity.” Yet acceptance of the technology among manufacturing firms was relatively sluggish. As Parsons recalled in a 2001 interview, “The NC concept was so strange to manufacturers and so slow to catch on that the U.S. Army itself finally had to build 120 NC machines and lease them to various manufacturers to begin popularizing its use.”
Once the technology caught on, though, it spread like wildfire. NC machining, in fact, was the manufacturing industry standard until CNC fabrication came along in the late 1960s. CNC technology uses the same basic principles as the numerical protocol system, but ditches the archaic punch and paper process for more advanced computer software programs.
CNC machining is performed on 3-axis, 4-axis or 5-axis milling equipment. In 3-axis milling, a workpiece moves along the x and y axes (side-to-side and forward-backward) and the cutting tool moves up and down along the z axis. The simplest way to mill a piece of material, according to experts, is by positioning—or fixturing—the workpiece in 90-degree setups. More complicated fixturing can be used on these machines, but the added intricacy is likely to increase both time and cost depending on the setup’s complexity.
Four-axis machines have a turntable that moves the workpiece around a rotational axis and automatically mills various sides of an industrial component while 5-axis equipment features a second rotational axis that cuts into the machined part at upward and downward angles. Both 4- and 5-axis processes are simpler operationally (neither requires manual repositioning of the workpiece) but costlier due to higher machine rates and engineering time, CNC experts contend.
The advent of CNC technology also begat such ancillary innovations as computer-aided design (CAD) and computer-aided manufacturing (CAM), procedures that conceptually are similar to the machining punch card system created in 1952 but give manufacturers greater flexibility in their operations.
The melding of design, machining and manufacturing software over the last two decades has opened up a whole new world to manufacturers, allowing them to craft incredibly tiny parts at warp speed (for a fraction of their traditionally-produced cost) and deliver Clarke’s Law-inspired services. Maple Plain, Minn.-based Proto Labs Inc., for example, offers a one-day service to manufacturers with small orders (50-50,000 items) for injection-molded parts made from steel, magnesium, copper, stainless steel and high-temperature medical grade resins including Ultem and polyetheretherketone. The service is akin to ordering business cards online: A medical device designer simply uploads his or her CAD file to a website (www.protomold.com), chooses from several preset options and then waits for shelf-worthy injected-molded parts to arrive on his doorstep.
Like magic.
Datron cast its own spell on the implant manufacturing world three years ago with the introduction of the D5 Dental Mill, a 5-axis, high-speed machining center that has a user-friendly touch screen Apple iPad to control all machine functions. The open architecture control software can interface with all standard scanning systems and CAD/CAM packages, according to the company. The touch operator interface of the iPad allows for simple programming and enables both machine operations and job status to be monitored remotely. By activating the Live View button, the iPad screen shows the machining area. A camera mounted inside the machine transmits the image to the iPad screen, thus enabling the operator to check the production status of the machine from a remote location like an office or even a ceramic station.
Within the D5 machining software, dental milling data generated by the CAM module constantly is synchronized with the job manager and is activated when needed, Datron executives note. The computer program also schedules a pre-defined tool exchange (replacement) based on function and machining time, which helps ensure ongoing quality control even while the equipment is unattended. Yet the most enchanting facet of the D5 may lie in its simplicity of use. “When we got the VMC [vertical machining center], it didn’t come with tools, tool holders, coolant…not even CAM software to go with it. We just got the machine and they were like, ‘here you go,’ so the biggest challenge was just trying to figure out what to do with it,” explained Imagine Milling Technologies LLC owner Felix Chung, who uses a D5 in his Reston, Va.-based company to mill titanium-, cobalt chromium- and poly(methyl methacrylate)/wax-based dental implants. “Before, we wasted a lot of money testing tools and finding the optimal milling parameters for each one. With the D5, Datron does all of that for you and has all of the milling strategies already set.”
Such wizardry has helped Datron address a growing need in the dental implant industry for CNC equipment that can be run by engineers or technicians rather than traditional machinists.
