What are you searching for?

Sign in
Features

Reinventing Assembly Automation

As Suppliers Hone in on Manufacturers' Requirements, Equipment and Processes Get Overhauled

By: Stacey L. Bell

NULL

A worker puts together syringe assemblies at Integrated BioSciences, which has shifted more to contract manufacturing from custom systems manufacturing. Photo courtesy of IBS.

The adage “what doesn’t kill you makes you stronger” is one that custom assembly and automation companies are familiar with. The past four years have been tough on them. Machine builders posted $5 billion in revenues in 2000 but just $2 billion in 2003, reported Richard P. Bodine Jr., chairman of Bodine Assembly & Test Systems in Bridgeport, CT.

“There’s been a massive shakeout in the industry,” he said. “There was a 60% contraction in the industry in the U.S. in the last three years, but with the economy improving slightly, and three and a half years of pent-up demand when projects were canceled or shelved, over the past six months we’ve seen a gradual phase-in to better times.”

During these difficult times, some companies have not only survived but thrived. They have examined their business models, offerings and customers’ needs and reinvented their companies in ways that are likely to benefit their clients.

Take, for example, East Providence, RI-based EFD, a part of the Nordson Corp. It found that many customers were creating combination products—combining drugs and devices such as with drug-eluting stents—and were seeking a “total solution” when designing and producing these products. In response, last year it was united with its sister businesses under the Nordson Life Science Group. The organization evaluates technologies that reside at various Nordson subsidiaries and pulls them together into complete solutions according to a customer’s specific needs.

Integrated BioSciences (IBS) in Harrisburg, PA took another approach. IBS determined in its research that more OEMs would look to outsource product development and manufacturing in the coming years as they try to cut costs and focus on core competencies. As a result, IBS has recently shifted its focus from strictly building automation systems to also becoming a contract manufacturer specializing in automation systems.

Aurora, CO-based Mikron Assembly Technology decided to develop a new line of products under the G05 (short for Generation 05) name. The company realized that when medical device manufacturers develop new products, they don’t scale up from one to 10 million pieces in the first year, which means fully automated systems fail to address lower-volume requirements. To offer a complete solution, Mikron has developed a flexible system that allows for manual assembly first and then shift to semi-automated cells before converting to a fully automated process. The underlying concepts and the assigned project team stay with the product from design phase through mass production, ensuring consistent quality and improved efficiency.

The Case for Automation

One reason why automation equipment manufacturers have faced such a tough time over the past few years is because OEMs, facing economic pressures of their own, have sought low-cost production and assembly processes.

“Automation’s biggest competition is offshore manual production,” said Julie Logothetis, president of Kahle USA in Summit, NJ. “I am often quoting against hand laborers outside the U.S.”

Although hand laborers might be less costly in the short run, Logothetis noted that automation delivers two strong advantages: faster order fulfillment and a significantly higher level of quality and repeatability over the long term. “As we develop more flexible equipment and assembly technology, the easier it is to justify purchasing automated assembly equipment,” Logothetis concluded.

Indeed, several factors are driving the need for automation, added Dan Adlon, vice president of strategic business development for IBS. “The miniaturization of devices is making it more difficult for manual operators to handle and assemble the components, and the addition of electronics in medical devices—in which sensors and motors are being incorporated—require even more complex assembly and testing requirements that are much better met by automation,” he said.

In some cases, automation is a no-brainer—for example, the processing of minute pieces too difficult to handle by hand or when production rates are too fast. In other instances, companies need to determine whether product complexity requires manual labor or automation, said Paul Beduze, business development manager for Mikron. “Each company will have its own rule of thumb, usually based on previous experience, but we generally say that if you’re producing several million pieces per year, have four or more parts to assemble and two or more processes, that product is a good candidate for automation.”

With medical products’ lifecycles shortening, and OEMs requiring faster turnaround times, custom automation and assembly companies are responding by upgrading their designs and systems.

“We try to stay a couple of generations ahead of our customers so that by the time they have a need, we have the solutions,” reported James Kasprzyk, director of global marketing for Machine Solutions Inc. (MSI) in Flagstaff, AZ.

