Benjamin Lichtman

Much effort has been put into trying to make robots and automation machines act like humans. Sensors are designedo endow them with the faculties of sight, hearing, and tactile sensing. Fuzzy logic seeks to model human reasoning in machines. Yet it can be argued that in the medical industry, the lure of automation equipment is precisely how inhuman it is.

"Machines take no sick leave or vacation," says Silke Fischer, company spokesperson at sortimat Technology GmbH & Co. (Winnenden, Germany). "What's more," she adds, "they rarely make mistakes—and if they do, they recognize them immediately." Although the days may have passed when companies dreamed of replacing entire human workforces with their android counterparts, automation continues to shape modern manufacturing by providing reduced production time and expanded capabilities.

The traditional purpose of industrial automation is to increase throughput while containing costs. "With bigger batch sizes and more emphasis on process control, the need for automation increases," says Adrian Schärli, product manager at Essemtec AG (Aesch, Switzerland). Medical OEMs are gradually implementing more automated systems, and machines now perform many repetitive tasks previously carried out by man. "Machines don't just assemble parts," says Fischer, "they also weld, apply adhesive, print labels, and coil tubes." Fischer points out that assembly equipment may also be pivotal in bringing a new product to market, noting that sortimat specialists played a role in the development of the first automated production line for infusion catheters.

Indeed, the demands of modern manufacturing, particularly in the medical sector, have given rise to a host of reasons to implement automated solutions. According to Jess Baker, president of Robotic Process Systems (RPS; Liberty Lake, WA, USA), the advantage of using automation equipment is twofold: absolute reproducibility of processes, including the generation of historical and statistical data, and reduced reliance on labour.

Increasing Productivity

As device OEMs seek to reduce time to market, they may find that they also need to produce multiple variations of products to appeal to niche markets. The most recent automation machinery available to device manufacturers is designed to meet these needs. "Lot sizes are getting smaller, and manufacturers are being asked to provide more customized solutions," says Michael Fraede, sales and product manager of the robot and handling systems department at Bosch Automation Technology (Stuttgart, Germany). Bosch produces production robots and aluminium frames for modular assembly systems. "Our equipment is designed to allow people to pick the best production system to meet these needs," says Fraede.

Lawrence Davie, sales and business development manager at AGR Automation Ltd. (Arbroath, Tayside, UK), notes a greater awareness in the automation sector of the significance of parts feeding in overall production line efficiency. In the medical sector, efficiency is critical, says Davie, adding that output speeds for disposables such as needle sets and inhalers are increasing to 500 parts per minute and faster.

Jean-François Bauer, marketing manager at Mikron S.A. Boudry (Boudry, Switzerland), agrees. "Products are getting more complex, and higher outputs are required," he says. "Our clients are demanding more accuracy, as well as more documentation."

Investing Wisely

"The medical industry used to say, 'Make us an [assembly] line, and we will pay you.' Now, device OEMs, just like automotive manufacturers, are looking for the best price using the best technology," says Bauer. When cost is critical, how does a manufacturer decide which processes to automate? According to Fraede, the three main factors to consider are throughput goals, motion efficiency, and quality requirements.

Others see the decision as a result of production figures. "If a manufacturer is only producing 100,000 to 200,000 parts per year, he can do it manually," says Bauer. "Beyond that, automation becomes an attractive option." Baker of RPS estimates that medical OEMs should expect to recoup their investment in automation equipment over a period of 1.5 years, as a rule of thumb. He adds that some items, such as implantables, are difficult to fabricate without the aid of automation, since manual production produces too much variation.

Certainly, the decision to automate will vary by application. Suggesting that there is no firm rule for the feasibility of such an investment, Davie says that "high volumes of any product with a two-year-plus life cycle must make it a candidate."

While cost reduction has become an important issue, an attractive price tag isn't the only thing that turns customers' heads. "We aim to [deliver systems] weeks or months ahead of our competitors," says Bauer, adding that customer service is an area in which Mikron seeks to add value to its clients' purchases. "We offer a single contact for our customers and provide project management services for up to six years," he says.

Schärli proposes a simple calculus for manufacturers considering the economics of purchasing automation equipment, based on the following factors: equipment cost, personnel costs, throughput, rework costs, and expected volume. But he also cites several other motivations that may drive OEMs to consider investing in automation equipment. "It may even be part of a company's strategy to invest in automation systems with an eye toward future growth, or to use it as a sales argument," he says. "Some orders can be won only if a manufacturer can prove his capabilities regarding production capacity and quality manufacturing," says Schärli, adding that production equipment "strongly influences the image of an enterprise." Furthermore, he notes that in production facilities that are running computer-integrated manufacturing, computer-controlled processes are a must.

Planning for Flexibility

With medical products becoming more complex, Fischer predicts that links between networks of assembly machines will become more important. She also foresees the diversification of laser and adhesive technology used in automatic assembly systems.

