Several years ago, automation in the medical device industry was confined to upstream and downstream applications, such as material handling equipment and packaging lines. Most assembly was performed manually by technicians seated at long rows of workstations. But, today, it's a totally different story. Manufacturers are investing heavily in flexible assembly machines, conveyors, feeders, robots, controls, vision systems and other equipment capable of repeatable, high-volume production.
Automation is having a big impact on the way cannulas, catheters, connectors, filters, inhalers, meters, pumps, syringes, valves and other products are assembled. The medical device industry has been harnessing automated systems to boost throughput, improve reliability, shorten time to market and reduce production costs. As the trend toward smaller, more complex products continues, the requirement for automation will increase.
Manufacturers want to automate their assembly lines for a variety of reasons. No matter what type of medical device they produce, engineers are scrambling to add value to the manufacturing process by reducing the amount of tedious manual labor, while increasing quantity, improving quality and reducing final part cost.
Above all, medical device manufacturers are looking for repeatable, consistent results. This basic need is largely driven by strict validation requirements enforced by government agencies, such as the U.S. Food and Drug Administration (FDA, Rockville, MD).
"The movement toward automated systems is for better quality control and assurance," says Bill Martineau, healthcare industry analyst at the Freedonia Group Inc. (Cleveland). ["Manufacturers are also automating] for faster, more cost-efficient production, avoidance of back orders, and the ability to respond more quickly to changing demand patterns."
More and more manufacturers are concerned about flexibility, ease of changeover and adaptability for reuse. "The industry has a unique problem in that [manufacturers] need to respond quickly to changes in the marketplace, yet they have to revalidate and recertify equipment if they make product or process changes according to the FDA," notes Jay Hallberg, regional sales manager at Epson Robots (Carson, CA). "They will have a much easier time with validation and certification if they can reuse existing equipment."
"Automation in the medical device industry is just at the beginning of a growth cycle," claims Steve Hoenig, relationship manager for the automation systems group at ATS Automation Tooling Systems Inc. (ATS, Cambridge, ON). "The trend in the automotive industry is to send manufacturing operations to Asia and Mexico.
"However, in the medical device industry, because of the stringent demands of regulatory bodies in North America and Europe, and the need to protect intellectual property, much of the manufacturing remains in the country of final sale," adds Hoenig. "Add to that the need to keep costs down in the more expensive manufacturing environments of the West, and there is an even greater incentive to automate."
Unlike many other markets, the medical device field keeps getting bigger and bigger. According to Medtech Insight (Newport Beach, CA), the worldwide industry is expected to grow 7.5 percent annually, from $220 billion in 2005 to $312 billion in 2010. Much of that growth will come from categories such as spinal products, neuromodulation devices, sleep apnea products, advanced molecular diagnostics, cardiac rhythm management products, orthopedic implants and endoscopy devices.
The number of surgical procedures performed annually is on the rise, due to the aging population and an increase in elective procedures. Analysts at Medtech Insight predict that the total number of open and minimally invasive surgical procedures and device implantations in the United States will exceed 38 million in 2012 vs. 28 million in 2004.
The majority of medical devices are disposable, single-use products. "Based on demand value, the largest group of disposable medical supplies consists of intravenous (IV), catheterization and related products," says Martineau. "This group includes a wide range of devices and accessories used in surgery, respiratory therapy and other patient treatment. As a whole, IV, catheterization and related products will provide the best growth opportunities among the four major classes of disposable medical supplies, with demand increasing 6.5 percent annually [between now and 2009]."
Martineau expects that growth to be spurred by "high value-added drug delivery devices," such as dry powder inhalers, prefilled syringes, renal catheters and premixed IV solutions. "Most other IV, catheterization and related products will see moderate growth opportunities," says Martineau, due to multiple supplier availability, limited pricing flexibility, advances in minimally invasive patient procedures and the impact of competing technologies."
Traditionally, cardiovascular, orthopedic and respiratory products have accounted for a large chunk of the lucrative medical device market, and that trend is expected to continue in the future.
Indeed, the U.S. market for therapeutic devices aimed at treating cardiovascular disease is expanding rapidly. Kalorama Information (New York) predicts the market for defibrillators, heart valves, pacemakers, stents and other devices will increase 15 percent annually, from $14 billion in 2005 to $25 billion by 2014.