“Five years ago, it might have taken one year to build a custom piece of equipment,” recalled Dennis Dell’Accio, director of marketing for Deringer-Ney Inc. in Bloomfield, CT. “Now it takes six to nine months. With the collaboration tools that have been developed and people better recognizing the importance of designing for manufacturability, we’ve been able to make tremendous gains.”

Dell’Accio noted that web-based collaboration software has become a popular tool. In the past, customers and vendors might mail or fax versions of a design in their attempts to, say, reduce a 15-component product to a five- or 10-component product. In contrast, today’s customer and vendor can simultaneously look at CAD drawings online and remotely make changes on the screen.

 

Versus Internal Resources

Certainly, time is a crucial concern for OEMs. Kasprzyk said his main competition is his customers’ internal operations. He said that MSI has succeeded by ramping up its turnaround times. On average, it can build equipment in six to eight weeks; custom machines average 12 weeks because they involve more development work.

Julian Joffe, president of Pad Print Machinery of Vermont in East Dorset, VT, noted that his company’s biggest investment has been in software. Not only have advances in software improved the equipment, but it also keeps everyone involved in the production process fully updated.

Kahle USA’s Logothetis added that flexibility is a key demand of automated systems today. Modular systems allow manufacturers to make modifications without disrupting other operations within the same system.

Some newer technologies allow OEMs to automate processes. MSI, for example, has automated stent crimping and the pleating and folding of balloon catheters with its patented segmental compression technology. Kasprzyk said just five years ago, doctors crimped stents at tableside and attached them to the balloon. Today, he added, 90% all stents are pre-crimped. In developed countries, that figure may be 100%
An advantage that new machines boast is their ability to meet ever-shrinking tolerances. Within the past year, stents have become .001” smaller, and manufacturers have changed materials. While today’s stents are made predominantly from laser-cut, stainless steel tubing, future technologies include cobalt chromium as well as plastics and bioresorbables. Each material has unique processing challenges, and custom assembly and automation companies have refined their processes to accommodate continuing changes in the area.

Another promising area is microelectronics. Bill Barthel, manager of manufacturing technology development for Plexus Corp. in Appleton, WI, noted that his company is working with flip chip technology, which allows the attachment of integrated chips to circuit boards—completely eliminating the need for other packaging.

“Flip chip technology enhances miniaturization capabilities, and in some cases, performance and functionality of a device,” Barthel noted. “OEMs can find unique ways to apply this technology to their products. It offers miniaturization opportunities that simply didn’t exist before.”

 

Top Business Trends

Custom assembly and automation companies see some common themes among customers.

 

• OEMs are finding new uses for custom equipment that they previously used for other purposes. EFD creates dispensing equipment to bond medical devices such as catheters, stents, balloons and plastic-to-plastic assembly. Recently, customers have started putting other fluids through the valves to dispense polymers, drugs, protein solutions and lubricants to prostheses, test strips, stents and more, reported Nancy Gleason, Nordson Life Science Group manager. “Customers are looking at the overall capabilities of our equipment and finding new uses,” she said.
•  OEMs are looking at how technologies that have produced results in other industries may help them, too. Gleason added that Nordson Corp. pioneered electrostatic technology, in which an electrostatic charge (50 kV-100 kv) is delivered to the fluid being sprayed. That coating is attracted to the grounded object on which it is applied.

Gleason noted that its benefits include lower material costs with maximum material use; reduced labor costs due to high-speed coating capability; good coverage of edges, recesses and hard-to-reach areas; uniform film deposition and reduced rejects.

