The Time is Now

Ford Motor Company founder Henry Ford once said, “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.”


Making an initial upfront investment, even during a global recession, is a good business strategy for

 

companies that focus on automation and assembly, according to Al Neumann, automation manager at Somerset, Wis.-based SMC Ltd., which offers contract manufacturing and molding services for medical device firms. “Cost is always a factor, and perhaps on smaller projects, manual jigs and fixtures may be adequate, but we have found that well-designed automation improves quality and reduces scrap rates,” he said.

Julie Logothetis, president of Summit, N.J.-based Kahle Automation, which specializes in assembly machinery, agrees the investment is a good idea in the long haul. “You can run a machine for up to 30 years, and each has a profit attached to it,” she said, adding that payback, in some cases, can be seen in as little as six months.

Some companies are able to make that investment immediately, but the economic downturn has caused others-particularly small medical device manufacturers-to put off such an investment.

Automating repetitive processes can improve quality and reduce scrap rates, ensuring a more repeatable result for OEMs. Photo courtesy of SMC Ltd.

Dave Schiebout, president and founder of Minneapolis, Minn.-based Delta Industrial Services, which designs and manufactures motion controlled web converting and packaging systems, sees this as a time for entrepreneurs to shine.

“There is strong culture from mom and pop to major corporations who are moving entrepreneurially,” said Schiebout. “People are planning to get by this [recession], and just keep going,” he added.

While the trend for the last several years has been for some medical device manufacturers to shift a portion of manufacturing overseas, that doesn’t seem to be the case with automation and assembly.

Rudy Pavlik, molding product development manager at the Millersburg, Pa., headquarters of Advanced Scientifics, which is a contract manufacturer that specializes in medical disposables, said

“Customers are ordering only at the point of need, and they are keeping their inventory to a minimum. A U.S. manufacturer can offer quick turnaround service. This kind of arrangement puts pressure on the manufacturing side to keep up with the on-time demand. Advanced Scientifics has an excellent reputation in the industry to provide such service with three weeks delivery time from the date of the purchase order with sterilization included.

Pavlik added that even though customers are waiting longer to order, it appears there hasn’t been a reduction in overall work. “‘Turnkey’ service Advanced Scientifics offers brings the additional value our customers are looking for,” he said.

Logothetis believes companies want more control. “They will outsource domestically. It keeps jobs here in the United States,” she said.

Besides longer gaps in order placements, automation and assembly managers have noticed a trend among foreign companies to outsource automation work with U.S. firms, according to Vasko Naumovski, products manager of Herrmann Ultrasonics’ plastics division.

Medical devices is one of the second strongest markets for the Bartlett, Ill.-based manufacturer of high-end ultrasonic welders.

“We get requests from customers in Mexico. We have seen some medical device customers in other countries asking for automation or looking to automate,” he said. When asked for a reason, he responded, “I think they need to be globally competitive as well. I think countries that have lower costs of labor and manufacturing, those markets are trying to be even more competitive, especially as far as medical devices go.”

Lori Pegon, spokeswoman for Eagleville, Pa.-based Inteprod, agreed with Naumovski. Inteprod is a supplier of design, development, contract manufacturing and assembly services for products in the medical device, medical diagnostic, food safety diagnostic and pathogen detection industries.

“The low value of the dollar and the continual quality issues and IP [intellectual property] concerns in outsourcing to China and other high production, low-cost foreign manufacturers has created more international interest in outsourcing to the U.S. More domestic companies are also opting to keep their manufacturing in the U.S.,” Pegon noted.

 

What Customers Want

Automation companies also are finding that customers’ demands have not changed. “There has always been the ongoing trend to make products faster and improve the quality and controls of the equipment. We’re building a machine now that’s 1,300 needles a minute,” Kahle Automation’s Logothetis said. “The theory is, if you can do it manually, you can do it automatically.”

Pegon said processes and technologies that would benefit from automated assembly include processes that require chemical and/or pharmaceutical integration; high volume, repetitive assembly processes (packaging, disposables, circuit boards, mass produced diagnostic analyzers); electronic assemblies and printed circuit boards; system testing; cleanroom assembly processes requiring a sterile and more controlled environment; and miniaturized component assembly, including micro and nano technologies.