“The medical industry is changing a little in the sense that we’re seeing more non-machinists like engineers and technicians venturing into the production side. So, we’re offering a user-friendly and turnkey solution to mill highly complicated parts,” Murphy told Medical Product Outsourcing. “The technology is changing rapidly. The software is getting better, the hardware is getting better. Going back 15 or 20 years ago, it took skilled machinists to mill the parts. But with most of our OEM customers we’re usually training technicians or engineers to use our equipment. When companies ask who the best person is to put on the [D5] system we never point to a machinist, we usually point to either a recent college graduate or a technician or a mechanical engineer. It’s easier to teach these people these new processes and techniques than it is to train a machinist from 20 years ago that is used to conventional milling technology. Some of the technology has changed that much—the CAD/CAM, the CNC, the digital scanning process, the high-speed machining techniques—it’s become a whole new ball game over the last 10 years.”
The industry’s ballparks, meanwhile, have shrunk. Consolidation, cost-cutting and Lean manufacturing has reduced medical manufacturing floor space and triggered redesigns of shop floors that increase overall square footage by combining storage space, eliminating non-essential computer workstations, decentralizing redundant storage, archiving files, resizing workbenches, and combining machinery.
Makino is helping to preserve premium shop floor space with its new compact, horizontal CNC machine. The company’s N2 platform—introduced earlier this year—takes up less than 26 square feet of floor space (including the coolant tank and standard chip management), measuring 45.3 inches wide by 83.7 inches long by 84.6 inches high. The 4-axis N2 offers a 400-mm high, 400-mm diameter cylindrical work envelope with x-, y- and z-axis travels of 300 mm-by-230 mm, and 300-mm diameter direct-drive rotary table. The machine is equipped with a 20,000-rpm HSK-40 spindle that accelerates to full rpm in 0.8 seconds. Four spindle nozzles provide coolant directly to the cutting zone for efficient cooling and improved part quality.
Direct-drive rotary axes offer a B-axis speed of 150 rpm and a 90-degree rotation time of 0.65 seconds. The N2 system works in concert with a responsive 1.4G z-axis to reduce common drill and tap operations by as much as 40 percent compared with traditional 400-mm horizontal machining centers.
“We see a trend in some of the medical orthopedic implant companies to shift to horizontal machining centers from vertical machining centers. The reasons for that are an increase in throughput and productivity and an increase in capability, particularly in tough-to-machine materials like cobalt chrome and titanium alloys for implants,” noted Mark Rentschler, marketing manager for Makino, a Tokyo, Japan-based CNC machining center developer/provider. “Many [companies] are hard-pressed for manufacturing floor space in their facilities and they don’t want to undergo further capital investment to expand operations. One of the other drivers in the device area is the ability to establish productivity as a basis of square footage necessary. The N2 machine has a very large 5-axis work zone for its size and is ideal for near-net shape machining of orthopedic implants like bone plates. With tight budgets and pressures to keep costs down, you’re really trying to enhance your throughput, enhance your productivity and do it with less overall total costs. We’ve heard directly from other medical manufacturers, ‘We don’t have the floor space for your standard machines, do you have anything smaller?’ The N2 is a reaction to those inquiries.”
Equipment Purchasing Strategies
Clarke’s brand of magic doesn’t come cheap. CNC milling machines cost tens of thousands of dollars, while injection molding equipment can run anywhere from $2,000 to $40,000 and higher depending on type, size and function. Hydraulic molding machines are the most widely used and usually the cheapest to purchase; hybrid systems incorporate the best qualities of a hydraulic and electric injector but use the same amount of electricity as all-electric molders, which help reduce energy consumption and increase productivity.
Improved manufacturing efficiency prompted Classic Industries Inc. executives to upgrade the company’s molding machines several years ago. The Latrobe, Pa.-based contract design, manufacturing, assembly, packaging and logistics services provider replaced 11 hydraulic presses with electric machines to better control its production processes. The switch, according to Classic bigwigs, increased the firm’s ratio of electric molding equipment at its headquarters to two-thirds.
“All electric machines are the workhorse for the future,” said Jay Smith, Classic Industries’ vice president of business development. “They are energy efficient and offer a repeatable injection profile. When these machines are used with a de-coupled process you have a repeatable fill pattern that overcomes material viscosity variation.”