Originally, this technology was used to apply paint to automobiles and appliances, but medical device companies are now exploring ways to use it for applying precise coatings on devices. Technologies developed for the electronics industry such as high-speed jetting of fluids and surface modification of substrates are also being used by medical device manufacturers.
• Custom assembly and automation companies are incorporating lean manufacturing techniques to provide better service and results to customers. Barthel noted that Plexus uses lean sigma, a combination of lean manufacturing techniques supported by Six Sigma statistical analysis, to drive improvements in its operations.
•  More companies are incorporating automated vision technology into their systems. “Prices for vision technology have declined dramatically over the past few years, allowing more companies to incorporate vision systems into their equipment. We recently built a machine that had 13 vision inspections on it,” reported Dave Carlberg, president of Kinematic Automation in Sonora, CA. Vision systems also have improved, offering better resolution, more differentiation in colors and faster processing speeds.
•  Validation services are now a must. In the past, OEMs would validate custom-built equipment once installed. Today, more automation companies are supplying the documentation required to validate both the assembly equipment and the manufacturing process to facilitate a quicker time to production.
•  Flexibility is key. Custom assembly and automation companies are adding technologies and techniques to help them stay flexible to varying customer demands, and they also offer other services as needed. Deringer-Ney’s Dell’Accio noted that some OEMs may need vendors to provide hand assembly work in addition to automated systems. “You may need nine months to get all the automation designed and built, but the OEM wants parts in four months, so you might have to hand assemble until all of the automation is in place,” he said.
• Thinking globally. Many companies are setting their sights on growth opportunities outside the U.S.

“We believe that contract assembly is where the real growth will be, and most of our investment will be in China as a producer and servicer of equipment there,” said Bodine. “The last industrial revolution is occurring there, and there will never be another one.

EFD’s Ultra 2400 Dispensing Station is among myriad of equipment available for assembling medical devices. Photo courtesy of EFD.

He added that it’s not practical to manufacture special equipment in the U.S. and ship it to China. Shipping time, language barriers, currency fluctuations all pose challenges. More likely, equipment will be installed and serviced from within China. Bodine noted that the vast majority of his customers either have a presence or plan to have one in China within the next year. “We’ll be right there with them,” he said.

Indeed, technologies being developed today keep multilingual needs in mind. For example, EFD’s Ultra 2400 Dispensing Work Station incorporates microprocessor technology with multilingual capability and time control.

“Reduction in the cost of electronics, vastly improved graphic user interface capability and improved global communication capability are great examples of how technology improvements and innovations are able to improve OEM and CM manufacturing techniques and product quality,” Gleason said.

OEMs want a total solution. “Years ago, companies would come to us for help with a current manufacturing issue. Today, they are looking more at the entire product life span and working with us in the initial design stages so that a total solution can be put into place from the very beginning,” reported EFD’s Tom Muccino, global business development manager for core product lines.

Further, OEMs want custom assembly and automation vendors to offer services such as design work and engineering services, said Jim Beretta of ATS Automation Tooling Systems in Cambridge, Canada.

Cost remains a concern. OEMs also are seeking reduced scrap rates in their efforts to cut costs. “It used to be the industry standard to specify a 2% scrap rate,” said Megan Mazzocco, marketing coordinator for sortimat Technology in Schaumburg, IL. “Today, that standard acceptable scrap rate specification has decreased to 1%.”

 

As medical OEMs look to automate more of their production processes, they are driving vendors to push the envelope in design and technology. Bodine Assembly & Test Systems is among many vendors supplying automated systems for assembly and testing of medical devices. Photo courtesy of Bodine.

Market Demands Change

Faster is better. To a large extent, the market, not technology, is driving the need for faster turnaround times due to shorter product lifecycles and increased competition, noted William E. Bodine, president of Bodine Assembly & Test Systems.

“Production equipment builders and manufacturing services providers have had to shorten engineering cycles and standardize more modular approaches,” he said.

Bodine added that projects completed today differ from those managed even five years ago. In 2000, a large project would have taken months longer to engineer and build and would have involved less crossover of the engineering team. Today, vendors are more involved, initially, and the customer is more involved throughout the design and build, he pointed out.

Advances in technology and new business models have positioned custom assembly and automation companies for brighter days ahead. As technologies continue to improve, processes that can be performed only manually today may become automated in the future.

IBS’ Adlon cautioned that OEMs “should be careful not to get caught up in the thinking that you must use every new technology. You must consider whether a technology really fits with your application.”

Experts also advise medical OEMs to make sure their selected partner thoroughly understands medical industry validation and testing standards.

Thorough knowledge of medical industry standards, coupled with innovative thinking in custom assembly and automation, will lead to better days ahead for both OEMs and vendors.

About The Author

Stacey L. Bell is a Tampa-FL-based freelance writer who specializes in business and marketing issues.

 

 

Keep Up With Our Content. Subscribe To Medical Product Outsourcing Newsletters

Topics