In addition, Kalorama analysts claim that the world market for inhalers and other respiratory equipment is ready to increase dramatically. For instance, the upcoming U.S. ban on chlorofluorocarbons, which takes effect in January 2008, will affect more than 95 percent of the inhalers currently on the market to treat asthma and emphysema.
People will also need more mass-produced components to replace old bones, jarred joints and weary organs. According to a recent study conducted by the Freedonia Group, demand for implantable medical devices, such as artificial hips and knees, will increase more than 10 percent annually to $36.4 billion by 2009. The market for orthopedic implants alone is growing 9 percent annually.
All that growth will fuel industrywide demand for faster production equipment. "Fierce competition in the medical device industry has forced companies to adopt automation technology to increase efficiency," says ATS Automation Tooling Systems' Hoenig. "Also, the proliferation of single-use instruments has expanded the market and driven the need for high-speed processes, including high-end vision technology, servo control, flexible programming and state-of-the-art process control."
Medical devices pose many unique challenges to equipment vendors, such as strict FDA requirements and stringent clean-room standards. That makes some products easier to automate than others.
Tom Kramer, president of Sortimat Technology (Schaumburg, IL), says today's products are more complex, with smaller parts and more components. He also says many products are often being developed at the same time as the machines.
"Product life-cycles are shorter, so people are looking for ways to run similar product families when products evolve," explains Kramer. That puts more pressure on machine builders and systems integrators. For instance, Kramer says many medical device manufacturers are requesting shorter deliveries. However, at the same time, they're looking for more technical features, such as more sophisticated test and inspection systems.
Many medical device applications constantly demand higher speed and better quality. "But, those two [needs] tend to conflict with one another in most assembly processes," says Bob Rice, applications team leader at Automation Tool Co. (ATC, Cookeville, TN). "With new medical devices, the return on [automation] investment is often accomplished in the first three to four months of production. By then, other manufacturers are offering lower-cost alternatives.
"The No. 1 concern in the medical device industry is quality," adds Rice. "New methods of high-speed testing to verify product integrity are necessary." As part of its ongoing commitment to quality, ATC recently enhanced its medical validation capabilities.
"Our goal is to improve our standards in an effort to meet our medical customers' needs," explains Rice. "By capitalizing on our ISO 9001:2000 standards, we will address the current GAMP4 and 21CFR qualification requirements, and model our procedures to meet these requirements." This will guarantee that all necessary processes are in place and followed through on every piece of medical assembly equipment built by ATC.
Lori Logan, marketing manager at Deprag Inc. (Lewisville, TX), agrees that medical device automation projects typically require an increase in production output, while simultaneously improving product quality. For instance, she says the following basic criteria are often required when designing an automatic assembly station: processing flexibility, including test and inspection; an ability to handle small, delicate and sensitive parts; an ability to process different materials; faster cycle times to reduce production cost; an ability to provide increased yield and quality; and an ability to ensure reliability, repeatability and traceability.
In addition, medical device applications are usually more complicated than most other automation projects, because the typical medical device is assembled in a class 100,000 or 10,000 clean room environment. "Conveyors, part feeders, robotics and vision systems need to be specially designed to minimize particulate generation," notes ATS Automation Tooling Systems' Hoenig. "Special materials may also be needed in the part contact zone."
In the past, some medical device manufacturers had bad experiences with automation. Often, machine builders had difficulty achieving the high production rates. However, Hoenig says that design for manufacturability (DFM) has helped address some of those issues.
"[We] like to participate, as much as possible, at the product design stage to ensure that manufacturing and assembly requirements are being correctly considered," he explains. "Where [we have] the opportunity to discuss DFM with customers early enough in the product design cycle, project success has been significantly enhanced."
According to Roger Nordy, senior business development engineer at Cox Automation Systems (Bloomingdale, IL), the medical device product evolution is heading in several different directions. "The parts are getting smaller," he points out. "With smaller components, the attributes that have historically been used by [machine builders] for feeding and orientation are also getting smaller.