Davie, for one, chooses to focus on the human side of automation, envisioning a future where automation suppliers become more active in advising clients throughout the various stages of product design. "We seek to gain a full understanding of a client's requirements and expectations during precontract meetings," he says, explaining that part the goal is to learn about a client's in-house engineering culture and the format of automation that suits the company best.

"In the future, I see a greater exploitation of flexible tools," says Fraede, observing that manufacturers are adopting more mix-and-match solutions that pair automated processes with manual ones. "The smartest companies will look at all the available technologies, evaluate their current and projected production needs, and build flexibility into their system."

The Syfast robotic system, manufactured by Mikron S.A. Boudry (Boudry, Switzerland), is designed to operate as an autonomous unit or as part of an assembly line composed of several cells connected to one another. The system can execute a variety of operations, including insertion, assembly, welding, crimping, greasing, marking, and inspection.

Each Syfast robot cell is designed to execute a fully automated job, such as loading and unloading, assembly, or technical processes. A SCARA robot is fixed horizontally, allowing the entire area beneath the robot to be utilized. An electric cabinet is located behind the robot cell and is placed at operator height for ergonomic access. An industrial PC manages all automated processes, collecting and displaying statistics in real time. A control panel swivels over 180 degrees, providing a clear view of the cell operating data in numerical or graphical form. Grippers—both mechanical and vacuum—are a specialty of the company, and can be equipped with a manual or an automatic tool changer. Each process is inspected using mechanical, electronic, or visual systems. Feeding systems, manual stations, and pallet-transfer systems are also available.

Each Syfast cell is supplied with a supporting frame and protective cowling, as well as computer control and basic software.

A company's closed-loop, servo-driven robot has been configured for soldering, assembly, and testing of medical devices. The Opus robot from Robotic Process Systems (RPS; Liberty Lake, WA, USA) features such options as high-speed optical pyrometry, laser height gauging, force gauging, and machine vision. The robot operates on a Windows NT platform and uses an intuitive menu interface.

Describing the Opus as "a four-axis Cartesian robot with an easily replaceable head," company president Jess Baker adds that RPS can build the robot to operate on any number of axes. "This is a very economical and powerful robot," he says. Recent applications for the Opus robot have included the laser brazing of various medical components and the fabrication of medical implantables.

RPS also manufactures laser marking units for direct part marking, as well as custom factory automation systems for processes such as assembly, coating, packaging, testing, and inspection. The firm has extensive experience in the medical and pharmaceutical sectors. The company's technical staff works closely with clients to provide innovative solutions to process and production needs.

A machine designed for pick-and-place and dispensing operations in surface-mount technology can accommodate up to 190 feeders and has space for a large assortment of components on tapes, sticks, or waffle trays. The CLM9000 can place parts and dispense adhesive or solder paste. Intelligent feeder cassettes can be programmed on-line or off-line and are recognized automatically when attached to the unit. The feeders feature a "drawer" design that reportedly enables them to be reloaded even while the machine is operating, thereby reducing production downtime.

The machine, manufactured by Essemtec AG (Aesch, Switzerland), is suited for the production of medical electronics and includes a noncontact laser centering system. An optional vision system features a built-in component library of ball-grid-array and fine-pitch components. High placement accuracy is achieved by closed-loop control with servomotors and a linear measuring system. A modular design allows for various attachments, such as an in-line conveyor system or a vacuum fixation system for flexible prints.

The CLM9000's built-in teaching camera and virtual-view software allow operators to double-check their placement program before production begins, saving costly mistakes. Product manager Adrian Schärli describes the unit as "the ideal low- to mid-volume production machine for small and medium-size contractors," adding that the machine may also be used for preproduction and prototyping for larger manufacturers. The company recently opened a German office in Zorneding, near München.

"The more challenging the medical or pharmaceutical product, the better," says Silke Fischer, company spokesperson at sortimat Technology GmbH & Co. (Winnenden, Germany). The company specializes in the production of precision assembly systems for the medical and other sectors, and has produced systems for such products as disposable syringes, disposable needles, inhalers, infusion and dialysis sets, dispensing and metering pumps, and catheters.

"The advantage of our production systems is that we don't adapt the product to the standards of our machinery; we operate on a custom basis," says Fischer. The company reports that its machines and feeders can accommodate even the most delicate and minuscule parts, such as 0.25-mm cannulae, with the utmost sensitivity. Holes can be drilled at sizes of 0.005 mm diam, and torque can be detected and measured to an accuracy of 0.005 N.m. The company has built an assembly machine that runs under Class 100 cleanroom conditions.

Assistance is provided for customers undergoing US FDA validation procedures. The company offers qualification services in the areas of design, installation, operation, and performance.

AGR Automation Ltd.

