Edward Kensik09.07.06
Automation Snatches OEM Business
Relieving Time and Price Pressures Attracts Medical
Device Manufacturing to Assembly and Automation
By Edward Kensik
While many processes in medical device manufacturing continue to employ manual labor, the beat of assembly and automation gets increasingly louder when it comes to equipment used to build medical products. In both the United States and abroad, manufacturers of automated machinery have seen a growing push from OEMs to incorporate this equipment into their operations.
The Catheter Laser Bonder LB750S, an automated pneumatic segmental gripper, is a handling system that automatically grasps the product for processing, which allows for a quick and easy loading and unloading of the machine. The handling system is capable of continuous rotational motion. Photo courtesy of Machine Solutions. |
As medical device companies continue to churn out a plethora of new products in today’s all too common speed-to-market race, builders of automated and assembly equipment find that they are benefiting from the flurry of activity.
And the movement toward automation will only keep flourishing, industry experts predict.
“Automation is being pressed into as many elements of manufacturing as possible,” said Matt Dingledy, IT administrator for Columbus, IN-based Makuta Technics, a contract manufacturer of precision micro-molded parts. “We continue to increase automation of our in-line part-monitoring devices as our machine manufacturer develops more sophisticated process monitoring technology.”
When it comes to automation, medical device OEMs find the benefits are numerous—quality, consistency, trackability, predictability, low cost, efficiency, verification and high capacity—and it’s not surprising that, as OEMs and others share tales of success, the providers of automated equipment are seeing business pick up more than ever.
Perhaps lower cost and higher quality are the biggest drivers fueling the industry’s desire for more automated assembly. Echoing other industry experts’ opinions that automation offers highly repeatable results, David Carlberg, president and co-founder of Sonora, CA-based Kinematic Automation, said, “With the human element out of the picture, there is much less chance for fatigue or inattention-related errors, etc.”
Quality Still a Top Driver
Modern manufacturers are finding that one of the best advantages automation offers is that FDA standards for compliance are more easily upheld—including in the cleanroom.
“The injection molding process has several inherent concepts that create an unclean environment in the area below the mold,” said Dingledy. “Automatic de-gating of parts releases small amounts of debris, lubricants can contaminate collection devices and any debris from the injection molding machine can contaminate parts. These elements make a hazardous environment for typical part drop collection. In these controlled conditions, extracting the part robotically from the side or from above the mold becomes necessary.”
A Kahle catheter tubing assembly machine is shown complete with ultrasonic hole punching and tip finishing. Photo courtesy of Kahle USA. |
Bob Coran, customer relations senior account manager of Schaumburg, IL-based sortimat, agreed, noting, “Automating production ensures a higher level of quality, repeatability and ‘validate-able’ processes than manual labor.”
For Carl Martin, CEO of Millersburg, PA-based Advanced Scientifics, the “repeatability” factor is one of the top reasons med-tech companies are moving to operating in automated environments. “Removing the human factor improves product repeatability,” he explained. “Technology has advanced, achieving immediate electronic maintenance of production—making it simpler for the FDA to audit.”
He added that automation can allow an OEM to integrate the inspection process, and electronic upgrades allow the customer to chart production quality for easy auditing.
Success Brings Challenges
While automation provides a multitude of benefits, one of the biggest challenges for providers of automated equipment is that which most of the industry finds daunting: increasingly shorter lead times.
For some companies, the lead times are between four to eight weeks (or even less) for new products. And companies that are switching the manufacture of a mature product line to automated equipment face similar time pressures.
A semi-automatic assembly cell assembles various medical devices. Right, syringes are being assembled. While automation continues to grow, there are some products that can not be fully automated. Photo courtesy of Integrated BioSciences. |
“Our customers are trying to go to market faster,” said Scott Thompson sales and business development manager for Technical Innovations in Brazoria, TX. “Four to eight weeks is not a very long time, but that has never been an issue for us.”
Although his company has a can-do attitude, Thompson still noted that most customers are understanding about the length of time it takes to make customized equipment.
One company’s solution to ensuring that tighter lead times are met is called “horizontal partnerships.” In this scenario, according to Dan Adlon, vice president of strategic business development for Integrated BioSciences in Lewisberry, PA, specialty firms handle these issues but not the manufacturing itself. “For faster response, we have developed standard equipment platforms and lean cells to minimize the time required to design and build automation,” Adlon explained.
Along similar lines of shrinking lead times, scheduling is another challenge. “Too frequently, the customer consumes all of its schedule in deciding what it wants to do and doesn’t leave enough time for the equipment provider to develop the equipment,” explained Carlberg. “Rushed schedules generally mean higher costs and more problems along the way. The industry doesn’t seem to understand that it takes many, many months, or even a year or longer, to design and build complex machine systems.”
