The Automation Equation

The Automation Equation

Assembly and automation continue to play a key role in cost reduction and process improvement.

Mark Crawford • Contributing Writer

Five years ago, Machine Solutions Inc.’s customers were pleased with a simple programmable logic controller (PLC), push-button, human-machine interface (HMI), and moving away from pneumatic motion toward servos. Today, however, things are different.

“Customers are specifying higher levels of automation, process control, and process data networking in order to eliminate the operator from the product quality equation,” said Jason Cronwall, director of global marketing for Machine Solutions Inc., a Flagstaff, Ariz.-based global supplier of assembly and automation equipment for manufacturers of balloon angioplasty and stent/graft delivery devices.

“They want machines where the operator simply dumps parts into one side of the machine and gets fully processed/assembled product on the other side with data about the process streamed to a network location for quality assurance purposes,” he continued. “They want multiple levels of password protection and functionality access, calibration data logged, etc. Developing and building today’s machines requires a totally different team of engineering talent.”

A robust automation work cell combines on-the-floor manufacturing knowledge with creative thinking and state-of-the-art technology to drive a solution for the OEM. Photo courtesy of SMC Ltd.

OEMs also are designing smaller, more complex devices that they want produced at lower cost, without jeopardizing quality.

“The challenge,” said Gordon Udall, medical product manager for Amphenol Medical Solutions in Brockton, Mass., a manufacturer of connectors, cable assemblies, and custom interconnect solutions for the medical device industry, “is that as components shrink in size they require more precision handling, which drives the need for more automation.”

As automation is implemented, medical device companies require a strong commitment to installation qualification, operational qualification, and performance qualification validation, followed by process control and change control, experts noted.

“Once we have established statistically that the automation equipment is installed properly, operates properly, and the process is repeatable and reliable, we then need to demonstrate we can maintain these results and will not deviate or change the process in any way without the customer’s approval. Although this is an intensive, and often time-consuming process up front, the results of consistent, high-quality product off the line make the investment worthwhile,” said Udall.

As OEMs shorten their supply chains to improve quality control and process validation they continue to look for contract manufacturers that can manufacture, assemble, package, and sterilize products under one roof, thereby reducing their supply chain management costs and boosting productivity and profitability.

“Customers are seeking to move mature product lines out of house to free up floor space for newer products,” added Rudy Pavlik, medical device manager for Advanced Scientifics in Millersburg, Penn., a provider of complex multi-component device assembly, testing, packaging, and sterilization services for medical device firms.

“As a result, CMOs (contract manufacturing organizations) are expanding their assembly and automation to comply with the requests for cost-effective, high-volume manufacturing.”

For example, Machine Solutions Inc. is investing heavily in enhancing its proprietary software platforms in order to address customer demands for higher levels of automation and data networking capabilities. The latest projects incorporate PLC controls with PC HMI, color vision systems for feature detection, simultaneous processing of multiple parts, and post-processing inline inspection.

“Compared to a very manual setup, a highly automated machine configuration can cost up to five times as much,” said Cronwall. “We also hold regular design reviews with customers to assure the machines we deliver meet their requirements/specifications.”

Quality Is a Driving Force

OEMs are asking contract manufacturers for faster speed to market, zero defects, and reduced labor costs. The U.S. Food and Drug Administration (FDA) also is pushing medical device manufacturers to a higher degree of supplier quality management, which is being passed down to sub-assembly providers such as Amphenol Medical Solutions.

“We, in turn, are ramping up our controls of our suppliers and asking them to do the same,” added Udall. “For example, we recently had to work with one supplier to implement tighter statistical process controls to a process that has produced parts flawlessly for decades.”

Interface Catheter Solutions, a Laguna Niguel, Calif.-based manufacturer of balloon catheter and testing equipment for medical device companies, is receiving more requests for automation within its equipment offerings and is now developing several upgrades to the equipment functions for automation.

“This is primarily with PLC controls and proprietary software programming that defines the equipment operation and reduces actual operator intervention,” said Juan Pomares, special projects manager. “For example, once programmed, an operator simply loads and unloads as needed.”

Interface Catheter Solutions uses its own proprietary equipment for balloon production and continually makes enhancements to equipment efficiency and streamlining production throughput.

SMC Ltd., a medical custom contract manufacturer for the pharmaceutical, orthopedic, cardio, and device markets in Somerset, Wis., has its own in-house automation department to serve medical customers. The company provides a variety of operational solutions, ranging from vision-guided robotic assembly work cells to simple assembly aids, gauges and testers.

“Robust work cells provide reliable verification of dimension and assembly,” said Al Neumann, SMC’s automation manager. “Having in-house knowledge about highly sophisticated technologies helps us provide work cells that integrate multiple secondary operations like sonic welding, pad printing, laser etching testing, and verification into one work cell.”

As an example, Neumann cited a finished product cell that was designed and built to meet the customer’s product requirements.