A company designs and builds complex, high-speed assembly systems for medical device components. A range of equipment is supplied, including vibratory and centrifugal feeders, rotary and linear assembly systems, and a variety of proprietary accessories for pick-and place, air-jet, and gripping operations.

AGR Automation Ltd. (Arbroath, Tayside, UK) produces machines capable of carrying out assembly, colour sensing, punching, laser drilling, ultrasound welding, leak and flow testing, part counting, ink-jet printing, and metal forming. Products assembled and processed include syringes, antitamper caps, dispenser tops, insulin pen needles, and blood collection tubes. The firm has designed a machine to drill and process products at 170 parts per minute, and can also lay claim to a unit that packages cannulae at 700 parts per minute. The company's Vibrolock vibration generator is reportedly the quietest of its type in the world. Lawrence Davie, sales and business development manager at AGR, says, "We offer a range of solutions, beginning with the handling and orientation of the parts to be assembled. Successful parts feeding is essential for high-speed automation, which is our other area of expertise."

Services offered to clients include installation, training and commissioning, CE certification, maintenance and refurbishment, and support for mechanical and electrical design.

Swivel-arm turbo SCARA robots are designed for electronic, microassembly, and pharmaceutical applications in cleanroom environments. The SR6 and SR8 robots from Bosch Automation Technology (Stuttgart, Germany) incorporate a suction device to prevent particle contamination. All rotating parts and drive elements are completely encapsulated, and electrical and pneumatic cables run from the sleeve to the gripper.

The Fraunhofer Institute for Production Technology and Automation in Stuttgart has certified the robots for use in Class 1 cleanrooms. The processing speed of the robots is precisely tuned to meet cleanroom conditions, so that flow relationships are influenced as little as possible and workpieces are protected. High positioning accuracy makes the units suitable for projects involving tight tolerances.

Typical applications include laser welding, pick-and-place operations, machine loading, palletizing, and other processes requiring precision movement. Bosch, which reportedly invented the SCARA robot, also supplies cleanroom-grade aluminium profiles that can be used to construct modular frames for assembly systems. Michael Fraede, sales and product manager at Bosch's robot and handling systems department, says, "We try to give manufacturers the ultimate flexibility in designing their production systems."

A company specializes in continuous motion machines for the assembly and testing of small products at high speeds. Lagniel S.A. (Douvres-la-Délivrande, France) has designed more than 25 custom machines for the medical and pharmaceutical industries. Past projects have included an assembly and vision control machine for producing three-component security syringes at 300 parts per minute, an assembly machine for injection pistons that functioned at 60 parts per minute, and a machine for the assembly of medical pouch connectors at rates up to 900 parts per hour. Operations carried out by the company's machinery include punching; ultrasonic and thermal welding; crimping; and leak, pressure, conformity, and functional testing.

Materials processed include glass, rubber, plastic, and steel. Lagniel prides itself on reliable machines, on-time delivery, and tight project management. The company, which can build machinery for use in cleanrooms to Class 100, is certified to ISO 9001.

Pick-and-place applications will benefit from a SCARA robot. The TMB100, manufactured by I & J Fisnar France S.A. (Pontoise, France), can be used for the loading and unloading of parts, and the placement of components, covers, lenses, and caps. A range of both vacuum and mechanical grippers is available, making the machine adaptable to many applications.

The TMB100 can carry a maximum of 5 kg with repeatability of ±0.02 mm. Maximum point-to-point movement speed is 1500 mm/sec. Lines and arcs are quickly interpolated by an on-board 32-bit processor. A secondary processor provides PLC functions, independent of the motion control system, allowing for easy integration with other equipment. The unit can be programmed using a teaching box or from a PC via an RS-232 connection. Software features include palletizing functions for easy setup of pick-and-place applications, block editing commands, conditional branching, labels, and loops. The direct teaching method allows point locations to be programmed simply by moving the robot arm to the desired positions.

Fully automated medical device assembly and testing equipment is designed and manufactured by Tecnoideal S.r.l. (Mirandola, Italy). Basic operations performed by the machines include tube cutting, joining or solvent bonding of components, and coiling and banding of finished product. Typical applications include subassemblies for infusion and transfusion sets, injection point connectors, pump segments, and tubing connectors and caps. Pictured is a unit for the assembly of a drip chamber with filter, spike, air vent, and cap.

Roberta Borsari, marketing and sales manager at Tecnoideal, observes that automation technology must be specialized for use in the medical sector. "Our automation equipment is dedicated to soft and deforming materials such as PVC, polypropylene, ABS, and other medical polymers," she says. "This is very different from processing metal or other rigid parts." She adds that replacing manual stations with automation equipment may make the most efficient use of cleanroom space in medical production facilities.

Tecnoideal designs all of its machine hardware and software. The machines feature a proprietary solvent-dispensing system, and most are equipped with a 100% in-line integrity test, with separation of good and rejected parts.