Such perks made Classic’s decision to upgrade its injection molding presses relatively easy. But capital equipment purchases rarely are based on one mitigating factor; rather, they are grounded in various elements like ROI (return on investment), speed to market, service agreements, technology, and lifespan. Smith said his company considers ROI, warranty, financing terms and hardware/software standardization when purchasing manufacturing equipment.
Automation increasingly is becoming a major determinant as well. The latest Pharma/Medical Device Segment Report from the Reston, Va.-based Packaging Machinery Manufacturers Institute (PMMI) indicates that life sciences firms are integrating automation into their production processes to better control systems that manage, command, regulate or inspect device behavior, reduce risk protective measures at the input/output, network central processing unit layers, and improve overall operations.
Design also is driving manufacturing equipment purchases, according to PMMI data. Nearly three-quarters (72 percent) of pharmaceutical and medical device companies have a “significant interest” in modular machinery, which can help improve flexibility and accelerate startup times while reducing a manufacturing plant’s total equipment footprint. Of those 72 percent, nearly half already use mechanisms with modular designs such as machines in sections for easy configurations or flexible arrangement on the plant floor.
Some companies, however, employ more unconventional methods to dictate equipment purchases. Elcam Medical, for instance, uses forecast models to determine the exact number of molding machine it needs. “You always need to have a certain overcapacity, so when we make a decision about a molding machine, we look at the forecast and we say, ‘Okay, based on the forecast, we need so many molding hours per year,’ and then we just go out and purchase the machines,” explained Amir Halperin, president of the Israeli firm’s U.S. operations (the 43-year-old company produces disposable medical devices and provides solutions for specialized flow control needs). “Unless your confidence is really shaky and you want to use a contract manufacturer in the short term, you just order [equipment] to your capacity. You don’t want to get caught in a situation where you don’t have enough molding time. Then you lose business. The decision here is not very difficult.”
The decision is not that difficult for companies with aging or obsolete equipment, either. Old machinery, in fact, has markedly influenced capital equipment purchases since the Great Recession, according to PMMI’s report. In 2008, pharmaceutical and medical device companies considered aging apparatuses to be the 15th most important factor in new equipment purchases; last year, outdated machines moved up to the No. 3 spot.
“We see a lot of companies that have equipment that they implemented 10 or 15 years ago when their challenges were different. There may be an opportunity here for them to leverage the latest technology and the efficiencies that come with it when they bring in new equipment,” Datron’s Murphy observed. “In that case, it’s an investment. You need to invest in the new piece of equipment, implement it and then run it for another 10 to 15 years making parts. Some companies buy a piece of equipment for a particular job they have and they’re really not sure what they’re going to do with the equipment afterwards, but they’ll find the work. Other companies, like St. Jude Medical, who we’ve sold machines to, they have a five- and 10-year plan for the equipment—they know exactly what the equipment is going to be doing for five or 10 years. In any case, whoever buys the equipment, it’s an investment. They need to look at how long is it going to take for this machine to pay itself off, and what it’s going to yield in terms of parts, volume and profit. It’s a tool.
Milling machines are basically just a tool for the engineers and machinists to make parts they need in a manner that will have the biggest impact on their business.”
Clarke, however, clearly baited destiny at times. He tended to lump his scientific rules and theories into groups of three á la Sir Isaac Newton, starting with the 1968 Law of Revolutionary Ideas and culminating with the addition of a third law of prediction (better known cumulatively as Clarke’s Laws) in a 1972 revision of his iconic “Profiles of the Future” essay compendium. The brilliant prognosticator added a fourth law to the 1999 edition of “Profiles”—“for every expert there is an equal and opposite expert”—but that decree generally is not as widely accepted as the first three and certainly not as revered as the third.