"These smaller features are making feeding with orientation more difficult, if not impossible," explains Nordy. "This in turn adds a level of complexity to the automation system."
In addition, Nordy says that subassemblies that have historically been two or three parts are now morphing into a more complex single component. "These components may have a live hinge or some other functional attribute," he points out. "These multifunctional components can add a new level of complexity to any feeding system."
Another trend in the medical device market today is the growing use of modular automation. "Unlike other industries, such as automotive, medical device manufacturers tend to integrate their own turnkey assembly systems instead of outsourcing those services to a systems integrator," claims Mark Dinges, product manager for material flow automation technologies at Bosch Rexroth Corp. (Buchanan, MI). "This tendency is due in large part to the proprietary design of many medical device components."
To limit the turnkey assembly burden, Dinges says medical device manufacturers tend to purchase preassembled modular conveying equipment, which features bolt-together components such as aluminum framing. By purchasing reconfigurable equipment, these companies are able to minimize low-value processes, such as mechanical assembly, and focus on high-value processes, such as controls and station integration.
"One of the largest challenges in using conveyors in medical device applications is particulate generation," says Dinges. "Many manufacturers require that their assembly equipment comply with a clean room rating of Class 10,000." That means that a cubic foot of air cannot contain more than 10,000 particles 0.5 micron in diameter. To minimize particulate generation, clean room modifications are available, such as vacuum ports and brushes, which can be integrated into certain drive modules.
The Freedonia Group's Martineau says several technical issues still need to be addressed before medical device manufacturers adopt faster assembly processes. "Adaptability to line changes, establishment of quality control and quality assurance protocols, and FDA certification requirements [need to be considered]," he points out.
Candice Mehmetli, medical market leader at the Edison Welding Institute (Columbus, OH), agrees with that assessment. "Process control for the scale of these components is not readily available," she explains. "We've found with our clients that much of the [assembly] is still heavily manual due to the small-scale nature of the components.
"With hand processing, the components can be inspected as they're produced rather than after-the-fact reinspection, which occurs in batches with components produced using an automated process," adds Mehmetli. "Automation comes into play [more often] with pick-and-place and when moving components to another assembly or inspection station."
Ease of Automation
Before medical device engineers select automation for their assembly needs, they first need to verify whether their production volumes justify the purchase of such equipment. According to Jess Leon, P.E., president of Telesis Automation Corp. (Baldwin Park, CA), a good rule of thumb is to measure payback based on labor cost per year.
"If a machine has a payback of one year or less, it's a good candidate for an automation project," says Leon, who specializes in the medical device industry. "Anything with a payback beyond two years typically is not a good candidate.
"More and more medical device manufacturers are concerned about the cost of automation today," adds Leon, who has been a systems integrator for more than 30 years. "Despite FDA paperwork, going overseas is becoming an attractive option, especially for manufacturers of IV sets and other types of disposables."
Today, manufacturers are under additional pressure to apply reliable low-cost solutions to their automation programs. Some companies are demanding alternate manufacturing methodologies with shorter payback schedules.
In response, Cox Automation has developed a lean platform that "allows us to provide our customers with a [machine] within a few weeks to both manufacture their products for clinical studies and then continue to produce these same products for initial production launches," claims Nordy. "When Lean Trac is used as a transitioning tool to production, process development risks are also mitigated."
The easiest types of products to automate are typically high-volume, low-tech devices such as plasma bags and disposable surgical kits. However, certain high-volume, high-tech devices, such as pacemakers, hearing aids and dialysis filters, may also be good candidates for automation.
"Mature products are easiest to automate, because the product is the same and predictable, and the technology to assemble them is proven," notes Paul Nordin, senior project engineer at Sortimat. "Items involving fewer ‘soft' processes, such as gluing and ultrasonic welding, are [usually] easier to automate." In addition, Nordin says components that have been designed for feedability are typically easier to automate.
"As long as production volumes are high enough, the assembly of virtually any medical device can be automated," claims Bosch Rexroth's Dinges. "But, even if manual assembly methods are chosen, it's probably worth the manufacturing engineer's time to consult with someone who can help optimize the assembly process. Many new products grow from manual assembly operations to automated, and early planning can help ease this transition.