“This work cell provides 100 percent test inspection and verification of the product functions,” he said. “Within this same cell we are also able to complete the labeling of the product including single component traceability. On another project we have improved the value stream throughput of the finished product by over 20 percent, with a product volume of 50,000 devices a year.”

By shortening the supply chain, OEMs also are intent on finding suppliers and manufacturers who can perform more in-house functions—including assembly and automation.

“More of our customers are looking to partner because we are able to provide assemblies that combine multiple materials including thermoplastics, silicone, and rubber,” stated Mark Brandstaetter, vice president of sales and marketing, for MRPC in Butler, Wis., which specializes in clean room molding, with a focus on silicone molding, two-material molding and micromolding.

Contract manufacturers also are reporting projects for medical device companies are increasing in their complexity.

“We have seen an increase in discussions regarding automation at the concept or design phase,” said Neumann. “Having a dedicated in-house automation group allows us to get involved during the conceptual phase of a new product, which can often lead to a part design that lends itself to better manufacturing process, allowing the OEM to see the benefits associated with automation.”
SMC creates custom complex work cells that eliminate the amount of routine manual labor involved, allowing the company to move its operators to areas that need a more hands-on approach.

“Our automation engineers custom build the equipment to fit specific programs,” Neumann continued. “This allows us greater flexibility in the equipment as well as the ability to respond in the needed timeframe for a project. It is far more involved than purchasing off-the-shelf equipment and putting it next to a molding press. We create solutions to solve a problem the customer may not even know he has by combining on-the-floor manufacturing knowledge with creative thinking and state-of-the-art technology.”

Competing with the World

Globalization drives the need for more efficient, lower-cost assembly in the United States—which means more automation. There are, of course, many benefits associated with U.S.-based manufacturing, including the elimination of language and time differences, more economical travel, and closer interaction with an OEM’s research and development group. Reducing labor costs through automation is the one big step that makes U.S. manufacturing more competitive with offshore locations.

“Eliminating repetitive tasks through automation certainly reduces labor costs and improves efficiency and quality,” said Neumann. “This allows us to deliver high-quality parts while adhering to cost-reduction requirements. When it makes sense for the customer to utilize outside U.S. manufacturing, SMC can provide automation and specialty fixtures to our global sites.”

“As a global organization, we also have the option to utilize low-cost countries for manufacturing,” added Udall. “In some cases our customers are moving their assembly to these countries and we are poised to follow them as needed. However, to service the North American market, we do what we can to keep manufacturing on this side of the ocean and automation or semi-automation is part of the equation.”

Advanced Scientifics has opened an ISO 13485-certified plant in Mexico that provides low-cost, custom-built assembly services. “The personnel are trained at our U.S. facility and our Mexico plant can provide the same manufacturing capabilities with a lower labor cost,” said Pavlik. “For each project, we use a spreadsheet to determine the most cost-effective methods of manufacturing and assembly for each individual project—the higher the volume, the greater the need for automation.”

New Technologies

Customers with automated assembly projects usually are most concerned about monitoring and insuring quality. Visual, dimensional and functional testing within the automated system needs to be provided. Advances in optical measurement equipment have allowed manufacturers to replace operator visual inspection with more repeatable and robust methods along the line.

“By utilizing such equipment, we have been able to replace manual human inspection methods which are less than 90 percent effective with precision optical methods that allow us to eliminate non-effective labor and improve the quality of products received by our customers,” said Brandstaetter.

High-speed automated optical inspection systems can be custom-designed for whatever steps the project requires. A full gantry configuration typically allows the camera to move over the parts across a range of distances, rather than having a system that moves parts past a stationary camera. Resolution can be as precise as 0.1 micron. Inspection and measurement programs are easy to build and modify using an intuitive graphical user interface. Other capabilities include color verification, defect detection, pattern matching, high-accuracy measurements, object counting and sizing, and assembly verification.

“Although most of our assembly is not automated, we do utilize automation in the fabrication, placement, and inspection of our electrical contacts, which are the heart and soul of our connectors,” said Udall. “Our focus is on higher-density terminations. We need to get more signals into a smaller space at a lower cost. This is where assembly and automation has its advantages. We are using special high-resolution, fully automated vision systems capable of making pass/fail decisions based on real-time variable data in our contact manufacturing and assembly processes.”

Interface Catheter Solutions’ new automated balloon visual inspection system (BVIS) provides both visual inspection and dimensional measurements of medical balloons in a single operation. Inspection includes classification and size of defects with pass/fail analysis based on user-selected criteria. The system operates with a sophisticated vision system and analysis program with an intuitive user interface.
“We can identify and classify visual defects and particulate contamination of manufactured balloons to a fine degree,” said Pomares. “The system also measures the width size of defects as well as the distance between them. The user can select the visual inspection criteria for size and type of defect for an automatic pass/fail report. The BVIS also provides balloon dimensions such as length, width, cone length, cone angle, and neck outer dimension.”