When it comes to the machinery itself, non-standard and inconsistent designs also can present challenges to suppliers, according to Mike Terry, global sales manager of Plantation, FL-based AccuPlace. Therefore, AccuPlace offers standardized equipment that requires little custom tooling. “We also offer a leasing program that allows our customers a no-risk lease of the machine,” said Terry. Such offerings can particularly aid smaller startup companies that have tight budgets.
Another company that has been developing creative solutions to serve customers better is sortimat. Multitask design, standard platforms that can be customized and strategic alliances with vendors to assure purchased components are crafted perfectly and arrive just in time are just a few of the company’s tactics for alleviating time crunches, according to Tom Kramer, president of sortimat, a manufacturer of assembly systems for OEMs.
As the medical device industry innovates with new technologies, the OEMs’ selection of materials can present a challenge to their automated equipment supplier. “Delicate membranes, flimsy soft materials, flexible tubing etc…all offer feeding, handling and fixturing challenges not often encountered in more traditional automation projects,” said Reszetylo. She believes that her customers would benefit from including automated machinery suppliers from the get-go in the project—as early as the R&D stage.
Of course, today’s suppliers are working toward innovating their own industry by challenging themselves to come up with even better equipment than what’s currently offered. Machine Solutions is one such company developing faster, more reliable equipment that is easier to maintain and validate, according to James Kasprzyk, director of global marketing for Flagstaff, AZ-based company.
While the product runs have become more flexible—as the medical devices themselves become more complex—the machinery manufacturers are devising more standardized equipment that can easily be customized. Suppliers have found that flexibility is key to serving their customers.
“We have tried over the last few years to get a little more standardized in our base level machine, so we can customize a more standard product with custom options as opposed to building a fully customized machine,” said Thompson, adding that Technical Innovations integrates several forms of capabilities into its standardized machinery. “Some customers might not use all of the capabilities of equipment, but the capabilities are there because it is easier to build everything upfront than it is to try to build specialized features for each individual machine.”
Importance of Communication
In spite of the challenges facing today’s automation providers, companies nonetheless are confident about the benefits their equipment offers customers. However, for the machinery to be optimally implemented, equipment providers believe the strength of the relationship between them and their customers is an integral part of ensuring success. In other words, clear communication is essential.
A slitting and vialing system is shown for blood glucose strips capable of producing up to 120,000 strips per hour including 100% machine vision inspection. The number of strips per vial is programmable. Photo courtesy of Kinematic Automation. |
Indeed, the marriage between the two parties is very important, as suppliers such as Carlberg describe the automation industry as a business that feeds off relationships.
“There must be a high level of trust and commitment between the customer and equipment provider,” said Carlberg. “It’s like a marriage and really must be treated as such for there to be a high level of success. Any sophisticated equipment is like a car—it needs care and maintenance.”
While customer support in the form of good communication is essential, machine companies have found that their own internal communication must be top-notch as well. “I think what is more important is our communication internally as we grow as a company,” said Kasprzyk, who additionally noted that he finds it particularly important for sales staff outside the United States to keep up the lines of communication with the main office to ensure that the company’s operation and engineering teams are informed about any developments as soon as possible.
A Fully Automated Future?
In the past, a manufacturer typically needed to have to run millions of pieces to justify the use of automated equipment. While that’s no longer the case, the decision to invest in automated equipment isn’t necessarily clear-cut.
“The issue is not easy to define,” said Adlon. “[However,] there is a simple equation of labor verses capital investment and payback period that most people use to determine when to automate.”
One factor many companies examine is the cost of scrap and rework. “Depending on the assembly, if there is a high scrap rate in hand assembly, this may add justification for automation,” said Adlon.
Another consideration in evaluating the need for automated equipment is the medical device itself. Not all medical products lend themselves well to automated manufacturing and assembly. For example, stents and catheters are two items that will take time—if it ever happens—to get to an automated production process, according to Kasprzyk.
“There are a few inspection stops and things in between for different processes. Some of those are automating into our equipment, whereas other manufacturers choose to do it at a separate stop as part of their process,” said Kasprzyk, whose company’s main concentration is those two products.
Nonetheless, the future of assembly and automation is bright, as more processes are being driven by lower costs and quicker time spans.
“Automation and assembly will experience continued growth,” predicted Paul Nordin, senior project manager and section head at sortimat. “The once low-cost countries are seeing rising labor and energy costs. Some of the newer medical devices and diagnostic products will require new automation concepts and technologies.”