Clarke’s Laws are a paradox of sorts, lacking any real basis in hard facts or science. They challenge both conformity and logic by blurring the line between fantasy and reality, and pushing the boundaries of conventional wisdom. While they originally were intended to be a guideline for predicting future scientific developments, Clarke’s Laws—particularly the third (naturally)—have allowed the science in mainstream science-fiction to transcend human technological limitations (i.e., the teleportation machine in “Travel by Wire,” the fourth spatial dimension in “Technical Error” and the hot-hydrogen balloon-supported aircraft that attempts a Jupiter landing in “A Meeting with Medusa”). Such inventions are completely justifiable under Clarke’s third Law: “Any sufficiently advanced technology is indistinguishable from magic.”
Over the last four decades, Clarke’s third Law has become the most popular of the four—and the most controversial. Science-fiction aficionados, futurists, journalists and bloggers alike have taken Clarke to task for daring to associate magic with modern technology. “What qualifies as magic?” io9 contributing reporter Esther Inglis-Arkell asked in a late April blog post. “Naturally, any alien or time traveler trying to put one over on a gullible new species can represent a technology as magic. That is the basis of the law. But I’m not sure that’s correct. When it comes to technology versus magic, the point isn’t the advanced state of the technology, the point is the exclusivity of the trick.”
Clarke, however, never assented to the criticism. In an interview with Venezuelan futurist and transhumanist scholar José Luis Cordeiro several years before his 2008 death, Clarke defended his Third Commandment and reaffirmed his belief in the increasingly accelerated pace of technology. When Cordeiro asked whether he’d consider revising any of his now-famous laws, Clarke confidently replied, “They stand as they are. Some technologies were pure magic only 20 years ago, and they are reality today, just like your digital camera and recorder.”
Clearly, Clarke’s list of technological magic is incomplete. It doesn’t include such obvious innovations as the Internet, iPhone, iPad, face scanners or virtual reality, nor does it incorporate medical advancements like minimally invasive surgery, bioresorbable stents, tissue regeneration, cloning or bionic body parts. Manufacturing equipment—particularly the machines used to create those cutting-edge medtech products—are excluded as well, though Clarke’s passion for mathematics and physics could explain the oversight.
Nevertheless, modern manufacturing marvels such as Swiss turning equipment, computer numeric controlled (CNC) milling equipment and micro abrasive waterjet machines are worthy candidates of Clarke’s list, having worked their own technological magic in recent years to create medical device parts with more complex geometries and tighter tolerances. Traditional CNC machining, for instance, has evolved from a heavily “front-end-loaded” process to a significantly faster, labor-saving digital procedure that helps minimize error and improve product quality. Similarly, Swiss turning machinery abandoned the cams and feed gears that defined its early success for the servo drives, encoders and precision ball screws needed to manufacture small electrical components and semiconductors.
“Manufacturing is definitely alive and well,” said Robert Murphy, vice president of Datron Dynamics Inc., a Milford, N.H.-based sales, service and support division for high-speed machining manufacturer Datron AG. “The medical industry is especially dynamic because all the companies we engage with are looking for outside-the-box technology to stay competitive. They’re fabricating extremely complex parts and in many cases, these parts are getting smaller and more precise. It’s really driving [machining] technology.”
From G-Codes to Software
Nineteenth- and early 20th-century manufacturing machines were not the most bewitching creatures (at least not by Clarke’s standards). They tended to be big, bulky monstrosities, and were based on a numerical control (NC) system first introduced in the 1800s to run textile looms and player pianos.
Machinist/salesman John T. Parsons of Traverse, City, Mich., was the first to envision an NC system, having conceptualized the idea while fulfilling a manufacturing contract for helicopter rotor blades during World War II. In 1949, he received U.S. Air Force funding to develop a numerical manufacturing technique involving servo controls (the use of pulse width modulation to remotely control servos); thanks to trial-and-error with the rotor blade contract, Parsons discovered that positional data input through a paper punch application system—scoffed at by aerospace behemoth Lockheed Corporation—could hasten manual processes and improve machining precision.
Parsons first worked with the Massachusetts Institute of Technology to create an experimental numerically controlled contour milling machine but he parted ways with the prestigious school after researchers negotiated their own government contract for a NC milling machine in 1950. Unlike Parson’s original punched card design, MIT’s plan used standard seven-track punch tape for input, with three of the tracks controlling different axes of the machine and the other four encoding various control data. MIT’s machine made its debut in September 1952 to critical acclaim despite its hefty $360,000 price tag ($3.11 million in 2013 dollars) and dizzying matrix of 250 vacuum tubes, 175 relays and numerous moving parts that reduced its production reliability.