Industry experts said OEMs are constantly concerned about the quality of their outsourcing partner’s product. “I believe the demand for more complex assemblies, with higher quality demands at reduced costs will continue. Automation that completes a routine process or verifies a human touch operation, ensures a more repeatable result for the OEM,” Neumann said. “Automating operational functions doesn’t necessarily reduce the work force. It can instead utilize human skills sets in better, more efficient ways,” he added.

Companies must use highly skilled workers to support automation and pay them a competitive wage for their knowledge. “People supporting automated equipment have to be highly qualified individuals,” Pavlik said.

Since technology is so important, it is always improving, Naumovski said.
 

Emerging Technology

To meet customer demand for faster throughputs, Herrmann Ultrasonics introduced a new generation of ultrasonic welder in June called the HiQ Evolution. “Using automatic start-triggering, the operator

The initial investment in automation equipment is well worth it, according to industry executives. Photo courtesy of Kahle Automation.

can load the part into the machine, and when they clear the light curtain, the welder will start automatically. This frees up extra time for the operator to inspect the parts or go to the next station,” said Naumovski. “We have also mounted actuators on mechanical cam-driven systems, so the stroke or the movement of the welder can be done a little more rapidly. “

He also has found that injection molding machines are a good match for automation.

“Automated work cells interfaced with injection molding machines work well. Building equipment with modularity in mind helps to ensure the machinery will be as flexible as possible, adapting to produce changes,” Naumovski said.

Naumovski also is seeing an increased use of modular work cells because they allow more flexibility in automation. “Our process is very easily integrated and very easily adapted to automation. A product that can be bowl fed is easily adapted to automation. It’s fed, it’s welded and then downstream, it’s tested with a leak tester or other method of testing. Medical devices in general, I think, are easily integrated into high-volume production,” he said.

Pavlik also has noticed a trend for more modular systems. “The automation industry,” said Pavlik, “is constantly evolving. I see a trend of more modular systems in the automation. The advantage is more flexiblity in making the automation always tailored to the product even if the product changes.”

Delta Industrial is integrating laser more and taking full advantage of the Internet, according to Schiebout. “It’s getting more secure from the standpoint of providing service online,” he said.

Pegon, at Inteprod, said the use of robotics has increased dramatically. “In automation, robotic systems can perform repetitive tasks that require increased accuracy, precision and sterile conditions to effectively reduce the potential for system error,” she said.
 

Advantages and Challenges

Quality is a major advantage in auto-mation for assembly, according to some industry experts. “If the project size justifies automation, the additional value of productivity and quality makes automation the easy choice,” said Pavlik.

One of the major challenges automation firms face is meeting regulations that medical device manufacturers must follow.

Herrmann Ultrasonics has created a new login system on their automation machines to keep a history of manufacturing for the equipment.

“We ourselves don’t deal with any types of regulation, but our customers do. One regulation that we’ve tried to help our customers with is 21 CFR Part 11 [login and traceability],” said Naumovski. All of the company’s machines have user names and passwords for each machine operator, allowing the machine to trace the history of the manufacturing process.

The U.S. Food and Drug Administration’s (FDA) 21 CFR Part 11 requires implementation of a standard development procedure for the database configuration.

Pegon said automation definitely has quality implications and requires quality inspection checkpoints to ensure there is conformity to the approved specifications.

“Medical devices must follow and meet FDA regulations that dictate the control of processes and procedures. Medical devices, whether produced via automation or assembly, must show evidence of conformity to the approved, required specifications,” she said.
 

The Future of Automation

Looking into their crystal balls, automation industry executives predict more large automation companies in the future and fewer smaller ones.

“Something that I’ve seen is it seems that in years past, there were many more smaller automation

Automation work cells that interface with injection molding machines can be cost effective and flexible to adapt to various product changes. Photo courtesy of SMC Ltd.

companies, but now the market seems to be dominated by larger automation companies. In the future I think there will continue to be more larger automation companies instead of many smaller automation companies,” said Naumovski.

Pavlik said keeping up with technology is the key to the future. “All aspects of automation are constantly changing. Just the PLC as one of the typical items used in automation is making tremendous progress from year to year. They are more user-friendly and less expensive,” he said.

Pegon said increasing flexibility and reducing costs always will be very important to manufacturers.

“For low volume and customized medical products, the risks associated with automation in terms of cost and time investments, and the potential for clients to unexpectedly stop or reduce production are too high for small and growing companies. Manual assembly processes greatly reduce the upfront costs of automation equipment and highly skilled personnel. It also allows growing companies more control and flexibility in adjusting production volumes and staff as needed,” she said.