"As medical devices continue to shrink in size and become more complex, they require additional assembly steps," adds Dinges. "Many of these assembly steps require a high level of repetitive positioning or involve the handling of sensitive or miniature components that are too small for manual assembly."
According to Francisco Carrillo, application engineering supervisor at ATS, "The [ability] to automate a process is mostly defined by its simplicity and repeatability, and this also holds true for validation of a process or operation." These concepts are typically addressed during DFM, which covers part, as well as process design.
"Products that have [been designed for assembly] will include items like feeding features, draft angles for insertion, robust processes, and assembly steps that can be easily verified," explains Carrillo. "Any element of the components that can [increase the] consistency of the process will make the automation easier to develop, whether we are talking about part orientation, bonding of components, testing functionality, or any step of the assembly." Typically, products with robust plastic and metal components tend to fit these criteria.
Of course, not all medical devices are ideal candidates for automated assembly. "[Products that contain] tubing and silicone parts are more difficult to automate," says Howard Speiden, customer dialogue section head at Sortimat. "Soft, flexible parts; parts that create their own static charge; and parts with broad or generous tolerances are more difficult to automate."
Other elements that make automation more difficult are the handling requirements of delicate products. "Examples would include the singulation and handling of electro-chemical sensors; the tactile sensing required to handle flexible products; and peeling an adhesive off a web-based product after singulation," notes Carrillo.
An example of a product that is most difficult to automate would be something that relies heavily on the visual acumen and dexterity of a human operator, such as assembling hair-thin suture material to extremely small-gauge needles. "The drive to design smaller and smaller intrusive or implantable medical devices is a challenge that automation integrators must [constantly overcome with] innovative processes," says Carrillo.
Most observers agree that the most difficult items to manufacture are implantable devices. These products tend to have very small form factors that are dictated by the geometry of the affliction they are intended to treat.
For example, the treatment of aneurysms in the brain with a process known as coil embolization requires the preforming of some extremely thin wire to achieve the desired profile of the coil in the aneurysm. Implantable devices also place tighter constraints on the entire manufacturing process.
"Substances used in the manufacturing process may come in contact with the device and can have deleterious effects when implanted in the body," explains Ron Rekowski, director of the laser and medical group at Aerotech Inc. (Pittsburgh). "For example, there is a well-documented failure of acetabular cups (the socket in a hip replacement procedure) that failed to bond with the pelvic bone of numerous patients due to the presence of trace amounts of mineral lubricants that were unintentionally introduced in the machining process."
Rekowski says most implantable devices rely on manufacturing technologies that are not widely used in the general automation market. "When they do share processes with commercial devices, the manufacturing tolerances and process validation requirements are an order of magnitude more stringent," he points out. "This is to be expected, as the failure of a commercial device does not necessarily have life-threatening consequences.
"If your MP3 player fails, you get it repaired or replaced," notes Rekowski. "However, if your implantable cardiac defibrillator fails, you have a real problem. Automation providers must be prepared to deal with the process validation requirements and be capable of deploying product that can hold the required tolerances throughout their expected lifetime."
Vendors are addressing these challenges by creating products that are targeted directly at specific medical device manufacturing applications. "The resulting products don't necessarily have applicability to the general automation industry," says Rekowski. "A good example of this is our VascuLathe product.
"It is targeted at laser cutting of tubular materials used in stent manufacturing," adds Rekowski. "Features are designed into the product to address the specific requirements of this process. The integral design approach results in a higher performance, highly specialized platform that will outperform machine implementations based on standard component-level solutions."
The VascuLathe is used for high-volume production of cardiovascular, neurovascular and peripheral stents. It is a motion and material handling system that helps manufacturers improve flexibility and increase throughput. The device features an automated, pneumatically activated collet assembly that enables the sequential, unattended manufacture of multiple stents from a single length of tubing material.
With higher throughput, Rekowski says fewer machines are required to produce an equivalent number of stents, resulting in lower total labor costs and reduced floor space requirements. "In some applications, we have been able to double or triple the throughput of the manufacturing process," he claims. "Customers have been able to expand capacity within the confines of their existing building infrastructure, while reducing the effective labor content per part."