By the mid-1950s, a proliferation of NC machining projects were underway at various companies, including one comprised of the MIT group that shafted Parsons out of a government contract. Many of the machines developed during this time used punch tape cards created by a typewriter-like machine known as the “flexowriter.” The cards were fed into a large control unit adjacent to the machinery and imprinted with a programming sequence called G-Code, named after the company that developed it, Gerber Scientific Instruments.
While it sounds downright Paleolithic now, the method was remarkably effective. A Boeing report at the time deemed numerical control a proven way to “reduce costs, reduce lead times, improve quality, reduce tooling and increase productivity.” Yet acceptance of the technology among manufacturing firms was relatively sluggish. As Parsons recalled in a 2001 interview, “The NC concept was so strange to manufacturers and so slow to catch on that the U.S. Army itself finally had to build 120 NC machines and lease them to various manufacturers to begin popularizing its use.”
Once the technology caught on, though, it spread like wildfire. NC machining, in fact, was the manufacturing industry standard until CNC fabrication came along in the late 1960s. CNC technology uses the same basic principles as the numerical protocol system, but ditches the archaic punch and paper process for more advanced computer software programs.
CNC machining is performed on 3-axis, 4-axis or 5-axis milling equipment. In 3-axis milling, a workpiece moves along the x and y axes (side-to-side and forward-backward) and the cutting tool moves up and down along the z axis. The simplest way to mill a piece of material, according to experts, is by positioning—or fixturing—the workpiece in 90-degree setups. More complicated fixturing can be used on these machines, but the added intricacy is likely to increase both time and cost depending on the setup’s complexity.
Four-axis machines have a turntable that moves the workpiece around a rotational axis and automatically mills various sides of an industrial component while 5-axis equipment features a second rotational axis that cuts into the machined part at upward and downward angles. Both 4- and 5-axis processes are simpler operationally (neither requires manual repositioning of the workpiece) but costlier due to higher machine rates and engineering time, CNC experts contend.
The advent of CNC technology also begat such ancillary innovations as computer-aided design (CAD) and computer-aided manufacturing (CAM), procedures that conceptually are similar to the machining punch card system created in 1952 but give manufacturers greater flexibility in their operations.
The melding of design, machining and manufacturing software over the last two decades has opened up a whole new world to manufacturers, allowing them to craft incredibly tiny parts at warp speed (for a fraction of their traditionally-produced cost) and deliver Clarke’s Law-inspired services. Maple Plain, Minn.-based Proto Labs Inc., for example, offers a one-day service to manufacturers with small orders (50-50,000 items) for injection-molded parts made from steel, magnesium, copper, stainless steel and high-temperature medical grade resins including Ultem and polyetheretherketone. The service is akin to ordering business cards online: A medical device designer simply uploads his or her CAD file to a website (www.protomold.com), chooses from several preset options and then waits for shelf-worthy injected-molded parts to arrive on his doorstep.
Like magic.
Datron cast its own spell on the implant manufacturing world three years ago with the introduction of the D5 Dental Mill, a 5-axis, high-speed machining center that has a user-friendly touch screen Apple iPad to control all machine functions. The open architecture control software can interface with all standard scanning systems and CAD/CAM packages, according to the company. The touch operator interface of the iPad allows for simple programming and enables both machine operations and job status to be monitored remotely. By activating the Live View button, the iPad screen shows the machining area. A camera mounted inside the machine transmits the image to the iPad screen, thus enabling the operator to check the production status of the machine from a remote location like an office or even a ceramic station.