Self-learning robotic systems that are being developed by leading companies such as Barrett eventually will have a big impact on automation and assembly systems. Barrett is well known for its advanced robotic graspers, a type of multi-fingered, multi-jointed robotic hand that does more than simple gripping. Robotic engineers are hard at work developing robots that actually learn from their own interactions with the environment, allowing them to perform independently of mechanical force or torque sensors with impressive dexterity and speed—such as Barrett’s WAM Arm, a naturally backdrivable manipulator with direct-drive capability.

Keeping Costs Down

Contract manufacturers are intent on providing OEM customers with the best possible value for the customized solutions they create. An easy first step for adding value is application of lean principles. Lean is an ongoing process that removes waste from manufacturing processes, improving efficiency and reducing costs. (Editor’s note: For more information on Lean manufacturing, see this month’s feature on page 52.)

“Through the use of Lean principles we have implemented very simple tools to simplify, organize, and optimize some of our equipment assembly processes,” said Pomares. “We started with the implementation of the 5S principles (sort, straighten, shine, standardize, and sustain). This organized the workstations so that only the tools that are needed are there when the workers need them, and in the right quantities. We also reorganized the flow of the assembly workstations so all the operations flowed easily around the room. This sort of visual management allows for easy and efficient floor management.”
Amphenol Medical Solutions incorporates value-stream mapping and kaizen events (rapidly implemented, short-term improvements) to help eliminate waste in the company’s processes.

“At the same time,” said Udall, “we are evaluating various capital equipment options that will help reduce the manual labor associated with connector assembly and cable termination.”

As a cost-saving measure, Advanced Scientifics is considering modular assembly systems that are easily convertible for the next-generation product within the same product family.

“This would involve using more standard/generic automation sub-systems versus custom items,” explained Pavlik. “Examples would be modular wedge systems like Demco Automation or Bosh pallet systems.”

Demco’s technology is centered on the “wedge,” a pie-shaped tooling plate that includes a controller, wiring, valve manifold and input blocks. Preconfigured wedges are available for different manufacturing processes such as pick-and-place, dispensing and marking. An individual wedge can operate alone as a tabletop station or, when plugged into a standard chassis, can perform as a benchtop, rotary indexing, or in-line model. The Microsoft Windows-based PLC programming utility allows the operator to simply check boxes for designated inputs and outputs, easily configuring the wedge station to the project’s requirements. Because it is modular, this technology can be designed to work from a prototyping scale through full-scale production.

Bosh pallet-based conveyor systems are divided into three categories based on pallet size and item weight. Each system is a work-piece pallet-based, non-synchronous conveyor designed to improve manufacturing productivity and product quality while providing maximum assembly flexibility. Conveying media consist of belt, flattop chain, or roller chain that can support a wide variety of pallet sizes. Work-piece pallets ride on twin strands of conveying media, which are contained in two T-slotted edge rails. This arrangement leaves an open center suitable for transfer, positioning, orientation, and work processing modules. Controlled sliding friction propels the pallets along until encountering a stop gate or another pallet. Pallets can slide on the low back pressure transport media and accumulate to provide non-synchronous cycle operation.

Because the components are pre-engineered and modular, they can be assembled according to the needs of the project. A pallet-based conveyor system can be reconfigured or relocated easily as production needs change. The system also can be expanded as time and budget permit; for example, start with a simple conveyor for basic assembly and expand into a fully automated, progressive assembly system later.

Parting Thoughts

Many tasks can be automated to some degree and OEMs realize there is a strong advantage to partnering with suppliers that utilize assembly equipment. After all, as famous automaker and industrialist Henry Ford observed, “If you need a machine and don’t buy it, then you will ultimately find that you have paid for it, but don’t have it.”

It’s rare that increased automation and control yield a lower initial capital outlay.

“The investment, however, is needed for customers to enjoy the benefits in terms of improved yields, reduced assembly/production staff, and enhanced compliance data,” said Cronwall. “It is not uncommon for customers to target higher-level automation to reduce staffing demands for a particular process by 50 percent or more.”

Pavlik pointed out that comparing the cost of an assembly with or without automation is not enough. “You must also make sure you have the staff to monitor and troubleshoot the equipment on all shifts,” he advised. “It definitely takes a specific skill set.”

Neumann agreed. “We create jobs by eliminating repetitive tasks through automation,” he said. “A robot, for example, may remove parts from a plastic injection molding machine and present those parts to a work cell that decorates, sonic welds, heat stakes, or tests the molded piece. Through automation we have removed many of the mundane and sometimes unskilled tasks from our facilities and retrained our employees to perform inspection and assembly tasks that may be too costly to fully automate, given the project’s volume. The need for a more technically trained workforce will become increasingly evident as even small to midsize companies automate. It’s important to get the word out to kids in high school that job opportunities will increase for those trained in electro-mechanical fields as companies incorporate automated work cells.”