Within the D5 machining software, dental milling data generated by the CAM module constantly is synchronized with the job manager and is activated when needed, Datron executives note. The computer program also schedules a pre-defined tool exchange (replacement) based on function and machining time, which helps ensure ongoing quality control even while the equipment is unattended. Yet the most enchanting facet of the D5 may lie in its simplicity of use. “When we got the VMC [vertical machining center], it didn’t come with tools, tool holders, coolant…not even CAM software to go with it. We just got the machine and they were like, ‘here you go,’ so the biggest challenge was just trying to figure out what to do with it,” explained Imagine Milling Technologies LLC owner Felix Chung, who uses a D5 in his Reston, Va.-based company to mill titanium-, cobalt chromium- and poly(methyl methacrylate)/wax-based dental implants. “Before, we wasted a lot of money testing tools and finding the optimal milling parameters for each one. With the D5, Datron does all of that for you and has all of the milling strategies already set.”
Such wizardry has helped Datron address a growing need in the dental implant industry for CNC equipment that can be run by engineers or technicians rather than traditional machinists.
“The medical industry is changing a little in the sense that we’re seeing more non-machinists like engineers and technicians venturing into the production side. So, we’re offering a user-friendly and turnkey solution to mill highly complicated parts,” Murphy told Medical Product Outsourcing. “The technology is changing rapidly. The software is getting better, the hardware is getting better. Going back 15 or 20 years ago, it took skilled machinists to mill the parts. But with most of our OEM customers we’re usually training technicians or engineers to use our equipment. When companies ask who the best person is to put on the [D5] system we never point to a machinist, we usually point to either a recent college graduate or a technician or a mechanical engineer. It’s easier to teach these people these new processes and techniques than it is to train a machinist from 20 years ago that is used to conventional milling technology. Some of the technology has changed that much—the CAD/CAM, the CNC, the digital scanning process, the high-speed machining techniques—it’s become a whole new ball game over the last 10 years.”
The industry’s ballparks, meanwhile, have shrunk. Consolidation, cost-cutting and Lean manufacturing has reduced medical manufacturing floor space and triggered redesigns of shop floors that increase overall square footage by combining storage space, eliminating non-essential computer workstations, decentralizing redundant storage, archiving files, resizing workbenches, and combining machinery.
Makino is helping to preserve premium shop floor space with its new compact, horizontal CNC machine. The company’s N2 platform—introduced earlier this year—takes up less than 26 square feet of floor space (including the coolant tank and standard chip management), measuring 45.3 inches wide by 83.7 inches long by 84.6 inches high. The 4-axis N2 offers a 400-mm high, 400-mm diameter cylindrical work envelope with x-, y- and z-axis travels of 300 mm-by-230 mm, and 300-mm diameter direct-drive rotary table. The machine is equipped with a 20,000-rpm HSK-40 spindle that accelerates to full rpm in 0.8 seconds. Four spindle nozzles provide coolant directly to the cutting zone for efficient cooling and improved part quality.
Direct-drive rotary axes offer a B-axis speed of 150 rpm and a 90-degree rotation time of 0.65 seconds. The N2 system works in concert with a responsive 1.4G z-axis to reduce common drill and tap operations by as much as 40 percent compared with traditional 400-mm horizontal machining centers.
“We see a trend in some of the medical orthopedic implant companies to shift to horizontal machining centers from vertical machining centers. The reasons for that are an increase in throughput and productivity and an increase in capability, particularly in tough-to-machine materials like cobalt chrome and titanium alloys for implants,” noted Mark Rentschler, marketing manager for Makino, a Tokyo, Japan-based CNC machining center developer/provider. “Many [companies] are hard-pressed for manufacturing floor space in their facilities and they don’t want to undergo further capital investment to expand operations. One of the other drivers in the device area is the ability to establish productivity as a basis of square footage necessary. The N2 machine has a very large 5-axis work zone for its size and is ideal for near-net shape machining of orthopedic implants like bone plates. With tight budgets and pressures to keep costs down, you’re really trying to enhance your throughput, enhance your productivity and do it with less overall total costs. We’ve heard directly from other medical manufacturers, ‘We don’t have the floor space for your standard machines, do you have anything smaller?’ The N2 is a reaction to those inquiries.”
Equipment Purchasing Strategies
Clarke’s brand of magic doesn’t come cheap. CNC milling machines cost tens of thousands of dollars, while injection molding equipment can run anywhere from $2,000 to $40,000 and higher depending on type, size and function. Hydraulic molding machines are the most widely used and usually the cheapest to purchase; hybrid systems incorporate the best qualities of a hydraulic and electric injector but use the same amount of electricity as all-electric molders, which help reduce energy consumption and increase productivity.
Improved manufacturing efficiency prompted Classic Industries Inc. executives to upgrade the company’s molding machines several years ago. The Latrobe, Pa.-based contract design, manufacturing, assembly, packaging and logistics services provider replaced 11 hydraulic presses with electric machines to better control its production processes. The switch, according to Classic bigwigs, increased the firm’s ratio of electric molding equipment at its headquarters to two-thirds.
“All electric machines are the workhorse for the future,” said Jay Smith, Classic Industries’ vice president of business development. “They are energy efficient and offer a repeatable injection profile. When these machines are used with a de-coupled process you have a repeatable fill pattern that overcomes material viscosity variation.”
Such perks made Classic’s decision to upgrade its injection molding presses relatively easy. But capital equipment purchases rarely are based on one mitigating factor; rather, they are grounded in various elements like ROI (return on investment), speed to market, service agreements, technology, and lifespan. Smith said his company considers ROI, warranty, financing terms and hardware/software standardization when purchasing manufacturing equipment.
Automation increasingly is becoming a major determinant as well. The latest Pharma/Medical Device Segment Report from the Reston, Va.-based Packaging Machinery Manufacturers Institute (PMMI) indicates that life sciences firms are integrating automation into their production processes to better control systems that manage, command, regulate or inspect device behavior, reduce risk protective measures at the input/output, network central processing unit layers, and improve overall operations.
Design also is driving manufacturing equipment purchases, according to PMMI data. Nearly three-quarters (72 percent) of pharmaceutical and medical device companies have a “significant interest” in modular machinery, which can help improve flexibility and accelerate startup times while reducing a manufacturing plant’s total equipment footprint. Of those 72 percent, nearly half already use mechanisms with modular designs such as machines in sections for easy configurations or flexible arrangement on the plant floor.
Some companies, however, employ more unconventional methods to dictate equipment purchases. Elcam Medical, for instance, uses forecast models to determine the exact number of molding machine it needs. “You always need to have a certain overcapacity, so when we make a decision about a molding machine, we look at the forecast and we say, ‘Okay, based on the forecast, we need so many molding hours per year,’ and then we just go out and purchase the machines,” explained Amir Halperin, president of the Israeli firm’s U.S. operations (the 43-year-old company produces disposable medical devices and provides solutions for specialized flow control needs). “Unless your confidence is really shaky and you want to use a contract manufacturer in the short term, you just order [equipment] to your capacity. You don’t want to get caught in a situation where you don’t have enough molding time. Then you lose business. The decision here is not very difficult.”
The decision is not that difficult for companies with aging or obsolete equipment, either. Old machinery, in fact, has markedly influenced capital equipment purchases since the Great Recession, according to PMMI’s report. In 2008, pharmaceutical and medical device companies considered aging apparatuses to be the 15th most important factor in new equipment purchases; last year, outdated machines moved up to the No. 3 spot.
“We see a lot of companies that have equipment that they implemented 10 or 15 years ago when their challenges were different. There may be an opportunity here for them to leverage the latest technology and the efficiencies that come with it when they bring in new equipment,” Datron’s Murphy observed. “In that case, it’s an investment. You need to invest in the new piece of equipment, implement it and then run it for another 10 to 15 years making parts. Some companies buy a piece of equipment for a particular job they have and they’re really not sure what they’re going to do with the equipment afterwards, but they’ll find the work. Other companies, like St. Jude Medical, who we’ve sold machines to, they have a five- and 10-year plan for the equipment—they know exactly what the equipment is going to be doing for five or 10 years. In any case, whoever buys the equipment, it’s an investment. They need to look at how long is it going to take for this machine to pay itself off, and what it’s going to yield in terms of parts, volume and profit. It’s a tool.
Milling machines are basically just a tool for the engineers and machinists to make parts they need in a manner that will have the biggest impact on their business.”